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  1. Nerve growth factor improves visual loss in childhood optic gliomas: a randomized, double-blind, phase II clinical trial.

    PubMed

    Falsini, Benedetto; Chiaretti, Antonio; Rizzo, Daniela; Piccardi, Marco; Ruggiero, Antonio; Manni, Luigi; Soligo, Marzia; Dickmann, Anna; Federici, Matteo; Salerni, Annabella; Timelli, Laura; Guglielmi, Gaspare; Lazzareschi, Ilaria; Caldarelli, Massimo; Galli-Resta, Lucia; Colosimo, Cesare; Riccardi, Riccardo

    2016-02-01

    Paediatric optic pathway gliomas are low-grade brain tumours characterized by slow progression and invalidating visual loss. Presently there is no strategy to prevent visual loss in this kind of tumour. This study evaluated the effects of nerve growth factor administration in protecting visual function in patients with optic pathway glioma-related visual impairment. A prospective randomized double-blind phase II clinical trial was conducted in 18 optic pathway glioma patients, aged from 2 to 23 years, with stable disease and severe visual loss. Ten patients were randomly assigned to receive a single 10-day course of 0.5 mg murine nerve growth factor as eye drops, while eight patients received placebo. All patients were evaluated before and after treatment, testing visual acuity, visual field, visual-evoked potentials, optic coherence tomography, electroretinographic photopic negative response, and magnetic resonance imaging. Post-treatment evaluations were repeated at 15, 30, 90, and 180 days Brain magnetic resonance imaging was performed at baseline and at 180 days. Treatment with nerve growth factor led to statistically significant improvements in objective electrophysiological parameters (electroretinographic photopic negative response amplitude at 180 days and visual-evoked potentials at 30 days), which were not observed in placebo-treated patients. Furthermore, in patients in whom visual fields could still be measured, visual field worsening was only observed in placebo-treated cases, while three of four nerve growth factor-treated subjects showed significant visual field enlargement. This corresponded to improved visually guided behaviour, as reported by the patients and/or the caregivers. There was no evidence of side effects related to nerve growth factor treatment. Nerve growth factor eye drop administration appears a safe, easy and effective strategy for the treatment of visual loss associated with optic pathway gliomas. PMID:26767384

  2. Efficacy of repetitive transcranial magnetic stimulation with quetiapine in treating bipolar II depression: a randomized, double-blinded, control study

    PubMed Central

    Hu, Shao-hua; Lai, Jian-bo; Xu, Dong-rong; Qi, Hong-li; Peterson, Bradley S.; Bao, Ai-min; Hu, Chan-chan; Huang, Man-li; Chen, Jing-kai; Wei, Ning; Hu, Jian-bo; Li, Shu-lan; Zhou, Wei-hua; Xu, Wei-juan; Xu, Yi

    2016-01-01

    The clinical and cognitive responses to repetitive transcranial magnetic stimulation (rTMS) in bipolar II depressed patients remain unclear. In this study, thirty-eight bipolar II depressed patients were randomly assigned into three groups: (i) left high-frequency (n = 12), (ii) right low-frequency (n = 13), (iii) sham stimulation (n = 13), and underwent four-week rTMS with quetiapine concomitantly. Clinical efficacy was evaluated at baseline and weekly intervals using the 17-item Hamilton Depression Rating Scale (HDRS-17) and Montgomery-Asberg Depression Rating Scale (MADRS). Cognitive functioning was assessed before and after the study with the Wisconsin Card Sorting Test (WCST), Stroop Word-Color Interference Test (Stroop), and Trail Making Test (TMT). Thirty-five patients were included in the final analysis. Overall, the mean scores of both the HDRS-17 and the MADRS significantly decreased over the 4-week trial, which did not differ among the three groups. Exploratory analyses revealed no differences in factor scores of HDRS-17s, or in response or remission rates. Scores of WCST, Stroop, or TMT did not differ across the three groups. These findings indicated active rTMS combined with quetiapine was not superior to quetiapine monotherapy in improving depressive symptoms or cognitive performance in patients with bipolar II depression. PMID:27460201

  3. Efficacy of repetitive transcranial magnetic stimulation with quetiapine in treating bipolar II depression: a randomized, double-blinded, control study.

    PubMed

    Hu, Shao-Hua; Lai, Jian-Bo; Xu, Dong-Rong; Qi, Hong-Li; Peterson, Bradley S; Bao, Ai-Min; Hu, Chan-Chan; Huang, Man-Li; Chen, Jing-Kai; Wei, Ning; Hu, Jian-Bo; Li, Shu-Lan; Zhou, Wei-Hua; Xu, Wei-Juan; Xu, Yi

    2016-01-01

    The clinical and cognitive responses to repetitive transcranial magnetic stimulation (rTMS) in bipolar II depressed patients remain unclear. In this study, thirty-eight bipolar II depressed patients were randomly assigned into three groups: (i) left high-frequency (n = 12), (ii) right low-frequency (n = 13), (iii) sham stimulation (n = 13), and underwent four-week rTMS with quetiapine concomitantly. Clinical efficacy was evaluated at baseline and weekly intervals using the 17-item Hamilton Depression Rating Scale (HDRS-17) and Montgomery-Asberg Depression Rating Scale (MADRS). Cognitive functioning was assessed before and after the study with the Wisconsin Card Sorting Test (WCST), Stroop Word-Color Interference Test (Stroop), and Trail Making Test (TMT). Thirty-five patients were included in the final analysis. Overall, the mean scores of both the HDRS-17 and the MADRS significantly decreased over the 4-week trial, which did not differ among the three groups. Exploratory analyses revealed no differences in factor scores of HDRS-17s, or in response or remission rates. Scores of WCST, Stroop, or TMT did not differ across the three groups. These findings indicated active rTMS combined with quetiapine was not superior to quetiapine monotherapy in improving depressive symptoms or cognitive performance in patients with bipolar II depression. PMID:27460201

  4. Undenatured type II collagen (UC-II®) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers

    PubMed Central

    2013-01-01

    Background UC-II contains a patented form of undenatured type II collagen derived from chicken sternum. Previous preclinical and clinical studies support the safety and efficacy of UC-II in modulating joint discomfort in osteoarthritis and rheumatoid arthritis. The purpose of this study was to assess the efficacy and tolerability of UC-II in moderating joint function and joint pain due to strenuous exercise in healthy subjects. Methods This randomized, double-blind, placebo-controlled study was conducted in healthy subjects who had no prior history of arthritic disease or joint pain at rest but experienced joint discomfort with physical activity. Fifty-five subjects who reported knee pain after participating in a standardized stepmill performance test were randomized to receive placebo (n = 28) or the UC-II (40 mg daily, n = 27) product for 120 days. Joint function was assessed by changes in degree of knee flexion and knee extension as well as measuring the time to experiencing and recovering from joint pain following strenuous stepmill exertion. Results After 120 days of supplementation, subjects in the UC-II group exhibited a statistically significant improvement in average knee extension compared to placebo (81.0 ± 1.3º vs 74.0 ± 2.2º; p = 0.011) and to baseline (81.0 ± 1.3º vs 73.2 ± 1.9º; p = 0.002). The UC-II cohort also demonstrated a statistically significant change in average knee extension at day 90 (78.8 ± 1.9º vs 73.2 ± 1.9º; p = 0.045) versus baseline. No significant change in knee extension was observed in the placebo group at any time. It was also noted that the UC-II group exercised longer before experiencing any initial joint discomfort at day 120 (2.8 ± 0.5 min, p = 0.019), compared to baseline (1.4 ± 0.2 min). By contrast, no significant changes were seen in the placebo group. No product related adverse events were observed during the study. At study conclusion, five

  5. A randomized, double-blind, placebo-controlled study of quetiapine in the treatment of bipolar I and II depression: improvements in quality of life.

    PubMed

    Endicott, Jean; Rajagopalan, Krithika; Minkwitz, Margaret; Macfadden, Wayne

    2007-01-01

    Bipolar depression is associated with significant morbidity, high risk of suicide and substantial impairment of health-related quality of life (QOL), which adversely affects family/social relationships and occupational functioning. Depressive symptomatology is the primary determinant of quality of life, and there is a paucity of clinical trial data on how treatments affect quality of life. This 8-week, randomized, double-blind, parallel-group, placebo-controlled study in 542 patients with bipolar I or II depression used the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire to assess the effect of quetiapine monotherapy, 300 or 600 mg/day, on quality of life. Quality of sleep was also measured using the Pittsburgh Sleep Quality Index. Both doses of quetiapine significantly improved quality of life over baseline values in comparison with placebo, which was evident at first assessment (week 4) and continued up to week 8. The improvement in quality of life was consistent over the majority of the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire domains, and was evident in patients classified as responders on the basis of clinical efficacy measures. Quetiapine therapy also effected a significant improvement in quality of sleep compared with placebo. Improved quality of life may enhance patient compliance, and assessment of quality of life should be incorporated into future clinical trials in bipolar depression.

  6. A randomized and blinded comparison of three bleeding time techniques: the Ivy method, and the Simplate II method in two directions.

    PubMed

    Srámek, R; Srámek, A; Koster, T; Briët, E; Rosendaal, F R

    1992-05-01

    We compared the Ivy bleeding time method and two alternatives of the Simplate II method (incisions in horizontal and vertical direction) with each other, with regard to the sensitivity, the specificity, the costs and the burden for the patient. In the aspirin study an aspirin-induced bleeding defect was used. Seventy-two healthy volunteers were randomized to receive either 500 mg acetylsalicylic acid (ASA) or a placebo. Double blinding was maintained throughout the study. In the anticoagulation study 62 patients participated, who received oral anticoagulants (OAC) for various reasons. All participants received two bleeding time methods. The burden for the participants of each method was screened by a small standard questionnaire. The differences in sensitivity and specificity between the three methods proved minimal. The Ivy method was more often preferred by the participants than the Simplate methods. Since a choice on the basis of sensitivity and specificity appears not possible, we prefer the Ivy method because of lower costs and less burden.

  7. A Randomized, Double Blind, Placebo-Controlled, Multicenter Phase II Trial of Allisartan Isoproxil in Essential Hypertensive Population at Low-Medium Risk

    PubMed Central

    Li, Ying; Li, Xiao-hui; Huang, Zhi-jun; Yang, Guo-ping; Zhang, Guo-gang; Zhao, Shui-ping; Guo, Ying; Lu, Shi-juan; Ma, Jian-lin; Meng, Fan-bo; Chen, Ping; Yuan, Hong

    2015-01-01

    Background Angiotensin II receptor blockers (ARBs) is a well-tolerated class of antihypertensive agents, exhibiting effective antihypertensive and cardiovascular protective function. The objective of the study was to examine the efficacy and safety of Allisartan Isoproxil, a newly developed, selective, nonpeptide blocker of the angiotensin II type 1 receptor (AT1R), in essential hypertensive patients at low-medium risk. Methods and Findings A Phase II prospective, randomized, double-blind, placebo-controlled, multicenter trial comparing Allisartan Isoproxil 240mg versus placebo was conducted in essential hypertensive patients at low-medium risk at 8 sites in China. After a 2-week placebo baseline period, 275 patients received once-daily treatment with Allisartan Isoproxil 240mg or placebo randomly for 8 weeks. Systolic/diastolic blood pressure (SBP/DBP) was measured at week 2, 4 and 8. By the end of treatment, mean reductions from baseline of SBP and DBP in Allisartan Isoproxil and placebo groups were 14.5/10.4 and 8.3/7.7 mmHg, respectively (P<0.01). The rate of effective blood pressure control in Allisartan Isoproxil group was significantly higher than in placebo group at week 4 (61.3% vs 50.0%, P<0.05) and week 8 (67.2% vs 48.6%, P<0.01). In terms of safety and tolerability, there were no report of death and serious adverse event (SAE) in all subjects. There was no difference of frequency between two groups in adverse event (AE) and adverse drug reaction (ADR) (P>0.05). No one withdraw because of an ADR in two groups. 124 patients received additional 56 weeks treatment with Allisartan Isoproxil and 84 of them completed the study. The rate of effective BP control kept up to 80% since week 24. No significant clinical change was observed and ADRs were generally mild or moderate during the long-term study. Conclusions/Significance Allisartan Isoproxil 240mg was effective and safe for essential hypertension patients at low-medium risk. Trial Registration http

  8. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial.

    PubMed

    Dubey, Anand Prakash; Agarkhedkar, Sharad; Chhatwal, Jugesh; Narayan, Arun; Ganguly, Satyabrata; Wartel, T Anh; Bouckenooghe, Alain; Menezes, Josemund

    2016-01-01

    Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18-45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults. PMID:26291554

  9. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial.

    PubMed

    Dubey, Anand Prakash; Agarkhedkar, Sharad; Chhatwal, Jugesh; Narayan, Arun; Ganguly, Satyabrata; Wartel, T Anh; Bouckenooghe, Alain; Menezes, Josemund

    2016-01-01

    Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18-45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults.

  10. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial

    PubMed Central

    Dubey, Anand Prakash; Agarkhedkar, Sharad; Chhatwal, Jugesh; Narayan, Arun; Ganguly, Satyabrata; Wartel, T Anh; Bouckenooghe, Alain; Menezes, Josemund

    2016-01-01

    Dengue is a mosquito-borne viral disease that is endemic in India. We evaluated the immunogenicity and safety of recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) in Indian adults. In this observer-blind, randomized, placebo-controlled, Phase II study, adults aged 18–45 years were randomized 2:1 to receive CYD-TDV or placebo at 0, 6 and 12 months in sub-cutaneous administration. Immunogenicity was assessed using a 50% plaque reduction neutralization test (PRNT50) at baseline and 28 days after each study injection. 189 participants were enrolled (CYD-TDV [n = 128]; placebo, [n = 61]). At baseline, seropositivity rates for dengue serotypes 1, 2, 3 and 4 ranged from 77.0% to 86.9%. Seropositivity rates for each serotype increased after each CYD-TDV injection with a more pronounced increase after the first injection. In the CYD-TDV group, geometric mean titres (GMTs) were 2.38 to 6.11-fold higher after the third injection compared with baseline but remained similar to baseline in the placebo group. In the CYD-TDV group, the GMTs were 1.66 to 4.95-fold higher and 9.23 to 24.6-fold higher after the third injection compared with baseline in those who were dengue seropositive and dengue seronegative, respectively. Pain was the most commonly reported solicited injection site reaction after the first injection in both the CYD-TDV (6.3%) and placebo groups (4.9%), but occurred less frequently after subsequent injections. No serious adverse events were vaccine-related, no immediate unsolicited adverse events, and no virologically-confirmed cases of dengue, were reported during the study. The immunogenicity and safety of CYD-TDV was satisfactory in both dengue seropositive and seronegative Indian adults. PMID:26291554

  11. Neuroplastic Effects of Transcranial Direct Current Stimulation on Painful Symptoms Reduction in Chronic Hepatitis C: A Phase II Randomized, Double Blind, Sham Controlled Trial

    PubMed Central

    Brietzke, Aline P.; Rozisky, Joanna R.; Dussan-Sarria, Jairo A.; Deitos, Alicia; Laste, Gabriela; Hoppe, Priscila F. T.; Muller, Suzana; Torres, Iraci L. S.; Alvares-da-Silva, Mário R.; de Amorim, Rivadavio F. B.; Fregni, Felipe; Caumo, Wolnei

    2016-01-01

    Introduction: Pegylated Interferon Alpha (Peg-IFN) in combination with other drugs is the standard treatment for chronic hepatitis C infection (HCV) and is related to severe painful symptoms. The aim of this study was access the efficacy of transcranial direct current stimulation (tDCS) in controlling the painful symptoms related to Peg-IFN side effects. Materials and Methods: In this phase II double-blind trial, twenty eight (n = 28) HCV subjects were randomized to receive either 5 consecutive days of active tDCS (n = 14) or sham (n = 14) during 5 consecutive days with anodal stimulation over the primary motor cortex region using 2 mA for 20 min. The primary outcomes were visual analogue scale (VAS) pain and brain-derived neurotrophic factor (BDNF) serum levels. Secondary outcomes were the pressure-pain threshold (PPT), the Brazilian Profile of Chronic Pain: Screen (B-PCP:S), and drug analgesics use. Results: tDCS reduced the VAS scores (P < 0.003), with a mean pain drop of 56% (p < 0.001). Furthermore, tDCS was able to enhance BDNF levels (p < 0.01). The mean increase was 37.48% in the active group. Finally, tDCS raised PPT (p < 0.001) and reduced the B-PCP:S scores and analgesic use (p < 0.05). Conclusions: Five sessions of tDCS were effective in reducing the painful symptoms in HCV patients undergoing Peg-IFN treatment. These findings support the efficacy of tDCS as a promising therapeutic tool to improve the tolerance of the side effects related to the use of Peg-IFN. Future larger studies (phase III and IV trials) are needed to confirm the clinical use of the therapeutic effects of tDCS in such condition. Trial registration: Brazilian Human Health Regulator for Research with the approval number CAAE 07802012.0.0000.5327. PMID:26793047

  12. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia

    PubMed Central

    2013-01-01

    Background Peripheral vascular disease of the lower extremities comprises a clinical spectrum that extends from no symptoms to presentation with critical limb ischemia (CLI). Bone marrow derived Mesenchymal Stem Cells (BM- MSCs) may ameliorate the consequences of CLI due to their combinatorial potential for inducing angiogenesis and immunomodulatory environment in situ. The primary objective was to determine the safety of BM- MSCs in patients with CLI. Methods Prospective, double blind randomized placebo controlled multi-center study was conducted in patients with established CLI as per Rutherford classification in category II-4, III-5, or III-6 with infra-inguinal arterial occlusive disease and were not suitable for or had failed revascularization treatment. The primary end point was incidence of treatment – related adverse events (AE). Exploratory efficacy end points were improvement in rest pain, increase in Ankle Brachial Pressure Index (ABPI), ankle pressure, healing of ulcers, and amputation rates. Twenty patients (BM-MSC: Placebo = 1:1) were administered with allogeneic BM-MSCs at a dose of 2 million cells/kg or placebo (PlasmaLyte A) at the gastrocnemius muscle of the ischemic limb. Results Improvement was observed in the rest pain scores in both the arms. Significant increase in ABPI and ankle pressure was seen in BM-MSC arm compared to the placebo group. Incidence of AEs in the BM-MSC arm was 13 vs. 45 in the placebo arm where as serious adverse events (SAE) were similar in both the arms (5 in BM-MSC and 4 in the placebo group). SAEs resulted in death, infected gangrene, amputations in these patients. It was observed that the SAEs were related to disease progression and not related to stem cells. Conclusion BM-MSCs are safe when injected IM at a dose of 2 million cells/kg body weight. Few efficacy parameters such as ABPI and ankle pressure showed positive trend warranting further studies. Trial registration NIH website (http

  13. THE PREGNANCY IN POLYCYSTIC OVARY SYNDROME II (PPCOS II) TRIAL: RATIONALE AND DESIGN OF A DOUBLE-BLIND RANDOMIZED TRIAL OF CLOMIPHENE CITRATE AND LETROZOLE FOR THE TREATMENT OF INFERTILITY IN WOMEN WITH POLYCYSTIC OVARY SYNDROME

    PubMed Central

    Legro, Richard S.; Kunselman, Allen R.; Brzyski, Robert G.; Casson, Peter R.; Diamond, Michael P.; Schlaff, William D.; Christman, Gregory M.; Coutifaris, Christos; Taylor, Hugh S.; Eisenberg, Esther; Santoro, Nanette; Zhang, Heping

    2012-01-01

    Polycystic Ovary Syndrome (PCOS) is a common cause of female infertility and first line treatment is currently oral clomiphene citrate, a selective estrogen receptor modulator, which results in both a high nonresponse rate and multiple pregnancy rate. Aromatase inhibitors such as letrozole may have more favorable ovarian and endometrial effects. The goal of the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) study is to determine the safety and efficacy of clomiphene citrate (CC) compared to letrozole, in achieving live birth in infertile women with PCOS. The population will consist of 750 infertile women with PCOS. Additionally, the couple will have no other major infertility factor. This will be a multi-center, prospective, double-blind clinical trial of CC vs. letrozole for 5 treatment cycles (or approximately up to 25 weeks). The randomization scheme will be coordinated through the central data coordinating center (DCC) and the randomization is stratified by each participating site. After progestin withdrawal as needed, 750 women will be equally randomized to two different treatment arms: A) CC 50 mg every day for 5 days (day 3–7 of cycle), or B) letrozole 2.5 mg every day for 5 days (day 3–7 of cycle), for a total of 5 cycles or 25 weeks. The dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of CC a day (× 5 days) or 7.5 mg of letrozole a day (× 5 days). The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms. PMID:22265923

  14. The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome.

    PubMed

    Legro, Richard S; Kunselman, Allen R; Brzyski, Robert G; Casson, Peter R; Diamond, Michael P; Schlaff, William D; Christman, Gregory M; Coutifaris, Christos; Taylor, Hugh S; Eisenberg, Esther; Santoro, Nanette; Zhang, Heping

    2012-05-01

    Polycystic Ovary Syndrome (PCOS) is a common cause of female infertility and first line treatment is currently oral clomiphene citrate, a selective estrogen receptor modulator, which results in both a high nonresponse rate and multiple pregnancy rate. Aromatase inhibitors such as letrozole may have more favorable ovarian and endometrial effects. The goal of the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) study is to determine the safety and efficacy of clomiphene citrate (CC) compared to letrozole, in achieving live birth in infertile women with PCOS. The population will consist of 750 infertile women with PCOS. Additionally, the couple will have no other major infertility factor. This will be a multi-center, prospective, double-blind clinical trial of CC vs. letrozole for 5 treatment cycles (or approximately up to 25 weeks). The randomization scheme will be coordinated through the central data coordinating center (DCC) and the randomization is stratified by each participating site. After progestin withdrawal as needed, 750 women will be equally randomized to two different treatment arms: A) CC 50mg every day for 5 days (days 3-7 of cycle), or B) letrozole 2.5mg every day for 5 days (days 3-7 of cycle), for a total of 5 cycles or 25 weeks. The dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of CC a day (×5 days) or 7.5mg of letrozole a day (×5 days). The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms. PMID:22265923

  15. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial.

    PubMed

    Ko, Kwang-Pil; Ma, Seung Hyun; Yang, Jae-Jeong; Hwang, Yunji; Ahn, Choonghyun; Cho, Young-Min; Noh, Dong-Young; Park, Byung-Joo; Han, Wonshik; Park, Sue K

    2015-09-01

    Previous observational studies have suggested that metformin in diabetes patients may reduce breast cancer risk more than the reductions from other anti-diabetes medications. This randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy of metformin for controlling physical and metabolic profiles related to prognosis and adverse events in non-diabetic breast cancer patients. Female breast cancer patients (N = 105), at least 6 months post-mastectomy, with obesity (≥25 kg/m(2)) and/or pre-diabetes (fasting blood sugar levels ≥100 mg/dL), were randomly assigned to three groups (placebo, metformin 500 mg, and metformin 1000 mg) stratified by tamoxifen use. A linear mixed model for repeated measurements among three groups and ANOVA for profile differences during 6 months of treatment were used for the intention-to-treat analysis. The metformin 1000 mg group had a significantly greater decline in glucose and HbA1c levels between treatment weeks 0 and 6 month (p = 0.008 and 0.009, respectively), and the declines increased with an increase in body mass index (BMI) level (p interaction with BMI = 0.007 and 0.067, respectively). A marginally significant different effect from the metformin 1000 mg treatment was detected for glucose and HbA1c levels (p interaction = 0.084 and 0.063, respectively) in the intention-to-treat analysis. Metformin 1000 mg treatment had a favorable effect on controlling glucose and HbA1C levels in obese non-diabetic breast cancer patients, indicating prognostic importance. Further trials are needed to elucidate the risk-benefit ratio of long-term use of metformin. PMID:26293146

  16. Evaluation of microleakage of class II dental composite resin restorations cured with LED or QTH dental curing light; Blind, Cluster Randomized, In vitro cross sectional study

    PubMed Central

    2014-01-01

    Background The aim of this study is to compare the microleakage of Class II dental composite resin restorations which have been cured by three different LED (light emitting diode) light curing modes compared to control samples cured by QTH (quartz tungsten halogen) light curing units (LCUs), to determine the most effective light curing unit and mode of curing. Results In this experimental study, class II cavities were prepared on 100 sound human premolars which have been extracted for orthodontic treatment. The teeth were randomly divided into four groups; three experimental and one control group of 25 teeth each. Experimental groups were cured by either conventional, pulse-delay, or ramped curing modes of LED. The control group was cured for 20 seconds by QTH. The restorations were thermocycled (1000 times, between 5 and 55°C, for 5 seconds dwell time), dyed, sectioned mesio-distally and viewed under stereo-microscope (40×) magnification. Teeth were then scored on a 0 to 4 scale based on the amount of microleakage. The data were analyzed by Chi-square test. No significant difference was demonstrated between the different LCUs (light curing units), or modes of curing, at the enamel side (p > 0.05). At the dentin side, all modes of LED curing could significantly reduce microleakage (p < 0.05). The results suggest that slow start curing improves marginal integrity and seal. High intense curing endangers those aims. Conclusions Comparison between the three LED mode cured composite resin restorations and QTH curing showed LED curing in all modes is more effective than QTH for reducing microleakage. Both LED and QTH almost completely eliminate the microleakage on the enamel side, however none of them absolutely eliminated microleakage on the dentin side. PMID:24990296

  17. Phase II randomized, double-blind, placebo-controlled study of whole-brain irradiation with concomitant chloroquine for brain metastases

    PubMed Central

    2013-01-01

    Background and purpose Chloroquine (CLQ), an antimalarial drug, has a lysosomotropic effect associated with increased radiationsensibility, which is mediated by the leakage of hydrolytic enzymes, increased apoptosis, autophagy and increased oxidative stress in vitro. In this phase II study, we evaluated the efficacy and safety of radiosensibilization using CLQ concomitant with 30 Gray (Gy) of whole-brain irradiation (WBI) to treat patients with brain metastases (BM) from solid tumors. Methods Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ arm). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) (Mexican version) before beginning radiotherapy and one month later. Results The overall response rate (ORR) was 54% for the CLQ arm and 55% for the control arm (p=0.92). The progression-free survival of brain metastases (BMPFS) rates at one year were 83.9% (95% CI 69.4-98.4) for the CLQ arm and 55.1% (95% CI 33.6-77.6) for the control arm. Treatment with CLQ was independently associated with increased BMPFS (RR 0.31,95% CI [0.1-0.9], p=0.046).The only factor that was independently associated with increased overall survival (OS) was the presence of< 4 brain metastases (RR 1.9, 95% CI [1.12-3.3], p=0.017). WBI was associated with improvements in cognitive and emotional function but also with worsened nausea in both patients groups. No differences in QoL or toxicity were found between the study arms. Conclusion Treatment with CLQ plus WBI improved the control of BM (compared with the control arm) with no increase in toxicity; however, CLQ did not improve the RR or OS. A phase III clinical trial is warranted to confirm these findings. PMID:24010771

  18. A randomized, double-blind, placebo-controlled, clinical trial on probiotic soy milk and soy milk: effects on epigenetics and oxidative stress in patients with type II diabetes.

    PubMed

    Hariri, Mitra; Salehi, Rasoul; Feizi, Awat; Mirlohi, Maryam; Ghiasvand, Reza; Habibi, Nahal

    2015-11-01

    This clinical trial aimed to discover the effects of probiotic soy milk and soy milk on MLH1 and MSH2 promoter methylation, and oxidative stress among type II diabetic patients. Forty patients with type II diabetes mellitus aged 35-68 years were assigned to two groups in this randomized, double-blind, controlled clinical trial. Patients in the intervention group consumed 200 ml/day of probiotic soy milk containing Lactobacillus plantarum A7, while those in the control group consumed 200 ml/d of conventional soy milk for 8 weeks. Fasting blood samples, anthropometric measurements, and 24-h dietary recalls were collected at the baseline and at the end of the study, respectively. Probiotic soy milk significantly decreased promoter methylation in proximal and distal MLH1 promoter region (P < 0.01 and P < 0.0001, respectively) compared with the baseline values, while plasma concentration of 8-hydroxy-2'-deoxyguanosine (8-OHdG) decreased significantly compared with soy milk (P < 0.05). In addition, a significant increase in superoxide dismutase (SOD) activity was observed in probiotic soy milk group compared with baseline value (P < 0.01). There were no significant changes from baseline in the promoter methylation of MSH2 within either group (P > 0.05). The consumption of probiotic soy milk improved antioxidant status in type II diabetic patients and may decrease promoter methylation among these patients, indicating that probiotic soy milk is a promising agent for diabetes management. PMID:26577825

  19. A randomized, double-blind, placebo-controlled, clinical trial on probiotic soy milk and soy milk: effects on epigenetics and oxidative stress in patients with type II diabetes.

    PubMed

    Hariri, Mitra; Salehi, Rasoul; Feizi, Awat; Mirlohi, Maryam; Ghiasvand, Reza; Habibi, Nahal

    2015-11-01

    This clinical trial aimed to discover the effects of probiotic soy milk and soy milk on MLH1 and MSH2 promoter methylation, and oxidative stress among type II diabetic patients. Forty patients with type II diabetes mellitus aged 35-68 years were assigned to two groups in this randomized, double-blind, controlled clinical trial. Patients in the intervention group consumed 200 ml/day of probiotic soy milk containing Lactobacillus plantarum A7, while those in the control group consumed 200 ml/d of conventional soy milk for 8 weeks. Fasting blood samples, anthropometric measurements, and 24-h dietary recalls were collected at the baseline and at the end of the study, respectively. Probiotic soy milk significantly decreased promoter methylation in proximal and distal MLH1 promoter region (P < 0.01 and P < 0.0001, respectively) compared with the baseline values, while plasma concentration of 8-hydroxy-2'-deoxyguanosine (8-OHdG) decreased significantly compared with soy milk (P < 0.05). In addition, a significant increase in superoxide dismutase (SOD) activity was observed in probiotic soy milk group compared with baseline value (P < 0.01). There were no significant changes from baseline in the promoter methylation of MSH2 within either group (P > 0.05). The consumption of probiotic soy milk improved antioxidant status in type II diabetic patients and may decrease promoter methylation among these patients, indicating that probiotic soy milk is a promising agent for diabetes management.

  20. A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

    PubMed

    Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

    2007-09-01

    Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base. PMID:18632524

  1. The clinical investigation of Citrullus colocynthis (L.) schrad fruit in treatment of Type II diabetic patients: a randomized, double blind, placebo-controlled clinical trial.

    PubMed

    Huseini, H Fallah; Darvishzadeh, F; Heshmat, R; Jafariazar, Z; Raza, Mohsin; Larijani, B

    2009-08-01

    Citrullus colocynthis (L.) Schrad fruit is an herbal medicine used by traditional herbalists for the treatment of diabetes in Iran. To determine its efficacy and toxicity, a 2 month clinical trial was conducted in 50 type II diabetic patients. Two groups of 25 each under standard antidiabetic therapy, received 100 mg C. colocynthis fruit capsules or placebos three times a day, respectively. The patients were visited monthly and glycosylated hemoglobin (HbA1c), fasting blood glucose, total cholesterol, LDL, HDL, triglyceride, aspartate transaminase, alanine transaminase, alkaline phosphatase, urea and creatinine levels were determined at the beginning and after 2 months. The results showed a significant decrease in HbA1c and fasting blood glucose levels in C. colocynthis treated patients. Other serological parameters levels in both the groups did not change significantly. No notable gastrointestinal side effect was observed in either group. In conclusion, C. colocynthis fruit treatment had a beneficial effect on improving the glycemic profile without severe adverse effects in type II diabetic patients. Further clinical studies are recommended to evaluate the long-term efficacy and toxicity of C. colocynthis in diabetic patients.

  2. A single blind randomized controlled clinical trial of mexiletine in amyotrophic lateral sclerosis: Efficacy and safety of sodium channel blocker phase II trial.

    PubMed

    Shibuya, Kazumoto; Misawa, Sonoko; Kimura, Hideki; Noto, Yu-Ichi; Sato, Yasunori; Sekiguchi, Yukari; Iwai, Yuta; Mitsuma, Satsuki; Beppu, Minako; Watanabe, Keisuke; Fujimaki, Yumi; Tsuji, Yukiko; Shimizu, Toshio; Mizuno, Toshiki; Nakagawa, Masanori; Sawaguchi, Kyoko; Hanaoka, Hideki; Kuwabara, Satoshi

    2015-01-01

    Fasciculations are characteristic features of amyotrophic lateral sclerosis (ALS), and suggest motor nerve hyperexcitability. Recent reports have shown that an increase in persistent nodal sodium current is associated with shorter survival in ALS patients. This objective of this trial is to study the efficacy and safety of mexiletine, a sodium channel blocker, for ALS. Sixty eligible participants were randomly allocated (1:1) to riluzole 100 mg or riluzole plus mexiletine 300 mg. The primary endpoint was change in the revised ALS functional rating scale (ALSFRS-R) scores during six months. We also monitored strength-duration time constant (SDTC, a measure of persistent sodium current) in median motor axons. Results showed that during six months of treatment, changes in the ALSFRS-R score and SDTC were -7.0 ± 7.1 and -0.04 ± 0.1, respectively, in the riluzole group and -6.9 ± 6.4 and 0.04 ± 0.1, respectively, in the mexiletine group (p = 0.96 and 0.049). Adverse events amounted 20% in the riluzole and 33% in the mexiletine groups. In conclusion, the results suggest that daily 300 mg mexiletine has no effects on axonal sodium current and ALSFRS-R deterioration in ALS. We have to attempt another trial using a higher dose of mexiletine or other agents to suppress sodium currents and ALS progression in the future. PMID:25960085

  3. Phase II, Randomized, Double-Blind, Multicenter Study Comparing the Safety and Pharmacokinetics of Tefibazumab to Placebo for Treatment of Staphylococcus aureus Bacteremia

    PubMed Central

    Weems, J. John; Steinberg, James P.; Filler, Scott; Baddley, John W.; Corey, G. Ralph; Sampathkumar, Priya; Winston, Lisa; John, Joseph F.; Kubin, Christine J.; Talwani, Rohit; Moore, Thomas; Patti, Joseph M.; Hetherington, Seth; Texter, Michele; Wenzel, Eric; Kelley, Violet A.; Fowler, Vance G.

    2006-01-01

    Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were <100 μg/ml by day 14. A CCE occurred in six patients (four placebo and two tefibazumab patients) and included five deaths (four placebo and one tefibazumab patient). Progression in the severity of sepsis occurred in four placebo and no tefibazumab patients. Tefibazumab was well tolerated, with a safety profile similar to those of other monoclonal antibodies. Additional trials are warranted to address the dosing range and efficacy of tefibazumab. PMID:16870768

  4. Oral liarozole in the treatment of patients with moderate/severe lamellar ichthyosis: results of a randomized, double-blind, multinational, placebo-controlled phase II/III trial

    PubMed Central

    Vahlquist, A; Blockhuys, S; Steijlen, P; van Rossem, K; Didona, B; Blanco, D; Traupe, H

    2014-01-01

    Summary Background Oral liarozole, a retinoic acid metabolism-blocking agent, may be an alternative to systemic retinoid therapy in patients with lamellar ichthyosis. Objective To demonstrate the efficacy and safety of once-daily oral liarozole in the treatment of moderate/severe lamellar ichthyosis. Methods This was a double-blind, multinational, parallel phase II/III trial (NCT00282724). Patients aged ≥ 14 years with moderate/severe lamellar ichthyosis [Investigator's Global Assessment (IGA) score ≥ 3] were randomized 3 : 3 : 1 to receive oral liarozole (75 or 150 mg) or placebo once daily for 12 weeks. Assessments included: IGA; a five-point scale for erythema, scaling and pruritus severity; Short Form-36 health survey; Dermatology Life Quality Index (DLQI); and safety parameters. The primary efficacy variable was response rate at week 12 (responder: ≥ 2-point decrease in IGA from baseline). Results Sixty-four patients were enrolled. At week 12, 11/27 (41%; liarozole 75 mg), 14/28 (50%; liarozole 150 mg) and one out of nine (11%; placebo) patients were responders; the difference between groups (liarozole 150 mg vs. placebo) was not significant (P = 0·056). Mean IGA and scaling scores decreased from baseline in both liarozole groups at weeks 8 and 12 vs. placebo; erythema and pruritus scores were similar between treatment groups. Improvement in DLQI score was observed in both liarozole groups. Treatment with liarozole for 12 weeks was well tolerated. Conclusions The primary efficacy variable did not reach statistical significance, possibly owing to the small sample size following premature termination. However, once-daily oral liarozole, 75 and 150 mg, improved scaling and DLQI and was well tolerated in patients with moderate/severe lamellar ichthyosis. PMID:24102348

  5. Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartan on Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study)

    PubMed Central

    Peters, Christian Daugaard; Kjaergaard, Krista Dybtved; Jensen, Jens Dam; Christensen, Kent Lodberg; Strandhave, Charlotte; Tietze, Ida Noerager; Novosel, Marija Kristina; Bibby, Bo Martin; Jespersen, Bente

    2015-01-01

    Background and Aim Little is known about the tolerability of antihypertensive drugs during hemodialysis treatment. The present study evaluated the use of the angiotensin II receptor blocker (ARB) irbesartan. Design Randomized, double-blind, placebo-controlled, one-year intervention trial. Setting and Participants Eighty-two hemodialysis patients with urine output >300 mL/day and dialysis vintage <1 year. Intervention Irbesartan/placebo 300 mg/day for 12 months administered as add-on to antihypertensive treatment using a predialytic systolic blood pressure target of 140 mmHg in all patients. Outcomes and Measurements Cardiac output, stroke volume, central blood volume, total peripheral resistance, mean arterial blood pressure, and frequency of intradialytic hypotension. Results At baseline, the groups were similar regarding age, comorbidity, blood pressure, antihypertensive medication, ultrafiltration volume, and dialysis parameters. Over the one-year period, predialytic systolic blood pressure decreased significantly, but similarly in both groups. Mean start and mean end cardiac output, stroke volume, total peripheral resistance, heart rate, and mean arterial pressure were stable and similar in the two groups, whereas central blood volume increased slightly but similarly over time. The mean hemodynamic response observed during a dialysis session was a drop in cardiac output, in stroke volume, in mean arterial pressure, and in central blood volume, whereas heart rate increased. Total peripheral resistance did not change significantly. Overall, this pattern remained stable over time in both groups and was uninfluenced by ARB treatment. The total number of intradialytic hypotensive episodes was (placebo/ARB) 50/63 (P = 0.4). Ultrafiltration volume, left ventricular mass index, plasma albumin, and change in intradialytic total peripheral resistance were significantly associated with intradialytic hypotension in a multivariate logistic regression analysis based on

  6. Comparison of the efficacy and safety of azilsartan with that of candesartan cilexetil in Japanese patients with grade I–II essential hypertension: a randomized, double-blind clinical study

    PubMed Central

    Rakugi, Hiromi; Enya, Kazuaki; Sugiura, Kenkichi; Ikeda, Yoshinori

    2012-01-01

    Azilsartan is a novel angiotensin receptor blocker being developed for hypertension treatment. This 16-week, multicenter, randomized, double-blind study compared the efficacy and safety of azilsartan (20–40 mg once daily by forced titration) and its ability to provide 24-h blood pressure (BP) control, with that of candesartan cilexetil (candesartan; 8–12 mg once daily by forced titration) in 622 Japanese patients with grade I–II essential hypertension. Efficacy was evaluated by clinic-measured sitting BP, and by ambulatory BP monitoring (ABPM) at week 14. Participants (mean age: 57 years, 61% males) had a mean baseline sitting BP of 159.8/100.4 mm Hg. The mean change from baseline in sitting diastolic BP at week 16 (primary endpoint) was −12.4 mm Hg in the azilsartan group and −9.8 mm Hg in the candesartan group, demonstrating a statistically significant greater reduction with azilsartan vs. candesartan (difference: −2.6 mm Hg, 95% confidence interval (CI): −4.08 to −1.22 mm Hg, P=0.0003). The week 16 (secondary endpoint) mean change from baseline in sitting systolic BP was −21.8 mm Hg and −17.5 mm Hg, respectively, a significant decrease with azilsartan vs. candesartan (difference: −4.4 mm Hg, 95% CI: −6.53 to −2.20 mm Hg, P<0.0001). On ABPM, the week 14 mean changes from baseline in diastolic and systolic BP were also significantly greater with azilsartan over a 24-h period, and during the daytime, night-time and early morning. Safety and tolerability were similar among the two groups. These data demonstrate that once-daily azilsartan provides a more potent 24-h sustained antihypertensive effect than that of candesartan but with equivalent safety. PMID:22278628

  7. Coblation tonsillectomy: a double blind randomized controlled study.

    PubMed

    Timms, M S; Temple, R H

    2002-06-01

    Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.

  8. A randomized double blind study of two oral contraceptives.

    PubMed

    Sanhueza, H; Sivin, I; Kumar, S; Kessler, M; Carrasco, A; Yee, J

    1979-07-01

    To study the question of whether one brand of oral contraceptives may be as acceptable as another for use of publicly-assisted family planning programs, a double blind study of two well-known brands, Ovral and Norinyl, was undertaken in Costa Rica and Trinidad. The pills were randomly assigned to 1,200 women. Common side effects - nausea, dizziness, vomiting, headaches - were associated with both Norinyl and Ovral. Differences in event rates for these conditions were much more marked by country than by the pill used. Ovral was associated with increases in skin problems, notably chloasma, in Cost Rica. A higher percentage of women using Norinyl reported intermenstrual bleeding and spotting in both countries. In Costa Rica continuation rates for Norinyl were adversely affected by this. With these exceptions there appear to be no important differences between the brands that would affect their use in family planning programs. PMID:477315

  9. Zonisamide for Bipolar Depression: A Randomized, Double Blind, Placebo-Controlled, Adjunctive Trial

    PubMed Central

    Dauphinais, Deborah; Knable, Michael; Rosenthal, Joshua; Polanski, Mark; Rosenthal, Norman

    2011-01-01

    Objective This is the first multicenter, double blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of adjunctive zonisamide for the treatment of bipolar depression. Experimental design One hundred two patients with bipolar disorder, type I or II in the depressed phase of illness were randomized to either adjunctive zonisamide or placebo. The study consisted of three phases, a 7 to 30 day screening and stabilization phase, 6 weeks of blinded treatment and a 1 to 3 week discontinuation phase. MADRS score was the primary outcome variable. Secondary outcome measures included the YMRS, CGI-S, CGI-I, Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and an a priori analysis of response and remission. Metabolic parameters including weight, waist-hip ratio, body mass index, fasting glucose, cholesterol and triglyceride levels were also evaluated. Side effects were measured using the SAFTEE. Principal observations There were no statistically significant differences in response between subjects treated with adjunctive zonisamide vs. placebo controls for the primary or secondary outcome measures. There were also no differences between the groups with regard to response rate or remission rate. Conclusions In contrast to preliminary open label studies that suggested a role for zonisamide in bipolar depression, we could not confirm these results in a large double blind controlled study.

  10. Randomized, Double-Blind, Phase II, Multicenter Study Evaluating the Safety/Tolerability and Efficacy of JNJ-Q2, a Novel Fluoroquinolone, Compared with Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infection ▿ †

    PubMed Central

    Covington, Paul; Davenport, J. Michael; Andrae, David; O'Riordan, William; Liverman, Lisa; McIntyre, Gail; Almenoff, June

    2011-01-01

    JNJ-Q2 is a fluoroquinolone with broad coverage including methicillin-resistant Staphylococcus aureus (MRSA). A double-blind, multicenter, phase II noninferiority study treated 161 patients for 7 to 14 days, testing the efficacy of JNJ-Q2 (250 mg, twice a day [BID]) versus linezolid (600 mg, BID) in patients with acute bacterial skin and skin structure infections (ABSSSI). The prespecified criterion for noninferiority was 15%. Primary intent-to-treat analysis was unable to declare noninferiority, as the risk difference lower bound of the 95% confidence interval between treatments was 19% at 36 to 84 h postrandomization for the composite end point of lesion assessment and temperature. Prespecified clinical cure rates 2 to 14 days after completion of therapy were similar (83.1% for JNJ-Q2 versus 82.1% for linezolid). Post hoc analyses revealed that JNJ-Q2 was statistically noninferior to linezolid (61.4% versus 57.7%, respectively; P = 0.024) based on the 2010 FDA guidance, which defines treatment success as lack of lesion spread and afebrile status within 48 to 72 h postrandomization. Despite evidence of systemic disease, <5% of patients presented with fever, suggesting fever is not a compelling surrogate measure of systemic disease resolution for this indication. Nausea and vomiting were the most common adverse events. Of the patients, 86% (104/121) had S. aureus isolated from the infection site; 63% of these were MRSA. The results suggest JNJ-Q2 shows promise as an effective treatment for ABSSSI, demonstrating (i) efficacy for early clinical response (i.e., lack of spread of lesions and absence of fever at 48 to 72 h), and (ii) cure rates for ABSSSI pathogens (especially MRSA) consistent with the historical literature. PMID:21947389

  11. Key predictive factors for efficacy of axitinib in first-line metastatic renal cell carcinoma: subgroup analysis in Japanese patients from a randomized, double-blind phase II study

    PubMed Central

    Tomita, Yoshihiko; Fukasawa, Satoshi; Oya, Mototsugu; Uemura, Hirotsugu; Shinohara, Nobuo; Habuchi, Tomonori; Rini, Brian I.; Chen, Ying; Bair, Angel H.; Ozono, Seiichiro; Naito, Seiji; Akaza, Hideyuki

    2016-01-01

    Objectives To conduct Japanese subgroup analyses of a randomized, global Phase II study of axitinib with and without dose titration in first-line metastatic renal cell carcinoma and to explore predictive factors for axitinib efficacy in first-line metastatic renal cell carcinoma. Methods The data included 44 Japanese and 169 non-Japanese treatment-naïve patients with metastatic renal cell carcinoma. Patients received twice-daily axitinib 5 mg during a 4-week lead-in period. Patients who met the pre-defined randomization criteria were stratified by Eastern Cooperative Oncology Group performance status and randomly assigned (1:1) to axitinib or placebo titration. The primary endpoint was objective response rate; secondary endpoints included progression-free survival and safety. Predictive factors were analyzed using data from all patients. Results The objective response rate (95% confidence interval) was 66% (50–80%) vs. 44% (36–52%) in Japanese and non-Japanese patients, respectively. At the primary analysis, median progression-free survival could not be estimated for Japanese patients, and was 27.6 months (95% confidence interval: 16.6–33.2) in an updated analysis. Hypertension, diarrhea, hand–foot syndrome, dysphonia, hypothyroidism and proteinuria were common adverse events in Japanese patients. Due to a small number of randomized patients, effects of axitinib dose titration could not sufficiently be confirmed among Japanese patients. The multivariate analysis identified time from histopathological diagnosis to treatment and sum of the longest diameter for target lesion at baseline as independent predictive factors for progression-free survival. Conclusions Axitinib is effective and well tolerated as first-line metastatic renal cell carcinoma therapy in Japanese patients. Predictive factors for axitinib efficacy endpoints identified in this setting warrant further investigation. PMID:27572087

  12. Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study—CALGB 30504 (Alliance)

    PubMed Central

    Ready, Neal E.; Pang, Herbert H.; Gu, Lin; Otterson, Gregory A.; Thomas, Sachdev P.; Miller, Antonius A.; Baggstrom, Maria; Masters, Gregory A.; Graziano, Stephen L.; Crawford, Jeffrey; Bogart, Jeffrey; Vokes, Everett E.

    2015-01-01

    Purpose To evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer (SCLC). Patients and Methods The Cancer and Leukemia Group B 30504 trial was a randomized, placebo-controlled, phase II study that enrolled patients before chemotherapy (cisplatin 80 mg/m2 or carboplatin area under the curve of 5 on day 1 plus etoposide 100 mg/m2 per day on days 1 to 3 every 21 days for four to six cycles). Patients without progression were randomly assigned 1:1 to placebo or sunitinib 37.5 mg per day until progression. Cross-over after progression was allowed. The primary end point was progression-free survival (PFS) from random assignment for maintenance placebo versus sunitinib using a one-sided log-rank test with α = .15; 80 randomly assigned patients provided 89% power to detect a hazard ratio (HR) of 1.67. Results One hundred forty-four patients were enrolled; 138 patients received chemotherapy. Ninety-five patients were randomly assigned; 10 patients did not receive maintenance therapy (five on each arm). Eighty-five patients received maintenance therapy (placebo, n = 41; sunitinib, n = 44). Grade 3 adverse events with more than 5% incidence were fatigue (19%), decreased neutrophils (14%), decreased leukocytes (7%), and decreased platelets (7%) for sunitinib and fatigue (10%) for placebo; grade 4 adverse events were GI hemorrhage (n = 1) and pancreatitis, hypocalcemia, and elevated lipase (n = 1; all in same patient) for sunitinib and thrombocytopenia (n = 1) and hypernatremia (n = 1) for placebo. Median PFS on maintenance was 2.1 months for placebo and 3.7 months for sunitinib (HR, 1.62; 70% CI, 1.27 to 2.08; 95% CI, 1.02 to 2.60; one-sided P = .02). Median overall survival from random assignment was 6.9 months for placebo and 9.0 months for sunitinib (HR, 1.28; 95% CI, 0.79 to 2.10; one-sided P = .16). Three sunitinib and no placebo patients achieved complete response during maintenance. Ten (77%) of 13 patients evaluable after cross

  13. Coblation versus traditional tonsillectomy: A double blind randomized controlled trial

    PubMed Central

    Omrani, Mohammadreza; Barati, Behrouz; Omidifar, Navid; Okhovvat, Ahmad Reza; Hashemi, Seyed Amirhossein Ghazizadeh

    2012-01-01

    BACKGROUND: Coblation tonsillectomy is a new surgical technique and demands further research to be proven as a suitable and standard method of tonsillectomy. This study compares coblation and traditional tonsillectomy techniques in view of their advantages and complications. METHODS: In a prospective double-blind randomized controlled trial information on operation time, intraoperative blood loss, postoperative pain, time needed to regain the normal diet and activity and postoperative hemorrhage were gathered and compared between two groups containing 47 patients in each group. RESULTS: We found statistically significant differences in operation time (p < 0.05), intraoperative blood loss (p < 0.05), postoperative pain (p < 0.001), time needed to find back the normal diet (p < 0.001) and normal activity (p < 0.001). However, post operation hemorrhage (p > 0.5) was not significantly different between two groups. CONCLUSIONS: This study revealed a significantly less intraoperative or postoperative complications and morbidity in coblation tonsillectomy in comparison with traditional method. Coblation was associated with less pain and quick return to normal diet and daily activity. These findings addressed coblation tonsillectomy as an advanced method. PMID:23248656

  14. The effect of probiotic soy milk and soy milk on anthropometric measures and blood pressure in patients with type II diabetes mellitus: A randomized double-blind clinical trial

    PubMed Central

    Hariri, Mitra; Salehi, Rasoul; Feizi, Awat; Mirlohi, Maryam; Kamali, Sara; Ghiasvand, Reza

    2015-01-01

    BACKGROUND The objective of this clinical trial was to assess the effects of probiotic soy milk and soy milk on anthropometric measures and blood pressure (BP) in type 2 diabetic (T2D) patients. METHODS A total of 40 patients with T2D, 35-68 years old, were assigned to two groups in this randomized, double-blind, controlled clinical trial. The patients in the intervention group consumed 200 ml/day of probiotic soy milk containing Lactobacillus planetarium A7 and those in control group consumed 200 ml/day of soy milk for 8 weeks. Anthropometric and BP measurements were performed according to standard protocols. For detecting within-group differences paired-sample t-tests was used and analysis of covariance was used for determining any differences between two groups. (The trial has been registered in the Iranian Registry of Clinical Trials, identifier: IRCT: IRCT201405265062N8). RESULTS In this study, we failed to find any significant changes between probiotic soy milk and soy milk in term of body mass index (26.65 ± 0.68 vs. 26.33 ± 0.74, P = 0.300) and waist to hip ratio (1.49 ± 0.08 vs. 1.54 ± 0.1, P = 0.170). Although soy milk did not have any effect on BP, probiotic soymilk significantly decreased systolic (14.7 ± 0.48 vs. 13.05 ± 0.16, P = 0.001) and diastolic BP (10 ± 0.7 vs. 9.1 ± 1, P = 0.031). CONCLUSION In our study, probiotic soy milk in comparing with soy milk did not have any beneficial effects on anthropometric measures in these patients. We need more clinical trial for confirming the effect of probiotic foods on anthropometric measure in diabetic patients. However, probiotic soy milk decreased systolic and diastolic BP significantly. PMID:26261453

  15. Safety and Efficacy of Atacicept in Combination With Rituximab for Reducing the Signs and Symptoms of Rheumatoid Arthritis: A Phase II, Randomized, Double‐Blind, Placebo‐Controlled Pilot Trial

    PubMed Central

    van Vollenhoven, R. F.; Wax, S.; Li, Y.; Tak, P. P.

    2015-01-01

    Objective To explore the safety and tolerability of atacicept in combination with rituximab in patients with active rheumatoid arthritis (RA) receiving rituximab re‐treatment. Methods In this randomized, double‐blind, placebo‐controlled pilot trial, 2 infusions (1,000 mg per infusion) of intravenous rituximab, given 2 weeks apart, were followed by once‐weekly subcutaneous injections of 150 mg atacicept or placebo for 25 weeks. Primary end points were the nature, incidence, and severity of adverse events (AEs). Secondary end points were the effects on peripheral blood B cells, disease activity biomarkers, and American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) response rates. Results Eighteen patients were randomized to receive atacicept and 9 to receive placebo. AEs occurred in 17 atacicept‐treated patients (94.4%) and in all 9 placebo‐treated patients (100%). There were no infection‐related serious adverse events. Hypersensitivity and injection site reactions were more common, and more patients withdrew due to AEs, in the atacicept group. Median reductions in Ig levels from baseline to week 32 were greater with atacicept (median change in IgG −31.2%, IgM −60.9%, and IgA −56.4%) than with placebo (median change in IgG −4.4%, IgM −15.9%, and IgA −8.2%). Peripheral B cell numbers remained low in all patients after rituximab‐mediated B cell depletion, limiting comparison of time to recovery between treatment groups. There were no between‐group differences in ACR20, ACR50, and ACR70 response rates. Conclusion In this exploratory trial, atacicept in combination with rituximab showed no new safety issues. Peripheral B cell counts remained too low to determine whether atacicept delayed B cell re‐expansion following rituximab‐mediated depletion. Despite clear biologic effects, adding atacicept to rituximab in patients with active RA was not associated with clinical benefit. PMID:26137975

  16. Methods of Blinding in Reports of Randomized Controlled Trials Assessing Pharmacologic Treatments: A Systematic Review

    PubMed Central

    Boutron, Isabelle; Estellat, Candice; Guittet, Lydia; Dechartres, Agnes; Sackett, David L; Hróbjartsson, Asbjørn; Ravaud, Philippe

    2006-01-01

    Background Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. Methods and Findings We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or

  17. Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty

    PubMed Central

    Golpanian, Samuel; DiFede, Darcy L.; Pujol, Marietsy V.; Lowery, Maureen H.; Levis-Dusseau, Silvina; Goldstein, Bradley J.; Schulman, Ivonne H.; Longsomboon, Bangon; Wolf, Ariel; Khan, Aisha; Heldman, Alan W.; Goldschmidt-Clermont, Pascal J.; Hare, Joshua M.

    2016-01-01

    Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty. PMID:26933813

  18. Evaluation of safety and immunogenicity of HNVAC, an MDCK-based H1N1 pandemic influenza vaccine, in Phase I single centre and Phase II/III multi-centre, double-blind, randomized, placebo-controlled, parallel assignment studies.

    PubMed

    Basavaraj, V H; Sampath, G; Hegde, Nagendra R; Mohan, V Krishna; Ella, Krishna M

    2014-07-31

    The clinical evaluation of the MDCK-based H1N1 pandemic influenza vaccine HNVAC in adults aged 18-65 years is reported. In the Phase I randomized, double-blind, placebo-controlled, single-centre study, 160 subjects were parallelly assigned 3:1 to vaccine:placebo groups (n=60:20) with both the aluminium hydroxide adjuvanted and non-adjuvanted vaccine formulations. A single dose of both the formulations containing 15 μg of haemagglutinin protein showed minimal adverse reactions, the most common of which were pain at injection site (11.67%) and fever (10.00%). Both formulations produced 74-81% seroprotection (SRP: titre of ≥40), 67-70% seroconversion (SRC: four-fold increase in titres between days 0 and 21), and a four-fold increase in geometric mean titres (GMT). Aluminium hydroxide did not have a significant effect either on immunogenicity or on reactogenicity. Nevertheless, based on its recognized positive effects on the stability and immunogenicity of many vaccines, and its marginal benefit in both pre-clinical and Phase I studies of HNVAC, alum adjuvanted HNVAC was further tested in a staggered Phase II/III randomized, double-blind, placebo-controlled, multi-centre study of 200 and 195 subjects, respectively, parallelly assigned 4:1 to adjuvanted vaccine and placebo groups. In these studies, the most common adverse reactions were pain at injection site (6.88% and 5.77% in Stage 1 and Stage 2, respectively) and fever (7.50% and 7.05%, respectively), and a single dose resulted in 87-90% SRP, 85-86% SRC, and a nearly six-fold increase in GMT, meeting or exceeding licensing criteria. It is concluded that HNVAC is safe and immunogenic to adults of 18-65 years.

  19. A randomized, double-blind, placebo-controlled trial of resveratrol for Alzheimer disease

    PubMed Central

    Thomas, Ronald G.; Craft, Suzanne; van Dyck, Christopher H.; Mintzer, Jacobo; Reynolds, Brigid A.; Brewer, James B.; Rissman, Robert A.; Raman, Rema; Aisen, Paul S.

    2015-01-01

    Objective: A randomized, placebo-controlled, double-blind, multicenter 52-week phase 2 trial of resveratrol in individuals with mild to moderate Alzheimer disease (AD) examined its safety and tolerability and effects on biomarker (plasma Aβ40 and Aβ42, CSF Aβ40, Aβ42, tau, and phospho-tau 181) and volumetric MRI outcomes (primary outcomes) and clinical outcomes (secondary outcomes). Methods: Participants (n = 119) were randomized to placebo or resveratrol 500 mg orally once daily (with dose escalation by 500-mg increments every 13 weeks, ending with 1,000 mg twice daily). Brain MRI and CSF collection were performed at baseline and after completion of treatment. Detailed pharmacokinetics were performed on a subset (n = 15) at baseline and weeks 13, 26, 39, and 52. Results: Resveratrol and its major metabolites were measurable in plasma and CSF. The most common adverse events were nausea, diarrhea, and weight loss. CSF Aβ40 and plasma Aβ40 levels declined more in the placebo group than the resveratrol-treated group, resulting in a significant difference at week 52. Brain volume loss was increased by resveratrol treatment compared to placebo. Conclusions: Resveratrol was safe and well-tolerated. Resveratrol and its major metabolites penetrated the blood–brain barrier to have CNS effects. Further studies are required to interpret the biomarker changes associated with resveratrol treatment. Classification of evidence: This study provides Class II evidence that for patients with AD resveratrol is safe, well-tolerated, and alters some AD biomarker trajectories. The study is rated Class II because more than 2 primary outcomes were designated. PMID:26362286

  20. Oral clonidine and gabapentin suppress pressor response: A prospective, randomized, double blind study

    PubMed Central

    Kapse, Upendra Kumar S.; Bhalerao, Pradnya Milind

    2016-01-01

    Background: Pressor response is a part of stress response caused by reflex sympathetic discharge due to direct laryngoscopy and tracheal intubation resulting in tachycardia, hypertension and arrhythmias. Both clonidine, and gabapentin administered orally can effectively blunt this detrimental hemodynamic response. Aim: To study the effect of oral clonidine to blunt the pressor response to direct laryngoscopy and to compare it with oral gabapentin. To observe for postoperative sedation and side effects if any. Settings and Design: Sixty patients of American Society of Anaesthesiologist Grade I and II scheduled for surgery under general anesthesia were considered in this prospective randomized double-blind study. They were randomly allocated into two groups of 30 each using computerized randomization. Materials and Methods: Group A was given oral clonidine 5 μg/kg and Group B was given oral gabapentin 800 mg. Both the drugs were given 90 min prior to surgery. Heart rate (HR) and blood pressure were monitored at baseline, 0, 1, 3, 5, 10, 15, and 30th min of laryngoscopy. Sedation was monitored by Ramsay Sedation Scale score and side effects were noted. Results: HR decreased in both groups at 0 and 1 min, increased at 3rd min and gradually decreased by 30th min. Statistically, significant difference was found between two groups at 1, 3, 5, 10, and 15th min (P < 0.05). Though there was no significant difference in systolic blood pressure, diastolic blood pressure and mean arterial pressure between the two groups, there was no rise in these parameters. Gabapentin produced more sedation than clonidine postoperatively, and few side effects were noted. Conclusion: Both oral clonidine and gabapentin are effective in obtunding pressor response to direct laryngoscopy, clonidine being better in terms of controlling HR. Gabapentin produces more postoperative sedation than clonidine. PMID:26957684

  1. Zonisamide for Bipolar Disorder, Mania or Mixed States: A Randomized, Double Blind, Placebo-Controlled Adjunctive Trial

    PubMed Central

    Dauphinais, Deborah; Knable, Michael; Rosenthal, Joshua; Polanski, Mark; Rosenthal, Norman

    2011-01-01

    Objective This is the first multicenter, double blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of adjunctive zonisamide for the treatment of bipolar mania or mixed state. Experimental design One hundred four patients with Bipolar Disorder, Type I, II or NOS, in a manic, hypomanic or mixed state of illness were randomized to either adjunctive zonisamide or placebo. The study consisted of three phases: a 7 to 30 day screening and stabilization phase, 6 weeks of blinded treatment and a 1 to 3 week discontinuation phase. The primary outcome variable for manic and hypomanic patients was the Young Mania Rating Scale (YMRS) both the YMRS and Montgomery Asberg Depression Rating Scale (MADRS) served as primary outcome variables for patients in mixed states. Secondary outcome measures included the Clinical Global Impression for Bipolar Disorder (CGI-BP), the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and an a priori analysis of response and remission. Metabolic parameters including weight, waist-hip ratio, body mass index, fasting glucose, cholesterol and triglyceride levels were also analyzed. Side effects were measured using the SAFTEE. Principal observations There were no statistically significant differences for any of the primary or secondary outcome measures between zonisamide and placebo-treated patients. Conclusions In contrast to previous studies that suggested efficacy of adjunctive zonisamide in bipolar mania or mixed state, these results were not confirmed in this double blind controlled study. PMID:22506436

  2. Blindness

    MedlinePlus

    ... The problem may affect one eye or both eyes. When you think of being blind, you might imagine total darkness. But most people who are blind can still see a little light or shadows. They just can't see things clearly. People who have some sight, but still need a lot of help, are ...

  3. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    PubMed Central

    Chow, Roberta; Pirotta, Marie

    2008-01-01

    Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection. PMID:18955233

  4. Maximum a posteriori blind image deconvolution with Huber-Markov random-field regularization.

    PubMed

    Xu, Zhimin; Lam, Edmund Y

    2009-05-01

    We propose a maximum a posteriori blind deconvolution approach using a Huber-Markov random-field model. Compared with the conventional maximum-likelihood method, our algorithm not only suppresses noise effectively but also significantly alleviates the artifacts produced by the deconvolution process. The performance of this method is demonstrated by computer simulations.

  5. Double-blind randomized controlled study of coblation tonsillotomy versus coblation tonsillectomy on postoperative pain.

    PubMed

    Arya, A; Donne, A J; Nigam, A

    2003-12-01

    This double-blind randomized controlled trial of coblation tonsillotomy versus coblation tonsillectomy uses visual analogue scoring to compare the pain experienced in the 24h postoperative period. No statistically significant difference in pain is demonstrated in the group of 14 patients studied. Tonsillectomy is recommended over tonsillotomy.

  6. Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

    ERIC Educational Resources Information Center

    Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

    2004-01-01

    Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

  7. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  8. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  9. Evaluation of immunogenicity and safety of the new tetanus-reduced diphtheria (Td) vaccines (GC1107) in healthy Korean adolescents: a phase II, double-blind, randomized, multicenter clinical trial.

    PubMed

    Rhim, Jung-Woo; Lee, Kyung-Yil; Kim, Sang-Yong; Kim, Jong-Hyun; Kim, Hyun-Hee; Kim, Hwang Min; Choi, Young-Youn; Ma, Sang-Hyuk; Kim, Dong-Ho; Ahn, Dong Ho; Kang, Jin-Han

    2013-04-01

    This phase II clinical trial was conducted to compare the immunogenicity and safety of a newly developed tetanus-reduced diphtheria (Td) vaccine (GC1107-T5.0 and GC1107-T7.5) and control vaccine. This study was also performed to select the proper dose of tetanus toxoid in the new Td vaccines. Healthy adolescents aged between 11 and 12 yr participated in this study. A total of 130 subjects (44 GC1107-T5.0, 42 GC1107-T7.5 and 44 control vaccine) completed a single dose of vaccination. Blood samples were collected from the subjects before and 4 weeks after the vaccination. In this study, all subjects (100%) in both GC1107-T5.0 and GC1107-T7.5 groups showed seroprotective antibody levels (≥ 0.1 U/mL) against diphtheria or tetanus toxoids. After the vaccination, the geometric mean titer (GMT) against diphtheria was significantly higher in Group GC1107-T5.0 (6.53) and GC1107-T7.5 (6.11) than in the control group (3.96). The GMT against tetanus was 18.6 in Group GC1107-T5.0, 19.94 in GC1107-T7.5 and 19.01 in the control group after the vaccination. In this study, the rates of local adverse reactions were 67.3% and 59.1% in GC1107-T5.0 and GC1107-7.5, respectively. No significant differences in the number of adverse reactions, prevalence and degree of severity of the solicited and unsolicited adverse reactions were observed among the three groups. Thus, both newly developed Td vaccines appear to be safe and show good immunogenicity. GC1107-T5.0, which contains relatively small amounts of tetanus toxoid, has been selected for a phase III clinical trial.

  10. A Wearable Proprioceptive Stabilizer (Equistasi®) for Rehabilitation of Postural Instability in Parkinson’s Disease: A Phase II Randomized Double-Blind, Double-Dummy, Controlled Study

    PubMed Central

    Volpe, Daniele; Giantin, Maria Giulia; Fasano, Alfonso

    2014-01-01

    Background Muscle spindles endings are extremely sensitive to externally applied vibrations, and under such circumstances they convey proprioceptive inflows to the central nervous system that modulate the spinal reflexes excitability or the muscle responses elicited by postural perturbations. The aim of this pilot study is to test the feasibility and effectiveness of a balance training program in association with a wearable proprioceptive stabilizer (Equistasi) that emits focal mechanical vibrations in patients with PD. Methods Forty patients with PD were randomly divided in two groups wearing an active or inactive device. All the patients received a 2-month intensive program of balance training. Assessments were performed at baseline, after the rehabilitation period (T1), and two more months after (T2). Posturographic measures were used as primary endpoint; secondary measures of outcome included the number of falls and several clinical scales for balance and quality of life. Results Both groups improved at the end of the rehabilitation period and we did not find significant between-group differences in any of the principal posturographic measures with the exception of higher sway area and limit of stability on the instrumental functional reach test during visual deprivation at T1 in the Equistasi group. As for the secondary outcome, we found an overall better outcome in patients enrolled in the Equistasi group: 1) significant improvement at T1 on Berg Balance Scale (+45.0%, p = .026), Activities-specific Balance Confidence (+83.7, p = .004), Falls Efficacy Scale (−33.3%, p = .026) and PDQ-39 (−48.8%, p = .004); 2) sustained improvement at T2 in terms of UPDRS-III, Berg Balance Scales, Time Up and Go and PDQ-39; 3) significant and sustained reduction of the falls rate. Conclusions This pilot trial shows that a physiotherapy program for training balance in association with focal mechanical vibration exerted by a wearable proprioceptive stabilizer

  11. Palonosetron and granisetron in postoperative nausea vomiting: A randomized double-blind prospective study

    PubMed Central

    Gugale, Amrita A.; Bhalerao, Pradnya Milind

    2016-01-01

    Background: Postoperative nausea and vomiting (PONV) is a common occurrence after laparoscopic surgeries. A number of pharmacological agents (antihistamines, butyrophenones, dopamine receptor antagonists) have been tried of which the 5-hydroxytryptamine type 3 receptor antagonists are devoid of most side effects and highly effective in prevention and treatment of PONV. Thus, we evaluated the effectiveness of granisetron and palonosetron in prevention of PONV after laparoscopic surgeries under general anesthesia. Aims: We conducted a study to evaluate the effectiveness of granisetron and palonosetron, to compare the duration of action and side effects if any, in patients undergoing elective laparoscopic surgery under general anesthesia. Settings and Design: This was a prospective, randomized, double-blinded, comparative study. Sixty patients (18–65 years of age) of the American Society of Anesthesiologists Grade I and II undergoing elective laparoscopic surgeries were considered. Materials and Methods: They were randomly allocated into one of the two groups (Group G and Group P) of thirty patients each. Group G received injection granisetron 0.05 mg/kg; Group P received injection palonosetron 1.5 mcg/kg intravenous bolus 30 min before the induction of anesthesia. Statistical Tests: All statistical analyses were performed using the SPSS® statistical package version 18.0 (Chicago: SPSS Inc). Two independent sample t-test was used for quantitative data, and the χ2 or Fisher's exact test was used for qualitative data. A difference was regarded as statistically significant at a P < 0.05. Results: The need for rescue antiemetic was significantly lower in Group P in the 24–72 h postoperative period (ρ - 0.007). The PONV score was significantly less in Group P in the same period (ρ - 0.008). The incidence of side effects was statistically insignificant in both the groups (ρ - 0.999). Conclusion: Prophylactic therapy with palonosetron is more effective than

  12. A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN®) in 56-80-Year-Old Subjects

    PubMed Central

    Greenberg, Richard N.; Hay, Christine M.; Stapleton, Jack T.; Marbury, Thomas C.; Wagner, Eva; Kreitmeir, Eva; von Krempelhuber, Alfred; Young, Philip; Nichols, Richard; Meyer, Thomas P.; Weigl, Josef; Virgin, Garth; Arndtz-Wiedemann, Nathaly; Chaplin, Paul

    2016-01-01

    Background Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56–80 years old population. Methods MVA with a virus titer of 1 x 108 TCID50/dose was administered via subcutaneous injection to 56–80 year old vaccinia-experienced subjects (N = 120). Subjects received either two injections of MVA (MM group) or one injection of Placebo and one injection of MVA (PM group) four weeks apart. Safety was evaluated by assessment of adverse events (AE), focused physical exams, electrocardiogram recordings and safety laboratories. Solicited AEs consisted of a set of pre-defined expected local reactions (erythema, swelling, pain, pruritus, and induration) and systemic symptoms (body temperature, headache, myalgia, nausea and fatigue) and were recorded on a memory aid for an 8-day period following each injection. The immunogenicity of the vaccine was evaluated in terms of humoral immune responses measured with a vaccinia-specific enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT) before and at different time points after vaccination. Results Vaccinations were well tolerated by all subjects. No serious adverse event related to MVA and no case of myopericarditis was reported. The overall incidence of unsolicited AEs was similar in both groups. For both groups immunogenicity responses two weeks after the final vaccination (i.e. Visit 4) were as follows: Seroconversion (SC) rates (doubling of titers from baseline) in vaccine specific antibody titers measured by ELISA were 83.3% in Group MM and 82.8% in Group PM (difference 0.6% with 95% exact CI [-13.8%, 15.0%]), and 90.0% for Group MM and 77.6% for Group PM measured by PRNT (difference 12.4% with 95% CI of [-1.1%, 27.0%]). Geometric mean titers (GMT) measured by ELISA two weeks after

  13. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    PubMed Central

    Jin, Yulian; Zhao, Qing; Zhou, Kehua; Jing, Xianghong; Yu, Xiaochun; Fang, Jiliang; Liu, Zhishun; Zhu, Bing

    2015-01-01

    In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD), patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group) versus acupuncture at nonacupoints without manipulation (control group) once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups) and secondary (in the eight patients of the treatment group) outcomes as compared with baseline (P = 0.0078 to <0.0001); treatment group has better outcomes in all primary outcome measures (P < 0.0001 except for SDS (P = 0.0005)). Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group). Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion. PMID:26294930

  14. Comparison of two doses of ketoprofen to treat pain: a double-blind, randomized, noninferiority trial.

    PubMed

    Riou, Bruno; Plaisance, Patrick; Lecomte, François; Soulat, Louis; Orcel, Philippe; Mazoit, Jean-Xavier

    2014-02-01

    The aim of our study was to compare the efficacy and safety of two doses of ketoprofen (200 mg vs. 300 mg/day) in ambulatory emergency patients with pain related to traumatic and nontraumatic bone and joint diseases. We tested the hypothesis that the efficacy of the lower dose was not lower than that of the higher dose in a double-blind, randomized, noninferiority trial. Patients included in the study were aged 18-65 years with closed benign trauma of the motor system or acute noninfectious rheumatologic conditions, with a resting pain intensity ≥3/10 on a numeric pain scale (NPS), requiring ketoprofen for 5 days. The main end-point was based on two efficacy co-criteria: (i) mean change from baseline of resting pain intensity at the end of the day over 5 days and (ii) total intake of concomitant analgesics. We included 409 patients: 200 in the 200-mg group and 209 in the 300-mg group. The mean change in pain intensity at rest (difference between groups: 0.0, 95% CI -0.4 to 0.4; P = 1.00) and in analgesic consumption (difference between groups: -0.6, 95% CI -1.9 to 0.6; P = 0.33) was not significantly different between the two groups, and the differences were lower than the predefined inferiority margins (0.5 and 1.5, respectively), thus demonstrating noninferiority. No significant difference was noted in the incidence of adverse events (21% vs. 20%, P = 0.71). The efficacy of the 200-mg daily dose of ketoprofen in relieving pain in emergency cases was not inferior to that of the 300-mg dose.

  15. Safety and Efficacy Assessment of Two New Leprosy Skin Test Antigens: Randomized Double Blind Clinical Study

    PubMed Central

    Rivoire, Becky L.; Groathouse, Nathan A.; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chatra B.; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B.; Hagge, Deanna A.; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J.

    2014-01-01

    Background New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. Methods A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. Findings In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens

  16. Cerebrolysin enhances cognitive recovery of mild traumatic brain injury patients: double-blind, placebo-controlled, randomized study.

    PubMed

    Chen, Chun-Chung; Wei, Sung-Tai; Tsaia, Shiu-Chiu; Chen, Xian-Xiu; Cho, Der-Yang

    2013-12-01

    In adults, mild traumatic brain injury (MTBI) frequently results in impairments of cognitive functions which would lead to psychological consequences in the future. Cerebrolysin is a nootropic drug, and can significantly improve cognitive function in patients with Alzheimer's disease and stroke. The purpose of this study was to investigate how Cerebrolysin therapy enhances cognitive recovery for mild traumatic brain injury patients using a double-blinded, placebo-controlled, randomized phase II pilot study. Patients having head injury within 24 h sent to our hospital were screened and recruited if patients were alert and conscious, and had intracranial contusion haemorrhage. From July 2009 to June 2010, totally, thirty-two patients were recruited in the double-blinded, placebo-controlled, and randomized study. Patients were randomized to receive Cerebrolysin (Group A, once daily intravenous infusion of 30 mL Cerebrolysin over a 60-min period for 5 days) or placebo (Group B, same dosage and administration of normal saline as Group A). The primary outcome measures were differences of cognitive function including Mini-Mental Status Examination (MMSE), and Cognitive Abilities Screening Instrument (CASI) scores between baseline and week 1, between baseline and week 4, and between baseline and week 12. Thirty-two patients completed the trial. For Group A, the CASI score difference between baseline and week 12 was 21.0 ± 20.4, a significantly greater change than that of Group B (7.6 ± 12.1) (p = 0.0461). Besides, drawing function (one of the domains of CASI; p = 0.0066) on week 4 and both drawing function (p = 0.0472) and long-term memory (one of the domains of CASI; p = 0.0256) on week 12 were also found to be significantly improved in the patients receiving Cerebrolysin treatment. Our results suggest that Cerebrolysin improves the cognitive function of the MTBI in patients at 3rd month after injury, especially for long-term memory and drawing function.

  17. A randomized double-blind trial of two low dose combined oral contraceptives.

    PubMed

    Bounds, W; Vessey, M; Wiggins, P

    1979-04-01

    Fifty-five women using Loestrin-20 (20 microgram ethinyl oestradiol and 1 mg norethisterone acetate) as an oral contraceptive have been compared with a like number using Microgynon-30 (30 microgram ethinyl oestradiol and 150 microgram levonorgestrel) in a randomized, double-blind trial. Despite the small sample size, the main finding in the trial is clear-cut; Loestrin-20 provides poor cycle control and is thus less acceptable as an oral contraceptive than Microgynon-30. Although there is also a suggestion that Loestrin-20 may be less effective than Microgynon-30, the difference in the accidental pregnancy rates is not statistically significant.

  18. Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study.

    PubMed

    Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

    2015-09-01

    The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.

  19. Efficacy of nebulized L-epinephrine for treatment of croup: a randomized, double-blind study.

    PubMed

    Eghbali, Aziz; Sabbagh, Ali; Bagheri, Bahador; Taherahmadi, Hassan; Kahbazi, Manijeh

    2016-02-01

    The objective of this study was to compare the effect of L-epinephrine plus dexamethasone vs. dexamethasone for treatment of croup in children. A randomized, double-blind clinical trial was implemented on 174 patients with croup, aged from 6 months to 6 years, and admitted to the Amir Kabir Pediatric Hospital (Arak, Iran). After randomized allocation, patients were administered dexamethasone, and then, they received either saline or L-epinephrine. Westley croup scores, heart rate, respiratory rate, and blood pressure were recorded every half an hour for a total of 120 min. There was a significant difference in mean of croup scores between two groups (P < 0.009). In addition, a significant difference was seen on mean of heart rate between two groups (P < 0.026). Our results showed a considerable difference in reduction of velocity of croup scores in patients who received nebulized L-epinephrine compared to patients who received placebo.

  20. Double-Blind Randomized Trial of Pirfenidone in Chinese Idiopathic Pulmonary Fibrosis Patients.

    PubMed

    Huang, Hui; Dai, Hua Ping; Kang, Jian; Chen, Bao Yuan; Sun, Tie Ying; Xu, Zuo Jun

    2015-10-01

    Idiopathic pulmonary fibrosis (IPF) lacks effective treatment. Pirfenidone has been used to treat IPF patients. N-acetylcysteine (NAC) exerts antioxidant and antifibrotic effects on IPF cases.This study is a double-blind, modified placebo-controlled, randomized phase II trial of pirfenidone in Chinese IPF patients. We randomly assigned the enrolled Chinese IPF patients with mild to moderate impairment of pulmonary function to receive either oral pirfenidone (1800 mg per day) and NAC (1800 mg per day) or placebo and NAC (1800 mg per day) for 48 weeks. The primary endpoints were the changes in forced vital capacity (FVC) and walking distance and the lowest SPO2 during the 6-minute walk test (6MWT) at week 48. The key secondary endpoint was the progression-free survival time. This study is registered in ClinicalTrials.gov as number NCT01504334.Eighty-six patients were screened, and 76 cases were enrolled (pirfenidone + NAC: 38; placebo + NAC: 38). The effect of pirfenidone treatment was significant at the 24th week, but this effect did not persist to the 48th week. At the 24th week, the mean decline in both FVC and ΔSPO2 (%) during the 6MWT in the pirfenidone group was lower than that in the control group (-0.08 ± 0.20 L vs -0.22 ± 0.29 L, P = 0.02 and -3.44% ± 4.51% vs -6.29% ± 6.06%, P = 0.03, respectively). However, there was no significant difference between these 2 groups at the 48th week (-0.15 ± 0.25 L vs -0.25 ± 0.28 L, P = 0.11 and -4.25% ± 7.27% vs -5.31% ± 5.49%, P = 0.51, respectively). The pirfenidone treatment group did not achieve the maximal distance difference on the 6MWT at either the 24th or the 48th week. But pirfenidone treatment prolonged the progression-free survival time in the IPF patients (hazard ratio = 1.88, 95% confidence interval: 1.092-3.242, P = 0.02). In the pirfenidone group, the adverse event (AE) rate (52.63%) was higher than that in the control group (26.3%, P = 0.03). Rash was more common in the pirfenidone group (39

  1. Salivary antioxidants of male athletes after aerobic exercise and garlic supplementation on: A randomized, double blind, placebo-controlled study

    PubMed Central

    Damirchi, Arsalan; Saati Zareei, Alireza; Sariri, Reyhaneh

    2015-01-01

    Purpose Production of reactive oxygen species and reactive nitrogen species is a natural biological event in metabolism. However, the presence of antioxidants can highly reduce the negative effect of free radicals. Thus, the efficiency of antioxidant system in the physiology of exercise is very important. Design Considering the known antioxidant capacity of garlic, the purpose of this study was to evaluate the effect on combining 14 days aerobic exercise till exhaustion with garlic extract supplementation on the antioxidant capacity of saliva. Methods Sixteen young men volunteered to participate in this randomized, double blind, placebo-controlled study and were randomly placed into two groups, placebo (Group I) and garlic extract (Group II). The participants performed exhaustive aerobic exercise on a treadmill before and after supplementation. Their unstimulated salivary samples were collected before, immediately after, and 1 h after the activity. The antioxidant activity in terms of peroxidase (POD), superoxide dismutase (SOD), and catalase (CAT) was then measured in the collected samples using their specific substrates. Results A significant increase in salivary antioxidant activity of SOD, POD, and CAT was observed in saliva of the supplement group compared to the placebo group (P ≤ 0.05). Conclusion The findings from this study suggest that increased activity of antioxidant enzymes could possibly decrease exercise-induced oxidative damage in male athletes. PMID:26605139

  2. Oral zinc sulphate supplementation for six months in SCA2 patients: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Velázquez-Pérez, Luis; Rodríguez-Chanfrau, Jorge; García-Rodríguez, Julio Cesar; Sánchez-Cruz, Gilberto; Aguilera-Rodríguez, Raúl; Rodríguez-Labrada, Roberto; Rodríguez-Díaz, Julio Cesar; Canales-Ochoa, Nalia; Gotay, Dennis Almaguer; Almaguer Mederos, Luis E; Laffita Mesa, José M; Porto-Verdecia, Marlene; Triana, Consuelo González; Pupo, Noemí Rodríguez; Batista, Idania Hidalgo; López-Hernandez, Orestes D; Polanco, Iverlis Díaz; Novas, Arelis Jayme

    2011-10-01

    Cuban patients with Spinocerebellar Ataxia type 2 (SCA2) have reduced concentrations of zinc in serum and cerebrospinal fluid (CSF). To assess the effect and safety of zinc supplementation, 36 Cuban SCA2 patients were randomly assigned to receive daily either 50 mg ZnSO(4) or placebo, together with neurorehabilitation therapy in a randomized, double-blind, placebo-controlled clinical trial during 6 months. Outcome measures included the changes of zinc levels in CSF and serum, ataxia score, oxidative stress and saccadic eye movements. At the end of the study, the Zinc-treated group showed: (i) a significant increase of the Zn levels in the CSF, (ii) mild decrease in the ataxia scale subscores for gait, posture, stance and dysdiadochocinesia (iii) reduction of lipid's oxidative damage, and (iv) reduction of saccadic latency when compared with the placebo group. The treatment was safe and well tolerated by all subjects. This study demonstrated the efficacy and safety of Zn supplementation, combined with neurorehabilitation for SCA2 patients and therefore it may encourage further studies on the clinical effect of zinc supplementation in SCA2 based in the conduction of future clinical trials with higher number of subjects.

  3. Comparative Evaluation of Commercially Available Freeze Dried Powdered Probiotics on Mutans Streptococci Count: A Randomized, Double Blind, Clinical Study

    PubMed Central

    Nagaraj, Anup; Ganta, Shravani; Sidiq, Mohsin; Pareek, Sonia; Vishnani, Preeti; Acharya, Siddharth; Singh, Kushpal

    2015-01-01

    Objectives: Probiotic approaches are being considered to eliminate pathogenic microorganisms and are an alternative and promising way to combat infections by using harmless bacteria to displace pathogenic microorganisms. The aim of this study was to evaluate the effectiveness of commercially available freeze dried powdered probiotics on mutans streptococci count among 12–15 year-old Indian schoolchildren. Materials and Methods: The study was conducted in two phases of in-vitro (phase I) and in-vivo (phase II) study, which was a double blind, randomized and placebo controlled clinical trial. A total of 33 schoolchildren between 12–15 years were included in the study. They were randomly allocated to three groups. Group A included 11 children using freeze dried Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium bifidum and Bifidobacterium lactis. Group B included 11 children using freeze dried lactic acid bacillus only. Group C included 11 children using placebo powder. The study was conducted over a period of three weeks and examination and sampling of the subjects were done on days 0 (baseline), seven, 14 and 21. Results: For both the intervention groups A and B, statistically significant reduction (P<0.05) in salivary mutans streptococci counts was recorded up to the second week. Conclusion: Oral administration of probiotics showed a short-term effect on reduction of mutans streptococci count and showed a preventive role in caries development. PMID:27252756

  4. Oral zinc sulphate supplementation for six months in SCA2 patients: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Velázquez-Pérez, Luis; Rodríguez-Chanfrau, Jorge; García-Rodríguez, Julio Cesar; Sánchez-Cruz, Gilberto; Aguilera-Rodríguez, Raúl; Rodríguez-Labrada, Roberto; Rodríguez-Díaz, Julio Cesar; Canales-Ochoa, Nalia; Gotay, Dennis Almaguer; Almaguer Mederos, Luis E; Laffita Mesa, José M; Porto-Verdecia, Marlene; Triana, Consuelo González; Pupo, Noemí Rodríguez; Batista, Idania Hidalgo; López-Hernandez, Orestes D; Polanco, Iverlis Díaz; Novas, Arelis Jayme

    2011-10-01

    Cuban patients with Spinocerebellar Ataxia type 2 (SCA2) have reduced concentrations of zinc in serum and cerebrospinal fluid (CSF). To assess the effect and safety of zinc supplementation, 36 Cuban SCA2 patients were randomly assigned to receive daily either 50 mg ZnSO(4) or placebo, together with neurorehabilitation therapy in a randomized, double-blind, placebo-controlled clinical trial during 6 months. Outcome measures included the changes of zinc levels in CSF and serum, ataxia score, oxidative stress and saccadic eye movements. At the end of the study, the Zinc-treated group showed: (i) a significant increase of the Zn levels in the CSF, (ii) mild decrease in the ataxia scale subscores for gait, posture, stance and dysdiadochocinesia (iii) reduction of lipid's oxidative damage, and (iv) reduction of saccadic latency when compared with the placebo group. The treatment was safe and well tolerated by all subjects. This study demonstrated the efficacy and safety of Zn supplementation, combined with neurorehabilitation for SCA2 patients and therefore it may encourage further studies on the clinical effect of zinc supplementation in SCA2 based in the conduction of future clinical trials with higher number of subjects. PMID:21562746

  5. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies

    PubMed Central

    Hróbjartsson, Asbjørn; Emanuelsson, Frida; Skou Thomsen, Ann Sofia; Hilden, Jørgen; Brorson, Stig

    2014-01-01

    Background: Blinding patients in clinical trials is a key methodological procedure, but the expected degree of bias due to nonblinded patients on estimated treatment effects is unknown. Methods: Systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control) involving blinded patients and another, otherwise identical, sub-study involving nonblinded patients. Within each trial, we compared the difference in effect sizes (i.e. standardized mean differences) between the sub-studies. A difference <0 indicates that nonblinded patients generated a more optimistic effect estimate. We pooled the differences with random-effects inverse variance meta-analysis, and explored reasons for heterogeneity. Results: Our main analysis included 12 trials (3869 patients). The average difference in effect size for patient-reported outcomes was –0.56 (95% confidence interval –0.71 to –0.41), (I2 = 60%, P = 0.004), i.e. nonblinded patients exaggerated the effect size by an average of 0.56 standard deviation, but with considerable variation. Two of the 12 trials also used observer-reported outcomes, showing no indication of exaggerated effects due lack of patient blinding. There was a larger effect size difference in 10 acupuncture trials [–0.63 (–0.77 to –0.49)], than in the two non-acupuncture trials [–0.17 (–0.41 to 0.07)]. Lack of patient blinding also increased attrition and use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control group co-intervention risk 1.55 (0.99 to 2.43). Conclusions: This study provides empirical evidence of pronounced bias due to lack of patient blinding in complementary/alternative randomized clinical trials with patient-reported outcomes. PMID:24881045

  6. Hydroxyurea: a radiation potentiator in carcinoma of the uterine cervix. A randomized double-blind study

    SciTech Connect

    Piver, M.S.; Barlow, J.J.; Vongtama, V.; Blumenson, L.

    1983-12-01

    From June, 1972, to December, 1976, 40 patients with FIGO (International Federation of Gynaecology and Obstetrics) Stage IIB carcinoma of the uterine cervix were entered into a prospective, double-blind, randomized study to evaluate the possible radiation-potentiating properties (i.e., improved survival) of the S-phase cell cycle-specific inhibitor of DNA synthesis, hydroxyurea. All patients were documented to be without aortic lymph node metastasis by pretherapy staging para-aortic lymphadenectomy. All 40 patients were followed up for longer than 5 years (5.2 to 9.2 years) or until death. The double-blind code was not broken until all patients had been followed up for a minimum of 2 to 5 years. Leukopenia (white blood cell count less than 2,500 mm3) was significantly increased in the patients given hydroxyurea as compared to those given placebo (P less than 0.0001). There was no statistically significant difference relative to anemia, thrombocytopenia, radiation-induced skin reaction, and radiation-induced intestinal reaction between the patients given placebo or those given hydroxyurea. Life-table survival for the patients given hydroxyurea was 94% as compared to 53% for the patients given placebo (P . 0.006). Only one (5%) patient given hydroxyurea died of cervical cancer. Of the other patients who died in the group given hydroxyurea, all were confirmed by postmortem examination to have been without recurrent cervical cancer. In contrast, 45% (nine) of the patients given placebo died of cervical cancer.

  7. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    PubMed Central

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution. PMID:27247936

  8. Perioperative Continuous Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

    PubMed

    Fassoulaki, Argyro; Vassi, Emilia; Korkolis, Dimitrios; Zotou, Marianna

    2016-02-01

    Wound infusion with local anesthetics has been used for postoperative pain relief with variable results. This randomized, controlled, double-blind clinical trial examines the effect of ropivacaine infusion on pain after laparoscopic cholecystectomy. A total of 110 patients were randomly assigned to 2 groups. After induction of anesthesia a 75-mm catheter was inserted subcutaneously and connected to an elastomeric pump containing either 0.75% ropivacaine (ropivacaine group) or normal saline (control group) for 24 hours postoperatively. Before skin closure, each hole was infiltrated with 2 mL of 0.75% ropivacaine or normal saline according to randomization. Pain at rest, pain during cough, and analgesic consumption were recorded in the postanesthesia care unit and at 2, 4, 8, 24, and 48 hours postoperatively. Analgesic requirements and pain scores were recorded 1 and 3 months after surgery. The ropivacaine group reported less pain during cough (P=0.044) in the postanesthesia care unit (P=0.017) and 4 hours postoperatively (P=0.038). Ropivacaine wound infusion had no effect on late and chronic pain. PMID:26679680

  9. Ondasetron versus haloperidol for the treatment of postcardiotomy delirium: a prospective, randomized, double-blinded study

    PubMed Central

    2012-01-01

    Background To investigate the controlling efficacy of ondasetron and haloperidol in regard to the postcardiotomy delirium. Methods We included in this prospective, randomized, double-blinded study 80 patients who developed delirium after heart surgery with the application of heart lung-machine. The patients were divided into two, equally-sized groups, which on detection of delirium received ondasetron 8 mg iv or haloperidol 5 mg iv respectively. The statistical analysis compared the baseline and demographic characteristics of the two groups (age, gender, comorbidities, years of education, type of surgery etc.). Results Both ondasetron and haloperidol had very good delirium controlling effects, without statistically significant differences. Discussion-Conclusions Ondasetron and haloperidol are efficient agents as far as the treatment of postcardiotomy delirium is concerned. As, in addition, ondasetron bares milder side-effects, we believe this could be the agent of choice in patients developing postcardiotomy delirium in the future. PMID:22436170

  10. Single-Blind, Prospective, Randomized Study of Cefmetazole and Cefoxitin in the Treatment of Postcesarean Endometritis

    PubMed Central

    Martens, Mark; Grimes, David A.; Chatterjee, Molly; Noah, Melvin; Stamp-Cole, Marion M.; Perry, Kimberly T.; the Cefmetazole Study Group

    1995-01-01

    Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery. Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g IV q 6 h in a 2:1 ratio. The patients were followed for clinical responses and side effects. Results: The cure rate for cefmetazole was 89% and for cefoxitin it was 79% (P = 0.006). The adverse events were similar in both groups. Conclusions: Cefmetazole was significantly more effective than cefoxitin in the treatment of endometritis following cesarean delivery. PMID:18475417

  11. Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial

    PubMed Central

    McCarney, R; Fisher, P; Spink, F; Flint, G; van Haselen, R

    2002-01-01

    Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information. PMID:11934908

  12. Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients.

    PubMed

    Jackson, Carlayne E; Gronseth, Gary; Rosenfeld, Jeffrey; Barohn, Richard J; Dubinsky, Richard; Simpson, C Blake; McVey, April; Kittrell, Pamela P; King, Ruth; Herbelin, Laura

    2009-02-01

    Twenty ALS patients with sialorrhea refractory to medical therapy were enrolled in this double-blind, randomized study to receive either 2,500 U of botulinum toxin type B (BTxb) or placebo into the bilateral parotid and submandibular glands using electromyographic guidance. Patients who received BTxb reported a global impression of improvement of 82% at 2 weeks compared to 38% of those who received placebo (P < 0.05). This significant effect was sustained at 4 weeks. At 12 weeks, 50% of patients who received BTxb continued to report improvement compared to 14% of those who received placebo. There were no significant adverse events, including dysphagia, in the BTxb group, and there was no significant increase in the rate of decline of vital capacity.

  13. Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial.

    PubMed

    McCarney, R; Fisher, P; Spink, F; Flint, G; van Haselen, R

    2002-04-01

    Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information. PMID:11934908

  14. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial.

    PubMed

    dos Santos, Gisele Munhoes; Bento, Ricardo Ferreira; de Medeiros, Italo Roberto Torres; Oiticcica, Jeanne; da Silva, Eleonora Csipai; Penteado, Silvio

    2014-07-23

    Hearing aids with an integrated sound generator have been used to enhance the treatment of tinnitus. The main aim of this study was to verify whether the combined use of amplification and sound generator is more effective than conventional amplification alone in reducing tinnitus annoyance by means of the use of a new hearing aid with an integrated sound generator. A total of 49 patients underwent a blind randomized clinical trial. Tinnitus annoyance was measured by Tinnitus Handicap Inventory and numerical scales, and psychoacoustic measures of tinnitus were also performed. The sound generator was set at the lowest intensity capable of providing relief from tinnitus. Results showed that 62.5% of the patients presented a reduction in tinnitus annoyance in the combined fitting group and in the group with amplification alone, 78% showed a reduction. This difference between the groups was not statistically significant.

  15. Reiki therapy for postoperative oral pain in pediatric patients: Pilot data from a double-blind, randomized clinical trial

    PubMed Central

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P.; Doorenbos, Ardith Z.

    2014-01-01

    Purpose To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Methods This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Results Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Implications Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. PMID:24439640

  16. Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single-blind controlled pilot study.

    PubMed

    Smykla, A; Walewicz, K; Trybulski, R; Halski, T; Kucharzewski, M; Kucio, C; Mikusek, W; Klakla, K; Taradaj, J

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  17. It is possible to perform a double-blind hyperbaric session: a double-blinded randomized trial performed on healthy volunteers.

    PubMed

    Jansen, T; Mortensen, C R; Tvede, M F

    2009-01-01

    In hyperbaric medicine, blinded trials are remarkably few, making results susceptible to criticism. The scopes of the present study are to present a method for a double-blinded randomized clinical study and evaluate the validity of the method in a hyperbaric setting. Twenty-two healthy volunteers with no diving experience were included. The volunteers were randomized either to a "therapeutic pressure" group (15 msw, 253 kPa) or to a "placebo" group (2 msw, 120 kPa). The two profiles were made equal regarding noise, temperature and ventilation. The volunteers were asked whether they had been exposed to placebo or therapeutic pressure. They were asked to present their certainness of the answer on a visual analogue scale (VAS). Fisher's exact test calculates a probability of P = 0,328, which indicates that the volunteers have no valid opinion as to whether they were exposed to 15 msw or to 2 msw. It is found that it is possible to perform a blinded treatment on healthy volunteers with no prior diving experience. PMID:20112525

  18. A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

    ERIC Educational Resources Information Center

    Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

    2012-01-01

    Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

  19. Intrathecal Baclofen in Children with Spastic Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study

    ERIC Educational Resources Information Center

    Hoving, Marjanke A.; van Raak, Elisabeth P. M.; Spincemaille, Geert H. J. J.; Palmans, Liesbeth J.; Sleypen, Frans A. M.; Vles, Johan S. H.

    2007-01-01

    Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB…

  20. A Double-Blind, Randomized, Placebo-Controlled Trial of Escitalopram in the Treatment of Pediatric Depression

    ERIC Educational Resources Information Center

    Wagner, Karen Dineen; Jonas, Jeffrey; Findling, Robert L.; Ventura, Daniel; Saikali, Khalil

    2006-01-01

    Objective: Escitalopram is a selective serotonin reuptake inhibitor antidepressant indicated for use in adults. This trial examined the efficacy and safety of escitalopram in pediatric depression. Method: Patients (6-17 years old) with major depressive disorder were randomized to receive 8 weeks of double-blind flexibly dosed treatment with…

  1. Efficacy of Trimetazidine Dihydrochloride for Relieving Chronic Tinnitus: A Randomized Double-Blind Study

    PubMed Central

    Kumral, Tolgar Lütfi; Yıldırım, Güven; Berkiten, Güler; Saltürk, Ziya; Ataç, Enes; Atar, Yavuz; Uyar, Yavuz

    2016-01-01

    Objectives. To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. Methods. A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. Results. The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). Conclusion. Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus. PMID:27230273

  2. Efficacy of total lymphoid irradiation in intractable rheumatoid arthritis. A double-blind, randomized trial

    SciTech Connect

    Strober, S.; Tanay, A.; Field, E.; Hoppe, R.T.; Calin, A.; Engleman, E.G.; Kotzin, B.; Brown, B.W.; Kaplan, H.S.

    1985-04-01

    Twenty-six patients participated in a randomized, double-blind study of the efficacy of total lymphoid irradiation in the treatment of intractable rheumatoid arthritis. All 26 patients, for whom therapy with gold compounds and penicillamine had failed, would ordinarily have been considered candidates for cytotoxic or antimetabolite drug therapy. Thirteen patients randomly assigned to receive full-dose total lymphoid irradiation (2000 rad) and 11 patients assigned to receive control low-dose total lymphoid irradiation (200 rad) completed radiotherapy. Alleviation of joint disease activity was significantly greater in the high-dose group as judged by morning stiffness, joint tenderness, and functional assessment (global composite score) at 3 and 6 months after radiotherapy. The high-dose group had a marked reduction in both T-lymphocyte function and numbers, but this finding was not observed in the low-dose group. Complications seen in the high-dose but not low-dose group included transient neutropenia, thrombocytopenia, pericarditis, and pleurisy.

  3. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    PubMed

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain. PMID:27537209

  4. A randomized, blinded, controlled trial investigating the gastrointestinal health effects of drinking water quality.

    PubMed Central

    Hellard, M E; Sinclair, M I; Forbes, A B; Fairley, C K

    2001-01-01

    A double-blinded, randomized, controlled trial was carried out in in Melbourne, Australia, to determine the contribution of drinking water to gastroenteritis. Melbourne is one of the few major cities in the world that draws drinking water from a protected forest catchment with minimal water treatment (chlorination only). Six hundred families were randomly allocated to receive either real or sham water treatment units (WTUs) installed in their kitchen. Real units were designed to remove viruses, bacteria, and protozoa. Study participants completed a weekly health diary reporting gastrointestinal symptoms during the 68-week observation period. There were 2,669 cases of highly credible gastroenteritis (HCG) during the study (0.80 cases/person/year). The ratio of HCG episode rates for the real WTU group compared to the sham WTU group was 0.99 (95% confidence interval, 0.85-1.15, p = 0.85). We collected 795 fecal specimens from participants with gastroenteritis, and pathogens were not more significantly common in the sham WTU group. We found no evidence of waterborne disease in Melbourne. The application of this methodology to other water supplies will provide a better understanding of the relationship between human health and water quality. PMID:11564611

  5. Bupropion and naltrexone for smoking cessation: A double-blind randomized placebo-controlled clinical trial.

    PubMed

    Mooney, M E; Schmitz, J M; Allen, S; Grabowski, J; Pentel, P; Oliver, A; Hatsukami, D K

    2016-10-01

    Combination of non-nicotine pharmacotherapies has been underexamined for cigarette smoking cessation. A randomized, double-blind, parallel-group double-dummy study evaluated two medications, bupropion (BUP) and naltrexone (NTX), in treatment-seeking cigarette smokers (N = 121) over a 7-week treatment intervention with 6-month follow-up. Smokers were randomized to either BUP (300 mg/day) + placebo (PBO) or BUP (300 mg/day) + NTX (50 mg/day). The primary outcome was biochemically verified (saliva cotinine, carbon monoxide) 7-day, point-prevalence abstinence. BUP + NTX was associated with significantly higher point-prevalence abstinence rates after 7-weeks of treatment (BUP + NTX, 54.1%; BUP + PBO, 33.3%), P = 0.0210, but not at 6-month follow-up (BUP + NTX, 27.9%; BUP + PBO, 15.0%), P = 0.09. Continuous abstinence rates did not differ, P = 0.0740 (BUP + NTX, 26.2%; BUP + PBO, 13.3%). Those receiving BUP + NTX reported reduced nicotine withdrawal, P = 0.0364. The BUP + NTX combination was associated with elevated rates of some side effects, but with no significant difference in retention between the groups. PMID:27213949

  6. A double-blind, randomized, placebo-controlled study of nifedipine on early renal allograft function.

    PubMed

    Wilkie, M E; Beer, J C; Evans, S J; Raftery, M J; Lord, R H; Moore, R; Marsh, F P

    1994-01-01

    A double-blind, randomized, placebo-controlled study was conducted to determine the effect of nifedipine on early renal allograft function when added to a triple therapy immunosuppression regime comprising low-dose cyclosporin (CsA), prednisolone and azathioprine. Fifty adult cadaveric renal allograft recipients were randomized to placebo (group P n = 17), nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 48 h, followed by matching placebo for 3 months (group NS n = 16) or nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 3 months (group NL n = 17). Donor and recipient exclusion criteria included recent calcium antagonist treatment. At 3 months after transplantation mean GFR adjusted for graft loss was significantly higher in group NL than in NS (mean +/- SD 61 +/- 28 versus 34 +/- 25 ml/min/1.73 m2; P < 0.05), group P being intermediate (45 +/- 34 ml/min/1.73 m2). Similarly, effective renal blood flow (ERBF) at 3 months was higher in group NL than in groups P and NS (mean +/- SD 351 +/- 175 versus 216 +/- 166 and 220 +/- 162 ml/min/1.73 m2; P < 0.05). The differences were not significant by 6 months post-transplantation. This study suggests that oral nifedipine commenced preoperatively and continued for 3 months following transplantation has beneficial effects on early renal allograft function when incorporated as part of an immunotherapy regimen based on cyclosporin.

  7. Randomized, blinded trial of weekend vs daily prednisone in Duchenne muscular dystrophy

    PubMed Central

    Hache, L.P.; Clemens, P.R.; Cnaan, A.; McDonald, C.M.; Viswanathan, V.; Kornberg, A.J.; Bertorini, T.E.; Nevo, Y.; Lotze, T.; Pestronk, A.; Ryan, M.M.; Monasterio, E.; Day, J.W.; Zimmerman, A.; Arrieta, A.; Henricson, E.; Mayhew, J.; Florence, J.; Hu, F.; Connolly, A.M.

    2011-01-01

    Objective: To perform a double-blind, randomized study comparing efficacy and safety of daily and weekend prednisone in boys with Duchenne muscular dystrophy (DMD). Methods: A total of 64 boys with DMD who were between 4 and 10 years of age were randomized at 1 of 12 centers of the Cooperative International Neuromuscular Research Group. Efficacy and safety of 2 prednisone schedules (daily 0.75 mg/kg/day and weekend 10 mg/kg/wk) were evaluated over 12 months. Results: Equivalence was met for weekend and daily dosing of prednisone for the primary outcomes of quantitative muscle testing (QMT) arm score and QMT leg score. Secondary strength scores for QMT elbow flexors also showed equivalence between the 2 treatment groups. Overall side effect profiles of height and weight, bone density, cataract formation, blood pressure, and behavior, analyzed at 12 months, did not differ between weekend and daily dosing of prednisone. Conclusions: Weekend dosing of prednisone is equally beneficial to the standard daily dosing of prednisone. Analysis of side effect profiles demonstrated overall tolerability of both dosing regimens. Classification of evidence: This study provides Class I evidence that weekend prednisone dosing is as safe and effective as daily prednisone in preserving muscle strength and preventing body mass index increases in boys with DMD over a 12-month period. PMID:21753160

  8. Efficacy of Trimetazidine Dihydrochloride for Relieving Chronic Tinnitus: A Randomized Double-Blind Study

    PubMed Central

    Kumral, Tolgar Lütfi; Yıldırım, Güven; Berkiten, Güler; Saltürk, Ziya; Ataç, Enes; Atar, Yavuz; Uyar, Yavuz

    2016-01-01

    Objectives: To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. Methods: A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. Results: The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). Conclusion: Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus. PMID:27230273

  9. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    PubMed

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  10. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    PubMed Central

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. Desire, arousal, lubrication, orgasm, satisfaction, and pain were measured at baseline and after 4 weeks after the end of the treatment by using the Female Sexual Function Index (FSFI). Two groups were compared by repeated measurement ANOVA test. Results Thirty women in placebo group and thirty women in drug group completed the study. At the end of the fourth week, patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI (p < 0.001), desire (p < 0.001), arousal (p = 0.037), lubrication (p < 0.001), satisfaction (p < 0.001) and pain (p = 0.041) domains of FSFI. Frequency of side effects was similar between the two groups. Conclusions Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder. Further investigation of Tribulus terrestris in women is warranted. PMID:24773615

  11. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    PubMed

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  12. A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease

    PubMed Central

    Bell, K.L.; Galasko, D.; Galvin, J.E.; Thomas, R.G.; van Dyck, C.H.; Aisen, P.S.

    2011-01-01

    Background: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. Objective: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. Methods: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale–cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior. Results: A total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment. Conclusion: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. Classification of evidence: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog. PMID:21795660

  13. Alpha-blockade and thiazide treatment of hypertension. A double-blind randomized trail comparing doxazosin and hydrochlorothiazide.

    PubMed

    Grimm, R H; Flack, J M; Schoenberger, J A; Gonzalez, N M; Liebson, P R

    1996-05-01

    This trial involved 107 patients in a two-group, parallel, double-blind, randomized study comparing the diuretic, hydrochlorothiazide (HCTZ) (dose 25 to 50 mg) and the alpha 1 antagonist, doxazosin (dose 2 to 16 mg). All randomized participants were followed for at least 1 year. Participants were recruited from the community. The study was carried out in four phases: Phase I-Baseline; Phase II-Monotherapy Titration; Phase III-Combination Therapy Titration; and Phase IV-Maintenance. The following measures were carried out: blood pressure, biochemistries, lipids/lipoproteins, quality of life, ambulatory electrocardiograms, echocardiograms, adverse experiences, and drug adherence. Both drugs were well tolerated, with only 4% taken off doxazosin and 7% off HCTZ. Adverse experiences were uncommon and mostly mild. Both drugs were effective in managing hypertension over 1 year of therapy. There was no difference noted in terms of efficacy of blood pressure lowering between the two study drugs, nor was there any evidence of tolerance developing or of any serious adverse effects. Average final doses for drugs were 7.8 mg for doxazosin and 36 mg for HCTZ. The results show that, over the course of 1 year, both drugs significantly lowered systolic and diastolic pressures compared to baseline; doxazosin (-19 and -16 mm Hg); HCTZ (-22 and 15 mm Hg). Blood pressure lowering was not significantly different between drugs. Sitting heart rate was not affected by drugs. Changes in quality of life measures were similar between groups. Echocardiographic measures at 1 year showed significant between-drug differences in change in left internal end systolic and diastolic dimensions and end systolic stress. Both doxazosin and HCTZ were effective drugs over 1 year for treating hypertension.

  14. Effects of negative air ions on oxygen uptake kinetics, recovery and performance in exercise: a randomized, double-blinded study

    NASA Astrophysics Data System (ADS)

    Nimmerichter, Alfred; Holdhaus, Johann; Mehnen, Lars; Vidotto, Claudia; Loidl, Markus; Barker, Alan R.

    2014-09-01

    Limited research has suggested that acute exposure to negatively charged ions may enhance cardio-respiratory function, aerobic metabolism and recovery following exercise. To test the physiological effects of negatively charged air ions, 14 trained males (age: 32 ± 7 years; : 57 ± 7 mL min-1 kg-1) were exposed for 20 min to either a high-concentration of air ions (ION: 220 ± 30 × 103 ions cm-3) or normal room conditions (PLA: 0.1 ± 0.06 × 103 ions cm-3) in an ionization chamber in a double-blinded, randomized order, prior to performing: (1) a bout of severe-intensity cycling exercise for determining the time constant of the phase II response ( τ) and the magnitude of the slow component (SC); and (2) a 30-s Wingate test that was preceded by three 30-s Wingate tests to measure plasma [adrenaline] (ADR), [nor-adrenaline] (N-ADR) and blood [lactate] (BLac) over 20 min during recovery in the ionization chamber. There was no difference between ION and PLA for the phase II τ (32 ± 14 s vs. 32 ± 14 s; P = 0.7) or SC (404 ± 214 mL vs 482 ± 217 mL; P = 0.17). No differences between ION and PLA were observed at any time-point for ADR, N-ADR and BLac as well as on peak and mean power output during the Wingate tests (all P > 0.05). A high-concentration of negatively charged air ions had no effect on aerobic metabolism during severe-intensity exercise or on performance or the recovery of the adrenergic and metabolic responses after repeated-sprint exercise in trained athletes.

  15. Visual BOLD Response in Late Blind Subjects with Argus II Retinal Prosthesis

    PubMed Central

    Castaldi, E.; Cicchini, G. M.; Cinelli, L.; Rizzo, S.; Morrone, M. C.

    2016-01-01

    Retinal prosthesis technologies require that the visual system downstream of the retinal circuitry be capable of transmitting and elaborating visual signals. We studied the capability of plastic remodeling in late blind subjects implanted with the Argus II Retinal Prosthesis with psychophysics and functional MRI (fMRI). After surgery, six out of seven retinitis pigmentosa (RP) blind subjects were able to detect high-contrast stimuli using the prosthetic implant. However, direction discrimination to contrast modulated stimuli remained at chance level in all of them. No subject showed any improvement of contrast sensitivity in either eye when not using the Argus II. Before the implant, the Blood Oxygenation Level Dependent (BOLD) activity in V1 and the lateral geniculate nucleus (LGN) was very weak or absent. Surprisingly, after prolonged use of Argus II, BOLD responses to visual input were enhanced. This is, to our knowledge, the first study tracking the neural changes of visual areas in patients after retinal implant, revealing a capacity to respond to restored visual input even after years of deprivation. PMID:27780207

  16. Blinding Measured: A Systematic Review of Randomized Controlled Trials of Acupuncture

    PubMed Central

    Moroz, Alex; Freed, Brian; Tiedemann, Laura; Bang, Heejung; Howell, Melanie; Park, Jongbae J.

    2013-01-01

    Background. There is no agreement among researchers on viable controls for acupuncture treatment, and the assessment of the effectiveness of blinding and its interpretation is rare. Purpose. To systematically assess the effectiveness of blinding (EOB) in reported acupuncture trials; to explore results of RCTs using a quantitative measure of EOB. Data Sources. A systematic review of published sham RCTs that assessed blinding. Study Selection. Five hundred and ninety studies were reviewed, and 54 studies (4783 subjects) were included. Data Extraction. The number of patients who guessed their treatment identity was extracted from each study. Variables with possible influence on blinding were identified. Data Synthesis. The blinding index was calculated for each study. Based on blinding indexes, studies were congregated into one of the nine blinding scenarios. Individual study characteristics were explored for potential association with EOB. Limitations. There is a possibility of publication or reporting bias. Conclusions. The most common scenario was that the subjects believed they received verum acupuncture regardless of the actual treatment received, and overall the subject blinding in the acupuncture studies was satisfactory, with 61% of study participants maintaining ideal blinding. Objectively calculated blinding data may offer meaningful and systematic ways to further interpret the findings of RCTs. PMID:23533515

  17. Blinding measured: a systematic review of randomized controlled trials of acupuncture.

    PubMed

    Moroz, Alex; Freed, Brian; Tiedemann, Laura; Bang, Heejung; Howell, Melanie; Park, Jongbae J

    2013-01-01

    Background. There is no agreement among researchers on viable controls for acupuncture treatment, and the assessment of the effectiveness of blinding and its interpretation is rare. Purpose. To systematically assess the effectiveness of blinding (EOB) in reported acupuncture trials; to explore results of RCTs using a quantitative measure of EOB. Data Sources. A systematic review of published sham RCTs that assessed blinding. Study Selection. Five hundred and ninety studies were reviewed, and 54 studies (4783 subjects) were included. Data Extraction. The number of patients who guessed their treatment identity was extracted from each study. Variables with possible influence on blinding were identified. Data Synthesis. The blinding index was calculated for each study. Based on blinding indexes, studies were congregated into one of the nine blinding scenarios. Individual study characteristics were explored for potential association with EOB. Limitations. There is a possibility of publication or reporting bias. Conclusions. The most common scenario was that the subjects believed they received verum acupuncture regardless of the actual treatment received, and overall the subject blinding in the acupuncture studies was satisfactory, with 61% of study participants maintaining ideal blinding. Objectively calculated blinding data may offer meaningful and systematic ways to further interpret the findings of RCTs.

  18. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS).

    PubMed

    Shapiro, Alice C; Adlis, Susan A; Robien, Kim; Kirstein, Mark N; Liang, Shuang; Richter, Sara A; Lerner, Rachel E

    2016-02-01

    The purpose of the study was to evaluate the efficacy and safety of vitamin D3 at 4000 IU/day as a treatment option for aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D3. We conducted a single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stages I-IIIA breast cancer, taking AI and experiencing AIMSS [breast cancer prevention trial symptom scale-musculoskeletal (BCPT-MS) subscale ≥1.5] were admitted. Following randomization, 116 patients had a run-in period of 1 month on 600 IU D3, then began the randomized assignment to either 600 IU D3 (n = 56) or 4000 IU D3 (n = 57) daily for 6 months. The primary endpoint was a change in AIMSS from baseline (after 1 month run-in) on the BCPT-MS (general MS pain, joint pain, muscle stiffness, range for each question: 0 = not at all to 4 = extremely). Groups had no statistically significant differences demographically or clinically. There were no discernable differences between the randomly allocated treatment groups at 6 months in measures of AIMSS, pharmacokinetics of anastrozole and letrozole, serum levels of reproductive hormones, or adverse events. We found no significant changes in AIMSS measures between women who took 4000 IU D3 daily compared with 600 IU D3. The 4000 IU D3 did not adversely affect reproductive hormone levels or the steady state pharmacokinetics of anastrozole or letrozole. In both groups, serum 25(OH)D remained in the recommended range for bone health (≥30 ng/mL) and safety (<50 ng/mL). PMID:26868123

  19. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS).

    PubMed

    Shapiro, Alice C; Adlis, Susan A; Robien, Kim; Kirstein, Mark N; Liang, Shuang; Richter, Sara A; Lerner, Rachel E

    2016-02-01

    The purpose of the study was to evaluate the efficacy and safety of vitamin D3 at 4000 IU/day as a treatment option for aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D3. We conducted a single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stages I-IIIA breast cancer, taking AI and experiencing AIMSS [breast cancer prevention trial symptom scale-musculoskeletal (BCPT-MS) subscale ≥1.5] were admitted. Following randomization, 116 patients had a run-in period of 1 month on 600 IU D3, then began the randomized assignment to either 600 IU D3 (n = 56) or 4000 IU D3 (n = 57) daily for 6 months. The primary endpoint was a change in AIMSS from baseline (after 1 month run-in) on the BCPT-MS (general MS pain, joint pain, muscle stiffness, range for each question: 0 = not at all to 4 = extremely). Groups had no statistically significant differences demographically or clinically. There were no discernable differences between the randomly allocated treatment groups at 6 months in measures of AIMSS, pharmacokinetics of anastrozole and letrozole, serum levels of reproductive hormones, or adverse events. We found no significant changes in AIMSS measures between women who took 4000 IU D3 daily compared with 600 IU D3. The 4000 IU D3 did not adversely affect reproductive hormone levels or the steady state pharmacokinetics of anastrozole or letrozole. In both groups, serum 25(OH)D remained in the recommended range for bone health (≥30 ng/mL) and safety (<50 ng/mL).

  20. A Prospective, Randomized, Double-Blind Study of Coblation versus Dissection Tonsillectomy in Adult Patients.

    PubMed

    Rakesh, Singh; Anand, T S; Payal, Garg; Pranjal, Kulshreshtha

    2012-09-01

    This randomized double blind study was conducted prospectively to determine whether coblation tonsillectomy fared better than the conventional dissection method in terms of postoperative pain, bleeding, and rapidity of healing in adult Indian patients undergoing tonsillectomy. Sixty adult patients undergoing tonsillectomy for benign indications were randomized to have one tonsil removed by subcapsular radiofrequency ablation method and the other by conventional dissection method. The operative time and blood loss was noted for each side. Patients were evaluated at 6, 12, 24, 48, 72 h and then on 7th and 20th postoperative day for postoperative pain (by visual analog scale), bleeding, and tonsillar fossa healing. Statistical comparison was done using appropriate tests. The two groups were demographically matched. It took longer to perform the coblation procedure (15 vs 11 min) (P > 0.05). The operative blood loss on the radiofrequency side was 11 ml, vs 34 ml on the conventional side (P = 0.009). 77% patients said that the coblation side was less painful for the overall 20-day recovery period. There were significant differences seen at 6, 12, 24, 48, and 72 h in terms of postoperative pain scores. Beyond that, the pain was consistently less on the coblation side, but the difference was not significant. There was no case of reactionary or secondary hemorrhage in either arm. The healing took longer on the radiofrequency side. Coblation tonsillectomy is an easy to learn technique with significantly reduced operative blood loss and postoperative pain. Longer operative times maybe further reduced with experience.

  1. DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL OF BENFOTIAMINE FOR SEVERE ALCOHOL DEPENDENCE

    PubMed Central

    Manzardo, Ann M.; He, Jianghua; Poje, Albert; Penick, Elizabeth C.; Campbell, Jan; Butler, Merlin G.

    2013-01-01

    Background Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analogue, benfotiamine (BF), and BF’s effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. Methods A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Results Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, −611±380 Std Dev; PL: N=11, −159±562 Std Dev, p-value=0.02). Conclusions BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism. PMID:23992649

  2. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial

    PubMed Central

    Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-01-01

    Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 PMID:26705327

  3. Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial

    PubMed Central

    2013-01-01

    Background In recent years, red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; however, the large majority of commercially available products have not been studied according to current research standards. Methods In a double blind placebo controlled randomized trial, 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were randomly allocated to receive a RYR extract or placebo for 8 weeks. As a primary outcome measure, we compared the before-after difference in lipid levels between both groups. As secondary outcome measures we looked at side-effects, CK elevation and a change in cardiovascular risk. Results LDL (low density lipoprotein) cholesterol was lowered with 36 mg/dL (22%) and total cholesterol with 37 mg/dL (15%) in the intervention group. This result was statistically significant as compared to the control group, in which no reduction in total cholesterol and LDL was observed (p < 0.001). There was no marked difference in CK (creatine kinase)-elevation or reported side-effects between study groups. In 5/31 participants in the intervention group, the lipid lowering effect resulted in lower cardiovascular risk as measured with SCORE (Systematic COronary Risk Evaluation). Conclusions The RYR formulation under study was effective in lowering cholesterol and LDL cholesterol in this study population. RYR therapy may be an attractive and relatively well studied alternative in patients who are intolerant for statins or who have objections against pharmacological lipid lowering. However, consumers need to be warned that the actual content of commercially available preparations is not assured by governmental regulations, which raises effectiveness and safety issues. Trial registration Clinicaltrials.gov, nr: NCT01558050 PMID:23866314

  4. Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children

    PubMed Central

    Ochoa, Theresa J.; Chea-Woo, Elsa; Baiocchi, Nelly; Pecho, Iris; Campos, Miguel; Prada, Ana; Valdiviezo, Gladys; Lluque, Angela; Lai, Dejian; Cleary, Thomas G.

    2012-01-01

    Objective To determine the effect of bovine lactoferrin on prevention of diarrhea in children. Study design We conducted a community-based randomized double-blind placebo controlled trial comparing supplementation with bovine lactoferrin versus placebo. Previously weaned children were enrolled at 12–18 months and followed for 6 months with daily home visits for data collection and supplement administration. Anthropometric measures were done monthly. Results 555 children were randomized: 277 to lactoferrin and 278 to placebo; 65 dropped out; 147,894 doses were administered (92% compliance). Overall there were 91,446 child-days of observation and 1,235 diarrhea episodes lasting 6,219 days. The main pathogens isolated during diarrheal episodes were norovirus (35.0%), enteropathogenic E. coli (11.4%), Campylobacter (10.6%), enteroaggregative E. coli (8.4%), enterotoxigenic E. coli (6.9%) and Shigella (6.6%). The diarrhea incidence was not different between groups: 5.4 vs. 5.2 episodes/child/year for lactoferrin and placebo, respectively (p=0.375). However, the diarrhea longitudinal prevalence was lower in the lactoferrin group (6.6% vs. 7.0%, p=0.017) as well as the median duration of episodes (4.8 vs. 5.3 days, p=0.046), proportion of episodes with moderate or severe dehydration (1.0% vs. 2.6%, p=0.045) and liquid stools load (95.0 vs. 98.6) liquid stools/child/year, p<0.001). There were no adverse events related to the intervention. Conclusions Although there was no decrease in diarrhea incidence, longitudinal prevalence and severity were decreased with lactoferrin. PMID:22939927

  5. Atomoxetine Does Not Alter Cocaine Use in Cocaine Dependent Individuals: A Double Blind Randomized Trial

    PubMed Central

    Middleton, Lisa S.; Wong, Conrad J.; Nuzzo, Paul A.; Campbell, Charles L.; Rush, Craig R.; Lofwall, Michelle R.

    2016-01-01

    Background Cocaine abuse continues to be a significant public health problem associated with morbidity and mortality. To date, no pharmacotherapeutic approach has proven effective for treating cocaine use disorders. Preclinical and clinical evidence suggests that noradrenergic activity may play a role in mediating some effects of cocaine and may be a rational target for treatment. Methods This double blind, placebo-controlled randomized, parallel group, 12-week outpatient clinical trial enrolled cocaine dependent individuals seeking treatment to examine the potential efficacy of the selective norepinephrine reuptake inhibitor, atomoxetine (80 mg/day; p.o.; n=25), compared to placebo (n=25). Subjects were initially stratified on cocaine use (<15 days or ≥15 days of the last 30), age and race using urn randomization. Attendance, medication adherence and study compliance were reinforced with contingency management, and weekly counseling was offered. An array of measures (vital signs, laboratory chemistries, cognitive and psychomotor tests, cocaine craving and urine samples for drug testing) was collected throughout the study and at follow-up. Results Survival analysis revealed no differences in study retention between the two groups, with approximately 56% of subjects completing the 12-week study (Cox analysis X2=.72; p=.40; Hazard Ratio 1.48 [CI 0.62–3.39]). GEE analysis of the proportion of urine samples positive for benzoylecgonine, a cocaine metabolite, revealed no differences between the atomoxetine and placebo groups (X2=0.2, p=.66; OR=0.89 [95% CI 0.41 – 1.74). Atomoxetine was generally well tolerated in this population. Conclusions These data provide no support for the utility of atomoxetine in the treatment of cocaine dependence. PMID:23200303

  6. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial

    PubMed Central

    Buigues, Cristina; Fernández-Garrido, Julio; Pruimboom, Leo; Hoogland, Aldert J.; Navarro-Martínez, Rut; Martínez-Martínez, Mary; Verdejo, Yolanda; Mascarós, Mari Carmen; Peris, Carlos; Cauli, Omar

    2016-01-01

    Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre® (Bonusan Besloten Vennootschap (BV), Numansdorp, The Netherlands) to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin). Participants were randomized to a parallel group intervention of 13 weeks’ duration with a daily intake of Darmocare Pre® or placebo. Either prebiotic or placebo were administered after breakfast (between 9–10 a.m.) dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis). The overall rate of frailty was not significantly modified by Darmocare Pre® administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p < 0.01 and p < 0.05, respectively). No significant effects were observed in functional and cognitive behavior or sleep quality. The use of novel therapeutic approaches influencing the gut microbiota–muscle–brain axis could be considered for treatment of the frailty syndrome. PMID:27314331

  7. Evaluation of Oral Ginger Efficacy against Postoperative Nausea and Vomiting: A Randomized, Double - Blinded Clinical Trial

    PubMed Central

    Montazeri, Akram Sadat; Hamidzadeh, Azam; Raei, Mehdi; Mohammadiun, Malihe; Montazeri, Azam Sadat; Mirshahi, Reza; Rohani, Hosein

    2013-01-01

    Background: Postoperative nausea and vomiting is one of the most common side effects associated with surgical procedures. Objectives: The aim of this study was to determine the effect of ginger on intensity of nausea and vomiting after surgical procedures. Patients and Methods: This study was a randomized, double blinded, clinical trial. 160 eligible patients were randomly assigned into experimental or placebo groups. The experimental group received 4 capsules containing 250 mg ginger and placebo group received 4 placebo capsules 1 hour before surgery. The severity of nausea and vomiting was measured at 2, 4, 6 hours post operation using visual analogue scale and a structured questionnaire. The data were analyzed by independent t - test, Mann-Whitney U test, chi –square and GEE using SPSS 16 and STATA version 11. Results: Mean nausea score at 2 hours post operation was significantly lower in the experimental group (P= 0.04). Mean nausea score at 4 and 6 hours post operation was lower in the experimental group; however, there was no significant difference between the groups at any time post operation. The frequencies of nausea in the experimental group at 2 and 6 hours post operation were lower than that in the placebo group, however, at 2 hours post operation, it was borderline significant (P = 0.05) There was no significant differences between two group in the intensity of vomiting at any time. Conclusions: Use of ginger was effective at decreasing postoperative nausea. Ginger could be used as a safe antiemetic drug at post operation. PMID:24693389

  8. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial.

    PubMed

    Buigues, Cristina; Fernández-Garrido, Julio; Pruimboom, Leo; Hoogland, Aldert J; Navarro-Martínez, Rut; Martínez-Martínez, Mary; Verdejo, Yolanda; Mascarós, Mari Carmen; Peris, Carlos; Cauli, Omar

    2016-01-01

    Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre(®) (Bonusan Besloten Vennootschap (BV), Numansdorp, The Netherlands) to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin). Participants were randomized to a parallel group intervention of 13 weeks' duration with a daily intake of Darmocare Pre(®) or placebo. Either prebiotic or placebo were administered after breakfast (between 9-10 a.m.) dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis). The overall rate of frailty was not significantly modified by Darmocare Pre(®) administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p < 0.01 and p < 0.05, respectively). No significant effects were observed in functional and cognitive behavior or sleep quality. The use of novel therapeutic approaches influencing the gut microbiota-muscle-brain axis could be considered for treatment of the frailty syndrome. PMID:27314331

  9. Prevention of COPD exacerbation by lysozyme: a double-blind, randomized, placebo-controlled study

    PubMed Central

    Fukuchi, Yoshinosuke; Tatsumi, Koichiro; Inoue, Hiromasa; Sakata, Yukinori; Shibata, Kai; Miyagishi, Hideaki; Marukawa, Yasuhiro; Ichinose, Masakazu

    2016-01-01

    Background/aim Lysozyme (mucopeptide N-acetyl-muramyl hydrolase) is widely used as a mucolytic and anti-inflammatory agent in Japan. We evaluated the effects of long-term lysozyme administration on COPD exacerbation. Methods In a 1-year, randomized, double-blind, placebo-controlled, parallel trial, patients with moderate-to-severe COPD and one or more episodes of COPD exacerbation in the previous year before enrollment were selected. Lysozyme (270 mg) or placebo was administered orally for 52 weeks as an add-on to the standard therapies such as bronchodilators. COPD exacerbation, pulmonary function, and COPD assessment test scores were analyzed. An exacerbation was defined as worsening of more than one symptom of COPD (cough, sputum volume, purulent sputum, or breathlessness) leading to a change in medication. The primary endpoint was exacerbation rate. Results A total of 408 patients were randomly assigned to the lysozyme and placebo groups. The baseline characteristics were similar between the two groups. The exacerbation rate was not significantly different between the two groups (1.4 vs 1.2; P=0.292, Poisson regression). However, a subgroup analysis showed that lysozyme might reduce exacerbation rate in patients with airway-dominant phenotype (1.2 vs 1.6). Moreover, the median time to first exacerbation was longer in patients with airway-dominant phenotype in the lysozyme group than that in the placebo group. The levels of improvement in forced expiratory volume in 1 second and COPD assessment test scores were not statistically different between the groups, but were always greater in the lysozyme group than in the placebo group over the 52 weeks of the study. Conclusion The effects of using lysozyme as an add-on to standard COPD therapy were not significantly different compared with placebo and were insufficient to prevent COPD exacerbation. PMID:27143873

  10. The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study

    PubMed Central

    Moon, Jee Youn; Lee, Shin Young; Lee, Mi Kyung; Kim, Jung Eun; Lee, Ji Eun; Lee, So Hyun

    2016-01-01

    Background Nefopam is a non-opioid, non-steroidal, centrally acting analgesic drug. The concomitant use of opioids and nefopam is believed to have many advantages over the administration of opioids alone for postoperative pain management. We conducted a randomized, double-blind study to determine the fentanyl-sparing effect of co-administration of nefopam with fentanyl for postoperative pain management via patient controlled analgesia (PCA). Methods Ninety female patients who underwent laparoscopic total hysterectomy under general anesthesia were randomized into 3 groups, Group A, fentanyl 1,000 µg; Group B, fentanyl 500 µg + nefopam 200 mg; and Group C, fentanyl 500 µg + nefopam 400 mg, in a total volume of 100 ml PCA to be administered over the first 48 h postoperatively without basal infusion. The primary outcome was total fentanyl consumption during 48 h; secondary outcomes included pain scores and incidence of side effects. Results Eighty-one patients were included in the analysis. The overall fentanyl-sparing effects of PCA with concomitant administration of nefopam during the first 48 h postoperatively were 54.5% in Group B and 48.9% group C. Fentanyl use was not significantly different between Groups B and C despite the difference in the nefopam dose. There were no differences among the three groups in terms of PCA-related side effects, although the overall sedation score of Group B was significantly lower than that of Group A. Conclusions The concomitant administration of nefopam with fentanyl for postoperative pain management may allow reduction of fentanyl dose, thereby reducing the risk of opioid-related adverse effects. PMID:27103966

  11. SSRIs and ejaculation: a double-blind, randomized, fixed-dose study with paroxetine and citalopram.

    PubMed

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-12-01

    Selective serotonin reuptake inhibitors (SSRIs) are known to induce delayed orgasm and ejaculation. However, different SSRIs may differentially delay ejaculation. A double-blind, fixed-dose study in healthy men with lifelong rapid ejaculation was performed to evaluate potential differences between clinically relevant doses of two selective serotonin reuptake inhibitors, paroxetine and citalopram, in their effects on ejaculation. Thirty men with an intravaginal ejaculation latency time (IELT) less than 1 minute were randomly assigned to receive paroxetine (20 mg/day) and citalopram (20 mg/day) for 5 weeks, after taking half the dosage in the first week. During the 1-month baseline and 6-week treatment period, IELTs were measured at home by using a stopwatch procedure. The trial was completed by 23 men. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.0004); the IELT after paroxetine and citalopram gradually increased from 18 and 21 seconds to approximately 170 and 44 seconds, respectively. Paroxetine 20 mg/day exerted a strong delay (8.9-fold increase), whereas citalopram 20 mg/day mildly delayed ejaculation (1.8-fold increase). These results indicate that paroxetine leads to a significant delay in orgasm and ejaculation, whereas citalopram seems to have less of an effect on it.

  12. DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY COMPARING POLYETHYLENE GLYCOL TO LACTULOSE FOR BOWEL PREPARATION IN COLONOSCOPY

    PubMed Central

    MENACHO, Aline Moraes; REIMANN, Adriano; HIRATA, Lie Mara; GANZERELLA, Caroline; IVANO, Flavio Heuta; SUGISAWA, Ricardo

    2014-01-01

    Background Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. PMID:24676290

  13. Corticosteroid iontophoresis to treat carpal tunnel syndrome: a double-blind randomized controlled trial.

    PubMed

    Amirjani, Nasim; Ashworth, Nigel L; Watt, M Joe; Gordon, Tessa; Chan, K Ming

    2009-05-01

    Even though injection of corticosteroids into the carpal tunnel alleviates the symptoms of mild to moderately severe carpal tunnel syndrome (CTS), it has not gained universal popularity due to its invasiveness. This study was designed to investigate the effectiveness of dexamethasone iontophoresis as a noninvasive method of treating CTS. We carried out a double-blind randomized controlled trial comparing six sessions of iontophoresis with 0.4% dexamethasone sodium phosphate with distilled water in 17 patients. Outcome measures including nerve conduction studies, the Levine Self-Assessment Questionnaire, and the Semmes-Weinstein Monofilaments were done monthly for 6 months after intervention. Most of the outcome measures did not show any significant change following treatment. Although there was subjective improvement of symptom severity scores in the treatment group as quantified by the Levine Self-Assessment Questionnaire, similar improvement was also observed in the control group (P < 0.05). Although corticosteroid iontophoresis is feasible in clinical settings and is well-tolerated by patients, iontophoresis of 0.4% dexamethasone was not effective in the treatment of mild to moderate CTS. Muscle Nerve 39: 627-633, 2009.

  14. SSRIs and ejaculation: a double-blind, randomized, fixed-dose study with paroxetine and citalopram.

    PubMed

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-12-01

    Selective serotonin reuptake inhibitors (SSRIs) are known to induce delayed orgasm and ejaculation. However, different SSRIs may differentially delay ejaculation. A double-blind, fixed-dose study in healthy men with lifelong rapid ejaculation was performed to evaluate potential differences between clinically relevant doses of two selective serotonin reuptake inhibitors, paroxetine and citalopram, in their effects on ejaculation. Thirty men with an intravaginal ejaculation latency time (IELT) less than 1 minute were randomly assigned to receive paroxetine (20 mg/day) and citalopram (20 mg/day) for 5 weeks, after taking half the dosage in the first week. During the 1-month baseline and 6-week treatment period, IELTs were measured at home by using a stopwatch procedure. The trial was completed by 23 men. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.0004); the IELT after paroxetine and citalopram gradually increased from 18 and 21 seconds to approximately 170 and 44 seconds, respectively. Paroxetine 20 mg/day exerted a strong delay (8.9-fold increase), whereas citalopram 20 mg/day mildly delayed ejaculation (1.8-fold increase). These results indicate that paroxetine leads to a significant delay in orgasm and ejaculation, whereas citalopram seems to have less of an effect on it. PMID:11763001

  15. Baclofen for stroke patients with persistent hiccups: a randomized, double-blind, placebo-controlled trial

    PubMed Central

    2014-01-01

    Background The results of preclinical studies suggest that baclofen may be useful in the treatment of stroke patients with persistent hiccups. This study was aimed to assess the possible efficacy of baclofen for the treatment of persistent hiccups after stroke. Methods In total, 30 stroke patients with persistent hiccups were randomly assigned to receive baclofen (n = 15) or a placebo (n = 15) in a double-blind, parallel-group trial. Participants in the baclofen group received 10 mg baclofen 3 times daily for 5 days. Participants assigned to the placebo group received 10 mg placebo 3 times daily for 5 days. The primary outcome measure was cessation of hiccups. Secondary outcome measures included efficacy in the two groups and adverse events. Results All 30 patients completed the study. The number of patients in whom the hiccups completely stopped was higher in the baclofen group than in the placebo group (relative risk, 7.00; 95% confidence interval, 1.91–25.62; P = 0.003). Furthermore, efficacy was higher in the baclofen group than in the placebo group (P < 0.01). No serious adverse events were documented in either group. One case each of mild transient drowsiness and dizziness was present in the baclofen group. Conclusions Baclofen was more effective than a placebo for the treatment of persistent hiccups in stroke patients. Trial registration Chinese Clinical Trials Register: ChiCTR-TRC-13004554 PMID:25052238

  16. Randomized double-blind trial of prednisone versus radiotherapy in Graves' ophthalmopathy

    SciTech Connect

    Prummel, M.F.; Mourits, M.; Blank, L.; Berghout, A.; Koornneef, L.; Wiersinga, W.M. )

    1993-10-16

    Corticosteriods are usually given for management of Graves' ophthalmopathy, but they have many and serious side-effects. By comparison, retrobulbar irradiation is well tolerated, although its efficacy has been evaluated only in uncontrolled studies. Therefore, the authors did a double-blind randomized trial, in which 28 patients with moderately severe Graves' ophthalmopathy were treated with a 3-month course of oral prednisone and sham irradiation, and 28 received retrobulbar irradiation (20 Gy) and placebo capsules. Therapeutic outcome, assessed twenty-four weeks after the start of treatment, was determined by the change in the highest NOSPECS class. A successful outcome was observed in 14 prednisone-treated and in 13 irradiated patients. Responders to treatment (but not nonresponders) in both groups showed improvements in total and subjective eye score and a decrease in eye-muscle volume. Response to either treatment was due largely to changes in soft-tissue involvement and eye-muscle motility. Radiotherapy and oral prednisone appear to be equally effective as initial treatment in patients with moderately severe Graves' ophthalmopathy. In view of its better tolerability, radiotherapy should be considered the treatment of first choice.

  17. A new acupuncture method for management of irritable bowel syndrome: A randomized double blind clinical trial

    PubMed Central

    Rafiei, Rahmatollah; Ataie, Mehdi; Ramezani, Mohammad Arash; Etemadi, Ali; Ataei, Behrooz; Nikyar, Hamidreza; Abdoli, Saman

    2014-01-01

    Background: Irritable bowel syndrome (IBS) is gastrointestinal functional disorder which is multifactorial with unknown etiology. There are several modalities for treatment of it. Acupuncture is increasingly used in numerous diseases, also in gastrointestinal disorders like IBS. The purpose of the study was to assess the effects of catgut embedding acupuncture in improving of IBS. Materials and Methods: A randomized double blind sham control clinical trial was designed. A total of 60 IBS patients assigned to three separated groups. The first group received clofac as drug only group (DO). The second one received catgut embedding acupuncture in special point (AP) and the last group received sham acupuncture (SA). Symptoms, pain, depression and anxiety assessed before and after two weeks at the end of study. Results: There was statistically significant difference between AP and SA and DO in constipation and bloating. Differences that were statistically significant favored acupuncture on pain (F = 6.409, P = 0.003), and depression (F = 6.735, P = 0.002) as the other outcomes. The average (standard deviation (SD)) of weight loss was 2 kg (0.88) in acupuncture group. Conclusion: Our finding showed a significant positive associated between acupuncture and IBS. Catgut embedding acupuncture is a new method which can eliminated IBS symptoms and can use as alternative therapeutic method for improvement of IBS. PMID:25538771

  18. A prospective, randomized, triple-blind comparison of articaine and bupivacaine for maxillary infiltrations

    PubMed Central

    Vílchez-Pérez, Miguel A.; Sancho-Puchades, Manuel; Valmaseda-Castellón, Eduard; Paredes-García, Jordi; Berini-Aytés, Leonardo

    2012-01-01

    Objectives: To compare the clinical anesthetic efficacy of 0.5% bupivacaine and 4% articaine (both with 1:200.000 adrenaline) for anterior maxillary infiltration in healthy volunteers. Material and methods: A triple-blind split-mouth randomized clinical trial was carried out in 20 volunteers. A supraperiosteal buccal injection of 0.9 ml of either solution at the apex of the lateral incisor was done in 2 appointments separated 2 weeks apart. The following outcome variables were measured: latency time, anesthetic efficacy (dental pulp, keratinized gingiva, alveolar mucosa and upper lip mucosa and tissue) and the duration of anesthetic effect. Hemodynamic parameters were monitored during the procedure. Results: Latency time recorded was similar for both anesthetic solutions (p>0.05). No statistically significant differences were found in terms of anesthetic efficacy for dental pulp, keratinized gingiva or alveolar mucosa. Articaine had a significant higher proportion of successful anesthesia at 10 minutes after infiltration in lip mucosa and lip skin (p=0.039). The duration of anesthesia was 336 minutes for bupivacaine and 167 minutes for articaine. (p<0.001). No significant hemodynamic alterations were noted during the procedure. Conclusions: Articaine and bupivacaine exhibited similar anesthetic efficacy for maxillary infiltrations. The duration of anesthesia was longer with the bupivacaine solution, but lip anesthesia was better with articaine. Key words:Articaine, bupivacaine, maxillary, infiltrative anesthesia, long-acting anesthetics. PMID:22143708

  19. Double-blind randomized trial on short-term efficacy of the Semont maneuver for the treatment of posterior canal benign paroxysmal positional vertigo.

    PubMed

    Mandalà, Marco; Santoro, Giovanni Paolo; Asprella Libonati, Giacinto; Casani, Augusto Pietro; Faralli, Mario; Giannoni, Beatrice; Gufoni, Mauro; Marcelli, Vincenzo; Marchetti, Pierpaolo; Pepponi, Emanuela; Vannucchi, Paolo; Nuti, Daniele

    2012-05-01

    The need for Class I and II studies on the efficacy of Semont's liberatory maneuver (SLM) in the treatment of posterior canal benign paroxysmal positional vertigo (PC-BPPV) motivated the present double-blind randomized trial on the short-term efficacy of SLM. A total of 342 patients with unilateral PC-BPPV were recruited for a multicenter study. Patients were randomly assigned to treatment by SLM (n = 174) or sham treatment (n = 168). Subjects were followed up twice (1 and 24 h) with the Dix-Hallpike maneuver by blinded examiners. At the 1 and 24 h follow-up, 79.3 and 86.8%, respectively, of patients undergoing SLM had recovered from vertigo, compared to none of the patients undergoing the sham maneuver (p < 0.0001). Patients who manifested liberatory nystagmus at the end of SLM showed a significantly higher percentage of recovery (87.1 vs. 55.7%; p < 0.0001). To the best of our knowledge, this is the first Class I study on the efficacy of SLM. SLM proved highly effective with respect to the sham maneuver (p < 0.0001). Liberatory nystagmus was demonstrated to be a useful prognostic factor for the efficacy of treatment. The present Class I study of efficacy of SLM changes the level of recommendation of the maneuver for treating PC-BPPV from level C to level B.

  20. Efficacy and tolerance of femoxetine and imipramine in the treatment of depressive states. A randomized, double-blind study.

    PubMed

    Suominen, J; Tamminen, T; Elosuo, R; Manniche, P M

    1988-09-01

    Fifty-two patients with depressive illness characterized by four symptoms (periodical course, psychomotor retardation, diurnal variation, unrealistic self-depreciation) and a score of at least 18 on the Hamilton Depression Scale 1-17 (HDS) were allocated to a double-blind randomized study with femoxetine and imipramine. Patients were diagnosed according to RDC and further classified according to the Newcastle-II index. During the six weeks of treatment, efficacy was evaluated by means of HDS and a global evaluation. Side-effect symptoms were recorded on a check-list by questioning. After six weeks of treatment with femoxetine or imipramine (recommended daily standard dosages are 600 mg femoxetine and 150 mg imipramine (b.i.d.); in the present study, dosages were flexible and could be adjusted according to effect/side-effects) evaluation of efficacy based on HDS, a six-item subscale, groups of HDS items as well as single items showed no statistically significant differences between the treatment groups except with regard to the factor for sleep disturbances in the HDS, where greatest reduction was seen in the femoxetine group. No statistically significant differences regarding side-effect profile were seen. However, in the imipramine group, higher frequencies of such moderate to severe symptoms as dry mouth, constipation and urination difficulties were observed (the greatest difference was seen for dry mouth, p 0.1, while p-values for the remaining two symptoms were greater than 0.1). Moreover, based on the patients' own opinion on side-effects, femoxetine seemed to be better tolerated. One patient took an overdosage of approx. 26 g femoxetine; half of the intake was removed by gastric emptying at the hospital.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Visual Rehabilitation in Chronic Cerebral Blindness: A Randomized Controlled Crossover Study.

    PubMed

    Elshout, Joris A; van Asten, Freekje; Hoyng, Carel B; Bergsma, Douwe P; van den Berg, Albert V

    2016-01-01

    The treatment of patients suffering from cerebral blindness following stroke is a topic of much recent interest. Several types of treatment are under investigation, such as substitution with prisms and compensation training of saccades. A third approach, aimed at vision restitution is controversial, as a proper controlled study design is missing. In the current study, 27 chronic stroke patients with homonymous visual field defects were trained at home with a visual training device. We used a discrimination task for two types of stimuli: a static point stimulus and a new optic flow-discontinuity stimulus. Using a randomized controlled crossover design, each patient received two successive training rounds, one with high contrast stimuli in their affected hemifield (test) and one round with low-contrast stimuli in their intact hemifield (control). Goldmann and Humphrey perimetry were performed at the start of the study and following each training round. In addition, reading performance was measured. Goldmann perimetry revealed a statistically significant reduction of the visual field defect after the test training, but not after the control training or after no intervention. For both training rounds combined, Humphrey perimetry revealed that the effect of a directed training (sensitivity change in trained hemifield) exceeded that of an undirected training (sensitivity change in untrained hemifield). The interaction between trained and tested hemifield was just above the threshold of significance (p = 0.058). Interestingly, reduction of the field defect assessed by Goldmann perimetry increases with the difference between defect size as measured by Humphrey and Goldmann perimetry prior to training. Moreover, improvement of visual sensitivity measured by Humphrey perimetry increases with the fraction of non-responsive elements (i.e., more relative field loss) in Humphrey perimetry prior to training. Reading speed revealed a significant improvement after training. Our

  2. Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine.

    PubMed

    Meador, Kimford J; Loring, David W; Boyd, Alan; Echauz, Javier; LaRoche, Suzette; Velez-Ruiz, Naymee; Korb, Pearce; Byrnes, William; Dilley, Deanne; Borghs, Simon; De Backer, Marc; Story, Tyler; Dedeken, Peter; Webster, Elizabeth

    2016-09-01

    Differential effectiveness of antiepileptic drugs (AEDs) is more commonly determined by tolerability than efficacy. Cognitive effects of AEDs can adversely affect tolerability and quality of life. This study evaluated cognitive and EEG effects of lacosamide (LCM) compared with carbamazepine immediate-release (CBZ-IR). A randomized, double-blind, double-dummy, two-period crossover, fixed-dose study in healthy subjects compared neuropsychological and EEG effects of LCM (150mg, b.i.d.) and CBZ-IR (200mg, t.i.d.). Testing was conducted at screening, predrug baseline, the end of each treatment period (3-week titration; 3-week maintenance), and the end of each washout period (4weeks after treatment). A composite Z-score was derived for the primary outcome variable (computerized cognitive tests and traditional neuropsychological measures) and separately for the EEG measures. Other variables included individual computer, neuropsychological, and EEG scores and adverse events (AEs). Subjects included 60 healthy adults (57% female; mean age: 34.4years [SD: 10.5]); 44 completed both treatments; 41 were per protocol subjects. Carbamazepine immediate-release had worse scores compared with LCM for the primary composite neuropsychological outcome (mean difference=0.33 [SD: 1.36], p=0.011) and for the composite EEG score (mean difference=0.92 [SD: 1.77], p=0.003). Secondary analyses across the individual variables revealed that CBZ-IR was statistically worse than LCM on 36% (4/11) of the neuropsychological tests (computerized and noncomputerized) and 0% of the four EEG measures; none favored CBZ-IR. Drug-related AEs occurred more with CBZ-IR (49%) than LCM (22%). Lacosamide had fewer untoward neuropsychological and EEG effects and fewer AEs and AE-related discontinuations than CBZ-IR in healthy subjects. Lacosamide exhibits a favorable cognitive profile. PMID:27517350

  3. A multicenter, randomized, double-blind, placebo-controlled trial of influenza immunization in multiple sclerosis.

    PubMed

    Miller, A E; Morgante, L A; Buchwald, L Y; Nutile, S M; Coyle, P K; Krupp, L B; Doscher, C A; Lublin, F D; Knobler, R L; Trantas, F; Kelley, L; Smith, C R; La Rocca, N; Lopez, S

    1997-02-01

    We determined the effect of influenza vaccine in patients with relapsing/remitting MS. Considerable controversy surrounds the question of whether to administer influenza vaccines to MS patients. Prevention of a febrile viral illness is clearly desirable in MS, and previous studies suggest that immunization is safe. Despite this, many clinicians avoid vaccination because they fear precipitating an MS exacerbation. We conducted a multicenter, prospective, randomized, double-blind trial of influenza immunization in patients with relapsing/remitting MS. In the autumn of 1993, 104 patients at five MS centers received either standard influenza vaccine or placebo. Patients were followed for 6 months for evaluation of neurologic status and the occurrence of influenza. Influenza was operationally defined as fever > or = 38 degrees C in the presence of coryza, cough, or sore throat at a time when the disease was present in the community. Attacks were defined in the standard manner, requiring objective change in the examination. Patients were examined at 4 weeks and 6 months after inoculation and were contacted by telephone at 1 week and 3 months. They were also examined at times of possible attacks but not when they were sick with flu-like illness. Three vaccine patients and two placebo patients experienced attacks within 28 days of vaccine (no significant difference). Exacerbation rates in the first month for both groups were equal to or less than expected from published series. The two groups showed no difference in attack rate or disease progression over 6 months. Influenza immunization in MS patients is neither associated with an increased exacerbation rate in the postvaccination period nor a change in disease course over the subsequent 6 months.

  4. The effect of flexible magnets on hand muscle strength: a randomized, double-blind study.

    PubMed

    Chaloupka, Edward C; Kang, Jie; Mastrangelo, M Alysia

    2002-02-01

    The purpose of this study was to determine the effect of a flexible magnet on hand grip and thumb-forefinger pinch strength. Flexible magnet use has become popular in sports medicine and rehabilitation for a number of reasons, including augmenting muscle force output. Thirty-five university students (18 men and 17 women) volunteered for this study. Each subject was tested for grip strength (grip dynamometer) and thumb-forefinger pinch strength (pinch gauge) under 3 different treatment conditions: baseline (no magnet), sham magnet (placebo), and flexible magnet (700-G intensity). The order of treatments was randomly assigned, and all data collection followed a double-blind format. For grip strength measurements, magnet placement was over the bellies of the flexor digitorum profundus and flexor digitorum superficialis, and for pinch strength measurements, it was over the bellies of the flexor pollicis brevis and opponens pollicis. Three trials for each strength measurement for each of the 3 conditions were performed. Magnets (700 G or sham) were placed on the appropriate areas of the skin 3 minutes before the first test trial, with each subsequent test trial separated by 1 minute. Comparison among the 3 treatment conditions was analyzed using a 1-way analysis of variance (ANOVA) with repeated measures. ANOVA revealed no statistically significant (p > 0.05) mean differences for strength among any of the 3 treatments (baseline, 700-G magnet, or sham magnet) for either hand grip or thumb-forefinger pinch within each sex subgroup or for the combined group. The findings indicate that flexible magnets with a field strength of 700 G do not increase muscle strength.

  5. Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Hauser, Goran; Salkic, Nermin; Vukelic, Karina; JajacKnez, Alenka; Stimac, Davor

    2015-05-01

    The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.

  6. Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation.

    PubMed

    Perng, R P; Hsieh, W C; Chen, Y M; Lu, C C; Chiang, S J

    1998-08-01

    Smoking cessation is an arduous process because nicotine withdrawal syndrome, which occurs following sudden interruption of nicotine use in long-term smokers, frequently prevents them from giving up the habit. Nicotine supplement systems may relieve smokers' nicotine withdrawal symptoms and, thus, help in the process of abstinence from smoking. The purpose of the present study was to investigate the effectiveness and safety of a 30-mg transdermal nicotine patch in a smoking cessation program for Chinese smokers. In this randomized, double-blind, placebo-controlled study, 30 heavy smokers, who had smoked more than 20 cigarettes per day for more than a year, were treated with 30-mg transdermal nicotine patches, and 32 heavy smokers were given placebo patches during a 6-week smoking cessation program. The clinical characteristics of the two groups were similar. After 6 weeks, the use of the transdermal nicotine patch was associated with markedly reduced nicotine dependence and severity of withdrawal symptoms. Nineteen (63%, 95% confidence interval, CI, 46%-80%) of the smokers treated with the transdermal nicotine patch had successfully quit smoking at the end of the program (6 weeks) and nine (30%, 95% CI 14%-46%) remained abstinent 1 year later. In contrast, only 11 (34%, 95% CI 18%-50%) of the smokers in the placebo group had successfully stopped smoking after 6 weeks, and three remained abstinent 1 year later (9%, 95% CI 0%-19%). However, there was no statistically significant difference between the two groups of smokers after 1 year of follow-up (p = 0.08). Side-effects were minimal and did not affect the efficacy of the skin patch. The results indicate that the transdermal nicotine patch is an effective aid in smoking cessation programs.

  7. Visual Rehabilitation in Chronic Cerebral Blindness: A Randomized Controlled Crossover Study

    PubMed Central

    Elshout, Joris A.; van Asten, Freekje; Hoyng, Carel B.; Bergsma, Douwe P.; van den Berg, Albert V.

    2016-01-01

    The treatment of patients suffering from cerebral blindness following stroke is a topic of much recent interest. Several types of treatment are under investigation, such as substitution with prisms and compensation training of saccades. A third approach, aimed at vision restitution is controversial, as a proper controlled study design is missing. In the current study, 27 chronic stroke patients with homonymous visual field defects were trained at home with a visual training device. We used a discrimination task for two types of stimuli: a static point stimulus and a new optic flow-discontinuity stimulus. Using a randomized controlled crossover design, each patient received two successive training rounds, one with high contrast stimuli in their affected hemifield (test) and one round with low-contrast stimuli in their intact hemifield (control). Goldmann and Humphrey perimetry were performed at the start of the study and following each training round. In addition, reading performance was measured. Goldmann perimetry revealed a statistically significant reduction of the visual field defect after the test training, but not after the control training or after no intervention. For both training rounds combined, Humphrey perimetry revealed that the effect of a directed training (sensitivity change in trained hemifield) exceeded that of an undirected training (sensitivity change in untrained hemifield). The interaction between trained and tested hemifield was just above the threshold of significance (p = 0.058). Interestingly, reduction of the field defect assessed by Goldmann perimetry increases with the difference between defect size as measured by Humphrey and Goldmann perimetry prior to training. Moreover, improvement of visual sensitivity measured by Humphrey perimetry increases with the fraction of non-responsive elements (i.e., more relative field loss) in Humphrey perimetry prior to training. Reading speed revealed a significant improvement after training. Our

  8. Randomized, Double-blind Study with Glycerol and Paraffin in Uremic Xerosis

    PubMed Central

    Balaskas, Elias; Szepietowski, Jacek C.; Bessis, Didier; Ioannides, Dimitrios; Ponticelli, Claudio; Ghienne, Corinne; Taberly, Alain

    2011-01-01

    Summary Background and objectives Uremic xerosis is a bothersome condition that is poorly responsive to moisturizing and emollient therapy. Design, setting, participants, & measurements A randomized, double-blind, intraindividual (left versus right comparison), multicentric clinical study was performed on 100 patients with moderate to severe uremic xerosis for 7 days, during which the patients applied twice daily an emulsion combining glycerol and paraffin (test product) on one allocated lower leg, and the emulsion alone (comparator) on the other lower leg. This was followed by an open-labeled use of the test product on all of the xerotic areas for 49 days. The main efficacy parameter was treatment response on each lower leg, as defined by a reduction from baseline of at least two grades in a five-point clinical score on day 7. Results Among the 99 patients analyzed, the test product was highly effective with a treatment response in 72 patients (73%), whereas 44 patients (44%) responded to the comparator (P < 0.0001, intergroup analysis). This was associated with an objective reduction in the density and thickness of the scales on day 7 (P < 0.0001 compared with the comparator) and a substantial improvement of the uremic pruritus (75%) and quality of life of the patients at study end (P < 0.001, intragroup analysis). The test product was very well tolerated, with product-related local intolerance (exacerbated pruritus, local burning, or erythema) occurring in only five patients (5%). Conclusions Uremic xerosis can be managed successfully when an appropriate emollient therapy is used. PMID:21258039

  9. Curcuminoid treatment for knee osteoarthritis: a randomized double-blind placebo-controlled trial.

    PubMed

    Panahi, Yunes; Rahimnia, Ali-Reza; Sharafi, Mojtaba; Alishiri, Gholamhossein; Saburi, Amin; Sahebkar, Amirhossein

    2014-11-01

    Treatment of osteoarthritis (OA) is challenging owing to the inefficacy and long-term adverse events of currently available medications including non-steroidal anti-inflammatory drugs. Curcuminoids are polyphenolic phytochemicals with established anti-inflammatory properties and protective effects on chondrocytes. The aim of this study is to investigate the clinical efficacy of curcuminoids in patients suffering from knee OA. A pilot randomized double-blind placebo-control parallel-group clinical trial was conducted among patients with mild-to-moderate knee OA. Patients were assigned to curcuminoids (1500 mg/day in 3 divided doses; n = 19) or matched placebo (n = 21) for 6 weeks. Efficacy measures were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne's pain functional index (LPFI) scores during the study. There was no significant difference in age, gender, body mass index, and VAS, WOMAC and LPFI scores between the study groups at baseline (p > 0.05). Treatment with curcuminoids was associated with significantly greater reductions in WOMAC (p = 0.001), VAS (p < 0.001) and LPFI (p = 0.013) scores compared with placebo. With respect to WOMAC subscales, there were significant improvements in the pain and physical function scores (p < 0.001) but not stiffness score (p > 0.05). There was no considerable adverse effect in both groups. To conclude, curcuminoids represent an effective and safe alternative treatment for OA. PMID:24853120

  10. Neurofeedback intervention in fibromyalgia syndrome; a randomized, controlled, rater blind clinical trial.

    PubMed

    Kayiran, Sadi; Dursun, Erbil; Dursun, Nigar; Ermutlu, Numan; Karamürsel, Sacit

    2010-12-01

    We designed a randomized, rater blind study to assess the efficacy of EEG Biofeedback (Neurofeedback-NFB) in patients with fibromyalgia syndrome (FMS). Eighteen patients received twenty sessions of NFB-sensory motor rhythm (SMR) treatment (NFB group) during 4 weeks, and eighteen patients were given 10 mg per day escitalopram treatment (control group) for 8 weeks. Visual Analog Scales for pain and fatigue, Hamilton and Beck Depression and Anxiety Inventory Scales, Fibromyalgia Impact Questionnaire and Short Form 36 were used as outcome measures which were applied at baseline and 2nd, 4th, 8th, 16th, 24th weeks. Mean amplitudes of EEG rhythms (delta, theta, alpha, SMR, beta1 and beta2) and theta/SMR ratio were also measured in NFB group. All post-treatment measurements showed significant improvements in both of the groups (for all parameters p < 0.05). NFB group displayed greater benefits than controls (for all parameters p < 0.05). Therapeutic efficacy of NFB was found to begin at 2nd week and reached to a maximum effect at 4th week. On the other hand, the improvements in SSRI treatment were also detected to begin at 2nd week but reached to a maximum effect at 8th week. No statistically significant changes were noted regarding mean amplitudes of EEG rhythms (p > 0.05 for all). However, theta/SMR ratio showed a significant decrease at 4th week compared to baseline in the NFB group (p < 0.05). These data support the efficacy of NFB as a treatment for pain, psychological symptoms and impaired quality of life associated with fibromyalgia. PMID:20614235

  11. Vaccine for Cocaine Dependence: A Randomized Double-Blind Placebo-Controlled Efficacy Trial

    PubMed Central

    Kosten, Thomas R.; Domingo, Coreen B.; Shorter, Daryl; Orson, Frank; Green, Charles; Somoza, Eugene; Sekerka, Rachelle; Levin, Frances R.; Mariani, John J.; Stitzer, Maxine; Tompkins, D. Andrew; Rotrosen, John; Thakkar, Vatsal; Smoak, Benjamin; Kampman, Kyle

    2014-01-01

    Aims We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. Methods This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. Results The 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥ 42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. Conclusions The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. PMID:24793366

  12. Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

    PubMed Central

    2014-01-01

    Background Unstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple, intuitive, and inexpensive alternative for primary sternal repair following open heart surgery. Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire. We present our initial experience in a prospective, randomized, single blinded pilot study utilizing this FDA approved system. Methods Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage. All surgeries were performed by a single board certified cardiothoracic surgeon. Data collected included: Age, BMI, pump time, off pump to surgical stop time, length of hospital stay after surgery, cost from time of surgery to discharge, and pain on a visual analog pain scale on the day of discharge, day 30, and day 60. Results The groups were well matched. Patients receiving the Figure 8 FlatWire (33) had a reduction in length of stay compared to patients receiving steel wire circlage (30), but it was not statistically significant (6.8 vs. 7.8 days respectively, p < 0.093). Additionally those with the FlatWire reported significantly decreased pain at day of discharge (3.07 vs. 4.92 points on pain scale, p < 0.0066), with similar pain scores at 30 and 60 days. Off pump to surgery stop time was increased by 15.9 minutes in patients receiving the FlatWire vs. steel wires (55.7 vs. 71.6 minutes, p = 0.00025). Mean cost from surgery until discharge was $87,820.98 in the FlatWire group vs. $91,930.29 in the steel wire group (p < 0.3082). Conclusion Early clinical results suggest that

  13. APCAP - activated protein C in acute pancreatitis: a double-blind randomized human pilot trial

    PubMed Central

    2010-01-01

    Introduction Previous human studies have shown low activity of protein C (APC) in severe acute pancreatitis (SAP). This, together with the findings in animal models, suggests that activated protein C (APC) may protect against pancreatic injury and ameliorate the disease. We, therefore, evaluated its effect on multiple organ dysfunction (MOD) measured by the SOFA (Sequential Organ Failure Assessment) and on organ-failure-free days, and the safety of APC in SAP. Methods A prospective double blind randomized pilot study was use. The study occurred in one university hospital tertiary intensive care unit (ICU) with eight beds. The patients were chosen according to the following inclusion criteria: 1) Those admitted to the hospital < 96 h from the onset of pain, 2) Those who had a three-fold increase in serum amylase over normal upper range or/and in whom computed tomography (CT) verification of SAP was noted, 3) Those who had one or more organ dysfunction (OD), and 4) Those in whom less than 48 hours had passed since their first OD. Of a total of 215 adult patients with SAP screened between June 2003 and August 2007, 158 fulfilled the study inclusion criteria. After exclusions 32 patients were randomized to the study. The intervention consisted of APC (N = 16) administered intravenously for 96 hours with a dose of 24 μg/kg/hour or placebo (N = 16) with a similar infusion rate. The sample size for the study was calculated according to the primary end-point: the change in SOFA during study drug infusion (Days 0 and 5). Comparisons between the study groups were performed using patient-related changes and calculation of difference in means (DIM, 95% CIs) and regarding categorical variables with Fisher's exact test. For all comparisons P < 0.05 was considered significant. Results No serious bleeding was detected clinically or by CT scans in either group. No significant difference in SOFA score change between the APC and placebo groups was found (difference in means (DIM) +2

  14. Efficacy of Zinc Sulfate in Peptic Ulcer Disease: A Randomized Double-Blind Clinical Trial Study

    PubMed Central

    Parhizkar, Baran; Sheikhesmaeili, Farshad; Roshani, Mohammad; Nayebi, Morteza; Gharibi, Fardin

    2016-01-01

    Introduction Peptic ulcer is a common disease that affects millions of people worldwide. Considering its global prevalence finding new approach for treating is important. Aim The aim of this study was to investigate the effect of zinc sulfate on gastric and duodenal ulcer treatment. Materials and Methods This double-blind clinical trial study was done on 90 patients who were admitted to the gastrointestinal endoscopy clinic of Tohid hospital in Sanandaj, Iran. All patients were diagnosed with gastric and duodenal ulcers. They were randomly divided into two-intervention and control groups, using block randomization with block sizes of 4. Patients and researcher were unaware of the grouping. To assess the level of zinc, blood samples were taken. In case of positive Rapid Urease Test (RUT), triple therapy regimen including amoxicillin, clarithromycin and omeprazole was administered for two weeks. For intervention group in addition to "triple therapy", an oral dose of Zinc Sulfate 220mg capsules were administered daily, while the control group received placebo capsules. Results A total of 54.5% and 57% of the patients in the intervention and control groups had gastric ulcer respectively. The Rapid Urease Test (RUT) result of 72.7% of intervention group and 83.3% of control group was positive (p = 0.24). Serum zinc level of 20.9% of intervention group and 35.7% of control group was lower than the normal level (p = 0.13). The mean of serum zinc level of intervention group and control group were 81.9 and 78.9 mg dL respectively (p = 0.4). After intervention, peptic ulcer in 81.8% of the intervention group and 83.3% of the control groups were improved (p= 0.85). Response to treatment were higher in patients with normal zinc levels compared to patients with abnormal levels (77.5% vs. 22.5%, p=0.019). Conclusion A daily dose of 220mg zinc sulfate was not significantly effective on peptic ulcer. However, patients with normal zinc levels had better ulcer treatment. PMID

  15. Davunetide for Progressive Supranuclear Palsy: a multicenter, randomized, double-blind, placebo controlled trial

    PubMed Central

    Boxer, Adam L.; Lang, Anthony E.; Grossman, Murray; Knopman, David S.; Miller, Bruce L.; Schneider, Lon S.; Doody, Rachelle S.; Lees, Andrew; Golbe, Lawrence I.; Williams, David R.; Corvol, Jean-Cristophe; Ludolph, Albert; Burn, David; Lorenzl, Stefan; Litvan, Irene; Roberson, Erik D.; Höglinger, Günter U.; Koestler, Mary; Jack, Clifford R.; Van Deerlin, Viviana; Randolph, Christopher; Lobach, Iryna V.; Heuer, Hilary W.; Gozes, Illana; Parker, Lesley; Whitaker, Steve; Hirman, Joe; Stewart, Alistair J.; Gold, Michael; Morimoto, Bruce H.

    2014-01-01

    Summary Background Davunetide (AL-108, NAP) is an eightamino acid peptide that promotes microtubule stability and decreases tau phosphorylation in pre-clinical studies. Since PSP is tightly linked to tau pathology, davunetide could be an effective treatment for PSP.The goals of this study were to evaluate the efficacy and safety of davunetide in PSP. Methods A phase 2/3 double-blind, parallel group, clinical trial of davunetide 30 mg or placebo (randomized 1:1) administered intranasally twice daily for 52 weeks was conducted at 48centers. Participants met modifiedNNIPPS criteria for possible or probable PSP. Co-primary endpointswere the change from baseline in PSP Rating Scale (PSPRS) and Schwab and England ADL(SEADL) scale at up to 52 weeks. Data from all individuals who received at least one dose of medication and had a post-baseline efficacy assessment were compared using a rank-based method.Secondary outcomes included the Clinical Global Impression of Change (CGIC) and the change in regional brain volumeon MRI. Clinicaltrials.gov identifier: NCT01110720. Findings 360 participants were screened, 313 were randomized and 243 (77.6%) completed the study. There were no group differences in PSPRS (mean difference: 0.49 [95% CI: −1.5, 2.5], p = 0.72) or SEADL (1% [−2, 4%], p = 0.76) change from baseline (CFB) and mean 52 week CFB PSPRS scores were similar between the davunetide (11.3 [9.8,12.8]) and placebo groups (10.9 [9.1, 13.0]). There wereno differences in any of the secondary or exploratory endpoints. There were 11deaths in the davunetide group and tenin the placebo group. There were more nasal adverse events in the davunetide group. Interpretation Davunetide is well tolerated but is not an effective treatment for PSP. Clinical trials of disease modifying therapy are feasible in PSP and should be pursued with other promising tau-directed therapies. Funding Allon Therapeutics PMID:24873720

  16. Immunomodulatory Effects of ResistAid™: A Randomized, Double-Blind, Placebo-Controlled, Multidose Study

    PubMed Central

    Udani, Jay K.

    2013-01-01

    Objective To evaluate the ability of a proprietary arabinogalactan extract from the larch tree (ResistAid, Lonza Ltd., Basel, Switzerland) to change the immune response in healthy adults to a standardized antigenic challenge (tetanus and influenza vaccines) in a dose-dependent manner compared to placebo. Methods This randomized, double-blind, placebo-controlled trial included 75 healthy adults (18–61 years old). Subjects were randomized to receive either 1.5 or 4.5 g/day of ResistAid or placebo for 60 days. At day 30, subjects were administered both tetanus and influenza vaccines. Serum antigenic response (tetanus immunoglobulin G [IgG], influenza A and B IgG and immunoglobulin M [IgM]) was measured at days 45 (15 days after vaccination) and 60 (30 days after vaccination) of the study and compared to baseline antibody levels. Frequency and intensity of adverse events were monitored throughout the study. Results As expected, all 3 groups demonstrated an expected rise in tetanus IgG levels 15 and 30 days following the vaccine. There was a strongly significant difference in the rise in IgG levels at day 60 in the 1.5 g/day group compared to placebo (p = 0.008). In the 4.5 g/day group, there was significant rise in tetanus IgG at days 45 and 60 compared to baseline (p < 0.01) but these values were not significant compared to placebo. Neither group demonstrated any significant elevations in IgM or IgG antibodies compared to placebo following the influenza vaccine. There were no clinically or statistically significant or serious adverse events. Conclusions ResistAid at a dose of 1.5 g/day significantly increased the IgG antibody response to tetanus vaccine compared to placebo. In conjunction with earlier studies, this validates the effect of ResistAid on the augmentation of the response to bacterial antigens (in the form of vaccine). PMID:24219376

  17. Mucolytic Effectiveness of Tyloxapol in Chronic Obstructive Pulmonary Disease - A Double-Blind, Randomized Controlled Trial

    PubMed Central

    Koppitz, Martin; Eschenburg, Charlotte; Salzmann, Emilia; Rosewich, Martin; Schubert, Ralf; Zielen, Stefan

    2016-01-01

    Objective Mucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9%) in COPD. Design A randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50) were screened, 21 were treated and 19 patients completed the study per protocol. Results A comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34–5.73 g at week 3) compared to saline (mean 2.63 g, 95% CI: 1.73–3.53 g at week 3). The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC) remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8) during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000), only 27 adverse events (20 during the Tyloxapol and seven during saline) were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure

  18. Randomized, Double-Blind, Crossover Trial of Amitriptyline for Analgesia in Painful HIV-Associated Sensory Neuropathy

    PubMed Central

    Dinat, Natalya; Marinda, Edmore; Moch, Shirra; Rice, Andrew S. C.; Kamerman, Peter R.

    2015-01-01

    We conducted a randomized, double-blind, placebo-controlled, crossover study at a single center in South Africa, to ascertain whether amitriptyline is an effective analgesic for painful HIV-associated sensory neuropathy of moderate to severe intensity in: i) antiretroviral drug naive individuals, and ii) antiretroviral drug users. 124 HIV-infected participants (antiretroviral drug naive = 62, antiretroviral drug users = 62) who met the study criteria for painful HIV-associated sensory neuropathy were randomized to once-daily oral amitriptyline (titrated to a median: interquartile range of 50: 25-50 mg) or placebo for six weeks, followed by a three-week washout period and subsequent treatment crossover. The primary outcome measure was change from baseline in worst pain intensity of the feet (measured by participant self-report using an 11-point numerical pain rating scale) after six weeks of treatment. 122 of 124 participants completed all study visits and were included in the analysis of the primary outcome. In the antiretroviral drug-naive group (n = 61) there was no significant difference in the mean change in pain score from baseline after six weeks of treatment with placebo or amitriptyline [amitriptyline: 2.8 (SD 3.3) vs. placebo: 2.8 (3.4)]. Similarly, there was no significant difference in the change in pain score after six weeks of treatment with placebo or amitriptyline in the antiretroviral drug-user group (n = 61) [amitriptyline: 2.7 (3.3) vs. placebo: 2.1 (2.8)]. Controlling for period effects and treatment order effects did not alter the outcome of the analyses. Nor did analyzing the intention-to-treat cohort (missing data interpolated using baseline observation carried forward) alter the outcome of the analyses. In summary, amitriptyline, at the doses used here, was no more effective than an inactive placebo at reducing pain intensity in individuals with painful HIV-associated sensory neuropathy of moderate to severe intensity, irrespective of whether

  19. He II heat transfer through random packed spheres: Pressure drop

    NASA Astrophysics Data System (ADS)

    Vanderlaan, M. H.; Van Sciver, S. W.

    2014-09-01

    Heat flow induced pressure drop through superfluid helium (He II) contained in porous media is examined. In this experiment, heat was applied to one side of a He II column containing a random pack of uniform size polyethylene spheres. Measured results include steady state pressure drops across the random packs of spheres (nominally 35 μm, 49 μm, and 98 μm diameter) for different heat inputs. Laminar, turbulent, and transition fluid flow regimes are examined. The laminar permeability and equivalent channel shape factor are compared to our past studies of the temperature drop through He II in the same porous media of packed spheres. Results from the pressure drop experiments are more accurate than temperature drop experiments due to reduced measurement errors achieved with the pressure transducer. Turbulent results are fitted to models with empirically derived friction factors. A turbulent model considering only dynamic pressure losses in the normal fluid yields the most consistent friction factors. The addition of the laminar and turbulent heat flow equations into a unifying prediction fits all regimes to within 10%.

  20. Single-blind and Double-blind Randomized Controlled Trials of Palmtherapy(R), an Alternative Medical Approach, for Anxiety before Cardiac Catheterization.

    PubMed

    Blaer, Yossef; Jafari, Jamal; Podberezsky, Anna; David, Tamar; Reizin, Leonardo; Benjamin, Jonathan

    2008-03-01

    Alternative medicine is widely used, but lacks consensus regarding its amenability to scientific investigation. Anxiety increases morbidity and mortality in ischemic heart disease. We performed two studies of Palmtherapy(R), an alternative treatment, for anxiety before cardiac catheterization. In the first study, patients were randomized to receive pressure at particular points on the palm, or at incorrect locations, for about 50 min, while the therapist conversed with them. In the second study, the conversation was conducted by a second, 'blind' investigator. In both studies, patients and nurses, all blind to treatment assignment, completed visual analog scale and National Institute of Mental Health measures of anxiety, respectively. Twenty-three subjects completed study 1, and 17 completed study 2. In study 1, palm therapy was superior to sham therapy for both outcome measures. In study 2, palm therapy was superior for self-reported anxiety, but not for nurses' assessments of anxiety. Future studies should attempt to separate possible mechanistic effects of Palmtherapy(R) from therapist-related variables. Whether alternative medicine deserves to be studied at all remains controversial. Palmtherapy(R) may offer anxiolytic benefit without the harm attributable to drugs.

  1. Hypercaloric enteral nutrition in Amyotrophic Lateral Sclerosis: a randomized double-blind placebo-controlled trial

    PubMed Central

    Wills, Anne-Marie; Hubbard, Jane; Macklin, Eric A.; Glass, Jonathan; Tandan, Rup; Simpson, Ericka P; Brooks, Benjamin; Gelinas, Deborah; Mitsumoto, Hiroshi; Mozaffar, Tahseen; Hanes, Gregory P.; Ladha, Shafeeq S.; Heiman-Patterson, Terry; Katz, Jonathan; Lou, Jau-Shin; Mahoney, Katy; Grasso, Daniela; Lawson, Robert; Yu, Hong; Cudkowicz, Merit

    2014-01-01

    Background Amyotrophic Lateral Sclerosis (ALS) is a rapidly fatal neurodegenerative disease with few therapeutic options. Mild obesity is associated with greater survival in ALS patients and calorie-dense diets increase survival in an ALS mouse model. We therefore hypothesized that hypercaloric diets might lead to weight gain and slow ALS disease progression. Methods In this double-blind, placebo-controlled, multi-center clinical trial, we enrolled adults with ALS without a history of diabetes, significant liver or cardiovascular disease, who were already receiving percutaneous enteral nutrition. We randomly assigned participants to one of three dietary interventions: replacement calories using an isocaloric diet (controls) vs. a high-carbohydrate hypercaloric diet (HC/HC), vs. a high-fat hypercaloric diet (HF/HC). Participants received the intervention diets for four months and were followed for five months. The primary outcomes were safety and tolerability. Secondary outcomes included measures of disease progression, survival, and metabolism. This trial is registered with Clinicaltrials.gov, number NCT00983983. Findings A total of 24 participants were enrolled of whom 20 initiated study diet (six control, eight HC/HC, six HF/HC). Baseline demographics were similar among the three study arms. The HC/HC diet was better tolerated with fewer serious adverse events than the control diet (zero vs. nine, p<0·001) and fewer dose discontinuations due to adverse events (0% vs. 50%). There were no deaths in the HC/HC arm vs. three deaths (43%) in the control arm (logrank p = 0·03). The HF/HC arm was not statistically different from the controls in adverse events, tolerability, deaths or disease progression. Interpretation Our results suggest that hypercaloric enteral nutrition is safe and tolerable in ALS and support the study of nutritional interventions at earlier stages of the disease. Funding The Muscular Dystrophy Association with additional support from the National

  2. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    PubMed Central

    Heukelbach, Jorg; Pilger, Daniel; Oliveira, Fabíola A; Khakban, Adak; Ariza, Liana; Feldmeier, Hermann

    2008-01-01

    Background Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group. Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709. PMID:18783606

  3. A Randomized Evaluator Blinded Study of Effect of Microneedling in Androgenetic Alopecia: A Pilot Study

    PubMed Central

    Dhurat, Rachita; Sukesh, MS; Avhad, Ganesh; Dandale, Ameet; Pal, Anjali; Pund, Poonam

    2013-01-01

    Introduction: Dermal papilla (DP) is the site of expression of various hair growth related genes. Various researches have demonstrated the underlying importance of Wnt proteins and wound growth factors in stimulating DP associated stem cells. Microneedling works by stimulation of stem cells and inducing activation of growth factors. Materials and Methods: Hundred cases of mild to moderate (III vertex or IV) androgenetic alopecia (AGA) were recruited into 2 groups. After randomization one group was offered weekly microneedling treatment with twice daily 5% minoxidil lotion (Microneedling group); other group was given only 5% minoxidil lotion. After baseline global photographs, the scalp were shaved off to ensure equal length of hair shaft in all. Hair count was done in 1 cm2 targeted fixed area (marked with tattoo) at baseline and at end of therapy (week 12). The 3 primary efficacy parameters assessed were: Change from baseline hair count at 12 weeks, patient assessment of hair growth at 12 weeks, and investigator assessment of hair growth at 12 weeks. A blinded investigators evaluated global photographic response. The response was assessed by 7- point scale. Results: (1) Hair counts – The mean change in hair count at week 12 was significantly greater for the Microneedling group compared to the Minoxidil group (91.4 vs 22.2 respectively). (2) Investigator evaluation – Forty patients in Microneedling group had +2 to +3 response on 7-point visual analogue scale, while none showed the same response in the Minoxidil group. (3) Patient evaluation – In the Microneedling group, 41 (82%) patients reported more than 50% improvement versus only 2 (4.5%) patients in the Minoxidil group. Unsatisfied patients to conventional therapy for AGA got good response with Microneedling treatment. Conclusion: Dermaroller along with Minoxidil treated group was statistically superior to Minoxidil treated group in promoting hair growth in men with AGA for all 3 primary efficacy

  4. Double-blind randomized study of lonidamine and radiotherapy in head and neck cancer

    SciTech Connect

    Magno, L.; Terraneo, F.; Bertoni, F.; Tordiglione, M.; Bardelli, D.; Rosignoli, M.T.; Ciottoli, G.B. )

    1994-04-30

    This Phase III double blind, placebo-controlled study was performed to evaluate whether lonidamine can increase the tumor control of radiotherapy in the treatment of advanced head and neck cancer without any synergistic toxic effects on the exposed normal tissues. Ninety-seven patients with Stages II-IV squamous cell carcinoma of the head and neck were enrolled. Separate analyses were done on the 96 eligible patients and the 90 patients who completed the prescribed treatment regimen. Patients received radiotherapy up to a planned total of 60-66 Gy, in 2 daily fractions of 1.5 Gy each and either lonidamine (450 mg p.o. in three divided daily doses) or placebo, given continuously for 3 months or up to 1 month after the end of radiotherapy. The rate of tumor clearance was 66% in the lonidamine group and 65% in the placebo group, while the subsequent failure rate was 50% and 77%, respectively. The 3 and 5 year locoregional control rates in the adequately treated patients achieving complete tumor clearance were 66% and 63% for lonidamine vs. 41% and 37% for placebo. The disease-free survival in adequately treated patients was significantly better in the lonidamine group, with 3 and 5 year rates of 44% and 40%, respectively, vs. 23% and 19% in the placebo group. The overall survival rate for all eligible patients at both 3 and 5 years was 44% in the lonidamine group and 44% and 31%, respectively, in the placebo group. Both acute and late radiation reactions were similar in the two groups. Myalgia and testicular pain were the most frequent side effects of lonidamine with an incidence of 8.5% and 4.2%, respectively. The addition of lonidamine to hyperfractionated radiotherapy was correlated with a statistically and clinically significant proportion of long-term disease-free patients. The toxicity of radiotherapy was not aggravated by the drug and the overall tolerance of the combined regimen was acceptable. 54 refs., 4 figs., 7 tabs.

  5. Immediate Effect of Postural Insoles on Gait Performance of Children with Cerebral Palsy: Preliminary Randomized Controlled Double-blind Clinical Trial.

    PubMed

    Neto, Hugo Pasini; Grecco, Luanda André Collange; Duarte, Natália Almeida Carvalho; Christovão, Thaluanna Calil Lourenço; Franco de Oliveira, Luis Vicente; Dumont, Arislander Jonathan Lopes; Galli, Manuela; Oliveira, Claudia Santos

    2014-07-01

    [Purpose] Improved gait efficiency is one of the goals of therapy for children with cerebral palsy (CP). Postural insoles can allow more efficient gait by improving biomechanical alignment. The aim of the present study was to assess the effect of postural insoles on gait performance of children with CP classified as levels I or II of the Gross Motor Function Classification System (GMFCS). [Subjects and Methods] the study was a randomized controlled double-blind clinical trial. After meeting the legal aspects and the eligibility criteria, 10 children between four and 12 years old were randomly divided into a two groups: a control group (n=5), and an experimental group (n=5). Children in the control group used a placebo insoles, and children in the experimental group used postural insoles. Evaluation consisted of three-dimensional gait analysis under three conditions: barefoot, shoes without insoles and shoes with postural insoles or shoes with placebo insoles. [Results] Regarding the immediate effects of insole use, significant improvements in gait velocity and cadence were observed in the experimental group in comparison to the control group. [Conclusion] The use of postural insoles led to improvements in gait velocity and cadence of the children with cerebral palsy classified as levels I or II of the GMFCS.

  6. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  7. Oral amrinone for the treatment of chronic congestive heart failure: results of a multicenter randomized double-blind and placebo-controlled withdrawal study.

    PubMed

    DiBianco, R; Shabetai, R; Silverman, B D; Leier, C V; Benotti, J R

    1984-11-01

    A placebo-controlled study was employed to evaluate the effects of oral amrinone in patients with congestive heart failure. After a baseline period of at least 4 weeks of standard treatment for refractory congestive heart failure, oral amrinone was added to the treatment regimen of 173 patients. Patients were predominantly male (89%), aged 24 to 76 years (mean 54), with ischemic (52%) or idiopathic (37%) dilated cardiomyopathy, in New York Heart Association functional class II (40%), III (59%) and IV (1%) and having a mean (+/- standard deviation) left ventricular ejection fraction of 25 +/- 15%. Phase 1: After the addition of amrinone (113 +/- 33 mg three times daily), 52 patients (30%) showed a maximal increase in treadmill exercise time exceeding 2 minutes (Naughton protocol), 72 (42%) had a lesser increase, 24 (14%) developed limiting adverse reactions, 20 (12%) died and 5 dropped out of the study. Fifty-two "responders" (30%) who were free of limiting side effects and had a greater than 2 minute increase in exercise time were randomized in double-blind fashion to continued amrinone or switched to placebo (each plus standard treatment) for an additional 12 weeks. Phase 2: Comparison of 31 of these 52 responders who continued to receive amrinone with the remaining 21 randomized to placebo revealed no significant differences in vital signs, indexes of left ventricular size and function, systolic time intervals or maximal exercise time. Continued follow-up study of patients receiving either amrinone or placebo revealed decreases in exercise times of 7 and 10%, respectively (both p less than 0.05 compared with before randomization). Episodes of worsened congestive heart failure severe enough to mandate termination of double-blind treatment were as frequent in patients taking placebo (4[18%] of 21) as in those taking amrinone (4[13%] of 31; p = NS). The average symptom score and functional class of each treatment group remained comparable. Adverse effects such as

  8. He II heat transfer through random packed spheres

    NASA Astrophysics Data System (ADS)

    Vanderlaan, Mark

    Superfluid helium (He II) contained in porous media is examined. In particular, heat transfer experiments were performed on He II contained in random packs of uniform size polyethylene spheres. Measured results include the steady state temperature and pressure drops across packs of spheres (35 micron, 49 micron, and 98 micron diameter) and the associated steady, step, and pulse heat inputs. Bath temperatures range from 1.6 K to 2.1 K to help grasp the superfluid effects. Laminar, turbulent, and transitional fluid flow regimes are examined. Turbulent results are fitted to an empirically derived turbulent He II heat flow in a channel equation with an added tortuosity (extra length traveled) term that accounts for the porous media. An average tortuosity of 1.33 +/- 0.07 was obtained, which is in good agreement with the values of 1.36 - 1.41 concluded from published work on classical fluid pressure drop across random packed spheres. Laminar permeability and shape factor results are compared to past studies of He II in porous media and in channel flows. The average critical heat flux, which describes the onset of turbulence, is predicted to be 0.19 W cm-2. The onset of turbulence is determined through a critical heat flux from which a critical Reynolds number is formulated, but does not describe He II turbulence in the normal fluid component. Other proposed He II "Reynolds numbers" are examined. The addition of the laminar and turbulent heat flow equations into a unifying prediction fits the transition regime data within 25 %. Transient temperatures compare favorably to a one-dimensional numerical solution that considers a variable Gorter-Mellink exponent and a piece-wise determination of the heat flux. Turbulent pressure drop results are fitted with empirically derived friction factors. The laminar permeability and equivalent channel shape factor derived from the pressure drop are compared the permeability and shape factor obtained from the temperature drop. Results

  9. The Glubran 2 glue for mesh fixation in Lichtenstein's hernia repair: a double-blind randomized study

    PubMed Central

    Dąbrowiecki, Stanisław; Pierściński, Stanisław

    2012-01-01

    Introduction With an average incidence rate of 11%, chronic pain is considered the most serious complication of inguinal hernioplasty after surgical site infection. One of the proposed solutions to this problem is to use tissue adhesive for mesh fixation, which helps prevent nerve and tissue damage. Aim The goal of this study was to compare mesh fixation with the use of sutures vs. adhesive in Lichtenstein's inguinal hernia repair in a randomized, double-blind one-center study. Material and methods The study group consisted of 41 males with primary inguinal hernia undergoing Lichtenstein's repair (20 – adhesive; 21 – suture) and remaining in follow-up from July 2008 to November 2010. Randomization took place during the operation. The follow-up was performed by one surgeon (blinded) according to a pre-agreed schedule; the end-of-study unblinding was performed during the last follow-up visit, usually 16 months postoperatively. Results In 1 patient from the “adhesive” group, a recurrence was observed one year after the initial repair. The early postoperative pain was less intense in this group. In later postoperative periods the method of mesh fixation had no influence on the pain experienced by the patient. Other complications were not correlated with the method of mesh fixation. Conclusions In this randomized, one-center double-blind clinical study of males with primary inguinal hernia it has been show during follow-up that the use of Glubran 2 cyanoacrylate adhesive for mesh implant fixation yields similar recurrence and chronic pain rates as the classical suture technique. In the early postoperative period, the pain reported by these patients was relatively weaker; patients undergoing adhesive mesh fixation experienced a quicker return to daily household activities. PMID:23256009

  10. Comparison of intranasal dexmedetomidine and dexmedetomidine-ketamine for premedication in pediatrics patients: A randomized double-blind study

    PubMed Central

    Bhat, Ravi; Santhosh, M.C.B.; Annigeri, Venkatesh M.; Rao, Raghavendra P.

    2016-01-01

    Background: Goal of premedication in pediatric anesthesia are relieving pre and postoperative anxiety, good parental separation, and smooth induction of anesthesia. Anxiety can produce aggressive reactions, increased distress, increased postoperative pain and postoperative agitation. The benzodiazepine, midazolam, is the most frequently used premedication in pediatric anesthesia. Midazolam has a number of beneficial effects when used as premedication in children: Sedation, fast onset, and limited duration of action. Though midazolam has a number of beneficial effects, it is far from an ideal premedicant having untoward side effects such as paradoxical reaction, respiratory depression, cognitive impairment, amnesia, and restlessness. Dexmedetomidine is a newer α-2-agonist, which can be used as premedicant. Aims: To compare the level of sedation, parental separation, mask acceptance, postoperative recovery of intranasal premedication with dexmedetomidine and dexmedetomidine-ketamine combination in pediatric patients. Settings and Design: Prospective randomized double-blind study. Subjects and Methods: After written informed consent from the patient's parents or legal guardian, 54 children of American Society of Anesthesiologists physical status I or II, aged between 1 and 6 years, scheduled to undergo elective minor surgery were enrolled. In group D patient received 1 μg/kg dexmedetomidine intranasally and in group DK received 1 μg/kg dexmedetomidine and 2 mg/kg ketamine intranasally. Patients were assessed every 10 min for the level of sedation, parenteral separation, heart rate, and oxygen saturation by an independent observer. Mask acceptance and postoperative agitation were noted using an appropriate scale. Statistical Analysis Used: Pearson Chi-square analysis to determine differences between two groups with respect to separation anxiety and acceptance of the anesthesia mask. Percentages used to represent frequencies. The level of significance was set at P< 0

  11. A randomized, double-blind comparison of the effectiveness of environmental cleaning between infection control professionals and environmental service workers.

    PubMed

    Xu, Hong; Jin, Hui; Zhao, Lan; Wei, Xiaojun; Hu, Liangen; Shen, Linhai; Wei, Lingya; Xie, Lijun; Kong, Qingxin; Wang, Yinghong; Ni, Xiaoping

    2015-03-01

    The hospital environment is a reservoir for pathogens, and environmental service workers (ESWs) play an important role in infection prevention. A randomized, double-blind comparison was carried out in a 23-bed intensive care unit of a traditional Chinese medical-Western medical hospital. Aerobic colony counts (ACC) and methicillin-resistant Staphylococcus aureus (MRSA) were used to compare the effectiveness of environmental cleaning between infection control professionals and ESWs. The results suggest that high-touch surfaces around MRSA patients are often not sufficiently cleaned and are even cross-contaminated by ESWs after cleaning. Further educational intervention is needed for improvement of environmental cleaning.

  12. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions

    SciTech Connect

    Mooney, V. )

    1990-07-01

    A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.

  13. Can low dose of propofol effectively suppress fentanyl-induced cough during induction of anaesthesia? A double blind randomized controlled trial

    PubMed Central

    Firouzian, Abolfazl; Emadi, Seyed Abdollah; Baradari, Afshin Gholipour; Mousavi, Robabeh; Kiasari, Alieh Zamani

    2015-01-01

    Background and Aims: Fentanyl-induced cough (FIC) is often seen after intravenous (IV) administration of fentanyl during the induction of general anesthesia. The aim of this study was to evaluate the effectiveness of low dose of propofol in suppressing of FIC during induction of anesthesia. Material and Methods: In a prospective double-blind randomized controlled trial, a total of 240 patients, American Society of Anesthesiologists physical status Class I and II, scheduled for elective surgery were randomly assigned into two equally sized groups (n = 120). Patients in Group A received low dose of propofol (10 mg) and patients in Group B received the same volume of normal saline (control group). Two minutes later, all patients were given fentanyl (2 μg/kg) over 2 s through the peripheral IV line in the forearm. The vital sign profiles and frequency and intensity of cough were recorded within 2 min after fentanyl bolus by a nurse blinded to study design. Data were analyzed using independent t-test, paired t-test and Chi-square test. Results: The incidences of FIC were 9.2% and 40.8% in Group A (propofol) and Group B (placebo) respectively (P = 0.04). Furthermore, there was a significant difference in the intensity of cough between Groups A and B (P < 0.0001). The hemodynamic value (systolic blood pressure, diastolic blood pressure, heart rate, mean arterial pressure and saturation of oxygen) were similar, and there was no significant difference between two groups in the baseline value or after propofol or placebo injection. PMID:26702212

  14. Effect of Transcranial Direct-Current Stimulation Combined with Treadmill Training on Balance and Functional Performance in Children with Cerebral Palsy: A Double-Blind Randomized Controlled Trial

    PubMed Central

    Duarte, Natália de Almeida Carvalho; Grecco, Luanda André Collange; Galli, Manuela; Fregni, Felipe; Oliveira, Cláudia Santos

    2014-01-01

    Background Cerebral palsy refers to permanent, mutable motor development disorders stemming from a primary brain lesion, causing secondary musculoskeletal problems and limitations in activities of daily living. The aim of the present study was to determine the effects of gait training combined with transcranial direct-current stimulation over the primary motor cortex on balance and functional performance in children with cerebral palsy. Methods A double-blind randomized controlled study was carried out with 24 children aged five to 12 years with cerebral palsy randomly allocated to two intervention groups (blocks of six and stratified based on GMFCS level (levels I-II or level III).The experimental group (12 children) was submitted to treadmill training and anodal stimulation of the primary motor cortex. The control group (12 children) was submitted to treadmill training and placebo transcranial direct-current stimulation. Training was performed in five weekly sessions for 2 weeks. Evaluations consisted of stabilometric analysis as well as the administration of the Pediatric Balance Scale and Pediatric Evaluation of Disability Inventory one week before the intervention, one week after the completion of the intervention and one month after the completion of the intervention. All patients and two examiners were blinded to the allocation of the children to the different groups. Results The experimental group exhibited better results in comparison to the control group with regard to anteroposterior sway (eyes open and closed; p<0.05), mediolateral sway (eyes closed; p<0.05) and the Pediatric Balance Scale both one week and one month after the completion of the protocol. Conclusion Gait training on a treadmill combined with anodal stimulation of the primary motor cortex led to improvements in static balance and functional performance in children with cerebral palsy. Trial Registration Ensaiosclinicos.gov.br/RBR-9B5DH7 PMID:25171216

  15. Prevention of postoperative nausea and vomiting with a subhypnotic dose of Propofol in patients undergoing lower abdominal surgery: A prospective, randomized, double-blind study

    PubMed Central

    Naghibi, Khosrou; Kashefi, Parviz; Azarnoush, Hamed; Zabihi, Parisa

    2015-01-01

    Background: Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia in patients undergoing elective lower abdominal surgery. We aimed to compare the effect of a sub hypnotic dose of Propofol in the prevention of PONV after lower abdominal surgery with that of the conventional antiemetic drug Metoclopramide. Materials and Methods: In this prospective, randomized, double-blind, placebo-controlled study, 104 patients with American Society of Anesthesiologists (ASA) class I or II status, aged 18–65 years, and undergoing elective lower abdominal surgery were randomized to one of four groups (n = 26 each). The patients in the four groups were administered intravenously Propofol 20 mg (G1), Propofol 30 mg (G2), Metoclopramide 10 mg (G3), and placebo (G4), 15 min before skin closure. All episodes of PONV during the first 24 h after anesthesia were recorded by an investigator who was blinded to treatment assignment. Results: There were no significant differences between the treatment groups with regard to their gender, age, ASA class, duration of surgery, duration of recovery time and hospital stay, and also body mass index (BMI) (P > 0.05). The prevalence of PONV 0-6 h after anesthesia was 23.08% with Propofol 20 mg (P = 0.005), 15.38% with Propofol 30 mg (P = 0.016), 15.38% with Metoclopramide 10 mg (P = 0.016), compared to 30.77% with placebo (P = 0.005). Conclusions: Administration of a subhypnotic dose of Propofol (30 mg) was found to be as effective as 10 mg Metoclopramide in reducing the incidence and severity of PONV in adult patients undergoing elective lower abdominal surgeries under Isoflurane-based anesthesia in the early postoperative period. PMID:25789261

  16. Effects of hypnosis as an adjunct to intravenous sedation for third molar extraction: a randomized, blind, controlled study.

    PubMed

    Mackey, Edward F

    2010-01-01

    The effects of hypnosis/therapeutic suggestion in connection with intravenous sedation and surgery have been described in many clinical publications; however, few randomized, controlled, and blind studies have been performed in the outpatient area. This study aimed to evaluate the use of hypnosis/therapeutic suggestion as an adjunct to intravenous (IV) sedation in patients having 3rd molar removal in an outpatient setting. The patients were randomly assigned to a treatment (n = 46) or control (n = 54) group. The treatment group listened to a rapid conversational induction and therapeutic suggestions via headphones throughout the entire surgical procedure along with a standard sedation dose of intravenous anesthetic. The control group listened to only music without any hypnotic intervention. Intraoperative Propofol administration, patient postoperative pain ratings, and postoperative prescription pain reliever consumption were all significantly reduced in the treatment compared to the control group. Implications of these results are discussed. PMID:20183736

  17. Is magnetotherapy applied to bilateral hips effective in ankylosing spondylitis patients? A randomized, double-blind, controlled study.

    PubMed

    Turan, Yasemin; Bayraktar, Kevser; Kahvecioglu, Fatih; Tastaban, Engin; Aydin, Elif; Kurt Omurlu, Imran; Berkit, Isil Karatas

    2014-03-01

    This double-blind, randomized controlled study was conducted with the aim to investigate the effect of magnetic field therapy applied to the hip region on clinical and functional status in ankylosing spondylitis (AS) patients. Patients with AS (n = 66) who were diagnosed according to modified New York criteria were enrolled in this study. Patients were randomly divided in two groups. Participants were randomly assigned to receive magnetic field therapy (2 Hz) (n = 35), or placebo magnetic field therapy (n = 31) each hip region for 20 min. Patients in each group were given heat pack and short-wave treatments applied to bilateral hip regions. Both groups had articular range of motion and stretching exercises and strengthening exercises for surrounding muscles for the hip region as well as breathing and postural exercises by the same physical therapist. These treatment protocols were continued for a total of 15 sessions (1 session per day), and patients were examined by the same physician at months 1, 3 and 6. Visual analogue scale (VAS) pain, VAS fatigue, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrologic Index (BASMI), DFI, Harris hip assessment index and Ankylosing Spondylitis Quality of Life scale (ASQOL) were obtained at the beginning of therapy and at month 1, month 3 and month 6 for each patient. There were no significant differences between groups in the VAS pain, VAS fatigue, morning stiffness, BASDAI, BASFI, BASMI, DFI, Harris hip assessment index and ASQoL at baseline, month 1, month 3 or month 6 (p > 0.05). Further randomized, double-blind controlled studies are needed in order to establish the evidence level for the efficacy of modalities with known analgesic and anti-inflammatory action such as magnetotherapy, particularly in rheumatic disorders associated with chronic pain.

  18. Is magnetotherapy applied to bilateral hips effective in ankylosing spondylitis patients? A randomized, double-blind, controlled study.

    PubMed

    Turan, Yasemin; Bayraktar, Kevser; Kahvecioglu, Fatih; Tastaban, Engin; Aydin, Elif; Kurt Omurlu, Imran; Berkit, Isil Karatas

    2014-03-01

    This double-blind, randomized controlled study was conducted with the aim to investigate the effect of magnetic field therapy applied to the hip region on clinical and functional status in ankylosing spondylitis (AS) patients. Patients with AS (n = 66) who were diagnosed according to modified New York criteria were enrolled in this study. Patients were randomly divided in two groups. Participants were randomly assigned to receive magnetic field therapy (2 Hz) (n = 35), or placebo magnetic field therapy (n = 31) each hip region for 20 min. Patients in each group were given heat pack and short-wave treatments applied to bilateral hip regions. Both groups had articular range of motion and stretching exercises and strengthening exercises for surrounding muscles for the hip region as well as breathing and postural exercises by the same physical therapist. These treatment protocols were continued for a total of 15 sessions (1 session per day), and patients were examined by the same physician at months 1, 3 and 6. Visual analogue scale (VAS) pain, VAS fatigue, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrologic Index (BASMI), DFI, Harris hip assessment index and Ankylosing Spondylitis Quality of Life scale (ASQOL) were obtained at the beginning of therapy and at month 1, month 3 and month 6 for each patient. There were no significant differences between groups in the VAS pain, VAS fatigue, morning stiffness, BASDAI, BASFI, BASMI, DFI, Harris hip assessment index and ASQoL at baseline, month 1, month 3 or month 6 (p > 0.05). Further randomized, double-blind controlled studies are needed in order to establish the evidence level for the efficacy of modalities with known analgesic and anti-inflammatory action such as magnetotherapy, particularly in rheumatic disorders associated with chronic pain. PMID:24399455

  19. The effect of thyme honey nasal spray on chronic rhinosinusitis: a double-blind randomized controlled clinical trial.

    PubMed

    Hashemian, Farnaz; Baghbanian, Neda; Majd, Zahra; Rouini, Mohammad-Reza; Jahanshahi, Javaneh; Hashemian, Farshad

    2015-06-01

    Chronic rhinosinusitis is a common disease which causes persisting inflammatory conditions of one or more sinuses. This study was designed to evaluate the effect of thyme honey nasal spray as an adjunctive medication on chronic rhinosinusitis after functional endoscopic sinus surgery. This was a randomized, placebo controlled, double-blind clinical study. 64 patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery were enrolled in this study. Patients were randomized and blinded to receive either placebo or thyme honey nasal spray in addition to the standard regimen postoperatively. Patients were visited on postoperative days 7, 30 and 60. The sino-nasal outcome test, endoscopic grading system and sinus CT-scan were scored before operation and on the day 60 after surgery. 54 patients completed the study. Significant improvement was observed in both treatment groups. There were no significant changes in SNOT-22, endoscopy and CT-scan scores between the two study groups. However, a greater reduction in endoscopic scores was shown in thyme honey group. The incidence of adverse effects was not significantly different between the groups, but synechiae formation and epistaxis were lower in treatment group. Thyme honey nasal spray seems to be a low-priced potential adjuvant remedy with excellent safety profile, to reduce inflammation and polyp formation and also fostering mucosal healing for patients suffering from chronic rhinosinusitis. However, further studies are recommended.

  20. Professional brushing study comparing the effectiveness of sonic brush heads with manual toothbrushes: a single blinded, randomized clinical trial.

    PubMed

    Pelka, Anna-Kristina; Nagler, Tonia; Hopp, Imke; Petschelt, Anselm; Pelka, Matthias Anton

    2011-08-01

    The aim of this study was to evaluate the plaque removal efficacy of four toothbrushes: the Philips Sonicare Elite with medium and mini brush heads, the Elmex Sensitive, and the American Dental Association (ADA) reference toothbrush. This study was a randomized, controlled, investigator-blinded, four-brush crossover design study, which examined plaque removal following a consecutive repeated use. All brushes were used on each participant in a randomly assigned quadrant of the mouth. A total of 90 subjects participated in the study. Prior to the experiment, they received a professional prophylaxis and were requested to refrain from toothbrushing for 48 h. Teeth were professionally brushed consecutively for 10 to 90 s per quadrant. A Turesky-modified Quigley Hein Index score was assessed at baseline and after each brushing interval by one blinded investigator. Results showed reduction of mean plaque scores for all brushes with time from 10 to 90 s. After 30 s (2-min whole mouth equivalent) of brushing, the Sonicare brushes cleaned 19, the ADA brush 16, and the Elmex Sensitive 10 of in average 28 tooth surfaces. With time, the number of additional cleaned surfaces decreased. Time is an important variable in the evaluation of plaque-removing efficacy since absolute efficacy increases with time and differs per toothbrush. No differences could be found between the two brush heads of the Sonicare.

  1. The effectiveness of intramuscular biperiden in acute akathisia: a double-blind, randomized, placebo-controlled study.

    PubMed

    Baskak, Bora; Atbasoglu, E Cem; Ozguven, Halise Devrimci; Saka, Meram Can; Gogus, Ali Kemal

    2007-06-01

    Neuroleptic-induced acute akathisia (NIA) is a distressing condition and an important clinical problem because it is associated with treatment noncompliance and suicidal or impulsive behavior. Anticholinergics are among the treatment options; however, a review of the literature fails to identify a double-blind, randomized, placebo-controlled study of these medications in NIA. In a randomized, double-blind, placebo-controlled design, we studied the effectiveness of intramuscular biperiden (n = 15) or isotonic saline (n = 15) in the treatment of NIA diagnosed with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria. Injections were repeated up to 3 times unless akathisia was completely treated (scored 0 for global akathisia with the Barnes Akathisia Rating Scale). Patients were assessed for akathisia, other movement disorders, and psychiatric symptoms at baseline and 3 times after the first injection at 2-hour intervals. Response was defined as at least a 2-point decline in the global akathisia score. The numbers of responders in the 2 groups were not significantly different (7 and 5 in the biperiden and placebo groups, respectively). The courses of individual items on the Barnes Akathisia Rating Scale were also similar. Our results suggest that intramuscular biperiden should not be considered as a first-line treatment of NIA.

  2. Single-blind and Double-blind Randomized Controlled Trials of Palmtherapy®, an Alternative Medical Approach, for Anxiety before Cardiac Catheterization

    PubMed Central

    Jafari, Jamal; Podberezsky, Anna; David, Tamar; Reizin, Leonardo; Benjamin, Jonathan

    2008-01-01

    Alternative medicine is widely used, but lacks consensus regarding its amenability to scientific investigation. Anxiety increases morbidity and mortality in ischemic heart disease. We performed two studies of Palmtherapy®, an alternative treatment, for anxiety before cardiac catheterization. In the first study, patients were randomized to receive pressure at particular points on the palm, or at incorrect locations, for about 50 min, while the therapist conversed with them. In the second study, the conversation was conducted by a second, ‘blind’ investigator. In both studies, patients and nurses, all blind to treatment assignment, completed visual analog scale and National Institute of Mental Health measures of anxiety, respectively. Twenty-three subjects completed study 1, and 17 completed study 2. In study 1, palm therapy was superior to sham therapy for both outcome measures. In study 2, palm therapy was superior for self-reported anxiety, but not for nurses’ assessments of anxiety. Future studies should attempt to separate possible mechanistic effects of Palmtherapy® from therapist-related variables. Whether alternative medicine deserves to be studied at all remains controversial. Palmtherapy® may offer anxiolytic benefit without the harm attributable to drugs. PMID:18317556

  3. A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases.

    PubMed

    Mazlan, Mazlina; Rajasegaran, Shivani; Engkasan, Julia Patrick; Nawawi, Ouzreiah; Goh, Khean-Jin; Freddy, Saini Jeffery

    2015-09-22

    This study aims to determine the most efficacious dose of Botulinum neurotoxin type A (BoNT-A) in reducing sialorrhea in Asian adults with neurological diseases. A prospective, double-blind randomized controlled trial was conducted over 24 weeks. Thirty patients with significant sialorrhea were randomly assigned to receive a BoNT-A (Dysport(®)) injection into the submandibular and the parotid glands bilaterally via an ultrasound guidance. The total dose given per patient was either BoNT-A injection of (i) 50 U; (ii) 100 U; or (iii) 200 U. The primary outcome was the amount of saliva reduction, measured by the differential weight (wet versus dry) of intraoral dental gauze at baseline and at 2, 6, 12, and 24 weeks after injection. The secondary outcome was the subjective report of drooling using the Drooling Frequency and Severity Scale (DFS). Saliva reduction was observed in response to all BoNT-A doses in 17 patients who completed the assessments. Although no statistically significant difference among the doses was found, the measured reduction was greater in groups that received higher doses (100 U and 200 U). The group receiving 200 U of Dysport(®) showed the greatest reduction of saliva until 24 weeks and reported the most significant improvement in the DFS score.

  4. Double-blind, randomized clinical trial of troxerutin-carbazochrome in patients with hemorrhoids.

    PubMed

    Squadrito, F; Altavilla, D; Oliaro Bosso, S

    2000-01-01

    This multicenter, double-blind, randomised study was undertaken to determine the efficacy and safety of a combination of troxerutin 150 mg and carbazochrome 1.5 mg compared to carbazochrome alone in patients with acute uncomplicated hemorrhoids. Patients were administered by the intramuscular route (one ampoule) twice daily for one week. Both subjective and objective efficacy variables significantly improved in the combination drug group only, thus demonstrating the rationale for a combination therapy. Treatments were safe and well tolerated either at a local or systemic level.

  5. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    PubMed Central

    Darlong, Vanlal; Garg, Rakesh; Pandey, Ravinder; Khokhar, Sudarshan; Chandralekha; Sinha, Renu; Punj, Jyotsna; Sinha, Rajesh

    2015-01-01

    Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766). Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for

  6. A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA®) and generic novo-methylphenidate ER-C (NOVO-generic)

    PubMed Central

    Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A.

    2016-01-01

    Objective: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child’s development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA® to the same dose of generic Novo-methylphenidate ER-C®. Methods: Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Results: Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Conclusion: Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted. PMID:27536342

  7. Cinnarizine versus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial

    PubMed Central

    ASHRAFI, Mahmoud Reza; NAJAFI, Zeinab; SHAFIEI, Masih; HEIDARI, Kazem; TOGHA, Mansoureh

    2014-01-01

    Objective Migraines, a common health problem in children and adolescents, still do not have an FDA approved preventive treatment for patients under the age of 18 years. This study compares and contrasts the efficacy and safety of cinnarizine and topiramate in preventing pediatric migraines. Materials & Methods In this randomized, double-blind clinical trial 44 migrainous (from 4–15 years of age) were equally allocated to receive cinnarizine or topiramate. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate. Efficacy measures were recorded at the baseline and at 4, 8, and 12 weeks of treatment. Results During the double-blind phase of the study, monthly migraine frequency and intensity were significantly decreased in both the cinnarizine and topiramate groups when compared to the baseline. However, at the end of the study, the cinnarizine group exhibits a significant decrease from the baseline in the mean monthly migraine intensity when compared to the topiramate group (4.7 vs. 3, respectively; 95% CI = -0.8 to -3.2). Conclusion No significant difference between cinnarizine and topiramate was found for the prevention of pediatric migraines. Both treatments were well tolerated. PMID:25657766

  8. Pilot Study of the Effects of Lisdexamfetamine on Cocaine Use: A Randomized, Double-Blind, Placebo-Controlled Trial*

    PubMed Central

    Mooney, Marc E.; Herin, David V.; Specker, Sheila; Babb, David; Levin, Frances R.; Grabowski, John

    2015-01-01

    Background Amphetamine analogues have been demonstrated to have some efficacy in reducing use in cocaine dependent individuals. However, these agents also have potential for abuse. Lisdexamfetamine (LDX), a lysine+dextroamphetamine formulation, has been approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and as a prodrug, has less abuse potential. Objective This pilot study sought to evaluate the safety, tolerability, and efficacy of LDX as a candidate treatment for cocaine dependence. Methods A randomized, double-blind, placebo-controlled parallel group study served to evaluate LDX in 43 cocaine-dependent individuals: (1) Placebo (PBO; 0 mg, n = 21), (2) LDX (70 mg, n = 22). Participants received medication for 14 weeks. Cocaine use was determined based on urine analysis for benzoylecgonine (BE; a cocaine metabolite). Results Retention rates were higher though not significantly different in the PBO (71.4%) than the LDX condition (57.1%). Compared to those in the PBO condition, those receiving LDX were more likely to report experiencing (ps < .05) diarrhea (45.5% vs. 14.3%), headaches (45.5% vs. 9.5%), and anxiety (31.8% vs. 4.8%). No differences in medication conditions were observed for blood pressure, heart rate, or body weight. In the randomized sample, no differences in cocaine use were seen. Those receiving LDX reported significantly less craving for cocaine than participants receiving PBO. Conclusions LDX did not significantly reduce cocaine use compared to PBO in the randomized sample. PMID:26116930

  9. Hydrogen peroxide release kinetics into saliva from different whitening products: a double-blind, randomized clinical trial.

    PubMed

    Marques, Duarte Nuno da Silva; da Mata, António Duarte Sola Pereira; Silveira, João Miguel Lourenço; Marques, Joana Rita Oliveira Faria; Amaral, João Pedro de Almeida Rato; Guilherme, Nuno Filipe Rito Parada Marques

    2012-02-01

    The objective of this study is to compare salivary hydrogen peroxide (HP) release kinetics and potential toxicity of systemic exposure of four different whitening products. A double-blind, randomized controlled trial was conducted in a Portuguese dental faculty clinic. Two hundred forty volunteers were randomized to eight intervention groups. Participants were randomly assigned to receive active or placebo applications of one of four different products: Opalescence 10% PF™ (OPL), Vivastyle® 10%™ (VS10%), Vivadent Paint On Plus™ (PO+), and Trés White Supreme™ (TWS). Saliva collection was obtained by established methods at different times. The HP salivary content was determined by a photometric method. Salivary HP variations, total amount of salivary HP, and counts of subjects above the safe daily HP dose were the main outcome measures. All whitening systems significantly released HP to the saliva when compared to placebo, and all showed different release kinetics. The adaptable tray system (TWS) presented a risk increase of 37% [20-54%, 95% confidence interval] when compared to the other systems. The use of an adaptable tray whitening system with higher concentration of HP increases the toxicity potential.

  10. Opium tincture versus methadone syrup in management of acute raw opium withdrawal: A randomized, double-blind, controlled trial.

    PubMed

    Tabassomi, Farzaneh; Zarghami, Mehran; Shiran, Mohammad-Reza; Farnia, Samaneh; Davoodi, Mohsen

    2016-01-01

    The aim of this study was to evaluate the effectiveness of opium tincture versus methadone syrup in the management of acute withdrawal syndrome in opium dependent patients during the detoxification period. In this double-blind randomized controlled study, a total of 74 adult male raw opium dependent patients were treated with opium tincture or methadone syrup 2 times daily for 5 consecutive days. Detoxification was initiated by tapered dose reductions to reach abstinence. At the end of the 10th day, the medications were discontinued. The Objective Opioid Withdrawal Scale was used to assess withdrawal symptoms every day. Significant decreases on the Objective Opioid Withdrawal Scale were found for both treatment methods during the study period (p < .0001). However, there was no significant difference between groups on the total Objective Opioid Withdrawal Scale, and adverse effects existed. Opium tincture can be considered as a potential substitute for methadone syrup for suppression of raw opium withdrawal symptoms, with minimal adverse effects.

  11. Influence of electroencephalography neurofeedback training on episodic memory: a randomized, sham-controlled, double-blind study.

    PubMed

    Guez, Jonathan; Rogel, Ainat; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Gordon, Shirley; Meiran, Nachshon; Todder, Doron

    2015-01-01

    The relationships between memory processes and oscillatory electroencephalography (EEG) are well established. Neurofeedback training (NFT) may cause participants to better regulate their brain EEG oscillations. The present study is a double-blind sham-controlled design investigating the effect of NFT on memory. NFT included up-training upper alpha (UA) band, up-training sensory-motor rhythm (SMR) band and sham protocol. Thirty healthy adult volunteers were randomly divided into three treatment groups. NFT sessions (30 min each) took place twice weekly for a total of 10 sessions while memory testing took place pre- and post-training. The results indicate dissociation between SMR and UA NFT and different memory processes. While the SMR protocol resulted in improving automatic, item-specific and familiarity-based processes in memory, the UA protocol resulted in improved strategic and controlled recollection. The implications of the results are discussed.

  12. A randomized, double blind, placebo controlled study of spirulina supplementation on indices of mental and physical fatigue in men.

    PubMed

    Johnson, Morgan; Hassinger, Lauren; Davis, Joshua; Devor, Steven T; DiSilvestro, Robert A

    2016-01-01

    Spirulina may increase people's ability to resist mental and physical fatigue. This study tested that hypothesis in a randomized, double blinded, placebo controlled study in men. After 1 week, a 3 g/day dose of spirulina produced a small, but statistically significant increase in exercise output (Kcals consumed in 30 min exercise on a cross trainer machine). A mathematical based mental fatigue test showed improved performance 4 h after the first time of supplementation as well as 8 weeks later. Similarly, a subjective survey for a sense of physical and mental fatigue showed improvement within 4 h of the first supplementation as well as 8 weeks later. These results show that spirulina intake can affect fatigue in men. PMID:26888417

  13. [Efficiency of homeopathic preparation combinations in sinusitis. Results of a randomized double blind study with general practitioners].

    PubMed

    Wiesenauer, M; Gaus, W; Bohnacker, U; Häussler, S

    1989-05-01

    In a controlled randomized double-blind trial carried out by 47 physicians in private practice with totally 152 patients with sinusitis the therapeutic success of the following homeopathic drug preparations was investigated: Group A: combination of luffa operculata D4, kalium bicromicum D4 and cinnabaris D3. Group B: combination of kalium bicromicum D4 and cinnabaris D3. Group C: luffa operculata D4. Group D: placebo. Criteria for the therapeutic result were headache, blocked nasal breathing, trigeminal tenderness, reddening and swelling of nasal mucosa and postnasal secretion. There was no remarkable difference in the therapeutic success among the investigated homeopathic drug combinations nor between the active drugs and placebo. Averaged over all four groups 81% of the patients with acute sinusitis and 67% of the patients with chronic sinusitis recovered. In the literature comparable therapeutic results are reported for antibiotic therapy, decongestant nose drops and for the drainage of nasal cavities.

  14. Opium tincture versus methadone syrup in management of acute raw opium withdrawal: A randomized, double-blind, controlled trial.

    PubMed

    Tabassomi, Farzaneh; Zarghami, Mehran; Shiran, Mohammad-Reza; Farnia, Samaneh; Davoodi, Mohsen

    2016-01-01

    The aim of this study was to evaluate the effectiveness of opium tincture versus methadone syrup in the management of acute withdrawal syndrome in opium dependent patients during the detoxification period. In this double-blind randomized controlled study, a total of 74 adult male raw opium dependent patients were treated with opium tincture or methadone syrup 2 times daily for 5 consecutive days. Detoxification was initiated by tapered dose reductions to reach abstinence. At the end of the 10th day, the medications were discontinued. The Objective Opioid Withdrawal Scale was used to assess withdrawal symptoms every day. Significant decreases on the Objective Opioid Withdrawal Scale were found for both treatment methods during the study period (p < .0001). However, there was no significant difference between groups on the total Objective Opioid Withdrawal Scale, and adverse effects existed. Opium tincture can be considered as a potential substitute for methadone syrup for suppression of raw opium withdrawal symptoms, with minimal adverse effects. PMID:26566681

  15. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease.

    PubMed

    2013-01-01

    BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect of latrepirdine on cognition and global function in patients with mild to moderate Huntington disease. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Sixty-four research centers in Australia, Europe, and North America. PATIENTS Four hundred three patients with mild to moderate Huntington disease and baseline cognitive impairment (Mini-Mental State Examination score, 10-26). INTERVENTION Latrepirdine (20 mg) vs matching placebo administered orally 3 times daily for 26 weeks. MAIN OUTCOME MEASURES The co-primary outcome measures were cognition as measured by the change in Mini-Mental State Examination score from baseline to week 26 and global function at week 26 as measured by the Clinician Interview-Based Impression of Change, plus carer interview, which ranges from 1 (marked improvement) to 7 (marked worsening). Secondary efficacy outcome measures included behavior, daily function, motor function, and safety. RESULTS The mean change in Mini-Mental State Examination score among participants randomized to latrepirdine (1.5-point improvement) did not differ significantly from that among participants randomized to placebo (1.3-point improvement) (P=.39). Similarly, the distribution of the Clinician Interview-Based Impression of Change, plus carer interview did not differ significantly among those randomized to latrepirdine compared with placebo (P=.84). No significant treatment effects were detected on the secondary efficacy outcome measures. The incidence of adverse events was similar between those randomized to latrepirdine (68.5%) and placebo (68.0%). CONCLUSION In patients with mild to moderate Huntington disease and cognitive impairment, treatment with

  16. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL MATRICARIA RECUTITA (CHAMOMILE) EXTRACT THERAPY OF GENERALIZED ANXIETY DISORDER

    PubMed Central

    Amsterdam, Jay D.; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

    2013-01-01

    Objective We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate Generalized Anxiety Disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Materials & Methods 61 outpatients with mild to moderate GAD were enrolled and 57 were randomized to either double blind chamomile extract (n=28) or placebo (n=29) therapy for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory score, Psychological Well Being score, Clinical Global Impression Severity score, and the proportion of patients with ≥50% reduction in baseline HAM-A score. Results We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (p=0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or ≥3 adverse events was not significantly different between groups (p=0.417). Conclusion This is the first, controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations. PMID:19593179

  17. Optimal duration of antibiotic therapy for uncomplicated urinary tract infection in older women: a double-blind randomized controlled trial

    PubMed Central

    Vogel, Thomas; Verreault, René; Gourdeau, Marie; Morin, Michèle; Grenier-Gosselin, Lise; Rochette, Louis

    2004-01-01

    Background The optimal duration of antibiotic therapy in older patients with uncomplicated urinary tract infection (UTI) is still a matter of debate. The aim of this randomized controlled double-blind noninferiority trial was to compare the efficacy and safety of 3-day and 7-day courses of oral ciprofloxacin for uncomplicated symptomatic UTI in older women. Methods A total of 183 women at least 65 years of age with acute uncomplicated UTI were recruited from ambulatory clinics and hospital acute care units. Patients with pyelonephritis, contraindications to fluoroquinolones, recent use of antibiotics, urinary tract abnormalities and diabetes mellitus were excluded. Women were randomly assigned to receive either ciprofloxacin 250 mg twice daily orally for 3 days followed by placebo for 4 days (the 3-day group, 93 patients) or ciprofloxacin 250 mg twice daily orally for 7 days (the 7-day group, 90 patients). Bacterial eradication, clinical improvement and occurrence of adverse events were determined 2 days after completion of treatment, and occurrence of reinfection or relapse were determined 6 weeks after completion of treatment. Bacterial eradication and relapse were determined by urine culture. Double-blind procedures were maintained throughout data collection. Results The proportion of patients with bacterial eradication at 2 days after treatment was 98% (91/93) in the 3-day group and 93% (83/89) in the 7-day group (p = 0.16). The frequency of adverse events, including drowsiness, headache, nausea or vomiting, and loss of appetite, was significantly lower in the 3-day group. Interpretation These results suggest that a 3-day course of antibiotic therapy is not inferior to a 7-day course for treatment of uncomplicated symptomatic UTI in older women, and that the shorter course is better tolerated. PMID:14970093

  18. Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial

    PubMed Central

    Park, Eun-Ah; Kang, Doo Kyoung; Kim, Sung Jin; Kim, Young-Ju; Kim, Yookyung; Sung, Yon Mi; Song, Soon-Young; Oh, Yu-Whan; Yong, Hwan Seok; Lee, Heon; Jeon, Eui-Yong; Jin, Gong-Yong; Choi, Byoung Wook; Choi, Sang-Il

    2016-01-01

    Objective This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. Materials and Methods Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader. Luminal attenuations (ascending aorta, left main coronary artery, and left ventricle) in Hounsfield units (HUs) and image quality on a 4-point scale were calculated. Results A total of 225 subjects were given contrast media (115 with iohexol-380 and 110 with iohexol-350). There was no difference in number of adverse drug reactions between groups: 75 events in 56 (48.7%) of 115 subjects in the iohexol-380 group vs. 74 events in 51 (46.4%) of 110 subjects in the iohexol-350 group (p = 0.690). No severe adverse drug reactions were recorded. Neither group showed an increase in serum creatinine. Significant differences in mean density between the groups was found in the ascending aorta: 375.8 ± 71.4 HU with iohexol-380 vs. 356.3 ± 61.5 HU with iohexol-350 (p = 0.030). No significant differences in image quality scores between both groups were observed for all three anatomic evaluations (all, p > 0.05). Conclusion Iohexol-380 provides improved enhancement of the ascending aorta and similar attenuation of the coronary arteries without any increase in adverse drug reactions, as compared with iohexol-350 using an identical amount of total iodine. PMID:27134522

  19. Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

    PubMed Central

    2013-01-01

    Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized

  20. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    PubMed

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  1. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today. PMID:24451886

  2. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today.

  3. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    PubMed Central

    2014-01-01

    Background Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP. Methods/Design This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be

  4. Randomized Phase II Trials: A Long-term Investment With Promising Returns

    PubMed Central

    Sharma, Manish R.; Stadler, Walter M.

    2011-01-01

    Given the multitude of novel anticancer drugs and the limited resources available to study them, phase II trials should identify drugs with the highest probability of succeeding in subsequent phase III trials. Currently, single-arm phase II trial results are interpreted relative to historical control subjects, introducing selection bias and confounding that may limit the validity of the conclusions. The rate of success (defined as a statistically significant difference between arms) in phase III oncology trials is only 40%, suggesting that current phase II trials are insufficiently informative. However, simulation studies suggest that randomized phase II trials would have lower error rates and greater predictive power for phase III results. Randomized phase II trials may also be more informative than single-arm phase II trials because of the hypotheses being tested, the variety of possible endpoints, and the opportunities for biomarker discovery. There are a wide variety of randomized phase II designs that can be used, including the randomized discontinuation design, the delayed-start design, adaptive (Bayesian) designs, selection designs, and phase II/III designs. The barriers to widespread adoption of randomized phase II trials include time to completion, sample size considerations, and ethical concerns, but none are insurmountable. We conclude that randomized phase II trials are a worthy investment considering finite patient and financial resources and should be the rule rather than the exception for evaluating novel therapies in oncology. PMID:21709274

  5. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40–120 mg/day) in patients with major depressive disorder

    PubMed Central

    Gommoll, Carl P.; Greenberg, William M.; Chen, Changzheng

    2014-01-01

    Objective Levomilnacipran ER is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved for the treatment of major depressive disorder (MDD). Efficacy and safety have been evaluated in five Phase II/III studies, four of which met the pre-specified primary efficacy outcome. Results of the negative trial (ClinicalTrials.gov NCT00969150) are reported here. Methods A Phase III randomized, double-blind, placebo-controlled trial comparing flexible-dose levomilnacipran ER 40–120 mg/day with placebo was conducted in outpatients with MDD. Patients met the DSM-IV-TR criteria for MDD, had a current episode of depression of at least 4 weeks’ duration, and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥30. The study comprised a 1-week, single-blind, placebo lead-in, 8-week double-blind treatment, and a 2-week down-taper. The primary and secondary efficacy measures were change from baseline to Week 8 in MADRS and Sheehan Disability Scale (SDS) total scores, respectively, analyzed using a mixed-effects model for repeated measures approach. Safety outcomes included adverse events (AEs), laboratory and vital sign measures, the Columbia-Suicide Severity Rating Scale, and the Arizona Sexual Experiences Scale (ASEX). Results Three hundred and fifty-five patients received the study drug and had ≥1 post-baseline MADRS total score assessment (ITT Population); 81.9% of placebo and 77.1% of levomilnacipran ER patients completed the study. For levomilnacipran ER vs placebo, MADRS (−15.7 vs −14.2) and SDS (−8.8 vs −8.2) total score improvements, and rates of MADRS response (38.5% vs 34.8%) and remission (25.3% vs 23.8%) were numerically greater but differences were not statistically significant. Levomilnacipran ER was generally well tolerated. More levomilnacipran ER patients vs placebo reported AEs; the most common AEs for levomilnacipran ER were nausea (17%) and headache (16%). Mean changes in most safety measures were

  6. Methylprednisolone pulse therapy in acute severe asthma. A randomized, double-blind study.

    PubMed

    Engel, T; Dirksen, A; Frølund, L; Heinig, J H; Svendsen, U G; Pedersen, B K; Weeke, B

    1990-04-01

    Methylprednisolone pulse therapy (MPPT) has been shown to possess a long-lasting effect in other immune-inflammatory diseases without the well-known side effects caused by long-term treatment with glucocorticosteroids. In an attempt to reduce the long-term use of oral steroids in asthmatics, we conducted this double-blind, double-dummy study to compare the use of MPPT (1 g of methylprednisolone intravenously) (8 patients) with a short course of oral prednisolone (10 patients) in asthmatics presenting with acute severe asthma. Both treatments were effective in relieving the acute attack of asthma. The MPPT-treated patients did not show a faster resolution than did the orally treated group. No patients needed assisted ventilation, and no deaths occurred. One week after the treatment FEV1 tended to decrease in the methylprednisolone group compared with the oral prednisolone group (P = 0.06). The patients initially receiving MPPT needed supplementary prednisolone earlier and in higher doses than did the patients receiving oral prednisolone as initial treatment. At the end of the 12 weeks' study period, the groups reached identical FEV1. In conclusion, we did not find intravenous methylprednisolone superior to oral prednisolone in the treatment of acute attacks of severe asthma, but methylprednisolone pulse therapy had a shorter duration as regards protection against future asthma attacks. PMID:2183645

  7. Effect of pretreatment with acetaminophen on withdrawal movements associated with injection of rocuronium: a prospective, randomized, double-blind, placebo controlled study

    PubMed Central

    Jeon, Younghoon; Baek, Sung-Uk; Park, Sung Sik; Kim, Si Oh; Baek, Woon-Yi

    2010-01-01

    Background Withdrawal movement during rocuronium injection is a common, unresolved adverse effect. We aimed to investigate the effect of IV acetaminophen pretreatment on withdrawal movement during rocuronium injection. Methods This study enrolled 120 American Society of Anesthesiologists (ASA) I-II patients undergoing general anesthesia. They were randomly assigned to three treatment groups. After occluding venous drainage using a tourniquet on the upper arm, the saline group received 5 ml of 0.9% sodium chloride solution, the lidocaine group received 40 mg of lidocaine, and the acetaminophen group received 50 mg of acetaminophen. During injection of pretreatment drug, pain was assessed on a four-point scale. The tourniquet was released after 120 seconds and anesthesia was performed using thiopental sodium 5 mg/kg followed by rocuronium 0.6 mg/kg. The withdrawal movement was graded on a four-point scale in a double-blind manner. Results The incidence of pain on pretreatment injection in saline, lidocaine, and acetaminophen groups was 7.7%, 5.1%, and 2.5%, respectively. The incidence of withdrawal movements was 77.5% in saline group, 32.5% in lidocaine group, and 37.5% in acetaminophen group (P < 0.05). Conclusions Acetaminophen and lidocaine reduced the incidence of withdrawal movement after rocuronium injection compared with saline. PMID:20651992

  8. Double-blind randomized study of 1 g versus 2 g intravenous ceftriaxone daily in the therapy of community-acquired infections.

    PubMed

    Segev, S; Raz, R; Rubinstein, E; Shmuely, H; Hassin, D; Rosen, N; Platau, E; Ben Assuli, S; Pitlik, S

    1995-10-01

    In a multicentre, double-blind, randomized study involving four general hospitals in Israel, the efficacy and safety of ceftriaxone 1 g/day i.v. was compared to that of 2 g/day i.v. in the treatment of moderate to severe community-acquired infections requiring hospitalization. Two hundred and twenty-two patients were enrolled; 112 received intravenous ceftriaxone 1 g/day, and 110 received 2 g/day. The two groups were matched demographically, and their mean APACHE II score (10 points) and mean duration of successful therapy (7 days) were identical. The sites of infection in the 1 g and 2 g groups respectively were lower respiratory tract in 57 versus 51 patients, urinary tract in 31 versus 40 patients, and soft tissue in 24 versus 19 patients. There were no significant differences in clinical outcome between the 1 g and 2 g groups, the outcome being cure in 91% versus 86% of patients, improvement in 3% versus 3% of patients, failure in 3% versus 8% of patients, and relapse in 3% versus 3% of patients. The findings of this study indicate that ceftriaxone 1 g/day is as effective as 2 g/day in the treatment of moderate to severe community-acquired infections. The low-dose form is a more economical means of treating these infections.

  9. A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of methamphetamine dependence.

    PubMed

    Johnson, Bankole A; Ait-Daoud, Nassima; Elkashef, Ahmed M; Smith, Edwina V; Kahn, Roberta; Vocci, Francis; Li, Shou-Hua; Bloch, Daniel A

    2008-02-01

    Methamphetamine dependence is an increasing public health problem in the United States. No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the rewarding effects of d-amphetamine in animal and human laboratory studies, we decided to test whether it would be superior to placebo at reducing methamphetamine use. In a preliminary, multi-site, randomized, double-blind, 8-wk controlled trial, 150 methamphetamine-dependent men and women received ondansetron (0.25 mg, 1 mg, or 4 mg b.i.d.) or placebo. Participants were assessed on several measures of methamphetamine use including urine methamphetamine level up to three times per week. As a psychosocial adjunct to the medication condition, cognitive behavioural therapy also was administered three times per week. Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events. Nevertheless, none of the ondansetron doses was superior to placebo at decreasing any of the measures of methamphetamine use, withdrawal, craving, or clinical severity of methamphetamine dependence. Our preliminary results do not support the utility of ondansetron, at the doses tested, as a treatment for methamphetamine dependence. These findings should be viewed in light of the possibility that a less intensive cognitive behavioural therapy regimen might have yielded more positive results in this initial phase II trial exploring for the efficacy of ondansetron.

  10. A Randomized Double-Blind Study of Atomoxetine versus Placebo for Attention-Deficit/Hyperactivity Disorder Symptoms in Children with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.

    2012-01-01

    Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind treatment with 1.2 mg/kg/day atomoxetine or…

  11. A Randomized, Rater-Blinded, Parallel Trial of Intensive Speech Therapy in Sub-Acute Post-Stroke Aphasia: The SP-I-R-IT Study

    ERIC Educational Resources Information Center

    Martins, Isabel Pavao; Leal, Gabriela; Fonseca, Isabel; Farrajota, Luisa; Aguiar, Marta; Fonseca, Jose; Lauterbach, Martin; Goncalves, Luis; Cary, M. Carmo; Ferreira, Joaquim J.; Ferro, Jose M.

    2013-01-01

    Background: There is conflicting evidence regarding the benefits of intensive speech and language therapy (SLT), particularly because intensity is often confounded with total SLT provided. Aims: A two-centre, randomized, rater-blinded, parallel study was conducted to compare the efficacy of 100 h of SLT in a regular (RT) versus intensive (IT)…

  12. A Randomized, Double-Blind, Placebo-Controlled Study of Modafinil Film-Coated Tablets in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

    ERIC Educational Resources Information Center

    Greenhill, Laurence L.; Biederman, Joseph; Boellner, Samuel W.; Rugino, Thomas A.; Sangal, R. Bart; Earl, Craig Q.; Jiang, John G.; Swanson, James M.

    2006-01-01

    Objective: To evaluate the efficacy and tolerability of modafinil in children and adolescents, ages 7 to 17, with attention-deficit/hyperactivity disorder (ADHD). Method: In this 9-week, double-blind, flexible-dose study, patients were randomized to once-daily modafinil (170-425 mg) or placebo. Assessments included ADHD Rating Scale-IV…

  13. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    ERIC Educational Resources Information Center

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  14. A Double-Blind Randomized Controlled Trial of Continuous Intravenous Ketorolac vs Placebo for Adjuvant Pain Control After Renal Surgery

    PubMed Central

    Grimsby, Gwen M.; Conley, Sarah P.; Trentman, Terrence L.; Castle, Erik P.; Andrews, Paul E.; Mihalik, Laurie A.; Hentz, Joseph G.; Humphreys, Mitchell R.

    2012-01-01

    Objective To evaluate the efficacy and safety of a novel, continuous intravenous infusion of ketorolac, a powerful nonopioid analgesic, for postoperative pain control. Patients and Methods A prospective, double-blind, randomized, placebo-controlled trial of a continuous infusion of ketorolac tromethamine in 1 L of normal saline vs placebo was performed in 135 patients aged 18 to 75 years after laparoscopic donor nephrectomy or percutaneous nephrolithotomy completed from October 7, 2008, through July 21, 2010. Primary study end points were the 24-hour differences in visual analog pain scores and total narcotic consumption, whereas secondary end points were differences in urine output, serum creatinine level, and hemoglobin level. Results The study was stopped after randomization of 135 patients (68 in the ketorolac group and 67 in the placebo group) when interim analysis indicated that the difference in mean pain scores between the 2 groups (difference, 0.6) was smaller than the 1-point threshold set forth in the power calculations. No statistically significant change was noted in hemoglobin levels from preoperative to postoperative values (P=.13) or in postoperative serum creatinine levels (P=.13). Conclusion Although continuous infusion of ketorolac produced only a modest decrease in the use of narcotics, it appears to offer a safe therapeutic option for nonnarcotic pain control. Trial Registration clinicaltrials.gov Identifiers: NCT00765128 and NCT00765232 PMID:23058854

  15. Increased calcium absorption from synthetic stable amorphous calcium carbonate: double-blind randomized crossover clinical trial in postmenopausal women.

    PubMed

    Vaisman, Nachum; Shaltiel, Galit; Daniely, Michal; Meiron, Oren E; Shechter, Assaf; Abrams, Steven A; Niv, Eva; Shapira, Yami; Sagi, Amir

    2014-10-01

    Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (CCC) using the dual stable isotope technique. The study was conducted in the Unit of Clinical Nutrition, Tel Aviv Sourasky Medical Center, Israel. The study population included 15 early postmenopausal women aged 54.9 ± 2.8 (mean ± SD) years with no history of major medical illness or metabolic bone disorder, excess calcium intake, or vitamin D deficiency. Standardized breakfast was followed by randomly provided CCC or ACC capsules containing 192 mg elemental calcium labeled with 44Ca at intervals of at least 3 weeks. After swallowing the capsules, intravenous CaCl2 labeled with 42Ca on was administered on each occasion. Fractional calcium absorption (FCA) of ACC and CCC was calculated from the 24-hour urine collection following calcium administration. The results indicated that FCA of ACC was doubled (± 0.96 SD) on average compared to that of CCC (p < 0.02). The higher absorption of the synthetic stable ACC may serve as a more efficacious way of calcium supplementation.

  16. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blind study.

    PubMed

    Roje, Zeljka; Racić, Goran; Dogas, Zoran; Pisac, Valdi Pesutić; Timms, Michael

    2009-03-01

    The aim of this prospective randomized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation, and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity, to compare intraoperative blood loss, postoperative pain severity, time to resuming normal physical activity, and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years. 72 children aged 3-16 years scheduled for tonsillectomy randomly assigned into two groups submitted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy, with a 14-day follow up. Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue (p < 0.001), intraoperative blood loss (p < 0.004), in postoperative pain severity (p < 0.05) and in time to resuming normal physical activity between the two groups (p < 0.001). There was no case of reactionary or secondary bleeding in either group. In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage: less thermal damage is associated with less postoperative morbidity.

  17. Galantamine efficacy and tolerability as an augmentative therapy in autistic children: A randomized, double-blind, placebo-controlled trial.

    PubMed

    Ghaleiha, Ali; Ghyasvand, Mohammad; Mohammadi, Mohammad-Reza; Farokhnia, Mehdi; Yadegari, Noorollah; Tabrizi, Mina; Hajiaghaee, Reza; Yekehtaz, Habibeh; Akhondzadeh, Shahin

    2014-07-01

    The role of cholinergic abnormalities in autism was recently evidenced and there is a growing interest in cholinergic modulation, emerging for targeting autistic symptoms. Galantamine is an acetylcholinesterase inhibitor and an allosteric potentiator of nicotinic receptors. This study aimed to evaluate the possible effects of galantamine as an augmentative therapy to risperidone, in autistic children. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 outpatients aged 4-12 years whom had a diagnosis of autism (DSM IV-TR) and a score of 12 or higher on the Aberrant Behavior Checklist-Community (ABC-C) Irritability subscale were equally randomized to receive either galantamine (up to 24 mg/day) or placebo, in addition to risperidone (up to 2 mg/day), for 10 weeks. We rated participants by ABC-C and a side effects checklist, at baseline and at weeks 5 and 10. By the study endpoint, the galantamine-treated patients showed significantly greater improvement in the Irritability (P = 0.017) and Lethargy/Social Withdrawal (P = 0.005) subscales than the placebo group. The difference between the two groups in the frequency of side effects was not significant. In conclusion, galantamine augmentation was shown to be a relatively effective and safe augmentative strategy for alleviating some of the autism-related symptoms.

  18. TOPICAL 0.03% ATROPINE VS. 15% ALUMINUM CHLORIDE IN TREATING MULTIPLE ECCRINE HIDROCYSTOMAS: A RANDOMIZED SINGLE BLIND CONTROLLED STUDY

    PubMed Central

    Amirhoushang, Ehsani; Mostafa, Mirshams Shashahani; Maryam, Akhyani; Pardis, Noormohamadpour; Pedram, Noormohamadpour

    2010-01-01

    Background: Multiple eccrine hidrocystomas pose a significant treatment challenge due to their facial location and tendency to scar after traditional surgical and other destructive modalities. Aims: To compare two frequently used non-destructive therapeutic modalities. Materials and Methods: Thirty patients with multiple eccrine hidrocystomas were enrolled in the study. They used topical 0.03% Atropine cream and 15% AlCl3 solution on left and right sides of their face randomly for 4 weeks. All the patients were visited before commencing the therapy as well as two and four weeks later by a dermatologist, blinded to the drugs and the number of lesions. Results: Twenty nine patients (25 females, four males) completed the study. The mean reduction in the number of lesions was significantly higher with Atropine cream in comparison with AlCl3 solution, 10.2±7.4 vs. 6.2±5.3 (P < 0.05). There were no recurrences after three months follow-up in both groups. Conclusion: It seems that both Atropine and AlCl3 are useful therapies in eccrine hidrocytomas but the former might be more effective. We think that other randomized clinical trials with larger sample sizes are needed. PMID:20418978

  19. Randomized, Double-Blind Clinical Trial to Assess the Acute Diuretic Effect of Equisetum arvense (Field Horsetail) in Healthy Volunteers

    PubMed Central

    Carneiro, Danilo Maciel; Freire, Ramias Calixto; Honório, Tereza Cristina de Deus; Zoghaib, Iury; Cardoso, Fabiana Fernandes de S. e Silva; Tresvenzol, Leonice Manrique F.; de Paula, José Realino; Sousa, Ana Luiza Lima; Jardim, Paulo César Brandão Veiga; da Cunha, Luiz Carlos

    2014-01-01

    In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n = 12) that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day), placebo (corn starch, 900 mg/day), or hydrochlorothiazide (25 mg/day), separated by a 10-day washout period. Each volunteer served as his own control, and the groups' results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers' water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine. PMID:24723963

  20. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial.

    PubMed

    Kazemipoor, Mahnaz; Radzi, Che Wan Jasimah Bt Wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377. PMID:24319489

  1. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study

    PubMed Central

    Faghihi, Gita; Iraji, Fariba; Behfar, Shadi; Abtahi-Naeini, Bahareh

    2016-01-01

    Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment (<0.001). The mean lesion size before treatment and at 30, 60, and 120 days was not different between the two groups (p > 0.05). No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases) of patients in the diclofenac sodium group (p = 0.005). Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion. PMID:27689135

  2. Compound Danshen Dripping Pill for Treating Early Diabetic Retinopathy: A Randomized, Double-Dummy, Double-Blind Study

    PubMed Central

    Luo, Dan; Qin, Yali; Yuan, Wei; Deng, Hui; Zhang, Youhua; Jin, Ming

    2015-01-01

    This randomized, double-dummy, double-blind study was to observe the therapeutic effects of compound Danshen dripping pill (CDDP) in treating early diabetic retinopathy (DR). All the 57 type 2 diabetes cases in nonproliferative diabetic retinopathy (NPDR) stage were divided into two groups randomly: 28 cases treated with CDDP as the treated group and 29 cases treated with calcium dobesilate as the control group. The best corrected visual acuity (BCVA) in the treated group was significantly improved after treatment when compared to that before treatment (P < 0.05). Mean defect (MD) of visual field, hemorrhage area of the fundus, microaneurysm number, fluorescent leakage area, and capillary nonperfusion area evaluated by visual field, fundus photography, and fundus fluorescein angiography in the treated group had the same results as BCVA. However, there was no statistical difference in each index between the two groups. No obvious adverse events with clinical significance occurred. Our present study showed that CDDP has a similar improvement and safety to calcium dobesilate for NPDR. In future DR treatments, CDDP may function as the auxiliary drug. PMID:26457110

  3. Insufflation with Humidified and Heated Carbon Dioxide in Short-Term Laparoscopy: A Double-Blinded Randomized Controlled Trial

    PubMed Central

    Herrmann, Anja; De Wilde, Rudy Leon

    2015-01-01

    Background. We tested the hypothesis that warm-humidified carbon dioxide (CO2) insufflation would reduce postoperative pain and morphine requirement compared to cold-dry CO2 insufflation. Methods. A double-blinded, randomized, controlled trial was conducted to compare warm, humidified CO2 and cold-dry CO2. Patients with benign uterine diseases were randomized to either treatment (n = 48) or control (n = 49) group during laparoscopically assisted vaginal hysterectomy. Primary endpoints of the study were rest pain, movement pain, shoulder-tip pain, and cough pain at 2, 4, 6, 24, and 48 hours postoperatively, measured by visual analogue scale. Secondary outcomes were morphine consumption, rejected boli, temperature change, recovery room stay, and length of hospital stay. Results. There were no significant differences in all baseline characteristics. Shoulder-tip pain at 6 h postoperatively was significantly reduced in the intervention group. Pain at rest, movement pain, and cough pain did not differ. Total morphine consumption and rejected boli at 24 h postoperatively were significantly higher in the control group. Temperature change, recovery room stay, and length of hospital were similar. Conclusions. Warm, humidified insufflation gas significantly reduces postoperative shoulder-tip pain as well as morphine demand. This trial is registered with Clinical Trial Registration Number  DRKS00003853 (German Clinical Trials Register (DRKS)). PMID:25722977

  4. Efficacy of betamethasone valerate medicated plaster on painful chronic elbow tendinopathy: a double-blind, randomized, placebo-controlled trial

    PubMed Central

    Frizziero, Antonio; Causero, Araldo; Bernasconi, Stefano; Papalia, Rocco; Longo, Mario; Sessa, Vincenzo; Sadile, Francesco; Greco, Pasquale; Tarantino, Umberto; Masiero, Stefano; Rovati, Stefano; Frangione, Valeria

    2016-01-01

    Summary Objective to investigate the efficacy and safety of a medicated plaster containing betamethasone valerate (BMV) 2.25 mg in patients with chronic elbow tendinopathy. Methods randomized, double-blind, placebo-controlled study with assignment 2:2:1:1 to BMV medicated plaster applied daily for 12 hours, daily for 24 hours or matched placebo. 62 patients aged ≥18 years with chronic lateral elbow tendinopathy were randomized. The primary efficacy variable was pain reduction (VAS) at day 28. Secondary objectives included summed pain intensity differences (SPID), overall treatment efficacy and tolerability. Results mean reduction in VAS pain score at day 28 was greater in both BMV medicated plaster groups, −39.35±27.69 mm for BMV12-h and −36.91±32.50 mm for BMV24-h, than with placebo, −20.20±27.32 mm. Considering the adjusted mean decreases, there was a statistically significant difference between BMV12-h and placebo (p=0.0110). Global pain relief (SPID) and overall treatment efficacy were significantly better with BMV. BMV and placebo plasters had similar local tolerability and there were few treatment-related adverse events. Conclusions BMV plaster was significantly more effective than placebo at reducing pain in patients with chronic elbow tendinopathies. The BMV plaster was safe and well tolerated. PMID:27331041

  5. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial.

    PubMed

    Kazemipoor, Mahnaz; Radzi, Che Wan Jasimah Bt Wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377.

  6. Intravenous iron supplementation may protect against acute mountain sickness: a randomized, double-blinded, placebo-controlled trial.

    PubMed

    Talbot, Nick P; Smith, Thomas G; Privat, Catherine; Nickol, Annabel H; Rivera-Ch, Maria; León-Velarde, Fabiola; Dorrington, Keith L; Robbins, Peter A

    2011-01-01

    Acute mountain sickness (AMS) is a common and disabling condition that occurs in healthy individuals ascending to high altitude. Based on the ability of iron to influence cellular oxygen sensing pathways, we hypothesized that iron supplementation would protect against AMS. To examine this hypothesis, 24 healthy sea-level residents were randomized to receive either intravenous iron(III)-hydroxide sucrose (200 mg) or saline placebo, before ascending rapidly to Cerro de Pasco, Peru (4340 m). The Lake Louise scoring system was used to assess incidence and severity of AMS at sea level and on the first full day at altitude. No significant difference in absolute AMS score was detected between the two groups either at baseline or at high altitude. However, the mean increase in AMS score was 65% smaller in the iron group than in the saline group (p<0.05), and the change in AMS score correlated negatively with the change in ferritin (R=-0.43; p<0.05). Hematocrit and arterial oxygen saturation were unaffected by iron. In conclusion, this preliminary randomized, double-blinded, placebo-controlled trial suggests that intravenous iron supplementation may protect against the symptoms of AMS in healthy volunteers.

  7. A comparative study of continuous versus pulsed radiofrequency discectomy for management of low backache: Prospective randomized, double-blind study

    PubMed Central

    Jena, Bhagya Ranjan; Paswan, Anil; Singh, Yashpal; Loha, Sandeep; Singh, Anil Prasad; Rastogi, Virendra

    2016-01-01

    Background: Radiofrequency (RF) is a minimally invasive target-selective technique that has been used with success for many years in the treatment of different pathologies, such as low back pain, trigeminal neuralgia, and others. Aim: The aim of this study is to compare different mode of RF - continuous RF (CRF) versus pulsed RF (PRF) along with steroid in the management of low back pain of discogenic origin. Setting and Design: Prospective, randomized, double-blind trial. Materials and Methods: Forty patients with chronic discogenic low back pain were randomized to receive CRF plus intradiscal triamcinolone 40 mg (Group 1) or to receive PRF plus intradiscal triamcinolone 40 mg (Group 2). Outcome measured includes immediate as well as long-term pain relief using visual analog scale, the Oswestry Disability Index and straight leg raising test. Statistical Analysis: The continuous variables were compared by one-way analysis of variance test. Discrete variables were compared by Fisher's exact test/Chi-square test/Student's t-test, whichever appropriate. The value of P < 0.05 was considered statistically significant. Results: There was a significant decrease in pain score after CRF without any added side effect. Pain relief after PRF was insignificant. Conclusion: CRF with steroid seems to be better for treatment of chronic discogenic low back pain than PRF with steroid. PMID:27746559

  8. Antioxidative Activity of Onion Peel Extract in Obese Women: A Randomized, Double-blind, Placebo Controlled Study

    PubMed Central

    Kim, Kyung-Ah; Yim, Jung-Eun

    2015-01-01

    Background: Quercetin, found abundantly in onion peel, has been known to have anticholesterol, antithrombotic and insulin-sensitizing properties. Here, we investigated the effect of quercetin-rich onion peel extract (OPE) on reactive oxygen species (ROS) production and antioxidative defense in obese woman. Methods: This study was randomized, double-blind, placebo controlled study. Thirty-seven healthy obese participants were randomly assigned that eighteen subjects received red soft capsuled OPE (100 mg/d, 50 mg bis in die), while the other nineteen subjects received same capsuled placebo for 12 weeks. ROS production and superoxide dismutase (SOD) activity in plasma were determined by using ROS and SOD assay kits, respectively. Results: Baseline characteristics of anthropometric indicators and blood metabolic profiles were not significantly different between the two groups. Compared with baseline values, OPE consumption significantly reduced waist and hip circumference. Plasma ROS level and SOD activity were decreased in both placebo and OPE groups compared with baseline values. However, plasma ROS level in OPE group was significantly lower than in placebo group while plasma SOD activity in OPE group was significantly higher than in placebo group after 12 weeks of consumption. Conclusions: These findings indicate that OPE consumption may exert antioxidative effect by preventing the decrease of SOD activity as well as the production of ROS in obese women. PMID:26473159

  9. Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial

    PubMed Central

    Gerami, Hooshang; Nemati, Shadman; Kazemnejad, Ehsan; Aghajanpour, Mohammad

    2012-01-01

    Background It is still a challenge to find an effective treatment for tinnitus. The aim of this study was the evaluation of carbamazepine and oxcarbazepine effects on tinnitus. Methods In a randomized double–blind clinical trial, 57 patients who were visited in a university hospital due to chronic non-pulsatile tinnitus, were randomized in three groups and treated with carbamazepine (300-600 mg/day), oxcarbazepine (450-900 mg/day) and placebo for 12 weeks. Visual analogue scale (VAS) and tinnitus severity index (TSI) were measured in all subjects in the beginning and at the end of the 8th and 12th weeks of the trial. Data was analyzed by repeated measure analysis, paired and independent t-test. Results Among 51 participants who completed the trial course (28 men, 23 women), carbamazepine, oxcarbazepine and placebo decreased tinnitus severity in 56.6%, 46.2% and 38.5% of patients according to VAS, and in 61.1%, 58.8% and 50% of patients according to TSI, respectively. The effects of carbamazepine and oxcarbazepine were better in the first 8 weeks of treatment. However, their effect on tinnitus did not show any statistical difference in comparison with placebo (P = 0.34, P = 0.28). Conclusion Carbamazepine and oxcarbazepine are not more effective than placebo in decreasing tinnitus severity. PMID:24250874

  10. Comparison between dexmedetomidine and fentanyl on intubation conditions during awake fiberoptic bronchoscopy: A randomized double-blind prospective study

    PubMed Central

    Mondal, Sudeshna; Ghosh, Sarmila; Bhattacharya, Susmita; Choudhury, Brojen; Mallick, Suchismita; Prasad, Anu

    2015-01-01

    Background and Aims: Various drugs are used for providing favorable intubation conditions during awake fiberoptic intubation (AFOI). However, most of them cause respiratory depression and airway obstruction leading to hypoxemia. The aim of this study was to compare intubation conditions, and incidence of desaturation between dexmedetomidine and fentanyl group during AFOI. Material and Methods: This randomized double-blind prospective study was conducted on a total of 60 patients scheduled for elective laparotomies who were randomly allocated into two groups: Group A received dexmedetomidine 1 mcg/kg and Group B received fentanyl 2 mcg/kg over 10 min. Patients in both groups received glycopyrrolate 0.2 mg intravenous, nebulization with 2% lidocaine 4 ml over 20 min and 10% lidocaine spray before undergoing AFOI. Adequacy of intubation condition was evaluated by cough score and post-intubation score. Incidence of desaturation, hemodynamic changes and sedation using Ramsay sedation scale (RSS) were noted and compared between two groups. Results: Cough Score (1-4), post-intubation Score (1-3) and RSS (1-6) were significantly favorable (P < 0.0001) along with minimum hemodynamic responses to intubation (P < 0.05) and less oxygen desaturation (P < 0.0001) in Group A than Group B. Conclusion: Dexmedetomidine is more effective than fentanyl in producing better intubation conditions, sedation along with hemodynamic stability and less desaturation during AFOI. PMID:25948903

  11. Preparation of nose for nasal endoscopy: cotton pledget packing versus topical spray. A prospective randomized blinded study.

    PubMed

    Mishra, Prasun; Kaushik, Maitri; Dehadaray, Arun; Qadri, Haris; Raichurkar, Annapurna; Seth, Tanvi

    2013-01-01

    During nasal endoscopy it is essential to have proper visualization of structures with minimal discomfort to patient and surgeon. For this it is essential that the nose is well prepared before the procedure. The main objective of the study is to compare and evaluate the efficacy of cotton pledget packing versus topical sprays in preparation of nose for nasal endoscopy. The method includes prospective randomized blinded study on 100 patients. Patients were randomly divided in two groups. In first group the nose was packed with 4% lignocaine with xylometazoline nasal drops and in the other group it was prepared with 10% lignocaine topical spray and xylometazoline nose drops. Following the procedure, patient and the surgeon were asked a pre-formed questionnaire to know their experience during endoscopy. It was observed the packing group required more preparatory time as compared to the spray group. The group which was packed had less discomfort, less pain while endoscopy. The visualization of structures was significantly better in the packed group. Eight patients in the packed group did have some mucosal bleed during the process of packing which was not seen in the spray group. Both methods of preparation have merits and demerits but in terms of discomfort, pain during procedure and visualization of structure, packing of nasal cavity with 4% lignocaine and xylometazoline drops is better than spraying of nose with 10% lignocaine and xylometazoline drops. PMID:22427029

  12. Antiobesity Effect of Caraway Extract on Overweight and Obese Women: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Radzi, Che Wan Jasimah Bt wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A.

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377. PMID:24319489

  13. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    PubMed

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  14. Acupoint Application in Patients with Chronic Stable Angina Pectoris: Study Protocol of a Randomized, Double-Blind, Controlled Trial

    PubMed Central

    Ren, Yulan; Li, Dehua; Lv, Junling; Leng, Junyan; Zhang, Linglin; Zhang, Jie; Fan, Hailong; Liang, Fanrong

    2014-01-01

    Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients' quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP. Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin or Suxiao Jiuxin pills, CCS angina classification, SAQ, SAS and SDS score. Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.gov NCT02029118. PMID:25250055

  15. A Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus reuteri for Chronic Functional Abdominal Pain in Children

    PubMed Central

    Eftekhari, Kambiz; Vahedi, Zahra; Kamali Aghdam, Mojtaba; Noemi Diaz, Diana

    2015-01-01

    Background: Functional abdominal pain (FAP) is one of the most common diseases, and large percentages of children suffer from it. Objectives: The purpose of the study was to evaluate the effect of Lactobacillus reuteri in treatment of children with functional abdominal pain. Patients and Methods: This study was a randomized double-blind placebo-controlled trial. Children aged 4 to 16 years with chronic functional abdominal pain (based on Rome III criteria) were enrolled in the study. They were randomly divided into two groups, one receiving probiotic and the other placebo. Results: Forty children received probiotic and forty others placebo. There were no significant differences in age, weight, sex, location of pain, associated symptoms, frequency and intensity of pain between the groups. The severity and frequency of abdominal pain in the first month compared to baseline was significantly less and at the end of the second month, there was no significant difference between both groups compared to the end of the first month. Conclusions: This study showed that the severity of pain was significantly reduced in both groups. There was no significant difference in pain scores between them. The effect of probiotic and placebo can probably be attributed to psychological effect of the drugs. PMID:26635937

  16. Aripiprazole versus risperidone for treating children and adolescents with tic disorder: a randomized double blind clinical trial.

    PubMed

    Ghanizadeh, Ahmad; Haghighi, Alireza

    2014-10-01

    There are some uncontrolled studies about the efficacy and safety of both aripiprazole and risperidone for treating tic disorder. Moreover, the efficacy of these medications has never been compared. This is the first double blind randomized clinical trial comparing the safety and efficacy of aripiprazole and risperidone for treating patients with tic disorder. Sixty children and adolescents with tic disorder were randomly allocated into one of the two groups to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was the score of Yale Global Tic Severity Scale. In addition, health related quality of life and adverse events were assessed. Both aripiprazole and risperidone decreased the Yale Global Tic Severity Scale score during this trial. Moreover, both medications increased the health related quality of life score. Both aripiprazole and risperidone were tolerated well. Aripiprazole [3.22 (1.9) mg/day] decreased tic score as much as risperidone [0.6 (0.2) mg/day]. Their adverse effects and their effects on health related quality of life were comparable. However, risperidone increased the patients' social functioning more than aripiprazole in short term.

  17. Effectiveness of probiotic, chlorhexidine and fluoride mouthwash against Streptococcus mutans – Randomized, single-blind, in vivo study

    PubMed Central

    Jothika, Mohan; Vanajassun, P. Pranav; Someshwar, Battu

    2015-01-01

    Aim: To determine the short-term efficiency of probiotic, chlorhexidine, and fluoride mouthwashes on plaque Streptococcus mutans level at four periodic intervals. Materials and Methods: This was a single-blind, randomized control study in which each subject was tested with only one mouthwash regimen. Fifty-two healthy qualified adult patients were selected randomly for the study and were divided into the following groups: group 1- 10 ml of distilled water, group 2- 10 ml of 0.2% chlorhexidine mouthwash, group 3- 10 ml of 500 ppm F/400 ml sodium fluoride mouthwash, and group 4- 10 ml of probiotic mouthwash. Plaque samples were collected from the buccal surface of premolars and molars in the maxillary quadrant. Sampling procedure was carried out by a single examiner after 7 days, 14 days, and 30 days, respectively, after the use of the mouthwash. All the samples were subjected to microbiological analysis and statistically analyzed with one-way analysis of variance (ANOVA) and post-hoc test. Results: One-way ANOVA comparison among groups 2, 3, and 4 showed no statistical significance, whereas group 1 showed statistically significant difference when compared with groups 2, 3, and 4 at 7th, 14th, and 30th day. Conclusion: Chlorhexidine, sodium fluoride, and probiotic mouthwashes reduce plaque S. mutans levels. Probiotic mouthwash is effective and equivalent to chlorhexidine and sodium fluoride mouthwashes. Thus, probiotic mouthwash can also be considered as an effective oral hygiene regimen. PMID:25984467

  18. A randomized, double-blind, placebo-controlled trial to determine the effects of topical insulin on wound healing.

    PubMed

    Rezvani, Omid; Shabbak, Elahe; Aslani, Abolfazl; Bidar, Ramin; Jafari, Mehrdad; Safarnezhad, Saeed

    2009-08-01

    Although the literature contains evidence demonstrating the beneficial effects of insulin on wound healing, no suitable method for the routine administration of insulin has been reported. A randomized, double-blind, placebo-controlled trial was conducted to determine the safety and efficacy of topical insulin on healing in 45 patients (29 men, mean age for both groups 40.62 years, range 12 to 71 years) with noninfected acute and chronic extremity wounds. Patients were randomly assigned to twice-daily topical application (spray) of 1 cc saline 0.9% for each 10 cm2 of wound with or without 10 units (0.1 cc) of insulin crystal and insulin. The endpoint was complete wound closure. Systemic glucose levels were measured before and 1 hour after treatment application. No patients developed signs or symptoms of hypoglycemia and glucose levels pre- and post-application did not differ significantly. Time to healing did not differ significantly between treatment groups. Healing rates were affected by baseline wound area, patient age, wound type (acute versus chronic), and treatment group. The mean rate of healing rate was 46.09 mm2/day in the treatment and 32.24 mm2/day in the control group (P = 0.029), independent of baseline wound size. In this study, the topical application of insulin was safe and effective. Clinical studies with a larger sample size and that include patients with diabetes mellitus are warranted.

  19. Effect of Atorvastatin on the Disease Activity and Severity of Rheumatoid Arthritis: Double-Blind Randomized Controlled Trial

    PubMed Central

    Mowla, Karim; Rajai, Elham; Ghorbani, Ali; Bahadoram, Mohammad; Mohammadi, Shooka

    2016-01-01

    Introduction HMG-CoA (3-hydroxy-3- methylglutary lcoenzyme A) reductase inhibitors (statins) have anti-inflammatory properties which may be particularly useful in rheumatoid arthritis to suppress disease activity and inflammatory factors. Aim The purpose of this clinical trial was to determine anti-inflammatory properties of statins in rheumatoid arthritis. Materials and Methods Eighty Iranian patients with rheumatoid arthritis, aged between 19 to 75 years were recruited to take part in this randomized, double-blind placebo-controlled trial. Subjects were randomly allocated to two groups to take atorvastatin or placebo 40 mg daily as an adjunct to current disease-modifying anti-rheumatic drugs (DMARDs) treatment. Disease Activity Score-28 (DAS28), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), swollen joint count (SJC) & tender joint count (TJC) were assessed before and after three months intervention. Results Analysis was based on intention to treat. DAS28 significantly declined in the atorvastatin group in comparison with placebo (p< 0.001). SJC, TJC, CRP and ESR also were significantly dropped in the atorvastatin group in comparison with placebo. Conclusion It can be concluded that atorvastatin can suppress RA activity and inflmmatory factors in RA patients for high to moderate grade of inflmmation. PMID:27437268

  20. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study

    PubMed Central

    Faghihi, Gita; Iraji, Fariba; Behfar, Shadi; Abtahi-Naeini, Bahareh

    2016-01-01

    Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment (<0.001). The mean lesion size before treatment and at 30, 60, and 120 days was not different between the two groups (p > 0.05). No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases) of patients in the diclofenac sodium group (p = 0.005). Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion.

  1. Curcumin for Radiation Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Thirty Breast Cancer Patients

    PubMed Central

    Ryan, Julie L.; Heckler, Charles E.; Ling, Marilyn; Katz, Alan; Williams, Jacqueline P.; Pentland, Alice P.; Morrow, Gary R.

    2014-01-01

    Radiation dermatitis occurs in approximately 95% of patients receiving radiotherapy (RT) for breast cancer. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the ability of curcumin to reduce radiation dermatitis severity in 30 breast cancer patients. Eligible patients were adult females with noninflammatory breast cancer or carcinoma in situ prescribed RT without concurrent chemotherapy. Randomized patients took 2.0 grams of curcumin or placebo orally three times per day (i.e., 6.0 grams daily) throughout their course of RT. Weekly assessments included Radiation Dermatitis Severity (RDS) score, presence of moist desquamation, redness measurement, McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaire. The 30 evaluable patients were primarily white (90%) and had a mean age of 58.1 years. Standard pooled variances t test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS =2.6 vs. 3.4; P =0.008). Fisher’s exact test revealed that fewer curcumin-treated patients had moist desquamation (28.6% vs. 87.5%; P =0.002). No significant differences were observed between arms for demographics, compliance, radiation skin dose, redness, pain or symptoms. In conclusion, oral curcumin, 6.0 g daily during radiotherapy, reduced the severity of radiation dermatitis in breast cancer patients. PMID:23745991

  2. Does platelet-rich plasma enhance healing in the idiopathic bone cavity? A single-blind randomized clinical trial.

    PubMed

    Tabrizi, R; Karagah, T; Shahidi, S; Zare, N

    2015-09-01

    The presence of an idiopathic bone cavity (IBC) is usually identified during routine dental radiographic examinations. The purpose of this study was to investigate the effect of platelet-rich plasma (PRP) on bone healing in the idiopathic bone cavity. This was a single-blind randomized clinical trial. Twenty-four subjects were assigned randomly to two groups. Subjects in group 1 received PRP through a buccal window approach, and those in group 2 underwent conventional management via the creation of a window on the buccal wall and curettage of the walls of the defect. Subjects were followed up at 3, 6, and 9 months after the intervention. The amount of bone formation as determined on panoramic radiographs was divided into four categories: stage 1: ≤25% of the defect showed opacity; stage 2: 25-50% of the defect showed opacity; stage 3: 50-75% of the defect showed opacity; and stage 4: >75% of the defect showed opacity. There was a significant difference between the two groups with regard to the various healing stages at the three time points (P<0.05). When compared with conventional management of the idiopathic bone cavity, the use of PRP may enhance bone formation. PMID:26074365

  3. The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

    PubMed

    Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

    2016-06-01

    Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p < 0.001). Pain severity decreased significantly in treatment group after eight weeks of treatment. There was a significant difference in pain intensity between the two groups after eight weeks of treatment and one month after the end of treatment (p < 0.001 for both). A weekly high dose (50 000 IU) oral vit D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.

  4. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study.

    PubMed

    Faghihi, Gita; Elahipoor, Azam; Iraji, Fariba; Behfar, Shadi; Abtahi-Naeini, Bahareh

    2016-01-01

    Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment (<0.001). The mean lesion size before treatment and at 30, 60, and 120 days was not different between the two groups (p > 0.05). No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases) of patients in the diclofenac sodium group (p = 0.005). Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion. PMID:27689135

  5. Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial.

    PubMed

    Ren, Yulan; Li, Dehua; Zheng, Hui; Lv, Junling; Leng, Junyan; Zhang, Linglin; Zhang, Jie; Fan, Hailong; Liang, Fanrong

    2014-01-01

    Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients' quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP. Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin or Suxiao Jiuxin pills, CCS angina classification, SAQ, SAS and SDS score. Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.gov NCT02029118. PMID:25250055

  6. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    PubMed Central

    Shin, Jae-Young; Ku, Boncho; Kim, Jaeuk U.; Lee, Yu Jung; Kang, Jae Hui; Heo, Hyun; Choi, Hyo-Joon; Lee, Jun-Hwan

    2015-01-01

    Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n = 28) or the sham laser acupuncture group (n = 28). Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version) were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain. PMID:26516333

  7. Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama.

    PubMed

    Sosa, Néstor; Capitán, Zeuz; Nieto, Javier; Nieto, Melissa; Calzada, José; Paz, Hector; Spadafora, Carmenza; Kreishman-Deitrick, Mara; Kopydlowski, Karen; Ullman, Diane; McCarthy, William F; Ransom, Janet; Berman, Jonathan; Scott, Charles; Grogl, Max

    2013-09-01

    In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis.

  8. Double-blind, randomized, controlled trial of zinc or vitamin A supplementation in young children with acute diarrhoea.

    PubMed

    Faruque, A S; Mahalanabis, D; Haque, S S; Fuchs, G J; Habte, D

    1999-02-01

    In a double-blind, controlled trial with a factorial design, 684 patients (aged 6 months to 2 y; excludes 6 early dropouts) with acute watery diarrhoea of 3 d or less and some dehydration, who were attending a hospital, were randomly assigned to 4 groups to receive: (a) vitamin A 4500 microg retinol equivalent daily for 15 d; (b) 14.2 mg elemental zinc as acetate for the first 417 patients and 40 mg of the remaining 273 patients randomized to this group for 15 d; (c) both vitamin A 4500 microg retinol equivalent and zinc at the above doses daily for 15 d; or (d) placebo mixtures for 15 d. Patients were observed in the hospital for 24 h and followed up at home for 15 d. All received ascorbic acid 30 mg with each dose of medicine or placebo. Zinc supplementation was associated with a reduced duration of diarrhoea (13%, p = 0.03) and markedly reduced rate (43%, p = 0.017) of prolonged diarrhoea (>7 d). Vitamin A supplementation was associated with a nonsignificant trend for reduced rate of prolonged diarrhoea (p = 0.089). In conclusion, zinc supplementation as adjunct therapy had a substantial impact on the rate of prolonged diarrhoea and some impact on duration and may be beneficial in children with diarrhoea in developing countries. PMID:10102147

  9. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial

    PubMed Central

    Montserrat-Bosch, Marta; Nogueira-Magalhães, Pedro; Arnabat-Dominguez, Josep; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-01-01

    Objectives: To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks (IANB). Study Design: A randomized, triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed. In the control group, all patients received an IANB using the conventional Halsted technique, whereas in the experimental group, a modified technique using a more inferior injection point was performed. Results: A total of 100 patients were randomized. The modified technique group showed a significantly higher onset time in the lower lip and chin area, and was frequently associated to a lingual electric discharge sensation. Three failures were recorded, 2 of them in the experimental group. No relevant local or systemic complications were registered. Conclusions: Both IANB techniques used in this trial are suitable for lower third molar removal. However, performing an inferior alveolar nerve block in a more inferior position (modified technique) extends the onset time, does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries. Key words:Dental anesthesia, inferior alveolar nerve block, lidocaine, third molar, intravascular injection. PMID:24608204

  10. Evaluation of a Crataegus-Based Multiherb Formula for Dyslipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Zeng, Weiwei; Tomlinson, Brian

    2014-01-01

    Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects. PMID:24834096

  11. Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Multiple chemical sensitivity (MCS) is a chronic condition of unknown etiology. MCS is characterized by recurrent nonspecific symptoms from multiple organ systems in response to chemical exposures in concentrations that are normally tolerated by the majority of the population. The symptoms may have severe impact on patients’ lives, but an evidence-based treatment for the condition is nonexisting. The pathophysiology is unclarified, but several indicators point towards abnormal processing of sensory signals in the central nervous system. Pulsed electromagnetic fields (PEMF) offer a promising new treatment for refractory depression and can be targeted at the brain, thereby activating biochemical cell processes. Methods/Design In a parallel, randomized, double-blind, placebo-controlled trial conducted at the Danish Research Centre for Chemical Sensitivities, the effects of PEMF in MCS patients will be assessed using the Re5 Independent System. Based on sample size estimation, 40 participants will be randomized to either PEMF therapy or placebo. The allocation sequence will be generated by computer. All involved parties (that is, participants, investigators, the research nurse, and the statistician) will be blinded to group allocation. The participants will receive PEMF therapy or placebo applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks. Outcomes will be measured at baseline, once weekly during treatment, post treatment, and at 2.5-month and 4.5-month follow-up according to a predefined timetable. The primary outcome will be a measurement of the impact of MCS on everyday life. The secondary outcomes will be measurements of MCS symptoms, psychological distress (stress, anxiety or depressive symptoms), capsaicin-induced secondary punctate hyperalgesia, immunological markers in serum, and quality of life. Discussion This trial will assess the effects of PEMF therapy for MCS. Currently, there is no treatment with a

  12. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    PubMed Central

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739

  13. Comparative effectiveness of quetiapine and haloperidol in delirium: A single blind randomized controlled study

    PubMed Central

    Grover, Sandeep; Mahajan, Sudhir; Chakrabarti, Subho; Avasthi, Ajit

    2016-01-01

    AIM To evaluate the effectiveness of quetiapine and haloperidol in patients of delirium referred to psychiatry consultation liaison services. METHODS The study followed a single blind randomised controlled trial design. Thirty-two patients in the haloperidol group and 31 patients in the quetiapine group were assessed at the baseline and 6 consecutive days. Flexible dosing regimen (haloperidol: 0.25-1.25 mg; quetiapine 12.5-75 mg/d) was used. Delirium Rating Scale-Revised-98 (DRS-R-98) and mini mental status examination (MMSE) were the primary and secondary efficacy measures respectively. RESULTS Baseline DRS-R-98 severity score and MMSE scores did not differ between the 2 study groups. From baseline to day 6, there was significant reduction in the total DRS-R-98 scores, DRS-R-98 cognitive domain scores, DRS-R-98 non-cognitive domain scores and significant increase in the MMSE scores in both the groups. Both the groups did not differ on any of the assessments in terms of DRS-R98 and MMSE scores. The effectiveness of both the medications was similar in adult and elderly (≥ 60 years) patients. At the end of the trial, 68.75% and 67.74% of subjects in the haloperidol and quetiapine group respectively had mean DRS-R-98 scores below 10. By 6th day, 12 (37.5%) patients in haloperidol group and 9 (29.03%) patients in the quetiapine group had DRS-R98 score of “0” with no significant difference between the two groups (P = 0.47). CONCLUSION Quetiapine is as effective as haloperidol in the management of delirium. PMID:27679777

  14. Varenicline Effects on Smoking, Cognition, and Psychiatric Symptoms in Schizophrenia: A Double-Blind Randomized Trial

    PubMed Central

    Si, Tian-Mei; Maayan, Lawrence; Jin, Hua; Boules, Sylvia; Sershen, Henry; Li, Chunbo; Ren, Juanjuan; Liu, Yanhong; Youseff, Mary; Lajtha, Abel; Guidotti, Alessandro; Weiser, Mark; Davis, John M.

    2016-01-01

    Schizophrenic patients have a high rate of smoking and cognitive deficits which may be related to a decreased number or responsiveness of nicotinic receptors in their brains. Varenicline is a partial nicotinic agonist which is effective as an antismoking drug in cigarette smokers, although concerns have been raised about potential psychiatric side-effects. We conducted a double-blind placebo controlled study in 87 schizophrenic smokers to evaluate the effects of varenicline (2 mg/day) on measures of smoking, cognition, psychiatric symptoms, and side-effects in schizophrenic patients who were cigarette smokers. Varenicline significantly decreased cotinine levels (P<0.001), and other objective and subjective measures of smoking (P < .01), and responses on a smoking urges scale (P = .02), more than placebo. Varenicline did not improve scores on a cognitive battery designed to test the effect of drugs on cognitive performance in schizophrenia (the MATRICS battery), either in overall MATRICS battery Composite or individual Domain scores, more than placebo. There were no significant differences between varenicline vs. placebo effects on total symptom scores on psychiatric rating scales, PANSS, SANS, or Calgary Depression scales, and there were no significant drug effects in any of these scales sub-scores when we used Benjamin-Hochberg corrected significance levels (α = .05). Varenicline patients did not show greater side-effects than placebo treated patients at any time point when controlled for baseline side-effect scores. Our study supports the use of varenicline as a safe drug for smoking reduction in schizophrenia but not as a cognitive enhancer. Trial Registration: ClinicalTrials.gov 00802919 PMID:26730716

  15. A randomized, double-blind, parallel group trial of iomeprol, iohexol and iopamidol in intravenous urography.

    PubMed

    Harding, J R; Bertazzoli, M; Spinazzi, A

    1995-07-01

    The aim of this study was to compare the safety, tolerance, and diagnostic efficacy of iomeprol 350 mg I ml-1, iohexol 350 mg I ml-1, and iopamidol 370 mg I ml-1 in 90 adult patients undergoing intravenous urography. Radiographs obtained 5, 10 and 15 min after contrast injection were blindly graded for quality on a four point scale as: 0, non-diagnostic; 1, diagnostic but of limited quality; 2, diagnostic and of good quality; 3, fully diagnostic and of very good quality. The sum of these scores indicated the overall diagnostic quality (0-4, non-diagnostic; 4-8, diagnostic; 9-12, good or excellent). Contrast tolerability was evaluated by discomfort (heat or pain) associated with injection of the test compounds, and patients were monitored and questioned for adverse experiences. The quality of the individual radiographs was assessed as diagnostic and good or fully diagnostic and very good in most cases, with no significant differences between the three study groups, and overall scores were predominantly good or excellent (p = 0.55). All adverse reactions were transient and non-serious, and most of them were reported as mild in intensity. There were no significant differences between the three groups for heat sensation (p = 0.29). Pain at the injection site was reported only in the iohexol group (p = 0.104). It is concluded that iomeprol 350 mg I ml-1 is at least as safe and effective as iohexol 350 mg I ml-1 or iopamidol 370 mg I ml-1 when used for intravenous urography.

  16. Comparative effectiveness of quetiapine and haloperidol in delirium: A single blind randomized controlled study

    PubMed Central

    Grover, Sandeep; Mahajan, Sudhir; Chakrabarti, Subho; Avasthi, Ajit

    2016-01-01

    AIM To evaluate the effectiveness of quetiapine and haloperidol in patients of delirium referred to psychiatry consultation liaison services. METHODS The study followed a single blind randomised controlled trial design. Thirty-two patients in the haloperidol group and 31 patients in the quetiapine group were assessed at the baseline and 6 consecutive days. Flexible dosing regimen (haloperidol: 0.25-1.25 mg; quetiapine 12.5-75 mg/d) was used. Delirium Rating Scale-Revised-98 (DRS-R-98) and mini mental status examination (MMSE) were the primary and secondary efficacy measures respectively. RESULTS Baseline DRS-R-98 severity score and MMSE scores did not differ between the 2 study groups. From baseline to day 6, there was significant reduction in the total DRS-R-98 scores, DRS-R-98 cognitive domain scores, DRS-R-98 non-cognitive domain scores and significant increase in the MMSE scores in both the groups. Both the groups did not differ on any of the assessments in terms of DRS-R98 and MMSE scores. The effectiveness of both the medications was similar in adult and elderly (≥ 60 years) patients. At the end of the trial, 68.75% and 67.74% of subjects in the haloperidol and quetiapine group respectively had mean DRS-R-98 scores below 10. By 6th day, 12 (37.5%) patients in haloperidol group and 9 (29.03%) patients in the quetiapine group had DRS-R98 score of “0” with no significant difference between the two groups (P = 0.47). CONCLUSION Quetiapine is as effective as haloperidol in the management of delirium.

  17. Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial

    PubMed Central

    2013-01-01

    Background One in ten people aged between 55 to 74 years have a significant hearing impairment in their better hearing ear (as defined by audiometric hearing thresholds). However, it is becoming increasingly clear that the challenges faced by older listeners cannot be explained by the audiogram alone. The ability for people with hearing loss to use cognition to support speech perception allows for compensation of the degraded auditory input. This in turn offers promise for new cognitive-based rehabilitative interventions. Working memory is known to be highly associated with language comprehension and recent evidence has shown significant generalization of learning from trained working memory tasks to improvements in sentence-repetition skills of children with severe to profound hearing loss. This evidence offers support for further investigation into the potential benefits of working memory training to improve speech perception abilities in other hearing impaired populations. Methods/Design This is a double-blind randomized active controlled trial aiming to assess whether a program of working memory training results in improvements in untrained measures of cognition, speech perception and self-reported hearing abilities in adult hearing aid users (aged 50 to 74 years) with mild-to-moderate hearing loss, compared with an active control group who receive a placebo version of the working memory training program. Discussion The present study aims to generate high-quality preliminary evidence for the efficacy of working memory training for adults with mild-to-moderate sensorineural hearing loss who are existing hearing aid users. This trial addresses a number of gaps in the published literature assessing training interventions for people with hearing loss, and in the general literature surrounding working memory training, such as the inclusion of an active control group, participant and tester blinding, and increased transparency in reporting. Trial registration

  18. Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial

    PubMed Central

    2009-01-01

    Background The aim of this trial was to assess the relative efficacy of a sage/echinacea spray and a chlorhexidine/lidocaine spray in the treatment of acute sore throats. Methods This was a multicenter, randomized, double-blind, double-dummy controlled trial carried out in eleven general practices in Switzerland. A total of 154 patients (133 analyzed in per protocol collective) at least 12 years old with acute sore throat present for not more than 72 hours prior to inclusion and with a throat score ≥6 participated in the study. They used either an echinacea/sage spray or a chlorhexidine/lidocaine spray with two puffs every 2 hours, in a double-dummy blinded manner, up to 10 times daily until they were symptom-free, for a maximum of 5 days. The main outcome measures was the comparison of response rates during the first three days. A response was defined as a decrease of at least 50% of the total symptoms compared to baseline. Results The echinacea/sage treatment exhibited similar efficacy to the chlorhexidine/lidocaine treatment in reducing sore throat symptoms during the first 3 days (P(x < Y) = .5083). Response rates after 3 days were 63.8% in the echinacea/sage group and 57.8% in the chlorhexidine/lidocaine group. For all secondary parameters, such as time to becoming symptom free, throat pain, and global assessments of efficacy by the physician and patient, no difference between the two treatments was seen. They were both very well tolerated. Conclusion An echinacea/sage preparation is as efficacious and well tolerated as a chlorhexidine/lidocaine spray in the treatment of acute sore throats. PMID:19748859

  19. Caffeine Intake, Short Bouts of Physical Activity, and Energy Expenditure: A Double-Blind Randomized Crossover Trial

    PubMed Central

    Júdice, Pedro B.; Matias, Catarina N.; Santos, Diana A.; Magalhães, João P.; Hamilton, Marc T.; Sardinha, Luís B.; Silva, Analiza M.

    2013-01-01

    PA energy expenditure (PAEE) is the most variable component of Total Energy Expenditure (TEE) and largely due to the balance of sedentary time (SedT) and low intensity physical activity (LIPA). There has been an emergence for seeking an understanding of factors which determine variations in SedT, LIPA, and PAEE. Sedentary behavior and physical activity are relatively resistant to change by experimental dietary treatments and significant body weight changes. Although caffeine (Caf) is by far the most heavily used nutritional agent ingested to promote a sense of vigor/alertness, it is still unknown if Caf is effective in increasing PAEE and physical activity. The aim of the study was to test the hypothesis that 2 daily doses of Caf (as a capsule to blind the treatment and divided equally during breakfast and lunch) increase PAEE and TEE, and it would do so through increasing the frequent and brief bouts of physical activity (~1-5 min long) through the day as measured by accelerometry. In 21 low Caf users (<100 mg day-1), we used a double-blind crossover trial (ClinicalTrials.govID;NCT01477294) with two conditions (4-day each with a 3-day washout period) randomly ordered as 5 mg kg-1 day-1 of Caf and maltodextrin as placebo (Plc). Resting energy expenditure (REE) by indirect calorimetry, total energy expenditure (TEE) from doubly labeled water, PAEE calculated as TEE-(REE+0.1TEE), and accelerometry measurements of both LIPA and MVPA were not different between conditions. However, regardless of caffeine or placebo, there were several significant relationships between brief bouts of LIPA and MVPA with PAEE. In conclusion, this double-blind study found that low and moderate-vigorous activity as well as the total volume of PAEE in free-living conditions is resistant to dietary caffeine intake that was equivalent to 5 cups of espresso or 7 cups of tea. Trial Registration ClinicalTrials.gov NCT01477294 PMID:23869233

  20. Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial

    PubMed Central

    Williams, Karen; Gerkovich, Mary M.; Gqaleni, Nceba; Syce, James; Bartman, Patricia; Johnson, Quinton; Folk, William R.

    2015-01-01

    Background Sutherlandia frutescens (L.) R. Br. is widely used as an over the counter complementary medicine and in traditional medications by HIV seropositive adults living in South Africa; however the plant’s safety has not been objectively studied. An adaptive two-stage randomized double-blind placebo controlled study was used to evaluate the safety of consuming dried S. frutescens by HIV seropositive adults with CD4 T-lymphocyte count of >350 cells/μL. Methods In Stage 1 56 participants were randomized to S. frutescens 400, 800 or 1,200 mg twice daily or matching placebo for 24 weeks. In Stage 2 77 additional participants were randomized to either 1,200 mg S. frutescens or placebo. In the final analysis data from Stage 1 and Stage 2 were combined such that 107 participants were analysed (54 in the S. frutescens 1,200 mg arm and 53 in the placebo arm). Results S. frutescens did not change HIV viral load, and CD4 T-lymphocyte count was similar in the two arms at 24 weeks; however, mean and total burden of infection (BOI; defined as days of infection-related events in each participant) was greater in the S. frutescens arm: mean (SD) 5.0 (5.5) vs. 9.0 (12.7) days (p = 0.045), attributed to two tuberculosis cases in subjects taking isoniazid preventive therapy (IPT). Conclusion A possible interaction between S. frutescens and IPT needs further evaluation, and may presage antagonistic interactions with other herbs having similar biochemical (antioxidant) properties. No other safety issues relating to consumption of S. frutescens in this cohort were identified. Trial Registration ClinicalTrials.gov NCT00549523 PMID:26186450

  1. The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: A Randomized Blinded Crossover Trial

    PubMed Central

    Lee, Yvonne C.; Massarotti, Elena; Edwards, Robert R.; Lu, Bing; Liu, ChihChin; Lo, Yuanyu; Wohlfahrt, Alyssa; Kim, Nancy D.; Clauw, Daniel J.; Solomon, Daniel H.

    2015-01-01

    Objective Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We examined the effect of milnacipran on self-reported pain intensity and experimental pain sensitivity among rheumatoid arthritis (RA) patients with widespread pain and stable RA disease activity. Methods In this double-blind, crossover study, RA patients with widespread pain, on a stable treatment regimen, were randomized (via a random number generator) to receive milnacipran 50 mg twice daily or placebo for 6 weeks, followed by a 3-week washout and crossed over to the other arm for the remaining 6 weeks. The primary outcome was change in average pain intensity, assessed by the Brief Pain Inventory short form. The sample size was calculated to detect a 30% improvement in pain with power = 0.80 and alpha = 0.05. Results Of the 43 randomized subjects, 41 received study drug, and 32 completed the 15-week study per protocol. On a 0–10 scale, average pain intensity decreased by 0.39 (95% CI −1.27, 0.49; P = 0.37) more points during 6 weeks of milnacipran treatment compared to placebo. In the subgroup of subjects with swollen joint count ≤ 1, average pain intensity decreased by 1.14 (95% CI −2.26, −0.01; P= 0.04) more points during 6 weeks of milnacipran compared to placebo. Common adverse events included nausea (26.8%) and loss of appetite (9.7%). Conclusion Compared to placebo, milnacipran did not improve overall, self-reported pain intensity among subjects with widespread pain taking stable RA medications. Trial registration: ClinicalTrials.gov NCT01207453 PMID:26628607

  2. Randomized Double-Blind Placebo-Controlled Trial of Bevacizumab Therapy for Radiation Necrosis of the Central Nervous System

    SciTech Connect

    Levin, Victor A.; Bidaut, Luc; Hou, Ping; Kumar, Ashok J.; Wefel, Jeffrey S.; Bekele, B. Nebiyou; Prabhu, Sujit; Loghin, Monica; Gilbert, Mark R.; Jackson, Edward F.

    2011-04-01

    Purpose: To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials: A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results: The volumes of necrosis estimated on T{sub 2}-weighted fluid-attenuated inversion recovery and T{sub 1}-weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T{sub 2}-weighted fluid-attenuated inversion recovery and T{sub 1}-weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients-and none of the placebo-treated patients-showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion: The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with

  3. Carbon dioxide insufflation in routine colonoscopy is safe and more comfortable: results of a randomized controlled double-blinded trial.

    PubMed

    Geyer, M; Guller, U; Beglinger, C

    2011-01-01

    Many patients experience pain and discomfort after colonoscopy. Carbon dioxide (CO(2)) can reduce periprocedural pain although air insufflation remained the standard procedure. The objective of this double-blinded, randomized controlled trial was to evaluate whether CO(2) insufflation does decrease pain and bloating during and after colonoscopy compared to room air. Methods. 219 consecutive patients undergoing colonoscopy were randomized to either CO(2) or air insufflation. Propofol was used in all patients for sedation. Transcutaneous CO(2) was continuously measured with a capnograph as a safety parameter. Pain, bloating, and overall satisfaction were assessed at regular intervals before and after the procedure. Results(data are mean ±SD). 110 patients were randomized to CO(2) and 109 to room air. The baseline characteristics were similar in both groups. The mean propofol dose was not different between the treatments, as were the time to reach the ileum and the withdrawal time. pCO(2) at the end of the procedure was 35.2 ± 4.3 mmHg (CO(2) group) versus 35.6 ± 6.0 mmHg in the room air group (P > .05). No relevant complication occurred in either group. There was significantly less bloating for the CO(2) group during the postprocedural recovery period (P < .001) and over the 24-hour period (P < .001). Also, patients with CO(2) insufflation experienced significantly less pain (P = .014). Finally, a higher overall satisfaction (P = .04 ) was found in the CO(2) group. Conclusions. This trial provides compelling evidence that CO(2) insufflation significantly reduces bloating and pain after routine colonoscopy in propofol-sedated patients. The procedure is safe with no significant differences in CO(2) between the two groups. PMID:21747649

  4. Comparisons of single-injection thoracic paravertebral block with ropivacaine and bupivacaine in breast cancer surgery: A prospective, randomized, double-blinded study

    PubMed Central

    Sahu, Ashutosh; Kumar, Rajnish; Hussain, Mumtaz; Gupta, Ajit; Raghwendra, K. H.

    2016-01-01

    Background: Regional anesthesia using paravertebral block has been suggested as an ideal adjunct to general anesthesia for modified radical mastectomy. Paravertebral block is an effective management of peri-operative pain for Modified radical mastectomy, however, there are no established guidelines regarding what is the most suitable strategy when varying drugs and dosages between different groups. Aim: To evaluate the effectiveness of paravertebral block comparing the most frequently employed drugs in this procedure (bupivacaine vs ropivacaine). Study Design: Prospective randomized double blind study. Methods: A total 70 ASA I and II adult female patients undergoing Modified radical mastectomy under paravertebral block followed by general anesthesia were randomly divided into two groups. The first group was administered 0.375% Ropivacaine in a dose 0.25 ml /kg in paravertebral block. The second group was administered bupivacaine 0.375% in dose 0.25 ml /kg in paravertebral block. Standard induction technique followed. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), were recorded pre block, post block 5 min, post block 10 min, at skin incision, post skin incision initially at 5 interval for first 15 min till one hour, and every 30 min till end of surgery. Post-operative visual analogue score for pain was recorded at 1 hr, 6 hr and 24 hr. Statistical Analysis: Chi-square test (Fisher's exact test) for qualitative variables. Independent sample t-test for quantitative data. Results: Ropivacaine and Bupivacaine had no difference in intraoperative analgesia as shown by intraoperative hemodynamic parameters. Bupivacaine got better post-operative VAS scores (P < 0.05) in mean and after first, 6 h and 24 h. PMID:27746568

  5. Granisetron versus ondansetron for post-operative nausea and vomiting prophylaxis in elective craniotomies for brain tumors: A randomized controlled double-blind study

    PubMed Central

    Gupta, Priyanka; Sabharwal, Nikki; Kale, Suniti; Gupta, Mayank; Gogia, Anoop R.

    2014-01-01

    Context: Post-operative nausea and vomiting (PONV) pose unique challenges in neurosurgical patients that warrant its study separate from other surgical groups. Setting and Design: This prospective, randomized, double-blind study was carried out to compare and to evaluate the efficacy and safety of three antiemetic combinations for PONV prophylaxis following craniotomy. Materials and Methods: A total of 75 anesthesiologist status I/II patients undergoing elective craniotomy for brain tumors were randomized into three groups, G, O and D, to receive single doses of dexamethasone 8 mg at induction with either granisetron 1 mg, ondansetron 4 mg or normal saline 2 ml at the time of dural closure respectively. Episodes of nausea, retching, vomiting and number of rescue antiemetic (RAE) were noted for 48 h post-operatively. Statistical Analysis: Analysis of variance with post-hoc significance and Chi-square test with fisher exact correction were used for statistical analysis. P <0.05 was considered to be significant and P < 0.001 as highly significant. Results: We found that the incidence and number of vomiting episodes and RAE required were significantly low in Group G and O compared with Group D; P < 0.05. However, incidence of nausea and retching were comparable among all groups. The anti-nausea and anti-retching efficacy of all the three groups was comparable. Conclusions: Single dose administration of granisetron 1 mg or ondansetron 4 mg at the time of dural closure with dexamethasone 8 mg provide an effective and superior prophylaxis against vomiting compared with dexamethasone alone without interfering with post-operative recovery and neurocognitive monitoring and hence important in post-operative neurosurgical care. PMID:25886108

  6. Diclofenac Suppository vs. IV Acetaminophen Combined With IV PCA for Postoperative Pain Management in Patients Undergoing Laminectomy: A Randomized, Double-Blinded Clinical Trial

    PubMed Central

    Nikooseresht, Mahshid; Seifrabiei, Mohammad Ali; Davoodi, Maryam; Aghajanlou, Mashhood; Sardari, Mohammad Taghi

    2016-01-01

    Background Tissue damage caused by surgical procedures nearly always results in pain. The effective management of postoperative pain remains a challenge because of its influence on the surgical outcome and its critical role in early mobilization and functionality. Recent research on postoperative pain management supports a treatment approach known as “multimodal analgesia,” which comprises the use of more than one method or modality of pain control and management. Objectives In the present study, we compared the effects of diclofenac suppository and intravenous (IV) acetaminophen combined with IV patient-controlled analgesia (PCA) for pain management after laminectomy surgery. Patients and Methods Our randomized, double-blinded controlled trial during 2013 at Besat hospital in Hamadan, Iran, included 102 ASA I-II patients aged 18 to 65 years who were candidates for laminectomy surgery. The patients were randomly assigned to receive the diclofenac suppository (100 mg) (n = 51) or IV acetaminophen (1 g in 100 mL normal saline) (n = 51) 10 minutes before completing surgery and 12 hours after the operation. Results The patients’ characteristics were the same in both study groups. The patients’ satisfaction levels were higher among those who received diclofenac when compared with the acetaminophen group, especially at the time points of 6 and 12 h after surgery. The consumed narcotic using the PCA pump within 24 h of surgery in the diclofenac group was significantly lower than that of the acetaminophen group (735.70 ± 59.61 µg vs. 819.70 ± 80.02 µg; P < 0.001). Conclusions The use of diclofenac suppository combined with IV PCA results in reduced narcotic usage and a higher level of patient satisfaction compared to the use of IV acetaminophen combined with IV PCA. PMID:27642582

  7. Comparison of peritonsillar infiltration effects of ketamine and tramadol on post tonsillectomy pain: a double-blinded randomized placebo-controlled clinical trial

    PubMed Central

    Ayatollahi, Vida; Behdad, Shekoufeh; Hatami, Maryam; Moshtaghiun, Hossein; Baghianimoghadam, Behnam

    2012-01-01

    Aim To assess the effect of peritonsillar infiltration of ketamine and tramadol on post tonsillectomy pain and compare the side effects. Methods The double-blind randomized clinical trial was performed on 126 patients aged 5-12 years who had been scheduled for elective tonsillectomy. The patients were randomly divided into 3 groups to receive either ketamine, tramadol, or placebo. They had American Society of Anesthesiologists physical status class I and II. All patients underwent the same method of anesthesia and surgical procedure. The three groups did not differ according to their age, sex, and duration of anesthesia and surgery. Post operative pain was evaluated using CHEOPS score. Other parameters such as the time to the first request for analgesic, hemodynamic elements, sedation score, nausea, vomiting, and hallucination were also assessed during 12 hours after surgery. Results Tramadol group had significantly lower pain scores (P = 0.005), significantly longer time to the first request for analgesic (P = 0.001), significantly shorter time to the beginning of liquid regimen (P = 0.001), and lower hemodynamic parameters such as blood pressure (P = 0.001) and heart rate (P = 0.001) than other two groups. Ketamine group had significantly greater presence of hallucinations and negative behavior than tramadol and placebo groups. The groups did not differ significantly in the presence of nausea and vomiting. Conclusion Preoperative peritonsillar infiltration of tramadol can decrease post-tonsillectomy pain, analgesic consumption, and the time to recovery without significant side effects. Registration No: IRCT201103255764N2 PMID:22522994

  8. Six months of resveratrol supplementation has no measurable effect in type 2 diabetic patients. A randomized, double blind, placebo-controlled trial.

    PubMed

    Bo, S; Ponzo, V; Ciccone, G; Evangelista, A; Saba, F; Goitre, I; Procopio, M; Pagano, G F; Cassader, M; Gambino, R

    2016-09-01

    The polyphenol resveratrol is considered to exert many beneficial actions, such as antioxidant, anti-inflammatory, insulin-sensitizer and anticancer effects. Its benefits in patients with type 2 diabetes mellitus (T2DM) are controversial. Our aims were to determine whether resveratrol supplementation at two different dosages (500 and 40mg/day) for 6 months i) reduced the concentrations of C-reactive-protein (CRP) and ii) ameliorated the metabolic pattern of T2DM patients. In the present double-blind, randomized, placebo-controlled trial, 192 T2DM patients were randomized to receive resveratrol 500mg/day (Resv500arm), resveratrol 40mg/day (Resv40arm) or placebo for 6-months. At baseline and at the trial end, CRP values, anthropometric, metabolic and liver parameters were determined. No serious adverse event occurred. A dose-dependent, though not significant, CRP decrease of 5.6% (Resv40arm) and 15.9% (Resv500arm) was observed vs placebo. We failed to detect significant differences in weight, BMI, waist circumference, and values of arterial blood pressure, fasting glucose, glycated hemoglobin, insulin, C-peptide, free fatty acids, liver transaminases, uric acid, adiponectin, interleukin-6, in both the Resv500 and Resv40 arms vs placebo. Total cholesterol and triglycerides slightly increased in the Resv500arm. Subgroup analyses revealed that lower diabetes duration (in both Resv500 and Resv40arms), and, in the Resv500arm, younger age, aspirin use and being a smoker were associated with a significantly higher CRP reduction vs placebo. The supplementations with 40mg/day or 500mg/day resveratrol did neither reduce CRP concentrations, nor improve the metabolic pattern of T2DM patients. PMID:27520400

  9. Effects of Coriandrum sativum Syrup on Migraine: A Randomized, Triple-Blind, Placebo-Controlled Trial

    PubMed Central

    Delavar Kasmaei, Hosein; Ghorbanifar, Zahra; Zayeri, Farid; Minaei, Bagher; Kamali, Seyed Hamid; Rezaeizadeh, Hossein; Amin, Gholamreza; Ghobadi, Ali; Mirzaei, Zohreh

    2016-01-01

    Background: Migraine is one of the most common and debilitating neurological problems. Although numerous preventive drugs are used to treat migraine, their complications are unavoidable. Application of herbal medicine, especially well-known medicinal plants, to treatment of chronic diseases, like migraine, could be effective. Coriandrum sativum L. (C. sativum) fruit is one of the most commonly prescribed herbs in Persian medicine, which has been used to treat headache. Objectives: This study was designed to evaluate the effects of C. sativum syrup on duration, severity and frequency of migraine. Patients and Methods: A total of 68 migraineurs, who had the eligibility criteria, according to international headache society diagnostic criteria, were randomly assigned to intervention group (n = 34) or control group (n = 34). In addition to 500 mg of sodium valproate per day, in intervention group, they received 15 mL of Coriander fruit syrup and 15 mL of placebo syrup, in control group, three times a day, during a month. The subjects were followed for clinical efficacy at weeks 1, 2, 3 and 4. The number of migraine attacks per week, as well as the duration and severity of attacks, were evaluated. Results: Of 68 patients randomized, 66 were included in analysis. The generalized estimating equations analysis showed that the Coriander fruit syrup decreased duration, severity and frequency of migraine, in the intervention group (P < 0.001). To be more precise, the mean migraine duration, severity and frequency, in the intervention group, were 5.7 hours, 3.65 units and about 50% less than control group, respectively. Conclusions: Results of this study showed that C. sativum fruit is efficient in reduction of the duration and frequency of migraine attacks and in diminishing pain degree. PMID:26889386

  10. Educational Methods for Deaf-Blind and Severely Handicapped Students. Volume II.

    ERIC Educational Resources Information Center

    Texas Education Agency, Austin. Div. of Special Education.

    The book presents 17 papers originally presented at a 1978 Texas conference on educational methods for deaf-blind and severely handicapped students, covering the areas of motor development, auditory assessment and hearing loss, communication, cognition, prevocational training, and functional living skills. Titles and authors include "An Overview…

  11. Trial participants' understanding of randomization, double-blinding, and placebo use in low literacy populations: findings from a study conducted within a microbicide trial in Malawi.

    PubMed

    Ndebele, Paul; Wassenaar, Douglas; Masiye, Francis; Munalula-Nkandu, Esther

    2014-07-01

    Concerns have been raised about the limits of understanding of consent by clinical trial participants in developing countries. Consequently, this empirical study was conducted in Malawi to assess microbicide trial participants' understanding of randomization, double-blinding, and placebo use. The study used a combination of quantitative and qualitative methods, including structured questionnaire interviews with a random sample of 203 individual participants, four in-depth interviews with research nurses, and two focus group discussions with 18 study participants. Most respondents earned high scores on questions related to randomization (85%) and placebo use (72%), while a greater proportion of the same respondents obtained low scores on questions related to double-blinding (68%) and personal implications of the study procedures (63%). Overall, most respondents (61%; n = 124) obtained low scores on combined understanding of all the three concepts under study.

  12. Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

    PubMed Central

    2011-01-01

    Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation) and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged <24 hours were randomly assigned to bathing with water and cotton wool (W) or with a cleaning product (CP). A minimum of bathing 3 times per week was advocated. Groups were stratified according to family history of atopic eczema. Transepidermal water loss (TEWL), stratum corneum hydration and skin surface pH were measured within 24 hours of birth and at 4 and 8 weeks post birth. Measurements were taken on the thigh, forearm and abdomen. Women also completed questionnaires and diaries to record bathing practices and medical treatments. Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI) for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data

  13. The statistical pitfalls of the partially randomized preference design in non-blinded trials of psychological interventions.

    PubMed

    Gemmell, Isla; Dunn, Graham

    2011-03-01

    In a partially randomized preference trial (PRPT) patients with no treatment preference are allocated to groups at random, but those who express a preference receive the treatment of their choice. It has been suggested that the design can improve the external and internal validity of trials. We used computer simulation to illustrate the impact that an unmeasured confounder could have on the results and conclusions drawn from a PRPT. We generated 4000 observations ("patients") that reflected the distribution of the Beck Depression Index (DBI) in trials of depression. Half were randomly assigned to a randomized controlled trial (RCT) design and half were assigned to a PRPT design. In the RCT, "patients" were evenly split between treatment and control groups; whereas in the preference arm, to reflect patient choice, 87.5% of patients were allocated to the experimental treatment and 12.5% to the control. Unadjusted analyses of the PRPT data consistently overestimated the treatment effect and its standard error. This lead to Type I errors when the true treatment effect was small and Type II errors when the confounder effect was large. The PRPT design is not recommended as a method of establishing an unbiased estimate of treatment effect due to the potential influence of unmeasured confounders.

  14. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate

    SciTech Connect

    Kochhar, R.; Patel, F.; Dhar, A.; Sharma, S.C.; Ayyagari, S.; Aggarwal, R.; Goenka, M.K.; Gupta, B.D.; Mehta, S.K. )

    1991-01-01

    In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.

  15. Effects of Lornoxicam on Anastomotic Healing: A Randomized, Blinded, Placebo-Control Experimental Study

    PubMed Central

    Drakopoulou, Stamatoula; Vezakis, Antonios; Karandrea, Despoina; Aravidou, Eftychia; Konti-Paphiti, Agathi; Argyra, Erifili; Voros, Dionisios

    2016-01-01

    Introduction and Aim. With the implementation of multimodal analgesia regimens, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are often administered for optimal pain control and reduction of opioid use. The aim of the study was to examine the effects of lornoxicam, a NSAID, on anastomotic healing employing an animal model. Materials and Methods. A total of 28 Wistar rats were randomly assigned in two groups. All animals underwent ascending colonic transection followed by an end-to-end hand sewn anastomosis. Group 1 received intraperitoneally lornoxicam before and daily after surgery. Group 2 received intraperitoneally an equal volume of placebo. Half of the animals in each group were euthanized on the 3rd pod and the remaining on the 7th pod. Macro- and microscopic indicators of anastomotic healing were compared using a two-tailed Fisher exact test. Results. The lornoxicam group significantly decreased fibroblast in growth and reepithelization of the mucosa at the anastomotic site on the 3rd pod and significantly increased occurrence of deep reaching defects, necrosis, and microabscess on the 7th pod. Conclusion. Lornoxicam administration during the perioperative period adversely affects histologic parameters of intestinal anastomotic healing. These effects of lornoxicam administration were not found to induce significant increase of anastomotic dehiscence in the rat model. PMID:27144224

  16. Computer-Assisted Cognitive Remediation for Schizophrenia: A Randomized Single-Blind Pilot Study

    PubMed Central

    Rass, Olga; Forsyth, Jennifer K.; Bolbecker, Amanda R; Hetrick, William P.; Breier, Alan; Lysaker, Paul H.; O’Donnell, Brian F.

    2012-01-01

    Cognitive impairment is a core symptom in schizophrenia that has a significant impact on psychosocial function, but shows a weak response to pharmacological treatment. Consequently, a variety of cognitive remediation strategies have been evaluated to improve cognitive function in schizophrenia. The efficacy of computer-based cognitive remediation as a stand-alone intervention on general measures of neuropsychological function remains unclear. We tested the effectiveness of biweekly training using computerized cognitive remediation programs on neuropsychological and event-related potential outcome measures. Schizophrenia patients were randomly assigned to cognitive remediation training (N=17), active control (TV-watching; N=17), or treatment as usual (N=10) groups for ten weeks and run in parallel. Functional, cognitive, and ERP measures revealed no differential improvement over time in the cognitive remediation group. Practice effects might explain change over time on several cognitive measures for all groups, consistent with studies indicating task-specific improvement. Computer-assisted cognitive remediation alone may not be sufficient for robust or generalized effects on cognitive and electrophysiological measures in schizophrenia patients. PMID:22682988

  17. Tap water nasal irrigation in adults with seasonal allergic rhinitis: a randomized double-blind study.

    PubMed

    Xiong, Min; Fu, Xiaoyan; Deng, Wenting; Lai, Huangwen; Yang, Chuanhong

    2014-06-01

    Saline nasal irrigation is effective in the treatment of seasonal allergic rhinitis, and sodium chloride itself has no antiallergic effects. The mechanism of saline nasal irrigation depends mainly on washing away allergens and inflammatory mediators induced by allergic reactions. Tap water has the same washing effects as saline. In this study, it was investigated if tap water nasal irrigation was effective in the treatment of seasonal allergic rhinitis. Sixty-four patients diagnosed with seasonal allergic rhinitis were enrolled. Patients were randomized to tap water nasal irrigation group and non-tap water nasal irrigation group for treatment. Patients of both groups were treated with desloratadine. Treatment outcomes were measured using allergic rhinitis Quality of Life (QoL) survey was completed at baseline and after 3 weeks of therapy. There were statistically significant differences in QoL scores between tap water nasal irrigation group and non-tap water nasal irrigation group. The tap water nasal irrigation group had better QoL scores than the non-tap water nasal irrigation group. Tap water nasal irrigation can be a valuable adjuvant therapy for patients with seasonal allergic rhinitis.

  18. Throat pain and pharyngeal packing: a controlled randomized double-blind comparison between gauze and tampons.

    PubMed

    Marais, J; Prescott, R J

    1993-10-01

    In order to determine whether patients having pharyngeal packing experience more or less post-operative throat pain when tampons were used, 80 patients were randomized into two groups to receive either gauze or tampon pharyngeal packing. A third control group of 40 patients were intubated but did not have any throat packs. Post-operative throat pain was subjectively rated at both 6 hours and at 24 hours by an independent observer. Thirty-eight per cent of patients had moderate or severe throat pain in the gauze group, whilst in the tampon and control groups these amounted to only 15% and 1% respectively. A significantly higher proportion of patients also had a moderate or severe sore throat at 24 hours in the former group. Intubation alone resulted in a sore throat post-operatively in 50% of patients, but 85% of those had a mild sore throat only. No differences in pain ratings in any group could be shown between men or women or between age groupings. Endotracheal intubation often causes post-operative throat pain which is exacerbated by the use of pharyngeal packing. The results presented suggest that tampons are a safe, effective alternative to gauze and result in less severe post-operative throat pain.

  19. Lévy flights do not always optimize random blind search for sparse targets

    PubMed Central

    Palyulin, Vladimir V.; Chechkin, Aleksei V.; Metzler, Ralf

    2014-01-01

    It is generally believed that random search processes based on scale-free, Lévy stable jump length distributions (Lévy flights) optimize the search for sparse targets. Here we show that this popular search advantage is less universal than commonly assumed. We study the efficiency of a minimalist search model based on Lévy flights in the absence and presence of an external drift (underwater current, atmospheric wind, a preference of the walker owing to prior experience, or a general bias in an abstract search space) based on two different optimization criteria with respect to minimal search time and search reliability (cumulative arrival probability). Although Lévy flights turn out to be efficient search processes when the target is far from the starting point, or when relative to the starting point the target is upstream, we show that for close targets and for downstream target positioning regular Brownian motion turns out to be the advantageous search strategy. Contrary to claims that Lévy flights with a critical exponent α = 1 are optimal for the search of sparse targets in different settings, based on our optimization parameters the optimal α may range in the entire interval (1, 2) and especially include Brownian motion as the overall most efficient search strategy. PMID:24516153

  20. Fascial Manipulation® for chronic aspecific low back pain: a single blinded randomized controlled trial

    PubMed Central

    Branchini, Mirco; Lopopolo, Francesca; Andreoli, Ernesto; Loreti, Ivano; Marchand, Aurélie M; Stecco, Antonio

    2016-01-01

    Background: The therapeutic approach to chronic aspecific low back pain (CALBP) has to consider the multifactorial aetiology of the disorder. International guidelines do not agree on unequivocal treatment indications. Recommendations for fascial therapy are few and of low level evidence but several studies indicate strong correlations between fascial thickness and low back pain. This study aims at comparing the effectiveness of Fascial Manipulation® associated with a physiotherapy program following guidelines for CALBP compared to a physiotherapy program alone. Methods: 24 subjects were randomized into two groups, both received eight treatments over 4 weeks. Outcomes were measured at baseline, at the end of therapy and at a 1 month and a 3 months follow-up. Pain was measured with the visual analogue scale (VAS) and the brief pain inventory (BPI), function with the Rolland-Morris disability questionnaire (RMDQ), state of well-being with the short-form 36 health-survey (SF-36). The mean clinical important difference (MCID) was also measured. Results: Patients receiving Fascial Manipulation® showed statistically and clinically significant improvements at the end of care for all outcomes, in the short (RMDQ, VAS, BPI) and medium term for VAS and BPI compared to manual therapy. The MCID show significant improvements in the means and percentage of subjects in groups in all outcomes post-treatment, in the short and medium term. Conclusion: Fascial tissues were implicated in the aetiology of CALBP and treatment led to decreased symptomatic, improved functional and perceived well-being outcomes that were of greater amplitude compared to manual therapy alone. PMID:26834998

  1. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial.

    PubMed

    Kayo, Andrea Harumi; Peccin, Maria Stella; Sanches, Carla Munhoz; Trevisani, Virgínia Fernandes Moça

    2012-08-01

    The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises (MS) and a walking program (WA) in reducing pain in patients with fibromyalgia. Ninety women, 30-55 years of age, diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria, were randomized into 3 groups: WA Group, MS Group, and control group. Pain (visual analog scale) was evaluated as the primary outcome. Physical functioning (Fibromyalgia Impact Questionnaire, FIQ), health-related quality of life (Short-Form 36 Health Survey, SF-36), and use of medication were evaluated as secondary outcomes. Assessments were performed at baseline, 8, 16, and 28 weeks. Intention-to-treat and efficacy analyses were conducted. Sixty-eight patients completed the treatment protocol. All 3 groups showed improvement after the 16-week treatment compared to baseline. At the 28-week follow-up, pain reduction was similar for the WA and MS groups (P = 0.39), but different from the control group (P = 0.01). At the end of the treatment, 80% of subjects in the control group took pain medication, but only 46.7% in the WA and 41.4% in the MS groups. Mean FIQ total scores were lower for the WA and MS groups (P = 0.96) compared with the control group (P < 0.01). Patients in the WA and MS groups reported higher scores (better health status) than controls in almost all SF-36 subscales. MS was as effective as WA in reducing pain regarding all study variables; however, symptoms management during the follow-up period was more efficient in the WA group.

  2. Omega 3 in Childhood Migraines: a Double Blind Randomized Clinical Trial

    PubMed Central

    FAYYAZI, Afshin; KHAJEH, Ali; GHAZAVI, Ahad; SANGESTANI, Mahsha

    2016-01-01

    Objective The effect of using omega-3 to prevent migraine attacks has been raised in recent studies. The majority of these studies have been conducted in adults. Conversely, other studies have yet to confirm the effect of omega-3. The main purpose of this study was to assess the effects of omega-3 in the prevention of migraine attacks in children. Materials & Methods In this study, children aged 5–15 years with a diagnosis of migraine were randomly assigned to case and control groups. The case group was treated with sodium valproate and 1 g of omega-3; the control group was treated with sodium valproate and a placebo for 2 months. The severity of attacks was evaluated before and after the treatment using PedMIDAS and parental satisfaction (CGI) using a 7-point Likert scale. Results In this study, 12 cases and 13 controls were enrolled. The average number of headache attacks per month decreased significantly in both groups after starting the treatment but there was no significant difference between the two groups. The severity of attacks decreased significantly in both groups after starting the treatment but it was not significant between them. Examination of the CGI average showed the average was 6.08 (SD = 0.52) in the case group and 6.07 (SD = 0.65) in the control group. Conclusion The present study indicated that omega-3 with a dose of 1 mg per day has no effect in reducing the severity and frequency of migraine attacks in children. Sodium valproate was effective in reducing the frequency and severity of attacks. PMID:27057181

  3. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    PubMed Central

    Butler, Andrew J.; Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.

    2015-01-01

    Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287

  4. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke.

    PubMed

    Butler, Andrew J; Kallos, Justiss; Housley, Stephen N; LaPlaca, Michelle C; Traynelis, Stephen F; Wolf, Steven L

    2015-01-01

    Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287

  5. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients

    PubMed Central

    Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

    2016-01-01

    Background Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. Method A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0–10) numerical rating scale at three months post-mastectomy. Results Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. Conclusions This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Trial Registration Clinicaltrials.gov NCT01536314 PMID:27050431

  6. A Randomized, Double-Blind, Placebo-Controlled Trial of Pregnenolone for Bipolar Depression

    PubMed Central

    Brown, E Sherwood; Park, John; Marx, Christine E; Hynan, Linda S; Gardner, Claire; Davila, Domingo; Nakamura, Alyson; Sunderajan, Prabha; Lo, Alexander; Holmes, Traci

    2014-01-01

    Depression in bipolar disorder (BPD) is challenging to treat. Therefore, additional medication options are needed. In the current report, the effect of the neurosteroid pregnenolone on depressive symptoms in BPD was examined. Adults (n=80) with BPD, depressed mood state, were randomized to pregnenolone (titrated to 500 mg/day) or placebo, as add-on therapy, for 12 weeks. Outcome measures included the 17-item Hamilton Rating Scale for Depression (HRSD), Inventory of Depressive Symptomatology—Self-Report (IDS-SR), Hamilton Rating Scale for Anxiety (HRSA), and Young Mania Rating Scale (YMRS). Serum neurosteroid levels were assessed at baseline and week 12. Data were analyzed using a mixed model ANCOVA with a between factor of treatment assignment, a within factor (repeated) of visit, and the baseline value, as well as age and gender, as covariates. In participants with at least one postbaseline visit (n=73), a significant treatment by week interaction for the HRSD (F(5,288)=2.61, p=0.025), but not IDS-SR, was observed. Depression remission rates were greater in the pregnenolone group (61%) compared with the placebo group (37%), as assessed by the IDS-SR (χ2(1)=3.99, p=0.046), but not the HRSD. Large baseline-to-exit changes in neurosteroid levels were observed in the pregnenolone group but not in the placebo group. In the pregnenolone group, baseline-to-exit change in the HRSA correlated negatively with changes in allopregnanolone (r(22)=−0.43, p=0.036) and pregNANolone (r(22)=−0.48, p=0.019) levels. Pregnenolone was well tolerated. The results suggest that pregnenolone may improve depressive symptoms in patients with BPD and can be safely administered. PMID:24917198

  7. Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial

    PubMed Central

    Fleischer, David M.; Burks, A. Wesley; Vickery, Brian P.; Scurlock, Amy M.; Wood, Robert A.; Jones, Stacie M.; Sicherer, Scott H.; Liu, Andrew H.; Stablein, Donald; Henning, Alice K.; Mayer, Lloyd; Lindblad, Robert; Plaut, Marshall; Sampson, Hugh A.

    2012-01-01

    Background There are presently no available therapeutic options for peanut-allergic patients. Objective To investigate the safety, efficacy, and immunologic effects of peanut sublingual immunotherapy (SLIT). Methods After a baseline oral food challenge (OFC) of up to 2g of peanut powder (~50% protein) (median successfully consumed dose [SCD] 46mg), 40 subjects, aged 12–37 (median 15) years, were randomized 1:1 across 5 sites to daily peanut or placebo SLIT. A 5g OFC was performed after 44 weeks followed by unblinding; placebo subjects then crossed over to higher dose peanut SLIT, followed by a subsequent crossover Week 44 5g OFC. Week 44 OFCs from both groups were compared to baseline OFCs; subjects successfully consuming 5g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders. Results After 44 weeks of SLIT, 14/20 (70%) subjects receiving peanut SLIT were responders compared to 3/20 (15%) subjects receiving placebo (p<0.001). In peanut-SLIT responders, median SCD increased from 3.5mg to 496mg. After 68 weeks of SLIT, median SCD significantly increased to 996mg (compared to week 44, p=0.05). The median SCD at the Week 44 crossover OFC was significantly higher than baseline (603mg vs 71mg; p=0.02). 7/16 (44%) crossover subjects were responders; median SCD increased from 21mg to 496mg among responders. Of 10,855 peanut doses through Week 44 OFCs, 63.1% were symptom-free; excluding oral/pharyngeal symptoms, 95.2% were symptom-free. Conclusions Peanut SLIT safely induced a modest level of desensitization in a majority of subjects compared to placebo. Longer duration of therapy showed statistically significant increases in the SCD. PMID:23265698

  8. Randomized, Double-Blinded Clinical Trial for Human Norovirus Inactivation in Oysters by High Hydrostatic Pressure Processing ▿ †

    PubMed Central

    Leon, Juan S.; Kingsley, David H.; Montes, Julia S.; Richards, Gary P.; Lyon, G. Marshall; Abdulhafid, Gwen M.; Seitz, Scot R.; Fernandez, Marina L.; Teunis, Peter F.; Flick, George J.; Moe, Christine L.

    2011-01-01

    Contamination of oysters with human noroviruses (HuNoV) constitutes a human health risk and may lead to severe economic losses in the shellfish industry. There is a need to identify a technology that can inactivate HuNoV in oysters. In this study, we conducted a randomized, double-blinded clinical trial to assess the effect of high hydrostatic pressure processing (HPP) on Norwalk virus (HuNoV genogroup I.1) inactivation in virus-seeded oysters ingested by subjects. Forty-four healthy, positive-secretor adults were divided into three study phases. Subjects in each phase were randomized into control and intervention groups. Subjects received Norwalk virus (8FIIb, 1.0 × 104 genomic equivalent copies) in artificially seeded oysters with or without HPP treatment (400 MPa at 25°C, 600 MPa at 6°C, or 400 MPa at 6°C for 5 min). HPP at 600 MPa, but not 400 MPa (at 6° or 25°C), completely inactivated HuNoV in seeded oysters and resulted in no HuNoV infection among these subjects, as determined by reverse transcription-PCR detection of HuNoV RNA in subjects' stool or vomitus samples. Interestingly, a white blood cell (granulocyte) shift was identified in 92% of the infected subjects and was significantly associated with infection (P = 0.0014). In summary, these data suggest that HPP is effective at inactivating HuNoV in contaminated whole oysters and suggest a potential intervention to inactivate infectious HuNoV in oysters for the commercial shellfish industry. PMID:21705552

  9. Effect of Zolpidem on Sleep Quality of Professional Firefighters; a Double Blind, Randomized, Placebo-Controlled Crossover Clinical Trial.

    PubMed

    Mehrdad, Ramin; Sadeghniiat Haghighi, Khosro; Naseri Esfahani, Amir Hossein

    2015-01-01

    Professional firefighting is among the most demanding jobs. Prior studies have showed the notable prevalence of poor sleep quality among professional firefighters that may result in catastrophes. The aim of this study was in field confirmation of zolpidem usage (10 mg/PO/bed time) for short term management of poor sleeps quality among professional firefighters. In a double-blind, randomized, placebo-controlled crossover clinical trial among professional firefighters, 27 poor sleepers were assigned randomly to one of the two groups. Two 14 days experimental periods were separated by a 14-day washout phase. Sleep quality was assessed using the Persian version of Pittsburgh Sleep Quality Index (PSQI). Six of the 27 enrolled voluntaries dropped out. Two rare side effects of zolpidem occurred in the study. A significant improvement of the PSQI score was detected in zolpidem period versus placebo in both groups (7.14 ± 3.02 vs 12.38 ± 2.51, P<0.001) although zolpidem had no significant effect on time of waking up (6.76 ± 1.21 vs.6.64 ± 1.27, P=0.89). Zolpidem significantly improved all components of PSQI (Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances and Daytime dysfunction) in the current study except the use of sleep medication. Sleep onset latency was the component of PSQI with the greatest degree of abnormality among firefighters in a previous study. Interestingly, sleep latency was the component of PSQI with the most treatment effect of zolpidem in the current study. Zolpidem can be used asa part of treatment regimens in short time management of poor sleep quality among professional firefighters. PMID:26553086

  10. Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

    PubMed Central

    van Bergen, Christiaan JA; Blankevoort, Leendert; de Haan, Rob J; Sierevelt, Inger N; Meuffels, Duncan E; d'Hooghe, Pieter RN; Krips, Rover; van Damme, Geert; van Dijk, C Niek

    2009-01-01

    Background Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. Methods/Design A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society – Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. Discussion This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. Trial registration Netherlands Trial Register (NTR1636) PMID:19591674

  11. The influence of ginger (Zingiber officinale) on human sperm quality and DNA fragmentation: A double-blind randomized clinical trial

    PubMed Central

    Hosseini, Jalil; Mardi Mamaghani, Azar; Hosseinifar, Hani; Sadighi Gilani, Mohammad Ali; Dadkhah, Farid; Sepidarkish, Mahdi

    2016-01-01

    Background: Although the effectiveness of ginger as an antioxidant agent has been exploited, little human research has been conducted on its activity on male reproductive functions. Objective: This study was designed to investigate the effects of ginger (Zingiber officinale) on sperm DNA fragmentation (SDF) in infertile men. Materials and Methods: This randomized double-blind, placebo-controlled trial with a 1:1 allocation was performed on 100 infertility treatment candidates who were admitted to Royan Institute for Reproductive Biomedicine, Tehran, Iran. Patients were randomly assigned to receive one of two treatments: ginger and placebo. Patients were given a 3-month oral treatment (members received capsules containing 250 mg of ginger powder twice a day in ginger and a placebo in other group). Before and after treatment, standardized semen samples were obtained to determine sperm concentration, motility, and SDF according to World Health Organization. Results: There was no significant difference between two groups regarding SDF at baseline (53.48. 95%CI: 37.95-69.02) in cases and (56.75, 95%CI: 40.01-73.5) in controls. The average positive percentage of SDF in patients receiving ginger (17.77, 95%CI: 6.16-29.39) was lower compared with placebo (40.54, 95%CI: 23.94-57.13) after three month of treatment (p=0.02). In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009). There were no significant differences between two groups regarding to semen parameters. Conclusion: The present study has demonstrated that ginger in a controlled study of efficacy was effective in decreasing SDF in infertile men. PMID:27679829

  12. Evaluation of the PPAR-γ Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial

    PubMed Central

    Anderson, J. R.; Pang, L.; Smith, K. M; Bailey, H.; Hodgson, D. B.; Shaw, D. E.; Knox, A. J.; Harrison, T. W.

    2016-01-01

    Background Peroxisome proliferator-activated receptor gamma (PPAR-γ) is a nuclear receptor that modulates inflammation in models of asthma. To determine whether pioglitazone improves measures of asthma control and airway inflammation, we performed a single-center randomized, double-blind, placebo-controlled, parallel-group trial. Methods Sixty-eight participants with mild asthma were randomized to 12 weeks pioglitazone (30 mg for 4 weeks, then 45 mg for 8 weeks) or placebo. The primary outcome was the adjusted mean forced expiratory volume in one second (FEV1) at 12 weeks. The secondary outcomes were mean peak expiratory flow (PEF), scores on the Juniper Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ), fractional exhaled nitric oxide (FeNO), bronchial hyperresponsiveness (PD20), induced sputum counts, and sputum supernatant interferon gamma-inducible protein-10 (IP-10), vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), and eosinophil cationic protein (ECP) levels. Study recruitment was closed early after considering the European Medicines Agency’s reports of a potential increased risk of bladder cancer with pioglitazone treatment. Fifty-five cases were included in the full analysis (FA) and 52 in the per-protocol (PP) analysis. Results There was no difference in the adjusted FEV1 at 12 weeks (-0.014 L, 95% confidence interval [CI] -0.15 to 0.12, p = 0.84) or in any of the secondary outcomes in the FA. The PP analysis replicated the FA, with the exception of a lower evening PEF in the pioglitazone group (-21 L/min, 95% CI -39 to -4, p = 0.02). Conclusions We found no evidence that treatment with 12 weeks of pioglitazone improved asthma control or airway inflammation in mild asthma. Trial Registration ClinicalTrials.gov NCT01134835 PMID:27560168

  13. A Randomized, Double‐Blind, Placebo‐Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis‐Related Arthritis

    PubMed Central

    Tse, Shirley M. L.; Horneff, Gerd; Pangan, Aileen L.; Kalabic, Jasmina; Goss, Sandra; Unnebrink, Kristina; Anderson, Jaclyn K.

    2015-01-01

    Objective Enthesitis‐related arthritis (ERA) is a juvenile idiopathic arthritis (JIA) category, primarily affecting entheses and peripheral joints. This study evaluated efficacy, safety, and pharmacokinetics of adalimumab versus placebo in patients with ERA. Methods This is a phase III, multicenter, randomized double‐blind study in patients ages ≥6 to <18 years with ERA treated with adalimumab (24 mg/m2, maximum dose 40 mg every other week) or placebo for 12 weeks, followed by up to 192 weeks of open‐label adalimumab. The primary end point was percent change from baseline in number of active joints with arthritis (AJC) at week 12. Samples were collected to determine adalimumab serum concentrations. Adverse events (AEs) were assessed throughout the study. Results Forty‐six patients were randomized (31 adalimumab/15 placebo). At baseline, mean age was 12.9 years, mean duration of ERA symptoms was 2.6 years, mean AJC was 7.8, and mean enthesitis count was 8.1. Mean percent change from baseline in AJC at week 12 was greater in the adalimumab group versus placebo (−62.6% versus −11.6%; P = 0.039). Most secondary variables favored adalimumab versus placebo at week 12. Treatment response further increased with continued adalimumab therapy through week 52. Mean steady‐state adalimumab serum concentrations were 7.5–11.8 μg/ml, similar to patients age ≥2 years with polyarticular JIA. AE rates were similar between placebo and adalimumab: any AE (53.3% versus 67.7%), serious AEs (0% versus 3.2%), and infectious AEs (20.0% versus 29.0%). Conclusion Adalimumab reduced signs and symptoms of ERA at week 12, with improvement sustained through week 52. The safety profile was consistent with previous adalimumab studies. PMID:26223543

  14. Effect of Microvascular Anastomosis Technique on End Product Outcome in Simulated Training: A Prospective Blinded Randomized Controlled Trial.

    PubMed

    Kim, Eunsol; Singh, Masha; Akelina, Yelena; Shurey, Sandra; Myers, Simon R; Ghanem, Ali M

    2016-09-01

    Background The aim of this article is to evaluate the difference in skills acquisition of two end-to-end microvascular anastomosis techniques-the triangulation and biangulation-in early microsurgery training. Method In this study, 32 candidates ranging from medical students to higher surgical trainees underwent a 5-day basic microsurgery course. On days 3 and 5 of the course, candidates performed two end-to-end anastomoses on cryopreserved rat aortas. One anastomosis was performed using the biangulation technique and the other using the triangulation technique. Candidates were randomized to the order of technique performed. Structural patency, errors performed, and suture distribution were evaluated randomly by a blinded reviewer using the anastomosis lapse index score and ImageJ (U.S. National Institutes of Health, Bethesda, MD) Software. Results A total of 128 anastomoses were evaluated during the study period. A total of six anastomoses performed with the biangulation technique, and four anastomoses with the triangulation technique, were physically occluded on day 3 of the course. On day 5, two biangulation technique anastomoses and one triangulation technique produced a nonpatent outcome. There was a statistically significant difference of patency rate between the 2 days of evaluation confirming evidence of skill acquisition but no statistically significant difference between the two techniques in relation to anastomotic patency, errors performed, or suture placement quality. Conclusion The biangulation and triangulation techniques of microvascular anastomosis produce similar outcomes in relation to vessel structural patency and quality of anastomosis when taught in early stages of microsurgery training. Our results suggest that both techniques are equally suitable in training novices, basic microsurgical skills. PMID:27303937

  15. Effect of Chlorhexidine with Fluoride Mouthrinse on Plaque Accumulation, Plaque pH - A Double Blind Parallel Randomized Clinical Trial

    PubMed Central

    Saha, Sabyasachi; Singh, Sanjay

    2016-01-01

    Introduction Mouthwashes are important means used in chemical control of dental plaque. There is strong evidence suggestive of better effectiveness, when fluoride is added to chlorhexidine mouthwash. Aim To assess the anti-plaque efficacy of Chlorhexidine combined with Fluoride mouthwash and to measure its impact on plaque accumulation and on plaque pH. Materials and Methods Initially 100 subjects were screened. A double blind, parallel randomized clinical trial was conducted on 30 subjects after applying inclusion and exclusion criteria. Other independent variables were matched before randomly allocating them in three groups: Group A-Chlorhexidine as positive control, Group B-Chlorhexidine + Fluoride as test group and Group C- Distilled water as negative control. Oral prophylaxis of participants was done before onset of the study. Plaque pH was assessed before and immediately after rinsing at 0, 5 and 10 minutes interval and after 7 days with digital pH electrode (pHepR pH meter, Hanna Instruments R10285) and accumulation of plaque was recorded by Turesky et al., modification of Quigley Hein Plaque Index (1970). ANOVA test was used for statistical analysis. Results Although there was a statistically significant reduction in mean plaque scores from baseline to seven days in both Groups A and B, Group B showed better anti-plaque efficacy . Almost equal drop in plaque pH was seen for both the groups at 5 and 10 minutes. Conclusion Better anti-plaque efficacy was observed in Group B (Chlorhexidine and Fluoride combination) with minimum variation of plaque pH.

  16. Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: A randomized double-blind placebo controlled trial

    PubMed Central

    2012-01-01

    Background Axonal sensory peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Omega-3 fatty acids have beneficial effects on neurological disorders from their effects on neurons cells and inhibition of the formation of proinflammatory cytokines involved in peripheral neuropathy. Methods This study was a randomized double blind placebo controlled trial to investigate the efficacy of omega-3 fatty acids in reducing incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN). Eligible patients with breast cancer randomly assigned to take omega-3 fatty acid pearls, 640 mg t.i.d during chemotherapy with paclitaxel and one month after the end of the treatment or placebo. Clinical and electrophysiological studies were performed before the onset of chemotherapy and one month after cessation of therapy to evaluate PIPN based on "reduced Total Neuropathy Score". Results Twenty one patients (70%) of the group taking omega-3 fatty acid supplement (n = 30) did not develop PN while it was 40.7%( 11 patients) in the placebo group(n = 27). A significant difference was seen in PN incidence (OR = 0.3, .95% CI = (0.10-0.88), p = 0.029). There was a non-significant trend for differences of PIPN severity between the two study groups but the frequencies of PN in all scoring categories were higher in the placebo group (0.95% CI = (−2.06 -0.02), p = 0.054). Conclusions Omega-3 fatty acids may be an efficient neuroprotective agent for prophylaxis against PIPN. Patients with breast cancer have a longer disease free survival rate with the aid of therapeutical agents. Finding a way to solve the disabling effects of PIPN would significantly improve the patients’ quality of life. Trial registration This trial was registered at ClinicalTrials.gov (NCT01049295) PMID:22894640

  17. The Effect of Melatonin on Climacteric Symptoms in Menopausal Women; A Double-Blind, Randomized Controlled, Clinical Trial

    PubMed Central

    PARANDAVAR, Nehleh; ABDALI, Khadijeh; KESHTGAR, Sara; EMAMGHOREISHI, Maasoumeh; AMOOEE, Seddegheh

    2014-01-01

    Abstract Background Menopause is one of the most critical periods of woman’s life. With reducing of ovarian estrogen; women are more prone to psychological and physical symptoms. The present study aimed to investigate the effect of melatonin on the climacteric symptoms. Methods The present double blind, placebo randomized controlled clinical trial was conducted on 240 menopausal women (40 - 60 years old) referring to the gynecology clinics of Shiraz University of Medical Sciences (January - November 2012). The participants were randomly divided into two groups through sortition. Demographic characteristics, Goldberg’s general health questionnaire (GHQ), Greene Climacteric Scale and level of Follicle Stimulating Hormone (FSH) were determined for both groups before the intervention. The intervention group received one 3mg melatonin tablet each night for 3 months and the control group received the placebo in the same period. Changes of climacteric symptoms and drug complications were measured 1, 2 and 3 months after the intervention Results We analyzed the data of 99 postmenopausal women in the intervention group and 101 postmenopausal women in the control group. In the melatonin group, the climacteric symptoms score decreased from 35.73+11.6 to 17.09+10.22 during the 3-month study period and regardless of time, a significant difference was observed between the two groups (P<0.001). In addition, a significant difference was found between the two groups regarding various dimensions of the climacteric symptoms over time (P<0.001). No significant difference was found regarding side effects between the two groups (P= 0.135). Conclusion The study findings showed that using melatonin improved the climacteric symptoms. PMID:26060703

  18. An integral topical gel for cellulite reduction: results from a double-blind, randomized, placebo-controlled evaluation of efficacy

    PubMed Central

    Dupont, Eric; Journet, Michel; Oula, Marie-Laure; Gomez, Juan; Léveillé, Claude; Loing, Estelle; Bilodeau, Diane

    2014-01-01

    Background Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. Objective To assess the clinical efficacy of a complex integral anti-cellulite gel. Methods This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25–55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. Results At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined). At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (P<0.05) over placebo, on all studied areas. Skin tonicity improved on average by +41% for buttocks, +35% for hips, and +31% for thighs. Orange peel appearance was reduced on average by −25% for buttocks, −22% for hips, and −22% for thighs. Stubborn cellulite was reduced on average by −19% for buttocks, −24% for hips, and −22% for thighs. Circumference measurements decreased in a significant manner (P<0.05) over placebo, for the abdomen (average value of −1.1 cm) and thighs (average value of −0.8 cm). The product was well tolerated and perceived by the volunteers themselves as better performing than placebo on all criteria. Conclusion All results validate the efficacy of the present integral formulation to significantly reduce signs of cellulite and reshape the silhouette. PMID:24600240

  19. Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results from a Randomized, Double-Blind, Placebo-Controlled Study

    PubMed Central

    Papakostas, George I.; Fava, Maurizio; Baer, Lee; Swee, Michaela B.; Jaeger, Adrienne; Bobo, William V.; Shelton, Richard C.

    2016-01-01

    Objective To test the efficacy of adjunctive ziprasidone in adults with non-psychotic unipolar major depression experiencing persistent symptoms following 8 weeks of open-label escitalopram. Method This was a multi-center, parallel randomized, double-blind, placebo-controlled trial conducted at three academic medical centers in the United States. The participant pool consisted of 139 outpatients with persistent symptoms of major depressive disorder following an 8-week open label trial of escitalopram (phase 1). Subjects were randomized (1:1, n=139) to adjunctive ziprasidone (escitalopram+ziprasidone, n=71) or adjunctive placebo (escitalopram+placebo, n=68), with 8 weekly follow-up assessments. Primary outcome was defined by clinical response according to the 17-item Hamilton Depression Rating Scale (HAMD-17) and determined by a 50% or greater reduction in scale scores. The Hamilton Anxiety Rating scale (HAM-A) and Visual Analogue Scale for Pain were defined a priori as key secondary outcome measures. Results Rates of clinical response (35.2% vs. 20.5%, p=0.04) and mean improvement in HAMD-17 total scores (−6.4 ± 6.4 vs. −3.3 ± 6.2, p=0.04) were significantly greater for the escitalopram+ziprasidone group. Several secondary measures of antidepressant efficacy were also in favor of adjunctive ziprasidone. Escitalopram+ziprasidone also resulted in significantly greater improvement in HAM-A, but not Visual Analogue Scale for Pain scores. Ten (14%) patients discontinued escitalopram+ziprasidone due to intolerance versus none for escitalopram+placebo (p<0.01 versus placebo). Conclusions Adjunctive ziprasidone, when added to escitalopram, demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms following 8 weeks of open-label escitalopram. PMID:26085041

  20. Randomized sham controlled double-blind trial of repetitive transcranial magnetic stimulation for adults with severe Tourette syndrome

    PubMed Central

    Landeros-Weisenberger, Angeli; Mantovani, Antonio; Motlagh, Maria; de Alvarenga, Pedro Gomes; Katsovich, Liliya; Leckman, James F.; Lisanby, Sarah H.

    2014-01-01

    Background A small proportion of individuals with Tourette syndrome (TS) have a lifelong course of illness that fails to respond to conventional treatments. Open label studies have suggested that low frequency (1-Hz) repetitive transcranial magnetic stimulation (rTMS) targeting the supplementary motor area (SMA) may be effective in reducing tic severity. Objective/Hypothesis To examine the efficacy of rTMS over the SMA for TS in a randomized double-blind sham-controlled trial (RCT). Methods We conducted a two-site RCT-rTMS with 20 adults with severe TS for 3 weeks. Treatment consisted of 15 sessions (1-Hz; 30 min; 1,800 pulses per day) of active or sham rTMS at 110% of the motor threshold over the SMA. A subsequent 3 week course of active rTMS treatment was offered. Results Of the 20 patients (16 males; mean age of 33.7 ± 12.2 years), 9 received active and 11 received sham rTMS. After 3 weeks, patients receiving active rTMS showed on average a 17.3% reduction in the YGTSS total tic score compared to a 13.2% reduction in those receiving sham rTMS, resulting in no statistically significant reduction in tic severity (p=0.27). An additional 3 week open label active treatment for those patients (n = 7) initially randomized to active rTMS resulted in a significant overall 29.7% reduction in tic severity compared to baseline (p=0.04). Conclusion This RCT did not demonstrate efficacy of 3-week SMA-targeted low frequency rTMS in the treatment of severe adult TS. Further studies using longer or alternative stimulation protocols are warranted. PMID:25912296

  1. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    PubMed Central

    Toscano, I. L.; Rezende, M.V.; Mello, L. F.; Pires, L.; Paulillo, D.; Glina, S.

    2016-01-01

    ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week). Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5) score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019) and 50.4° and 42.08° before and after verapamil, respectively (p=0.012). The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23) in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58). In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine. PMID:24893912

  2. The influence of ginger (Zingiber officinale) on human sperm quality and DNA fragmentation: A double-blind randomized clinical trial

    PubMed Central

    Hosseini, Jalil; Mardi Mamaghani, Azar; Hosseinifar, Hani; Sadighi Gilani, Mohammad Ali; Dadkhah, Farid; Sepidarkish, Mahdi

    2016-01-01

    Background: Although the effectiveness of ginger as an antioxidant agent has been exploited, little human research has been conducted on its activity on male reproductive functions. Objective: This study was designed to investigate the effects of ginger (Zingiber officinale) on sperm DNA fragmentation (SDF) in infertile men. Materials and Methods: This randomized double-blind, placebo-controlled trial with a 1:1 allocation was performed on 100 infertility treatment candidates who were admitted to Royan Institute for Reproductive Biomedicine, Tehran, Iran. Patients were randomly assigned to receive one of two treatments: ginger and placebo. Patients were given a 3-month oral treatment (members received capsules containing 250 mg of ginger powder twice a day in ginger and a placebo in other group). Before and after treatment, standardized semen samples were obtained to determine sperm concentration, motility, and SDF according to World Health Organization. Results: There was no significant difference between two groups regarding SDF at baseline (53.48. 95%CI: 37.95-69.02) in cases and (56.75, 95%CI: 40.01-73.5) in controls. The average positive percentage of SDF in patients receiving ginger (17.77, 95%CI: 6.16-29.39) was lower compared with placebo (40.54, 95%CI: 23.94-57.13) after three month of treatment (p=0.02). In multivariate analysis, SDF was significantly lower in patients receiving ginger compared with placebo (mean difference: 3.21, 95%CI: 0.78-5.63, p=0.009). There were no significant differences between two groups regarding to semen parameters. Conclusion: The present study has demonstrated that ginger in a controlled study of efficacy was effective in decreasing SDF in infertile men.

  3. Rhodiola crenulata extract for prevention of acute mountain sickness: a randomized, double-blind, placebo-controlled, crossover trial

    PubMed Central

    2013-01-01

    Background Rhodiola crenulata (R. crenulata) is widely used to prevent acute mountain sickness in the Himalayan areas and in Tibet, but no scientific studies have previously examined its effectiveness. We conducted a randomized, double-blind, placebo-controlled crossover study to investigate its efficacy in acute mountain sickness prevention. Methods Healthy adult volunteers were randomized to 2 treatment sequences, receiving either 800 mg R. crenulata extract or placebo daily for 7 days before ascent and 2 days during mountaineering, before crossing over to the alternate treatment after a 3-month wash-out period. Participants ascended rapidly from 250 m to 3421 m on two separate occasions: December 2010 and April 2011. The primary outcome measure was the incidence of acute mountain sickness, as defined by a Lake Louise score ≥ 3, with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness, or difficulty sleeping. Results One hundred and two participants completed the trial. There were no demographic differences between individuals taking Rhodiola-placebo and those taking placebo-Rhodiola. No significant differences in the incidence of acute mountain sickness were found between R. crenulata extract and placebo groups (all 60.8%; adjusted odds ratio (AOR) = 1.02, 95% confidence interval (CI) = 0.69–1.52). The incidence of severe acute mountain sickness in Rhodiola extract vs. placebo groups was 35.3% vs. 29.4% (AOR = 1.42, 95% CI = 0.90–2.25). Conclusions R. crenulata extract was not effective in reducing the incidence or severity of acute mountain sickness as compared to placebo. Trial registration ClinicalTrials.gov NCT01536288. PMID:24176010

  4. Treatment of rheumatoid arthritis with marine and botanical oils: an 18-month, randomized, and double-blind trial.

    PubMed

    Reed, George W; Leung, Katherine; Rossetti, Ronald G; Vanbuskirk, Susan; Sharp, John T; Zurier, Robert B

    2014-01-01

    Objective. To determine whether a combination of borage seed oil rich in gamma linolenic acid (GLA) and fish oil rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is superior to either oil alone for treatment of rheumatoid arthritis (RA). Methods. Patients were randomized into a double-blind, 18-month trial. Mixed effects models compared trends over time in disease activity measures. Results. No significant differences were observed in changes in disease activity among the three randomized groups. Each group exhibited significant reductions in disease activity (DAS28) at 9 months (fish: -1.56[-2.16, -0.96], borage: -1.33[-1.83, -0.84], combined: -1.18[-1.83, -0.54]) and in CDAI (fish: -16.95[-19.91, -13.98], borage: -11.20[-14.21, -8.19], and combined: -10.31[-13.61, -7.01]). There were no significant differences in change of RA medications among the three groups. Reduced disease activity in study patients was similar to matched patients from an RA registry, and reduction in DMARD use was greater (P < 0.03) in study patients. Conclusion. All 3 treatment groups exhibited similar meaningful clinical responses after 9 months, improvements which persisted for 18 months, and a response similar to matched patients from an RA registry. Study patients were able to reduce DMARD therapy given in combination with TNF antagonists to a greater extent than registry patients. This paper is dedicated to the memory of Dr. John T. Sharp, M.D., a pioneer and innovator in the field of musculoskeletal radiology. PMID:24803948

  5. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

    PubMed Central

    Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M

    2016-01-01

    Background/Aims The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. Methods We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. Results In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (P<0.05). Moreover, the patients in the gluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (P<0.05), and their symptoms worsened within 1 week of the rechallenge. Conclusions A gluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions. PMID:27799885

  6. Ultramicronized palmitoylethanolamide in spinal cord injury neuropathic pain: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Andresen, Sven R; Bing, Jette; Hansen, Rikke M; Biering-Sørensen, Fin; Johannesen, Inger L; Hagen, Ellen Merete; Rice, Andrew S C; Nielsen, Jørgen F; Bach, Flemming W; Finnerup, Nanna B

    2016-09-01

    Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide that is produced in many cells in the body, is thought to potentiate the action of endocannabinoids and to reduce pain and inflammation. This randomized, double-blind, placebo-controlled, parallel multicenter study was performed to investigate the effect of ultramicronized PEA (PEA-um) as add-on therapy on neuropathic pain in individuals with SCI. A pain diary was completed and questionnaires were completed before and after the 12-week treatment with either placebo or PEA-um. The primary outcome measure was the change in mean neuropathic pain intensity from the 1-week baseline period to the last week of treatment measured on a numeric rating scale ranging from 0 to 10. The primary efficacy analysis was the intention to treat (baseline observation carried forward). Secondary outcomes included a per protocol analysis and effects on spasticity, evoked pain, sleep problems, anxiety, depression, and global impression of change. We randomized 73 individuals with neuropathic pain due to SCI, of which 5 had a major protocol violation, and thus 68 were included in the primary analysis. There was no difference in mean pain intensity between PEA-um and placebo treatment (P = 0.46, mean reductions in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2-1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo. PMID:27227691

  7. Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Yousefichaijan, Parsa; Cyrus, Ali; Dorreh, Fatemeh; Rafeie, Mohammad; Sharafkhah, Mojtaba; Frohar, Faryar; Safi, Fatemeh

    2015-01-01

    Background: Nephrolithiasis in children is associated with a high rate of complications and recurrence. Objectives: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. Patients and Methods: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. Results: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001) in a way that the decrease in the intervention group showed no difference with the control group. Conclusions: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field. PMID:26635934

  8. Effect of Chlorhexidine with Fluoride Mouthrinse on Plaque Accumulation, Plaque pH - A Double Blind Parallel Randomized Clinical Trial

    PubMed Central

    Saha, Sabyasachi; Singh, Sanjay

    2016-01-01

    Introduction Mouthwashes are important means used in chemical control of dental plaque. There is strong evidence suggestive of better effectiveness, when fluoride is added to chlorhexidine mouthwash. Aim To assess the anti-plaque efficacy of Chlorhexidine combined with Fluoride mouthwash and to measure its impact on plaque accumulation and on plaque pH. Materials and Methods Initially 100 subjects were screened. A double blind, parallel randomized clinical trial was conducted on 30 subjects after applying inclusion and exclusion criteria. Other independent variables were matched before randomly allocating them in three groups: Group A-Chlorhexidine as positive control, Group B-Chlorhexidine + Fluoride as test group and Group C- Distilled water as negative control. Oral prophylaxis of participants was done before onset of the study. Plaque pH was assessed before and immediately after rinsing at 0, 5 and 10 minutes interval and after 7 days with digital pH electrode (pHepR pH meter, Hanna Instruments R10285) and accumulation of plaque was recorded by Turesky et al., modification of Quigley Hein Plaque Index (1970). ANOVA test was used for statistical analysis. Results Although there was a statistically significant reduction in mean plaque scores from baseline to seven days in both Groups A and B, Group B showed better anti-plaque efficacy . Almost equal drop in plaque pH was seen for both the groups at 5 and 10 minutes. Conclusion Better anti-plaque efficacy was observed in Group B (Chlorhexidine and Fluoride combination) with minimum variation of plaque pH. PMID:27630956

  9. Treatment of Rheumatoid Arthritis with Marine and Botanical Oils: An 18-Month, Randomized, and Double-Blind Trial

    PubMed Central

    Reed, George W.; Leung, Katherine; Rossetti, Ronald G.; VanBuskirk, Susan; Sharp, John T.; Zurier, Robert B.

    2014-01-01

    Objective. To determine whether a combination of borage seed oil rich in gamma linolenic acid (GLA) and fish oil rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is superior to either oil alone for treatment of rheumatoid arthritis (RA). Methods. Patients were randomized into a double-blind, 18-month trial. Mixed effects models compared trends over time in disease activity measures. Results. No significant differences were observed in changes in disease activity among the three randomized groups. Each group exhibited significant reductions in disease activity (DAS28) at 9 months (fish: −1.56[−2.16, −0.96], borage: −1.33[−1.83, −0.84], combined: −1.18[−1.83, −0.54]) and in CDAI (fish: −16.95[−19.91, −13.98], borage: −11.20[−14.21, −8.19], and combined: −10.31[−13.61, −7.01]). There were no significant differences in change of RA medications among the three groups. Reduced disease activity in study patients was similar to matched patients from an RA registry, and reduction in DMARD use was greater (P < 0.03) in study patients. Conclusion. All 3 treatment groups exhibited similar meaningful clinical responses after 9 months, improvements which persisted for 18 months, and a response similar to matched patients from an RA registry. Study patients were able to reduce DMARD therapy given in combination with TNF antagonists to a greater extent than registry patients. This paper is dedicated to the memory of Dr. John T. Sharp, M.D., a pioneer and innovator in the field of musculoskeletal radiology PMID:24803948

  10. Thoracic sympathetic block for the treatment of complex regional pain syndrome type I: a double-blind randomized controlled study.

    PubMed

    Rocha, Roberto de Oliveira; Teixeira, Manoel Jacobsen; Yeng, Lin Tchia; Cantara, Mirlene Gardin; Faria, Viviane Gentil; Liggieri, Victor; Loduca, Adrianna; Müller, Barbara Maria; Souza, Andrea C M S; de Andrade, Daniel Ciampi

    2014-11-01

    Pain relief in complex regional pain syndrome (CRPS) remains a major challenge, in part due to the lack of evidence-based treatment trials specific for this condition. We performed a long-term randomized, double-blinded active-control study to evaluate the efficacy of thoracic sympathetic block (TSB) for upper limb type I CRPS. The study objective was to evaluate the analgesic effect of TSB in CRPS. Patients with CRPS type I were treated with standardized pharmacological and physical therapy and were randomized to either TSB or control procedure as an add-on treatment. Clinical data, pain intensity, and interference (Brief Pain Inventory), pain dimensions (McGill Pain Questionnaire [MPQ]), neuropathic characteristics (Neuropathic Pain Symptom Inventory [NPSI]), mood, upper limb function (Disabilities of Arm, Shoulder and Hand), and quality of life were assessed before, and at 1 month and 12 months after the procedure. Thirty-six patients (19 female, 44.7 ± 11.1 years of age) underwent the procedure (17 in the TSB group). Average pain intensity at 1 month was not significantly different after TSB (3.5 ± 3.2) compared to control procedure (4.8 ± 2.7; P=0.249). At 12 months, however, the average pain item was significantly lower in the TSB group (3.47 ± 3.5) compared to the control group (5.86 ± 2.9; P=0.046). Scores from the MPQ, evoked-pain symptoms subscores (NPSI), and depression scores (Hospital Anxiety and Depression Scale) were significantly lower in the TSB group compared to the control group at 1 and at 12 months. Other measurements were not influenced by the treatment. Quality of life was only slightly improved by TSB. No major adverse events occurred. Larger, multicentric trials should be performed to confirm these original findings.

  11. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    PubMed

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans. PMID:6749701

  12. Effect of adding clonidine to intrathecal bupivacaine on the quality of subarachnoid block: A prospective randomized double-blind study

    PubMed Central

    Yallapragada, Srivishnu Vardhan; Vemuri, Nagendra Nath; Shaik, Mastan Saheb

    2016-01-01

    Context: The purpose of adding an adjuvant to local anesthetic in a central neuraxial blockade is to augment the desirable pharmacological actions of the agent and/or to minimize its undesirable pharmacological effects. Clonidine is an alfa-2 receptor agonist which has gained popularity in recent times as an adjuvant in spinal anesthesia. Aims: To evaluate the influence of clonidine on the hemodynamic stability and the duration of anesthesia when added to intrathecal hyperbaric bupivacaine. Settings and Design: Prospective randomized double blind study. Subjects and Methods: Fifty patients scheduled for spinal anesthesia were randomized into two Groups A and B with 25 in each. Group A patients received 3 ml 0.5% heavy bupivacaine + 30 μg (0.2 ml) clonidine and Group B patients received 3 ml 0.5% heavy bupivacaine + 0.2 ml normal saline in the subarachnoid space. The blood pressure and heart rate were closely monitored. The time for attaining peak sensory block, time for two segment regression, decrease in the heart rate, total requirement of mephentermine to counter the hypotension, and the number of patients requiring mephentermine in each group was tabulated and analyzed. Statistical Analysis Used: Descriptive and inferential statistical methods were used to analyse the data. The power of the study was calculated using online power calculator for two independent sample study. Results: The time for attaining peak sensory block was similar in both the groups. The time for two segment regression in Group A was 62.6 min and in Group B was 38.08 min. Twelve percent of patients in Group A and 52% of patients in Group B required mephentermine with the mean consumption being 0.72 mg in Group A and 5.65 mg in Group B. Conclusions: Addition of low-dose clonidine to intrathecal bupivacaine not only prolonged the duration of spinal anesthesia but also provided a stable intraoperative hemodynamic profile. PMID:27746531

  13. Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study.

    PubMed

    Golomb, Beatrice A; Allison, Matthew; Koperski, Sabrina; Koslik, Hayley J; Devaraj, Sridevi; Ritchie, Janis B

    2014-11-01

    We sought to assess whether coenzyme Q10 (CoQ10) benefits the chronic multisymptom problems that affect one-quarter to one-third of 1990-1 Gulf War veterans, using a randomized, double-blind, placebo-controlled study. Participants were 46 veterans meeting Kansas and Centers for Disease Control criteria for Gulf War illness. Intervention was PharmaNord (Denmark) CoQ10 100 mg per day (Q100), 300 mg per day (Q300), or an identical-appearing placebo for 3.5 ± 0.5 months. General self-rated health (GSRH), the primary outcome, differed across randomization arms at baseline, and sex significantly predicted GSRH change, compelling adjustment for baseline GSRH and prompting sex-stratified analysis. GSRH showed no significant benefit in the combined-sex sample. Among males (85% of participants), Q100 significantly benefited GSRH versus placebo and versus Q300, providing emphasis on Q100. Physical function (summary performance score, SPS) improved on Q100 versus placebo. A rise in CoQ10 approached significance as a predictor of improvement in GSRH and significantly predicted SPS improvement. Among 20 symptoms each present in half or more of the enrolled veterans, direction-of-difference on Q100 versus placebo was favorable for all except sleep problems; sign test 19:1, p=0.00004) with several symptoms individually significant. Significance for these symptoms despite the small sample underscores large effect sizes, and an apparent relation of key outcomes to CoQ10 change increases prospects for causality. In conclusion, Q100 conferred benefit to physical function and symptoms in veterans with Gulf War illness. Examination in a larger sample is warranted, and findings from this study can inform the conduct of a larger trial.

  14. Effect of Probiotic Curd on Salivary pH and Streptococcus mutans: A Double Blind Parallel Randomized Controlled Trial

    PubMed Central

    Saha, Sabyasachi; Kumari, Minti; Mohd, Shafaat

    2016-01-01

    Background Dairy products like curd seem to be the most natural way to ingest probiotics which can reduce Streptococcus mutans level and also increase salivary pH thereby reducing the dental caries risk. Objectives To estimate the role of probiotic curd on salivary pH and Streptococcus mutans count, over a period of 7 days. Materials and Methods This double blind parallel randomized clinical trial was conducted at the institution with 60 caries free volunteers belonging to the age group of 20-25 years who were randomly allocated into two groups. Test Group consisted of 30 subjects who consumed 100ml of probiotic curd daily for seven days while an equal numbered Control Group were given 100ml of regular curd for seven days. Saliva samples were assessed at baseline, after ½ hour 1 hour and 7 days of intervention period using pH meter and Mitis Salivarius Bacitracin agar to estimate salivary pH and S. mutans count. Data was statistically analysed using Paired and Unpaired t-test. Results The study revealed a reduction in salivary pH after ½ hour and 1 hour in both the groups. However after 7 days, normal curd showed a statistically significant (p< 0.05) reduction in salivary pH while probiotic curd showed a statistically significant (p< 0.05) increase in salivary pH. Similarly with regard to S. mutans colony counts probiotic curd showed statistically significant reduction (p< 0.05) as compared to normal curd. Conclusion Short-term consumption of probiotic curds showed marked salivary pH elevation and reduction of salivary S. mutans counts and thus can be exploited for the prevention of enamel demineralization as a long-term remedy keeping in mind its cost effectiveness. PMID:27042577

  15. Self-Efficacy in Foot-Care and Effect of Training: A Single-Blinded Randomized Controlled Clinical Trial

    PubMed Central

    Seyyedrasooli, Alehe; Parvan, Kobra; Valizadeh, Leila; Rahmani, Azad; Zare, Maryam; Izadi, Tayyebeh

    2015-01-01

    Background Diabetes mellitus (DM) is one of the most common metabolic and non-communicable disorders worldwide and the mortality rates caused by the complications associated with the disease, such as diabetic foot ulcer, is increasing dramatically. Patient education is considered as an essential part of controlling DM. Therefore, we aimed to compare the effects of individual and group training methods on self-efficacy in foot care among the patients with DM. Methods In this single-blinded, randomized controlled clinical trial, we enrolled 150 patients with type 1 and 2 DM. The final participants were randomly assigned into two intervention groups (collective and individual training group) and a control group. Data were collected using foot-care self-efficacy questionnaire (Corrbet, 2003). A research assistant collected the data by interviewing the participants using the questionnaire once before and once one month after the intervention. The participants of the intervention groups attended a training program consisting of three sessions per week for one week. Statistical descriptive tests such as mean and standard deviation (SD) percentage were used to describe the features of the data inferential statistics test such as Chi-square, independent t-test and repeated measures analysis of variance and analysis co-variance (ANOVA, ANCOVA) tests were also used as appropriate. The significance level was set at <0.05. Results The results indicated that there was no significant difference between the three groups regarding the mean of self-efficacy scores before foot-care training intervention (P=0.39). But, comparison of the scores before and after the intervention showed that both group and individual training interventions increased the patients’ self-efficacy (P≤0/05). Conclusion It can be concluded that both group and individual training approaches could increase foot care self-efficacy in the patients with DM. Trial Registration Number: IRCT201203086918N6. PMID

  16. Antidepressant Augmentation Using the NMDA-Antagonist Memantine: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Smith, Eric G.; Deligiannidis, Kristina M.; Ulbricht, Christine M.; Landolin, Chelsea S.; Patel, Jayendra K.; Rothschild, Anthony J.

    2014-01-01

    Objective Intravenous NMDA antagonists have shown promising results in rapidly ameliorating depression symptoms, but placebo-controlled trials of oral NMDA antagonists as monotherapy have not observed efficacy. We conducted a randomized, double-blind, placebo-controlled trial (NCT00344682) of the NMDA antagonist memantine as an augmentation treatment for patients with DSM-IV major depressive disorder. Method 31 participants with partial or nonresponse to their current antidepressant were randomized (from 2006–2011) to add memantine (flexible dose 5–20 mg/day, with all memantine group participants reaching the dose of 20 mg/day) (n= 15) or placebo (n= 16) to their existing treatment for 8 weeks. The primary outcome, change in Montgomery-Asberg Depression Rating Score (MADRS), was evaluated with repeated measures mixed effects models using last-observation-carried-forward methods. Secondary outcomes included other depression and anxiety rating scales, suicidal and delusional ideation, and other adverse effects. Results Participants receiving memantine did not show a statistically or clinically significant change in MADRS scores compared to placebo, either over the entire study (β=0.133, favoring placebo, p=0.74) or at study completion (week 8 MADRS score change: −7.13 +/−6.61 (memantine); −7.25 +/−11.14 (placebo), p=0.97). A minimal-to-small effect size (comparing change to baseline variability) was observed (d=0.19), favoring placebo. Similarly, no substantial effect sizes favoring memantine, nor statistically significant between-group differences, were observed on secondary efficacy or safety outcomes. Conclusions This trial did not detect significant statistical or effect size differences between memantine and placebo augmentation among nonresponders or poor responders to conventional antidepressants. While the small number of participants is a limitation, this study suggests memantine lacks substantial efficacy as an augmentation treatment against

  17. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder

    PubMed Central

    Cosmo, Camila; Baptista, Abrahão Fontes; de Araújo, Arão Nogueira; do Rosário, Raphael Silva; Miranda, José Garcia Vivas; Montoya, Pedro; de Sena, Eduardo Pondé

    2015-01-01

    Background Current standardized treatments for cognitive impairment in attention-deficit/hyperactivity disorder remain limited and their efficacy restricted. Transcranial direct current stimulation (tDCS) is a promising tool for enhancing cognitive performance in several neuropsychiatric disorders. Nevertheless, the effects of tDCS in reducing cognitive impairment in patients with attention-deficit/hyperactivity disorder (ADHD) have not yet been investigated. Methods A parallel, randomized, double-blind, sham-controlled trial was conducted to examine the efficacy of tDCS on the modulation of inhibitory control in adults with ADHD. Thirty patients were randomly allocated to each group and performed a go/no-go task before and after a single session of either anodal stimulation (1 mA) over the left dorsolateral prefrontal cortex or sham stimulation. Results A nonparametric two-sample Wilcoxon rank-sum (Mann-Whitney) test revealed no significant differences between the two groups of individuals with ADHD (tDCS vs. sham) in regard to behavioral performance in the go/no go tasks. Furthermore, the effect sizes of group differences after treatment for the primary outcome measures—correct responses, impulsivity and omission errors—were small. No adverse events resulting from stimulation were reported. Conclusion According to these findings, there is no evidence in support of the use of anodal stimulation over the left dorsolateral prefrontal cortex as an approach for improving inhibitory control in ADHD patients. To the best of our knowledge, this is the first clinical study to assess the cognitive effects of tDCS in individuals with ADHD. Further research is needed to assess the clinical efficacy of tDCS in this population. Trial Registration ClinicalTrials.gov NCT01968512 PMID:26267861

  18. A double-blind, randomized, cross-over, placebo-controlled, pilot trial with Sativex in Huntington's disease.

    PubMed

    López-Sendón Moreno, Jose Luis; García Caldentey, Juan; Trigo Cubillo, Patricia; Ruiz Romero, Carolina; García Ribas, Guillermo; Alonso Arias, M A Alonso; García de Yébenes, María Jesús; Tolón, Rosa María; Galve-Roperh, Ismael; Sagredo, Onintza; Valdeolivas, Sara; Resel, Eva; Ortega-Gutierrez, Silvia; García-Bermejo, María Laura; Fernández Ruiz, Javier; Guzmán, Manuel; García de Yébenes Prous, Justo

    2016-07-01

    Huntington's disease (HD) is a neurodegenerative disease for which there is no curative treatment available. Given that the endocannabinoid system is involved in the pathogenesis of HD mouse models, stimulation of specific targets within this signaling system has been investigated as a promising therapeutic agent in HD. We conducted a double-blind, randomized, placebo-controlled, cross-over pilot clinical trial with Sativex(®), a botanical extract with an equimolecular combination of delta-9-tetrahydrocannabinol and cannabidiol. Both Sativex(®) and placebo were dispensed as an oral spray, to be administered up to 12 sprays/day for 12 weeks. The primary objective was safety, assessed by the absence of more severe adverse events (SAE) and no greater deterioration of motor, cognitive, behavioral and functional scales during the phase of active treatment. Secondary objectives were clinical improvement of Unified Huntington Disease Rating Scale scores. Twenty-six patients were randomized and 24 completed the trial. After ruling-out period and sequence effects, safety and tolerability were confirmed. No differences on motor (p = 0.286), cognitive (p = 0.824), behavioral (p = 1.0) and functional (p = 0.581) scores were detected during treatment with Sativex(®) as compared to placebo. No significant molecular effects were detected on the biomarker analysis. Sativex(®) is safe and well tolerated in patients with HD, with no SAE or clinical worsening. No significant symptomatic effects were detected at the prescribed dosage and for a 12-week period. Also, no significant molecular changes were observed on the biomarkers. Future study designs should consider higher doses, longer treatment periods and/or alternative cannabinoid combinations.Clincaltrals.gov identifier: NCT01502046. PMID:27159993

  19. Six-month efficacy and safety of amfepramone in obese Mexican patients: a double-blinded, randomized, controlled trial.

    PubMed

    Soto-Molina, Herman; Pizarro-Castellanos, Mariel; Rosado-Pérez, Juana; Rizzoli-Córdoba, Antonio; Lara-Padilla, Eleazar; del Valle-Laisequilla, Cecilia Fernández; Reyes-García, Juan Gerardo

    2015-07-01

    Amfepramone, also known as diethylpropion, is an anorectic drug used for the short-term treatment of obesity; however, its efficacy and safety during periods greater than 3 months has been scarcely studied. To evaluate the 6-month efficacy and safety of amfepramone treatment in obese adult Mexican patients resistant to diet and exercise, a double-blinded, randomized, and placebo-controlled clinical trial study was designed on 156 volunteers with a body mass index (BMI) greater than 30 kg/m2 and less than 45 kg/m2. Patients were randomized to receive a 75 mg tablet of amfepramone or placebo daily for 6 months. Primary outcome was the absolute body weight loss, whereas secondary outcomes were the percentage of patients who achieved at least 5% or 10% weight loss, as well as the improvement of anthropometric and metabolic parameters. Amfepramone treatment produced a superior efficacy to decrease body weight than placebo at 3 months (-4.9±0.25 kg vs. -0.7±0.32 kg) and 6 months (-7.7±0.52 kg vs. -1.1±0.7 kg). In addition, 64 and 34 patients achieved at least 5% or 10% weight loss, respectively, with amfepramone at 6 months, compared with 8 and 0 patients on placebo. Amfepramone also significantly improved BMI and waist circumference, but it only showed a favorable tendency in the waist-hip index (WHI), glucose, total cholesterol, low-density lipoproteins (LDL), high-density lipoproteins (HDL), triglycerides, heart rate, systolic blood pressure, and diastolic blood pressure at 3 and 6 months. Amfepramone produced only mild adverse events, and they were presented in a greater number than placebo only at 3 months, dry mouth being the the main adverse event. Data suggest that amfepramone is effective and well tolerated in obese Mexican patients during a 6-month regimen.

  20. Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial

    PubMed Central

    2014-01-01

    Background This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibited a dysfunctional gait. We hypothesized that subjects who received electrical stimulation would have greater improvement than those who had a control device after a 14-week intervention. Gait disturbance is a common problem for people with multiple sclerosis (MS). Current management may include exercise, pharmacology, functional electrical stimulation, compensatory strategies, use of assistive devices, and implanted electrical devices. We have developed an effective rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain. Methods The study is a within-subject blinded randomized control design. Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group. Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive. Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI). Results The DGI scores improved for both groups. There were significant between-group differences, with the active group showing statistically greater improvement than the control group mean. Conclusion People with MS demonstrated improved gait with CN-NINM training in a pilot randomized controlled trial. This study suggests that tongue-based neurostimulation may amplify the benefits of exercise for improving gait in people with chronic MS. PMID:24885412

  1. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    PubMed

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.

  2. A Randomized, Double, Blind, Placebo, Controlled Trial of Venlafaxine for the Treatment of Depressed Cocaine-Dependent Patients

    PubMed Central

    Raby, Wilfrid Noel; Rubin, Eric A.; Garawi, Fatima; Cheng, Wendy; Mason, Ella; Sanfilippo, Lisa; Lord, Stephanie; Bisaga, Adam; Aharonovich, Efrat; Levin, Frances; McDowell, David; Nunes, Edward V.

    2014-01-01

    Objective This study tested the hypothesis that the antidepressant venlafaxine would be an effective treatment for cocaine abusers with concurrent depressive disorders. Methods This was a randomized, 12-week, double-blind, placebo-controlled trial of outpatients (N = 130) meeting DSM-IIIR criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with venlafaxine, up to 300 mg/day versus placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included Clinical Global Impression Scale (CGI), self-reported cocaine use, urine toxicology and the Hamilton Depression Scale (Ham-D). Results Mood response, defined as a 50% reduction in the Ham-D between randomization and end of study, was 41% (26/64) on venlafaxine, and 33% (22/66) on placebo (p = .39). Measures of depression (Ham-D and CGI) improved more rapidly on venlafaxine than placebo, but these differences disappeared by weeks 6–8. Cocaine outcomes did not differ between treatment groups, and the proportion of patients achieving three or more consecutive weeks of urine-confirmed abstinence was low (venlafaxine: 16%; placebo: 15%). Reduction in cocaine use was associated with mood response. Conclusions Overall, venlafaxine was not superior to placebo on either mood or cocaine use outcomes. Mood improvement was associated with improvement in cocaine use. However, placebo mood response was only moderate, and the proportion of patients achieving sustained abstinence was low. This suggests that the subgroup of cocaine-dependent patients with depressive disorders is relatively treatment resistant, and that further research is needed to improve outcomes for these patients. PMID:24313244

  3. Rapid and reliable smooth extubation – Comparison of fentanyl with dexmedetomidine: A randomized, double-blind clinical trial

    PubMed Central

    Rani, P.; Hemanth Kumar, V. R.; Ravishankar, M.; Sivashanmugam, T.; Sripriya, R.; Trilogasundary, M.

    2016-01-01

    Background: Fentanyl and dexmedetomidine have been tried to attenuate airway and circulatory reflexes during emergence and extubation individually but have not been compared with respect to the level of sedation to evolve a reliable technique for rapid and smooth extubation. Aim: To compare the effects of fentanyl and dexmedetomidine in attenuating airway and circulatory reflexes during emergence and extubation of the endotracheal tube. Setting and Design: This double-blind, randomized, controlled study was done in patients undergoing surgery under general anesthesia belonging to the American Society of Anesthesiologists physical status 1 or 2. Methodology: All patients received a standardized anesthetic protocol. Patients were randomized to receive either fentanyl 1 μg/kg or dexmedetomidine 0.75 μg/kg. Fifteen minutes before expected last surgical suture, isoflurane was cutoff and equal amount of test solution was given when train-of-four ratio was 0.3. The degree of sedation, airway, and circulatory responses at the time of suction and extubation were analyzed. Statistical Analysis Used: Chi-square test for nonparametric data and t-test for parametric data. Results: Heart rate (HR) was comparable in both the groups until endotracheal extubation. Later, there was rise in HR in fentanyl group. There was stastisticaly significant drop in blood pressure at 5 min after test drug administration in both the groups. Airway response for suctioning and extubation was better in dexmedetomidine group and it was associated with better sedation score than fentanyl group. Conclusion: Single dose of 0.75 μg/kg dexmedetomidine given 15 min before extubation provides smooth extubation when compared to fentanyl. PMID:27746558

  4. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial

    PubMed Central

    Khosravi Samani, M.; Mahmoodian, H.; Moghadamnia, AA.; Poorsattar Bejeh Mir, A.; Chitsazan, M.

    2011-01-01

    Background and the purpose of the study Extract of Boswellia Serrata species has been used in the Indian traditional medicine in the treatment of various inflammatory diseases. The present study was designed to evaluate anti-inflammatory effects of Frankincense in the treatment of gingivitis, which is a periodontal tissue inflammatory disease. Methods This double blind randomized placebo controlled trial was carried out among high school female students with moderate plaque-induced gingivitis. Based on either administration of 0.1 gram of Frankincense extract or 0.2 gram of its powder or placebo and whether the patients undergone scaling and root planning (SRP) or not, they were randomly assigned to 6 groups. The primary efficacy outcome was changes in Gingival Index (Loe & Sillness) and the secondary outcomes were alteration in plaque index (Sillness & Loe), bleeding index (Cowell) and probing pocket depth (WHO probe). All indices were measured in the 0, 7th and 14th days of the study. Results Seventy five patients ranged of 15–18 years old were enrolled. At the end of the study, the indices in all groups showed significant decreases in comparison to the first day (p< 0.05), except for the bleeding index in the group without SRP and drug therapy (p=0.111). More precise analysis of data revealed that SRP in association with Frankincense application (either extract or powder) can lead to remarkable decrease in inflammatory indices in comparison to the groups without SRP and drug therapy (p<0.001). In addition, no significant difference was observed between powder or extract therapy (p >0.05) and between patients received either SRP or treatment alone (p=0.169). Conclusion Frankincense, a safe and low-cost herbal medicine, may be feasibly applied to improve inflammation based disease of gingival as an adjunct to the conventional mechanical therapy. PMID:22615671

  5. Randomized Double-Blinded Dose Escalation Trial of Triptorelin for Ovary Protection in Childhood-Onset Systemic Lupus Erythematosus

    PubMed Central

    Brunner, Hermine I.; Silva, Clovis A; Reiff, Andreas; Higgins, Gloria C.; Imundo, Lisa; Williams, Calvin B.; Wallace, Carol A; Aikawa, Nadia E.; Nelson, Shannen; Klein-Gitelman, Marisa S.; Rose, Susan R.

    2015-01-01

    Objectives To determine for females with childhood-onset systemic lupus erythematosus (cSLE) who require cyclophosphamide the dose of triptorelin that suffices to maintain complete ovarian suppression (COS); measure the time needed to achieve ovarian suppression after triptorelin initiation, and explore the safety of triptorelin. Methods In this randomized double-blind placebo-controlled dose-escalation study females (< 21 years) were randomized 4:1 to receive triptorelin or placebo (25 triptorelin, 6 placebo). Starting doses of triptorelin between 25 and 100 microgram/kg/dose were used. Triptorelin dosage was escalated until COS was maintained. The primary outcome was the weight-adjusted dose of triptorelin that for at least 90% of the patients provides COS based on Gonadotropin-releasing-hormone Agonist Stimulation Testing. Secondary outcomes were time to ovarian suppression measured by unstimulated FSH and LH levels after study drug initiation. Results Triptorelin dosed at 120 microgram/kg bodyweight led to sustained COS in 90% of the patients. After the initial dose of triptorelin 22 days were needed for achieve COS. Rates of adverse events (AE) and serious adverse events (SAE) per 100 patient-month of follow-up were not higher in the triptorelin group as compared to the placebo group (triptorelin vs. placebo; AE: 189 vs. 362; SAE: 2.05 vs. 8.48). Conclusions For achieving and maintaining COS high doses of triptorelin are needed but appear to be well tolerated in adolescent females with cSLE. Our data suggest that a lag time of 22 days after triptorelin initiation is required before starting or continuing cyclophosphamide-therapy. Trial Registration Number clinicaltrials.gov identifier: NCT00124514 PMID:25676588

  6. Oxidative stress markers in laparoscopic vs. open appendectomy for acute appendicitis: A double-blind randomized study

    PubMed Central

    Aktimur, Recep; Gokakin, Ali Kagan; Deveci, Koksal; Atabey, Mustafa; Topcu, Omer

    2016-01-01

    BACKGROUND: Oxidative stress is a complicated process, which was defined as an increase in prooxidants and decrease in antioxidants caused by various mechanisms, including inflammation and surgical trauma. The association between acute appendicitis and oxidative stress has been showed in previous studies. However, comparison of oxidative stress in laparoscopic or open appendectomy (OA) has not been established. PATIENTS AND METHODS: Patients who were diagnosed as acute appendicitis between October 2012 and January 2013 were randomized to open (OA, n = 50) and laparoscopic appendectomy (LA, n = 50). Blood samples for oxidative stress markers (total oxidant status [TOS] and total antioxidant status [TAS]), C-reactive protein (CRP) and white blood cells (WBC’s) were collected just before the surgery and 24 h after surgery. RESULTS: There were no differences in preoperative values of WBC and CRP between LA and OA groups (P = 0.523 and 0.424), however, in postoperative 24th h, CRP was reduced in LA group (P = 0.031). There were no differences in preoperative levels of TOS, TAS, and oxidative stress index (OSI) between LA and OA groups. In the postoperative 24th h, TOS and OSI were found to be significantly higher in OA group when compared to LA group (P = 0.017 and 0.002) whereas no difference was detected in TAS level in the postoperative 24th h (P = 0.172). CONCLUSIONS: This double-blind, randomized clinical trial provides evidence that LA for uncomplicated appendicitis is associated with significantly lower oxidative stress compared with OA. Some of the advantages of LA may be attributed to the significant reduction of oxidative stress in these patients. PMID:27073307

  7. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2016-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14-65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood. PMID:26870678

  8. Pain modulation by intranasal oxytocin and emotional picture viewing - a randomized double-blind fMRI study.

    PubMed

    Zunhammer, Matthias; Geis, Sandra; Busch, Volker; Eichhammer, Peter; Greenlee, Mark W

    2016-01-01

    The hormone oxytocin has been hypothesized to influence the emotional dimension of pain. This randomized, placebo-controlled, double-blind, crossover study explored whether intranasal oxytocin and emotional context can affect heat pain perception in 30 healthy male volunteers. After receiving 36 IU oxytocin or placebo, participants underwent functional Magnetic Resonance Imaging (fMRI) during which noxious and non-noxious thermode heat stimuli were applied. Simultaneously, scenes from the International Affective Pictures System (IAPS) with positive, neutral, and negative emotional valence were shown. Heat intensity and unpleasantness ratings were obtained. The activity of whole-brain correlates of heat processing was quantified via multi-voxel pattern analysis. We observed no appreciable main effects of oxytocin on ratings or neural pain correlates. Effects of emotional picture valence on ratings were smaller than reported in previous studies. Nevertheless, oxytocin was found to significantly enhance the influence of picture valence on unpleasantness ratings at noxious heat levels. No corresponding changes in whole-brain correlates of heat intensity processing were found. Our study provides evidence that intranasal oxytocin increases the effects of emotional context on the subjective unpleasantness of experimental heat pain. Future studies are needed to determine whether this effect can be utilized in clinical settings. PMID:27546446

  9. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial

    PubMed Central

    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant changes after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean of MDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeks of intervention (p<0.001). Conclusion: Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis.

  10. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone.

    PubMed

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-06-01

    Antidepressant medication is often associated with sexual side effects. A double-blind, placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin (5-HT) reuptake inhibitors--paroxetine and sertraline--and the 5-HT2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate. Forty-eight men with an intravaginal ejaculation latency time (IELT) of a maximum of 1 minute were randomly assigned to receive paroxetine (20 mg/day), sertraline (50 mg/day), nefazodone (400 mg/day), or placebo for 6 weeks. During the 1-month baseline and 6-week treatment period, IELTs were measured at home with a stopwatch. The trial was completed by 40 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was stable at approximately 20 seconds. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.002); the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds, respectively, compared with 28 seconds in the nefazodone group. The paroxetine and sertraline groups differed significantly (p < 0.001 and p = 0.024, respectively) from placebo, but the nefazodone group did not (p = 0.85). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, whereas sertraline delayed it only moderately. There was no clinically relevant delay in ejaculation with nefazodone.

  11. Randomized, double-blinded comparison of tropisetron and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy.

    PubMed

    Madenoglu, Halit; Yildiz, Karamehmet; Dogru, Kudret; Kurtsoy, Ali; Güler, Gülen; Boyaci, Adem

    2003-04-01

    This prospective, randomized, placebo-controlled, double-blinded study was designed to evaluate the efficacy of tropisetron in preventing postoperative nausea and vomiting after elective supratentorial craniotomy in adult patients. We studied 65 ASA physical status I-III patients aged 18 to 76 years who were undergoing elective craniotomy for resection of various supratentorial tumors. Patients were divided into two groups and received either 2 mg of tropisetron (group T) or saline placebo (group P) intravenously at the time of dural closure. A standard general anesthetic technique was used. Episodes of nausea and vomiting and the need for rescue antiemetic medication were recorded during 24 hours postoperatively. Demographic data, duration of surgery and anesthesia, and sedation scores were comparable in both groups. Nausea occurred in 30% of group T patients and in 46.7% of group P patients (P >.05). The incidence of emetic episodes was 26.7% and 56.7% in the two groups (P <.05). Rescue antiemetic medication was needed in 26.7% and 60% of the patients (P <.05). Administration of a single dose of tropisetron (2 mg intravenously) given at the time of dural closure was effective in reducing postoperative nausea and vomiting after elective craniotomy for supratentorial tumor resection in adult patients. PMID:12657991

  12. Randomized, double-blind, 3-month parallel study of the effects of pramipexole, pergolide, and placebo on Parkinsonian tremor.

    PubMed

    Navan, Prithiva; Findley, Leslie J; Jeffs, Jim A R; Pearce, Ronald K B; Bain, Peter G

    2003-11-01

    We compared the antitremor effect of pramipexole, pergolide, or placebo in Parkinson's disease (PD). A double-blind, randomly controlled, parallel protocol was deployed to examine the effects of placebo, pergolide, and pramipexole [doses escalated to 1.5 mg three times daily (t.i.d.) over 3 months] on a compound Tremor Index (TI) and Unified Parkinson's Disease Rating Scale (UPDRS) part III. Thirty PD patients (19 men, 11 women; mean age 69 years, range 54-80 years; mean disease duration 3.9 years, range, 0.5-10 years) participated in the study, with 10 patients in each arm. Six subjects failed to complete the study (4 on pergolide and 2 on placebo). Analysis of covariance demonstrated strong evidence for a treatment effect on both TI and UPDRS III. There was no significant difference between the active treatments on either TI or UPDRS III. Both pergolide and pramipexole were significantly better than placebo. The results indicate that pergolide and pramipexole (1.5 mg t.i.d.) have similar anti-PD tremor and UPDRS III actions that are significantly superior to placebo. Patients on pergolide were more likely to drop out because of adverse events than those on pramipexole.

  13. Dairy proteins and the response to pneumovax in senior citizens: a randomized, double-blind, placebo-controlled pilot study.

    PubMed

    Freeman, Samara L; Fisher, Laura; German, J Bruce; Leung, Patrick S; Prince, Harry; Selmi, Carlo; Naguwa, Stanley M; Gershwin, M Eric

    2010-03-01

    With the progressive aging of the world's population, immunosenescence is rapidly becoming a clinical concern as it accounts for a higher incidence of severe infections and poor response to vaccines. To identify nutritional approaches that may counteract immunosenescence is of obvious importance in clinical practice. Dairy products in general and whey proteins in particular share the capacity to stimulate the immune system within the digestive tract while the antibody response to Streptococcus pneumoniae vaccine is a good marker of the immune function. We performed a controlled, randomized, double-blind pilot study to determine if an eight-week supplementation with whey protein (or soy protein used as control) could enhance the serum response to pneumococcal vaccine in healthy senior citizens. Out of 127 volunteers, 17 subjects were eligible and completed the study receiving the vaccine after four weeks of supplementation. Antibody levels were measured at baseline and the end of the study against 14 pneumococcal types and a detailed nutritional questionnaire was administered to all subjects. Subjects receiving whey protein manifested a serum response higher compared to the control soy supplementation against 12/14 bacterial types. In particular, whey led to a higher frequency of response to all four more virulent types (4, 9, 14, and 23). Calorie and protein intake data suggest a better nutritional status in the whey group. Whey protein supplementation is a promising supplement to stimulate the immune response to vaccine in senior citizens and possibly to counteract immunosenescence while larger studies are warranted.

  14. Pain modulation by intranasal oxytocin and emotional picture viewing — a randomized double-blind fMRI study

    PubMed Central

    Zunhammer, Matthias; Geis, Sandra; Busch, Volker; Eichhammer, Peter; Greenlee, Mark W.

    2016-01-01

    The hormone oxytocin has been hypothesized to influence the emotional dimension of pain. This randomized, placebo-controlled, double-blind, crossover study explored whether intranasal oxytocin and emotional context can affect heat pain perception in 30 healthy male volunteers. After receiving 36 IU oxytocin or placebo, participants underwent functional Magnetic Resonance Imaging (fMRI) during which noxious and non-noxious thermode heat stimuli were applied. Simultaneously, scenes from the International Affective Pictures System (IAPS) with positive, neutral, and negative emotional valence were shown. Heat intensity and unpleasantness ratings were obtained. The activity of whole-brain correlates of heat processing was quantified via multi-voxel pattern analysis. We observed no appreciable main effects of oxytocin on ratings or neural pain correlates. Effects of emotional picture valence on ratings were smaller than reported in previous studies. Nevertheless, oxytocin was found to significantly enhance the influence of picture valence on unpleasantness ratings at noxious heat levels. No corresponding changes in whole-brain correlates of heat intensity processing were found. Our study provides evidence that intranasal oxytocin increases the effects of emotional context on the subjective unpleasantness of experimental heat pain. Future studies are needed to determine whether this effect can be utilized in clinical settings. PMID:27546446

  15. Effect of a mangosteen dietary supplement on human immune function: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Tang, Yu-Ping; Li, Peng-Gao; Kondo, Miwako; Ji, Hong-Ping; Kou, Yan; Ou, Boxin

    2009-08-01

    The effect of a mangosteen product containing multivitamins and essential minerals was tested on immune function and well-being in healthy adults. A randomized, double blinded, placebo-controlled study was conducted in 59 healthy human subjects (40-60 years old). Changes from baseline immune function were measured after a 30-day consumption of the mangosteen product and the placebo. The subjects' self-appraisal of their health status was also surveyed. A xanthone-rich mangosteen product intake increased mean values for peripheral T-helper cell frequency (P = .020) and reduced the serum C-reactive protein concentration (P = .014). Increases in peripheral CD4/CD8 double-positive (DP) T-cell frequency and serum complement C3, C4, and interleukin (IL)-1alpha concentrations were significantly higher in the experimental group than in the placebo group (DP, P = .038; C3, P = .017; C4, P = .031; IL-1alpha, P = .006). At the end of study, serum IL-1alpha and IL-1beta concentrations in the study group were significantly higher than that in the placebo group (IL-1alpha, P = .033; IL-1beta, P = .04). Furthermore, more participants in the experimental group reported greatly improved overall health status compared with participants receiving placebo (P = .001). The results indicated that the intake of an antioxidant-rich product significantly enhanced immune responses and improved the subject's self-appraisal on his or her overall health status.

  16. Randomized placebo-controlled, single blind trial of holy basil leaves in patients with noninsulin-dependent diabetes mellitus.

    PubMed

    Agrawal, P; Rai, V; Singh, R B

    1996-09-01

    Experimental studies on albino rats reported that leaf extract of Ocimum sanctum and Ocimum album (holy basil) had hypoglycemic effect. To explore further evidence we studied the effects of treatment with holy basil leaves on fasting and postprandial blood glucose and serum cholesterol levels in humans through randomized, placebo-controlled, crossover single blind trial. Results indicated a significant decrease in fasting and postprandial blood glucose levels during treatment with holy basil leaves compared to during treatment with placebo leaves. Fasting blood glucose fell by 21.0 mg/dl, confidence interval of difference -31.4 - (-)11.2 (p < 0.001), and postprandial blood glucose fell by 15.8 mg/dl, confidence interval -27.0 - (-)5.6 (p < 0.02). The lower values of glucose represented reductions of 17.6% and 7.3% in the levels of fasting and postprandial blood glucose, respectively. Urine glucose levels showed similar trend. Mean total cholesterol levels showed mild reduction during basil treatment period. The findings from this study suggest that basil leaves may be prescribed as adjunct to dietary therapy and drug treatment in mild to moderate NIDDM. PMID:8880292

  17. Memantine as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Ghaleiha, Ali; Asadabadi, Mahtab; Mohammadi, Mohammad-Reza; Shahei, Maryam; Tabrizi, Mina; Hajiaghaee, Reza; Hassanzadeh, Elmira; Akhondzadeh, Shahin

    2013-05-01

    Autism is a neurodevelopmental disorder that causes significant impairment in socialization and communication. It is also associated with ritualistic and stereotypical behaviour. Recent studies propose both hyper-and hypoglutamatergic ideologies for autism. The objective of this study was to assess the effects of memantine plus risperidone in the treatment of children with autism. Children with autism were randomly allocated to risperidone plus memantine or placebo plus risperidone for a 10-wk, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 3 mg/d and memantine was titrated to 20 mg/d. Children were assessed at baseline and after 2, 4, 6, 8 and 10 wk of starting medication protocol. The primary outcome measure was the irritability subscale of Aberrant Behavior Checklist-Community (ABC-C). Difference between the two treatment arms was significant as the group that received memantine had greater reduction in ABC-C subscale scores for irritability, stereotypic behaviour and hyperactivity. Eight side-effects were observed over the trial, out of the 25 side-effects that the checklist included. The difference between the two groups in the frequency of side-effects was not significant. The present study suggests that memantine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated. This trial is registered with the Iranian Clinical Trials Registry (IRCT1138901151556N10; www.irct.ir).

  18. Deep mineral water accelerates recovery after dehydrating aerobic exercise: a randomized, double-blind, placebo-controlled crossover study

    PubMed Central

    2014-01-01

    Background The effect of deep mineral water (DMW) with moderate mineralization on the recovery of physical performance after prolonged dehydrating aerobic exercise in the heat was studied in nine healthy, physically active (VO2max = 45.8 ± 8.4 mL kg−1 min−1) women aged 24.0 ± 3.7 years. Methods We conducted a randomized, double-blind, placebo-controlled crossover human study to evaluate the effect of ingestion of natural mineral water extracted from a depth of 689 m on recovery from prolonged fatiguing aerobic running conducted at 30°C. Results Mean body weight decreased by 2.6–2.8% following dehydrating exercise. VO2max was 9% higher after 4 h of recovery after rehydrating with DMW compared with plain water. Leg muscle power recovered better during the slow phase of recovery and was significantly higher after 48 h of recovery after rehydrating with DMW compared with plain water. Conclusions DMW with moderate mineralization was more effective in inducing recovery of aerobic capacity and leg muscle power compared with plain water following prolonged dehydrating aerobic running exercise. PMID:25002835

  19. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

    PubMed Central

    COELHO-DE-SOUZA, Fábio Herrmann; CAMARGO, Junara Cristina; BESKOW, Tiago; BALESTRIN, Matheus Dalmolin; KLEIN-JÚNIOR, Celso Afonso; DEMARCO, Flávio Fernando

    2012-01-01

    Objective This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. Material and Methods Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint) and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond) and composite resin (Filtek P60). A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa), according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p<0.05). Results Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05) than butt joint restorations. Conclusions It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities. PMID:22666833

  20. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone.

    PubMed

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-06-01

    Antidepressant medication is often associated with sexual side effects. A double-blind, placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin (5-HT) reuptake inhibitors--paroxetine and sertraline--and the 5-HT2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate. Forty-eight men with an intravaginal ejaculation latency time (IELT) of a maximum of 1 minute were randomly assigned to receive paroxetine (20 mg/day), sertraline (50 mg/day), nefazodone (400 mg/day), or placebo for 6 weeks. During the 1-month baseline and 6-week treatment period, IELTs were measured at home with a stopwatch. The trial was completed by 40 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was stable at approximately 20 seconds. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.002); the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds, respectively, compared with 28 seconds in the nefazodone group. The paroxetine and sertraline groups differed significantly (p < 0.001 and p = 0.024, respectively) from placebo, but the nefazodone group did not (p = 0.85). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, whereas sertraline delayed it only moderately. There was no clinically relevant delay in ejaculation with nefazodone. PMID:11386492

  1. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2016-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14-65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood.

  2. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2015-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14–65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood. PMID:26870678

  3. Early postoperative treatment of thyroidectomy scars using botulinum toxin: a split-scar, double-blind randomized controlled trial.

    PubMed

    Kim, Youn Sung; Lee, Hyun Joo; Cho, Sang Hyun; Lee, Jeong Deuk; Kim, Hei Sung

    2014-01-01

    Operational scars, especially those located on the exposed parts of the body, can be distressing. Despite high demand for an early intervention to minimize surgical scars, there is yet no universal consensus on optimal treatment. A split-scar, double-blind randomized controlled trial was held to assess the safety and efficacy of early postoperative botulinum toxin type A (BTA) injection in surgical scars. A single session of treatment was performed where BTA was allocated to one half of the scar and 0.9% saline to the control half. Scars were assessed using the modified Stony Brook Scar Evaluation Scale (SBSES) with standardized photographs. Fifteen patients completed the study, and their data were analyzed. At 6 months' follow-up, a significant improvement in SBSES score was noted for the BTA-treated halves of the scars (p < 0.001), with minimal change on the saline-treated side (p = 0.785). The mean calculated difference in SBSES scores (final/initial) between the BTA-treated side and the saline-treated side was also significant (p < 0.001). Early postoperative BTA injection was safe and effective in modulating thyroidectomy scars and may be a promising option for scar prevention.

  4. Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: Remission Analysis Following a Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Pearlstein, Teri B.; Bellew, Kevin M.; Endicott, Jean; Steiner, Meir

    2005-01-01

    Objective: To compare the efficacy and safety of paroxetine controlled release (CR) (12.5 mg/day or 25 mg/day) versus placebo in premenstrual dysphoric disorder (PMDD). Method: A double-blind, randomized, placebo-controlled trial was conducted over 3 menstrual cycles in women aged 18–45 years with confirmed DSM-IV PMDD in 47 outpatient centers across the United States and Canada from November 1999 to January 2002. The primary efficacy measure was the visual analog scale (VAS)-Mood, which is the mean of 4 core symptoms: irritability, tension, depressed mood, and affective lability. Results: A statistically significant difference was observed in favor of paroxetine CR 25 mg versus placebo on the VAS-Mood (adjusted mean difference = −12.58 mm, 95% CI = −18.40 to −6.76; p < .001) and for paroxetine CR 12.5 mg versus placebo (adjusted mean difference = −7.51 mm, 95% CI = −13.40 to −1.62; p = .013). Paroxetine CR was generally well tolerated. Conclusion: Paroxetine CR doses of 12.5 mg/day and 25 mg/day are effective in treating PMDD and are well tolerated. PMID:15841196

  5. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial

    PubMed Central

    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant changes after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean of MDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeks of intervention (p<0.001). Conclusion: Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis. PMID:27683642

  6. A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers.

    PubMed

    Bishop, J B; Phillips, L G; Mustoe, T A; VanderZee, A J; Wiersema, L; Roach, D E; Heggers, J P; Hill, D P; Taylor, E L; Robson, M C

    1992-08-01

    Chronic wounds such as venous stasis ulcers have become a socioeconomic problem. Even with successful initial management, the recurrence rate approaches 70%. With the advent of new wound healing agents, nonoperative attempts to heal these wounds appear indicated. This study reports a prospective randomized evaluator-blinded trial comparing two potential wound healing agents to an inert vehicle placebo. Eighty-six evaluable patients completed the trial. Silver sulfadiazine 1% in a cream proved to statistically reduce the ulcer size compared with a biologically active tripeptide copper complex 0.4% cream formulation or the placebo. There was no difference between the latter two treatments. Silver sulfadiazine has been shown to allow keratinocyte replication and to have antiinflammatory properties. In this trial its antibacterial action was not used since all ulcers had comparable bacterial levels (less than or equal to 10(5)/gm of tissue) before treatment. These results suggest that the silver sulfadiazine cream used in this study may facilitate healing in wounds healing largely by the process of epithelialization. PMID:1495150

  7. Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease

    PubMed Central

    Carrasco, Anna; Ibarra, Montserrat; Temiño, Rocío; Salas, Antonio; Esteve, Maria

    2016-01-01

    Background The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned. Aim To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS), which presented with lymphocytic enteritis, positive celiac genetics and negative celiac serology. Methods Double-blind randomized clinical trial of gluten vs placebo rechallenge. Inclusion criteria: >18 years of age, HLA-DQ2/8+, negative coeliac serology and gluten-dependent lymphocytic enteritis, and GI symptoms, with clinical and histological remission at inclusion. Eighteen patients were randomised: 11 gluten (20 g/day) and 7 placebo. Clinical symptoms, quality of life (GIQLI), and presence of gamma/delta+ cells and transglutaminase deposits were evaluated. Results 91% of patients had clinical relapse during gluten challenge versus 28.5% after placebo (p = 0.01). Clinical scores and GIQLI worsened after gluten but not after placebo (p<0.01). The presence of coeliac tissue markers at baseline biopsy on a gluten-free diet allowed classifying 9 out of the 18 (50%) patients as having probable ‘coeliac lite’ disease. Conclusion This proof-of-concept study indicates that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for NCGS. They were characterized by positive celiac genetics, lymphocytic enteritis, and clinical and histological remission after a gluten-free diet. Trial Registration ClinicalTrials.gov NCT02472704 PMID:27392045

  8. A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee.

    PubMed

    Vishal, Amar A; Mishra, Artatrana; Raychaudhuri, Siba P

    2011-01-01

    Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin(®) and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin(®) in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin(®) or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA. PMID:22022214

  9. Community-Based Randomized Double-Blind Study of Gastrointestinal Effects and Copper Exposure in Drinking Water

    PubMed Central

    Araya, Magdalena; Olivares, Manuel; Pizarro, Fernando; Llanos, Adolfo; Figueroa, Guillermo; Uauy, Ricardo

    2004-01-01

    We assessed gastrointestinal effects in 1,365 adults exposed to either < 0.01 (controls), 2, 4, or 6 mg copper/L of drinking water for 2 months in a randomized, double-blind community-based study. The risk of symptoms increased with increasing Cu exposure and decreased with time. The best model by counting-process analysis included Cu concentration and sex. The risk of symptoms remained significantly higher in women than in men during weeks 1–4 for all concentrations tested; at week 1 comparison with the < 0.01-mg/L group showed that differences became significant in women at 4 mg/L [relative risk (RR) = 1.53; 95% confidence interval (CI), 1.02–2.05), and in men at 6 mg/L (RR = 1.9; 95% CI, 1.02–2.79). At week 2 for men and week 4 in women, the Cu concentration required to obtain significant differences on symptom report was > 6 mg Cu/L. We conclude that exposure to Cu in drinking water results in gastrointestinal symptoms, which are modulated by Cu concentration, time, and sex. PMID:15238279

  10. Local blanching after epicutaneous application of EMLA cream. A double-blind randomized study among 50 healthy volunteers.

    PubMed

    Villada, G; Zetlaoui, J; Revuz, J

    1990-01-01

    EMLA cream is a topical formulation based upon the eutectic mixture of lidocaine and prilocaine and is used in clinical settings to produce local analgesia after application under occlusive dressing. A blanching reaction has been reported to occur locally after application, but it is not clear whether this reaction is caused by the anesthetic mixture, by the vehicle or the occlusion. We studied this blanching reaction in 50 healthy volunteers in a double-blind randomized assay: EMLA versus placebo, under occlusive dressing for 1 h, each subject being his own control. We found 33 cases (66%) of blanching after application of EMLA cream versus 3 cases (6%) after placebo, this difference being highly significant. Blanching was observed without delay, after removal of the dressing, and was very transient, disappearing in less than 3 h in all cases. We thus conclude that the blanching reaction is (1) frequent but very transient, and (2) determined by the anesthetic mixture included in EMLA cream and not by the vehicle alone, nor by the occlusion, since it is not found with the placebo. The precise mechanism of this reaction is unknown.

  11. Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

    PubMed Central

    Udani, Jay K

    2013-01-01

    Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35–65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood. PMID:24371452

  12. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial.

    PubMed

    de Paula, E A; Kossatz, S; Fernandes, D; Loguercio, A D; Reis, A

    2014-01-01

    This study evaluated the effect of ascorbic acid, 500 mg every eight hours, on bleaching-induced tooth sensitivity. A triple-blind, parallel design, and placebo-controlled randomized clinical trial was conducted on 39 adults. The pills (placebo or ascorbic acid) were administered three times per day for 48 hours; the first dose was given one hour prior to each bleaching session. Two bleaching sessions with 35% hydrogen peroxide gel were performed with a one-week interval. Tooth sensitivity was recorded up to 48 hours after bleaching. The color evaluation was performed before and 30 days after bleaching. The absolute risk and intensity of tooth sensitivity were evaluated by Fisher exact and Mann-Whitney U-tests, respectively. Color changes were evaluated by unpaired t-test (α=0.05). There were no significant differences in the absolute risk and intensity of tooth sensitivity and color change between the groups. Both groups showed a similar risk of tooth sensitivity (p>0.05). The perioperative use of an antioxidant, such as ascorbic acid (500 mg, three times daily) perorally, was not able to prevent bleaching-induced tooth sensitivity or reduce its intensity. PMID:23802640

  13. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial.

    PubMed

    Esmaeilzadeh, Hossein; Nabavi, Mohammad; Aryan, Zahra; Arshi, Saba; Bemanian, Mohammad Hassan; Fallahpour, Morteza; Mortazavi, Negar

    2015-10-01

    The effect of aspirin desensitization (AD) on immunologic profile of patients with AERD has been poorly understood. This study is aimed at investigating the effect of AD on clinical and immunological markers of patients with AERD. This randomized double-blind placebo-controlled trial comprised 34 adult patients (67.6% female) with chronic rhinosinusitis, nasal polyps, and aspirin-intolerant asthma. The active group underwent AD over a 2-day period with increasing doses of aspirin (60, 125, 325, and 625 mg), followed by receiving aspirin 625 mg twice daily for 6 months. Symptom scores and medication needs of patients with AERD who have undergone AD were significantly lower compared to the placebo group after 6 months (7.5 ± 3.5 vs. 10.6 ± 3.8 and 9.3 ± 2.0 vs. 11.0 ± 3.1, respectively, all p < 0.05). However, no significant difference was observed in serum concentration of IL-10, IFN-γ, and TGF-β between two groups neither at baseline nor at the end of study.

  14. Role of silicone derivative plus onion extract gel in presternal hypertrophic scar protection: a prospective randomized, double blinded, controlled trial.

    PubMed

    Jenwitheesuk, Kamonwan; Surakunprapha, Palakorn; Jenwitheesuk, Kriangsak; Kuptarnond, Chusak; Prathanee, Sompop; Intanoo, Worawit

    2012-08-01

    Use of silicone derivative and onion extract had been reported in the prevention of hypertrophic scarring. Our experience showed the preventive use of silicone derivative plus onion extract gel on hypertrophic scars after median sternotomy. In a randomized, double blinded, placebo-controlled study, 60 patients after median sternotomy incisions were separated into two groups. All patients were treated either with silicone derivative plus onion extract gel (Cybele(®) scagel) or placebo gel twice daily for a total treatment period of 12 weeks. During each visit, pain and itching scores were graded by the patients and scar characteristics were observed by surgeons using the Vancouver scar scale. Pain and itch score values from patients' who applied silicone derivative plus onion extract gel was less than another group (P < 0·05). Pigmentation was significantly different between two groups (P < 0·05) and the reduction of scores on vascularity, pliability, height in treated group was not superior to the untreated group. No adverse events were reported by any of the patients. A silicone derivative plus onion extract gel is safe and effective for the preventing the hypertrophic scarring after median sternotomy. PMID:22168750

  15. SSRI enhances sensitivity to background outcomes and modulates response rates: A randomized double blind study of instrumental action and depression.

    PubMed

    Msetfi, Rachel M; Kumar, Poornima; Harmer, Catherine J; Murphy, Robin A

    2016-05-01

    Serotonin reuptake inhibitors (SSRIs) have immediate effects on synaptic levels of serotonin but their therapeutic effects are often delayed. This delay has been suggested to reflect time required for new learning and therefore that SSRIs might be having effects on the learning process. We examined the effects of elevating serotonin levels, through short-term SSRI administration (escitalopram), on learning about perceptions of instrumental control. A randomised double blind procedure was used to allocate healthy people, categorised as mildly depressed (high BDI⩾10: n=76) or not depressed (low BDI⩽5: n=78) to either a drug (escitalopram, 10mg/7days) or placebo control group. Following treatment, participants were trained with a simple task that involved learning the effectiveness of an instrumental action (key press) and the background context at eliciting an outcome (auditory cue) where there was no programmed contingency. The effects of the drug were (i) to moderate response rates and (ii) to enhance sensitivity to the background or context rate of occurrence of the outcome. These findings suggest that serotonin modulates learning about the long-term rate of outcomes, which supports perception of instrumental control, and that this may provide a clue to the mechanism for supporting the development of the therapeutic effects of the drug. PMID:26976091

  16. Xylitol pediatric topical oral syrup to prevent dental caries: a double blind, randomized clinical trial of efficacy

    PubMed Central

    Milgrom, Peter; Ly, Kiet A.; Tut, Ohnmar K.; Mancl, Lloyd; Roberts, Marilyn C.; Briand, Kennar; Gancio, Mary Jane

    2009-01-01

    Objective To evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries of very young children. Design Randomized, double-blinded, controlled trial. Setting Communities in the Republic of the Marshall Islands. Participants 108 children aged 9 to 15 months were screened and 100 were enrolled. Intervention Children were randomized and parents administered topical oral xylitol syrup two times (Xyl-2X, two xylitol 4.00 g/dose + one sorbitol dose) or three times (Xyl-3X, three xylitol 2.67 g/dose) per day (total 8 g) or control (one xylitol 2.67 g/dose + two sorbitol dose). Outcome Measures The outcome end-point of the study was the number of decayed primary teeth. Results Ninety-four of 100 children (mean±SD age, 15.0±2.7 months at randomization) with at least one follow-up exam were included in the intent-to-treat analysis. The mean±SD follow-up period was 10.5±2.2 months. Nearly 52% of children in the control condition had tooth decay compared to 40.6% among Xyl-3X and 24.2% among Xyl-2X conditions. The mean±SD number of decayed teeth was 1.9±2.4 for control, 1.0±1.4 for Xyl-3X, and 0.6±1.1 for Xyl-2X condition. Compared to controls, there was significantly fewer decayed teeth in the Xyl-2X (relative risk [RR], 0.30; 95% confidence interval [CI] 0.13, 0.66; P=.003) and Xyl-3X (RR, 0.50; 95% CI 0.26, 0.96; P=0.037) conditions. There was no statistical difference between the two xylitol treatment conditions (P=0.22). Conclusion Oral xylitol syrup administered topically two or three times each day at a total dose of 8 g was effective in preventing Early Childhood Caries. PMID:19581542

  17. The VITAH Trial Vitamin D supplementation and cardiac autonomic tone in hemodialysis: a blinded, randomized controlled trial

    PubMed Central

    2014-01-01

    Background Patients with end-stage kidney disease (ESKD) have a high rate of mortality and specifically an increased risk of sudden cardiac death (SCD). Impaired cardiac autonomic tone is associated with elevated risk of SCD. Moreover, patients with ESKD are often vitamin D deficient, which we have shown may be linked to autonomic dysfunction in humans. To date, it is not known whether vitamin D supplementation normalizes cardiac autonomic function in the high-risk ESKD population. The VITamin D supplementation and cardiac Autonomic tone in Hemodialysis (VITAH) randomized trial will determine whether intensive vitamin D supplementation therapies improve cardiac autonomic tone to a greater extent than conventional vitamin D supplementation regimens in ESKD patients requiring chronic hemodialysis. Methods/Design A total of 60 subjects with ESKD requiring thrice weekly chronic hemodialysis will be enrolled in this 2x2 crossover, blinded, randomized controlled trial. Following a 4-week washout period from any prior vitamin D therapy, subjects are randomized 1:1 to intensive versus standard vitamin D therapy for 6 weeks, followed by a 12-week washout period, and finally the remaining treatment arm for 6 weeks. Intensive vitamin D treatment includes alfacalcidiol (activated vitamin D) 0.25mcg orally with each dialysis session combined with ergocalciferol (nutritional vitamin D) 50 000 IU orally once per week and placebo the remaining two dialysis days for 6 weeks. The standard vitamin D treatment includes alfacalcidiol 0.25mcg orally combined with placebo each dialysis session per week for 6 weeks. Cardiac autonomic tone is measured via 24 h Holter monitor assessments on the first dialysis day of the week every 6 weeks throughout the study period. The primary outcome is change in the low frequency: high frequency heart rate variability (HRV) ratio during the first 12 h of the Holter recording at 6 weeks versus baseline. Secondary outcomes include additional

  18. Butorphanol suppresses fentanyl-induced cough during general anesthesia induction: A randomized, double-blinded, placebo-controlled clinical trial.

    PubMed

    Cheng, Xiao-Yan; Lun, Xiao-Qin; Li, Hong-Bo; Zhang, Zhi-Jie

    2016-06-01

    Fentanyl-induced cough (FIC) is unwanted in the patients requiring stable induction of general anesthesia. This study was designed to evaluate the suppressive effects of butorphanol pretreatment on the incidence and severity of FIC during the induction of general anesthesia. A total of 315 patients of American Society of Anesthesiologists physical status I and II, scheduled for elective surgery under general anesthesia were randomized into 3 equally sized groups (n = 0105). Two minutes before fentanyl bolus, group I received intravenously 5 mL normal saline, groups II and III received butorphanol 0.015 and 0.03 mg/kg (diluted with saline to 5 mL), respectively. Patients were then administrated with fentanyl 2.5 μg/kg within 5 s. The incidence and severity of FIC was recorded for 2 minutes after fentanyl bolus. During experimental period, the mean arterial pressure, heart rate, and peripheral capillary oxygen saturation (SpO2) were recorded before the administration of butorphanol or normal saline (T0), 2 minutes (T1) after butorphanol injection, and 2 minutes (T2) after fentanyl injection. The incidence of FIC was 31.4% in group I, 11.4% in group II, and 3.8% in group III. Group III had a lowest incidence of FIC among 3 groups (P < 0.001, vs group I; P < 0.05, vs group II). The severe FIC was not observed in groups II and III, but was recoded from 6 patients in group I. At 2 minutes after fentanyl injection (T2), the mean arterial pressure was significantly higher in group I than that in groups II and III (P < 0.01, vs group II; P < 0.05, vs group III), but the values remained within safe limits. In conclusion, pretreatment with butorphanol could effectively and safely suppress FIC during anesthesia induction. PMID:27367987

  19. Randomized Phase II Trial of Lyophilized Strawberries in Patients with Dysplastic Precancerous Lesions of the Esophagus

    PubMed Central

    Chen, Tong; Yan, Fei; Qian, Jiaming; Guo, Mingzhou; Zhang, Hongbing; Tang, Xiaofei; Chen, Fang; Stoner, Gary D.; Wang, Xiaomin

    2016-01-01

    Dysplasia is a histologic precursor of esophageal squamous cell carcinoma (SCC). We previously showed that dietary freeze-dried, or lyophilized, strawberry powder inhibits N-nitrosomethylbenzylamine-induced SCC in the rat esophagus. On the basis of this observation, we conducted a randomized (noncomparative) phase II trial in China to investigate the effects of two doses of freeze-dried strawberries in patients with esophageal dysplastic lesions in a high-risk area for esophageal cancer. We randomly assigned 75 patients identified by endoscopy to have dysplastic esophageal premalignant lesions to receive freeze-dried strawberry powder at either 30 g/d (37 patients) or 60 g/d (38 patients) for six months; the powder was mixed with water and drunk. After six months, we assessed the changes in histologic grade of these lesions (primary endpoint) in a blinded fashion. The dose of 30 g/d, did not significantly affect histology or any other measured parameter. The dose of 60 g/d, however, reduced the histologic grade of dysplastic premalignant lesions in 29 (80.6%) of the 36 patients at this dose who were evaluated for histology (P < 0.0001). The strawberry powder was well tolerated, with no toxic effects or serious adverse events. Strawberries (60 g/d) also reduced protein expression levels of inducible nitric oxide synthase (iNOS) by 79.5% (P < 0.001), cyclooxygenase-2 (COX-2) by 62.9% (P < 0.001), phospho-nuclear factor kappa B (NFκB)-p65 (pNFκB-p65) by 62.6% (P < 0.001), and phospho-S6 (pS6) by 73.2% (P < 0.001). Freeze-dried strawberries (60 g/d) also significantly inhibited the Ki-67 labeling index by 37.9% (P = 0.023). Our present results indicate the potential of freeze-dried strawberry powder for preventing human esophageal cancer, supporting further clinical testing of this natural agent in this setting. PMID:22135048

  20. The Effect of Intra-Articular Meperidine and Bupivacaine 0.5% on Postoperative Pain of Arthroscopic Knee Surgery; a Randomized Double Blind Clinical Trial

    PubMed Central

    Imani, Farnad; Entezary, Saeidreza; Razi, Mohammad; Jafarian, Ali Akbar; Yousefshahi, Fardin; Etemadi, Hasan; Safari, Saeid

    2015-01-01

    Background: Arthroscopic knee surgeries have a painful postoperative course, which often necessitates acute pain management. Among different analgesia techniques, Intra-articular injection is the technique of choice for many pain specialists, based on its confined effect to the surgical site (knee), lack of systemic effects and promotion of safe early ambulation. Objectives: The aim of this study was to compare analgesic effects of intra-articular meperidine, bupivacaine 0.5% or their combination after knee arthroscopic surgery. Patients and Methods: Sixty ASA class I-II patients’ candidates for arthroscopy knee surgery enrolled in a randomized double blind study to receive either 20 mL of bupivacaine 0.5%; 100 mg meperidine (diluted in normal saline) or bupivacaine 0.5% along with 100 mg meperidine. A written informed consent was obtained from all patients. Postoperative analgesia duration, VAS at 2, 6, 12 and 24 hours, the first analgesic request time, total fentanyl consumption in first 24 hours, patients’ satisfaction and adverse effects were recorded. Results: The bupivacaine-meperidine group had better duration of postoperative analgesia (P = 0.001), latter first analgesic request (P ≤ 0.001), lower total fentanyl consumption in first 24 hours after the operation (P = 0.001), less mean VAS at 2 hours (P = 0.001) and more patients’ overall satisfaction (P = 0.01) compared with each medication alone. VAS at 6, 12 and 24 postoperative hours were not different between the groups of study. No adverse effects were observed. Conclusions: Although postoperative intra-articular meperidine is a better alternative for bupivacaine, their combination could improve their analgesic effects compared with each other alone. PMID:25830119

  1. A randomized, double-blinded comparison of ondansetron, granisetron, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy.

    PubMed

    Jain, Virendra; Mitra, Jayanta K; Rath, Girija P; Prabhakar, Hemanshu; Bithal, Parmod K; Dash, Hari H

    2009-07-01

    Postoperative nausea and vomiting (PONV) are frequent and distressing complications after neurosurgical procedures. We evaluated the efficacy of ondansetron and granisetron to prevent PONV after supratentorial craniotomy. In a randomized double-blind, placebo controlled trial, 90 adult American Society of Anesthesiologists I, II patients were included in the study. A standard anesthesia technique was followed. Patients were divided into 3 groups to receive either placebo (saline), ondansetron 4 mg, or granisetron 1 mg intravenously at the time of dural closure. After extubation, episodes of nausea and vomiting were noted for 24 hours postoperatively. Statistical analysis was performed using chi2 test and 1-way analysis of variance. Demographic data, duration of surgery, intraoperative fluids and analgesic requirement, and postoperative pain (visual analog scale) scores were comparable in all 3 groups. It was observed that the incidence of vomiting in 24 hours, severe emetic episodes, and requirement of rescue antiemetics were less in ondansetron and granisetron groups as compared with placebo (P<0.001). Both the study drugs had comparable effect on vomiting. However, the incidence of nausea was comparable in all 3 groups (P=0.46). A favorable influence on the patient satisfaction scores, and number needed to prevent emesis was seen in the 2 drug groups. No significant correlation was found between neurosurgical factors (presence of midline shift, mass effect, pathologic diagnosis of tumor, site of tumor) and the occurrence of PONV. We conclude that ondansetron 4 mg and granisetron 1 mg are comparably effective at preventing emesis after supratentorial craniotomy. However, neither drugs prevented nausea effectively. PMID:19543000

  2. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction—A Phase III Double Blind, Randomized Clinical Trial

    PubMed Central

    Pereira, Valeria Fontenelle Angelim; Pietrobon, Ricardo S.; Schmidt, Andre P.; Oses, Jean P.; Portela, Luis V.; Souza, Diogo O.; Vissoci, João Ricardo Nickenig; da Luz, Vinicius Fernando; Trintoni, Leticia Maria de Araujo de Souza; Nielsen, Karen C.; Carmona, Maria José Carvalho

    2016-01-01

    Postoperative cognitive dysfunction (POCD) is a multifactorial adverse event most frequently in elderly patients. This study evaluated the effect of dexamethasone on POCD incidence after noncardiac and nonneurologic surgery. METHODS: One hundred and forty patients (ASA I-II; age 60–87 years) took part in a prospective phase III, double blind, randomized study involving the administration or not of 8 mg of IV dexamethasone before general anesthesia under bispectral index (BIS) between 35–45 or 46–55. Neuropsychological tests were applied preoperatively and on the 3rd, 7th, 21st, 90th and 180th days after surgery and compared with normative data. S100β was evaluated before and 12 hours after induction of anesthesia. The generalized estimating equations (GEE) method was applied, followed by the posthoc Bonferroni test considering P<0.05 as significant. RESULTS: On the 3rd postoperative day, POCD was diagnosed in 25.2% and 15.3% of patients receiving dexamethasone, BIS 35–45, and BIS 46–55 groups, respectively. Meanwhile, POCD was present in 68.2% and 27.2% of patients without dexamethasone, BIS 35–45 and BIS 46–55 groups (p<0.0001). Neuropsychological tests showed that dexamethasone associated to BIS 46–55 decreased the incidence of POCD, especially memory and executive function. The administration of dexamethasone might have prevented the postoperative increase in S100β serum levels. CONCLUSION: Dexamethasone can reduce the incidence of POCD in elderly patients undergoing surgery, especially when associated with BIS 46–55. The effect of dexamethasone on S100β might be related with some degree of neuroprotection. Trial Registration: www.clinicaltrials.gov NCT01332812 PMID:27152422

  3. Safety and Tolerability of an Antiasthma Herbal Formula (ASHMI™) in Adult Subjects with Asthma: A Randomized, Double-Blinded, Placebo-Controlled, Dose-Escalation Phase I Study

    PubMed Central

    Kelly-Pieper, Kristin; Patil, Sangita P.; Busse, Paula; Yang, Nan; Sampson, Hugh; Li, Xiu-Min; Kattan, Meyer

    2009-01-01

    Abstract Background Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI™; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China. Objective The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma. Design Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title. Interventions Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study. Outcome measures Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs). Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels. Results Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected. Conclusion In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI. PMID:19586409

  4. Mechanisms Regulating Insulin Response to Intragastric Glucose in Lean and Non-Diabetic Obese Subjects: A Randomized, Double-Blind, Parallel-Group Trial

    PubMed Central

    Meyer-Gerspach, Anne Christin; Cajacob, Lucian; Riva, Daniele; Herzog, Raphael; Drewe, Juergen; Beglinger, Christoph; Wölnerhanssen, Bettina K.

    2016-01-01

    Background/Objectives The changes in blood glucose concentrations that result from an oral glucose challenge are dependent on the rate of gastric emptying, the rate of glucose absorption and the rate of insulin-driven metabolism that include the incretins, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). The rate of insulin-driven metabolism is clearly altered in obese subjects, but it is controversial which of these factors is predominant. We aimed to quantify gastric emptying, plasma insulin, C-peptide, glucagon and glucose responses, as well as incretin hormone secretions in obese subjects and healthy controls during increasing glucose loads. Subjects/Methods The study was conducted as a randomized, double-blind, parallel-group trial in a hospital research unit. A total of 12 normal weight (6 men and 6 women) and 12 non-diabetic obese (BMI > 30, 6 men and 6 women) participants took part in the study. Subjects received intragastric loads of 10 g, 25 g and 75 g glucose dissolved in 300 ml tap water. Results Main outcome measures were plasma GLP-1 and GIP, plasma glucagon, glucose, insulin, C-peptide and gastric emptying. The primary findings are: i) insulin resistance (P < 0.001) and hyperinsulinemia (P < 0.001); ii) decreased insulin disposal (P < 0.001); iii) trend for reduced GLP-1 responses at 75 g glucose; and iv) increased fasting glucagon levels (P < 0.001) in obese subjects. Conclusions It seems that, rather than changes in incretin secretion, fasting hyperglucagonemia and consequent hyperglycemia play a role in reduced disposal of insulin, contributing to hyperinsulinemia and insulin resistance. Trial Registration ClinicalTrials.gov NCT01875575 PMID:26942445

  5. Different doses of intravenous Magnesium sulfate on cardiovascular changes following the laryngoscopy and tracheal intubation: A double-blind randomized controlled trial

    PubMed Central

    Honarmand, Azim; Safavi, Mohammadreza; Badiei, Sajad; Daftari-Fard, Neda

    2015-01-01

    Objective: Laryngoscopy and intratracheal intubation may cause acute hemodynamic instabilities due to catecholamine release. Magnesium sulfate (MgSO4) prevents catecholamine release and results in bradycardia and vasodilatation, so can be used to diminish complications of laryngoscopy and intubation in doses > 50 mg/kg. The aim of this study was to compare the different doses of MgSO4 used to improve cardiovascular instabilities due to laryngoscopy and intratracheal intubation. Methods: In this double-blind randomized controlled trial, 120 patients undergoing elective surgery were divided equally into four groups (n = 30) and received different doses of MgSO4 as case groups (Group I: 30 mg/kg, Group II: 40 mg/kg, Group III: 50 mg/kg) or the equal volume of normal saline as a control group. The patients’ hemodynamic status was recorded at baseline, before laryngoscopy and in 1, 3, 5, and 10 minutes after laryngoscopy. Bradycardia, tachycardia, hypertension, hypotension, ST-T changes, arrhythmias, and duration of extubation and laryngoscopy were also recorded. Findings: There was no significant difference in heart rate between four groups (Pbaseline = 0.46, Ppreoperation = 0.55, P1 min = 0.86, P3 min = 0.30, P5 min = 0.63, P10 min = 0.74). Systolic, diastolic and mean arterial pressures were statistically significant less at 1, 3, and 5 minutes after intubation in comparison with other times of following-up in the three groups received MgSO4 than the control group. Conclusion: The use of MgSO4 in doses less than 50 mg/kg can be effective to reduce cardiovascular instability related to laryngoscopy and tracheal intubation. PMID:25984545

  6. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial.

    PubMed

    Durgam, Suresh; Earley, Willie; Li, Rui; Li, Dayong; Lu, Kaifeng; Laszlovszky, István; Fleischhacker, W Wolfgang; Nasrallah, Henry A

    2016-10-01

    Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3-9mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9mg/d) or placebo for double-blind treatment (up to 72weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n=99) or cariprazine (n=101). Time to relapse was significantly longer in cariprazine- versus placebo-treated patients (P=.0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI]=0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥10% of patients during open-label treatment; there were no cariprazine adverse events ≥10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060.

  7. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial.

    PubMed

    Durgam, Suresh; Earley, Willie; Li, Rui; Li, Dayong; Lu, Kaifeng; Laszlovszky, István; Fleischhacker, W Wolfgang; Nasrallah, Henry A

    2016-10-01

    Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3-9mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9mg/d) or placebo for double-blind treatment (up to 72weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n=99) or cariprazine (n=101). Time to relapse was significantly longer in cariprazine- versus placebo-treated patients (P=.0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI]=0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥10% of patients during open-label treatment; there were no cariprazine adverse events ≥10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. PMID:27427558

  8. Frovatriptan is Effective and Well Tolerated in Korean Migraineurs: A Double-Blind, Randomized, Placebo-Controlled Trial

    PubMed Central

    Moon, Heui-Soo; Chu, Min Kyung; Park, Jeong Wook; Oh, Kyungmi; Chung, Jae Myun; Cho, Yong Jin; Kim, Eung Gyu; Do, Jin Kuk; Jung, Hyong Gi

    2010-01-01

    Background and Purpose Frovatriptan is a selective 5-HT1B/1D agonist with a long duration of action and a low incidence of side effects. Although several placebo-controlled trials have documented the clinical efficacy and safety of frovatriptan in adults with migraine, this drug has not previously been studied in Asian including Korean patients. Methods In this double-blind multicenter trial, 229 patients with migraine were randomized to receive frovatriptan 2.5 mg or placebo upon the occurrence of a moderate-to-severe migraine. The primary outcome was the 2-hour headache response rate. Results Frovatriptan significantly increased the 2-hour headache response rate compared with placebo (52.9% vs. 34.0%, p=0.004). The headache response rates at 4, 6, and 12 hours were significantly higher in the frovatriptan group than in the placebo group, as was the pain-free rate at 2 hours (19.0% vs. 5.7%, p=0.004), 4 hours (40.7% vs. 23.0%, p=0.006), and 6 hours (56.1% vs. 34.0%, p=0.002). The median time to a headache response was significantly shorter in the frovatriptan group than in the placebo group (2.00 hours vs. 3.50 hours, p<0.001). The use of rescue medications was more common in the placebo group (p=0.005). Chest tightness associated with triptan was infrequent (2.5%), mild, and transient. Conclusions These results demonstrate that 2.5-mg frovatriptan is effective and well tolerated in Korean migraineurs for acute treatment of migraine attacks. PMID:20386640

  9. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial.

    PubMed

    Nielsen, Rikke V; Siegel, Hanna; Fomsgaard, Jonna S; Andersen, Johnny D H; Martusevicius, Robertas; Mathiesen, Ole; Dahl, Jørgen B

    2015-12-01

    Glucocorticoids have attracted increasing attention as adjuvants in the treatment of acute postoperative pain. Furthermore, anecdotal reports may support glucocorticoids for preventing sustained postoperative pain. We explored preoperative dexamethasone combined with paracetamol and ibuprofen on acute and sustained pain after lumbar disk surgery. In this blinded study, 160 patients undergoing lumbar disk surgery were randomly assigned to 16 mg IV dexamethasone or placebo. All patients received perioperative paracetamol and ibuprofen, and postoperative IV patient-controlled analgesia with morphine. Primary outcome was pain during mobilization (visual analog scale) 2 to 24 hours postoperatively. Secondary outcomes were acute pain at rest, morphine consumption, nausea, vomiting, ondansetron consumption, sedation, and quality of sleep. Patients were followed up by written questionnaire 3 months postoperatively. Acute pain during mobilization (weighted average area under the curve, 2-24 hours) was significantly reduced in the dexamethasone group: 33 (22) mm vs placebo 43 (18) mm, (95% confidence interval [CI] 3-16) P = 0.005. Vomiting 0 to 24 hours postoperatively was reduced in the dexamethasone group (17 episodes) vs placebo (51 episodes) P = 0.036. No other differences were observed. However, 6.5% (95% CI 2-15) in the dexamethasone group vs placebo 0% had an antibiotically treated wound infection (P = 0.13). Sixteen percent (95% CI 7-26) vs 8% (95% CI 0-17) reported new weakness/paralysis of the legs in the dexamethasone and placebo groups, respectively, 3 months postoperatively (P = 0.20). In conclusion, preoperative dexamethasone significantly reduced pain during mobilization and vomiting, after lumbar disk surgery. No significant effects were observed 3 months postoperatively.

  10. Low and high-frequency TENS in post-episiotomy pain relief: a randomized, double-blind clinical trial

    PubMed Central

    Pitangui, Ana C. R.; Araújo, Rodrigo C.; Bezerra, Michelle J. S.; Ribeiro, Camila O.; Nakano, Ana M. S.

    2014-01-01

    Objective To evaluate the effectiveness of low-frequency TENS (LFT) and high-frequency TENS (HFT) in post-episiotomy pain relief. Method A randomized, controlled, double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain. TENS was applied for 30 minutes to groups: HFT(100 Hz; 100 µs), LFT (5 Hz; 100 µs), and placebo (PT). Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale. The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating. The third and fourth evaluation took place 30 and 60 minutes after TENS removal, only in the resting position. Intragroup differences were verified using the Friedman and Wilcoxon tests, and the intergroup analysis employed the Kruskal-Wallis test. Results In the intragroup analysis, there was no significant difference in the PT during rest, sitting, and ambulation (P>0.05). In the HFT and LFT, a significant difference was observed in all activities (P<0.001). In the intergroup analysis, there was a significant difference in the resting position in the HFT and LFT (P<0.001). In the sitting activity, a significant difference was verified in the second evaluation in the HFT and LFT (P<0.008). No significant difference was verified among the groups in ambulation (P<0.20). Conclusions LFT and HFT are an effective resource that may be included in the routine of maternity wards. PMID:24675915

  11. Effect of tamoxifen on ovarian reserve: A randomized controlled assessor-blind trial in a mouse model

    PubMed Central

    Akduman, Ayşe Topçu; Özerkan, Kemal; Zik, Berrin; Peker, Sabire; Avcı, Berrin; Ata, Barış

    2014-01-01

    Objective To determine whether tamoxifen (TMX) exposure causes a permanent decrease in ovarian reserve. Material and Methods A randomized controlled assessor-blind trial including 30 adult female inbred BALB/C mice. Fifteen mice in the TMX group were given a single 0.1-mg dose of TMX intraperitoneally. Fifteen mice in the control group were given a single dose of the vehicle at the same volume intraperitoneally. Two cycles later, blood samples were collected for determination of anti-Müllerian hormone (AMH) levels, and the mice were sacrificed. After gonadectomy, ovarian size was measured, and follicles were counted under light microscopy. Results Median serum AMH levels were 6.53 and 6.14 ng/ml in the control and TMX groups, respectively (p=0.03). Ovarian size was significantly decreased in the TMX group. While the number of primordial (9 vs 8), primary (6 vs 3), and secondary (4.5 vs 5) follicles were similar, there were significantly fewer preantral (11.5 vs 6, p<0.01) and antral (2 vs 1, p: 0.03) follicles, as well as corpora lutea (6 vs 3, p: 0.04), in the TMX group than in the control group. The number of atretic (2.5 vs 5, p: 0.048) follicles was increased in the TMX group. Conclusion Tamoxifen administration leads to arrested growth of gonadotropin-sensitive follicles, while insensitive follicles can remain unaffected. TMX is merely an endocrine disruptor, and it does not cause a decrease in primordial follicle pool. PMID:25584031

  12. IQP-GC-101 Reduces Body Weight and Body Fat Mass: A Randomized, Double-Blind, Placebo-Controlled Study

    PubMed Central

    Chong, Pee-Win; Beah, Zhi-Ming; Grube, Barbara; Riede, Linda

    2014-01-01

    IQP-GC-101 is a patented blend of the standardized extracts of Garcinia cambogia, Camellia sinensis, unroasted Coffea arabica, and Lagerstroemia speciosa. These individual ingredients of IQP-GC-101 have each shown promise in promoting weight loss; however, the efficacy of the blend has not been established. This randomized, placebo-controlled, double-blind, parallel group study conducted over 14 weeks (including a 2-week run-in phase) aimed to investigate the efficacy and safety of IQP-GC-101 in reducing body weight and body fat mass in overweight Caucasian adults. Subjects took three IQP-GC-101 or placebo tablets, twice a day, 30 min before main meals. All subjects also adhered to a 500 kcal/day energy deficit diet with 30% of energy from fat. Ninety-one overweight and mildly obese subjects (46 in the IQP-GC-101 group, 45 in the placebo group) completed the study. After 12-week intervention, IQP-GC-101 resulted in a mean (±SD) weight loss of 2.26 ± 2.37 kg compared with 0.56 ± 2.34 kg for placebo (pU = 0.002). There was also significantly more reduction in body fat mass, waist circumference, and hip circumference in the IQP-GC-101 group. No serious adverse events were reported. The use of IQP-GC-101 has been shown to result in body weight and body fat reduction in the current study, with good tolerability. © 2014 InQpharm Group Sdn Bhd. Phytotherapy Research published by John Wiley & Sons, Ltd. PMID:24797657

  13. Randomized, double-blind, placebo-controlled trial of spironolactone for hypokalemia in continuous ambulatory peritoneal dialysis patients.

    PubMed

    Yongsiri, Somchai; Thammakumpee, Jiranuch; Prongnamchai, Suriya; Tengpraettanakorn, Pechngam; Chueansuwan, Rachaneeporn; Tangjaturonrasme, Siriporn; Dinchuthai, Pakaphan

    2015-02-01

    The incidence of hypokalemia in continuous ambulatory peritoneal dialysis (CAPD) patients is about 15-60%, leading to significant complications. There is no standard treatment other than potassium supplement in this setting. The aim of this study was to evaluate effect of spironolactone 25 mg/day in CAPD patients who have a history of hypokalemia. This is a randomized, double-blind, placebo-controlled, cross-over study in CAPD patients who had a history of hypokalemia. Study intervention is 4 weeks of oral spironolactone 25 mg/day or placebo, cross-over after a 2-week wash-out period. The primary outcome was the difference of serum potassium before and after 4 weeks of spironolactone treatment. Serum potassium was measured every 2 weeks, serum magnesium, urine and peritoneal fluid potassium measured before and after each treatment period. We enrolled 24 patients, and 20 completed the cross-over study. Ten patients were anuric. The total doses of potassium supplement were the same during the study period. Serum potassium levels before and after study intervention were not significantly different in both groups (4.23 ± 0.64 vs. 3.90 ± 0.59 mEq/L for spironolactone P = 0.077 and 3.84 ± 0.62 vs. 3.91 ± 0.52 for placebo P = 0.551). Total 24-h potassium, magnesium, sodium excretion, urine volume and ultrafiltration volume were not affected by spironolactone or placebo. There was one episode of hyperkalemia (5.6 mEq/L) during the spironolactone treatment period. Spironolactone 25 mg/day does not have a significant effect on serum potassium or urine and peritoneal excretion rate in CAPD patients who have a history of hypokalemia.

  14. A randomized, double-blind, placebo-controlled trial of injected capsaicin for pain in Morton's neuroma.

    PubMed

    Campbell, Claudia M; Diamond, Eric; Schmidt, William K; Kelly, Margaret; Allen, Robert; Houghton, William; Brady, Kerrie L; Campbell, James N

    2016-06-01

    Intermetatarsal neuroma or Morton's neuroma is a painful condition of the foot resulting from an entrapment of the common digital nerve typically in the third intermetatarsal space. The pain can be severe and especially problematic with walking. Treatment options are limited and surgery may lead to permanent numbness in the toes. Capsaicin, the pungent ingredient of hot peppers, produces analgesia by inducing retraction of nociceptive afferents from the area of innervation and is effective in treating certain neuropathic pain disorders. A randomized double-blind placebo-controlled study was conducted to test the efficacy, tolerability, and safety of a single 0.1 mg dose of capsaicin vs placebo injected into the region of the neuroma. A total of 58 subjects diagnosed with Morton's neuroma with foot pain ≥4 (0-10 numerical pain rating scale) were injected with 2 mL of lidocaine into the intermetatarsal space proximal to the neuroma to provide local anesthesia. After 5 minutes, 0.1 mg capsaicin or placebo was injected into the intermetatarsal space containing the painful neuroma. Average foot pain was rated for 2 weeks before through 4 weeks after injection. At weeks 1 and 4, the decrease in pain was significantly greater in the subjects treated with capsaicin (P = 0.021 and P = 0.019, respectively). A trend toward significance was noted at weeks 2 and 3. Improvements in functional interference scores and reductions in oral analgesic use were also seen in the capsaicin-treated group. These findings suggest that injection of capsaicin is an efficacious treatment option for patients with painful intermetatarsal neuroma.

  15. Double-blind randomized trial of risperidone versus divalproex in pediatric bipolar disorder: fMRI outcomes

    PubMed Central

    Pavuluri, Mani N.; Passarotti, Alessandra M.; Lu, Lisa H.; Carbray, Julie A; Sweeney, John A.

    2011-01-01

    To determine the relative effects of risperidone and divalproex on brain function in pediatric mania. This is a double-blind 6-week fMRI trial with 24 unmedicated manic patients randomized to risperidone or divalproex, and 14 healthy controls (HC) matched for IQ and demographic factors (mean age: 13.1±3.3 years). A pediatric affective color matching task, in which subjects matched the color of a positive, negative or neutral word with one of two colored circles, was administered. The primary clinical measure was the Young Mania Rating Scale (YMRS). The risperidone group, relative to HC, showed an increase in activation from pre- to post-treatment in right pregenual and subgenual anterior cingulate cortex and decreased activation in bilateral middle frontal gyrus during the negative condition; and decreased activation in left inferior and medial, and right middle frontal gyri, left inferior parietal lobe, and right striatum with positive condition. In the divalproex group, relative to HC, there was an increased activation in right superior temporal gyrus in the negative condition; and in left medial frontal gyrus and right precuneus with the positive condition. Greater pre-treatment right amygdala activity with negative and positive condition in the risperidone group, and left amygdala activity with positive condition in divalproex group, predicted poor response on YMRS. Risperidone and divalproex yield differential patterns of prefrontal activity during an emotion processing task in pediatric mania. Increased amygdala activity at baseline is a potential biomarker predicting poor treatment response to both the risperidone and divalproex. PMID:21592741

  16. Pregabalin and pain after total knee arthroplasty: a double-blind, randomized, placebo-controlled, multidose trial†

    PubMed Central

    YaDeau, J. T.; Lin, Y.; Mayman, D. J.; Goytizolo, E. A.; Alexiades, M. M.; Padgett, D. E.; Kahn, R. L.; Jules-Elysee, K. M.; Ranawat, A. S.; Bhagat, D. D.; Fields, K. G.; Goon, A. K.; Curren, J.; Westrich, G. H.

    2015-01-01

    Background Pregabalin may reduce postoperative pain and opioid use. Higher doses may be more effective, but may cause sedation and confusion. This prospective, randomized, blinded, placebo-controlled study tested the hypothesis that pregabalin reduces pain at 2 weeks after total knee arthroplasty, but increases drowsiness and confusion. Methods Patients (30 per group) received capsules containing pregabalin (0, 50, 100, or 150 mg); two capsules before surgery, one capsule twice a day until postoperative day (POD) 14, one on POD15, and one on POD16. Multimodal analgesia included femoral nerve block, epidural analgesia, oxycodone–paracetamol, and meloxicam. The primary outcome was pain with flexion (POD14). Results Pregabalin did not reduce pain at rest, with ambulation, or with flexion at 2 weeks (P=0.69, 0.23, and 0.90, respectively). Pregabalin increased POD1 drowsiness (34.5, 37.9, 55.2, and 58.6% in the 0, 50, 100, and 150 mg arms, respectively; P=0.030), but did not increase confusion (0, 3.5, 0, and 3.5%, respectively; P=0.75). Pregabalin had no effect on acute or chronic pain, opioid consumption, or analgesic side-effects. Pregabalin reduced POD14 patient satisfaction [1–10 scale, median (first quartile, third quartile): 9 (8, 10), 8 (7, 10), 8 (5, 9), and 8 (6, 9.3), respectively; P=0.023). Protocol compliance was 63% by POD14 (50.0, 70.0, 76.7, and 56.7% compliance, respectively), with no effect of dose on compliance. Per-protocol analysis of compliant patients showed no effect of pregabalin on pain scores. Conclusions Pregabalin had no beneficial effects, but increased sedation and decreased patient satisfaction. This study does not support routine perioperative pregabalin for total knee arthroplasty patients. Clinical trial registration. ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/study/NCT01333956. PMID:26170351

  17. High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Vial, Pablo A.; Valdivieso, Francisca; Ferres, Marcela; Riquelme, Raul; Rioseco, M. Luisa; Calvo, Mario; Castillo, Constanza; Díaz, Ricardo; Scholz, Luis; Cuiza, Analia; Belmar, Edith; Hernandez, Carla; Martinez, Jessica; Lee, Sang-Joon; Mertz, Gregory J.; Abarca, Juan; Tomicic, Vinko; Aracena, M. Eugenia; Rehbein, Ana Maria; Velásquez, Soledad; Lavin, Victoria; Garrido, Felipe; Godoy, Paula; Martinez, Constanza; Chamorro, Juan Carlos; Contreras, Jorge; Hernandez, Jury; Pino, Marcelo; Villegas, Paola; Zapata, Viviana; León, Marisol; Vega, Ivonne; Otarola, Irisol; Ortega, Carlos; Daube, Elizabeth; Huecha, Doris; Neira, Alda; Ruiz, Ines; Nuñez, M. Antonieta; Monsalve, Luz; Chabouty, Henriette; Riquelme, Lorena; Palma, Samia; Bustos, Raul; Miranda, Ruben; Mardones, Jovita; Hernandez, Nora; Betancur, Yasna; Sanhueza, Ligia; Inostroza, Jaime; Donoso, Solange; Navarrete, Maritza; Acuña, Lily; Manriquez, Paulina; Castillo, Fabiola; Unzueta, Paola; Aguilera, Teresa; Osorio, Carola; Yobanolo, Veronica; Mardones, Jorge; Aranda, Sandra; Carvajal, Soledad; Sandoval, Moisés; Daza, Soraya; Vargas, Felipe; Diaz, Violeta; Riquelme, Mauricio; Muñoz, Miriam; Carriel, Andrea; Lanino, Paola; Hernandez, Susana; Schumacher, Patricia; Yañez, Lia; Marco, Claudia; Ehrenfeld, Mildred; Delgado, Iris; Rios, Susana; Vial, Cecilia; Bedrick, Edward

    2013-01-01

    Background. Andes virus (ANDV)–related hantavirus cardiopulmonary syndrome (HCPS) has a 35% case fatality rate in Chile and no specific treatment. In an immunomodulatory approach, we evaluated the efficacy of intravenous methylprednisolone for HCPS treatment, through a parallel-group, placebo-controlled clinical trial. Methods. Patients aged >2 years, with confirmed or suspected HCPS in cardiopulmonary stage, admitted to any of 13 study sites in Chile, were randomized by study center in blocks of 4 with a 1:1 allocation and assigned through sequentially numbered envelopes to receive placebo or methylprednisolone 16 mg/kg/day (≤1000 mg) for 3 days. All personnel remained blinded except the local pharmacist. Infection was confirmed by immunoglobulin M antibodies or ANDV RNA in blood. The composite primary endpoint was death, partial pressure of arterial oxygen/fraction of inspired oxygen ratio ≤55, cardiac index ≤2.2, or ventricular tachycardia or fibrillation within 28 days. Safety endpoints included the number of serious adverse events (SAEs) and quantification of viral RNA in blood. Analysis was by intention to treat. Results. Infection was confirmed in 60 of 66 (91%) enrollees. Fifteen of 30 placebo-treated patients and 11 of 30 methylprednisolone-treated patients progressed to the primary endpoint (P = .43). We observed no significant difference in mortality between treatment groups (P = .41). There was a trend toward more severe disease in placebo recipients at entry. More subjects in the placebo group experienced SAEs (P = .02). There were no SAEs clearly related to methylprednisolone administration, and methylprednisolone did not increase viral load. Conclusions. Although methylprednisolone appears to be safe, it did not provide significant clinical benefit to patients. Our results do not support the use of methylprednisolone for HCPS. Clinical Trials Registration. NCT00128180. PMID:23784924

  18. Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study

    PubMed Central

    Hernández-Ojeda, Jaime; Román-Pintos, Luis Miguel; Rodríguez-Carrízalez, Adolfo Daniel; Troyo-Sanromán, Rogelio; Cardona-Muñoz, Ernesto Germán; Alatorre-Carranza, María del Pilar; Miranda-Díaz, Alejandra Guillermina

    2014-01-01

    Background Diabetic neuropathy affects 50%–66% of patients with diabetes mellitus. Oxidative stress generates nerve dysfunction by causing segmental demyelinization and axonal degeneration. Antioxidants are considered to be the only etiologic management for diabetic polyneuropathy, and statins such as rosuvastatin increase nitric oxide bioavailability and reduce lipid peroxidation. The aim of this study was to evaluate the antioxidant effect of rosuvastatin in diabetic polyneuropathy. Methods We conducted a randomized, double-blind, placebo-controlled Phase IIa clinical trial in patients with type 2 diabetes and diabetic polyneuropathy (DPN) stage ≥1b. We allocated subjects to two parallel groups (1:1) that received rosuvastatin 20 mg or placebo for 12 weeks. Primary outcomes were neuropathic symptom score, disability score, and nerve conduction studies, and secondary outcomes were glycemic control, lipid and hepatic profile, lipid peroxidation, and nerve growth factor beta (NGF-β) levels. Results Both groups were of similar age and duration since diagnosis of diabetes and DPN. We observed improvement of DPN in the rosuvastatin group from stage 2a (88.2%) to stage 1b (41.2%), improvement of neuropathic symptom score from 4.5±2 to 2.4±1.8, and significant (P=0.001) reductions of peroneal nerve conduction velocity (from 40.8±2.2 to 42.1±1.6 seconds) and lipid peroxidation (from 25.4±2 to 12.2±4.0 nmol/mL), with no significant change in glycemic control or β-NGF. Conclusion The severity, symptoms, and nerve conduction parameters of DPN improved after 12 weeks of treatment with rosuvastatin. These beneficial effects appear to be attributable to reductions in lipid peroxidation and oxidative stress. PMID:25214797

  19. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    NASA Astrophysics Data System (ADS)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-06-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  20. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  1. Effects of Oral Vitamin C Supplementation on Anxiety in Students: A Double-Blind, Randomized, Placebo-Controlled Trial.

    PubMed

    de Oliveira, Ivaldo Jesus Lima; de Souza, Victor Vasconcelos; Motta, Vitor; Da-Silva, Sérgio Leme

    2015-01-01

    Vitamin C ascorbic acid) is a well-known antioxidant that is involved in anxiety, stress, depression, fatigue and mood state in humans. Studies have suggested that oxidative stress may trigger neuropsychological disorders. Antioxidants may play an important therapeutic role in combating the damage caused by oxidative stress in individuals that suffer from anxiety. In this context, it was hypothesized that oral vitamin C supplementation would reduce anxiety. However, few up to date studies have evaluated the consequences of oral vitamin C supplementation on anxiety in humans. The present study examined the effects of oral vitamin C supplements in 42 high school students, in a randomized, double-blind, placebo-controlled trial. The students were given either vitamin C (500 mg day(-1)) or placebo. Plasma concentrations of vitamin C and blood pressure were measured before the intervention and then one day after the intervention. Anxiety levels were evaluated for each student before and after 14 days following supplementation with the Beck Anxiety Inventory. Results showed that vitamin C reduced anxiety levels and led to higher plasma vitamin C concentration compared to the placebo. The mean heart rates were also significantly different between vitamin C group and placebo control group. Present study results not only provide evidence that vitamin C plays an important therapeutic role for anxiety but also point a possible use for antioxidants in the prevention or reduction of anxiety. This suggests that a diet rich in vitamin C may be an effective adjunct to medical and psychological treatment of anxiety and improve academic performance. PMID:26353411

  2. Oxytocin to modulate emotional processing in schizophrenia: A randomized, double-blind, cross-over clinical trial.

    PubMed

    Brambilla, Michela; Cotelli, Maria; Manenti, Rosa; Dagani, Jessica; Sisti, Davide; Rocchi, Marco; Balestrieri, Matteo; Pini, Stefano; Raimondi, Sara; Saviotti, Francesco Maria; Scocco, Paolo; de Girolamo, Giovanni

    2016-10-01

    Deficits in social cognition, including emotional processing, are hallmarks of schizophrenia and antipsychotic agents seem to be ineffectual to improve these symptoms. However, oxytocin does seem to have beneficial effects on social cognition. The aim of this study was to examine the effects of four months of treatment with intranasal oxytocin, in 31 patients with schizophrenia, on distinct aspects of social cognition. This was assessed using standardized and experimental tests in a randomized, double-blind, placebo-controlled, cross-over trial. All patients underwent clinical and experimental assessment before treatment, four months after treatment and at the end of treatment. Social cognition abilities were assessed with the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Reading the Mind in the Eyes task (RMET). Furthermore, an Emotional Priming Paradigm (EPP) was developed to examine the effects of oxytocin on implicit perceptual sensitivity to affective information and explicit facial affect recognition. We found that oxytocin improved performance on MSCEIT compared to placebo in Branch 3-Understanding Emotion (p-value=0.004; Cohen׳s d=1.12). In the EPP task, we observed a significant reduction of reaction times for facial affect recognition (p-value=0.021; Cohen׳s d=0.88). No effects were found for implicit priming or for theory of mind abilities. Further study is required in order to highlight the potential for possible integration of oxytocin with antipsychotic agents as well as to evaluate psycho-social treatment as a multi-dimensional approach to increase explicit emotional processing abilities and compensate social cognition deficits related to schizophrenia.

  3. A randomized, double-blind, placebo-controlled study of oral antioxidant supplement therapy in patients with dry eye syndrome

    PubMed Central

    Huang, Jehn-Yu; Yeh, Po-Ting; Hou, Yu-Chih

    2016-01-01

    Purpose To evaluate the efficacy of oral antioxidant supplementation in the treatment of patients with dry eye syndrome (DES). Methods A prospective, randomized, double-blinded study compared the effects of an antioxidant supplement (containing anthocyanosides, astaxanthin, vitamins A, C, and E, and several herbal extracts, including Cassiae semen and Ophiopogonis japonicus) with placebo on patients with DES. We assessed dry eye symptoms, visual acuity, Schirmer’s test, tear film breakup time, cornea and conjunctiva fluorescein staining, serum anti-SSA/anti-SSB antibodies, and the level of reactive oxygen species (ROS) in tears. The supplementation period was 8 weeks and patients were followed up every 4 weeks for 16 weeks. A linear mixed model was used to compare the groups, while within-group differences were tested by repeated-measures analysis of variance. Results Forty-three patients, 20 and 23 in treatment and placebo groups, respectively, completed the study. Liver and renal functions were normal. Diastolic blood pressure decreased in the treatment group. There were no significant differences in systolic blood pressure, dry eye symptoms, serum anti-SSA and anti-SSB, visual acuity, intraocular pressure, or fluorescein corneal staining between the groups. Tear film breakup time scores and Schirmer’s test without topical anesthesia significantly improved in the treatment group. Tear ROS level differed between the groups and decreased after treatment. Overall subjective impression revealed a significant improvement with treatment compared with placebo. Conclusion Oral antioxidant supplementations may increase tear production and improve tear film stability by reducing tear ROS. The vegetable-based antioxidant supplement used in this study is safe and can be utilized as an adjuvant therapy to conventional artificial tear therapy for patients with DES. PMID:27274185

  4. A Preliminary Randomized Double Blind Placebo-Controlled Trial of Intravenous Immunoglobulin for Japanese Encephalitis in Nepal

    PubMed Central

    Rayamajhi, Ajit; Nightingale, Sam; Bhatta, Nisha Keshary; Singh, Rupa; Ledger, Elizabeth; Bista, Krishna Prasad; Lewthwaite, Penny; Mahaseth, Chandeshwar; Turtle, Lance; Robinson, Jaimie Sue; Galbraith, Sareen Elizabeth; Wnek, Malgorzata; Johnson, Barbara Wilmot; Faragher, Brian

    2015-01-01

    Background Japanese encephalitis (JE) virus (JEV) is a mosquito-borne flavivirus found across Asia that is closely related to West Nile virus. There is no known antiviral treatment for any flavivirus. Results from in vitro studies and animal models suggest intravenous immunoglobulin (IVIG) containing virus-specific neutralizing antibody may be effective in improving outcome in viral encephalitis. IVIG’s anti-inflammatory properties may also be beneficial. Methodology/Principal Findings We performed a pilot feasibility randomized double-blind placebo-controlled trial of IVIG containing anti-JEV neutralizing antibody (ImmunoRel, 400mg/kg/day for 5 days) in children with suspected JE at two sites in Nepal; we also examined the effect on serum neutralizing antibody titre and cytokine profiles. 22 children were recruited, 13 of whom had confirmed JE; 11 received IVIG and 11 placebo, with no protocol violations. One child (IVIG group) died during treatment and two (placebo) subsequently following hospital discharge. Overall, there was no difference in outcome between treatment groups at discharge or follow up. Passive transfer of anti-JEV antibody was seen in JEV negative children. JEV positive children treated with IVIG had JEV-specific neutralizing antibody titres approximately 16 times higher than those treated with placebo (p=0.2), which was more than could be explained by passive transfer alone. IL-4 and IL-6 were higher in the IVIG group. Conclusions/Significance A trial of IVIG for JE in Nepal is feasible. IVIG may augment the development of neutralizing antibodies in JEV positive patients. IVIG appears an appealing option for JE treatment that warrants further study. Trial Registration ClinicalTrials.gov NCT01856205 PMID:25886645

  5. Lovastatin for the Treatment of Adult Patients With Dengue: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Whitehorn, James; Nguyen, Chau Van Vinh; Khanh, Lam Phung; Kien, Duong Thi Hue; Quyen, Nguyen Than Ha; Tran, Nguyen Thi Thanh; Hang, Nguyen Thuy; Truong, Nguyen Thanh; Hue Tai, Luong Thi; Cam Huong, Nguyen Thi; Nhon, Vo Thanh; Van Tram, Ta; Farrar, Jeremy; Wolbers, Marcel; Simmons, Cameron P.; Wills, Bridget

    2016-01-01

    Background. Dengue endangers billions of people in the tropical world, yet no therapeutic is currently available. In part, the severe manifestations of dengue reflect inflammatory processes affecting the vascular endothelium. In addition to lipid lowering, statins have pleiotropic effects that improve endothelial function, and epidemiological studies suggest that outcomes from a range of acute inflammatory syndromes are improved in patients already on statin therapy. Methods. Following satisfactory review of a short pilot phase (40 mg lovastatin vs placebo in 30 cases), we performed a randomized, double-blind, placebo-controlled trial of 5 days of 80 mg lovastatin vs placebo in 300 Vietnamese adults with a positive dengue NS1 rapid test presenting within 72 hours of fever onset. The primary outcome was safety. Secondary outcomes included comparisons of disease progression rates, fever clearance times, and measures of plasma viremia and quality of life between the treatment arms. Results. Adverse events occurred with similar frequency in both groups (97/151 [64%] placebo vs 82/149 [55%] lovastatin; P = .13), and were in keeping with the characteristic clinical and laboratory features of acute dengue. We also observed no difference in serious adverse events or any of the secondary outcome measures. Conclusions. We found lovastatin to be safe and well tolerated in adults with dengue. However, although the study was not powered to address efficacy, we found no evidence of a beneficial effect on any of the clinical manifestations or on dengue viremia. Continuing established statin therapy in patients who develop dengue is safe. Chinese Clinical Trials Registration. ISRCTN03147572. PMID:26565005

  6. Comparative Effect of Cinnamon and Ibuprofen for Treatment of Primary Dysmenorrhea: A Randomized Double-Blind Clinical Trial

    PubMed Central

    Jaafarpour, Molouk; Hatefi, Masoud; Khajavikhan, Javaher

    2015-01-01

    Background and Aims Primary dysmenorrheal has a negative impact on women's quality of life. The purpose of this study was to compare the effect of Cinnamon and Ibuprofen for treatment of primary dysmenorrheal in a sample of Iranian female college students from Ilam University of Medical Sciences (western Iran). Materials and Methods In a randomized, double-blind trial, out of 114, control group received placebo (empty capsules contain starch, TDS, n= 38) a test group received Ibuprofen (capsule containing 400mg Ibuprofen, TDS, n=38), or another test group received Cinnamon (capsule containing 420 mg Cinnamon, TDS, n= 38) in 24 h. To determine severity of pain, we used the VAS scale. Pain intensity and duration of pain were monitored in the group during first 72 h of cycle. Results The mean pain severity score and mean duration of pain in Ibuprofen and Cinnamon were less than placebo group respectively (p< 0.001). Of 4 hours after the intervention there were no statistically significant differences between the Cinnamon and placebo group (p> 0.05). Of eight hours after the intervention, the mean pain severity in the cinnamon group was significantly lower than placebo group (p< 0.001). At various time intervals the mean pain severity in the Ibuprofen group were significantly less than Cinnamon and placebo groups (p< 0.001). Conclusion Cinnamon compared with placebo significantly reduced the severity and duration of pain during menstruation, but this effect was lower compared with Ibuprofen. Cinnamon can be regarded as a safe and effective treatment for primary dysmenorrhea. More researches are recommended to study the efficacy of Cinnamon on reducing menstrual bleeding. PMID:26023601

  7. Protection of Salivary Function by Concomitant Pilocarpine During Radiotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

    SciTech Connect

    Burlage, Fred R. Roesink, Judith M.; Kampinga, Harm H.; Coppes, Rob P.; Terhaard, Chris; Langendijk, Johannes A.; Luijk, Peter van; Stokman, Monique A.; Vissink, Arjan

    2008-01-01

    Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with HNSCC was executed to study the protective effect of pilocarpine on radiotherapy-induced parotid gland dysfunction. The primary objective endpoint was parotid flow rate complication probability (PFCP) scored 6 weeks, 6 months, and 12 months after radiotherapy. Secondary endpoints included Late Effects of Normal Tissue/Somatic Objective Management Analytic scale (LENT SOMA) and patient-rated xerostomia scores. For all parotid glands, dose-volume histograms were assessed because the dose distribution in the parotid glands is considered the most important prognostic factor with regard to radiation-induced salivary dysfunction. Results: Although no significant differences in PFCP were found for the two treatments arms, a significant (p = 0.03) reduced loss of parotid flow 1 year after radiotherapy was observed in those patients who received pilocarpine and a mean parotid dose above 40 Gy. The LENT SOMA and patient-rated xerostomia scores showed similar trends toward less dryness-related complaints for the pilocarpine group. Conclusions: Concomitant administration of pilocarpine during radiotherapy did not improve the PFCP or LENT SOMA and patient-rated xerostomia scores. In a subgroup of patients with a mean dose above 40 Gy, pilocarpine administration resulted in sparing of parotid gland function. Therefore, pilocarpine could be provided to patients in whom sufficient sparing of the parotid is not achievable.

  8. Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients

    PubMed Central

    2011-01-01

    Background Natural rubber latex allergy is a common and unsolved health problem. Since the avoidance of exposure is very difficult, immunotherapy is strongly recommended, but before its use in patients, it is essential to prove the efficacy and safety of extracts. The aim of the present randomised, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of latex sublingual immunotherapy in adult patients undergoing permanent latex avoidance. Methods Twenty-eight adult latex-allergic patients (5 males and 23 females), with mean age of 39 years (range 24-57) were randomized to receive a commercial latex-sublingual immunotherapy or placebo during one year, followed by another year of open, active therapy. The following outcomes were measured at baseline and at the end of first and second year of follow-up: skin prick test, gloves-use score, conjunctival challenge test, total and specific IgE, basophil activation test, and adverse reactions monitoring. Results No significant difference in any of the efficacy in vivo variables was observed between active and placebo groups at the end of the placebo-controlled phase, nor when each group was compared with their baseline values at the end of the two year-study. An improvement in the average percentage of basophils activated was observed. During the induction phase, 4 reactions in the active group and 5 in the placebo group were recorded. During the maintenance phase, two patients dropped out due to pruritus and to acute dermatitis respectively. Conclusion Further studies are needed to evaluate latex-sublingual immunotherapy, since efficacy could not be demonstrated in adult patients with avoidance of the allergen. Trial registration number ACTRN12611000543987 PMID:21827704

  9. IQP-GC-101 reduces body weight and body fat mass: a randomized, double-blind, placebo-controlled study.

    PubMed

    Chong, Pee-Win; Beah, Zhi-Ming; Grube, Barbara; Riede, Linda

    2014-10-01

    IQP-GC-101 is a patented blend of the standardized extracts of Garcinia cambogia, Camellia sinensis, unroasted Coffea arabica, and Lagerstroemia speciosa. These individual ingredients of IQP-GC-101 have each shown promise in promoting weight loss; however, the efficacy of the blend has not been established. This randomized, placebo-controlled, double-blind, parallel group study conducted over 14 weeks (including a 2-week run-in phase) aimed to investigate the efficacy and safety of IQP-GC-101 in reducing body weight and body fat mass in overweight Caucasian adults. Subjects took three IQP-GC-101 or placebo tablets, twice a day, 30 min before main meals. All subjects also adhered to a 500 kcal/day energy deficit diet with 30% of energy from fat. Ninety-one overweight and mildly obese subjects (46 in the IQP-GC-101 group, 45 in the placebo group) completed the study. After 12-week intervention, IQP-GC-101 resulted in a mean (±SD) weight loss of 2.26 ± 2.37 kg compared with 0.56 ± 2.34 kg for placebo (pU  = 0.002). There was also significantly more reduction in body fat mass, waist circumference, and hip circumference in the IQP-GC-101 group. No serious adverse events were reported. The use of IQP-GC-101 has been shown to result in body weight and body fat reduction in the current study, with good tolerability.

  10. Magnesium Replacement Does Not Improve Insulin Resistance in Patients With Metabolic Syndrome: A 12-Week Randomized Double-Blind Study

    PubMed Central

    Lima de Souza e Silva, Maria de Lourdes; Cruz, Thomaz; Rodrigues, Luiz Erlon; Ladeia, Ana Marice; Bomfim, Olivia; Olivieri, Lucas; Melo, Juliana; Correia, Raquel; Porto, Mirna; Cedro, Alexandre

    2014-01-01

    Background To evaluate the effect of magnesium (Mg) replacement on insulin resistance and cardiovascular risk factors in women with metabolic syndrome (MS) without diabetes. Methods This 12-week clinical randomized double-blind study compared the effects of 400 mg/day of Mg with those of a placebo (n = 72) on fasting glucose, insulin, HOMA-IR, lipid profile and CRP. Mg was measured in serum (SMg) and in mononuclear cells (MMg). Results Hypomagnesemia (SMg < 1.7 mg/dL) was seen in 23.2% of patients and intracellular depletion in 36.1% of patients. The MMg means were lower in patients with obesity (0.94 ± 0.54 μg/mg vs. 1.19 ± 0.6 μg/mg, P = 0.04), and insulin resistance (0.84 ± 0.33 μg/mg vs. 1.14 ± 0.69 µg/mg, P < 0.05). Mg replacement did not alter SMg (1.82 ± 0.14 mg/dL vs. 1.81 ± 0.16 mg/dL, P = 0.877) and tended to increment MMg (0.90 ± 0.40 μg/mg vs. 1.21 ± 0.73 μg/mg, P = 0.089). HOMA-IR did not alter in interventions nor in placebo group (3.2 ± 2.0 to 2.8 ± 1.9, P = 0.368; 3.6 ± 1.9 to 3.2 ± 1.8, respectively), neither did other metabolic parameters. Conclusion Serum and intracellular Mg depletion is common in patients with MS; however, Mg replacement in recommended dosage did not increase significantly Mg levels, neither reduced insulin resistance or metabolic control. PMID:25247020

  11. Homeopathic remedy for arsenic toxicity?: Evidence-based findings from a randomized placebo-controlled double blind human trial.

    PubMed

    Belon, Philippe; Banerjee, Antara; Karmakar, Susanta Roy; Biswas, Surjyo Jyoti; Choudhury, Sandipan Chaki; Banerjee, Pathikrit; Das, Jayanta Kumar; Pathak, Surajit; Guha, Bibhas; Paul, Saili; Bhattacharjee, Nandini; Khuda-Bukhsh, Anisur Rahman

    2007-10-01

    Millions of people are at risk of groundwater arsenic contamination, but supply of arsenic-free drinking water is grossly inadequate. The present study was intended to examine if a potentized homeopathic remedy reportedly showing ameliorating potentials in people inhabiting high-risk arsenic-contaminated areas but drinking arsenic-free water, can also ameliorate arsenic toxicity in subjects living in high-risk arsenic-contaminated areas, and drinking arsenic-contaminated water. This pilot study was conducted on 20 males and 19 females of village Dasdiya (arsenic contaminated) who initially agreed to act as volunteers; but as many as 14, mostly placebo-fed subjects, later dropped out. 18 volunteers, 14 males and 4 females, from a distant village, Padumbasan (arsenic-free), served as negative controls. In a double blind placebo-controlled study, a potentized remedy of homeopathic Arsenicum Album-30 and its placebo (Succussed Alcohol-30) were given randomly to volunteers. Arsenic contents in urine and blood and several widely accepted toxicity biomarkers and pathological parameters in blood were analyzed before and after 2 months of administration of either verum or placebo. Elevated levels of ESR, creatinine and eosinophils and increased activities of AST, ALT, LPO and GGT were recorded in arsenic exposed subjects. Decreased levels of hemoglobin, PCV, neutrophil percentages, and GSH content and low G-6-PD activity were also observed in the arsenic exposed people. The administration of "verum" appeared to make positive modulations of these parameters, suggestive of its ameliorative potentials. Most of the subjects reported better appetite and improvement in general health, thereby indicating possibility of its use in remote arsenic-contaminated areas as an interim health support measure to a large population at risk.

  12. Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial

    PubMed Central

    McGraw, Thomas

    2016-01-01

    AIM: To evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in subjects with self-reported occasional constipation. METHODS: Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial. Evaluations were conducted before (baseline) and after a 7-d treatment period. The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools. Secondary efficacy variables assessed the severity of the subjects’ daily bowel movement (BM) symptoms, and preference of laxatives based on diary entries, visual analog scale scores, and questionnaires. RESULTS: Of the 203 subjects enrolled in the study, 11 had major protocol violations. Complete resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94 (24.5%) in the placebo group (P = 0.0595). The number of complete BMs without straining or lumpy stools was similar between both groups. Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a 7-d period (P < 0.0001). Subjects reported that PEG 3350 had a better effect on their daily lives, provided better control over a BM, better relief from constipation, cramping, and bloating, and was their preferred laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo groups. No deaths, serious AEs, or discontinuations due to AEs were reported. This trial is registered at clinicaltrials.gov as NCT00770432. CONCLUSION: Oral administration of 17 g PEG 3350 once daily for a week is effective, safe, and well tolerated in subjects with occasional constipation. PMID:27158544

  13. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial.

    PubMed

    Gualano, Bruno; Macedo, André Regis; Alves, Christiano Robles Rodrigues; Roschel, Hamilton; Benatti, Fabiana Braga; Takayama, Liliam; de Sá Pinto, Ana Lucia; Lima, Fernanda Rodrigues; Pereira, Rosa Maria Rodrigues

    2014-05-01

    This study aimed to examine the efficacy of creatine supplementation, associated or not with resistance training, in vulnerable older women. A 24-week, double-blind, randomized, placebo-controlled trial was performed. Sixty subjects were assigned to compose the following groups: placebo (PL), creatine supplementation (CR), placebo with resistance training (PL+RT), and creatine supplementation with resistance training (CR+RT). The subjects were assessed at baseline and after 24weeks. The primary outcome was muscle strength, as assessed by one-repetition maximum (1-RM) tests. Secondary outcomes included appendicular lean mass, bone mass, biochemical bone markers, and physical function tests. The changes in 1-RM leg press were significantly greater in the CR+RT group (+19.9%) than in the PL (+2.4%) and the CR groups (+3.7%), but not than in the PL+RT group (+15%) (p=0.002, p=0.002, and p=0.357, respectively). The CR+RT group showed superior gains in 1-RM bench press (+10%) when compared with all the other groups (p≤0.05). The CR+RT group (+1.31%) showed greater appendicular lean mass accrual than the PL (-1.2%), the CR (+0.3%), and the PL+RT groups (-0.2%) (p≤0.05). The CR and the PL+RT groups experienced comparable gains in appendicular lean mass (p=0.62), but superior to those seen in the PL group. Changes in fat mass, bone mass and serum bone markers did not significantly differ between the groups (p>0.05). In conclusion, creatine supplementation combined with resistance training improved appendicular lean mass and muscle function, but not bone mass, in older vulnerable women. Clinicaltrials.gov: NCT01472393. PMID:24530883

  14. Oxytocin to modulate emotional processing in schizophrenia: A randomized, double-blind, cross-over clinical trial.

    PubMed

    Brambilla, Michela; Cotelli, Maria; Manenti, Rosa; Dagani, Jessica; Sisti, Davide; Rocchi, Marco; Balestrieri, Matteo; Pini, Stefano; Raimondi, Sara; Saviotti, Francesco Maria; Scocco, Paolo; de Girolamo, Giovanni

    2016-10-01

    Deficits in social cognition, including emotional processing, are hallmarks of schizophrenia and antipsychotic agents seem to be ineffectual to improve these symptoms. However, oxytocin does seem to have beneficial effects on social cognition. The aim of this study was to examine the effects of four months of treatment with intranasal oxytocin, in 31 patients with schizophrenia, on distinct aspects of social cognition. This was assessed using standardized and experimental tests in a randomized, double-blind, placebo-controlled, cross-over trial. All patients underwent clinical and experimental assessment before treatment, four months after treatment and at the end of treatment. Social cognition abilities were assessed with the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Reading the Mind in the Eyes task (RMET). Furthermore, an Emotional Priming Paradigm (EPP) was developed to examine the effects of oxytocin on implicit perceptual sensitivity to affective information and explicit facial affect recognition. We found that oxytocin improved performance on MSCEIT compared to placebo in Branch 3-Understanding Emotion (p-value=0.004; Cohen׳s d=1.12). In the EPP task, we observed a significant reduction of reaction times for facial affect recognition (p-value=0.021; Cohen׳s d=0.88). No effects were found for implicit priming or for theory of mind abilities. Further study is required in order to highlight the potential for possible integration of oxytocin with antipsychotic agents as well as to evaluate psycho-social treatment as a multi-dimensional approach to increase explicit emotional processing abilities and compensate social cognition deficits related to schizophrenia. PMID:27527256

  15. A randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus

    PubMed Central

    DeVincenzo, John; Lambkin-Williams, Robert; Wilkinson, Tom; Cehelsky, Jeffrey; Nochur, Sara; Walsh, Edward; Meyers, Rachel; Gollob, Jared; Vaishnaw, Akshay

    2010-01-01

    RNA interference (RNAi) is a natural mechanism regulating protein expression that is mediated by small interfering RNAs (siRNA). Harnessing RNAi has potential to treat human disease; however, clinical evidence for the effectiveness of this therapeutic approach is lacking. ALN-RSV01 is an siRNA directed against the mRNA of the respiratory syncytial virus (RSV) nucleocapsid (N) protein and has substantial antiviral activity in a murine model of RSV infection. We tested the antiviral activity of ALN-RSV01 in adults experimentally infected with wild-type RSV. Eighty-eight healthy subjects were enrolled into a randomized, double-blind, placebo-controlled trial. A nasal spray of ALN-RSV01 or saline placebo was administered daily for 2 days before and for 3 days after RSV inoculation. RSV was measured serially in nasal washes using several different viral assays. Intranasal ALN-RSV01 was well tolerated, exhibiting a safety profile similar to saline placebo. The proportion of culture-defined RSV infections was 71.4 and 44.2% in placebo and ALN-RSV01 recipients, respectively (P = 0.009), representing a 38% decrease in the number of infected and a 95% increase in the number of uninfected subjects. The acquisition of infection over time was significantly lower in ALN-RSV01 recipients (P = 0.007 and P = 0.03, viral culture and PCR, respectively). Multiple logistic regression analysis showed that the ALN-RSV01 antiviral effect was independent of other factors, including preexisting RSV antibody and intranasal proinflammatory cytokine concentrations. ALN-RSV01 has significant antiviral activity against human RSV infection, thus establishing a unique proof-of-concept for an RNAi therapeutic in humans and providing the basis for further evaluation in naturally infected children and adults. PMID:20421463

  16. Effects of add-on mirtazapine on neurocognition in schizophrenia: a double-blind, randomized, placebo-controlled study.

    PubMed

    Stenberg, Jan-Henry; Terevnikov, Viatcheslav; Joffe, Marina; Tiihonen, Jari; Tchoukhine, Evgueni; Burkin, Mark; Joffe, Grigori

    2010-05-01

    Mirtazapine added to antipsychotics appears to improve the clinical picture of schizophrenia, including both negative and positive symptoms. This study explored the effect of adjunctive mirtazapine on neurocognition in patients with schizophrenia who had shown an insufficient response to first-generation antipsychotics (FGAs). Thirty-seven schizophrenia patients, who were at least moderately ill despite their FGA treatment, received add-on mirtazapine (n=19) or placebo (n=18) in a 6-wk double-blind, randomized trial. Widely used neuropsychological tests were performed to explore visual-spatial functions, verbal and visual memory, executive functions, verbal fluency and general mental and psychomotor speed. The data were analysed on the modified intent-to-treat basis with last observation carried forward. False discovery rate was applied to correct for multiple testing. Mirtazapine outperformed placebo in the domains of visual-spatial ability and general mental speed/attentional control as assessed by, correspondingly, Block Design and Stroop dots. The difference in the degree of change (i.e. change while on mirtazapine minus that on placebo) was 18.6% (p=0.044) and 11.1% (p=0.044), respectively. Adjunctive mirtazapine might offer a safe, effective and cost-saving option as a neurocognitive enhancer for FGA-treated schizophrenia patients. Mirtazapine+FGA combinations may become especially useful in light of the currently increasing attention towards FGAs. Larger and longer studies that incorporate functional outcomes, as well as comparisons with second-generation antipsychotics are, however, still needed for more definite conclusions. PMID:19941694

  17. Clinical Evidence of Effects of Lactobacillus plantarum HY7714 on Skin Aging: A Randomized, Double Blind, Placebo-Controlled Study.

    PubMed

    Lee, Dong Eun; Huh, Chul-Sung; Ra, Jehyeon; Choi, Il-Dong; Jeong, Ji-Woong; Kim, Sung-Hwan; Ryu, Ja Hyun; Seo, Young Kyoung; Koh, Jae Sook; Lee, Jung-Hee; Sim, Jae-Hun; Ahn, Young-Tae

    2015-12-28

    The beneficial effects of probiotics are now widely reported, although there are only a few studies on their anti-aging effects. We have found that Lactobacillus plantarum HY7714 (HY7714) improves skin hydration and has anti-photoaging effects, and in the present study, we have further evaluated the anti-aging effect of HY7714 via a randomized, double blind, placebo-controlled clinical trial. The trial included 110 volunteers aged 41 and 59 years who have dry skin and wrinkles. Participants took 1 × 10(10) CFU/day of HY7714 (probiotic group) or a placebo (placebo group) for 12 weeks. Skin hydration, wrinkles, skin gloss, and skin elasticity were measured every 4 weeks during the study period. There were significant increases in the skin water content in the face (p < 0.01) and hands (p < 0.05) at week 12 in the probiotic group. Transepidermal water loss decreased significantly in both groups at weeks 4, 8, and 12 (p < 0.001 compared with baseline), and was suppressed to a greater extent in the face and forearm in the probiotic group at week 12. Volunteers in the probiotic group had a significant reduction in wrinkle depth at week 12, and skin gloss was also significantly improved by week 12. Finally, skin elasticity in the probiotic group improved by 13.17% (p < 0.05 vs. controls) after 4 weeks and by 21.73% (p < 0.01 vs. controls) after 12 weeks. These findings are preliminary confirmation of the anti-aging benefit to the skin of L. plantarum HY7714 as a nutricosmetic agent.

  18. Effect of Broccoli Sprouts on Nasal Response to Live Attenuated Influenza Virus in Smokers: A Randomized, Double-Blind Study

    PubMed Central

    Noah, Terry L.; Zhang, Hongtao; Zhou, Haibo; Glista-Baker, Ellen; Müller, Loretta; Bauer, Rebecca N.; Meyer, Megan; Murphy, Paula C.; Jones, Shannon; Letang, Blanche; Robinette, Carole; Jaspers, Ilona

    2014-01-01

    Background Smokers have increased susceptibility and altered innate host defense responses to influenza virus infection. Broccoli sprouts are a source of the Nrf2 activating agentsulforaphane, and short term ingestion of broccoli sprout homogenates (BSH) has been shown to reduce nasal inflammatory responses to oxidant pollutants. Objectives Assess the effects of BSH on nasal cytokines, virus replication, and Nrf2-dependent enzyme expression in smokers and nonsmokers. Methods We conducted a randomized, double-blind, placebo-controlled trial comparing the effects of BSH on serially sampled nasal lavage fluid (NLF) cytokines, viral sequence quantity, and Nrf2-dependent enzyme expression in NLF cells and biopsied epithelium. Healthy young adult smokers and nonsmokers ingested BSH or placebo (alfalfa sprout homogenate) for 4 days, designated Days -1, 0, 1, 2. On Day 0 they received standard vaccine dose of live attenuated influenza virus (LAIV) intranasally. Nasal lavage fluids and nasal biopsies were collected serially to assess response to LAIV. Results In area under curve analyses, post-LAIV IL-6 responses (P = 0.03) and influenza sequences (P = 0.01) were significantly reduced in NLF from BSH-treated smokers, whileNAD(P)H: quinoneoxidoreductasein NLF cells was significantly increased. In nonsmokers, a similar trend for reduction in virus quantity with BSH did not reach statistical significance. Conclusions In smokers, short term ingestion of broccoli sprout homogenates appears to significantly reduce some virus-induced markers of inflammation, as well as reducing virus quantity. Nutritional antioxidant interventions have promise as a safe, low-cost strategy for reducing influenza risk among smokers and other at risk populations. Trial Registration ClinicalTrials.gov NCT01269723 PMID:24910991

  19. Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind Trial, N07C2

    PubMed Central

    2013-01-01

    Background Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF. Methods A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) provider grading. Results Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms. Conclusions Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed. PMID:23853057

  20. A randomized triple blind trial to assess the effect of an anthelmintic programme for working equids in Morocco

    PubMed Central

    2011-01-01

    Background Gastro-intestinal parasitism has been identified as a significant cause of disease in working equids in many countries. This randomized triple-blind trial was designed to assess the impact of an anthelmintic treatment programme (using oral ivermectin and fenbendazole) comparing treated and placebo control populations of working donkeys, mules and horses in field conditions in Morocco. In particular, we assessed animal body weight and condition score, together with a questionnaire-based owner evaluation of number of subjective animal health parameters. Faecal worm egg count was also measured. Results 239 animals completed the full study, 130 in the treatment group and 109 in the control group. Although the average animal weight increased during the study, this change was not significantly different between the two groups. Animals in the treatment group had a significantly lower strongyle worm egg count and increased in body condition score compared to animals in the control group at each examination during the study period. Owners of animals in the treatment group reported improvement in health and work ability and a beneficial effect on pruritus during the early period of the study. These differences in owner perception between treatment groups had disappeared in the latter stages of the study. Conclusion This study demonstrated that a routine anthelmintic treatment programme of three treatments annually can have a significant effect on faecal worm egg count. There may be beneficial consequences for the animal health and productivity. Further research on other populations of working equids in different environments would facilitate the objective planning of effective parasite control strategies for specific situations and provide better understanding of the likely clinical benefits of such programmes. PMID:21208398

  1. Residual effects of zolpidem, triazolam, rilmazafone and placebo in healthy elderly subjects: a randomized double-blind study.

    PubMed

    Uemura, Sachiko Ito; Kanbayashi, Takashi; Wakasa, Masahiko; Satake, Masahiro; Ito, Wakako; Shimizu, Kazumi; Shioya, Takanobu; Shimizu, Tetsuo; Nishino, Seiji

    2015-11-01

    With current hypnotic agents, next-day residual effects are a common problem. The purpose of the present study was to evaluate the residual effects of the commercially available hypnotics - zolpidem, triazolam, and rilmazafone - on the physical and cognitive functions of healthy elderly people in the early morning and the day following drug administration. In this study, the next-day residual effects of zolpidem, triazolam, and rilmazafone, following bedtime dosing in elderly subjects, were evaluated. Women (n = 11) and men (n = 2) aged 60-70 years received a single dose (at 23:00) of one of these, zolpidem 5 mg, triazolam 0.125 mg, rilmazafone 1 mg and placebo in a randomized, double-blind, crossover design. Measures of objective parameters and psychomotor performances (Timed up and Go test, Functional Reach Test, body sway test, critical flicker fusion test, simple discrimination reaction test, short-term memory test) and subjective ratings were obtained at 04:00, 07:00, and the next time of the day. All hypnotics were generally well tolerated; there were no serious adverse side effects and no subjects discontinued the evaluations. Compared to placebo, zolpidem and rilmazafone had good results on the Functional Reach Test. Although subjective assessments tended to be poor in the early morning, rilmazafone significantly improved the body sway test in the other hypnotics. A single dose of zolpidem 5 mg and triazolam 0.125 mg did not have any next-day residual effects on healthy elderly subjects. Residual effects appeared to be related to the compound's half-life and the dose used. Rilmazafone 1 mg exhibited steadiness in static and dynamic balance and seemed to be more favorable for the elderly with early morning awakening. PMID:26498242

  2. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study

    PubMed Central

    Forero, Giovanna; Mathews, Maju; Nunez, Rene; Tang, Xiongwen; Durgam, Suresh; Sambunaris, Angelo

    2015-01-01

    Vilazodone is a selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist that is approved for treatment of major depressive disorder in adults in the USA and Mexico. The efficacy, safety, and tolerability of vilazodone for generalized anxiety disorder (GAD) were investigated in a clinical trial (NCT01766401 ClinicalTrials.gov). Participants (18–70 years, inclusive) who met Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text revision, criteria for GAD were randomized (1 : 1) to placebo or flexible-dose vilazodone (20–40 mg/day) for 8 weeks of double-blind treatment. Primary and secondary efficacy parameters were changes from baseline to week 8 in Hamilton Rating Scale for Anxiety and Sheehan Disability Scale total scores, respectively. Analysis was based on a mixed-effects model for repeated measures approach on the intent-to-treat population. The intent-to-treat population comprised 395 patients (placebo=197, vilazodone=198); 77% completed the study. The least squares mean difference in change from baseline to week 8 in the Hamilton Rating Scale for Anxiety total score was statistically significant for vilazodone versus placebo [−1.50 (−2.96, −0.04), P=0.0438]. The mean change from baseline to week 8 in the Sheehan Disability Scale total score for vilazodone versus placebo was not statistically significant. Adverse events were reported in 60% of placebo-treated and 83% of vilazodone-treated patients. This was a positive clinical trial of 20–40 mg/day vilazodone versus placebo in the treatment of GAD. PMID:26291335

  3. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial.

    PubMed

    Nielsen, Rikke V; Siegel, Hanna; Fomsgaard, Jonna S; Andersen, Johnny D H; Martusevicius, Robertas; Mathiesen, Ole; Dahl, Jørgen B

    2015-12-01

    Glucocorticoids have attracted increasing attention as adjuvants in the treatment of acute postoperative pain. Furthermore, anecdotal reports may support glucocorticoids for preventing sustained postoperative pain. We explored preoperative dexamethasone combined with paracetamol and ibuprofen on acute and sustained pain after lumbar disk surgery. In this blinded study, 160 patients undergoing lumbar disk surgery were randomly assigned to 16 mg IV dexamethasone or placebo. All patients received perioperative paracetamol and ibuprofen, and postoperative IV patient-controlled analgesia with morphine. Primary outcome was pain during mobilization (visual analog scale) 2 to 24 hours postoperatively. Secondary outcomes were acute pain at rest, morphine consumption, nausea, vomiting, ondansetron consumption, sedation, and quality of sleep. Patients were followed up by written questionnaire 3 months postoperatively. Acute pain during mobilization (weighted average area under the curve, 2-24 hours) was significantly reduced in the dexamethasone group: 33 (22) mm vs placebo 43 (18) mm, (95% confidence interval [CI] 3-16) P = 0.005. Vomiting 0 to 24 hours postoperatively was reduced in the dexamethasone group (17 episodes) vs placebo (51 episodes) P = 0.036. No other differences were observed. However, 6.5% (95% CI 2-15) in the dexamethasone group vs placebo 0% had an antibiotically treated wound infection (P = 0.13). Sixteen percent (95% CI 7-26) vs 8% (95% CI 0-17) reported new weakness/paralysis of the legs in the dexamethasone and placebo groups, respectively, 3 months postoperatively (P = 0.20). In conclusion, preoperative dexamethasone significantly reduced pain during mobilization and vomiting, after lumbar disk surgery. No significant effects were observed 3 months postoperatively. PMID:26270586

  4. Kiwifruit-derived supplements increase stool frequency in healthy adults: a randomized, double-blind, placebo-controlled study.

    PubMed

    Ansell, Juliet; Butts, Christine A; Paturi, Gunaranjan; Eady, Sarah L; Wallace, Alison J; Hedderley, Duncan; Gearry, Richard B

    2015-05-01

    The worldwide growth in the incidence of gastrointestinal disorders has created an immediate need to identify safe and effective interventions. In this randomized, double-blind, placebo-controlled study, we examined the effects of Actazin and Gold, kiwifruit-derived nutritional ingredients, on stool frequency, stool form, and gastrointestinal comfort in healthy and functionally constipated (Rome III criteria for C3 functional constipation) individuals. Using a crossover design, all participants consumed all 4 dietary interventions (Placebo, Actazin low dose [Actazin-L] [600 mg/day], Actazin high dose [Actazin-H] [2400 mg/day], and Gold [2400 mg/day]). Each intervention was taken for 28 days followed by a 14-day washout period between interventions. Participants recorded their daily bowel movements and well-being parameters in daily questionnaires. In the healthy cohort (n = 19), the Actazin-H (P = .014) and Gold (P = .009) interventions significantly increased the mean daily bowel movements compared with the washout. No significant differences were observed in stool form as determined by use of the Bristol stool scale. In a subgroup analysis of responders in the healthy cohort, Actazin-L (P = .005), Actazin-H (P < .001), and Gold (P = .001) consumption significantly increased the number of daily bowel movements by greater than 1 bowel movement per week. In the functionally constipated cohort (n = 9), there were no significant differences between interventions for bowel movements and the Bristol stool scale values or in the subsequent subgroup analysis of responders. This study demonstrated that Actazin and Gold produced clinically meaningful increases in bowel movements in healthy individuals.

  5. Preoperative peribulbar block in patients undergoing retinal detachment surgery under general anesthesia: a randomized double-blind study.

    PubMed

    Morel, Jérôme; Pascal, Jean; Charier, David; De Pasquale, Véronique; Gain, Philippe; Auboyer, Christian; Molliex, Serge

    2006-04-01

    Retinal detachment surgery is frequently associated with significant postoperative pain and emesis in adults. In this randomized, double-blind, controlled study we sought to demonstrate that 1% ropivacaine peribulbar (PB) block in conjunction with general anesthesia (GA) improves operative conditions and postoperative analgesia compared with GA combined with subcutaneous normal saline injection into the inferior eyelid. Thirty-one patients were included in each group. Anesthesia was performed with target-controlled infusion propofol and continuous remifentanil infusion adjusted to maintain bispectral index values between 40 and 50. Postoperative analgesia included fixed-dose IV infusion of propacetamol and IV injection of nefopam via a patient-controlled analgesia device. Tramadol was infused IV as rescue medication. Demographic data were comparable between the groups and bispectral index values were maintained at the objective target. In the PB group, fewer patients presented an oculocardiac reflex (6 versus 17; P < 0.01); bleeding interfering with the surgical field was reduced (1 versus 11 patients; P < 0.01); mean time to first nefopam request was longer (148 +/- 99 versus 46 +/- 58 min; P < 0.01); mean nefopam consumption was diminished during the first 6 h after tracheal extubation (18.9 +/- 13.9 versus 28.5 +/- 14.7 mg; P < 0.05); immediate postoperative pain scores were lower; and fewer patients required rescue medication (5 versus 23; P < 0.01). The two groups were similar with respect to the incidence of postoperative nausea and vomiting. Overall, PB block combined with GA improved operating conditions and postoperative analgesia in retinal detachment surgery. PMID:16551903

  6. Effect of myrtle fruit syrup on abnormal uterine bleeding: a randomized double-blind, placebo-controlled pilot study

    PubMed Central

    2014-01-01

    Background Myrtle (Myrtus communis L.) has been used in the Iranian Traditional Medicine as a treatment for abnormal uterine bleeding-menometrorrhagia. The main aim of this study is to evaluate the effect of myrtle fruit syrup on abnormal uterine bleeding-menometrorrhagia. Methods A randomized, double-blind, placebo-controlled pilot study was conducted on 30 women suffering from abnormal uterine bleeding-menometrorrhagia. Treatment comprised of giving 15 ml oral myrtle syrup daily (5 ml three times a day) for 7 days starting from the onset of bleeding. The myrtle syrup along with placebo was repeated for 3 consecutive menstrual periods. Menstrual duration and number of used pads were recorded by the Pictorial Blood loss Assessment Chart at the end of each menstrual period. The quality of life was also evaluated using the menorrhagia questionnaire. Results The mean number of bleeding days significantly declined from 10.6 ± 2.7 days to 8.2 ± 1.9 days after 3 months treatment with the syrup (p = 0.01) and consequently the participants in the intervention group used fewer pads after 3 months (16.4 ± 10.7) compared with the number of pads used at the beginning of the treatment (22.7 ± 12.0, p = 0.01). Bleeding days and number of pads used by the participants in the placebo group did not change significantly. Also significant changes of quality of life scores were observed in the intervention group after 3 months compared to the baseline. Conclusion Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia. PMID:24888316

  7. Ultrasound-guided rectus sheath block or wound infiltration in children: A randomized blinded study of analgesia and bupivacaine absorption

    PubMed Central

    Flack, Sean H.; Martin, Lizabeth D.; Walker, Benjamin J.; Bosenberg, Adrian T.; Helmers, Laurilyn D.; Goldin, Adam B.; Haberkern, Charles M.

    2014-01-01

    Background Rectus sheath block can provide analgesia following umbilical hernia repair. However, conflicting reports on its analgesic effectiveness exist. No study has investigated plasma local anesthetic concentration following ultrasound-guided rectus sheath block (USGRSB) in children. Objectives Compare the effectiveness and bupivacaine absorption following USGRSB or wound infiltration (WI) for umbilical hernia repair in children. Methods A randomized blinded study comparing WI to USGRSB in 40 children undergoing umbilical hernia repair was performed. Group WI (n=20) received wound infiltration 1mg/kg 0.25% bupivacaine. Group RS (n=20) received USGRSB 0.5mg/kg 0.25% bupivacaine per side in the posterior rectus sheath compartment. Pain scores and rescue analgesia were recorded. Blood samples were drawn at 0, 10, 20, 30, 45 and 60 minutes. Results Patients in the WI group had a 2-fold increased risk of requiring morphine (Hazard ratio 2.06, 95% CI 1.01, 4.20, p=0.05). When required, median time to first morphine dose was longer in the USGRSB group (65.5 min vs 47.5 min, p=0.049). Peak plasma bupivacaine concentration was higher following USGRSB than WI (median: 631.9 ng/ml IQR: 553.9 – 784.1 vs 389.7 ng/ml IQR: 250.5-502.7, p= 0.002). Tmax was longer in the USGRSB group (median 45 min IQR: 30 - 60 vs 20 min IQR: 20 – 45, p= 0.006). Conclusions USGRSB provides more effective analgesia than WI for umbilical hernia repair. USGRSB with 1mg/kg 0.25% bupivacaine is associated with safe plasma bupivacaine concentration that peaks higher and later than WI. Caution against using larger volumes of higher concentration local anesthetic for USGRSB is advised. PMID:24853314

  8. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise.

  9. Assessing experimental visceral pain in dairy cattle: A pilot, prospective, blinded, randomized, and controlled study focusing on spinal pain proteomics.

    PubMed

    Rialland, P; Otis, C; de Courval, M-L; Mulon, P-Y; Harvey, D; Bichot, S; Gauvin, D; Livingston, A; Beaudry, F; Hélie, P; Frank, D; Del Castillo, J R E; Troncy, E

    2014-01-01

    Few studies have verified the validity of behavioral and physiological methods of pain assessment in cattle. This prospective, blinded, randomized controlled experimental study aimed to validate different methods of pain assessment during acute and chronic (up to 21 d postintervention) conditions in dairy cattle, in response to 3 analgesic treatments for traumatic reticuloperitonitis. Cerebrospinal fluid (CSF) biomarkers and mechanical sensitization were measured as indicators of centralized pain. Proteomics in the CSF were examined to detect specific (to pain intensity) and sensitive (responsive to analgesia) markers. Recordings of spontaneous behavior with video analysis, telemetered motor activity, pain scales, electrodermal activity, and plasma cortisol concentration were quantified at regular intervals. Cows were assigned to group 1 (n=4, standard control receiving aspirin), group 2 (n=5, test group receiving preemptive tolfenamic acid), or group 3 (n=3, positive control receiving preemptive multimodal analgesia composed of epidural morphine, plus tolfenamic acid and butorphanol). Rescue analgesia was administered as needed. Generalized estimating equations tested group differences and the influence of rescue analgesia on the measurements. All 3 groups demonstrated a long-term decrease in a CSF protein identified as transthyretin. The decrease in transthyretin expression inversely correlated with the expected level of analgesia (group 1<2<3). Moreover, in group 1, CSF noradrenaline decreased long term, cows were hypersensitive to mechanical stimulation, and they demonstrated signs of discomfort with higher motor activity and "agitation while lying" recorded from video analysis. Decreased "feeding behavior," observer-reported pain scales, electrodermal activity, and plasma cortisol concentration were inconsistent to differentiate pain intensity between groups. In summary, changes in CSF biomarkers and mechanical sensitization reflected modulation of central

  10. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study.

    PubMed

    Ennis, William J; Foremann, Phil; Mozen, Neal; Massey, Joi; Conner-Kerr, Teresa; Meneses, Patricio

    2005-08-01

    An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.

  11. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  12. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  13. Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic Cadazolid in Patients with Clostridium difficile Infection

    PubMed Central

    Nord, Carl Erik; Talbot, George H.; Wilcox, Mark; Gerding, Dale N.; Buitrago, Martha; Kracker, Hilke; Charef, Pascal; Cornely, Oliver A.

    2015-01-01

    Cadazolid, a novel fluoroquinolone-oxazolidinone antibiotic, exhibits potent in vitro activity against Clostridium difficile, including the epidemic BI/NAP1/027 strain. This multicenter, randomized, double-blind, active reference group, phase 2 study evaluated the efficacy and safety of oral cadazolid in treatment of adult patients with C. difficile infection (CDI). Eligible patients with first occurrence/first recurrence of CDI were randomized 1:1:1:1 to 250, 500, or 1,000 mg cadazolid twice daily (BID) or oral 125 mg vancomycin four times daily (QID) for 10 days. The primary endpoint was clinical cure at test of cure (48 ± 24 h after the end of treatment; modified intent-to-treat population), defined as resolution of diarrhea with no further CDI treatment required. Secondary endpoints included recurrence rate, sustained clinical response (clinical cure without recurrence), and time to diarrhea resolution. Of 84 patients enrolled, 20, 22, 20, and 22 received 250, 500, or 1,000 mg cadazolid BID or 125 mg vancomycin QID, respectively. The primary endpoint was achieved in 76.5% (80% confidence interval [CI], 58.4, 89.3), 80.0% (63.9, 91.0), 68.4% (51.1, 82.5), and 68.2% (52.3, 81.3) of patients, respectively. There was no evidence of a cadazolid dosage-dependent response. Each dosage of cadazolid resulted in a lower recurrence rate than with vancomycin (18.2 to 25.0% versus 50%). Consequently, higher sustained clinical response rates were observed with cadazolid (46.7 to 60.0%) than with vancomycin (33.3%). The times to diarrhea resolution were similar for cadazolid and vancomycin. Cadazolid was well tolerated, with no safety signal observed. The results of this phase 2 study support further clinical development of cadazolid. (This study has been registered in the United States at ClinicalTrials.gov under registration no. NCT01222702 and in Europe with the European Medicines Agency under registration no. EUDRA-CT 2010-020941-29.) PMID:26248357

  14. Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic Cadazolid in Patients with Clostridium difficile Infection.

    PubMed

    Louie, Thomas; Nord, Carl Erik; Talbot, George H; Wilcox, Mark; Gerding, Dale N; Buitrago, Martha; Kracker, Hilke; Charef, Pascal; Cornely, Oliver A

    2015-10-01

    Cadazolid, a novel fluoroquinolone-oxazolidinone antibiotic, exhibits potent in vitro activity against Clostridium difficile, including the epidemic BI/NAP1/027 strain. This multicenter, randomized, double-blind, active reference group, phase 2 study evaluated the efficacy and safety of oral cadazolid in treatment of adult patients with C. difficile infection (CDI). Eligible patients with first occurrence/first recurrence of CDI were randomized 1:1:1:1 to 250, 500, or 1,000 mg cadazolid twice daily (BID) or oral 125 mg vancomycin four times daily (QID) for 10 days. The primary endpoint was clinical cure at test of cure (48 ± 24 h after the end of treatment; modified intent-to-treat population), defined as resolution of diarrhea with no further CDI treatment required. Secondary endpoints included recurrence rate, sustained clinical response (clinical cure without recurrence), and time to diarrhea resolution. Of 84 patients enrolled, 20, 22, 20, and 22 received 250, 500, or 1,000 mg cadazolid BID or 125 mg vancomycin QID, respectively. The primary endpoint was achieved in 76.5% (80% confidence interval [CI], 58.4, 89.3), 80.0% (63.9, 91.0), 68.4% (51.1, 82.5), and 68.2% (52.3, 81.3) of patients, respectively. There was no evidence of a cadazolid dosage-dependent response. Each dosage of cadazolid resulted in a lower recurrence rate than with vancomycin (18.2 to 25.0% versus 50%). Consequently, higher sustained clinical response rates were observed with cadazolid (46.7 to 60.0%) than with vancomycin (33.3%). The times to diarrhea resolution were similar for cadazolid and vancomycin. Cadazolid was well tolerated, with no safety signal observed. The results of this phase 2 study support further clinical development of cadazolid. (This study has been registered in the United States at ClinicalTrials.gov under registration no. NCT01222702 and in Europe with the European Medicines Agency under registration no. EUDRA-CT 2010-020941-29.).

  15. An Exploratory Short-Term Double-Blind Randomized Trial of Varenicline versus Nicotine Patch for Smoking Cessation in Women

    PubMed Central

    Gray, Kevin M.; McClure, Erin A.; Baker, Nathaniel L.; Hartwell, Karen J.; Carpenter, Matthew J.; Saladin, Michael E.

    2015-01-01

    Aims Within a parent study examining ovarian hormone effects on smoking cessation in women, we conducted an exploratory short-term trial of varenicline versus transdermal nicotine patch. Design Double-blind double-dummy randomized trial. Setting Single-site outpatient research clinic in the United States. Participants Female smokers, ages 18-45 and averaging ≥10 cigarettes per day for at least 6 months (N=140). Interventions Participants were randomized to receive a four-week course of (a) varenicline tablets and placebo patches (n=67), or (b) placebo tablets and nicotine patches (n=73). Two brief cessation counseling sessions were provided for all participants. Measurements The outcome of primary clinical interest was two-week end-of-treatment abstinence. Secondary outcomes included one- and four-week end-of treatment abstinence and abstinence at a post-treatment follow-up visit occurring four weeks after treatment conclusion. Breath carbon monoxide (≤10 parts per million) was used to confirm biochemically self-reported abstinence. Findings Two-week end-of-treatment abstinence was achieved by 37.3% (25/67) of varenicline participants and by 17.8% (13/73) of nicotine patch participants (odds ratio [OR] (95% confidence interval [CI]) 2.7 (1.3-6.0), p=0.011). One-week (44.8% vs 20.6%, OR 3.1 (1.5-6.6), p=0.003) and four-week (22.4% vs 9.6%, OR 2.7 (1.0-7.2), p=0.043) end-of-treatment abstinence similarly favored varenicline, though post-treatment follow-up Russell Standard abstinence was not significantly different between groups (23.9% vs 13.7%, OR 2.0 (0.8-4.7), p=0.126). Conclusion In an exploratory four-week head-to-head trial in female smokers, varenicline, compared with nicotine patch, more than doubled the odds of end-of-treatment abstinence, although this diminished somewhat at post-treatment follow-up. PMID:25727442

  16. Postoperative Neurocognitive Dysfunction in Patients Undergoing Cardiac Surgery after Remote Ischemic Preconditioning: A Double-Blind Randomized Controlled Pilot Study

    PubMed Central

    Meybohm, Patrick; Renner, Jochen; Broch, Ole; Caliebe, Dorothee; Albrecht, Martin; Cremer, Jochen; Haake, Nils; Scholz, Jens; Zacharowski, Kai; Bein, Berthold

    2013-01-01

    Background Remote ischemic preconditioning (RIPC) has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD) in patients undergoing complex cardiac surgery. Methods We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5–7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion) or if the combined Z score was 1.96 or greater (Z score criterion). Results According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5–7 days after surgery (p = 0.753). The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30) compared to the RIPC group (1.14±4.02; p = 0.228). Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19–1.94) µg/L vs. 0.48 (0.07–1.84) µg/L] and 24 hours after surgery [0.36 (0.14–1.89) µg/L vs. 0.26 (0.07–0.90) µg/L]. Conclusions We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. Trial Registration ClinicalTrials.gov NCT00877305 PMID:23741380

  17. Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial

    PubMed Central

    Steenhoff, Andrew P.; Schall, Joan I.; Samuel, Julia; Seme, Boitshepo; Marape, Marape; Ratshaa, Bakgaki; Goercke, Irene; Tolle, Michael; Nnyepi, Maria S.; Mazhani, Loeto; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

    2015-01-01

    Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902 PMID:25706751

  18. Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study

    PubMed Central

    2012-01-01

    Background Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) – a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. Methods 78 men aged 25–50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator’s Global assessment and Subjects’ opinion. Results In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator’s global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject’s rating for tolerability of treatment was similar in both groups. Conclusions Vig

  19. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial

    PubMed Central

    Ruha, Anne-Michelle; Seifert, Steven A.; Morgan, David L.; Lewis, Brandon J.; Arnold, Thomas C.; Clark, Richard F.; Meggs, William J.; Toschlog, Eric A.; Borron, Stephen W.; Figge, Gary R.; Sollee, Dawn R.; Shirazi, Farshad M.; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D.; Boyer, Leslie V.

    2015-01-01

    Background. Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. Methods. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count < 150 K/mm3, fibrinogen level < 150 mg/dL) between end of maintenance dosing and day 8. Results. 121 patients were randomized at 18 clinical sites and received at least one dose of study drug. 114 completed the study. Of these, 11/37 (29.7%) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. Conclusions. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation

  20. Blindness - resources

    MedlinePlus

    Resources - blindness ... The following organizations are good resources for information on blindness : American Foundation for the Blind -- www.afb.org Foundation Fighting Blindness -- www.blindness.org National Eye Institute -- ...

  1. Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

    PubMed Central

    Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

    2016-01-01

    Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

  2. SMA CARNI-VAL Trial Part I: Double-Blind, Randomized, Placebo-Controlled Trial of L-Carnitine and Valproic Acid in Spinal Muscular Atrophy

    PubMed Central

    Swoboda, Kathryn J.; Scott, Charles B.; Crawford, Thomas O.; Simard, Louise R.; Reyna, Sandra P.; Krosschell, Kristin J.; Acsadi, Gyula; Elsheik, Bakri; Schroth, Mary K.; D'Anjou, Guy; LaSalle, Bernard; Prior, Thomas W.; Sorenson, Susan L.; Maczulski, Jo Anne; Bromberg, Mark B.; Chan, Gary M.; Kissel, John T.

    2010-01-01

    Background Valproic acid (VPA) has demonstrated potential as a therapeutic candidate for spinal muscular atrophy (SMA) in vitro and in vivo. Methods Two cohorts of subjects were enrolled in the SMA CARNIVAL TRIAL, a non-ambulatory group of “sitters” (cohort 1) and an ambulatory group of “walkers” (cohort 2). Here, we present results for cohort 1: a multicenter phase II randomized double-blind intention-to-treat protocol in non-ambulatory SMA subjects 2–8 years of age. Sixty-one subjects were randomized 1∶1 to placebo or treatment for the first six months; all received active treatment the subsequent six months. The primary outcome was change in the modified Hammersmith Functional Motor Scale (MHFMS) score following six months of treatment. Secondary outcomes included safety and adverse event data, and change in MHFMS score for twelve versus six months of active treatment, body composition, quantitative SMN mRNA levels, maximum ulnar CMAP amplitudes, myometry and PFT measures. Results At 6 months, there was no difference in change from the baseline MHFMS score between treatment and placebo groups (difference = 0.643, 95% CI = −1.22–2.51). Adverse events occurred in >80% of subjects and were more common in the treatment group. Excessive weight gain was the most frequent drug-related adverse event, and increased fat mass was negatively related to change in MHFMS values (p = 0.0409). Post-hoc analysis found that children ages two to three years that received 12 months treatment, when adjusted for baseline weight, had significantly improved MHFMS scores (p = 0.03) compared to those who received placebo the first six months. A linear regression analysis limited to the influence of age demonstrates young age as a significant factor in improved MHFMS scores (p = 0.007). Conclusions This study demonstrated no benefit from six months treatment with VPA and L-carnitine in a young non-ambulatory cohort of subjects with SMA. Weight gain, age

  3. A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron

    PubMed Central

    2014-01-01

    Background Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients. Methods A total of 160 American Society of Anesthesiologists physical status I–II patients aged 19–65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n  =  55), ondansetron (8 mg; group B, n  =  54), or ramosetron (0.3 mg; group C, n  =  51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively. Results Among the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P  <  0.001; vomiting, P  =  0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P  <  0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0–2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2–48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events. Conclusion Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients

  4. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-01-01

    Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group

  5. Glucosamine-containing supplement improves locomotor functions in subjects with knee pain: a randomized, double-blind, placebo-controlled study

    PubMed Central

    Kanzaki, Noriyuki; Ono, Yoshiko; Shibata, Hiroshi; Moritani, Toshio

    2015-01-01

    Background The aim of this study was to investigate the ability of a glucosamine-containing supplement to improve locomotor functions in subjects with knee pain. Methods A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted for 16 weeks in 100 Japanese subjects (age, 51.8±0.8 years) with knee pain. Subjects were randomly assigned to one of the two supplements containing 1) 1,200 mg of glucosamine hydrochloride, 60 mg of chondroitin sulfate, 45 mg of type II collagen peptides, 90 mg of quercetin glycosides, 10 mg of imidazole peptides, and 5 μg of vitamin D per day (GCQID group, n=50) or 2) a placebo (placebo group, n=50). Japanese Knee Osteoarthritis Measure, visual analog scale score, normal walking speed, and knee-extensor strength were measured to evaluate the effects of the supplement on knee-joint functions and locomotor functions. Results In subjects eligible for efficacy assessment, there was no significant group × time interaction, and there were improvements in knee-joint functions and locomotor functions in both groups, but there was no significant difference between the groups. In subjects with mild-to-severe knee pain at baseline, knee-extensor strength at week 8 (104.6±5.0% body weight vs 92.3±5.5% body weight, P=0.030) and the change in normal walking speed at week 16 (0.11±0.03 m/s vs 0.05±0.02 m/s, P=0.038) were significantly greater in the GCQID group than in the placebo group. Further subgroup analysis based on Kellgren–Lawrence (K–L) grade showed that normal walking speed at week 16 (1.36±0.05 m/s vs 1.21±0.02 m/s, P<0.05) was significantly greater in the GCQID group than in the placebo group in subjects with K–L grade I. No adverse effect of treatment was identified in the safety assessment. Conclusion In subjects with knee pain, GCQID supplementation was effective for relieving knee pain and improving locomotor functions. PMID:26604721

  6. Effects of isoflurane, sevoflurane, and desflurane on platelet function: A prospective, randomized, single-blind, in vivo study

    PubMed Central

    Bozdogan, Nesrin; Madenoglu, Halit; Dogru, Kudret; Yildiz, Karamehmet; Kotanoglu, Mustafa S.; Cetin, Mustafa; Boyaci, Adem

    2005-01-01

    Background: The primary physiologic function of platelets is to facilitate hemostasisby aggregation. Volatile anesthetics have been reported to decrease platelet aggregation in vivo and in vitro. Objective: The aim of this study was to investigate the hematologic effectsof the anesthetics isoflurane, sevoflurane, and desflurane on hemoglobin (Hb), hematocrit (Hct), platelet count, activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), and platelet aggregation after minor surgery. Methods: Patients aged 20 to 60 years who were scheduled to undergominor surgery and American Society of Anesthesiologists physical status P1 or P2 (healthy or mild systemic disease) were randomized to 1 of 3 groups: 1 minimum alveolar concentration (MAC) of isoflurane, sevoflurane, or desflurane. None of the patients received premedication. Anesthesia was induced using IV thiopental 5 to 6 mg/kg, fentanyl 1 to 2 μg/kg, and vecuronium 0.1 mg/kg, and maintained with 1 MAC of isoflurane, sevoflurane, or desflurane in 66% nitrous oxide and 33% oxygen. Vecuronium 0.03 mg/kg was given when necessary for muscle relaxation. All patients were monitored throughout surgery; isotonic saline was given at a rate of 5 mL/kg · h. Hematologic studies were performed preoperatively, 15 minutes after intubation, and 1 hour after the end of surgery. Platelet aggregation tests were performed in a laboratory using a platelet function analyzer (PFA), collagen/epinephrine PFA test cartridges, collagen/adenosine diphosphate PFA test cartridges, and PFA trigger solution. Results: This prospective, randomized, single-blind, in vivo study was conducted at Gevher Nesibe Teaching Hospital, Erciyes University, Kayseri, Turkey. Thirty patients (15 men, 15 women) were randomized to the 3 treatment groups (each, n = 10). Hb, Hct, platelet count, aPTT, PT, and INR were statistically similar between all 3 groups. The measured parameters were not significantly different

  7. Protective Effect of Folic Acid on Oxidative DNA Damage: A Randomized, Double-Blind, and Placebo Controlled Clinical Trial.

    PubMed

    Guo, Xiaojuan; Cui, Huan; Zhang, Haiyang; Guan, Xiaoju; Zhang, Zheng; Jia, Chaonan; Wu, Jia; Yang, Hui; Qiu, Wenting; Zhang, Chuanwu; Yang, Zuopeng; Chen, Zhu; Mao, Guangyun

    2015-11-01

    Although previous reports have linked DNA damage with both transmissions across generations as well as our own survival, it is unknown how to reverse the lesion. Based on the data from a Randomized, Double-blind, Placebo Controlled Clinical Trial, this study aimed to assess the efficacy of folic acid supplementation (FAS) on DNA oxidative damage reversal.In this randomized clinical trial (RCT), a total of 450 participants were enrolled and randomly assigned to 3 groups to receive folic acid (FA) 0.4 mg/day (low-FA), 0.8 mg/day (high-FA), or placebo (control) for 8 weeks. The urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) and creatinine (Cr) concentration at pre- and post-FAS were measured with modified enzyme-linked immunosorbent assay (ELISA) and high-performance liquid chromatography (HPLC), respectively. A multivariate general linear model was applied to assess the individual effects of FAS and the joint effects between FAS and hypercholesterolemia on oxidative DNA damage improvement. This clinical trial was registered with ClinicalTrials.gov, number NCT02235948.Of the 438 subjects that received FA fortification or placebo, the median (first quartile, third quartile) of urinary 8-OHdG/Cr for placebo, low-FA, and high-FA groups were 58.19 (43.90, 82.26), 53.51 (38.97, 72.74), 54.73 (39.58, 76.63) ng/mg at baseline and 57.77 (44.35, 81.33), 51.73 (38.20, 71.30), and 50.65 (37.64, 76.17) ng/mg at the 56th day, respectively. A significant decrease of urinary 8-OHdG was observed after 56 days FA fortification (P < 0.001). Compared with the placebo, after adjusting for some potential confounding factors, including the baseline urinary 8-OHdG/Cr, the urinary 8-OHdG/Cr concentration significantly decreased after 56 days FAS [β (95% confidence interval) = -0.88 (-1.62, -0.14) and P = 0.020 for low-FA; and β (95% confidence interval) = -2.68 (-3.42, -1.94) and P < 0.001 for high-FA] in a dose-response fashion (Ptrend < 0.001). Test of

  8. Intranasal adminsitration of oxytocin in postnatal depression: implications for psychodynamic psychotherapy from a randomized double-blind pilot study

    PubMed Central

    Clarici, Andrea; Pellizzoni, Sandra; Guaschino, Secondo; Alberico, Salvatore; Bembich, Stefano; Giuliani, Rosella; Short, Antonia; Guarino, Giuseppina; Panksepp, Jaak

    2015-01-01

    Oxytocin is a neuropeptide that is active in the central nervous system and is generally considered to be involved in prosocial behaviors and feelings. In light of its documented positive effect on maternal behavior, we designed a study to ascertain whether oxytocin exerts any therapeutic effects on depressive symptoms in women affected by maternal postnatal depression. A group of 16 mothers were recruited in a randomized double-blind study: the women agreed to take part in a brief course of psychoanalytic psychotherapy (12 sessions, once a week) while also being administered, during the 12-weeks period, a daily dose of intranasal oxytocin (or a placebo). The pre-treatment evaluation also included a personality assessment of the major primary-process emotional command systems described by Panksepp () and a semi-quantitative assessment by the therapist of the mother’s depressive symptoms and of her personality. No significant effect on depressive symptomatology was found following the administration of oxytocin (as compared to a placebo) during the period of psychotherapy. Nevertheless, a personality trait evaluation of the mothers, conducted in our overall sample group, showed a decrease in the narcissistic trait only within the group who took oxytocin. The depressive (dysphoric) trait was in fact significantly affected by psychotherapy (this effect was only present in the placebo group so it may reflect a positive placebo effect enhancing the favorable influence of psychotherapy on depressive symptoms) but not in the presence of oxytocin. Therefore, the neuropeptide would appear to play some role in the modulation of cerebral functions involved in the self-centered (narcissistic) dimension of the suffering that can occur with postnatal depression. Based on these results, there was support for our hypothesis that what is generally defined as postnatal depression may include disturbances of narcissistic affective balance, and oxytocin supplementation can

  9. Inhibition of Tongue Coat and Dental Plaque Formation by Stabilized Chlorine Dioxide Vs Chlorhexidine Mouthrinse: A Randomized, Triple Blinded Study

    PubMed Central

    Kini, Vineet Vaman; Padhye, Ashvini

    2015-01-01

    Background Chlorine dioxide (ClO2) is an oxidizing agent with known bactericidal, viricidal and fungicidal properties. Its efficacy in reducing the halitosis has been established by previous literature. However, data evaluating its antiplaque property is scarce. Chlorhexidine (CHX) is considered as the gold standard and an effective adjunctive to mechanical plaque removal. However, it is associated with few reversible side effects. Therefore a study was conducted to assess the antiplaque property of ClO2 containing mouthrinse against CHX mouthrinse. Aims and Objectives To evaluate the efficacy of stabilized chlorine dioxide containing mouthrinse and CHX containing mouthrinse in inhibition of tongue coat accumulation and dental plaque formation using a four day plaque regrowth model clinically and microbiologically in a healthy dental cohort. Materials and Methods A Single Center, Randomized, Triple blinded, Microbiological clinical trial was conducted involving 25 healthy dental students volunteers (11 males, 14 females). Two commercially available mouthrinse: Mouthrinse A – Aqueous based ClO2 mouthrinse Freshchlor® and Mouthrinse B - Aqueous based 0.2% CHX mouthrinse Hexidine® were selected as the test products. Subjects were asked to rinse and gargle for 1 minute with the allocated mouthrinse under supervision after supragingival scaling, polishing and tongue coat removal. After four hours, smears were taken from the buccal mucosa and tooth surface. On the fifth day from baseline of four day non brushing plaque regrowth model the samples were again taken from buccal mucosa and tooth surface followed by recording of plaque scores by Rastogi Modification of Navy Plaque index, extent of tongue coat by Winkel’s tongue coating index and measuring tongue coat wet weight in grams. The samples collected were subjected to microbial analysis and the results were expressed as colony forming units (CFUs) per sample. Statistical Analysis The Data was analysed using SPSS

  10. Double-blind, vehicle-controlled randomized twelve-month neurodevelopmental toxicity study of common aluminum salts in the rat.

    PubMed

    Poirier, J; Semple, H; Davies, J; Lapointe, R; Dziwenka, M; Hiltz, M; Mujibi, D

    2011-10-13

    This good laboratory practice (GLP) study of aluminum salts in Sprague-Dawley rats was conducted according to double-blind, vehicle-controlled randomized design by exposing offspring to aluminum citrate in-utero, through lactation, and then in drinking water post-weaning. Three dose levels were used: 30, 100, 300 mg Al/kg bw/day, in addition to control groups that received either water or a sodium citrate solution (27.2 g/L). Endpoints were assessed in both female and male pups: behavioral (motor activity, T-maze, auditory startle, the Functional Observational Battery (FOB) with domains targeting autonomic function, activity, neuromuscular function, sensimotor function, and physiological function), cognitive function (Morris swim maze), brain weight, clinical chemistry, hematology, tissue/blood levels of aluminum and neuropathology. The most notable treatment-related effect observed in the offspring was renal pathology, most prominently in the male pups. Higher mortality and significant morbidity were observed in the male pups in the high Al-citrate dose group; leading to euthanization of this group at day 89. There was evidence for dose-response relationships between neuromuscular measurements-hind-limb and fore-limb grip strength-and Al-treatment in both males and females, although some of the effects may be secondary to body weight changes. No consistent treatment-related effects were observed in ambulatory counts (motor activity) in the different cohorts. No significant effects were observed for the auditory startle response, T-maze tests (pre-weaning day 23 cohort) or the Morris water maze test (day 120 cohort). None of the lesions seen on histopathological examination of brain tissues of the day 364 group was reported as treatment-related and, as these were also seen in the control group, were likely due to aging. In conclusion, these results indicate that concentrations of aluminum in the drinking water that are required to produce minimally detectable

  11. Dietary nitrate improves vascular function in patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled study123

    PubMed Central

    Velmurugan, Shanti; Gan, Jasmine Ming; Rathod, Krishnaraj S; Khambata, Rayomand S; Ghosh, Suborno M; Hartley, Amy; Van Eijl, Sven; Sagi-Kiss, Virag; Chowdhury, Tahseen A; Curtis, Mike; Kuhnle, Gunter GC; Wade, William G; Ahluwalia, Amrita

    2016-01-01

    Background: The beneficial cardiovascular effects of vegetables may be underpinned by their high inorganic nitrate content. Objective: We sought to examine the effects of a 6-wk once-daily intake of dietary nitrate (nitrate-rich beetroot juice) compared with placebo intake (nitrate-depleted beetroot juice) on vascular and platelet function in untreated hypercholesterolemics. Design: A total of 69 subjects were recruited in this randomized, double-blind, placebo-controlled parallel study. The primary endpoint was the change in vascular function determined with the use of ultrasound flow-mediated dilatation (FMD). Results: Baseline characteristics were similar between the groups, with primary outcome data available for 67 patients. Dietary nitrate resulted in an absolute increase in the FMD response of 1.1% (an ∼24% improvement from baseline) with a worsening of 0.3% in the placebo group (P < 0.001). A small improvement in the aortic pulse wave velocity (i.e., a decrease of 0.22 m/s; 95% CI: −0.4, −0.3 m/s) was evident in the nitrate group, showing a trend (P = 0.06) to improvement in comparison with the placebo group. Dietary nitrate also caused a small but significant reduction (7.6%) in platelet-monocyte aggregates compared with an increase of 10.1% in the placebo group (P = 0.004), with statistically significant reductions in stimulated (ex vivo) P-selectin expression compared with the placebo group (P < 0.05) but no significant changes in unstimulated expression. No adverse effects of dietary nitrate were detected. The composition of the salivary microbiome was altered after the nitrate treatment but not after the placebo treatment (P < 0.01). The proportions of 78 bacterial taxa were different after the nitrate treatment; of those taxa present, 2 taxa were responsible for >1% of this change, with the proportions of Rothia mucilaginosa trending to increase and Neisseria flavescens (P < 0.01) increased after nitrate treatment relative to after placebo

  12. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study

    PubMed Central

    Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

    2016-01-01

    Background Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. Methods This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014—June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Results Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects. Conclusion This study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for

  13. Double-blind, vehicle-controlled randomized twelve-month neurodevelopmental toxicity study of common aluminum salts in the rat.

    PubMed

    Poirier, J; Semple, H; Davies, J; Lapointe, R; Dziwenka, M; Hiltz, M; Mujibi, D

    2011-10-13

    This good laboratory practice (GLP) study of aluminum salts in Sprague-Dawley rats was conducted according to double-blind, vehicle-controlled randomized design by exposing offspring to aluminum citrate in-utero, through lactation, and then in drinking water post-weaning. Three dose levels were used: 30, 100, 300 mg Al/kg bw/day, in addition to control groups that received either water or a sodium citrate solution (27.2 g/L). Endpoints were assessed in both female and male pups: behavioral (motor activity, T-maze, auditory startle, the Functional Observational Battery (FOB) with domains targeting autonomic function, activity, neuromuscular function, sensimotor function, and physiological function), cognitive function (Morris swim maze), brain weight, clinical chemistry, hematology, tissue/blood levels of aluminum and neuropathology. The most notable treatment-related effect observed in the offspring was renal pathology, most prominently in the male pups. Higher mortality and significant morbidity were observed in the male pups in the high Al-citrate dose group; leading to euthanization of this group at day 89. There was evidence for dose-response relationships between neuromuscular measurements-hind-limb and fore-limb grip strength-and Al-treatment in both males and females, although some of the effects may be secondary to body weight changes. No consistent treatment-related effects were observed in ambulatory counts (motor activity) in the different cohorts. No significant effects were observed for the auditory startle response, T-maze tests (pre-weaning day 23 cohort) or the Morris water maze test (day 120 cohort). None of the lesions seen on histopathological examination of brain tissues of the day 364 group was reported as treatment-related and, as these were also seen in the control group, were likely due to aging. In conclusion, these results indicate that concentrations of aluminum in the drinking water that are required to produce minimally detectable

  14. Recombinant Human Erythropoietin for Treating Treatment-Resistant Depression: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial

    PubMed Central

    Miskowiak, Kamilla W; Vinberg, Maj; Christensen, Ellen M; Bukh, Jens D; Harmer, Catherine J; Ehrenreich, Hannelore; Kessing, Lars V

    2014-01-01

    Pharmacological treatments for depression have insufficient efficacy in 30–40% of patients and fail to reverse cognitive deficits. Erythropoietin (EPO) has neurotrophic actions and aids neurocognitive function. The aim of this exploratory study was to determine whether recombinant human EPO improves mood and memory in treatment-resistant depression. Forty treatment-resistant depressed unipolar patients with Hamilton Depression Rating Scale-17 (HDRS-17) score ⩾17 were randomized to eight weekly EPO (Eprex; 40 000 IU) or saline infusions in a double-blind, placebo-controlled, parallel-group design. Patients were assessed at baseline and at weeks 5, 9, and 14. Primary outcome was reduction in HDRS-17 score. Global assessment of function (GAF) was reported in addition. Secondary outcome was remission rate, and tertiary outcomes were changes in Rey Auditory Verbal Learning Test (RAVLT), Beck Depression Inventory-21 (BDI-21), and World Health Organization Quality of life-BREF (WHOQOL-BREF). Exploratory outcomes were depression and cognition composite scores. HDRS-17, GAF, and remission rates showed no effects of EPO over saline at week 9 (P-value ⩾0.09). However, EPO improved BDI (P=0.02) and WHOQOL-BREF (P=0.01), and this was maintained at follow-up week 14 (P-values ⩽0.04). EPO enhanced verbal recall (P=0.02) and recognition (P=0.03), which was sustained at follow-up (P-values ⩽0.04). Exploratory analysis in patients fulfilling depression severity criteria at trial start revealed ameliorated HDRS-17 in EPO (N=14) vs saline groups (N=17), which was sustained at week 14 (P-values ⩽0.05). Exploratory analysis in the complete cohort showed that EPO reduced depression composite at weeks 9 and 14 (P-values=0.02). The findings of this exploratory study highlight EPO as an interesting compound for treatment-resistant depression, which deserves further investigation. PMID:24322509

  15. Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

    PubMed Central

    2011-01-01

    Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the

  16. A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer

    PubMed Central

    Paller, CJ; Ye, X; Wozniak, PJ; Gillespie, BK; Sieber, PR; Greengold, RH; Stockton, BR; Hertzman, BL; Efros, MD; Roper, RP; Liker, HR; Carducci, MA

    2012-01-01

    BACKGROUND Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome. METHODS This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm. RESULTS: Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P<0.001). PSADT lengthened in the low-dose group from 11.9 to 18.8 months and 12.2 to 17.5 months in the high-dose group, with no significant difference between dose groups (P =0.554). PSADT increases >100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively. CONCLUSIONS POMx treatment was associated with ≥6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population. PMID:22689129

  17. A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia

    PubMed Central

    Tandon, Rajiv; Cucchiaro, Josephine; Phillips, Debra; Hernandez, David; Mao, Yongcai; Pikalov, Andrei; Loebel, Antony

    2016-01-01

    Objective: To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia. Method: Adults experiencing an acute exacerbation of schizophrenia initially received 12–24 weeks of open-label treatment with lurasidone (40–80 mg/d, flexibly dosed). Patients who maintained clinical stability for ⩾12 weeks were randomized in double-blind fashion to placebo or lurasidone (40–80 mg/d, flexibly dosed) for an additional 28-week treatment period. The primary efficacy endpoint was time to relapse (based on Kaplan–Meier survival analysis). Results: A total of 676 patients enrolled in the open-label phase; 285 met protocol-specified stabilization criteria and were randomized to lurasidone (N=144) or placebo (N=141). During the open-label phase, mean Positive and Negative Syndrome Scale total score decreased from 90.1 to 54.4 in patients who met clinical stability criteria and were randomized. In the double-blind phase, lurasidone significantly delayed time to relapse compared with placebo (log-rank test, p=0.039), reflecting a 33.7% reduction in risk of relapse (Cox hazard ratio (95% confidence interval), 0.663 (0.447–0.983); p=0.041). Probability of relapse at the double-blind week 28 endpoint (based on Kaplan–Meier analysis) was 42.2% in the lurasidone group and 51.2% in the placebo group. Minimal changes in weight, lipid, glucose, and prolactin were observed throughout the study. Conclusions: This multicenter, placebo-controlled, randomized withdrawal study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia. PMID:26645209

  18. Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients with Barrett's Esophagus.

    PubMed

    Joe, Andrew K; Schnoll-Sussman, Felice; Bresalier, Robert S; Abrams, Julian A; Hibshoosh, Hanina; Cheung, Ken; Friedman, Richard A; Yang, Chung S; Milne, Ginger L; Liu, Diane D; Lee, J Jack; Abdul, Kazeem; Bigg, Michelle; Foreman, Jessica; Su, Tao; Wang, Xiaomei; Ahmed, Aqeel; Neugut, Alfred I; Akpa, Esther; Lippman, Scott M; Perloff, Marjorie; Brown, Powel H; Lightdale, Charles J

    2015-12-01

    This study was conducted to determine the safety and efficacy of the green tea-derived Polyphenon E (Poly E) in patients with Barrett's Esophagus (BE). Subjects were randomized to a 6-month, twice daily (BID) oral treatment of placebo or Poly E (200, 400, or 600 mg). Endoscopic evaluation, including biopsies, was performed before and after treatment. The primary objective was to demonstrate safety; secondary objectives investigated catechin accumulation and effects in clinical specimens. Of the 44 enrolled subjects, 11 received placebo, and 33 received Poly E. No dose-limiting toxicities were encountered, and a maximum tolerated dose (MTD) was not reached. The recommended phase II dose was 600 mg twice daily. The most common treatment-related adverse events (AE) in Poly E-treated subjects were grade I and II nausea, grade I belching, and grade I lactate dehydrogenase (LDH) elevation. No treatment-related AEs were reported in placebo-treated subjects, aside from grade I laboratory abnormalities. Pill counts and subject diaries were not consistently collected, and compliance was difficult to determine. However, on the basis of an intention-to-treat analysis, there was a significant relationship between Poly E dose and esophageal EGCG level--mean changes (pmol/g) of 0.79 (placebo), 6.06 (200 mg), 35.67 (400 mg), and 34.95 (600 mg); P = 0.005. There was a possible relationship between Poly E dose and urine PGE-M concentration. In conclusion, Poly E was well-tolerated, and treatment with Poly E (400 and 600 mg) but not Poly E (200 mg) or placebo resulted in clinically relevant and detectable EGCG accumulation in the target organ, esophageal mucosa. PMID:26471236

  19. A Randomized Blinded Study of the Left Ventricular Myocardial Performance Index Comparing Epinephrine to Levosimendan following Cardiopulmonary Bypass

    PubMed Central

    Salgado Filho, Marcello Fonseca; Barral, Marselha; Barrucand, Louis; Cavalcanti, Ismar Lima; Verçosa, Nubia

    2015-01-01

    Background The objective was to evaluate the effect of epinephrine and levosimendan on the left ventricle myocardial performance index in patients undergoing on-pump coronary artery by-pass grafting (CABG). Methods In a double-blind, randomized clinical trial, 81 patients (age: 45–65 years) of both genders were randomly divided to receive either epinephrine at a dosage of 0.06 mcg.kg1.min-1 (epinephrine group, 39 patients) or levosimendan at 0.2 mcg.kg1.min-1 (levosimendan group, 42 patients) during the rewarming of cardiopulmonary by-pass (CPB). Hemodynamic data were collected 30 minutes after tracheal intubation, before chest open (pre-CPB) and 10 minutes after termination of protamine (post-CPB). As the primary outcome, we evaluated the left ventricle myocardial performance index by the Doppler echocardiography. The myocardial performance index is the sum of the isovolumetric contraction time and the isovolumetric relaxation time, divided by the ejection time. Secondary outcomes were systolic and diastolic evaluations of the left ventricle and postoperative troponin I and MB-CK levels. Results Of the 81 patients allocated to the research, we excluded 2 patients in the epinephrine group and 6 patients in the levosimendan group because they didn’t wean from CPB in the first attempt. There was no statistical difference between the groups in terms of patient characteristics, risk factors, or CPB time. The epinephrine group had a lower left ventricle myocardial performance index (p = 0.0013), higher cardiac index (p = 0.03), lower systemic vascular resistance index (p = 0.01), and higher heart rate (p = 0.04) than the levosimendan group at the post-CPB period. There were no differences between the groups in diastolic dysfunction. The epinephrine group showed higher incidence of weaning from CPB in the first attempt (95% vs 85%, p = 0.0001) when compared to the levosimendan group and the norepinephrine requirement was higher in the levosimenandan group than

  20. Effects of Lactobacillus gasseri OLL2716 on Helicobacter pylori-Associated Dyspepsia: A Multicenter Randomized Double-Blind Controlled Trial.

    PubMed

    Takagi, Atsushi; Yanagi, Hidetaka; Ozawa, Hideki; Uemura, Naomi; Nakajima, Shigemi; Inoue, Kazuhiko; Kawai, Takashi; Ohtsu, Toshihiro; Koga, Yasuhiro

    2016-01-01

    Some Lactobacillus spp. suppress Helicobacter pylori in the stomach and have potential therapeutic applications for the treatment of gastrointestinal conditions. In this study, the effects of Lactobacillus strains on functional dyspepsia associated with H. pylori infection were examined. Volunteers were screened using the (13)C-urea breath test (UBT) and H. pylori stool test, and 131 participants who met the selection criteria (mean age: 48.9 years) were randomly given L. gasseri OLL2716-containing yogurt or placebo yogurt once daily for 12 weeks. Gastrointestinal symptoms (epigastric pain, bloating, postprandial fullness, nausea, and heartburn) and the levels of serum pepsinogen (PG), (13)C-UBT, and H. pylori stool antigen were assessed. No significant differences were observed between the groups in UBT results, H. pylori stool antigens, or the serum PGI/II ratio. In the L. gasseri group, postprandial fullness was significantly lower at the end of the trial compared to the initial level (p < 0.05) and significantly fewer patients had a VAS score of >10 for bloating compared to the placebo group (p < 0.05). Dietary supplementation with L. gasseri OLL2716-containing yogurt may effectively suppress dyspeptic symptoms in H. pylori-infected patients. This study was registered at the University Hospital Medical Network Clinical Trial Registry (UMIN000016746). PMID:27478434

  1. Effects of Lactobacillus gasseri OLL2716 on Helicobacter pylori-Associated Dyspepsia: A Multicenter Randomized Double-Blind Controlled Trial

    PubMed Central

    Ozawa, Hideki; Uemura, Naomi; Inoue, Kazuhiko; Kawai, Takashi; Ohtsu, Toshihiro; Koga, Yasuhiro

    2016-01-01

    Some Lactobacillus spp. suppress Helicobacter pylori in the stomach and have potential therapeutic applications for the treatment of gastrointestinal conditions. In this study, the effects of Lactobacillus strains on functional dyspepsia associated with H. pylori infection were examined. Volunteers were screened using the 13C-urea breath test (UBT) and H. pylori stool test, and 131 participants who met the selection criteria (mean age: 48.9 years) were randomly given L. gasseri OLL2716-containing yogurt or placebo yogurt once daily for 12 weeks. Gastrointestinal symptoms (epigastric pain, bloating, postprandial fullness, nausea, and heartburn) and the levels of serum pepsinogen (PG), 13C-UBT, and H. pylori stool antigen were assessed. No significant differences were observed between the groups in UBT results, H. pylori stool antigens, or the serum PGI/II ratio. In the L. gasseri group, postprandial fullness was significantly lower at the end of the trial compared to the initial level (p < 0.05) and significantly fewer patients had a VAS score of >10 for bloating compared to the placebo group (p < 0.05). Dietary supplementation with L. gasseri OLL2716-containing yogurt may effectively suppress dyspeptic symptoms in H. pylori-infected patients. This study was registered at the University Hospital Medical Network Clinical Trial Registry (UMIN000016746). PMID:27478434

  2. Emergence of patterns in random processes. II. Stochastic structure in random events.

    PubMed

    Newman, William I

    2014-06-01

    Random events can present what appears to be a pattern in the length of peak-to-peak sequences in time series and other point processes. Previously, we showed that this was the case in both individual and independently distributed processes as well as for Brownian walks. In addition, we introduced the use of the discrete form of the Langevin equation of statistical mechanics as a device for connecting the two limiting sets of behaviors, which we then compared with a variety of observations from the physical and social sciences. Here, we establish a probabilistic framework via the Smoluchowski equation for exploring the Langevin equation and its expected peak-to-peak sequence lengths, and we introduce a concept we call "stochastic structure in random events," or SSRE. We extend the Brownian model to include antipersistent processes via autoregressive (AR) models. We relate the latter to describe the behavior of Old Faithful Geyser in Yellowstone National Park, and we devise a further test for the validity of the Langevin and AR models. Given our analytic results, we show how the Langevin equation can be adapted to describe population cycles of three to four years observed among many mammalian species in biology.

  3. Emergence of patterns in random processes. II. Stochastic structure in random events.

    PubMed

    Newman, William I

    2014-06-01

    Random events can present what appears to be a pattern in the length of peak-to-peak sequences in time series and other point processes. Previously, we showed that this was the case in both individual and independently distributed processes as well as for Brownian walks. In addition, we introduced the use of the discrete form of the Langevin equation of statistical mechanics as a device for connecting the two limiting sets of behaviors, which we then compared with a variety of observations from the physical and social sciences. Here, we establish a probabilistic framework via the Smoluchowski equation for exploring the Langevin equation and its expected peak-to-peak sequence lengths, and we introduce a concept we call "stochastic structure in random events," or SSRE. We extend the Brownian model to include antipersistent processes via autoregressive (AR) models. We relate the latter to describe the behavior of Old Faithful Geyser in Yellowstone National Park, and we devise a further test for the validity of the Langevin and AR models. Given our analytic results, we show how the Langevin equation can be adapted to describe population cycles of three to four years observed among many mammalian species in biology. PMID:25019731

  4. Emergence of patterns in random processes. II. Stochastic structure in random events

    NASA Astrophysics Data System (ADS)

    Newman, William I.

    2014-06-01

    Random events can present what appears to be a pattern in the length of peak-to-peak sequences in time series and other point processes. Previously, we showed that this was the case in both individual and independently distributed processes as well as for Brownian walks. In addition, we introduced the use of the discrete form of the Langevin equation of statistical mechanics as a device for connecting the two limiting sets of behaviors, which we then compared with a variety of observations from the physical and social sciences. Here, we establish a probabilistic framework via the Smoluchowski equation for exploring the Langevin equation and its expected peak-to-peak sequence lengths, and we introduce a concept we call "stochastic structure in random events," or SSRE. We extend the Brownian model to include antipersistent processes via autoregressive (AR) models. We relate the latter to describe the behavior of Old Faithful Geyser in Yellowstone National Park, and we devise a further test for the validity of the Langevin and AR models. Given our analytic results, we show how the Langevin equation can be adapted to describe population cycles of three to four years observed among many mammalian species in biology.

  5. Multivitamins in the Prevention of Cancer in Men: The Physicians’ Health Study II Randomized Controlled Trial

    PubMed Central

    Gaziano, J. Michael; Sesso, Howard D.; Christen, William G.; Bubes, Vadim; Smith, Joanne P.; MacFadyen, Jean; Schvartz, Miriam; Manson, JoAnn E.; Glynn, Robert J.; Buring, Julie E.

    2012-01-01

    Context Multivitamin preparations are the most common dietary supplement, taken by at least one-third of all US adults. Limited observational studies have not provided evidence regarding associations of multivitamin use with total and site-specific cancer incidence or mortality. Objective To determine whether long-term multivitamin supplementation decreases the risk of total and site-specific cancer events among men. Design The Physicians’ Health Study II is a randomized, double-blind, placebo-controlled trial of a common multivitamin that began in 1997 with treatment and follow-up through June 1, 2011. Setting and Participants A total of 14,641 male U.S. physicians initially aged ≥50 years (mean [± SD] age; 64.3 [± 9.2] years), including 1,312 men with a history of cancer at randomization, were enrolled. Intervention Daily multivitamin, as Centrum Silver. Main Outcome Measures A primary outcome was total cancer (excluding non-melanoma skin cancer), with prostate, colorectal, and other site-specific cancers among secondary endpoints included in this report. Results During a median (interquartile range) follow-up of 11.2 (10.7 to 13.3) years, there were 2,669 men with confirmed cancer, including 1,373 cases of prostate cancer and 210 cases of colorectal cancer. Compared with placebo, men taking a daily multivitamin had a statistically significant reduction in the incidence of total cancer (active and placebo multivitamin groups, 17.0 and 18.3 events, respectively, per 1,000 person-years; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.86–0.998; P=0.044). There was no significant effect of a daily multivitamin on prostate cancer (HR, 0.98; 95% CI, 0.88–1.09; P=0.76), colorectal cancer (HR, 0.89; 95% CI, 0.68–1.17; P=0.39), or other site-specific cancers There was a lower risk of cancer mortality that did not reach statistical significance (HR, 0.88; 95% CI, 0.77–1.01; P=0.