Science.gov

Sample records for study comparing duloxetine

  1. Duloxetine

    MedlinePlus

    Duloxetine is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). Duloxetine is also used to treat pain ...

  2. Study on fluorescence characteristics of duloxetine hydrochloride

    NASA Astrophysics Data System (ADS)

    Liu, Xiangping; Du, Yingxiang; Wu, Xiulan

    2008-12-01

    The fluorescence characteristics of duloxetine hydrochloride are studied in this paper. The fluorescence emission spectra of duloxetine demonstrate that intramolecular charge-transfer takes place between thiophene ring and napthalenyloxy group upon irradiation. The effects of excitation light, solvent system, variation of solution pH value, metal ions and vitamin C on the fluorescence spectra of duloxetine hydrochloride are elucidated, respectively. A spectrofluorometric method of quantitative determination of duloxetine in dosage form is reported for the first time, the linear range is 7.14 × 10 -8 mol/L to 1.43 × 10 -5 mol/L, the linear correlation coefficient r is equal to 0.9997, and the detection limit is 3.5 × 10 -8 mol/L. The accuracy and the precision are satisfactory.

  3. Effectiveness of duloxetine compared with pregabalin and gabapentin in diabetic peripheral neuropathic pain: results from a German observational study.

    PubMed

    Happich, Michael; Schneider, Edith; Boess, Frank G; Wilhelm, Stefan; Schacht, Alexander; Birklein, Frank; Ziegler, Dan

    2014-10-01

    This study aimed to compare the effectiveness of duloxetine (DLX) and the anticonvulsants pregabalin (PGB) and gabapentin (GBP) for the treatment of diabetic peripheral neuropathic pain (DPNP) in routine clinical care. Data from a 6-month, noninterventional study involving 2575 patients in whom treatment of DPNP was initiated with or changed to DLX, PGB, or GBP (n=1523) were analyzed post hoc; patients treated with other medications or combinations were excluded from this analysis. Propensity scoring was used to compare patient groups, assessing Brief Pain Inventory (BPI), Clinical and Patient Global Impression (CGI/PGI), the Hospital Anxiety and Depression Scale (HADS), the Sheehan Disability Scale (SDS), and the Short Form Health Survey (SF 12). Mean median daily dosage over 6 months was 53.9 mg for DLX (N=931), 173.5 mg for PGB (N=248), and 727.8 mg for GBP (N=351). BPI average pain severity (last observation carried forward, mean [SD]) decreased by 2.3 [2.30] points for DLX patients, and by 1.9 [2.22] in PGB, and 1.1 [2.15] in GBP patients. This difference remained statistically significant (DLX vs. PGB: P=0.029; DLX vs. GBP: P<0.001) after adjustment by propensity scores. Similar findings were also seen for the BPI interference score, CGI and PGI, the HADS anxiety score, the HADS depression score. When compared with DLX, the low doses of PGB and GBP used in this noninterventional study might have contributed to the lower effectiveness found for both anticonvulsants in the treatment of patients with DPNP.

  4. Duloxetine compared with fluoxetine and venlafaxine: use of meta-regression analysis for indirect comparisons

    PubMed Central

    Eckert, Laurent; Lançon, Christophe

    2006-01-01

    Background Data comparing duloxetine with existing antidepressant treatments is limited. A comparison of duloxetine with fluoxetine has been performed but no comparison with venlafaxine, the other antidepressant in the same therapeutic class with a significant market share, has been undertaken. In the absence of relevant data to assess the place that duloxetine should occupy in the therapeutic arsenal, indirect comparisons are the most rigorous way to go. We conducted a systematic review of the efficacy of duloxetine, fluoxetine and venlafaxine versus placebo in the treatment of Major Depressive Disorder (MDD), and performed indirect comparisons through meta-regressions. Methods The bibliography of the Agency for Health Care Policy and Research and the CENTRAL, Medline, and Embase databases were interrogated using advanced search strategies based on a combination of text and index terms. The search focused on randomized placebo-controlled clinical trials involving adult patients treated for acute phase Major Depressive Disorder. All outcomes were derived to take account for varying placebo responses throughout studies. Primary outcome was treatment efficacy as measured by Hedge's g effect size. Secondary outcomes were response and dropout rates as measured by log odds ratios. Meta-regressions were run to indirectly compare the drugs. Sensitivity analysis, assessing the influence of individual studies over the results, and the influence of patients' characteristics were run. Results 22 studies involving fluoxetine, 9 involving duloxetine and 8 involving venlafaxine were selected. Using indirect comparison methodology, estimated effect sizes for efficacy compared with duloxetine were 0.11 [-0.14;0.36] for fluoxetine and 0.22 [0.06;0.38] for venlafaxine. Response log odds ratios were -0.21 [-0.44;0.03], 0.70 [0.26;1.14]. Dropout log odds ratios were -0.02 [-0.33;0.29], 0.21 [-0.13;0.55]. Sensitivity analyses showed that results were consistent. Conclusion Fluoxetine

  5. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder.

    PubMed

    Atkinson, Sarah D; Prakash, Apurva; Zhang, Qi; Pangallo, Beth A; Bangs, Mark E; Emslie, Graham J; March, John S

    2014-05-01

    The purpose of this study was to evaluate the efficacy and safety of duloxetine flexible dose in children (7-11 years) and adolescents (12-17 years) with major depressive disorder (MDD). Patients (n=337) in this 36 week study (10 week acute and 26 week extension treatment) received duloxetine (60-120 mg once daily [QD], n=117), fluoxetine (20-40 mg QD, n=117), or placebo (n=103). Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS). Neither active drug (duloxetine or fluoxetine) separated significantly (p<0.05) from placebo on mean change from baseline to end-point (10 weeks) on the CDRS-R total score. There were no significant differences between the duloxetine or fluoxetine groups compared with placebo on serious AEs (SAEs), total TEAEs, or discontinuation for AE during acute treatment. There were no completed suicides or deaths, and no clinically significant electrocardiogram (ECG) abnormalities observed during the study. One fluoxetine and one duloxetine patient experienced alanine aminotransferase (ALT) three or more times the upper limit of normal, which resolved during the study. A total of 8 (7.1%) duloxetine patients, 7 (6.8%) placebo patients, and 9 (8.0%) fluoxetine patients had worsening of suicidal ideation from baseline during acute treatment. Of the patients with suicidal ideation at baseline, 15/19 (79%) duloxetine, 19/19 (100%) placebo, and 16/19 (84%) fluoxetine had improvement in suicidal ideation at end-point during acute treatment. One duloxetine and two fluoxetine patients had treatment-emergent suicidal behavior during the 36 week study. Trial results were inconclusive, as neither the investigational drug (duloxetine) nor the active control (fluoxetine) separated from placebo on the CDRS-R at 10 weeks. No new duloxetine safety signals were identified relative to those seen in adults. Clinical Trial Registry Number: NCT00849901.

  6. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder.

    PubMed

    Katona, Cornelius; Hansen, Thomas; Olsen, Christina Kurre

    2012-07-01

    The efficacy and tolerability of Lu AA21004 at 5 mg/day, a novel multimodal antidepressant, were assessed in elderly patients with recurrent major depressive disorder. Patients were randomly assigned (1:1:1) to Lu AA21004 5 mg/day, duloxetine 60 mg/day (reference) or to placebo in an 8-week double-blind study. The primary efficacy measure was the 24-item Hamilton Depression Scale (HAM-D(24)) total score (analysis of covariance, last observation carried forward). Patients (mean age 70.6 years) had a mean baseline HAM-D(24) score of 29.0. Lu AA21004 showed significantly (P = 0.0011) greater improvement on the primary efficacy endpoint compared with placebo at week 8 (3.3 points). Duloxetine also showed superiority to placebo at week 8, thereby validating the study. HAM-D(24) response (53.2 vs. 35.2%) and HAM-D(17) remission (29.2 vs. 19.3%) rates at endpoint were higher for Lu AA21004 than for placebo. Lu AA21004 showed superiority to placebo in cognition tests of speed of processing, verbal learning and memory. The withdrawal rate due to adverse events was 5.8% (Lu AA21004), 9.9% (duloxetine) and 2.8% (placebo). Whereas nausea was the only adverse event with a significantly higher incidence on treatment with Lu AA21004 (21.8%) compared with placebo (8.3%), the incidence of nausea, constipation, dry mouth, hyperhidrosis and somnolence was higher for duloxetine. In conclusion, Lu AA21004 was efficacious and well tolerated in the treatment of elderly patients with recurrent major depressive disorder.

  7. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD.

    PubMed

    Mahableshwarkar, Atul R; Jacobsen, Paula L; Chen, Yinzhong; Serenko, Michael; Trivedi, Madhukar H

    2015-06-01

    Vortioxetine has reduced depressive symptoms in adults with major depressive disorder (MDD) in multiple clinical trials. The aim of this study is to evaluate the efficacy, safety, and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD. Patients were randomized 1:1:1:1 to vortioxetine 15 mg, vortioxetine 20 mg, duloxetine 60 mg (active reference), or placebo. The primary efficacy endpoint was mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8 (MMRM). Safety/tolerability assessments included physical examinations, vital signs, laboratory evaluations, electrocardiograms, adverse events (AEs), Columbia-Suicide Severity Rating Scale, Arizona Sexual Experiences Scale, and Discontinuation-Emergent Signs and Symptoms checklist. Six hundred and fourteen patients were randomized. Mean changes in MADRS scores were -12.83 (±0.834), -14.30 (±0.890), -15.57 (±0.880), and -16.90 (±0.884) for placebo, vortioxetine 15 mg (P = .224), vortioxetine 20 mg (P = .023), and duloxetine 60 mg (P < .001) (P vs placebo), respectively. AEs reported by ≥5 % of vortioxetine patients included nausea, headache, diarrhea, dizziness, dry mouth, constipation, vomiting, insomnia, fatigue, and upper respiratory infection. Treatment-emergent sexual dysfunction, suicidal ideation or behavior, and discontinuation symptoms were not significantly different between vortioxetine and placebo. Vortioxetine 20 mg significantly reduced MADRS total scores after 8 weeks of treatment. Both vortioxetine doses were well tolerated. ClinicalTrials.gov identifier NCT01153009; www.clinicaltrials.gov/ .

  8. Comparing the Effects of Sertraline with Duloxetine for Depression Severity and Symptoms: A Double-Blind, Randomized Controlled Trial.

    PubMed

    Mowla, Arash; Dastgheib, Seyed Ali; Razeghian Jahromi, Leila

    2016-07-01

    Selecting the most effective treatment for major depressive disorder (MDD) is a challenge for clinicians. The aim of this study was to compare the effects of sertraline with duloxetine on major depression signs and symptoms. The trial was a 6-week, randomized, controlled, double-blind study. Sixty-three patients with diagnosis of MDD according to DSM-IV-TR criteria were randomly assigned to receive either duloxetine (31 patients) or sertraline (32 patients). The mean dosage of duloxetine was 55 mg/day (range 40-60 mg/day) and the mean dosage of sertraline was 146 mg/day (range 50-200 mg/day). Subjects were assessed at baseline, and at the end of week 6. Depression severity and symptoms were assessed by 21-item Hamilton Depression Rating Scale (HAM-D). Of 63 patients who were randomized to treatment, 54 patients including 28 in the sertraline group and 26 in the duloxetine group completed the trial. The HAM-D total score for both groups was significantly reduced at the end of the trial period without significant difference from each other (p = 0.463). Of the symptoms studied, psychomotor retardation, general somatic symptoms and sexual problems improved more in the duloxetine group. On the other hand, agitation, anxiety symptoms and hypochondriasis ameliorated better in the sertraline group. There was no difference between the two groups regarding the other symptoms. Our study shows that the antidepressant mechanism of action has influence on its effects on different signs and symptoms. Clinician awareness of an antidepressant's special effects can help in selecting appropriate medicine.

  9. Comparative efficacy and tolerability of duloxetine, pregabalin, and milnacipran for the treatment of fibromyalgia: a Bayesian network meta-analysis of randomized controlled trials.

    PubMed

    Lee, Young Ho; Song, Gwan Gyu

    2016-05-01

    The aim of this study was to assess the relative efficacy and tolerability of duloxetine, pregabalin, and milnacipran at the recommended doses in patients with fibromyalgia. Randomized controlled trials (RCTs) examining the efficacy and safety of duloxetine 60 mg, pregabalin 300 mg, pregabalin 150 mg, milnacipran 200 mg, and milnacipran 100 mg compared to placebo in patients with fibromyalgia were included in this Bayesian network meta-analysis. Nine RCTs including 5140 patients met the inclusion criteria. The proportion of patients with >30 % improvement from baseline in pain was significantly higher in the duloxetine 60 mg, pregabalin 300 mg, milnacipran 100 mg, and milnacipran 200 mg groups than in the placebo group [pairwise odds ratio (OR) 2.33, 95 % credible interval (CrI) 1.50-3.67; OR 1.68, 95 % CrI 1.25-2.28; OR 1.62, 95 % CrI 1.16-2.25; and OR 1.61; 95 % CrI 1.15-2.24, respectively]. Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that duloxetine 60 mg had the highest probability of being the best treatment for achieving the response level (SUCRA = 0.9431), followed by pregabalin 300 mg (SUCRA = 0.6300), milnacipran 100 mg (SUCRA = 0.5680), milnacipran 200 mg (SUCRA = 0.5617), pregabalin 150 mg (SUCRA = 0.2392), and placebo (SUCRA = 0.0580). The risk of withdrawal due to adverse events was lower in the placebo group than in the pregabalin 300 mg, duloxetine 60 mg, milnacipran 100 mg, and milnacipran 200 mg groups. However, there was no significant difference in the efficacy and tolerability between the medications at the recommended doses. Duloxetine 60 mg, pregabalin 300 mg, milnacipran 100 mg, and milnacipran 200 mg were more efficacious than placebo. However, there was no significant difference in the efficacy and tolerability between the medications at the recommended doses.

  10. Evaluation of the effect of duloxetine treatment on functioning as measured by the Sheehan disability scale: pooled analysis of data from six randomized, double-blind, placebo-controlled clinical studies.

    PubMed

    Mancini, Michele; Sheehan, David V; Demyttenaere, Koen; Amore, Mario; Deberdt, Walter; Quail, Deborah; Sagman, Doron

    2012-11-01

    The purpose of this work is to describe the effect of duloxetine on functioning as measured by the Sheehan disability scale (SDS) compared with placebo in patients with major depressive disorder (MDD). Pooled data from six randomized, parallel, double-blind, placebo-controlled duloxetine studies in adult MDD patients were analyzed at the short-term (7-13 weeks) and the long-term (>24 weeks) endpoint. The primary variable was the SDS total score. Secondary variables included functional remission (SDS total ≤ 6) rates, Hamilton rating scale for depression total score, and pain visual analog scale. Analysis of covariance and logistic regression methods were used to assess differences in treatment and identify prognostic baseline factors. In total, 2496 patients (1424 duloxetine; 1072 placebo) were included. The between-treatment difference of -2.52 between duloxetine and placebo in the SDS total score at the short-term endpoint was statistically significant in favor of duloxetine vs. placebo (95% confidence interval: -3.17, -1.87; P < 0.001). The endpoint functional remission rates were 39.5% with duloxetine and 28.7% with placebo. Time since first depression episode, antidepressant pretreatment (yes/no), baseline visual analog scale pain (≤30 / >30 mm), and sex were significant prognostic factors. The effect of duloxetine was maintained at the long-term endpoint. Duloxetine is effective in improving MDD patients' functioning. Further antidepressant studies focusing on functioning would be helpful.

  11. Prescribing patterns of duloxetine in France: a prescription assessment study in real-world conditions.

    PubMed

    Augendre-Ferrante, Beatrice; Picard, Hernan; Evans, David; Arkoub, Hafida; Pamulapati, Sireesha; Perrot, Serge; Valensi, Paul; Rouillon, Frederic

    2014-01-01

    Duloxetine is a serotonin and norepinephrine reuptake inhibitor approved in the European Union for the treatment of major depressive disorder, generalized anxiety disorder, and diabetic peripheral neuropathic pain in adults. This study aimed to assess the real-world conditions of duloxetine use in France. Between April 2009 and January 2010, 290 dispensing pharmacies, randomly selected from a nationally representative list, included 1,104 patients who presented a duloxetine prescription and consented to the study. Demographic, clinical, and prescription data were extracted from pharmacy records and requested from prescribing physicians. Of the 294 patients with full data available, the mean age (standard deviation) was 54.5 (13.5) years; 74.1% were female; and 86.7% presented with a renewal prescription. 73.5% of patients had major depressive disorder; 3.4% generalized anxiety disorder; and 3.4% diabetic peripheral neuropathic pain. Overall, 78.2% (95% CI: 73.1; 82.8) of patients received duloxetine for an EU-approved indication; 95.2% (95% CI: 92.1; 97.4) of patients had no contra-indication to duloxetine; and 99.0% (95% CI: 97.0; 99.8) received an approved dose. Combining these three criteria, the overall approved use of duloxetine was 73.7% (95% CI: 68.3; 78.7). The strengths and limitations of the study design are discussed.

  12. Treatment of seasonal affective disorder with duloxetine: an open-label study.

    PubMed

    Pjrek, E; Willeit, M; Praschak-Rieder, N; Konstantinidis, A; Semlitsch, H V; Kasper, S; Winkler, D

    2008-05-01

    The aim of this observational study was to evaluate the effects of duloxetine in the treatment of seasonal affective disorder (SAD). 26 SAD patients were treated with open-label duloxetine 60-120 mg per day over 8 weeks. Ratings included the Structured Interview Guide for the Hamilton Depression Rating Scale (SAD version; SIGH-SAD) and the Clinical Global Impression (CGI). To estimate treatment effects on social functioning in SAD we employed the Social Adaptation Self Evaluation Scale (SASS), the Sheehan Disability Scale (SDS), and assessments of days lost due to illness and days with reduction in productivity. Duloxetine led to a significant improvement (p<0.001) of SIGH-SAD, CGI severity, SASS, and SDS scores. Days lost due to illness and days with reduction in productivity were significantly diminished during treatment (p<0.001). Treatment with duloxetine over 8 weeks yielded a response rate (SIGH-SAD<50% of baseline value) of 80.8% and a remission rate (SIGH-SAD<8) of 76.9% in the intention to treat sample. The drop-out rate due to side effects was 15.4%. Our preliminary results indicate that duloxetine might be effective and able to ameliorate the negative social consequences of SAD.

  13. Duloxetine Eli Lilly.

    PubMed

    Anttila, Sami; Leinonen, Esa

    2002-08-01

    Duloxetine is a serotonin (5-HT) and norepinephrine (NE) uptake inhibitor in pre-registration for depression. In vivo studies demonstrate that duloxetine inhibits 5-HT and NE transporters and this may induce an antidepressant effect [159168]. In humans, duloxetine has a low affinity for most 5-HT subtypes and for muscarinic, histamine H1, alpha1-adrenergic, alpha2-adrenergic and dopamine D2 receptors [444103]. Thus, it is not surprising that the meta-analysis of four recent clinical studies suggests duloxetine is a potent and well-tolerated antidepressant [429723]. By December 2001, Lilly had filed an NDA for depression. The launch of duloxetine is planned for the second half of 2002 [434250], [436220]. In April 2002, filing for stress urinary incontinence was anticipated for later in 2002 [456894]. Analysts at Banc of America predicted in April 2002, that the drug will be launched in the first quarter of 2003. The company projects US $400 million in revenue in 2003 and anticipates duloxetine to reach peak sales of over US $1 billion [450920]. Analysts at Morgan Stanley, projected US $25 million in sales in the fourth quarter 2002, rising to US $900 million in 2006 [450937]. At the same time, Credit Suisse First Boston anticipated launch for late 2002, with US $220 million in duloxetine revenues in 2003 and US $457 million in 2004 [450936].

  14. Evaluation of anti-obesity activity of duloxetine in comparison with sibutramine along with its anti-depressant activity: an experimental study in obese rats.

    PubMed

    Chudasama, H P; Bhatt, P A

    2009-11-01

    5-HT and noradrenaline are important neurotransmitters that control increase in body mass and are involved in the pathophysiology of obesity and depression. Sibutramine, an established anti-obesity agent, and duloxetine, an anti-depressant agent, are serotonin noradrenaline reuptake inhibitors (SNRIs). The objective of the present study was to compare the anti-obesity effect of duloxetine with sibutramine along with its effect on blood pressure and depression in obese rats. The secondary objective of the study was to determine if a relationship exists between obesity and depression. Obesity was induced by high-fat diet (HFD) in healthy male Sprague-Dawley rats. After 5 weeks of feeding HFD, animals were overweight (17.57%) with high food intake (57.15%) in comparison with normal animals. These obese animals were treated with duloxetine (30 mg x kg(-1), p.o.) and sibutramine (5 mg x kg(-1), p.o.) for 4 weeks. Control animals were treated with duloxetine alone (30 mg x kg(-1), p.o.). Our results depict that duloxetine was as effective as sibutramine in reducing food intake, body mass, and relative adiposity, and increasing rectal temperature with an added advantage of decreasing blood pressure, which sibutramine failed to do. Besides reduction in body mass, unlike sibutramine, duloxetine improved depressive state as evaluated by despair swimming test, tail suspension test, and open field test, speculating its use as an anti-obesity agent in obese-depressive animals. Since obese control animals reflected decreased locomotor activity, a positive relationship can be speculated to exist between obesity and depression. Further studies on various antidepressant models are required to confirm this relationship.

  15. Duloxetine in the treatment of generalized anxiety disorder.

    PubMed

    Norman, Trevor R; Olver, James S

    2008-12-01

    Duloxetine, a medication with effects on both serotonin and noradrenaline transporter molecules, has recently been approved for the treatment of generalized anxiety disorder. The evidence for its efficacy lies in a limited number of double blind, placebo controlled comparisons. Statistically significant improvements in the Hamilton Anxiety Rating Scale from baseline were demonstrated in all studies at doses of 60 to 120 mg per day. The significance of such changes in terms of clinical improvements compared to placebo is less certain, particularly when the effect size of the change is calculated. In comparative trials with venlafaxine, duloxetine was as effective in providing relief of anxiety symptoms. In addition to improvements in clinical symptoms duloxetine has also been associated with restitution of role function as measured by disability scales. Duloxetine use is associated with nausea, dizziness, dry mouth, constipation, insomnia, somnolence, hyperhidrosis, decreased libido and vomiting. These treatment emergent side effects were generally of mild to moderate severity and were tolerated over time. Using a tapered withdrawal schedule over two weeks in the clinical trials, duloxetine was associated with only a mild withdrawal syndrome in up to about 30% of patients compared to about 17% in placebo treated patients. Duloxetine in doses of up to 200 mg twice daily did not prolong the QTc interval in healthy volunteers. Like other agents with dual neurotransmitter actions duloxetine reduces the symptoms of generalized anxiety disorder in short term treatments. Further evidence for its efficacy and safety in long term treatment is required.

  16. Maintaining efficacy in the treatment of diabetic peripheral neuropathic pain: role of duloxetine

    PubMed Central

    Zilliox, Lindsay; Russell, James W

    2010-01-01

    Introduction Neuropathy is one of the most frequent complications of diabetes. Of all the symptoms associated with diabetic neuropathy, pain has the largest impact on sleep and quality of life. In the past few years further medications have been added to the available therapies for neuropathic pain. One of these medications, duloxetine hydrochloride (duloxetine), is a balanced and potent selective serotonin and norepinephrine reuptake inhibitor. Methods Medline was searched from January 2005 to September 2009 using the key words duloxetine and peripheral neuropathy for clinical trials limited to human research published in English and duloxetine and pharmacology in the nervous system. Results Duloxetine has been shown to effectively reduce diabetic peripheral neuropathic pain compared to placebo at doses of 60 mg/day and 120 mg/day with minimal to moderate side effects. This effect is seen with minimal effects on glycemic control and without any clinically relevant effects on lipid control, or cardiovascular parameters. In addition, its efficacy and tolerability is comparable to other medications commonly used in the management of neuropathic pain. Furthermore, duloxetine performs favorably both in terms of quality of life and in cost utility analyses. Discussion and conclusion This article reviewed the issues related to management of diabetic peripheral neuropathic pain, the pharmacology and rationale for use of duloxetine, efficacy studies, and the safety and tolerability of treatment with duloxetine. Duloxetine is an acceptable initial or alternative treatment for patients with diabetic neuropathic pain. PMID:21437071

  17. Cost comparison of drug-drug and drug-condition interactions in patients with painful diabetic peripheral neuropathy treated with pregabalin versus duloxetine.

    PubMed

    Johnston, Stephen S; Udall, Margarita; Cappelleri, Joseph C; Johnson, Barbara H; Shrady, George; Chu, Bong-Chul; Silverman, Stuart L

    2013-12-15

    The frequency and financial impact of potential drug-drug interactions (DDIs) and drug-condition interactions (DCIs) in patients with painful diabetic peripheral neuropathy (DPN) treated with either pregabalin or duloxetine were compared. This retrospective cohort study was conducted using a large U.S. administrative claims database. Patients selected for study inclusion had a diagnosis of DPN and were newly initiated on either pregabalin or duloxetine between July 1, 2008, and October 1, 2010. Data on potential DDIs and DCIs were collected. Health care costs were measured as the sum of gross covered payments for all medical and prescription claims incurred during the six months after the index date. The study sample comprised 2499 pregabalin users and 1354 duloxetine users. Among pregabalin users, 48 (1.8%) had at least one potential pregabalin DCI; none had potential pregabalin DDIs. Among duloxetine users, 966 (71%) had at least one potential duloxetine DDI or DCI. The frequencies of potential DDIs and DCIs differed significantly between pregabalin and duloxetine users (p < 0.001). Potential duloxetine DDIs and DCIs were associated with a significant increase in mean health care costs in duloxetine users (p = 0.002). Potential pregabalin DDIs and DCIs were not associated with additional health care costs in pregabalin users. Among patients with painful DPN treated with either pregabalin or duloxetine, the frequency of potential duloxetine DDIs and DCIs was substantially higher than that of pregabalin. Potential DDIs and DCIs were associated with significantly increased health care costs in duloxetine users.

  18. Open-label study of duloxetine for the treatment of obsessive-compulsive disorder.

    PubMed

    Dougherty, Darin D; Corse, Andrew K; Chou, Tina; Duffy, Amanda; Arulpragasam, Amanda R; Deckersbach, Thilo; Jenike, Michael A; Keuthen, Nancy J

    2015-01-01

    This study sought to investigate the efficacy of duloxetine for the treatment of obsessive-compulsive disorder (DSM-IV). Twenty individuals were enrolled in a 17-week, open-label trial of duloxetine at Massachusetts General Hospital. Data were collected between March 2007 and September 2012. Study measures assessing obsessive-compulsive disorder symptoms, quality of life, depression, and anxiety were administered at baseline and weeks 1, 5, 9, 13, and 17. The primary outcome measures were the Yale-Brown Obsessive Compulsive Scale and Clinical Global Improvement scale. For the 12 study completers, pre- and posttreatment analyses revealed significant improvements (P<.05) on clinician- and self-rated measures of obsessive-compulsive disorder symptoms and quality of life. Among the 12 completers, more than one-half (n=7) satisfied full medication response criteria. Intention-to-treat analyses (n=20) showed similar improvements (P<.05) on primary and secondary study outcome measures. The results of this study suggest that duloxetine may provide a significant reduction in symptoms for patients with obsessive-compulsive disorder. ClinicalTrials.gov NCT00464698; http://clinicaltrials.gov/ct2/show/NCT00464698?term=NCT00464698&rank=1. © The Author 2015. Published by Oxford University Press on behalf of CINP.

  19. Duloxetine: a review of its use in the treatment of generalized anxiety disorder.

    PubMed

    Carter, Natalie J; McCormack, Paul L

    2009-01-01

    Duloxetine (Cymbalta(R)) is a potent serotonin and noradrenaline (norepinephrine) reuptake inhibitor (SNRI) in the CNS. It is indicated for the treatment of generalized anxiety disorder (GAD) as well as other indications. In patients with GAD of at least moderate severity, oral duloxetine 60-120 mg once daily was effective with regard to improvement from baseline in assessments of anxiety and functional impairment, and numerous other clinical endpoints. Longer-term duloxetine 60-120 mg once daily also demonstrated efficacy in preventing or delaying relapse in responders among patients with GAD. In addition, duloxetine was generally well tolerated, with most adverse events being of mild to moderate severity in patients with GAD in short- and longer-term trials. Additional comparative and pharmacoeconomic studies are required to position duloxetine among other selective serotonin reuptake inhibitors and SNRIs. However, available clinical data, and current treatment guidelines, indicate that duloxetine is an effective first-line treatment option for the management of GAD. Duloxetine is a potent and selective inhibitor of serotonin and noradrenaline transporters, and a weak inhibitor of dopamine transporters. It has a low affinity for neuronal receptors, such as alpha(1)- and alpha(2)-adrenergic, dopamine D(2), histamine H(1), muscarinic, opioid and serotonin receptors, as well as ion channel binding sites and other neurotransmitter transporters, such as choline and GABA transporters. It does not inhibit monoamine oxidase types A or B. The pharmacokinetics of duloxetine in healthy volunteers were dose proportional over the range of 40-120 mg once daily. Steady state was typically reached by day 3 of administration. Duloxetine may be administered without regard to food or time of day. Duloxetine is highly protein bound and is widely distributed throughout tissues. It is rapidly and extensively metabolized in the liver by cytochrome P450 (CYP) 1A2 and 2D6, and its

  20. Duloxetine and pregabalin: high-dose monotherapy or their combination? The "COMBO-DN study"--a multinational, randomized, double-blind, parallel-group study in patients with diabetic peripheral neuropathic pain.

    PubMed

    Tesfaye, Solomon; Wilhelm, Stefan; Lledo, Alberto; Schacht, Alexander; Tölle, Thomas; Bouhassira, Didier; Cruccu, Giorgio; Skljarevski, Vladimir; Freynhagen, Rainer

    2013-12-01

    This multicentre, double-blind, parallel-group study in diabetic peripheral neuropathic pain addressed whether, in patients not responding to standard doses of duloxetine or pregabalin, combining both medications is superior to increasing each drug to its maximum recommended dose. For initial 8-week therapy, either 60 mg/day duloxetine (groups 1, 2) or 300 mg/day pregabalin (groups 3, 4) was given. Thereafter, in the 8-week combination/high-dose therapy period, only nonresponders received 120 mg/day duloxetine (group 1), a combination of 60 mg/day duloxetine and 300 mg/day pregabalin (groups 2, 3), or 600 mg/day pregabalin (group 4). Primary outcome (Brief Pain Inventory Modified Short Form [BPI-MSF] 24-hour average pain change after combination/high-dose therapy) was analyzed comparing combination (groups 2, 3 pooled) with high-dose monotherapy (groups 1, 4 pooled). Secondary end points included response rates, BPI-MSF severity items, and comparison of duloxetine and pregabalin in BPI-MSF average pain. Eight hundred four patients were evaluated for initial therapy and 339 for combination/high-dose therapy. There were no significant differences between combination and high-dose monotherapy regarding BPI-MSF average pain (mean change: combination: -2.35; high-dose monotherapy: -2.16; P = 0.370) and most secondary end points, which, however, consistently favoured combination therapy. Fifty-percent response rates were 52.1% for combination and 39.3% for high-dose monotherapy (P = 0.068). In exploratory analyses of the initial 8-week therapy uncorrected for multiple comparisons, 60 mg/day duloxetine was found superior to 300 mg/day pregabalin (P < 0.001). Both drugs and their combination were well tolerated. Although not significantly superior to high-dose monotherapy, combination therapy was considered to be effective, safe, and well tolerated.

  1. Efficacy of duloxetine add on in treatment of inflammatory bowel disease patients: A double-blind controlled study

    PubMed Central

    Daghaghzadeh, Hamed; Naji, Fateme; Afshar, Hamid; Sharbafchi, Mohammad Reza; Feizi, Awat; Maroufi, Mohsen; Tabatabaeeyan, Mahshid; Adibi, Peyman; Tavakoli, Hamid

    2015-01-01

    Background: Treating inflammatory bowel disease (IBD) with antidepressants might be of utility to improve patient's condition. The aim of this study was to assess the efficacy of Duloxetine on depression, anxiety, severity of symptoms, and quality of life (QOL) in IBD patients. Materials and Methods: In a randomized, double-blind, controlled clinical trial on 2013-2014, in Alzahra Hospital (Isfahan, Iran), 44 IBD patients were chosen to receive either duloxetine (60 mg/day) or placebo. They were treated in a 12 weeks program, and all of the participants also received mesalazine, 2-4 g daily. We assessed anxiety and depression with Hospital Anxiety and Depression Scale, the severity of symptoms with Lichtiger Colitis Activity Index and QOL with World Health Organization Quality of Life Instruments, before and just after the treatment. The data were analyzed using Paired sample t-test and ANCOVA. Results: In 35 subjects who completed the study, the mean (standard error [SE]) scores of depression and anxiety were reduced in duloxetine more than placebo group, significantly (P = 0.041 and P = 0.049, respectively). The mean (SE) scores of severity of symptom were also reduced in duloxetine more than the placebo group, significantly (P = 0.02). The mean (SE) scores of physical, psychological, and social dimensions of QOL were increased after treatment with duloxetine more than placebo group, significantly (P = 0.001, P = 0.038, and P = 0.015, respectively). The environmental QOL was not increased significantly (P = 0.260). Conclusion: Duloxetine is probably effective and safe for reducing depression, anxiety and severity of physical symptoms. It also could increase physical, psychological, and social QOL in patients. PMID:26600836

  2. Implications of Pain in Generalized Anxiety Disorder: Efficacy of Duloxetine

    PubMed Central

    Hartford, James T.; Endicott, Jean; Kornstein, Susan G.; Allgulander, Christer; Wohlreich, Madelaine M.; Russell, James M.; Perahia, David G. S.; Erickson, Janelle S.

    2008-01-01

    Objective: To conduct a post hoc evaluation of the prevalence of clinically significant pain and the efficacy of duloxetine in patients with generalized anxiety disorder (GAD) and concurrent pain. Method: Data from two 9- to 10-week double-blind, placebo-controlled, randomized clinical trials of duloxetine (60 to 120 mg) in DSM-IV–defined GAD were analyzed (study 1 was conducted from July 2004 to September 2005; study 2 was conducted from August 2004 to June 2005). Efficacy was assessed with the Hamilton Rating Scale for Anxiety (HAM-A), visual analog scales (VAS) for pain, the Hospital Anxiety Depression Scale (HADS), the Clinical Global Impressions-Improvement of Illness (CGI-I) scale, the Patient Global Impressions-Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS) global functional impairment scale. Results: Of 840 patients randomly assigned to treatment, 61.3% (302 duloxetine, 213 placebo) had VAS scores ≥ 30 mm on at least 1 of the pain scales, indicating clinically significant pain. Among those patients with concurrent pain at baseline, change from baseline to endpoint in the HAM-A total score (42.9% change in mean scores for duloxetine, 31.4% for placebo), HADS anxiety scale (40.3% vs. 22.8%), HADS depression scale (36.1% vs. 20.5%), HAM-A psychic factor (45.9% vs. 29.9%), and SDS global functional improvement score (45.5% vs. 22.1%) was significantly (all p's < .001) greater for duloxetine compared with placebo. Improvement on the CGI-I (p = .003) and PGI-I (p < .001) was also significantly greater for duloxetine. Response (HAM-A total score decrease ≥ 50%) (49% vs. 29%) and remission (HAM-A total score ≤ 7 at endpoint) (29% vs. 18%) rates were significantly greater for duloxetine compared with placebo (p < .001 and p = .041, respectively). Duloxetine demonstrated statistically significantly greater reduction in pain on all 6 VAS pain scales (all p's < .001 except headaches with p < .002) (for duloxetine, percent change in means from

  3. Comparative pain and mood effects in patients with comorbid fibromyalgia and major depressive disorder: secondary analyses of four pooled randomized controlled trials of duloxetine.

    PubMed

    Marangell, Lauren B; Clauw, Daniel J; Choy, Ernest; Wang, Fujun; Shoemaker, Scarlett; Bradley, Laurence; Mease, Philip; Wohlreich, Madelaine M

    2011-01-01

    The objective of this paper is to better understand the relationship of pain and mood in patients with fibromyalgia and comorbid major depressive disorder (MDD). Pooled data from 4 double-blind, placebo-controlled, randomized trials of duloxetine hydrochloride 60-120mg/day in patients with fibromyalgia were included (N=1332). Of these, 350 (26% [147 placebo, 203 duloxetine]) had comorbid MDD (per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria) and were included in these analyses. Primary measures included Brief Pain Inventory average pain; Hamilton Depression Rating Scale or Beck Depression Inventory. Logistic regression was used to evaluate the consistency of treatment effect across various subgroups. Path analysis was used to assess the effect of duloxetine on improvement in pain in the presence of improvement in mood and vice versa. Results indicated that 69% of improvement in pain was a direct effect of treatment, with improvement in mood accounting for 31% of pain response. In conclusion, consistent with our hypothesis, duloxetine produced a substantial direct effect on pain improvement and change in mood exerted a modest indirect effect on pain improvements in patients with fibromyalgia and MDD. Hence, both direct and indirect analgesic and antidepressant properties appear to be relevant for the treatment of these comorbid patients with duloxetine. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  4. Relationship between major depressive disorder and associated painful physical symptoms: analysis of data from two pooled placebo-controlled, randomized studies of duloxetine.

    PubMed

    Robinson, Michael J; Sheehan, David; Gaynor, Paula J; Marangell, Lauren B; Tanaka, Yoko; Lipsius, Sarah; Ohara, Fumihiro; Namiki, Chihiro

    2013-11-01

    The aim of this study was to evaluate the relationship between painful physical symptoms (PPS) and outcomes in major depressive disorder (MDD). Post-hoc analysis of two identically designed 8-week trials compared the efficacy of 60 mg/day duloxetine (N=523) with that of placebo (N=532) in treating PPS associated with MDD. The Montgomery-Åsberg Depression Rating Scale (MADRS) total score, the Brief Pain Inventory (BPI) average pain score, and the Sheehan Disability Scale global functional impairment score assessed depression symptoms, pain, and functioning, respectively. Remission was defined as a MADRS score of 10 or less, and the BPI response subgroup was defined as a 50% or greater reduction from baseline. Path analyses assessed relationships among variables. Duloxetine-treated patients who had a 50% or greater reduction in BPI score at endpoint had higher rates of remission. Path analysis indicated that 16% of likelihood of remission in depression symptoms was because of the direct effect of treatment, 41% because of pain reduction, and 43% because of functional improvement. Path analysis also indicated that 51% of improvement in functioning was attributed to pain improvement and 43% to mood improvement. Results demonstrate that improvement in pain and mood contributes to functional improvement, and pain reduction and functional improvement increase the likelihood of remission of depressive symptoms with duloxetine treatment in patients with both MDD and PPS at baseline.

  5. Duloxetine: a review of its use in the management of major depressive disorder in older adults.

    PubMed

    Dhillon, Sohita

    2013-01-01

    Duloxetine (Cymbalta(®)) is a selective serotonin norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD). This article reviews the therapeutic efficacy and tolerability of duloxetine in older adults with MDD and summarizes its pharmacological properties. Treatment with duloxetine significantly improved several measures of cognition, depression, anxiety, pain and health-related quality-of-life (HR-QOL) in older adults with MDD in two 8-week, double-blind, placebo-controlled trials. However, no significant improvements in measures of depression were observed at week 12 (primary endpoint) of a 24-week, double-blind trial, although symptoms of depression did improve significantly at earlier timepoints. Benefit of treatment was also observed during continued therapy in the 24-week study (i.e. after the 12-week primary endpoint) and in an open-label, 52-week study, with improvements being observed in some measures of depression, pain and HR-QOL. Duloxetine was generally well tolerated in these studies, with nausea, dizziness and adverse events reflecting noradrenergic activity (e.g. dry mouth, constipation) being the most common treatment-emergent adverse events during treatment for up to 52 weeks. Duloxetine therapy had little effect on cardiovascular parameters and bodyweight. Although further well designed and long-term studies in this patient population are required to confirm the efficacy of duloxetine and to compare it with that of other antidepressants, current evidence suggests that treatment with duloxetine may be beneficial in older adults with MDD.

  6. The Combination of Antidepressant Duloxetine with Piracetam in Mice does not Produce Enhancement of Nootropic Activity.

    PubMed

    Kale, Pravin Popatrao; Addepalli, Veeranjaneyulu; Sarkar, Amrita; Patel, Sonam; Savai, Jay

    2014-09-01

    There is a strong association between depression and memory impairment. The present study aims to assess the nootropic activity of duloxetine and piracetam combination. Male Swiss Albino mice were divided randomly into 4 groups. Treatment of normal saline (10 ml/kg), duloxetine (10 mg/kg), piracetam (100 mg/kg), and duloxetine (5 mg/kg) plus piracetam (50 mg/kg) were given through intra-peritoneal route to group I-IV, respectively. Transfer latency in elevated plus maze (EPM) and time spent in target quadrant in Morris water maze (MWM) were recorded. Estimation of brain monoamines in hippocampus, cerebral cortex, and whole brain were done using HPLC with fluorescence detector. Piracetam treated group showed significant decrease in transfer latency in EPM and increase in time spent in target quadrant recorded in MWM. Combination treated group failed to produce statistically significant nootropic effect in both EPM and MWM. Combination treated group failed to increase brain monoamine levels when compared against duloxetine and piracetam treated groups, separately. But there was exception of significant increase in norepinephrine levels in hippocampi when compared against duloxetine treated group. Results indicate no cognitive benefits with piracetam plus duloxetine combination. These findings can be further probed with the aim of understanding the interaction between duloxetine and piracetam as a future endeavor.

  7. Multimodal antidepressant vortioxetine increases frontal cortical oscillations unlike escitalopram and duloxetine – a quantitative EEG study in rats

    PubMed Central

    Leiser, S C; Pehrson, A L; Robichaud, P J; Sanchez, C

    2014-01-01

    Background and Purpose EEG studies show that 5-HT is involved in regulation of sleep–wake state and modulates cortical oscillations. Vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B partial agonist, 5-HT1A agonist, and 5-HT transporter inhibitor. Preclinical (animal) and clinical studies with vortioxetine show positive impact on cognitive metrics involving cortical function. Here we assess vortioxetine's effect on cortical neuronal oscillations in actively awake rats. Experimental Approach Telemetric EEG recordings were obtained with the following treatments (mg·kg−1, s.c.): vehicle, vortioxetine (0.1, 1.0, 3.0, 10), 5-HT1A agonist flesinoxan (2.5), 5-HT3 antagonist ondansetron (0.30), 5-HT7 antagonist SB-269970-A (10), escitalopram (2.0), duloxetine (10) and vortioxetine plus flesinoxan. Target occupancies were determined by ex vivo autoradiography. Key Results Vortioxetine dose-dependently increased wakefulness. Flesinoxan, duloxetine, ondansetron, but not escitalopram or SB-269970-A increased wakefulness. Quantitative spectral analyses showed vortioxetine alone and with flesinoxan increased θ (4–8 Hz), α (8–12 Hz) and γ (30–50 Hz) power. Duloxetine had no effect on θ and γ, but decreased α power, while escitalopram produced no changes. Ondansetron and SB-269970 (≈31–35% occupancy) increased θ power. Flesinoxan (≈41% occupancy) increased θ and γ power. Conclusions and Implications Vortioxetine increased wakefulness and increased frontal cortical activity, most likely because of its 5-HT7 and 5-HT3 antagonism and 5-HT1A agonism. Vortioxetine differs from escitalopram and duloxetine by increasing cortical θ, α and γ oscillations. These preclinical findings suggest a role of vortioxetine in modulating cortical circuits known to be recruited during cognitive behaviours and warrant further investigation as to their clinical impact. PMID:24846338

  8. Multimodal antidepressant vortioxetine increases frontal cortical oscillations unlike escitalopram and duloxetine--a quantitative EEG study in rats.

    PubMed

    Leiser, S C; Pehrson, A L; Robichaud, P J; Sanchez, C

    2014-09-01

    EEG studies show that 5-HT is involved in regulation of sleep-wake state and modulates cortical oscillations. Vortioxetine is a 5-HT3 , 5-HT7 , and 5-HT1D receptor antagonist, 5-HT1B partial agonist, 5-HT1A agonist, and 5-HT transporter inhibitor. Preclinical (animal) and clinical studies with vortioxetine show positive impact on cognitive metrics involving cortical function. Here we assess vortioxetine's effect on cortical neuronal oscillations in actively awake rats. Telemetric EEG recordings were obtained with the following treatments (mg·kg(-1) , s.c.): vehicle, vortioxetine (0.1, 1.0, 3.0, 10), 5-HT1A agonist flesinoxan (2.5), 5-HT3 antagonist ondansetron (0.30), 5-HT7 antagonist SB-269970-A (10), escitalopram (2.0), duloxetine (10) and vortioxetine plus flesinoxan. Target occupancies were determined by ex vivo autoradiography. Vortioxetine dose-dependently increased wakefulness. Flesinoxan, duloxetine, ondansetron, but not escitalopram or SB-269970-A increased wakefulness. Quantitative spectral analyses showed vortioxetine alone and with flesinoxan increased θ (4-8 Hz), α (8-12 Hz) and γ (30-50 Hz) power. Duloxetine had no effect on θ and γ, but decreased α power, while escitalopram produced no changes. Ondansetron and SB-269970 (≈31-35% occupancy) increased θ power. Flesinoxan (≈41% occupancy) increased θ and γ power. Vortioxetine increased wakefulness and increased frontal cortical activity, most likely because of its 5-HT7 and 5-HT3 antagonism and 5-HT1A agonism. Vortioxetine differs from escitalopram and duloxetine by increasing cortical θ, α and γ oscillations. These preclinical findings suggest a role of vortioxetine in modulating cortical circuits known to be recruited during cognitive behaviours and warrant further investigation as to their clinical impact. © 2014 The British Pharmacological Society.

  9. A Randomized Placebo-Controlled Trial of Duloxetine for Central Pain in Multiple Sclerosis

    PubMed Central

    Slee, April

    2015-01-01

    Background: Pain is common in multiple sclerosis (MS). Duloxetine has a potential therapeutic role in treating MS-related pain. Methods: Thirty-eight MS patients were randomized 1:1 to receive duloxetine (n = 18) or matched placebo (n = 20). The dosing regimen was 30 mg daily for 1 week, then 60 mg daily for 5 weeks. The primary outcome measure was change in worst pain for week 6 relative to baseline recorded on a daily pain diary. Results: Of 38 randomized patients, 14 (78%) patients randomized to duloxetine and 18 (90%) randomized to placebo completed treatment per protocol. These participants had an average age of 55.5 years, 25% were male, and 66% had relapsing-remitting MS (RRMS). Baseline characteristics were similar. Discontinuations were due primarily to drug intolerance. Among those who completed treatment, worst pain at 6 weeks was reduced by 29% (±20%) for duloxetine versus 12% (±18%) for placebo (P = .016). Average daily pain at 6 weeks was reduced by 39% (±29%) in the duloxetine group compared to 10% (±18.8%) in the placebo group (P = .002). There were no significant changes (week 6 vs. baseline) or between-group differences for subject global impression, Beck Depression Inventory, 36-item Short Form Health Status Survey (SF-36), or sleep quality score. Conclusions: Fewer patients could tolerate duloxetine compared to placebo. Among patients who completed 6 weeks of treatment, there were significant reductions in average and worst daily pain scores with duloxetine compared to placebo. This study suggests that duloxetine has a direct pain-relieving effect in MS. PMID:25892978

  10. Effects of duloxetine on norepinephrine and serotonin transporter activity in healthy subjects.

    PubMed

    Chappell, Jill C; Eisenhofer, Graeme; Owens, Michael J; Haber, Harry; Lachno, D Richard; Dean, Robert A; Knadler, Mary Pat; Nemeroff, Charles B; Mitchell, Malcolm I; Detke, Michael J; Iyengar, Smriti; Pangallo, Beth; Lobo, Evelyn D

    2014-02-01

    Duloxetine selectively inhibits the serotonin (5-HT) and norepinephrine (NE) transporters (5-HTT and NET, respectively), as demonstrated in vitro and in preclinical studies; however, transporter inhibition has not been fully assessed in vivo at the approved dose of 60 mg/d. Here, the in vivo effects of dosing with duloxetine 60 mg once daily for 11 days in healthy subjects were assessed in 2 studies: (1) centrally (n = 11), by measuring concentrations of 5-hydroxyindoleacetic acid, 3,4-dihydroxyphenylglycol (DHPG), and NE in cerebrospinal fluid, and (2) versus escitalopram 20 mg/d (n = 32) in a 2-period crossover study by assessing the ΔDHPG/ΔNE ratio in plasma during orthostatic testing and by pharmacokinetic/pharmacodynamic modeling of reuptake inhibition using subjects' serum in cell lines expressing cloned human 5-HTT or NET. At steady state, duloxetine significantly reduced concentrations of DHPG and 5-hydroxyindoleacetic acid (P < 0.05), but not NE, in cerebrospinal fluid; DHPG was also decreased in plasma and urine. The ΔDHPG/ΔNE ratio in plasma decreased significantly more with duloxetine than escitalopram (65% and 21%, respectively; P < 0.0001). Ex vivo reuptake inhibition of 5-HTT was comparable (EC50 = 44.5 nM) for duloxetine and escitalopram, but duloxetine inhibited NET more potently (EC50 = 116 nM and 1044 nM, respectively). Maximal predicted reuptake inhibition for 5-HTT was 84% for duloxetine and 80% for escitalopram, and that for NET was 67% and 14%, respectively. In summary, duloxetine significantly affected 5-HT and NE turnover in the central nervous system and periphery; these effects presumably occurred via inhibition of reuptake by the 5-HTT and NET, as indicated by effects on functional reuptake inhibition ex vivo.

  11. Treatment patterns associated with Duloxetine and Venlafaxine use for Major Depressive Disorder

    PubMed Central

    2011-01-01

    Background Duloxetine and venlafaxine extended release (venlafaxine XR) are SNRIs indicated for the treatment of MDD. This study addresses whether duloxetine and venlafaxine XR are interchangeable in their patterns of use with patients who are depressed or are used more selectively based on treatment history, background characteristics, and presenting symptoms. Methods This was a retrospective analysis of an administrative insurance claims database. We studied patients in managed care with major depressive disorder (MDD) treated with duloxetine or venlafaxine XR. Predictors of treatment and cost were assessed using Chi-square and logistic regression analyses of demographics and past-year medication use and comorbidities. Results Patients with MDD treated with duloxetine (n = 9,641) versus venlafaxine XR (n = 8,514) tended to be older, slightly more likely to be female, and treated by a psychiatrist (P < 0.0001). In the prior year, more duloxetine patients (vs. venlafaxine XR) received ≥3 unique antidepressants (20.8% vs. 16.6%), ≥3 unique pain medications (25.5% vs. 15.6%), and had ≥8 unique diagnosed comorbid medical and psychiatric conditions (38.6% vs. 29.1%). The prior 6-month total health care costs were $1,731 higher for duloxetine than for venlafaxine XR and declined for both medications in the 6 months after treatment began. Logistic regression analysis revealed that 61% of duloxetine patients and 61% of venlafaxine XR patients were predictable from prior patient and treatment factors. Conclusions Patients with MDD treated with duloxetine tended to have a more complex and costly antecedent clinical presentation compared with venlafaxine XR patients, suggesting that physicians do not use the medications interchangeably. PMID:21281479

  12. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    PubMed Central

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence and changes in quality-of-life scores, such as Patient Global Impression of Improvement rating) and harms (both general harms, including discontinuation because of adverse events, and harms related to suicidality, violent behaviour and their potential precursors, such as akathisia and activation [stimulating effects such as insomnia, anxiety and agitation]). RESULTS: Duloxetine was significantly better than placebo in terms of percentage change in weekly incontinence episodes (mean difference −13.56%, 95% confidence interval [CI] −21.59% to −5.53%) and change in Incontinence Quality of Life total score (mean difference 3.24, 95% CI 2.00 to 4.48). However, the effect sizes were small, and a sensitivity analysis (with removal of one trial) showed that the number needed to treat for a Patient Global Impression of Improvement rating of “much better or very much better” was 8 (95% CI 6 to 13). The numbers needed to harm were 7 (95% CI 6 to 8) for discontinuing because of an adverse event and 7 (95% CI 6 to 9) for experiencing an activation event. No suicidality

  13. Duloxetine in the treatment of major depressive disorder.

    PubMed

    Goldstein, David J

    2007-04-01

    Since depression impacts all body systems, antidepressant treatments should relieve both the emotional and physical symptoms of depression. Duloxetine demonstrated antidepressant efficacy at a dose of 60 mg qd in two placebo-controlled, randomized, double-blind studies and significantly improved remission rates compared with placebo. Duloxetine-treated patients had significant reduction in severity of the symptoms of depression as assessed by the HAM-D(17), anxious symptoms as measured by the HAM-A and quality of life measures compared to placebo. Duloxetine also improved somatic symptoms, particularly painful symptoms which may have contributed to significantly improved remission rates compared to placebo. Approximately 10% of the 1139 patients with major depressive disorder in placebo-controlled trials discontinued treatment due to an adverse event, compared to 4% of the 777 patients receiving placebo. In addition to nausea (1.4% incidence), which was the most common reason for discontinuation, dizziness, somnolence, and fatigue were the most common AEs reported as reasons for discontinuation and all were considered drug-related. Duloxetine treatment lacks effects on ECG, increases heart rate, and has little effect on blood pressure or weight.

  14. Augmentation of antidepressant effects of duloxetine and bupropion by caffeine in mice.

    PubMed

    Kale, Pravin Popatrao; Addepalli, Veeranjaneyulu

    2014-09-01

    There is an unmet need in the treatment of depression suggesting requirement of new therapeutic approaches having better efficacy and safety profile. Patients receiving antidepressant therapy generally consume caffeine in the form of tea or coffee. The objective of the present study was to evaluate the augmentation of antidepressant effects of duloxetine and/or bupropion with caffeine. Male Swiss Albino mice received treatment of normal saline (10 ml/kg), 'caffeine alone' (10mg/kg), 'duloxetine alone' (10mg/kg), 'bupropion alone' (10mg/kg), caffeine+duloxetine (5mg/kg, each), bupropion+caffeine (5mg/kg, each), and bupropion+duloxetine (5mg/kg, each) through the intra-peritoneal route. The immobility period was analyzed 30 min after the treatment in forced swim and tail suspension tests. Norepinephrine, dopamine, and serotonin levels were analyzed in hippocampus, cerebral cortex and whole brain using HPLC with fluorescence detector. Euthanasia was performed 1h after treatment. Comparison between vehicle treated group and other groups showed significant decrease in immobility in all drug treated groups in both antidepressant models. Caffeine plus duloxetine treated group was better among the combination treated groups in terms of decrease in immobility and increase in norepinephrine, dopamine, and serotonin levels in hippocampi, cerebral cortices, and whole brain when compared to their respective monotherapy treated groups. These combination approaches may help in reducing the dose of duloxetine/bupropion, and consequently lower the associated side/adverse effects.

  15. Duloxetine versus other anti-depressive agents for depression

    PubMed Central

    Cipriani, Andrea; Koesters, Markus; Furukawa, Toshi A; Nosè, Michela; Purgato, Marianna; Omori, Ichiro M; Trespidi, Carlotta; Barbui, Corrado

    2014-01-01

    Background Although pharmacological and psychological interventions are both effective for major depression, in primary and secondary care settings antidepressant drugs remain the mainstay of treatment. Amongst antidepressants many different agents are available. Duloxetine hydrochloride is a dual reuptake inhibitor of serotonin and norepinephrine and has been licensed by the Food and Drug Administration in the US for major depressive disorder (MDD), generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain. Objectives To assess the evidence for the efficacy, acceptability and tolerability of duloxetine in comparison with all other antidepressant agents in the acute-phase treatment of major depression. Search methods MEDLINE (1966 to 2012), EMBASE (1974 to 2012), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to March 2012. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical company marketing duloxetine and experts in this field were contacted for supplemental data. Selection criteria Randomised controlled trials allocating patients with major depression to duloxetine versus any other antidepressive agent. Data collection and analysis Two review authors independently extracted data and a double-entry procedure was employed. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability. Main results A total of 16 randomised controlled trials (overall 5735 participants) were included in this systematic review. Of these, three trials were unpublished. We found 11 studies (overall 3304 participants) comparing duloxetine with one selective serotonin reuptake inhibitor (SSRI) (six studies versus paroxetine, three studies

  16. Impact of Pretreatment With Antidepressants on the Efficacy of Duloxetine in Terms of Mood Symptoms and Functioning: An Analysis of 15 Pooled Major Depressive Disorder Studies

    PubMed Central

    Barros, Bruno R.; Schacht, Alexander; Happich, Michael; Televantou, Foula; Berggren, Lovisa; Walker, Daniel J.

    2014-01-01

    Objective: This post hoc analysis aimed to determine whether patients with major depressive disorder (MDD) in duloxetine trials who were antidepressant naive or who were previously exposed to antidepressants exhibited differences in efficacy and functioning. Method: Data were pooled from 15 double-blind, placebo- and/or active-controlled duloxetine trials of adult patients with MDD conducted by Eli Lilly and Company. The individual studies took place between March 2000 and November 2009. Data were analyzed using 4 pretreatment subgroups: first-episode never treated, multiple-episode never treated, treated previously only with selective serotonin reuptake inhibitors (SSRIs), and previously treated with antidepressants other than just SSRIs. Measures included the 17-item Hamilton Depression Rating Scale (HDRS-17) total and somatic symptom subscale scores, Montgomery-Asberg Depression Rating Scale (MADRS) total score, and Sheehan Disability Scale total score. Response rates (50% and 30%) were based on the HDRS-17 total score and remission rates on either the HDRS-17 or MADRS total score. Results: Response and remission rates were significantly greater (P < .05 in 11 of 12 comparisons) for duloxetine versus placebo in the 4 subgroups. A trend of greater response and remission occurred for first-episode versus multiple-episode patients; both groups were generally higher than the antidepressant-treated groups. Mean changes in efficacy measures were mostly significantly greater (P < .05 in 13 of 16 comparisons) for duloxetine versus placebo within each pretreatment subgroup, with some (P < .05 in 2 of 24 comparisons) significant interaction effects between subgroups on HDRS-17 total and somatic symptoms scores. Conclusions: Duloxetine was generally superior to placebo on response and remission rates and in mean change on efficacy measures. Response and remission rates were numerically greater for first-episode versus multiple-episode and drug-treated patients. Mean change

  17. [Treatment of Persistent Somatoform Pain Disorder by Floating Needle Therapy and Duloxetine].

    PubMed

    Ren, Wan-wen; Zhou, Zhi-ying; Xu, Mi-mi; Long, Sen; Tang, Guang-zheng; Mao, Hong-jing; Chen, Shu-lin

    2016-02-01

    To evaluate clinical effect and safety of floating needle therapy and duloxetine in treating patients with persistent somatoform pain disorder (PSPD). Totally 108 PSPD patients were randomly assigned to the floating needle treatment group, the duloxetine treatment group, and the placebo treatment group, 36 in each group. Patients in the floating needle treatment group received floating needle therapy and placebo. Those in the duloxetine treatment group received duloxetine and simulated floating needle therapy. Those in the placebo treatment group received the placebo and simulated floating needle therapy. All treatment lasted for six weeks. Efficacy and adverse reactions were evaluated using Simple McGill pain scale (SF-MPQ) and Treatment Emergent Symptom Scale (TESS) before treatment and immediately after treatment, as well as at the end of 1st, 2nd, 4th, and 6th week of treatment, respectively. Hamilton Depression Scale (HAMD, 17 items), Hamilton Anxiety Scale (HAMA) were assessed before treatment and at the end of 1st, 2nd, 4th, and 6th week of treatment, respectively. Patients in the floating needle treatment group and the duloxetine treatment group with the total reducing score rate of SF-MPQ in Pain Rating index (PRI) ≥ 50% after 6 weeks' treatment were involved in the follow-up study. (1) Compared with the same group before treatment, SF-MPQ score, HAMD score and HAMA total scores all decreased in all the three groups at the end of 1st, 2nd, 4th, and 6th week of treatment (P < 0.05, P < 0.01). Besides , each item of SF-MPQ significantly decreased immediately after treatment in the floating needle treatment group (P < 0.01). Compared with the placebo treatment group, SF-MPQ, HAMD, and HAMA total score in the floating needle treatment group significantly decreased after 1, 2, 4, and 6 weeks of treatment (P < 0.05, P < 0.01). SF-MPQ score, HAMD score and HAMA total score in the duloxetine treatment group also significantly decreased after 2, 4, and 6 weeks of

  18. A retrospective, matched cohort study of potential drug-drug interaction prevalence and opioid utilization in a diabetic peripheral neuropathy population initiated on pregabalin or duloxetine.

    PubMed

    Ellis, Jeffrey J; Sadosky, Alesia B; Ten Eyck, Laura L; Mudumby, Pallavi; Cappelleri, Joseph C; Ndehi, Lilian; Suehs, Brandon T; Parsons, Bruce

    2015-04-15

    Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers. The purpose of this study was to examine the impact of newly initiated pregabalin or duloxetine treatment on Medicare Advantage Prescription Drug (MAPD) plan pDPN patients' encounters with potential drug-drug interactions, the healthcare cost and utilization consequences of those interactions, and opioid utilization. Study subjects required a pregabalin or duloxetine pharmacy claim between 07/01/2008-06/30/2012 (index event), ≥1 inpatient or ≥2 outpatient medical claims with pDPN diagnosis between 01/01/2008-12/31/2012, and ≥12 months pre- and ≥6 post-index enrollment. Propensity score matching was used to balance the pregabalin and duloxetine cohorts on pre-index demographics and comorbidities. Potential DDIs were defined by Micromedex 2.0 and identified by prescription claims. Six-month post-index healthcare utilization (HCU) and costs were calculated using pharmacy and medical claims. No significant differences in pre-index demographics or comorbidities were found between pregabalin subjects (n = 446) and duloxetine subjects (n = 446). Potential DDI prevalence was significantly greater (p < 0.0001) among duoxetine subjects (56.7%) than among pregabalin subjects (2.9%). There were no significant differences in HCU or costs between pregablin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($13,908 vs. $9,830; p = 0.001), more subjects with ≥1 inpatient visits (35.6% vs 25.4%; p = 0.02), and more subjects with ≥1 emergency room visits (32.8% vs. 20.7%; p = 0.005) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a difference between pregabalin and duloxetine subjects in their respective pre-versus-post differences in milligrams (mg) of

  19. Acute and long-term treatment of late-life major depressive disorder: duloxetine versus placebo.

    PubMed

    Robinson, Michael; Oakes, Tina Myers; Raskin, Joel; Liu, Peng; Shoemaker, Scarlett; Nelson, J Craig

    2014-01-01

    To compare the efficacy of duloxetine with placebo on depression in elderly patients with major depressive disorder. Multicenter, 24-week (12-week short-term and 12-week continuation), randomized, placebo-controlled, double-blind trial. United States, France, Mexico, Puerto Rico. Age 65 years or more with major depressive disorder diagnosis (one or more previous episode); Mini-Mental State Examination score ≥20; Montgomery-Asberg Depression Rating Scale total score ≥20. Duloxetine 60 or 120 mg/day or placebo; placebo rescue possible. Primary-Maier subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17) at week 12. Secondary-Geriatric Depression Scale, HAMD-17 total score, cognitive measures, Brief Pain Inventory (BPI), Numeric Rating Scales (NRS) for pain, Clinical Global Impression-Severity scale, Patient Global Impression of Improvement in acute phase and acute plus continuation phase of treatment. Compared with placebo, duloxetine did not show significantly greater improvement from baseline on Maier subscale at 12 weeks, but did show significantly greater improvement at weeks 4, 8, 16, and 20. Similar patterns for Geriatric Depression Scale and Clinical Global Impression-Severity scale emerged, with significance also seen at week 24. There was a significant treatment effect for all BPI items and 4 of 6 NRS pain measures in the acute phase, most BPI items and half of the NRS measures in the continuation phase. More duloxetine-treated patients completed the study (63% versus 55%). A significantly higher percentage of duloxetine-treated patients versus placebo discontinued due to adverse event (15.3% versus 5.8%). Although the antidepressant efficacy of duloxetine was not confirmed by the primary outcome, several secondary measures at multiple time points suggested efficacy. Duloxetine had significant and meaningful beneficial effects on pain. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights

  20. Duloxetine enters the brain - But why is it not found in the cerebrospinal fluid.

    PubMed

    Paulzen, Michael; Gründer, Gerhard; Veselinovic, Tanja; Wolf, Bernhard; Hiemke, Christoph; Lammertz, Sarah E

    2016-01-01

    Antidepressants enter the brain to reach their site of action in a different extent. However, there has been no study to date about duloxetine's ability to enter the brain and cerebrospinal fluid. Aim of this study was to measure blood and cerebrospinal fluid concentrations of duloxetine and to account for the distribution between the two compartments. Concentrations of duloxetine were measured in blood serum and cerebrospinal fluid of 19 patients treated with daily doses of 30-120mg. Daily doses were correlated with serum and cerebrospinal fluid concentrations and serum concentrations were correlated with concentrations in cerebrospinal fluid. Serum concentrations of duloxetine showed a moderate but significant correlation with the applied daily dose, r=+0.473, p=0.04. Duloxetine concentrations in the cerebrospinal fluid above the designated limit of quantification of 2.0ng/mL were only found in three of the 19 patients. Contrasting to own preceding studies on venlafaxine, mirtazapine and citalopram with comparably high concentrations in cerebrospinal fluid, the here presented findings indicate that duloxetine shows a very different distribution pattern. Very low concentrations in the cerebrospinal fluid may be due to the fact that the drug crosses the blood-cerebrospinal fluid barrier much worse than other antidepressants do, suggesting a low ability of duloxetine to enter the brain. Alternatively, low drug concentrations may be interpreted in a sense of a missing residence time in cerebrospinal fluid due to active transport mechanisms out of this environment either back into the bloodstream or into the brain. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

    PubMed Central

    Chappell, Amy S; Bradley, Laurence A; Wiltse, Curtis; Detke, Michael J; D’Souza, Deborah N; Spaeth, Michael

    2008-01-01

    Objective: Assess the efficacy of duloxetine 60/120 mg (N = 162) once daily compared with placebo (N = 168) in the treatment of patients with fibromyalgia, during six months of treatment. Methods: This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine. Results: There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI) average pain severity from baseline to endpoint (P = 0.053) and the Patient’s Global Impressions of Improvement (PGI-I) at endpoint (P = 0.073). Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Questionnaire pain score, BPI least pain score and average interference score, Clinical Global Impressions of Severity scale, area under the curve of pain relief, Multidimensional Fatigue Inventory mental fatigue dimension, Beck Depression Inventory-II total score, and 36-item Short Form Health Survey mental component summary and mental health score. Nausea was the most common treatment-emergent adverse event in the duloxetine group. Overall discontinuation rates were similar between groups. Conclusions: Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures. PMID:20428412

  2. Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo‐controlled trial of duloxetine

    PubMed Central

    Kwakye, Isaac N.; Garner, Matthew; Baldwin, David S.; Bamford, Susan; Pinkney, Verity

    2016-01-01

    Objective The objective of this study was to develop an in‐depth understanding of healthy volunteers' experiences of mental health trials. Methods A qualitative study was nested within a healthy volunteer placebo‐controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis. Results Interviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self‐monitored their bodies' reactions, and guessed which treatment they received. On being un‐blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed. Conclusions Small changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; “active” placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un‐blinding participants to treatment allocation. © 2016 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons, Ltd. PMID:27378326

  3. Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial.

    PubMed

    Raskin, Joel; Wiltse, Curtis G; Siegal, Alan; Sheikh, Javaid; Xu, Jimmy; Dinkel, James J; Rotz, Benjamin T; Mohs, Richard C

    2007-06-01

    This study compared the effects of duloxetine, 60 mg/day, versus placebo on cognition, depression, and pain in elderly patients with recurrent major depressive disorder. Patients were randomly assigned (2:1) to duloxetine, 60 mg/day (N=207), or placebo (N=104) for 8 weeks in a double-blind study. The primary outcome measure was a prespecified composite cognitive score composed of four individual tests. Secondary measures included the Geriatric Depression Scale, the Hamilton Depression Rating Scale, the Visual Analogue Scale assessing pain, and standard safety and tolerability assessments. Patients had a median age of 72 years (range=65-90). Duloxetine demonstrated significantly greater improvement in the composite cognitive score versus placebo (least-squares mean change from baseline to endpoint: 1.95 versus 0.76), driven by improved verbal learning and memory. Duloxetine treatment showed significantly greater baseline-to-endpoint reductions in both Hamilton depression scale (-6.49 versus -3.72) and Geriatric Depression Scale (-4.07 versus -1.34) total scores compared with placebo. Hamilton depression scale response (37.3% versus 18.6%) and remission (27.4% versus 14.7%) rates at endpoint were significantly higher for duloxetine than for placebo. Duloxetine significantly improved Visual Analogue Scale scores for back pain and time in pain while awake versus placebo. Significantly fewer patients receiving duloxetine withdrew from the study because of lack of efficacy (2.9% versus 9.6%); the incidences of discontinuation due to adverse events were similar for duloxetine and placebo (9.7% versus 8.7%). Duloxetine improved cognition, depression, and some pain measures and was safe and well tolerated in elderly patients with recurrent major depressive disorder.

  4. Duloxetine Add-On to Risperidone for Treatment of Negative Symptoms in Patients with Stable Schizophrenia: Randomized Double-Blind Placebo-Controlled Study.

    PubMed

    Nikbakhat, M-R; Arabzadeh, S; Zeinoddini, A; Khalili, Z; Rezaei, F; Mohammadinejad, P; Ghaleiha, A; Akhondzadeh, S

    2016-07-01

    Although the pathogenesis of symptoms of schizophrenia is largely unknown, a variety of neurotransmitters are implicated, including serotonin and norepinephrine. Here we investigate the effectiveness of duloxetine as a serotonin-norepinephrine inhibitor in the treatment of negative symptoms. We performed a double-blind clinical trial on 64 patients with stable schizophrenia and no prominent symptoms of depression. Patients received risperidone (up to 6 mg/day) plus either duloxetine (60 mg/day) or placebo. Psychotic symptoms were assessed by the Positive and Negative Syndrome Scale (PANSS) at the onset of the trial, and at 2, 4, 6 and 8 weeks of therapy. Compared to the placebo group, the duloxetine group showed significantly higher improvement in negative symptoms (p<0.001), PANSS total (p<0.001), and the general psychopathology subscale scores (p=0.001), but no significant difference in positive symptoms (p=0.13). The side effect profiles of the 2 treatment regimens were not significantly different. Duloxetine adjuvant to risperidone seems to be a tolerable and efficacious treatment for primary negative symptoms of schizophrenia. © Georg Thieme Verlag KG Stuttgart · New York.

  5. Efficacy of Duloxetine for the Treatment of Generalized Anxiety Disorder: Implications for Primary Care Physicians

    PubMed Central

    Koponen, Hannu; Allgulander, Christer; Erickson, Janelle; Dunayevich, Eduardo; Pritchett, Yili; Detke, Michael J.; Ball, Susan G.; Russell, James M.

    2007-01-01

    Objective: This study examined the efficacy and tolerability of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, for the treatment of patients with generalized anxiety disorder (GAD). Method: Patients were ≥ 18 years old and recruited from 5 European countries, the United States, and South Africa. The study had a 9-week, multicenter, randomized, double-blind, fixed-dose, placebo-controlled, parallel-group design. A total of 513 patients (mean age = 43.8 years; 67.8% female) with a DSM-IV–defined GAD diagnosis received treatment with duloxetine 60 mg/day (N = 168), duloxetine 120 mg/day (N = 170), or placebo (N = 175). The primary efficacy measure was the Hamilton Rating Scale for Anxiety (HAM-A) total score. Secondary measures included the Sheehan Disability Scale, HAM-A psychic and somatic anxiety factor scores, and HAM-A response, remission, and sustained improvement rates. The study was conducted from July 2004 to September 2005. Results: Both groups of duloxetine-treated patients demonstrated significantly greater improvements in anxiety symptom severity compared with placebo-treated patients as measured by HAM-A total score and HAM-A psychic and somatic anxiety factor scores (p values ranged from ≤ .01 to ≤ .001). Duloxetine-treated patients had greater functional improvements in Sheehan Disability Scale global and specific domain scores (p ≤ .001) than placebo-treated patients. Both duloxetine doses also resulted in significantly greater HAM-A response, remission, and sustained improvement rates compared with placebo (p values ranged from ≤ .01 to ≤ .001). The rate of study discontinuation due to adverse events was 11.3% for duloxetine 60 mg and 15.3% for duloxetine 120 mg versus 2.3% for placebo (p ≤ .001). Conclusion: The results of this study demonstrate that duloxetine 60 mg/day and 120 mg/day were efficacious and well tolerated and thus may provide primary care physicians with a useful pharmacologic intervention for

  6. Clinical study of duloxetine hydrochloride combined with doxazosin for the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome: An observational study.

    PubMed

    Zhang, Mingxin; Li, Hanzhong; Ji, Zhigang; Dong, Dexin; Yan, Su

    2017-03-01

    To explore the safety and efficacy of the selective 5-serotonin and norepinephrine reuptake inhibitor duloxetine hydrochloride and alpha-adrenergic receptor blocker (alpha-blocker) doxazosin mesylate-controlled tablets in the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).In all, 150 patients were enrolled and 126 patients completed the study (41 patients in the doxazosin group, 41 patients in the sertraline group, and 44 patients in the duloxetine group). This was an open randomized 6-month study. CP/CPPS patients who met the diagnostic criteria were randomized into 3 groups. The patients in the duloxetine group received doxazosin 4 mg + duloxetine 30 mg once a day, and the dosage of duloxetine was increased to 60 mg after a week. The patients in the doxazosin group received doxazosin 4 mg once a day. The patients in the sertraline group received doxazosin 4 mg + sertraline 50 mg once a day. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, the short-form McGill Pain questionnaire (SF-MPQ), and the hospital anxiety and depression scale (HAD) were applied for evaluations during follow-up of 1, 3, and 6 months after treatment.There were slight positive significant correlations between NIH-CPSI scores and HAD scores, moderate positive significant correlations between the quality of life (QOL) and SF-MPQ, and slight positive significant correlations between HAD and QOL. The effective rate in the doxazosin group was 4.88%, 19.51%, and 56.10% after 1, 3, and 6 months, respectively (P < 0.05). The SF-MPQ score in the doxazosin group decreased to 1.80 ± 1.29, 2.66 ± 1.57, and 3.24 ± 1.67 after 1, 3, and 6 months, respectively (P < 0.05). The HAD score in the doxazosin group decreased to 2.24 ± 2.17, 4 ± 2.11, and 4.90 ± 2.62 after 1, 3, and 6 months, respectively (P < 0.05). The effective rate in the sertraline group was 9.76%, 36.59%, and 63

  7. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients.

    PubMed

    Murakami, Masato; Osada, Kenichi; Mizuno, Hiromichi; Ochiai, Toshimitsu; Alev, Levent; Nishioka, Kusuki

    2015-08-22

    Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia. This randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure. Overall, 393 patients were randomized to receive either duloxetine (n = 196) or placebo (n = 197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups. Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and

  8. Differential inhibition of cardiac and neuronal Na(+) channels by the selective serotonin-norepinephrine reuptake inhibitors duloxetine and venlafaxine.

    PubMed

    Stoetzer, Carsten; Papenberg, Bastian; Doll, Thorben; Völker, Marc; Heineke, Joerg; Stoetzer, Marcus; Wegner, Florian; Leffler, Andreas

    2016-07-15

    Duloxetine and venlafaxine are selective serotonin-norepinephrine-reuptake-inhibitors used as antidepressants and co-analgesics. While venlafaxine rather than duloxetine induce cardiovascular side-effects, neither of the substances are regarded cardiotoxic. Inhibition of cardiac Na(+)-channels can be associated with cardiotoxicity, and duloxetine was demonstrated to block neuronal Na(+)-channels. The aim of this study was to investigate if the non-life threatening cardiotoxicities of duloxetine and venlafaxine correlate with a weak inhibition of cardiac Na(+)-channels. Effects of duloxetine, venlafaxine and amitriptyline were examined on endogenous Na(+)-channels in neuroblastoma ND7/23 cells and on the α-subunits Nav1.5, Nav1.7 and Nav1.8 with whole-cell patch clamp recordings. Tonic block of the cardiac Na(+)-channel Nav1.5 and rat-cardiomyocytes (CM) revealed a higher potency for duloxetine (Nav 1.5 IC50 14±1µM, CM IC50 27±3µM) as compared to venlafaxine (Nav 1.5 IC50 671±26µM, CM IC50 452±34µM). Duloxetine was as potent as the cardiotoxic antidepressant amitriptyline (IC50 13±1µM). While venlafaxine almost failed to induce use-dependent block on Nav1.5 and cardiomyocytes, low concentrations of duloxetine (1, 10µM) induced prominent use-dependent block similar to amitriptyline. Duloxetine, but not venlafaxine stabilized fast and slow inactivation and delayed recovery from inactivation. Duloxetine induced an unselective inhibition of neuronal Na(+)-channels (IC50 ND7/23 23±1µM, Nav1.7 19±2µM, Nav1.8 29±2). Duloxetine, but not venlafaxine inhibits cardiac Na(+)-channels with a potency similar to amitriptyline. These data indicate that an inhibition of Na(+)-channels does not predict a clinically relevant cardiotoxicity. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial.

    PubMed

    Gilron, Ian; Chaparro, Luis E; Tu, Dongsheng; Holden, Ronald R; Milev, Roumen; Towheed, Tanveer; DuMerton-Shore, Deborah; Walker, Sarah

    2016-07-01

    Fibromyalgia is a syndrome characterized by chronic widespread pain and associated with sleep disturbance, depression, fatigue, and cognitive dysfunction. Polypharmacy is commonly used, but supportive evidence is limited. Most fibromyalgia trials focus primarily on pain reduction with monotherapy. This trial compares a pregabalin-duloxetine combination to each monotherapy. Using a randomized, double-blind, 4-period crossover design, participants received maximally tolerated doses of placebo, pregabalin, duloxetine, and pregabalin-duloxetine combination-for 6 weeks. Primary outcome was daily pain (0-10); secondary outcomes included global pain relief, Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events, and other measures. Of 41 participants randomized, 39 completed ≥2 treatments. Daily pain during placebo, pregabalin, duloxetine, and combination was 5.1, 5.0, 4.1, and 3.7, respectively (P < 0.05 only for combination vs placebo, and pregabalin). Participants (%) reporting ≥moderate global pain relief were 18%, 39%, 42%, and 68%, respectively (P < 0.05 for combination vs placebo, pregabalin, and duloxetine). Fibromyalgia Impact Questionnaire scores were 42.9, 37.4, 36.0, and 29.8, respectively (P < 0.05 for combination vs placebo, pregabalin, and duloxetine). SF-36 scores were 50.2, 55.7, 56.0, and 61.2, respectively (P < 0.05 for combination vs placebo, pregabalin, and duloxetine). Medical Outcomes Study Sleep Scale scores were 48.9, 35.2, 46.1, and 32.1, respectively (P < 0.05 only for combination vs placebo, and duloxetine). BDI-II scores were 11.9, 9.9, 10.7, and 8.9, respectively (P < 0.05 only for combination vs placebo). Moderate-severe drowsiness was more frequent during combination vs placebo. Combining pregabalin and duloxetine for fibromyalgia improves multiple clinical outcomes vs monotherapy. Continued research should compare this and other combinations to monotherapy

  10. Duloxetine in the treatment of Major Depressive Disorder: a comparison of efficacy in patients with and without melancholic features.

    PubMed

    Mallinckrodt, Craig H; Watkin, John G; Liu, Chaofeng; Wohlreich, Madelaine M; Raskin, Joel

    2005-01-04

    The most prominent feature of melancholic depression is a near-total loss of the capacity to derive pleasure from activities or other positive stimuli. Additional symptoms can include psychomotor disturbances, anorexia, excessive guilt, and early awakening from sleep. Melancholic patients may exhibit treatment responses and outcomes that differ from those of non-melancholic patients. Pooled data from double-blind, placebo-controlled studies were utilized to compare the efficacy of duloxetine in depressed patients with and without melancholic features. Efficacy data were pooled from 8 double-blind, placebo-controlled clinical trials of duloxetine. The presence of melancholic features (DSM-IV criteria) was determined using results from the Mini International Neuropsychiatric Interview (MINI). Patients (aged >or= 18 years) meeting DSM-IV criteria for major depressive disorder (MDD) received duloxetine (40-120 mg/d; melancholic, N = 759; non-melancholic, N = 379) or placebo (melancholic, N = 519; non-melancholic, N = 256) for up to 9 weeks. Efficacy measures included the 17-item Hamilton Rating Scale for Depression (HAMD17) total score, HAMD17 subscales (Maier, anxiety, retardation, sleep), the Clinical Global Impression of Severity (CGI-S) and Patient Global Impression of Improvement (PGI-I) scales, and Visual Analog Scales (VAS) for pain. In data from all 8 studies, duloxetine's advantage over placebo did not differ significantly between melancholic and non-melancholic patients (treatment-by-melancholic status interactions were not statistically significant). Duloxetine demonstrated significantly greater improvement in depressive symptom severity, compared with placebo, within both melancholic and non-melancholic cohorts (p duloxetine-treated male and female melancholic patients. In the two studies that

  11. Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty

    PubMed Central

    Blikman, T; Rienstra, W; van Raaij, T M; ten Hagen, A J; Dijkstra, B; Zijlstra, W P; Bulstra, S K; van den Akker-Scheek, I; Stevens, M

    2016-01-01

    Introduction Residual pain is a major factor in patient dissatisfaction following total hip arthroplasty or total knee arthroplasty (THA/TKA). The proportion of patients with unfavourable long-term residual pain is high, ranging from 7% to 34%. There are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. It is thus hypothesised that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine has been shown to be effective for several chronic pain syndromes, including knee osteoarthritis (OA), in which CS is most likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain compared with care-as-usual. Methods and analysis This multicentre, pragmatic, prospective, open-label, randomised controlled trial includes patients with idiopathic hip/knee OA who are on a waiting list for primary THA/TKA. Patients at risk for CS will be randomly allocated to the preoperative duloxetine treatment programme group or the care-as-usual control group. The primary end point is the degree of postoperative pain 6 months after THA/TKA. Secondary end points at multiple time points up to 12 months postoperatively are: pain, neuropathic pain-like symptoms, (pain) sensitisation, pain catastrophising, joint-associated problems, physical activity, health-related quality of life, depressive and anxiety symptoms, and perceived improvement. Data will be analysed on an intention-to-treat basis. Ethics and dissemination The study is approved by the local Medical Ethics Committee (METc 2014/087) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard (GCP), and in compliance with the Medical Research Involving Human Subjects Act (WMO). Trial registration number 2013-004313-41; Pre

  12. Clinical study of duloxetine hydrochloride combined with doxazosin for the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome

    PubMed Central

    Zhang, Mingxin; Li, Hanzhong; Ji, Zhigang; Dong, Dexin; Yan, Su

    2017-01-01

    Abstract To explore the safety and efficacy of the selective 5-serotonin and norepinephrine reuptake inhibitor duloxetine hydrochloride and alpha-adrenergic receptor blocker (alpha-blocker) doxazosin mesylate-controlled tablets in the treatment of pain disorder in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). In all, 150 patients were enrolled and 126 patients completed the study (41 patients in the doxazosin group, 41 patients in the sertraline group, and 44 patients in the duloxetine group). This was an open randomized 6-month study. CP/CPPS patients who met the diagnostic criteria were randomized into 3 groups. The patients in the duloxetine group received doxazosin 4 mg + duloxetine 30 mg once a day, and the dosage of duloxetine was increased to 60 mg after a week. The patients in the doxazosin group received doxazosin 4 mg once a day. The patients in the sertraline group received doxazosin 4 mg + sertraline 50 mg once a day. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, the short-form McGill Pain questionnaire (SF-MPQ), and the hospital anxiety and depression scale (HAD) were applied for evaluations during follow-up of 1, 3, and 6 months after treatment.There were slight positive significant correlations between NIH-CPSI scores and HAD scores, moderate positive significant correlations between the quality of life (QOL) and SF-MPQ, and slight positive significant correlations between HAD and QOL. The effective rate in the doxazosin group was 4.88%, 19.51%, and 56.10% after 1, 3, and 6 months, respectively (P < 0.05). The SF-MPQ score in the doxazosin group decreased to 1.80 ± 1.29, 2.66 ± 1.57, and 3.24 ± 1.67 after 1, 3, and 6 months, respectively (P < 0.05). The HAD score in the doxazosin group decreased to 2.24 ± 2.17, 4 ± 2.11, and 4.90 ± 2.62 after 1, 3, and 6 months, respectively (P < 0.05). The effective rate in the sertraline group was 9.76%, 36

  13. Vortioxetine versus Duloxetine in the Treatment of Patients with Major Depressive Disorder: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Li, Guangjian; Wang, Xu; Ma, Dihui

    2016-07-01

    Vortioxetine and duloxetine are two new antidepressant drugs that have been used clinically in the treatment of major depressive disorder (MDD). The objectives of this meta-analysis were to evaluate the efficacy and tolerability of vortioxetine compared with duloxetine in MDD. Randomized controlled trials (RCTs) published in PubMed, EMBASE, Web of Science, and ClinicalTrials.gov were systematically reviewed to compare vortioxetine with duloxetine in terms of efficacy and tolerability in patients with MDD. Results were expressed as the risk ratio (RR) with 95 % confidence intervals (CIs), and weighted mean difference (WMD). Pooled estimates were calculated by using a fixed-effects model or a randomized-effects model, depending on the heterogeneity among studies. A total of five RCTs involving 2287 patients met the inclusion criteria and were included in this meta-analysis. Pooled results showed that duloxetine was associated with a higher response rate than vortioxetine, as well as showing a similar remission rate with vortioxetine. The changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS), 24-item Hamilton Rating Scale for Depression (HAM-D24), Clinical Global Impression-Improvement scale (CGI-I), CGI-Severity scale (CGI-S), Sheehan Disability Scale (SDS), and Hamilton Anxiety Rating Scale (HAM-A) scores were significantly greater in the duloxetine group than in the vortioxetine group. The incidence of treatment-emergent adverse events was significantly higher in the duloxetine group than in the vortioxetine group. Duloxetine was more effective but less well-tolerated than vortioxetine in MDD. Considering the potential limitations of this meta-analysis, more large-scale RCTs are needed to confirm these findings.

  14. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications.

    PubMed

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Jørgensen, Karsten Juhl; Lundh, Andreas; Schroll, Jeppe; Gøtzsche, Peter C

    2014-06-04

    To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms. Data on primary efficacy analysis and major harms extracted from each data source and compared. Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder. Clinical study reports, including protocols as appendices (total 13,729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer's online clinical trial registry were searched for trial results. Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor inconsistencies in the population in the primary efficacy analysis between the protocol and clinical study report and within the clinical study report for one trial. Furthermore, we found contradictory information within the reports for seven serious adverse events and eight adverse events that led to discontinuation but with no apparent bias. In each trial, a median of 406 (range 177-645) and 166 (100-241) treatment emergent adverse events (adverse events that emerged or worsened after study drug was started) in the randomised phase were not reported in journal articles and Lilly trial registry reports, respectively. We also found publication bias in relation to beneficial effects. Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There

  15. Duloxetine compliance and its association with healthcare costs among patients with diabetic peripheral neuropathic pain.

    PubMed

    Wu, N; Chen, S; Boulanger, L; Fraser, K; Bledsoe, S L; Zhao, Y

    2009-09-01

    Duloxetine is approved to treat diabetic peripheral neuropathic pain (DPNP) in the US. The study objective was to examine the predictors of duloxetine compliance, and its association with healthcare costs among DPNP patients. The study used administrative claims databases to identify non-depressed DPNP patients with a duloxetine prescription dispensed between October 1, 2004 and December 31, 2006. Two cohorts of patients were constructed based on compliance to duloxetine therapy over 1-year follow-up with high compliance defined as a medication possession ratio (MPR) > or =0.80. All-cause, diabetes-, and DPNP-related healthcare costs during 1-year follow-up were estimated. Logistic regressions were performed to examine how average daily dose (ADD) of duloxetine and other factors may influence compliance. Multivariate regressions were estimated to examine the association between compliance and healthcare costs. The study included 1,380 commercially insured (mean age 55 years) and 974 patients with employer-sponsored Medicare supplemental insurance (mean age 75 years). In both populations, patients with an ADD >30 mg were more likely to be compliant with the therapy compared with those with an ADD of < or =30 mg (odds ratio ranged 1.79-3.38, all p<0.05). Controlling for differences in demographics, clinical and economic characteristics, commercially insured low duloxetine compliance patients had greater all-cause ($5,334, p<0.05) and diabetes-related healthcare costs ($3,414, p<0.05) than high-compliance patients, with the biggest difference from inpatient costs (all-cause: $7,508; diabetes-related: $3,785, all p<0.05). Similar trends were found in the Medicare supplemental insured population; however, differences in all-cause healthcare costs were not significant. DPNP patients with a higher ADD of duloxetine over a 1-year follow-up period were more compliant with the therapy. Duloxetine patients with high compliance were also associated with lower healthcare costs

  16. Efficacy of duloxetine in the treatment of generalized anxiety disorder in patients with clinically significant pain symptoms.

    PubMed

    Russell, James M; Weisberg, Risa; Fava, Maurizio; Hartford, James T; Erickson, Janelle S; D'Souza, Deborah N

    2008-01-01

    Anxiety disorders often are accompanied by painful physical symptoms. This report assessed the effectiveness of duloxetine in improving anxiety symptoms, pain severity, and patient functioning in adults diagnosed with generalized anxiety disorder (GAD), who presented with clinically significant pain symptoms. Data were pooled from two multicenter, randomized, double-blind, placebo-controlled clinical studies evaluating the efficacy of duloxetine 60-120 mg once daily compared with placebo in the treatment of GAD. The primary patient population for these analyses was patients with baseline Visual Analog Scale (VAS) overall pain severity score > or =30. Of the 798 randomized patients that had baseline VAS scores, approximately 44.4% of GAD patients were identified as having baseline VAS overall pain severity score > or =30 (duloxetine N=208, placebo N=146). Duloxetine-treated patients had significantly greater improvement compared with placebo-treated patients on anxiety symptoms (measured by Hamilton Anxiety Scale total score), on patient functioning (measured by the Sheehan Disability Scale Global Functional Impairment Score and across all Sheehan Disability Scale domains), and on all VAS pain items. Patients achieving remission at endpoint, and patients with lower scores on the Clinical Global Impression of Improvement and Patient Global Impression of Improvement scales had greater improvement in VAS pain severity scores. These results suggest that in patients with GAD who present with clinically significant pain symptoms, duloxetine is effective in reducing anxiety symptoms, pain severity, and in improving patient functioning.

  17. Imaging pain relief in osteoarthritis (IPRO): protocol of a double-blind randomised controlled mechanistic study assessing pain relief and prediction of duloxetine treatment outcome.

    PubMed

    Reckziegel, Diane; Bailey, Helen; Cottam, William J; Tench, Christopher R; Mahajan, Ravi P; Walsh, David A; Knaggs, Roger D; Auer, Dorothee P

    2017-06-26

    Osteoarthritis (OA) pain is a major cause of long-term disability and chronic pain in the adult population. One in five patients does not receive satisfactory pain relief, which reflects the complexity of chronic pain and the current lack of understanding of mechanisms of chronic pain. Recently, duloxetine has demonstrated clinically relevant pain relief, but only in half of treated patients with OA. Here, the aim is to investigate the neural mechanisms of pain relief and neural signatures that may predict treatment response to duloxetine in chronic knee OA pain. This is an ongoing single-centre randomised placebo-controlled mechanistic study (2:1 (placebo) allocation), using a multimodal neuroimaging approach, together with psychophysiological (quantitative sensory testing), genetics and questionnaire assessments. Eighty-one subjects with chronic knee OA pain are planned to power for between-group comparisons (placebo, duloxetine responder and duloxetine non-responder). Participants have a baseline assessment and, following 6 weeks of duloxetine (30 mg for 2 weeks, then 60 mg for 4 weeks), a follow-up evaluation. Brain imaging is performed at 3T with blood-oxygen-level dependent functional MRI at rest and during pin-prick nociceptive stimulation for main outcome assessment; arterial spin labelling and structural imaging (T1-weighted) for secondary outcome assessment. Questionnaires evaluate pain, negative affect, quality of sleep and cognition. The study has been approved by the East Midlands, Nottingham and is being carried out under the principles of the Declaration of Helsinki (64th, 2013) and Good Clinical Practice standards. Results will be disseminated in peer-reviewed journals and at scientific conferences. This trial is registered at ClinicalTrials.gov (NCT02208778).This work was supported by Arthritis Research UK (Grant 18769). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  18. Safety and tolerability of duloxetine in the treatment of patients with fibromyalgia: pooled analysis of data from five clinical trials.

    PubMed

    Choy, Ernest H S; Mease, Philip J; Kajdasz, Daniel K; Wohlreich, Madelaine M; Crits-Christoph, Paul; Walker, Daniel J; Chappell, Amy S

    2009-09-01

    The purpose of this report is to describe the overall safety profile of both short- and longer-term duloxetine treatment of fibromyalgia. Data from four double-blind, randomized, placebo-controlled studies (two with 6-month open-label extension phases) and a 1-year, open-label safety study were included. Safety measures included treatment-emergent adverse events (TEAEs), adverse events leading to discontinuation, serious adverse events (SAEs), clinical laboratory tests, vital signs, and electrocardiograms. The most common TEAEs for short-term treatment with duloxetine were nausea (29.3%), headache (20.0%), dry mouth (18.2%), insomnia (14.5%), fatigue (13.5%), constipation (14.5%), diarrhea (11.6%), and dizziness (11.0%; all p < 0.05 vs. placebo). Most TEAEs emerged early and were mild to moderate in severity. The profile of adverse events in patients enrolled at least 6 months, and for patients in the 1-year study, was similar to that found in the short-term treatment studies, with no new adverse events emerging at a notable rate. About 20% of patients discontinued due to adverse events in the short-term treatment studies and in the 1-year study. SAEs were uncommon, and none occurred at a significantly higher frequency for duloxetine compared with placebo. Mean changes in vital signs and weight were small. Rates of treatment-emergent potentially clinically significant (PCS) vital sign, laboratory, and electrocardiogram measures were low, with only PCS rates of alanine aminotransferase being significantly higher for duloxetine compared with placebo in the placebo-controlled treatment studies. In the 1-year study, four patients (1.1%) had suicide-related behavior. The data provided here summarize short- and long-term safety from five clinical studies in patients treated with duloxetine for fibromyalgia. In addition, postmarketing surveillance continues for adverse events reported with duloxetine in fibromyalgia, as in other indications.

  19. Characterization of stress degradation products of duloxetine hydrochloride employing LC-UV/PDA and LC-MS/TOF studies.

    PubMed

    Chadha, Renu; Bali, Alka; Bansal, Gulshan

    2016-03-20

    Duloxetine HCl was subjected to forced degradation under conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A(R2). The drug showed significant degradation under acidic, alkaline and aqueous hydrolytic as well as photolytic conditions. The drug remained stable under thermal and oxidative stress conditions. In total, seventeen degradation products (I-XVII) were formed under varied conditions, which could be separated by chromatography of respective degraded solutions on C18 (250 mm×4.6 mm; 5 μ, Nulceodur) column using isocratic elution method. Detection wavelength was selected as 290 nm. MS/TOF accurate mass studies were carried out to establish the complete fragmentation pathway of the drug and degradation products, which, in turn, was utilized in characterization of the products. The degradation pathway of the drug leading to generation of fifteen products I-X, XII-XIII, XV-XVII was postulated and this has not been reported so far.

  20. A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine.

    PubMed

    Martiny, Klaus; Refsgaard, Else; Lund, Vibeke; Lunde, Marianne; Sørensen, Lene; Thougaard, Britta; Lindberg, Lone; Bech, Per

    2012-09-01

    The onset of action of antidepressants often takes 4 to 6 weeks. The antidepressant effect of wake therapy (sleep deprivation) comes within hours but carries a risk of relapse. The objective of this study was to investigate whether a new chronotherapeutic intervention combining wake therapy with bright light therapy and sleep time stabilization could induce a rapid and sustained augmentation of response and remission in major depressive disorder. 75 adult patients with DSM-IV major depressive disorder, recruited from psychiatric wards, psychiatric specialist practices, or general medical practices between September 2005 and August 2008, were randomly assigned to a 9-week chronotherapeutic intervention using wake therapy, bright light therapy, and sleep time stabilization (n = 37) or a 9-week intervention using daily exercise (n = 38). Patients were evaluated at a psychiatric research unit. The study period had a 1-week run-in phase in which all patients began treatment with duloxetine. This phase was followed by a 1-week intervention phase in which patients in the wake therapy group did 3 wake therapies in combination with daily morning light therapy and sleep time stabilization and patients in the exercise group began daily exercise. This phase was followed by a 7-week continuation phase with daily light therapy and sleep time stabilization or daily exercise. The 17-item Hamilton Depression Rating Scale was the primary outcome measure, and the assessors were blinded to patients' treatment allocation. Both groups responded well to treatment. Patients in the wake therapy group did, however, have immediate and clinically significantly better response and remission compared to the exercise group. Thus, immediately after the intervention phase (week 2), response was obtained in 41.4% of wake therapy patients versus 12.8% of exercise patients (odds ratio [OR] = 4.8; 95% CI, 1.7-13.4; P = .003), and remission was obtained in 23.9% of wake therapy patients versus 5.4% of

  1. Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty.

    PubMed

    Blikman, T; Rienstra, W; van Raaij, T M; ten Hagen, A J; Dijkstra, B; Zijlstra, W P; Bulstra, S K; van den Akker-Scheek, I; Stevens, M

    2016-03-01

    Residual pain is a major factor in patient dissatisfaction following total hip arthroplasty or total knee arthroplasty (THA/TKA). The proportion of patients with unfavourable long-term residual pain is high, ranging from 7% to 34%. There are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. It is thus hypothesised that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine has been shown to be effective for several chronic pain syndromes, including knee osteoarthritis (OA), in which CS is most likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain compared with care-as-usual. This multicentre, pragmatic, prospective, open-label, randomised controlled trial includes patients with idiopathic hip/knee OA who are on a waiting list for primary THA/TKA. Patients at risk for CS will be randomly allocated to the preoperative duloxetine treatment programme group or the care-as-usual control group. The primary end point is the degree of postoperative pain 6 months after THA/TKA. Secondary end points at multiple time points up to 12 months postoperatively are: pain, neuropathic pain-like symptoms, (pain) sensitisation, pain catastrophising, joint-associated problems, physical activity, health-related quality of life, depressive and anxiety symptoms, and perceived improvement. Data will be analysed on an intention-to-treat basis. The study is approved by the local Medical Ethics Committee (METc 2014/087) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard (GCP), and in compliance with the Medical Research Involving Human Subjects Act (WMO). 2013-004313-41; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already

  2. Usefulness of duloxetine for Paclitaxel-induced peripheral neuropathy treatment in gynecological cancer patients.

    PubMed

    Otake, Akiko; Yoshino, Kiyoshi; Ueda, Yutaka; Sawada, Kenjiro; Mabuchi, Seiji; Kimura, Toshihiro; Kobayashi, Eiji; Isobe, Aki; Egawa-Takata, Tomomi; Matsuzaki, Shinya; Fujita, Masami; Kimura, Tadashi

    2015-01-01

    The present study aimed at evaluating the usefulness and adverse effects of duloxetine treatment for paclitaxel-induced peripheral neuropathy in gynecological cancer patients. Medical records of gynecological cancer patients treated with duloxetine were retrospectively studied to evaluate the drug's efficacy for paclitaxel-induced peripheral neuropathy. RESULTS from 25 patients showed that an improved response was observed in 14 (56%). By univariate and multivariate analysis, the patient's age, tumor origin, regimen of chemotherapy, accumulated doses of paclitaxel or carboplatin, previous medication, maintenance dosage and timing of treatment with duloxetine were found not to be associated with the effectiveness of duloxetine treatment. Adverse effects with duloxetine were mild and well-tolerated. As an option, duloxetine can be effectively used for paclitaxel-induced peripheral neuropathy in patients with gynecological cancers, irrespective of patients' age, origin of the tumor, regimen of chemotherapy, or previous medication. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  3. A randomized, placebo-controlled, double-blinded trial of duloxetine in the treatment of general fatigue in patients with chronic fatigue syndrome.

    PubMed

    Arnold, Lesley M; Blom, Thomas J; Welge, Jeffrey A; Mariutto, Elizabeth; Heller, Alicia

    2015-01-01

    To assess the efficacy and safety of duloxetine in patients with chronic fatigue syndrome. A 12-week, randomized, double-blind study was designed to compare duloxetine 60-120 mg/d (n = 30) with placebo (n = 30) for efficacy and safety in the treatment of patients with chronic fatigue syndrome. The primary outcome measure was the Multidimensional Fatigue Inventory general fatigue subscale (range: 4-20, with higher scores indicating greater fatigue). Secondary measures were the remaining Multidimensional Fatigue Inventory subscales, Brief Pain Inventory, Medical Outcomes Study Short Form-36, Hospital Anxiety and Depression Scale, Centers for Disease Control and Prevention Symptom Inventory, Patient Global Impression of Improvement, and Clinical Global Impression of Severity. The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent-to-treat sample, with treatment-by-time interaction as the measure of effect. The improvement in the Multidimensional Fatigue Inventory general fatigue scores for the duloxetine group was not significantly greater than for the placebo group (P = 0.23; estimated difference between groups at week 12 = -1.0 [95% CI: -2.8, 0.7]). The duloxetine group was significantly superior to the placebo group on the Multidimensional Fatigue Inventory mental fatigue score, Brief Pain Inventory average pain severity and interference scores, Short Form-36 bodily pain domain, and Clinical Global Impression of Severity score. Duloxetine was generally well tolerated. The primary efficacy measure of general fatigue did not significantly improve with duloxetine when compared with placebo. Significant improvement in secondary measures of mental fatigue, pain, and global measure of severity suggests that duloxetine may be efficacious for some chronic fatigue syndrome symptom domains, but larger controlled trials are needed to confirm these results. Copyright © 2015 The Academy of Psychosomatic Medicine. Published by

  4. Enhancement of nootropic effect of duloxetine and bupropion by caffeine in mice.

    PubMed

    Kale, Pravin Popatrao; Addepalli, Veeranjaneyulu

    2015-01-01

    The existing evidence suggests an association between depression and memory impairment. The objective of present study was to assess the effect of low dose caffeine with duloxetine and bupropion on memory. Mice were divided randomly into seven groups. Intra-peritoneal treatment of normal saline (10 ml/kg), caffeine (10 mg/kg), duloxetine (10 mg/kg), bupropion alone (10 mg/kg), caffeine + duloxetine (5 mg/kg, each), caffeine + bupropion (5 mg/kg, each), and bupropion + duloxetine (5 mg/kg, each) were given to groups I-VII, respectively. Elevated plus maze was used to evaluate transfer latency (TL) and Morris water maze was used to estimate the time spent in target quadrant. Caffeine with duloxetine treated group was better than other combination treated groups in terms of a significant decrease in TL and increase in the time spent in target quadrant recorded. Combining lower dose of caffeine with duloxetine may enhance cognitive benefits than respective monotherapies.

  5. The Effect of Initial Duloxetine Dosing Strategy on Nausea in Korean Patients with Major Depressive Disorder

    PubMed Central

    Lee, Min-Soo; Ahn, Yong Min; Chung, Seockhoon; Walton, Richard; Kim, Mun Sung

    2012-01-01

    Objective To assess the relative severity of nausea in patients from Korea with major depressive disorder (MDD) who were treated with duloxetine at low (30 mg) or high (60 mg) doses, with or without food, for the first week of an 8 week treatment. Methods Adult patients (n=249), with MDD and a 17-item Hamilton Rating Scale for Depression (HAMD17) score of ≥15, received open-label once daily duloxetine. At Week 0, patients were randomized to 4 groups: 30 mg with food (n=63), 60 mg with food (n=59), 30 mg without food (n=64), and 60 mg without food (n=63). At Week 1, all patients switched to duloxetine 60 mg for 7 weeks. The primary outcome measure was item 112 (nausea) of the Association for Methodology and Documentation in Psychiatry adverse event scale. Effectiveness was assessed by change in HAMD17 total score. Results Overall, 94.4% (235/249) of patients completed Week 1 and 55.0% (137/249) of patients completed the study. For Week 1, nausea was significantly less severe for patients who received 30 mg compared with 60 mg duloxetine (p=0.003), regardless of food intake. In all groups, nausea severity was highest at Week 1 and declined throughout the study. HAMD17 score was reduced in all groups and the most common adverse event reported was nausea (145/249; 58.2%). Conclusion To minimize nausea, Korean patients with MDD who require duloxetine treatment could be given 30 mg once daily, regardless of food, for the first week followed by 60 mg once daily for the course of therapy. PMID:23251205

  6. The role of duloxetine in the treatment of anxiety disorders

    PubMed Central

    De Berardis, Domenico; Serroni, Nicola; Carano, Alessandro; Scali, Marco; Valchera, Alessandro; Campanella, Daniela; D’Albenzio, Alessandro; Di Giuseppe, Berardo; Moschetta, Francesco Saverio; Salerno, Rosa Maria; Ferro, Filippo Maria

    2008-01-01

    Anxiety disorders (ADs) are the most common type of psychiatric disorders, with a mean incidence of 18.1% and a lifetime prevalence of 28.8%. Pharmacologic options studied for treating ADs may include benzodiazepines, tricyclic antidepressants (TCA), selective serotonin reuptake inhibitors (SSRIs), noradrenergic and specific serotonergic drug (NaSSA) and dual-reuptake inhibitors of serotonin and norepinephrine (SNRIs). In this context, the development of SNRIs (venlafaxine and duloxetine) has been particularly useful. As a dual-acting intervention that targets two neurotransmitter systems, these medications would appePar promising for the treatment of ADs. The purpose of this review was to elucidate current facts and views about the role of duloxetine in the treatment of ADs. In February 2007, duloxetine was approved by FDA for the treatment of generalized anxiety disorder (GAD). The results of trials evaluating the use duloxetine in the treatment of GAD are supportive on its efficacy even if further studies on long-term use are needed. Apart from some interesting case reports, no large studies are, to date, present in literature about duloxetine and other ADs such as panic disorder, social anxiety disorder, obsessive-compulsive disorder and post-traumatic stress disorder. Therefore, the clinical efficacy and the relative good tolerability of duloxetine may be further investigated to widen the therapeutic spectrum of ADs. PMID:19183783

  7. The role of duloxetine in the treatment of anxiety disorders.

    PubMed

    De Berardis, Domenico; Serroni, Nicola; Carano, Alessandro; Scali, Marco; Valchera, Alessandro; Campanella, Daniela; D'Albenzio, Alessandro; Di Giuseppe, Berardo; Moschetta, Francesco Saverio; Salerno, Rosa Maria; Ferro, Filippo Maria

    2008-10-01

    Anxiety disorders (ADs) are the most common type of psychiatric disorders, with a mean incidence of 18.1% and a lifetime prevalence of 28.8%. Pharmacologic options studied for treating ADs may include benzodiazepines, tricyclic antidepressants (TCA), selective serotonin reuptake inhibitors (SSRIs), noradrenergic and specific serotonergic drug (NaSSA) and dual-reuptake inhibitors of serotonin and norepinephrine (SNRIs). In this context, the development of SNRIs (venlafaxine and duloxetine) has been particularly useful. As a dual-acting intervention that targets two neurotransmitter systems, these medications would appePar promising for the treatment of ADs. The purpose of this review was to elucidate current facts and views about the role of duloxetine in the treatment of ADs. In February 2007, duloxetine was approved by FDA for the treatment of generalized anxiety disorder (GAD). The results of trials evaluating the use duloxetine in the treatment of GAD are supportive on its efficacy even if further studies on long-term use are needed. Apart from some interesting case reports, no large studies are, to date, present in literature about duloxetine and other ADs such as panic disorder, social anxiety disorder, obsessive-compulsive disorder and post-traumatic stress disorder. Therefore, the clinical efficacy and the relative good tolerability of duloxetine may be further investigated to widen the therapeutic spectrum of ADs.

  8. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study

    PubMed Central

    Karp, Jordan F.; Weiner, Debra K.; Dew, Mary A.; Begley, Amy; Miller, Mark D.; Reynolds, Charles F.

    2010-01-01

    Objective: In older adults, major depressive disorder (MDD) and chronic low back pain (CLBP) are common and mutually exacerbating. We predicted that duloxetine pharmacotherapy and Depression and Pain Care Management (DPCM) would result in (1) significant improvement in MDD and CLBP and (2) significant improvements in health-related quality of life, anxiety, disability, self-efficacy, and sleep quality. Design and Intervention: Twelve week open-label study using duloxetine up to 120 mg/day + DPCM. Setting: Outpatient late-life depression research clinic. Patients: Thirty community-dwelling adults >60 years old. Outcome Measures: Montgomery Asberg Depression Rating Scale (MADRS) and McGill Pain Questionnaire-Short Form (MPQ-SF). Results: 46.7% (n = 14) of the sample had a depression remission. All subjects who met criteria for the depression remission also had a pain response. 93.3% (n = 28) had a significant pain response. Of the subjects who met criteria for a low back pain response, 50% (n = 14) also met criteria for the depression remission. The mean time to depression remission was 7.6 (SE = 0.6) weeks. The mean time to pain response was 2.8 (SE = 0.5) weeks. There were significant improvements in mental health-related quality of life, anxiety, sleep quality, somatic complaints, and both self-efficacy for pain management and for coping with symptoms. Physical health-related quality of life, back pain-related disability, and self-efficacy for physical functioning did not improve. Conclusions: Serotonin and norepinephrine reuptake inhibitors like duloxetine delivered with DPCM may be a good choice to treat these linked conditions in older adults. Treatments that target low self-efficacy for physical function and improving disability may further increase response rates. PMID:19750557

  9. Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study.

    PubMed

    Tsuji, Toshinaga; Itoh, Naohiro; Ishida, Mitsuhiro; Ochiai, Toshimitsu; Konno, Shinichi

    2017-01-01

    Duloxetine is efficacious for chronic low back pain (CLBP). This post hoc analysis of a Japanese randomized, placebo-controlled trial (ClinicalTrials.gov, NCT01855919) assessed whether patients with CLBP with early pain reduction or treatment-related adverse events of special interest (TR-AESIs; nausea, somnolence, constipation) have enhanced responses to duloxetine. Patients (N = 456) with CLBP for ≥6 months and Brief Pain Inventory (BPI) average pain severity score of ≥4 were randomized (1:1) to duloxetine 60 mg/day or placebo for 14 weeks. Primary outcome was change from baseline in BPI average pain severity score (pain reduction). Subgroup analyses included early pain reduction (≥30%, 10%-30%, or <10% at Week 4) and early TR-AESIs (with or without TR-AESIs by Week 2). Measures included changes from baseline in BPI average pain severity score and BPI Interference scores (quality of life; QOL), and response rate (≥30% or ≥50% pain reduction at Week 14). Patients with ≥30% early pain reduction (n = 108) or early TR-AESIs (n = 50) had significantly greater improvements in pain and QOL than placebo-treated patients (n = 226), whereas patients with 10%-30% (n = 63) or <10% (n = 48) pain reduction did not; patients without early TR-AESIs (n = 180) had significant improvements in pain at Week 14. Response rates (≥30%/≥50% pain reduction) were 94.4%/82.4%, 66.7%/49.2%, and 25.0%/18.8% for patients with ≥30%, 10%-30%, and <10% early pain reduction, respectively, 74.0%/64.0% for patients with early TR-AESIs, 67.2%/54.4% for patients without early TR-AESIs, and 52.2%/39.4% for placebo. Early pain reduction or TR-AESIs may predict which CLBP patients are most likely to respond to duloxetine with improvements in pain and QOL.

  10. Randomized, Double-blind, Placebo-controlled Phase III Trial of Duloxetine Monotherapy in Japanese Patients With Chronic Low Back Pain

    PubMed Central

    Konno, Shinichi; Oda, Natsuko; Ochiai, Toshimitsu; Alev, Levent

    2016-01-01

    Study Design. A 14-week, randomized, double-blind, multicenter, placebo-controlled study of Japanese patients with chronic low back pain (CLBP) who were randomized to either duloxetine 60 mg once daily or placebo. Objective. This study aimed to assess the efficacy and safety of duloxetine monotherapy in Japanese patients with CLBP. Summary of Background Data. In Japan, duloxetine is approved for the treatment of depression, diabetic neuropathic pain, and pain associated with fibromyalgia; however, no clinical study of duloxetine has been conducted for CLBP. Methods. The primary efficacy measure was the change in the Brief Pain Inventory (BPI) average pain score from baseline to Week 14. Secondary efficacy measures included BPI pain (worst pain, least pain, pain right now), Patient's Global Impression of Improvement, Clinical Global Impressions of Severity, and Roland-Morris Disability Questionnaire, among other measures, and safety and tolerability. Results. In total, 458 patients were randomized to receive either duloxetine (n = 232) or placebo (n = 226). The BPI average pain score improved significantly in the duloxetine group compared with that in the placebo group at Week 14 [−2.43 ± 0.11 vs. −1.96 ± 0.11, respectively; between-group difference (95% confidence interval), − 0.46 [−0.77 to−0.16]; P = 0.0026]. The duloxetine group showed significant improvement in many secondary measures compared with the placebo group, including BPI pain (least pain, pain right now) (between-group difference: −1.69 ± 0.10, P = 0.0009; −2.42 ± 0.12, P P = 0.0230, respectively), Patient's Global Impression of Improvement (2.46 ± 0.07, P = 0.0026), Clinical Global Impressions of Severity (−1.46 ± 0.06, P = 0.0019), and Roland-Morris Disability Questionnaire (−3.86 ± 0.22, P = 0.0439). Adverse events occurring at a significantly higher incidence in the duloxetine group were somnolence

  11. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial

    PubMed Central

    Smith, Ellen M. Lavoie; Pang, Herbert; Cirrincione, Constance; Fleishman, Stewart; Paskett, Electra D.; Ahles, Tim; Bressler, Linda R.; Fadul, Camilo E.; Knox, Chetaye; Le-Lindqwister, Nguyet; Gilman, Paul B.; Shapiro, Charles L.

    2013-01-01

    Context There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy (CIPN). Objective The primary objective was to determine the effect of duloxetine 60 mg daily on CIPN “average” pain severity Design Randomized, double-blind, placebo-controlled crossover Setting Eight National Cancer Institute (NCI)-funded cooperative research networks recruited patients from community and academic settings between April 2008 and March 2011. Study follow-up was completed July 2012. Patients 231 patients ≥ 25 years of age were randomized (stratified by chemotherapy drug and CIPN comorbid risk) to receive either duloxetine followed by placebo or placebo followed by duloxetine. Eligible patients reported ≥ Grade 1 sensory CIPN per the NCI Common Toxicity Criteria for Adverse Events and ≥ 4/10 average CIPN-related pain following paclitaxel or oxaliplatin treatment. 81% completed the initial treatment period. Intervention The initial treatment consisted of duloxetine/placebo 30mg/one capsule daily for the first week, then 60mg/two capsules for four additional weeks Outcome Measure The primary hypothesis was that duloxetine would be more effective than placebo in decreasing CIPN pain. Pain severity was assessed using the Brief Pain Inventory-Short Form “average pain” item [0 (no pain) – 10 (as bad as can imagine)]. Results Individuals receiving duloxetine as initial treatment (weeks 1–5) reported a larger mean decrease in average pain (1.06; 95% CI: 0.72, 1.40) compared to placebo-treated patients (0.34; 95% CI: 0.01, 0.66) (p = 0.003) (effect size = 0.513). The observed mean difference in the average pain score between the duloxetine and placebo groups was 0.73 (95% CI: 0.26, 1.20). 59% of duloxetine-treated patients compared to 38% of placebo-treated patients reported decreased pain of any amount. Conclusions Among patients with painful CIPN, the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in

  12. Analysis of duloxetine hydrochloride and its related compounds in pharmaceutical dosage forms and in vitro dissolution studies by stability indicating UPLC.

    PubMed

    Rao, Dantu Durga; Sait, Shakil S; Reddy, A Malleswara; Chakole, Dinesh; Reddy, Y Ramakoti; Mukkanti, K

    2010-11-01

    A reproducible gradient reversed-phase ultra-performance liquid chromatographic method is developed for quantitative determination of duloxetine hydrochloride in pharmaceutical dosage forms. The method is also applicable for analysis of related substances and for study of in vitro dissolution profiles. Chromatographic separation is achieved on a 50 mm × 4.6 mm, 1.8 μm C-18 column. Mobile phase A contains a mixture of 0.01 M KH(2)PO(4) (pH 4.0) buffer, tetrahydro furan, and methanol in the ratio 67:23:10 (v/v/v), respectively, and mobile phase B contains a mixture of 0.01 M KH(2)PO(4), (pH 4.0) buffer, and acetonitrile in the ratio 60:40 (v/v), respectively. The flow rate is 0.6 mL/min, and the detection wavelength is monitored at 236 nm. Resolution of duloxetine hydrochloride and three potential impurities is greater than 2.0 for all pairs of components. The drug was subjected to ICH prescribed hydrolytic, oxidative, photolytic, and thermal stress conditions. Method is validated for linearity, specificity, accuracy, precision, ruggedness, and robustness.

  13. Effect of duloxetine in patients with fibromyalgia: tiredness subgroups

    PubMed Central

    2010-01-01

    Introduction This study tested the hypothesis that baseline ratings of fatigue/tiredness would be negatively associated with the efficacy of duloxetine on measures of pain and functional ability in patients with fibromyalgia. Methods A post hoc analysis of pooled data from 4 double-blind, placebo-controlled studies of duloxetine in fibromyalgia was performed. The fibromyalgia impact questionnaire (FIQ) tiredness item score (0 to 10 scale) was used to define tiredness subgroups. Patients were stratified into 3 subgroups: mild (0 to 3), moderate (4 to 6), and severe (7 to 10) tiredness. Analysis of covariance models and logistic regressions were used to test treatment-by-tiredness subgroup interactions. Results Data from the first 3 months are included in this post hoc analysis (duloxetine N = 797, placebo N = 535). At baseline, the distribution of tiredness severity in the duloxetine and placebo groups respectively was 3.64% and 3.75% mild, 16.71% and 15.57% moderate, and 79.65% and 80.68% severe. Rates of clinically significant (≥30% and ≥50%) improvement in brief pain inventory (BPI) average pain were similar across the tiredness subgroups. Tiredness severity at baseline was not negatively associated with the effects of duloxetine on patients' reports of functional ability using the FIQ total score, FIQ measures of physical impairment, interference with work, pain, stiffness, and depression and the medical outcomes study short form-36 (SF-36). Conclusions Studies of duloxetine in fibromyalgia have demonstrated clinically significant improvements in pain and functional ability (FIQ, SF-36). This post hoc analysis of data shows that the efficacy of duloxetine among patients with fibromyalgia does not vary as a function of baseline ratings of fatigue/tiredness. PMID:20630058

  14. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD).

    PubMed

    Baldwin, David S; Loft, Henrik; Dragheim, Marianne

    2012-07-01

    The efficacy, safety, and tolerability of Lu AA21004 versus placebo, using duloxetine as active reference, in patients with DSM-IV-TR diagnosed major depressive disorder (MDD) were evaluated in this 8-week, multi-site study. Patients (n=766) had a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 and were randomly assigned (1:1:1:1:1) to 2.5, 5 or 10 mg Lu AA21004, placebo, or 60 mg duloxetine. The 5mg and 10mg doses of Lu AA21004 were tested separately versus placebo at p≤0.025 in a pre-specified order. In the pre-defined primary efficacy analysis [mean change from baseline in MADRS total score at Week 8, full analysis set, ANCOVA, last observation carried forward (LOCF)], the differences to placebo (n=145) of -1.7 (Lu AA21004 5 mg, n=155) and -1.5 points (Lu AA21004 10 mg, n=151) were not statistically significant; nor were those for Lu AA21004 2.5 mg (-1.4 points, n=155) or duloxetine (-2.0 points, n=149). Using mixed model, repeated measures (MMRM) analyses of the primary endpoint and most secondary endpoints were supportive of likely efficacy for Lu AA21004 5 mg and 10 mg and duloxetine. Treatment-emergent adverse events led to the withdrawal of 72 patients: 8% (placebo), 12% (duloxetine), and 6%, 11% and 9% in the Lu AA21004 groups (2.5 mg, 5 mg and 10 mg, respectively). The most common adverse events were nausea, headache, dizziness, and dry mouth. No clinically relevant changes were seen in vital signs, weight, ECG, or laboratory results. In summary, none of the active treatment groups, including duloxetine, separated from placebo in the primary analysis in this 'failed' study. Findings on secondary outcome measures, using MMRM instead of LOCF, were supportive of likely efficacy for Lu AA21004 5mg and 10mg and duloxetine. Lu AA21004 (2.5, 5 and 10 mg) was well tolerated. Copyright © 2011 Elsevier B.V. All rights reserved.

  15. Early effects of duloxetine on emotion recognition in healthy volunteers.

    PubMed

    Bamford, Susan; Penton-Voak, Ian; Pinkney, Verity; Baldwin, David S; Munafò, Marcus R; Garner, Matthew

    2015-05-01

    The serotonin-noradrenaline reuptake inhibitor (SNRI) duloxetine is an effective treatment for major depression and generalised anxiety disorder. Neuropsychological models of antidepressant drug action suggest therapeutic effects might be mediated by the early correction of maladaptive biases in emotion processing, including the recognition of emotional expressions. Sub-chronic administration of duloxetine (for two weeks) produces adaptive changes in neural circuitry implicated in emotion processing; however, its effects on emotional expression recognition are unknown. Forty healthy participants were randomised to receive either 14 days of duloxetine (60 mg/day, titrated from 30 mg after three days) or matched placebo (with sham titration) in a double-blind, between-groups, repeated-measures design. On day 0 and day 14 participants completed a computerised emotional expression recognition task that measured sensitivity to the six primary emotions. Thirty-eight participants (19 per group) completed their course of tablets and were included in the analysis. Results provide evidence that duloxetine, compared to placebo, may reduce the accurate recognition of sadness. Drug effects were driven by changes in participants' ability to correctly detect subtle expressions of sadness, with greater change observed in the placebo relative to the duloxetine group. These effects occurred in the absence of changes in mood. Our preliminary findings require replication, but complement recent evidence that sadness recognition is a therapeutic target in major depression, and a mechanism through which SNRIs could resolve negative biases in emotion processing to achieve therapeutic effects. © The Author(s) 2015.

  16. Early effects of duloxetine on emotion recognition in healthy volunteers

    PubMed Central

    Bamford, Susan; Penton-Voak, Ian; Pinkney, Verity; Baldwin, David S; Munafò, Marcus R; Garner, Matthew

    2015-01-01

    The serotonin-noradrenaline reuptake inhibitor (SNRI) duloxetine is an effective treatment for major depression and generalised anxiety disorder. Neuropsychological models of antidepressant drug action suggest therapeutic effects might be mediated by the early correction of maladaptive biases in emotion processing, including the recognition of emotional expressions. Sub-chronic administration of duloxetine (for two weeks) produces adaptive changes in neural circuitry implicated in emotion processing; however, its effects on emotional expression recognition are unknown. Forty healthy participants were randomised to receive either 14 days of duloxetine (60 mg/day, titrated from 30 mg after three days) or matched placebo (with sham titration) in a double-blind, between-groups, repeated-measures design. On day 0 and day 14 participants completed a computerised emotional expression recognition task that measured sensitivity to the six primary emotions. Thirty-eight participants (19 per group) completed their course of tablets and were included in the analysis. Results provide evidence that duloxetine, compared to placebo, may reduce the accurate recognition of sadness. Drug effects were driven by changes in participants’ ability to correctly detect subtle expressions of sadness, with greater change observed in the placebo relative to the duloxetine group. These effects occurred in the absence of changes in mood. Our preliminary findings require replication, but complement recent evidence that sadness recognition is a therapeutic target in major depression, and a mechanism through which SNRIs could resolve negative biases in emotion processing to achieve therapeutic effects. PMID:25759400

  17. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial.

    PubMed

    Russell, I Jon; Mease, Philip J; Smith, Timothy R; Kajdasz, Daniel K; Wohlreich, Madelaine M; Detke, Michael J; Walker, Daniel J; Chappell, Amy S; Arnold, Lesley M

    2008-06-01

    The primary objectives of this study were to assess the efficacy and safety of duloxetine for reducing pain severity in fibromyalgia patients with or without current major depressive disorder. This was a 6-month, multicenter, randomized, double-blind, placebo-controlled study. In total, 520 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to duloxetine (20 mg/day, 60 mg/day, or 120 mg/day) or placebo, administered once daily, for 6 months (after 3 months, the duloxetine 20-mg/day group titrated to 60 mg/day). The co-primary outcome measures were the Brief Pain Inventory (BPI) average pain severity score and Patient Global Impressions of Improvement (PGI-I) score. Safety was assessed via treatment-emergent adverse events, and changes in vital sign, laboratory, and ECG measures. Compared with placebo-treated patients, those patients treated with duloxetine 120 mg/day improved significantly more on the co-primary outcome measures at 3 months (change in BPI score [-2.31 vs -1.39, P<0.001] and PGI-I [2.89 vs 3.39, P=0.004]) and at 6 months (change in BPI [-2.26 vs -1.43, P=0.003] and PGI-I [2.93 vs 3.37, P=0.012]). Compared with placebo, treatment with duloxetine 60 mg/day also significantly improved the co-primary measures at 3 months and BPI at 6 months. Duloxetine was efficacious in patients both with and without major depressive disorder. There were no clinically significant differences between treatment groups in changes in vital signs, laboratory measures, or ECG measures. Study results demonstrated that duloxetine at doses of 60 mg/day and 120 mg/day appears to be safe and efficacious in patients with fibromyalgia.

  18. Duloxetine-related panic attacks.

    PubMed

    Sabljić, Vladimir; Rakun, Radmir; Ružić, Klementina; Grahovac, Tanja

    2011-03-01

    Side-effects arising on the grounds of antidepressant administration pose as a substantial obstacle hindering successful depressive disorder treatment. Side-effects, especially those severe or those manifested through dramatic clinical presentations such as panic attacks, make the treatment far more difficult and shake patients' trust in both the treatment and the treating physician. This case report deals with a patient experiencing a moderately severe depressive episode, who responded to duloxetine treatment administered in the initial dose of 30 mg per day with as many as three panic attacks in two days. Upon duloxetine withdrawal, these panic attacks ceased as well. The patient continued tianeptine and alprazolam treatment during which no significant side-effects had been seen, so that she gradually recovered. Some of the available literature sources have suggested the possibility of duloxetine administration to the end of generalised anxiety disorder and panic attack treatment. However, they are outnumbered by the contributions reporting about duloxetine-related anxiety, aggressiveness and panic attacks. In line with the foregoing, further monitoring of each and every duloxetine-administered patient group needs to be pursued so as to be able to evaluate treatment benefits and weigh them against risks of anxiety or panic attack onset.

  19. Study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled phase III trial investigating additive efficacy of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: the DIRECT study.

    PubMed

    Matsuoka, Hiromichi; Ishiki, Hiroto; Iwase, Satoru; Koyama, Atsuko; Kawaguchi, Takashi; Kizawa, Yoshiyuki; Morita, Tatsuya; Matsuda, Yoshinobu; Miyaji, Tempei; Ariyoshi, Keisuke; Yamaguchi, Takuhiro

    2017-08-28

    Management of patients with cancer suffering from neuropathic pain refractory to opioids and gabapentinoids remains an important challenge. Duloxetine is one of the choices after first-line treatment fails. The efficacy of duloxetine has been reported in patients with non-cancer disease and in chemotherapy-induced peripheral neuropathy, but no randomised clinical trials have examined its effects on neuropathic cancer pain refractory to first-line treatment. The objective of this study is to assess the analgesic efficacy of duloxetine in patients suffering from neuropathic cancer pain refractory to opioids and gabapentinoids. A multi-institutional, prospective, randomised, double-blind, placebo-controlled, two-parallel trial is planned. The inclusion criteria are adult patients with cancer suffering from neuropathic cancer pain refractory to opioids and gabapentinoids, patients with a Numerical Rating Scale (NRS) pain score of 4 or higher and patients with a total Hospital Anxiety and Depression Scale score of less than 20. Patients with chemotherapy-induced peripheral neuropathy are excluded. The study will take place at 14 sites across Japan. Participants will be randomised (1:1 allocation ratio) to a duloxetine intervention group or a placebo control group. Evaluations will be made at baseline (T0 randomisation), day 0 (T1), day 3 (T2) and day 10 (T3). The primary endpoint is defined as the difference in NRS score for pain intensity (average over the previous 24 hours) at T3 between the duloxetine and placebo groups. A sample size of 70 patients will be examined between July 2015 and March 2018. Ethics approval was obtained at all participating sites.The results of this study will be submitted for publication in international peer-reviewed journals and the key findings presented at international scientific conferences. UMIN000017647; Pre-results. 2.2, 26 April 2017. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article

  20. Real-world comparison of health care utilization between duloxetine and pregabalin initiators with fibromyalgia

    PubMed Central

    Peng, X; Sun, P; Novick, D; Andrews, J; Sun, S

    2014-01-01

    Objectives To compare health care utilization of duloxetine initiators and pregabalin initiators among fibromyalgia patients in a real-world setting. Methods A retrospective cohort study was conducted based on a US national commercial health claims database (2006–2009). Fibromyalgia patients who initiated duloxetine or pregabalin in 2008, aged 18–64 years, and who maintained continuous health insurance coverage 1 year before and 1 year after initiation were assigned to duloxetine or pregabalin cohorts on the basis of their initiated agent. Patients who had pill coverage of the agents over the course of 90 days preceding the initiation were excluded. The two comparative cohorts were constructed using propensity score greedy match methods. Descriptive analysis and paired t-test were performed to compare health care utilization rates in the postinitiation year and the changes of these rates from the preinitiation year to the postinitiation year. Results Both matched cohorts (n=1,265 pairs) had a similar mean initiation age (49–50 years), percentage of women (87%–88%), and prevalence of baseline comorbid conditions (neuropathic pain other than diabetic peripheral neuropathic pain, low back pain, cardiovascular disease, hypertension, headache or migraine, and osteoarthritis). In the preinitiation year, both cohorts had similar inpatient, outpatient, and medication utilization rates (inpatient, 15.7%–16.1%; outpatient, 100.0%; medication, 97.9%–98.7%). The utilization rates diverged in the postinitiation year, with the pregabalin cohort using more fibromyalgia-related inpatient care (3.2% versus 2.2%; P<0.05), any inpatient care (19.3% versus 16.8%; P<0.05), and fibromyalgia-related outpatient care (62.1% versus 51.8%; P<0.05). From the preinitiation period to the postinitiation period, the duloxetine cohort experienced decreases in certain utilization rates, whereas the pregabalin cohort had increases (percentage of patients with a fibromyalgia

  1. Duloxetine for the management of fibromyalgia syndrome

    PubMed Central

    Scholz, Beth A; Hammonds, Cara L; Boomershine, Chad S

    2009-01-01

    Fibromyalgia syndrome (FMS) is a widespread pain condition associated with a wide range of additional symptoms including fatigue, insomnia, depression, anxiety and stiffness. Duloxetine is one of three medications currently FDA approved for use in FMS management. Duloxetine is a mixed serotonin and norepinephrine reuptake inhibitor (SNRI) that functions by increasing central nervous system levels of serotonin and norepinephrine. This review is a primer on use of duloxetine in FMS management and includes information on pharmacology and pharmacokinetics, a review of the three duloxetine FMS treatment trials currently in publication, a discussion of the safety and tolerability of duloxetine, and patient-focused perspectives on duloxetine use in FMS management. Duloxetine has proven efficacy in managing pain and mood symptoms in adult FMS patients with and without major depressive disorder. However, due to side effects, duloxetine must be used with caution in patients with fatigue, insomnia, gastrointestinal complaints, headache, cardiovascular disease, bleeding-risk, and in those 24 years of age and younger due to risk of suicidality. Duloxetine use should be avoided in patients with liver disease or alcoholics. As with all medications, duloxetine is best used as part of an individualized regimen that includes nonpharmacologic modalities of exercise, education and behavioral therapies. PMID:21197298

  2. Functioning in patients with major depression treated with duloxetine or a selective serotonin reuptake inhibitor in East Asia

    PubMed Central

    Novick, Diego; Montgomery, William; Haro, Josep Maria; Moneta, Maria Victoria; Zhu, Gang; Yue, Li; Hong, Jihyung; Dueñas, Héctor; Brugnoli, Roberto

    2016-01-01

    Purpose To assess and compare the levels of functioning in patients with major depressive disorder treated with either duloxetine with a daily dose of ≤60 mg or a selective serotonin reuptake inhibitor (SSRI) as monotherapy for up to 6 months in a naturalistic setting in East Asia. In addition, this study examined the impact of painful physical symptoms (PPS) on the effects of these treatments. Patients and methods Data for this post hoc analysis were taken from a 6-month prospective observational study involving 1,549 patients with major depressive disorder without sexual dysfunction. The present analysis focused on a subgroup of patients from East Asia (n=587). Functioning was measured using the Sheehan Disability Scale (SDS). Depression severity was assessed using the 16-item Quick Inventory of Depressive Symptomatology-Self Report. PPS were rated using the modified Somatic Symptom Inventory. A mixed model with repeated measures was fitted to compare the levels of functioning between duloxetine-treated (n=227) and SSRI-treated (n=225) patients, adjusting for baseline patient characteristics. Results The mean SDS total score was similar between the two treatment cohorts (15.46 [standard deviation =6.11] in the duloxetine cohort and 16.36 [standard deviation =6.53] in the SSRI cohort, P=0.077) at baseline. Both descriptive and regression analyses confirmed improvement in functioning in both groups during follow-up, but duloxetine-treated patients achieved better functioning. At 24 weeks, the estimated mean SDS total score was 4.48 (standard error =0.80) in the duloxetine cohort, which was statistically significantly lower (ie, better functioning) than that of 6.76 (standard error =0.77) in the SSRI cohort (P<0.001). This treatment difference was more apparent in the subgroup of patients with PPS at baseline. Similar patterns were also observed for SDS subscores (work, social life, and family life). Conclusion Depressed patients treated with duloxetine achieved

  3. The short- and long-term effect of duloxetine on painful physical symptoms in patients with generalized anxiety disorder: results from three clinical trials.

    PubMed

    Beesdo, Katja; Hartford, James; Russell, James; Spann, Melissa; Ball, Susan; Wittchen, Hans-Ulrich

    2009-12-01

    Generalized anxiety disorder (GAD) is associated with painful physical symptoms (PPS). These post hoc analyses of previous trial data assessed PPS and their response to duloxetine treatment in GAD patients. Studies 1 and 2 (n=840) were 9- to 10-week efficacy trials; study 3 (n=887) was a relapse prevention trial comprising a 26-week open-label treatment phase and a 26-week double-blind, placebo-controlled treatment continuation phase. Mean baseline visual analog scale scores (VAS, 0-100; n=1727) ranged from 26 to 37 for overall pain, headache, back pain, shoulder pain, interference with daily activities, and time in pain while awake. In studies 1 and 2, improvement on all VAS scores was greater in duloxetine-treated than in placebo-treated patients (pstudy 3, pain symptoms worsened in responders switched to placebo compared with those maintained on duloxetine (pduloxetine was efficacious in the short- and long-term treatment of PPS, which are common in GAD patients.

  4. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

    PubMed Central

    Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient’s trial identification number. Using the patient’s trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. Setting 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Data sources Clinical study reports obtained from the EMA in 2011. Results Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Conclusion Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the

  5. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

    PubMed

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-06-04

    To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives

  6. Efficacy, safety and tolerability of duloxetine in idiopathic trigeminal neuralgia.

    PubMed

    Anand, K S; Dhikav, V; Prasad, A; Shewtengna

    2011-04-01

    Trigeminal neuralgia (TN) is the most common type of neuralgia affecting facial region and is considered to be one of the most painful conditions. Treatment is often unsatisfactory. Newer treatment modalities are therefore being tried. Duloxetine is FDA approved drug for painful diabetic neuropathy and has been used in painful symptoms of depression as well. Safety and efficacy of duloxetine was evaluated in patients with trigeminal neuralgia; another chronically painful condition, in an open label manner. A total of 15 patients who fulfilled the diagnostic criteria of International Headache Society for Trigeminal Neuralgia were administered duloxetine 40 mg daily. The efficacy of the drug was evaluated by face scale and Likert's numerical scale. Statistically significant pain relief was reported in 9 out of 15 patients of trigeminal neuralgia. The pain relief was reported as early as in one week and was maintained for 16 weeks. The drug was well tolerated and side-effects reported were mild and reversible. No adverse drug reaction requiring hospitalisation or drug discontinuation was reported in the present study. Duloxetine showed statistically significant pain relief in trigeminal neuralgia. Double-blind, placebo-controlled studies are needed to confirm findings at a large scale.

  7. Efficacy of Duloxetine on Painful Physical Symptoms in Major Depressive Disorder for Patients With Clinically Significant Painful Physical Symptoms at Baseline: A Meta-Analysis of 11 Double-Blind, Placebo-Controlled Clinical Trials

    PubMed Central

    Desaiah, Durisala; Spann, Melissa E.; Zhang, Qi; Russell, James M.; Robinson, Michael J.; Demyttenaere, Koen

    2011-01-01

    Objective: To review efficacy of duloxetine for physical symptoms and depressive illness in patients with at least mild to moderate major depressive disorder (MDD; DSM-IV) and clinically significant painful physical symptoms at baseline. Data Sources: Global database of duloxetine clinical trials (Eli Lilly and Company). Study Selection: All 11 acute, double-blind, placebo-controlled studies of duloxetine (7 with duloxetine 60-mg doses and 4 with non–60-mg doses) in the database that used a scale to measure painful physical symptoms and were completed before March 17, 2011. Data Extraction: For each study, patients with clinically significant pain levels at baseline (Visual Analog Scale overall pain rating ≥ 30, Numerical Rating Scale score ≥ 3, or Brief Pain Inventory 24-hour average pain rating ≥ 3) were selected in order to determine the effect sizes of duloxetine (compared with placebo for each trial) on the pain and depression measures. Overall effect sizes for both painful physical symptoms and MDD were obtained from the mean of individual-trial effect sizes, and each effect size was weighted relative to the number of patients within each study. Data Synthesis: The overall mean effect sizes were as follows: painful physical symptoms—60-mg trials, 0.29 (95% CI, 0.06 to 0.52); non–60-mg trials, 0.13 (95% CI, −0.19 to 0.45); MDD—60-mg trials, 0.29 (95% CI, 0.18 to 0.40); non–60-mg trials, 0.16 (95% CI, 0.00 to 0.32). Across the 11 studies, the weighted effect size for painful physical symptoms was 0.26 (95% CI, 0.00 to 0.51) and for MDD, 0.25 (95% CI, 0.16 to 0.34). Conclusions: According to this meta-analysis, duloxetine 60 mg once daily is as effective in improving painful physical symptoms as it is for depression in patients with MDD and clinically significant painful physical symptoms. The results of this meta-analysis indicate that duloxetine has small effect sizes in reducing painful physical symptoms and depressive symptoms in patients

  8. An assessment of drug-drug interactions: the effect of desvenlafaxine and duloxetine on the pharmacokinetics of the CYP2D6 probe desipramine in healthy subjects.

    PubMed

    Patroneva, Albena; Connolly, Sandra M; Fatato, Penny; Pedersen, Ron; Jiang, Qin; Paul, Jeffrey; Guico-Pabia, Christine; Isler, Jennifer A; Burczynski, Michael E; Nichols, Alice I

    2008-12-01

    A number of antidepressants inhibit the activity of the cytochrome P450 2D6 enzyme system, which can lead to drug-drug interactions. Based on its metabolic profile, desvenlafaxine, administered as desvenlafaxine succinate, a new serotonin-norepinephrine reuptake inhibitor, is not expected to have an impact on activity of CYP2D6. This single-center, randomized, open-label, four-period, crossover study was undertaken to evaluate the effect of multiple doses of desvenlafaxine (100 mg/day, twice the recommended therapeutic dose for major depressive disorder in the United States) and duloxetine (30 mg b.i.d.) on the pharmacokinetics (PK) of a single dose of desipramine (50 mg). A single dose of desipramine was given first to assess its PK. Desvenlafaxine or duloxetine was then administered, in a crossover design, so that steady-state levels were achieved; a single dose of desipramine was then coadministered. The geometric least-square mean ratios (coadministration versus desipramine alone) for area under the plasma concentration versus time curve (AUC) and peak plasma concentrations (C(max)) of desipramine and 2-hydroxydesipramine were compared using analysis of variance. Relative to desipramine alone, increases in AUC and C(max) of desipramine associated with duloxetine administration (122 and 63%, respectively) were significantly greater than those associated with desvenlafaxine (22 and 19%, respectively; P < 0.001). Duloxetine coadministered with desipramine was also associated with a decrease in 2-hydroxydesipramine C(max) that was significant compared with the small increase seen with desvenlafaxine and desipramine (-24 versus 9%; P < 0.001); the difference between changes in 2-hydroxydesipramine AUC did not reach statistical significance (P = 0.054). Overall, desvenlafaxine had a minimal impact on the PK of desipramine compared with duloxetine, suggesting a lower risk for CYP2D6-mediated drug interactions.

  9. Health-related quality of life in patients with depression treated with duloxetine or a selective serotonin reuptake inhibitor in a naturalistic outpatient setting

    PubMed Central

    Hong, Jihyung; Novick, Diego; Montgomery, William; Moneta, Maria Victoria; Dueñas, Héctor; Peng, Xiaomei; Haro, Josep Maria

    2015-01-01

    Purpose To assess the levels of quality of life (QoL) in major depressive disorder (MDD) patients treated with either duloxetine or a selective serotonin reuptake inhibitor (SSRI) as monotherapy for up to 6 months in a naturalistic clinical setting mostly in the Middle East, East Asia, and Mexico. Patients and methods Data for this post hoc analysis were taken from a 6-month prospective observational study involving 1,549 MDD patients without sexual dysfunction. QoL was measured using the EQ-5D instrument. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16), while pain severity was measured using the pain items of the Somatic Symptom Inventory. Regression analyses were performed to compare the levels of QoL between duloxetine-treated (n=556) and SSRI-treated (n=776) patients, adjusting for baseline patient characteristics. Results These MDD patients, on average, had moderately impaired QoL at baseline, and the level of QoL impairment was similar between the duloxetine and SSRI groups (EQ-5D score of 0.46 [SD =0.32] in the former and 0.47 [SD =0.33] in the latter, P=0.066). Both descriptive and regression analyses confirmed QoL improvements in both groups during follow-up, but duloxetine-treated patients achieved higher QoL. At 24 weeks, the estimated mean EQ-5D score was 0.90 in the duloxetine cohort, which was statistically significantly higher than that of 0.83 in the SSRI cohort (P<0.001). Notably, pain severity at baseline was also statistically significantly associated with poorer QoL during follow-up (P<0.001). In addition, this association was observed in the subgroup of SSRI-treated patients (P<0.001), but not in that of duloxetine-treated patients (P=0.479). Conclusion Depressed patients treated with duloxetine achieved higher QoL, compared to those treated with SSRIs, possibly in part due to its moderating effect on the link between pain and

  10. A subtle grey-matter increase in first-episode, drug-naive major depressive disorder with panic disorder after 6 weeks' duloxetine therapy.

    PubMed

    Lai, Chien-Han; Hsu, Yuan-Yu

    2011-03-01

    We designed this study to investigate the modulating effects of duloxetine on symptoms and grey matter of patients with major depressive disorder combined with panic disorder. We also aimed to discover if there was any persistence of grey-matter deficits after remission and to find 'trait markers' for this comorbidity. High-resolution magnetic resonance imaging and voxel-based morphometric measurements were performed on 15 patients at baseline and remitted status (week 6) compared to 15 healthy control subjects who were scanned twice within 6 wk. The rating scales of depressive and panic symptoms improved with statistical significance (corrected p<0.001). A widespread pattern of grey-matter deficits in infero-frontal, limbic, occipital, temporo-parietal, cerebellar areas (trait marker regions) in drug-naive patients were observed compared to controls at baseline (family-wise error corrected p<0.0002). There were no significant changes of grey matter in healthy controls over the 6-wk period. Duloxetine-induced increases of grey matter were very subtle in left infero-frontal cortex, right fusiform gyrus, and right cerebellum VIIIa areas (state marker regions) after 6-wk therapy (uncorrected p<0.0005). Duloxetine did not increase grey matter to the level of control subjects and grey-matter deficits in patients appear largely unaffected by duloxetine. We suggest that short-term duloxetine therapy improved the clinical symptoms of patients with major depressive disorder combined with panic disorder. These improvements might be related to a modest increase of grey matter in state marker regions of the brain. The deficits of trait marker regions were more evident and are likely to be important for pathogenesis.

  11. Investigation on the enantioseparation of duloxetine by capillary electrophoresis, NMR, and mass spectrometry.

    PubMed

    Sánchez-López, Elena; Salgado, Antonio; Crego, Antonio L; Marina, María Luisa

    2014-10-01

    The enantiomeric separation of the antidepressant drug duloxetine was investigated by CE using 15 neutral CDs as chiral selectors. Among them, (2-hydroxypropyl)-β-CD and methyl-γ-CD gave rise to the highest enantioresolution. The enantiomer migration order for duloxetine was found to be reversed depending on the CD employed: R-duloxetine was the first-migrating enantiomer for (2-hydroxypropyl)-β-CD while it was the second-migrating enantiomer for methyl-γ-CD. NMR and MS experiments were performed in order to justify this behavior. Although the elucidation of the structure of the enantiomer-CD complexes was not possible, their averaged stoichiometry was studied and their apparent and averaged equilibrium constants were calculated. The results obtained showed that the chiral separation of duloxetine by CE depends not only on the thermodynamic stability of the enantiomer-chiral selector complexes but also on their electrophoretic mobility.

  12. Duloxetine for the treatment of fibromyalgia

    PubMed Central

    Wright, Cheryl L; Mist, Scott D; Ross, Rebecca L; Jones, Kim D

    2011-01-01

    This article presents a brief review of the physiologic abnormalities seen in fibromyalgia, current theories of widespread pain, and treatment options, including emerging therapeutics, with a focus on the use of duloxetine to manage fibromyalgia symptoms. Major clinical trials that examine the efficacy and effectiveness of duloxetine to date are reviewed, and safety issues are discussed. PMID:20828282

  13. Duloxetine for the treatment of fibromyalgia.

    PubMed

    Wright, Cheryl L; Mist, Scott D; Ross, Rebecca L; Jones, Kim D

    2010-09-01

    This article presents a brief review of the physiologic abnormalities seen in fibromyalgia, current theories of widespread pain, and treatment options, including emerging therapeutics, with a focus on the use of duloxetine to manage fibromyalgia symptoms. Major clinical trials that examine the efficacy and effectiveness of duloxetine to date are reviewed, and safety issues are discussed.

  14. Dispersive liquid-liquid microextraction based on solidification of floating organic droplets followed by high performance liquid chromatography for the determination of duloxetine in human plasma.

    PubMed

    Suh, Joon Hyuk; Lee, Yun Young; Lee, Hee Joo; Kang, Myunghee; Hur, Yeoun; Lee, Sun Neo; Yang, Dong-Hyug; Han, Sang Beom

    2013-03-05

    A novel dispersive liquid-liquid microextraction method based on solidification of floating organic droplets (DLLME-SFO) technique was developed for the determination of duloxetine in human plasma samples by high performance liquid chromatography with fluorescence detection (HPLC-FLD). During the extraction procedure, plasma protein was precipitated by using a mixture of zinc sulfate solution and acetonitrile. After the protein precipitation step, duloxetine in an alkaline sample solution was quickly extracted by DLLME-SFO with 50 μL of 1-undecanol (extractant). Disperser was unnecessary because the small amount of remaining acetonitrile, which acts as a protein precipitating reagent, was also employed as a disperser; therefore, organic solvent consumption was reduced as much as possible. The emulsion was centrifuged and then fine droplets were floated to the top of the sample solution. The floated droplets were solidified in an ice bath and easily transferred. Various DLLME-SFO parameters such as extractant type, extractant amount, ionic strength, pH and extraction time were optimized. The chromatographic separation of duloxetine was carried out using ethanol as mobile phase. Validation of the method was performed with respect to linearity, intra- and inter-day accuracy and precision, limit of quantification (LOQ), and recovery. Calibration curves for duloxetine showed good linearity with correlation coefficients (r²) higher than 0.99. The method showed good precision and accuracy, with intra- and inter-assay coefficients of variation less than 15% (LOQ: less than 20%) at all concentrations. The recovery was carried out following the standard addition procedure with yields ranging from 59.6 to 65.5%. A newly developed environmentally friendly method was successfully applied to the pharmacokinetic study of duloxetine in human plasma and was shown to be an alternative green approach compared with the conventional solid-phase microextraction (SPME) and dispersive

  15. Antinociceptive effects of AS1069562, the (+)-isomer of indeloxazine, on spinal hypersensitivity induced by intrathecal injection of prostaglandin in mice: comparison with duloxetine and amitriptyline.

    PubMed

    Murai, Nobuhito; Tsukamoto, Mina; Tamura, Seiji; Aoki, Toshiaki; Matsuoka, Nobuya

    2014-06-15

    The (+)-isomer of indeloxazine AS1069562 exerts multiple pharmacological actions including the inhibition of serotonin (5-HT) and norepinephrine reuptake and analgesia in experimental animal pain models. Here, we evaluated the antinociceptive effects of AS1069562 and the antidepressants duloxetine and amitriptyline in mouse models of prostaglandin-induced spinal hypersensitivity. Prostaglandin E2 (PGE2) and F2α (PGF2α) were intrathecally administered to induce spinal hypersensitivity, causing tactile allodynia in mice. Allodynia induced by PGF2α but not by PGE2 was suppressed by desensitization of C-fibers with systemic pretreatment with resiniferatoxin. C-fiber hyperexcitability might therefore play a role in allodynia induced by PGF2α but not PGE2. In the PGE2-induced allodynia model, AS1069562 and duloxetine significantly suppressed allodynia, whereas amitriptyline did not. In the PGF2α-induced allodynia model, AS1069562 and amitriptyline significantly ameliorated allodynia, whereas duloxetine did not. To demonstrate the broad effects of AS1069562 compared to duloxetine, additional studies were conducted to elucidate other target mechanisms of AS1069562 beyond 5-HT and norepinephrine reuptake inhibition. AS1069562 exhibited affinity for both 5-HT1A and 5-HT3 receptors, and the analgesic effect of AS1069562 on PGF2α-induced allodynia was significantly blocked by the 5-HT1A receptor antagonist (S)-WAY100135 and the 5-HT3 receptor agonist SR57227. Taken together, these results indicate that AS1069562 inhibits both C-fiber- and non-C-fiber-dependent prostaglandin-induced allodynia, while duloxetine inhibits only non-C-fiber-triggered allodynia, and amitriptyline inhibits only C-fiber-triggered allodynia. These broad antinociceptive effects of AS1069562 may be due not only to 5-HT and norepinephrine reuptake inhibition but also to its effects on 5-HT receptors such as 5-HT1A and 5-HT3 receptors.

  16. Is duloxetine's effect on painful physical symptoms in depression an indirect result of improvement of depressive symptoms? Pooled analyses of three randomized controlled trials.

    PubMed

    Harada, Eiji; Tokuoka, Hirofumi; Fujikoshi, Shinji; Funai, Jumpei; Wohlreich, Madelaine M; Ossipov, Michael H; Iwata, Nakao

    2016-03-01

    In treating Major Depressive Disorder with associated painful physical symptoms (PPS), the effect of duloxetine on PPS has been shown to decompose into a direct effect on PPS and an indirect effect on PPS via depressive symptoms (DS) improvement. To evaluate the changes in relative contributions of the direct and indirect effects over time, we analyzed pooled data from 3 randomized double-blind studies comparing duloxetine 60 mg/d with placebo in patients with major depressive disorder and PPS. Changes from baseline in Montgomery-Åsberg Depression Rating Scale total and Brief Pain Inventory-Short Form average pain score were assessed over 8 weeks. Path analysis examined the (1) direct effect of treatment on PPS and/or indirect effect on PPS via DS improvement and (2) direct effect of treatment on DS and/or indirect effect on DS via PPS improvement. At week 1, the direct effect of duloxetine on PPS (75.3%) was greater than the indirect effect through DS improvement (24.7%) but became less (22.6%) than the indirect effect (77.4%) by week 8. Initially, the direct effect of duloxetine on PPS was markedly greater than its indirect effect, whereas later the indirect effect predominated. Conversely, at week 1, the direct effect of treatment on DS (46.4%) was less than the indirect effect (53.6%), and by week 8 it superseded (62.6%) the indirect effect (37.4%). Thus, duloxetine would relieve PPS directly in the initial phase and indirectly via improving DS in the later phase.

  17. Predictors of Treatment with Duloxetine or Venlafaxine XR among Adult Patients Treated for Depression in Primary Care Practices in the United Kingdom

    PubMed Central

    Shi, Nianwen; Durden, Emily; Torres, Amelito; Cao, Zhun; Happich, Michael

    2012-01-01

    Background. Knowledge about real-world use of duloxetine and venlafaxine XR to treat depression in the UK is limited. Aims. To identify predictors of duloxetine or venlafaxine XR initiation. Method. Adult depressed patients who initiated duloxetine or venlafaxine XR between January 1, 2006 and September 30, 2007 were identified in the UK's General Practice Research Database. Demographic and clinical predictors of treatment initiation with duloxetine and venlafaxine XR were identified using logistic regression. Results. Patients initiating duloxetine (n = 909) were 4 years older than venlafaxine XR recipients (n = 1286). Older age, preexisting unexplained pain, respiratory disease, and pre-period use of anticonvulsants, opioids, and antihyperlipidemics were associated with increased odds of initiating duloxetine compared to venlafaxine XR. Pre-period anxiety disorder was associated with decreased odds of receiving duloxetine. Conclusion. Initial treatment choice with duloxetine versus venlafaxine XR was primarily driven by patient-specific mental and medical health characteristics. General practitioners in the UK favor duloxetine over venlafaxine XR when pain conditions coexist with depression. PMID:22720149

  18. Enhancement of nootropic effect of duloxetine and bupropion by caffeine in mice

    PubMed Central

    Kale, Pravin Popatrao; Addepalli, Veeranjaneyulu

    2015-01-01

    Objective: The existing evidence suggests an association between depression and memory impairment. The objective of present study was to assess the effect of low dose caffeine with duloxetine and bupropion on memory. Materials and Methods: Mice were divided randomly into seven groups. Intra-peritoneal treatment of normal saline (10 ml/kg), caffeine (10 mg/kg), duloxetine (10 mg/kg), bupropion alone (10 mg/kg), caffeine + duloxetine (5 mg/kg, each), caffeine + bupropion (5 mg/kg, each), and bupropion + duloxetine (5 mg/kg, each) were given to groups I-VII, respectively. Elevated plus maze was used to evaluate transfer latency (TL) and Morris water maze was used to estimate the time spent in target quadrant. Results: Caffeine with duloxetine treated group was better than other combination treated groups in terms of a significant decrease in TL and increase in the time spent in target quadrant recorded. Conclusion: Combining lower dose of caffeine with duloxetine may enhance cognitive benefits than respective monotherapies. PMID:25878382

  19. A randomised, double-blind, placebo-controlled, duloxetine-referenced study of the efficacy and tolerability of vortioxetine in the acute treatment of adults with generalised anxiety disorder.

    PubMed

    Mahableshwarkar, A R; Jacobsen, P L; Chen, Y; Simon, J S

    2014-01-01

    This study aims to evaluate the efficacy and tolerability of vortioxetine 2.5-, 5- and 10-mg once-daily doses vs. placebo in the treatment of generalised anxiety disorder (GAD). In this 8-week, multicentre, double-blind, placebo-controlled, parallel-group, phase 3 study, patients with a primary GAD diagnosis were randomised to receive placebo (n = 157), vortioxetine 2.5 mg, vortioxetine 5 mg, vortioxetine 10 mg or duloxetine 60 mg once daily (n = 156 each). The primary end-point, mean change from baseline in Hamilton Anxiety Scale (HAM-A) total score and key secondary end-points for the 5- and 10-mg vortioxetine doses were analysed in a prespecified sequential testing procedure (all at week 8). Sexual dysfunction was evaluated using the Arizona Sexual Experiences Scale. Differences from placebo in the primary efficacy end-point were not statistically significant for the vortioxetine groups. The mean difference from placebo was significant in the duloxetine arm. For all secondary efficacy end-points, results were similar among the vortioxetine groups and did not reach statistical significance. The vortioxetine 10-mg group showed separation from placebo on the Hospital Anxiety and Depression anxiety subscore (nominal p = 0.036). Duloxetine 60 mg significantly improved the primary end-point (p < 0.05 vs. placebo), validating the study. Nausea, dry mouth, diarrhoea, nasopharyngitis, headache, dizziness, somnolence, vomiting, dyspepsia, constipation and fatigue were reported in ≥ 5% of patients receiving vortioxetine. Rates of treatment-emergent sexual dysfunction (TESD) in the vortioxetine dosing groups were similar to placebo. In this study, vortioxetine 2.5-, 5- and 10-mg once-daily doses showed no significant improvement in HAM-A total scores vs. placebo. Vortioxetine was well tolerated at all doses and was not associated with TESD. © 2013 John Wiley & Sons Ltd.

  20. Might different cytokine trends in depressed patients receiving duloxetine indicate differential biological backgrounds.

    PubMed

    Fornaro, Michele; Rocchi, Giulio; Escelsior, Andrea; Contini, Paola; Martino, Matteo

    2013-03-05

    Correlational studies investigating neurohormonal-cytokine modulation by antidepressants suggest, among others, variations in cytokines balances as state markers of different biological subtypes of major depressive disorder (MDD) and response predictors to specific treatments. Objective of the study was to investigate cytokines modulation by duloxetine, a relatively newer SNRI with "clean" dual serotonin/norepinephrine mechanism. 30 MDD patients and 32 healthy controls were assessed using Hamilton Depression Scale (HAM-D) and monitored for levels of IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ and TNF-α, at baseline, week 6 and week 12 of duloxetine treatment (60mg/day) and at baseline, respectively. Early responders (ER: defined at week 6 by reduction >50% of baseline HAM-D score) and early non-responders (ENR) showed opposite trends in cytokine levels during duloxetine treatment: ENR were characterized by baseline Th2 shift compared to controls (lower IL-1β, IFN-γ and TNF-α) with increase in Th1 cytokines levels during treatment (increase of IL-1β, IL-12, IFN-γ, IL-1β/IL-10 and TNF-α/IL-10, decrease of IL-10), achieving clinical response at week 12; ER were characterized by baseline Th2-to-Th1 relative switch compared to ENR (higher IL-1β, IL-1β/IL-10 and TNF-α/IL-10) with reduction in Th1 cytokines levels during treatment (decrease of TNF-α and TNF-α/IL-10), achieving clinical response at week 6. Small sample size. In accordance to early clinical response, duloxetine treatment could divide depressed patients into at least 2 subgroups characterized by clinical and laboratory differentiated behavior, suggesting different neurobiological background within depressive syndrome differentially sensitive to different drug components: pro-serotonergic effect and increase in Th1 cytokines in ENR vs. pro-noradrenergic effect and decrease in Th1 cytokines in ER. Copyright © 2012 Elsevier B.V. All rights reserved.

  1. Disposable screen-printed sensors for determination of duloxetine hydrochloride

    PubMed Central

    2012-01-01

    A screen-printed disposable electrode system for the determination of duloxetine hydrochloride (DL) was developed using screen-printing technology. Homemade printing has been characterized and optimized on the basis of effects of the modifier and plasticizers. The fabricated bi-electrode potentiometric strip containing both working and reference electrodes was used as duloxetine hydrochloride sensor. The proposed sensors worked satisfactorily in the concentration range from 1.0 × 10-6-1.0 × 10-2 mol L-1 with detection limit reaching 5.0 × 10-7 mol L-1 and adequate shelf life of 6 months. The method is accurate, precise and economical. The proposed method has been applied successfully for the analysis of the drug in pure and in its dosage forms. In this method, there is no interference from any common pharmaceutical additives and diluents. Results of the analysis were validated statistically by recovery studies. PMID:22264225

  2. Duloxetine-related posterior reversible encephalopathy syndrome

    PubMed Central

    Zappella, Nathalie; Perier, François; Pico, Fernando; Palette, Catherine; Muret, Alexandre; Merceron, Sybille; Girbovan, Andrei; Marquion, Fabien; Legriel, Stephane

    2016-01-01

    Abstract Background: Posterior reversible encephalopathy syndrome (PRES) has well-established links with several drugs. Whether a link also exists with serotonin–norepinephrine reuptake inhibitor such as duloxetine is unclear. Methods: We report on a patient who developed PRES with a coma and myoclonus related to hypertensive encephalopathy a few days after starting duloxetine treatment. Magnetic resonance imaging was performed and catecholamine metabolites assayed. Results: The patient achieved a full recovery after aggressive antihypertensive therapy and intravenous anticonvulsant therapy. Conclusions: The clinical history, blood and urinary catecholamine and serotonin levels, and response to treatment strongly suggest that PRES was induced by duloxetine. Duloxetine should be added to the list of causes of PRES. PMID:27537580

  3. Synergistic Analgesia of Duloxetine and Celecoxib in the Mouse Formalin Test: A Combination Analysis

    PubMed Central

    Zhao, Guo-Li; Lu, Gui-Jun; Yang, Jing; Wu, Sheng-Xi; Gu, Ze-Xu; Wang, Wen

    2013-01-01

    Duloxetine, a serotonin and noradrenaline reuptake inhibitor, and celecoxib, a non-steroidal anti-inflammatory drug, are commonly used analgesics for persistent pain, however with moderate gastrointestinal side effects or analgesia tolerance. One promising analgesic strategy is to give a combined prescription, allowing the maximal or equal efficacy with fewer side effects. In the current study, the efficacy and side effects of combined administration of duloxetine and celecoxib were tested in the mouse formalin pain model. The subcutaneous (s.c.) injection of formalin into the left hindpaw induced significant somatic and emotional pain evaluated by the biphasic spontaneous flinching of the injected hindpaw and interphase ultrasonic vocalizations (USVs) during the 1 h after formalin injection, respectively. Pretreatment with intraperitoneal (i.p.) injection of duloxetine or celecoxib at 1 h before formalin injection induced the dose-dependent inhibition on the second but not first phase pain responses. Combined administration of duloxetine and celecoxib showed significant analgesia for the second phase pain responses. Combination analgesia on the first phase was observed only with higher dose combination. A statistical difference between the theoretical and experimental ED50 for the second phase pain responses was observed, which indicated synergistic interaction of the two drugs. Concerning the emotional pain responses revealed with USVs, we assumed that the antinociceptive effects were almost completely derived from duloxetine, since celecoxib was ineffective when administered alone or reduced the dosage of duloxetine when given in combination. Based on the above findings, acute concomitant administration of duloxetine and celecoxib showed synergism on the somatic pain behavior but not emotional pain behaviors. PMID:24116126

  4. Synergistic analgesia of duloxetine and celecoxib in the mouse formalin test: a combination analysis.

    PubMed

    Sun, Yong-Hai; Dong, Yu-Lin; Wang, Yu-Tong; Zhao, Guo-Li; Lu, Gui-Jun; Yang, Jing; Wu, Sheng-Xi; Gu, Ze-Xu; Wang, Wen

    2013-01-01

    Duloxetine, a serotonin and noradrenaline reuptake inhibitor, and celecoxib, a non-steroidal anti-inflammatory drug, are commonly used analgesics for persistent pain, however with moderate gastrointestinal side effects or analgesia tolerance. One promising analgesic strategy is to give a combined prescription, allowing the maximal or equal efficacy with fewer side effects. In the current study, the efficacy and side effects of combined administration of duloxetine and celecoxib were tested in the mouse formalin pain model. The subcutaneous (s.c.) injection of formalin into the left hindpaw induced significant somatic and emotional pain evaluated by the biphasic spontaneous flinching of the injected hindpaw and interphase ultrasonic vocalizations (USVs) during the 1 h after formalin injection, respectively. Pretreatment with intraperitoneal (i.p.) injection of duloxetine or celecoxib at 1 h before formalin injection induced the dose-dependent inhibition on the second but not first phase pain responses. Combined administration of duloxetine and celecoxib showed significant analgesia for the second phase pain responses. Combination analgesia on the first phase was observed only with higher dose combination. A statistical difference between the theoretical and experimental ED50 for the second phase pain responses was observed, which indicated synergistic interaction of the two drugs. Concerning the emotional pain responses revealed with USVs, we assumed that the antinociceptive effects were almost completely derived from duloxetine, since celecoxib was ineffective when administered alone or reduced the dosage of duloxetine when given in combination. Based on the above findings, acute concomitant administration of duloxetine and celecoxib showed synergism on the somatic pain behavior but not emotional pain behaviors.

  5. Occupancy of Norepinephrine Transporter by Duloxetine in Human Brains Measured by Positron Emission Tomography with (S,S)-[18F]FMeNER-D2.

    PubMed

    Moriguchi, Sho; Takano, Harumasa; Kimura, Yasuyuki; Nagashima, Tomohisa; Takahata, Keisuke; Kubota, Manabu; Kitamura, Soichiro; Ishii, Tatsuya; Ichise, Masanori; Zhang, Ming-Rong; Shimada, Hitoshi; Mimura, Masaru; Meyer, Jeffrey H; Higuchi, Makoto; Suhara, Tetsuya

    2017-08-03

    The norepinephrine transporter in the brain has been targeted in the treatment of psychiatric disorders. Duloxetine is a serotonin and norepinephrine reuptake inhibitor that has been widely used for the treatment of depression. However, the relationship between dose and plasma concentration of duloxetine and norepinephrine transporter occupancy in the human brain has not been determined. In this study, we examined norepinephrine transporter occupancy by different doses of duloxetine. We calculated norepinephrine transporter occupancies from 2 positron emission tomography scans using (S,S)-[18F]FMeNER-D2 before and after a single oral dose of duloxetine (20 mg, n = 3; 40 mg, n = 3; 60 mg, n =2). Positron emission tomography scans were performed from 120 to 180 minutes after an i.v. bolus injection of (S,S)-[18F]FMeNER-D2. Venous blood samples were taken to measure the plasma concentration of duloxetine just before and after the second positron emission tomography scan. Norepinephrine transporter occupancy by duloxetine was 29.7% at 20 mg, 30.5% at 40 mg, and 40.0% at 60 mg. The estimated dose of duloxetine inducing 50% norepinephrine transporter occupancy was 76.8 mg, and the estimated plasma drug concentration inducing 50% norepinephrine transporter occupancy was 58.0 ng/mL. Norepinephrine transporter occupancy by clinical doses of duloxetine was approximately 30% to 40% in human brain as estimated using positron emission tomography with (S,S)-[18F]FMeNER-D2.

  6. Effects of duloxetine on microRNA expression profile in frontal lobe and hippocampus in a mouse model of depression.

    PubMed

    Pan, Bing; Liu, Yamei

    2015-01-01

    Depression is a major mood disorder affecting people worldwide. The posttranscriptional gene regulation mediated by microRNAs (miRNAs) which may have critical roles in the pathogenesis of depression. However, to date, little is known about the effects of the antidepressant drug duloxetine on miRNA expression profile in chronic unpredictable mild stress (CUMS)-induced depression model in mice. Healthy adult male Kunming mice were randomly divided into three groups: control group, model group and duloxetine group. Sucrose preference test and open field test were used to represent the behavioral change. MiRNAs levels in frontal lobe and hippocampus of mice were analyzed using miRNA microarrays assay. We observed that long-term treatment with duloxetine significantly ameliorated the CUMS procedure-induced sucrose preference decreases and mice treated with duloxetine demonstrated a reversal of the number of crossings, and rearings reduced by CUMS. A significant upregulation of miR-132 and miR-18a in hippocampus in the duloxetine treatment group compared with model group, whereas the levels of miR-134 and miR-124a were significantly downregulated. Furthermore, miR-18a showed significant upregulation in frontal lobe in the duloxetine treatment group relative to model group. Our data showed that miRNA expression profile in frontal lobe and hippocampus was affected by duloxetine in mice model of depression. The effect was especially pronounced in the hippocampus, suggesting that hippocampus might be the action site of duloxetine, which presumably worked by regulating the expression of miRNA levels.

  7. Evidences for amelioration of reserpine-induced fibromyalgia in rat by low dose of gamma irradiation and duloxetine.

    PubMed

    Shibrya, Eman E; Radwan, Rasha R; Abd El Fattah, Mai A; Shabaan, Esmat A; Kenawy, Sanaa A

    2017-05-01

    Fibromyalgia is a prevalent disorder characterized by chronic widespread pain and complex symptoms. This study was conducted to investigate the potential therapeutic effect of low-dose irradiation (LDI) alone or in combination with duloxetine on the reserpine-induced fibromyalgia in rats. Fibromyalgia was induced by administration of reserpine (1 mg/kg/s.c) for 3 consecutive days. Duloxetine (30 mg/kg, p.o) was administered 60 min before a forced swimming test (FST), and rats were exposed to a single dose of γ-radiation (0.5 Gy) 1 day before the FST. Reserpine significantly increased immobility time in the FST, decreased the amount of 5-hydroxytryptamine, dopamine, and norepinephrine in cerebral cortex. It also increased malondialdehyde and nitric oxide and reduced glutathione contents in brain tissue. LDI alone or combined with duloxetine completely antagonized reserpine-induced fibromyalgia as assessed by the measured parameters. One of the most significant findings in this study was that the therapeutic effect of duloxetine was more pronounced by its combination with LDI. A possible mechanism of action of LDI and duloxetine responsible for their therapeutic effect was discussed. On the basis of the presented evidences, it could be concluded that LDI alone or combined with duloxetine could be of value in the management of fibromyalgia.

  8. Duloxetine in the treatment of adolescents with somatoform disorders: a report of two cases.

    PubMed

    García Martín, Inés; Miranda Vicario, Eva M; Soutullo, César A

    2012-01-01

    Our goal was to evaluate the effectiveness, safety and tolerability of duloxetine in the treatment of children and adolescents with somatoform disorder. We describe two cases, those of an 11-year old girl and a 17-year old boy, evaluated in our Department after being studied by a Pediatrician and Neuropediatrician due to complex physical symptoms. The evaluations to rule out medical causes were normal. We diagnosed somatoform disorder. The pharmacological treatments with antidepressants, benzodiazepines, stimulants and mood stabilizers only produced brief and partial improvement. After switching the treatment to duloxetine (30 and 60 mg/day, respectively) both patients experienced a gradual improvement that was maintained at 7 and 14 months. Conclusion. Duloxetine may be effective and well tolerated in the treatment of adolescents with somatoform disorder. Controlled trials are need.

  9. Validation of the geriatric anxiety inventory in a duloxetine clinical trial for elderly adults with generalized anxiety disorder.

    PubMed

    Ball, Susan G; Lipsius, Sarah; Escobar, Rodrigo

    2015-09-01

    The Generalized Anxiety Inventory (GAI) has been developed for use in the assessment of anxiety symptoms in older adults (≥ 65 years), but previous validation work has not examined the psychometric qualities of the instrument in relation to treatment. The objective of this study was to examine the performance of the GAI for its internal reliability, convergent and divergent validity, and its sensitivity to treatment. Elderly patients with generalized anxiety disorder (GAD) participated in a 10-week double-blind study of duloxetine treatment for patients with GAD. Anxiety symptoms were assessed with the Hamilton Anxiety Rating Scale (HAMA), the Hospital Anxiety and Depression Scale (HADS) anxiety and depression subscales, and the GAI. Internal reliability of the GAI was assessed with Cronbach's α. Correlations among the HAMA, HADS, and GAI scores were analyzed to determine convergent and divergent validity. Patients were also compared on remission status using recommended cut-off scores for the GAI. Patients with GAD, who were at least 65 years of age, were randomly assigned to double-blind treatment with either duloxetine (N = 151) or placebo (N = 140) for 10 weeks acute therapy. The mean change on the GAI was significantly greater with duloxetine compared with placebo treatment (-8.36 vs. -4.96, respectively, p ≤ 0.001). The GAI demonstrated good internal consistency, good convergent and divergent validity, but suggested cut-off values for caseness with the GAI did not correspond to remission status as measured by the HAMA. Within an elderly patient population with GAD, the GAI demonstrated sound psychometric qualities and sensitivity to change with treatment.

  10. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder

    PubMed Central

    Loft, Henrik; Olsen, Christina Kurre

    2014-01-01

    This study assessed the efficacy, tolerability and safety of vortioxetine versus placebo in adults with recurrent major depressive disorder. This double-blind, randomized, placebo-controlled study included 608 patients [Montgomery–Åsberg Depression Rating Scale (MADRS) total score≥26 and Clinical Global Impression – Severity score≥4]. Patients were randomly assigned (1 : 1 : 1 : 1) to vortioxetine 15 mg/day, vortioxetine 20 mg/day, duloxetine 60 mg/day or placebo. The primary efficacy endpoint was change from baseline in MADRS total score at week 8 (mixed model for repeated measurements). Key secondary endpoints were: MADRS responders; Clinical Global Impression – Improvement scale score; MADRS total score in patients with baseline Hamilton Anxiety Rating Scale ≥20; remission (MADRS≤10); and Sheehan Disability Scale total score at week 8. On the primary efficacy endpoint, both vortioxetine doses were statistically significantly superior to placebo, with a mean difference to placebo (n=158) of −5.5 (vortioxetine 15 mg, P<0.0001, n=149) and −7.1 MADRS points (vortioxetine 20 mg, P<0.0001, n=151). Duloxetine (n=146) separated from placebo, thus validating the study. In all key secondary analyses, both vortioxetine doses were statistically significantly superior to placebo. Vortioxetine treatment was well tolerated; common adverse events (incidence≥5%) were nausea, headache, diarrhea, dry mouth and dizziness. No clinically relevant changes were seen in clinical safety laboratory values, weight, ECG or vital signs parameters. Vortioxetine was efficacious and well tolerated in the treatment of patients with major depressive disorder. PMID:24257717

  11. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder.

    PubMed

    Boulenger, Jean-Philippe; Loft, Henrik; Olsen, Christina Kurre

    2014-05-01

    This study assessed the efficacy, tolerability and safety of vortioxetine versus placebo in adults with recurrent major depressive disorder. This double-blind, randomized, placebo-controlled study included 608 patients [Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 26 and Clinical Global Impression - Severity score ≥ 4]. Patients were randomly assigned (1 : 1 : 1 : 1) to vortioxetine 15 mg/day, vortioxetine 20 mg/day, duloxetine 60 mg/day or placebo. The primary efficacy endpoint was change from baseline in MADRS total score at week 8 (mixed model for repeated measurements). Key secondary endpoints were: MADRS responders; Clinical Global Impression - Improvement scale score; MADRS total score in patients with baseline Hamilton Anxiety Rating Scale ≥ 20; remission (MADRS ≤ 10); and Sheehan Disability Scale total score at week 8. On the primary efficacy endpoint, both vortioxetine doses were statistically significantly superior to placebo, with a mean difference to placebo (n = 158) of -5.5 (vortioxetine 15 mg, P < 0.0001, n = 149) and -7.1 MADRS points (vortioxetine 20 mg, P < 0.0001, n = 151). Duloxetine (n = 146) separated from placebo, thus validating the study. In all key secondary analyses, both vortioxetine doses were statistically significantly superior to placebo. Vortioxetine treatment was well tolerated; common adverse events (incidence ≥ 5%) were nausea, headache, diarrhea, dry mouth and dizziness. No clinically relevant changes were seen in clinical safety laboratory values, weight, ECG or vital signs parameters. Vortioxetine was efficacious and well tolerated in the treatment of patients with major depressive disorder.

  12. Is there a place for duloxetine?

    PubMed

    2007-04-01

    Duloxetine, a combined serotonin and norepinephrine reuptake inhibitor, is licensed in the UK under two brand names for a total of three different indications. It is available as Cymbalta (jointly promoted by Boehringer Ingelheim and Lilly) for the treatment of patients with major depression, or with diabetic peripheral neuropathic pain; and as Yentreve (Lilly) for the treatment of women with "moderate to severe" stress urinary incontinence. Here we consider whether duloxetine has a role in the treatment of patients with any of these conditions.

  13. Duloxetine for the treatment of painful diabetic peripheral neuropathy in Venezuela: economic evaluation.

    PubMed

    Carlos, Fernando; Espejel, Luis; Novick, Diego; López, Rubén; Flores, Daniel

    2015-09-25

    Painful diabetic peripheral neuropathy affects 40-50% of patients with diabetic neuropathy, leading to impaired quality of life and substantial costs. Duloxetine and pregabalin have evidence-based support, and are formally approved for controlling painful diabetic peripheral neuropathy. We used a 12-week decision model for examining painful diabetic peripheral neuropathy first-line therapy with daily doses of duloxetine 60mg or pregabalin 300mg, under the perspective of the Instituto Venezolano de los Seguros Sociales. We gathered model parameters from published literature and expert´s opinion, focusing on the magnitude of pain relief, the presence of adverse events, the possibility of withdrawal owing to intolerable adverse events or due to lack of efficacy, and the quality-adjusted life years expected in each strategy. We analyzed direct medical costs (which are expressed in Bolívares Fuertes, BsF) comprising drug acquisition besides additional care devoted to treatment of adverse events and poor pain relief. We conducted both deterministic and probabilistic sensitivity analyses. Total expected costs per 1000 patients were BsF 1 046 146 (26%) lower with duloxetine than with pregabalin. Most of these savings (91%) corresponds to the difference in the acquisition’s cost of each medication. duloxetine also provided 23 more patients achieving good pain relief and a gain of about two quality-adjusted life years per 1000 treated. Model was robust to plausible changes in main parameters. Duloxetine remained the preferred option in 93.9% of the second-order Monte Carlo simulations. This study suggests duloxetine dominates (i.e., is more effective and lead to gains in quality-adjusted life years), remaining less costly than pregabalin for treatment of painful diabetic peripheral neuropathy.

  14. The efficacy and safety of duloxetine in a multidrug regimen for chronic prostatitis/chronic pelvic pain syndrome.

    PubMed

    Giannantoni, Antonella; Porena, Massimo; Gubbiotti, Marilena; Maddonni, Stefania; Di Stasi, Savino M

    2014-02-01

    To evaluate the efficacy and safety of duloxetine hydrochloride in the treatment of patients affected by chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Thirty-eight CP/CPPS patients completed the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and International Index of Erectile Function-Erectile Function-5 (IIEF-5) questionnaires, uroflowmetry, and evaluation of psychologic status using Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D). Patients were randomly assigned to 2 treatments groups. Treatment in group 1 consisted of a simultaneous oral administration of tamsulosin (0.4 mg/d, 60 mg/d), saw palmetto (320 mg/d), and duloxetine (60 mg/d). Treatment in group 2 consisted of tamsulosin (0.4 mg/d) and saw palmetto (320 mg/d). NIH-CPSI and IIEF-5 questionnaires, uroflowmetry, and evaluation of the psychological status were repeated at 16 weeks of follow-up. At 16 weeks, a significant improvement in NIH-CPSI pain subscore, NIH-CPSI quality of life subscore, and NIH-CPSI total score were observed in group 1 patients compared with those in group 2 (P <.01, respectively), together with a significant improvement in HAM-A and HAM-D scores (P <.01, respectively). Patients in group 2 showed a significant improvement in NIH-CPSI total score, in the urinary symptoms subscore, and in the HAM-A total score. No significant differences were observed in IIEF-5 scores in the 2 groups. Maximum flow rate significantly increased in both groups. In group 1, 20% of patients stopped the study due to adverse effects. The use of duloxetine in a multimodal treatment with an α-blocker medication and a saw palmetto extract allowed better results in controlling clinical symptoms, psychologic status and quality of life patients affected by CP/CPPS. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Duloxetine attenuated morphine withdrawal syndrome in the rat.

    PubMed

    Charkhpour, M; Jafari, R M; Ghavimi, H; Ghanbarzadeh, S; Parvizpur, A

    2014-08-01

    Long term exposure to morphine can induce dependence. The exact mechanisms of dependence are not yet fully understood. Many studies have been conducted to find new drugs that can prevent dependence. This study examined the effects of the chronic administration of duloxetine on the morphine withdrawal syndrome in rats. To this end, male Wistar rats (170-220 g) were randomly divided into 5 groups including one saline treated group (non-depend­ent group) and 4 morphine dependent groups. The experimental groups received additive doses of morphine for 9 days in order to induce dependence according to the following protocol: day 1:5 mg/kg/12 h, days 2 and 3: 10 mg/kg/12 h, days 4, 5:15 mg/kg/12 h, days 6 and 7: 20 mg/kg/12 h and days 8 and 9: 25 mg/kg/12 h. On the ninth day, the morning dose of morphine was only injected. It is worth noting that 30 min before the morning dose of morphine, duloxetine (10, 20, and 40 mg/kg) was injected intraperitoneally. In addition, 2 h after the last injection of morphine, the morphine withdrawal was precipitated by naloxone. The withdrawal signs were recorded for 30 min; these signs included jumping, rearing, genital grooming, abdominal writhing, wet dog shaking, and teeth grinding. The results of the study revealed that the chronic administration of duloxetine decreased all the withdrawal signs. Besides, it attenuated the total withdrawal scores significantly. Results indicate that the regulatory effects on serotonergic and noradrenergic parameters might be associated with the amelioration of the withdrawal symptoms. © Georg Thieme Verlag KG Stuttgart · New York.

  16. Galactorrhea during duloxetine treatment: a case report.

    PubMed

    Korkmaz, Sevda; Kuloğlu, Murat; Işık, Umut; Sağlam, Sadullah; Atmaca, Murad

    2011-01-01

    High prolactin hormone level in the blood is known as hyperprolactinemia. The most common symptom of hyperprolactinemia is galactorrhea, in which spontaneous milky discharge is seen from all ducts of the 2 mammary glands. Galactorrhea occurs due to different medical conditions, including the use of antidepressant medications. Herein we report a hyperprolactinemia case with galactorrhea due to duloxetine treatment for depression.

  17. In vitro stability, potency, and dissolution of duloxetine enteric-coated pellets after exposure to applesauce, apple juice, and chocolate pudding.

    PubMed

    Wells, Kevin A; Losin, William G

    2008-07-01

    Difficulty swallowing is a common problem in the clinical setting, particularly in elderly patients, and can significantly affect an individual's ability to maintain a proper level of nutrition. The purpose of this in vitro study was to determine if mixing duloxetine enteric-coated pellets in food substances is an acceptable alternative method for administering this oral formulation to patients with swallowing difficulties. To determine whether administration in food substances with varying pH values (applesauce and apple juice, pH = approximately 3.5; chocolate pudding, pH = approximately 5.5-6.0) affects the enteric coating of the formulation, duloxetine pellets (ie, the contents of a 20-mg duloxetine capsule) were exposed to applesauce, apple juice, and chocolate pudding at room temperature and tested in triplicate for potency and impurities; for dissolution, 6 replicates were tested. To assess product stability and integrity of the enteric coating, potency, impurities, and dissolution tests of the pellets were conducted and compared with pellets not exposed to food. The duloxetine pellets were extracted from the food material using a solution of 0.1 normal (N) hydrochloric acid (HCl) prepared from concentrated HCl (commercially available) and deionized water. For the potency and impurities tests, a 40:60 solution of acetonitrile and pH 8.0 phosphate buffer was used as the sample solvent to extract the active pharmaceutical ingredient from the formulation to prepare the samples for testing. The amount of active pharmaceutical ingredient released (in vitro dissolution) from the pellets after exposure to the food substances was determined using 2 media solutions, 0.1 N HCl followed by pH 6.8 phosphate buffer. Applesauce and chocolate pudding were selected as vehicles for oral administration, while apple juice was intended to be used as a wash for a nasogastric tube. Mean (SD) potency results for the 20-mg capsule strength were 20.256 (0.066), 20.222 (0.163), and

  18. Cost effectiveness of duloxetine in the treatment of fibromyalgia in the United States.

    PubMed

    Beard, S M; Roskell, N; Le, T K; Zhao, Y; Coleman, A; Ang, D; Lawson, K

    2011-01-01

    To evaluate the cost effectiveness of duloxetine when considered as an alternative treatment for patients in the United States (US) being treated for fibromyalgia pain. A Markov model was used to evaluate the economic and clinical advantages of duloxetine in controlling fibromyalgia pain symptoms over a 2-year time horizon. A base-case treatment sequence was adopted from clinical guidelines, based on tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, and opioids. Treatment response was modeled using changes from baseline in pain severity, and response thresholds: full response (at least a 50% change), response (30-49% change), and no response (less than a 30% change). Clinical efficacy and discontinuation data were taken from placebo- and active-controlled trials identified in a systematic literature review and mixed-treatment comparison. Utility data were based on EQ-5D data. Additional symptom-control months (SCMs), defined as the amount of time at a response level of 30% or less, and quality-adjusted life-years (QALYs) over a 2-year time horizon. For every 1000 patients, first-line duloxetine resulted in an additional 665 SCMs and 12.3 QALYs, at a cost of $582,911 (equivalent to incremental cost-effectiveness ratios [ICERs] of $877 per SCM and $47,560 per QALY). Second-line duloxetine resulted in an additional 460 SCMs and 8.7 QALYs, at a cost of $143,752 (equivalent to ICERs of $312 per SMC and $16,565 per QALY). Response data for TCAs are limited to 30% improvement levels, reported trials are small, and have low placebo response rates. The model necessarily assumes that response rates are independent of placement in the treatment sequence. The results suggest that the introduction of duloxetine into the standard treatment sequence for fibromyalgia not only provides additional patient benefits, reflected by time spent in pain control, but also is cost effective when compared with commonly adopted thresholds.

  19. Prescribing patterns and safety monitoring of duloxetine using the Danish Register of Medicinal Product Statistics as a source.

    PubMed

    Johansen, Anja Nygaard; Stenzhorn, Annette Aalykke; Rosenzweig, Mary; Thirstrup, Steffen; Gazerani, Parisa

    2013-12-01

    The safety and pattern of use of a medicinal product cannot be fully studied prior to its marketing. In Denmark, the Danish Health and Medicines Authority (DHMA) monitors marketed drugs. An available source is the Register of Medicinal Product Statistics (RMPS), which can possibly be used for these purposes. To investigate utilisation and potential safety issues of relatively new antidepressants containing the active ingredient duloxetine (Cymbalta(®) and Xeristar(®)) by using dispensing data available in the RMPS. A retrospective study using dispensing data was designed to estimate the size and composition of the user population and patterns of use of the antidepressants Cymbalta(®) and Xeristar(®) (active ingredient: duloxetine) in the period from 1 January 2005 to 31 December 2010. Data were retrieved from Epikur, a register subset of the RMPS. Both women and men in different age groups used duloxetine for depression. Some users switched to another antidepressant. Prescription of the drug for persons below the age of 18 years revealed a potential safety issue. Concomitant treatment with Cymbalta(®) or Xeristar(®) and fluvoxamine, isocarboxazid, Yentreve(®), or ciprofloxacin also revealed potential safety issues. The present study indicated that the RMPS is applicable in monitoring the pattern of use and potential safety issues related to duloxetine when it is prescribed for depression. Switching to other antidepressants could reflect some potential safety issues. Use of duloxetine for persons below the age of 18 years and its concomitant use with contraindicated drugs also indicated potential safety issues.

  20. Associated with intrathecal baclofen treatment and duloxetine in patients with multiple sclerosis.

    PubMed

    Ranieri, M; Putignano, P; Fiore, P; Santamato, A; Megna, G; Bellomo, R G; Cristella, G; Saggini, R; Megna, M

    2012-01-01

    Baclofen is now used in treatment of patients with severe spasticity secondary to neurological diseases through the direct infusion of the drug into the subarachnoid space with an implanted programmable pump. Among patients whose quality of life improved after the use of intrathecal systems, a very important role belongs to people with multiple sclerosis (MS): a disease that due to a great variety of symptoms and signs, seriously affects the activities of daily living. Among the clinical manifestations of MS are also found mental health problems including depression mood. The drugs most commonly offered, for treatment of depression in patients with MS, are selective serotonin reuptake inhibitors (SSRIs), reuptake inhibitors of serotonin and norepinephrine (SNRIs) and tricyclic antidepressants (TCA). Duloxetine presents a high affinity for transporters reuptake of serotonin and noradrenalin, and exerts its activity on both molecules. In addiction, Duloxetine has demonstrated very effective in treatment of depressive disorders of mood as demonstrated by scientific evidences about the utility of Duloxetine in the modulation of painful physical symptoms associated with depression and in treatment of pain associated with diabetic neuropathy. The purpose of our study is to evaluate the effects of antidepressant therapy with duloxetine, 60 mg/day in 7 patients with multiple sclerosis treated with intrathecal baclofen for spastic modulation of tone. The experience we gained, according to data from several multicenter trials confirmed the efficacy of Baclofen intrathecally administered, especially with regards to modulation of spasticity. Our study also showed, although the limitations of a small sample size still, a good clinical response to combined treatment Baclofen intrathecal/duloxetine 60 mg/day.

  1. Switching to duloxetine from selective serotonin reuptake inhibitors in non- or partial responders: Results from a Spanish sample.

    PubMed

    Irene, Romera; Luis, Montejo Angel; Helena, Delgado-Cohen; David, Perahia; Ramon, Domenech Josep; Inmaculada, Gilaberte

    2009-01-01

    Objectives. To evaluate the efficacy and safety of switching from a selective serotonin reuptake inhibitor (SSRI) to duloxetine in non- or partial responders. Methods. This is a post-hoc analysis of the pooled data of the Spanish sample from an open-label, multicentre study. Additionally, a 6-month continuation safety phase was performed. Results. A total of 156 patients were switched to duloxetine from SSRIs. More than 83% completed the acute phase, of whom 75% went into the continuation phase. At baseline, the mean duration of SSRI treatment was 71.2 weeks and the HAM-D17 mean score was 22.4. In the acute-phase, symptoms severity significantly improved after 10 weeks of duloxetine treatment as measured by mean change from baseline in HAM-D17 total score (-10.5; P<0.001) and all secondary efficacy measures, including painful symptoms. Response (≥50% decrease in HAM-D17 total score) and remission rates (HAM-D17 total score ≤ 7) were 52.9 and 27.7%, respectively. The most common adverse events reported in both phases were headache (11.5% [acute]; 6.1% [continuation]) and nausea (6.4% [acute]; 5.1% [continuation]). Conclusions. In a population of Spanish SSRI non- and partial responders, switch to duloxetine was associated with significant improvement in emotional and painful symptoms of depression. Duloxetine was well tolerated and safe during both phases.

  2. Duloxetine Inhibits Microglial P2X4 Receptor Function and Alleviates Neuropathic Pain after Peripheral Nerve Injury

    PubMed Central

    Yamashita, Tomohiro; Yamamoto, Shota; Zhang, Jiaming; Kometani, Miho; Tomiyama, Daisuke; Kohno, Keita; Tozaki-Saitoh, Hidetoshi; Inoue, Kazuhide; Tsuda, Makoto

    2016-01-01

    P2X4 receptors (P2X4R) are a family of ATP-gated non-selective cation channels. We previously demonstrated that activation of P2X4R in spinal microglia is crucial for neuropathic pain, a highly debilitating chronic pain condition, suggesting that P2X4R is a potential therapeutic target for treating neuropathic pain. Thus, the identification of a compound that has a potent inhibitory effect on P2X4R is an important clinical challenge. In the present study, we screened a chemical library of clinically approved drugs and show for the first time that duloxetine, a serotonin and noradrenaline reuptake inhibitor, has an inhibitory effect on rodent and human P2X4R. In primary cultured microglial cells, duloxetine also inhibited P2X4R-, but not P2X7R-, mediated responses. Moreover, intrathecal administration of duloxetine in a model of neuropathic pain produced a reversal of nerve injury-induced mechanical allodynia, a cardinal symptom of neuropathic pain. In rats that were pretreated with a serotonin-depleting agent and a noradrenaline neurotoxin, the antiallodynic effect of duloxetine was reduced, but still remained. Based on these results, we suggest that, in addition to duloxetine’s primary inhibitory action on serotonin and noradrenaline transporters, an inhibitory effect on P2X4R may be involved at least in part in an antiallodynic effect of intrathecal duloxetine in a model of neuropathic pain. PMID:27768754

  3. Duloxetine in the management of diabetic peripheral neuropathic pain

    PubMed Central

    Ormseth, Michelle J; Scholz, Beth A; Boomershine, Chad S

    2011-01-01

    Diabetic neuropathy affects up to 70% of diabetics, and diabetic peripheral neuropathic pain (DPNP) is the most common and debilitating of the diabetic neuropathies. DPNP significantly reduces quality of life and increases management costs in affected patients. Despite the impact of DPNP, management is poor with one-quarter of patients receiving no treatment and many treated with medications having little or no efficacy in managing DPNP. Duloxetine is one of two drugs approved by the United States Food and Drug Administration for DPNP management. Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) proven safe, effective, and cost-saving in reducing DPNP symptoms at a dose of 60 mg/day. Duloxetine doses greater than 60 mg/day for DPNP management are not recommended since they are no more efficacious and associated with more side effects; addition of pregabalin or gabapentin for these patients may be beneficial. Side effects of duloxetine are generally mild and typical for the SNRI class including nausea, dizziness, somnolence, fatigue, sweating, dry mouth, constipation, and diarrhea. Given its other indications, duloxetine is a particularly good choice for DPNP treatment in patients with coexisting depression, anxiety, fibromyalgia, or chronic musculoskeletal pain. Duloxetine treatment had no clinically significant effect on glycemic control and did not increase the risk of cardiovascular events in diabetes patients. However, duloxetine use should be avoided in patients with hepatic disease or severe renal impairment. Given its safety, efficacy, and tolerability, duloxetine is an excellent choice for DPNP treatment in many patients. PMID:21845034

  4. Duloxetine in treating generalized anxiety disorder in adults: A meta-analysis of published randomized, double-blind, placebo-controlled trials.

    PubMed

    Zhang, Yingli; Huang, Guoping; Yang, Shichang; Liang, Wei; Zhang, Lei; Wang, Changhong

    2016-09-01

    We carried out a meta-analysis of published randomized, double-blind, placebo-controlled trails to assess the efficacy and tolerability of duloxetine in treating generalized anxiety disorder (GAD). A literature search was conducted using PubMed, ISI Web of Science, Medline, Cochrane Central Register of Controlled Trials databases until October 2014. The search terms used were "anxiety or anxious or generalized anxiety disorder" and "duloxetine or Cymbalta." Meta-analysis was conducted using Revman 5.1. A fixed-effects model was carried out on the response rates, remission rates, and symptom improvement. Risk ratio (RR) and mean difference (MD) were calculated. The overall effect size was calculated with 95% confidence intervals (CIs). Seven studies (n = 2,674) were found eligible for inclusion in analysis. Six studies provided data on response, which showed a significant difference between duloxetine and placebo (n = 1,975, RR = 1.48, 95% CI, 1.34-1.63). Remission rates revealed significant superiority of duloxetine (n = 2,399, RR = 1.60, 95% CI, 1.43-1.80). Change from baseline scores on Hamilton Rating Scale for Anxiety showed a reduction in anxiety symptoms to be significantly efficient for duloxetine (n = 1,135, MD = 3.34, 95% CI, 2.37-4.32). Duloxetine increased statistically Sheehan Disability Scale total score (n = 1,652, MD = 2.84, 95% CI, 2.08-3.60). The discontinuation of the duloxetine was not significantly different from that of the placebo. Duloxetine is moderately effective in treating GAD with improvement in overall function and well tolerability. © 2015 Wiley Publishing Asia Pty Ltd.

  5. Efficacy and Tolerability of Duloxetine Treatment in Elderly Patients with Major Depressive Disorder and Concurrent Anxiety Symptoms

    PubMed Central

    Raskin, Joel; Wiltse, Curtis; Walker, Daniel; Brawman-Mintzer, Olga

    2007-01-01

    Objective: To compare the efficacy and tolerability of duloxetine 60mg/day versus placebo in treating elderly patients with major depressive disorder (MDD) and concurrent anxiety symptoms. Methods: Patients (≥65) were randomized to eight weeks of treatment with duloxetine 60mg/day (n=207) or placebo (n=104). Anxiety measures were analyzed for all patients, by age (<75 and ≥75), and in patients having concurrent high anxiety (HAMD17, item 10; Psychic Anxiety baseline score of 2, 3, or 4). Psychic Anxiety, Somatic Anxiety item 11, and the Anxiety/Somatization subscale were analyzed for all patients and subgroups by mean change from baseline to endpoint and repeated measures. Tolerability was assessed via treatment-emergent adverse events (TEAEs), and adverse events were reported as the reason for discontinuation. The analyses presented are primarily post hoc in nature. Results: Duloxetine produced significantly greater reductions than placebo in Psychic Anxiety (least-squares mean change: -0.62 vs. -0.18, p<0.001) and the Anxiety/Somatization subscale (-1.88 vs. -0.99, p=0.002). Repeated measures analyses showed separation between the treatment groups beginning at Week 1 for Psychic Anxiety and Week 4 for the Anxiety/Somatization subscale. Significant improvement occurred in the <75 and ≥75 age groups for Psychic Anxiety, but only the <75 group for the Anxiety/Somatization subscale. Duloxetine-treated patients with high anxiety showed significant improvement compared with placebo-treated patients on Psychic Anxiety, Anxiety/Somatization subscale, the 17-item Hamilton Depression Rating Scale (HAMD17) total score, and several other measures. Duloxetine and placebo had similar TEAE rates and discontinuation rates due to adverse events. Conclusion: Duloxetine (60mg/day) was efficacious and tolerable in elderly patients with MDD and concurrent anxiety symptoms. PMID:20711334

  6. Duloxetine and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial.

    PubMed

    YaDeau, Jacques T; Brummett, Chad M; Mayman, David J; Lin, Yi; Goytizolo, Enrique A; Padgett, Douglas E; Alexiades, Michael M; Kahn, Richard L; Jules-Elysee, Kethy M; Fields, Kara G; Goon, Amanda K; Gadulov, Yuliya; Westrich, Geoffrey

    2016-09-01

    Duloxetine is effective for chronic musculoskeletal and neuropathic pain, but there are insufficient data to recommend the use of antidepressants for postoperative pain. The authors hypothesized that administration of duloxetine for 15 days would reduce pain with ambulation at 2 weeks after total knee arthroplasty. In this triple-blinded, randomized, placebo-controlled trial, patients received either duloxetine or placebo for 15 days, starting from the day of surgery. Patients also received a comprehensive multimodal analgesic regimen including neuraxial anesthesia, epidural analgesia, an adductor canal block, meloxicam, and oxycodone/acetaminophen as needed. The primary outcome was the pain score (0 to 10 numeric rating scale) with ambulation on postoperative day 14. One hundred six patients were randomized and analyzed. On day 14, duloxetine had no effect on pain with ambulation; mean pain was 3.8 (SD, 2.3) for placebo versus 3.5 (SD, 2.1) for duloxetine (difference in means [95% CI], 0.4 [-0.5 to 1.2]; P = 0.386). Symptoms potentially attributable to duloxetine discontinuation at study drug completion (nausea, anxiety) occurred among nine patients (duloxetine) and five patients (placebo); this was not statistically significant (P = 0.247). Statistically significant secondary outcomes included opioid consumption (difference in mean milligram oral morphine equivalents [95% CI], 8.7 [3.3 to 14.1], P = 0.002 by generalized estimating equation) over the postoperative period and nausea on day 1 (P = 0.040). There was no difference in other side effects or in anxiety and depression scores. When included as a part of a multimodal analgesic regimen for knee arthroplasty, duloxetine does not reduce subacute pain with ambulation.

  7. Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

    PubMed

    Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

    2013-01-01

    Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine

  8. Pregabalin, the lidocaine plaster and duloxetine in patients with refractory neuropathic pain: a systematic review

    PubMed Central

    2010-01-01

    Background Patients frequently fail to receive adequate pain relief from, or are intolerant of, first-line therapies prescribed for neuropathic pain (NeP). This refractory chronic pain causes psychological distress and impacts patient quality of life. Published literature for treatment in refractory patients is sparse and often published as conference abstracts only. The aim of this study was to identify published data for three pharmacological treatments: pregabalin, lidocaine plaster, and duloxetine, which are typically used at 2nd line or later in UK patients with neuropathic pain. Methods A systematic review of the literature databases MEDLINE, EMBASE and CCTR was carried out and supplemented with extensive conference and grey literature searching. Studies of any design (except single patient case studies) that enrolled adult patients with refractory NeP were included in the review and qualitatively assessed. Results Seventeen studies were included in the review: nine of pregabalin, seven of the lidocaine plaster, and one of duloxetine. No head-to-head studies of these treatments were identified. Only six studies included treatments within UK licensed indications and dose ranges. Reported efficacy outcomes were not consistent between studies. Pain scores were most commonly assessed in studies including pregabalin; trials of pregabalin and the lidocaine plaster reported the proportion of responders. Significant improvements in the total, sensory and affective scores of the Short-form McGill Pain Questionnaire, and in function interference, sleep interference and pain associated distress, were associated with pregabalin treatment; limited or no quality of life data were available for the other two interventions. Limitations to the review are the small number of included studies, which are generally small, of poor quality and heterogeneous in patient population and study design. Conclusions Little evidence is available relevant to the treatment of refractory

  9. Parkinsonism secondary to duloxetine use: a case report

    PubMed Central

    Bayrak, Arzu; Cetin, Bugra; Meteris, Handan; Kesebir, Sermin

    2015-01-01

    In literature, there are more than hundred cases of extrapyramidal symptoms (EPS) associated with selective serotonin reuptake intibitors (SSRI) whereas EPS case reports associated with serotonin noradrenaline reuptake inhibitors (SNRI) are in a relatively small number. A SNRI group drug duloxetine that is used for indication of major depression since 2004 is a double acting antidepressant that acts by blocking serotonin and noradrenaline reuptake. Side effects of duloxetine on extrapyramidal system are not expected due to low affinity to D2 receptors. In this case, report manifestations of parkinsonism developed in a patient who used duloxetine for major depression are presented. Since any duloxetine induced EPS case has not reported so far, we have thought that this case can contribute to the literature. PMID:28058376

  10. A case of retrobulbar optic neuritis caused by duloxetine.

    PubMed

    Bicer, Tolga; Kosker, Mustafa; Celikay, Osman; Gurdal, Canan

    2016-09-01

    Psychotropic medications may cause many ocular adverse effects including toxic optic neuropathy. We present a unique case of a 44-year-old woman using duloxetine who presented with unilateral visual loss due to retrobulbar neuritis. Physicians and patients should be alerted to this potential side effect. To the best of our knowledge, this is the first case of developing retrobulbar neuritis related to duloxetine usage.

  11. Treatment discontinuation and tolerability as a function of dose and titration of duloxetine in the treatment of major depressive disorder.

    PubMed

    Harada, Eiji; Shirakawa, Osamu; Satoi, Yoichi; Marangell, Lauren B; Escobar, Rodrigo

    2016-01-01

    We sought to better understand how dose and titration with duloxetine treatment may impact tolerability and treatment discontinuation in patients with major depressive disorder. We investigated Phase III duloxetine trials. Group 1 was a single placebo-controlled study with a 20 mg initial dose and a slow titration to 40 and 60 mg. Group 2 was a single study with a 40 mg initial dose and final "active" doses of 40 and 60 mg (5 mg control group), with 1-week titration. Group 3 consisted of eight placebo-controlled studies with starting doses of 40, 60, and 80 mg/day with minimal titration (final dose 40-120 mg/day). Tolerability was measured by rate of discontinuation due to adverse events (DCAE). The DCAE in Group 1 were 3.6% in the 60 mg group, 3.3% in the 40 mg group, and 3.2% in the placebo group. In Group 2, the DCAE were 15.0% in the 60 mg group, 8.1% in the 40 mg group, and 4.9% in the 5 mg group. In Group 3, the DCAE were 9.7% and 4.2% in the duloxetine and placebo groups, respectively. This study suggests that starting dose and titration may have impacted tolerability and treatment discontinuation. A lower starting dose of duloxetine and slower titration may contribute to improving treatment tolerability for patients with major depressive disorder.

  12. The safety of duloxetine during pregnancy and lactation.

    PubMed

    Andrade, Chittaranjan

    2014-12-01

    Depression is common in women, especially during pregnancy and the postpartum period. Untreated depression is associated with many adverse gestational outcomes. It is therefore important to know about the safety of different antidepressant drugs during pregnancy and lactation so that informed decisions can be made regarding treatment. This article summarizes published literature on the subject with regard to duloxetine, an antidepressant with serotonin-norepinephrine reuptake inhibition properties. In general, it appears that the use of duloxetine during pregnancy is associated with an increase in the risk of spontaneous abortion, but no increase in other adverse outcomes, such as major fetal malformations. Late-pregnancy exposure to duloxetine may be associated with poor neonatal adaptation syndrome, but the magnitude of this risk is not known. Infant exposure to duloxetine in breast milk is less than 1% of the maternal weight-adjusted dose, suggesting that duloxetine can be safely administered to a woman who is breastfeeding her infant. In general, the very limited data available on the subject do not uncover a signal that the use of duloxetine during pregnancy or lactation increases the risk of adverse outcomes.

  13. Duloxetine and other antidepressants in the treatment of patients with fibromyalgia.

    PubMed

    Arnold, Lesley M

    2007-09-01

    To review the use of duloxetine, a new selective serotonin and norepinephrine reuptake inhibitor (SNRI), and other antidepressants in the treatment of patients with fibromyalgia. Two randomized, placebo-controlled, double-blind, parallel-group, 12-week trials of duloxetine in the treatment of fibromyalgia were reviewed. Other published, randomized, placebo-controlled, double-blind trials, and meta-analyses of antidepressant treatment of fibromyalgia were identified by a PubMed search that was augmented by reference cross-check. Duloxetine has been shown to be an effective and safe treatment for many of the symptoms associated with fibromyalgia, particularly for women. Other selective SNRIs also show promise in the treatment of fibromyalgia. Until recently, tricyclic agents that have serotonin and norepinephrine reuptake inhibitory activity had been the most commonly studied group of antidepressants, and they are effective in treating pain and other symptoms associated with fibromyalgia, although their use may be limited by safety and tolerability concerns. There are few randomized, controlled studies of selective serotonin reuptake inhibitors in fibromyalgia, and the results have been mixed. Antidepressants play an important role in the treatment of patients with fibromyalgia. Agents with dual effects on serotonin and norepinephrine appear to have more consistent benefits than selective serotonin antidepressants for the treatment of persistent pain associated with fibromyalgia.

  14. First-Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review.

    PubMed

    Lassen, Dorte; Ennis, Zandra Nymand; Damkier, Per

    2016-01-01

    Major depressive disorder is common among women in child-bearing age, and medical treatment is subject to substantial discussions and controversies. For Selective Serotonin reuptake inhibitors, SSRIs, a vast amount of data are available. For the newer antidepressant group of serotonin and noradrenaline reuptake inhibitors, SNRIs, significantly less data are available. Following the PRISMA guideline for systematic reviews, we performed a systematic search on the risk of major congenital malformations after first trimester in utero exposure to venlafaxine or duloxetine. We identified eight cohort studies reporting on the outcome upon in utero exposure to venlafaxine or duloxetine during the first trimester. The cumulated data for venlafaxine were 3186 exposed infants and 107 major malformations, resulting in a relative risk estimate and 95% confidence interval of 1.12 (0.92-1.35). The corresponding data for duloxetine were 668 infants and 16 major malformations, resulting in a relative risk estimate and 95% confidence interval of 0.80 (0.46-1.29). First-trimester in utero exposure to venlafaxine is not associated with an increased risk of major congenital malformations. The amount of data for duloxetine are significantly smaller but does not suggest a clinically important increased risk. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  15. Rescue Pharmacotherapy With Duloxetine for Selective Serotonin Reuptake Inhibitor Nonresponders in Late-Life Depression: Outcome and Tolerability

    PubMed Central

    Karp, Jordan F.; Whyte, Ellen M.; Lenze, Eric J.; Dew, Mary A.; Begley, Amy; Miller, Mark D.; Reynolds, Charles F.

    2010-01-01

    Background Up to 50% of depressed older adults either do not adequately respond to or are unable to tolerate treatment with a serotonin-specific reuptake inhibitor. On the basis of previous experience with serotonin-norepinephrine reuptake inhibitors, we predicted at least a 50% response rate to open-label treatment with duloxetine in subjects who were resistant to treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram. Method Community-dwelling subjects aged 65 years or older with current nonpsychotic major depressive disorder as established by the Structured Clinical Interview for DSM-IV received escitalopram under protocolized conditions between April 2004 and September 2006. Subjects who failed to meet response criteria or relapsed after achieving an initial response were subsequently switched to open treatment with duloxetine up to 120 mg/day. Side effects were assessed at every visit. Results Subjects (N = 40) switched to duloxetine had a mean (SD) age of 74.4 (7.0) years and a baseline (before escitalopram) 17-item Hamilton Rating Scale for Depression (HAM-D-17) score of 20.0 (3.5) and were predominantly female (65.0%) and white (82.5%). The mean (SD) maximum dose of duloxetine was 93.0 (27.8) mg/day. Subjects received this maximum dose for a median duration of 6.9 weeks. Fifty percent of subjects (N = 20) met criteria for full response, 17.5% (N = 7) were partial responders, and 32.5% (N = 13) did not respond. The median time to response was 12.0 weeks (95% CI = 8.4 to 14.6). Five of the subjects (12.5%) discontinued duloxetine because of intolerable side effects. Discussion These open-label data suggest that duloxetine at doses up to 120 mg/day is a well-tolerated and potentially effective treatment for older adults who fail to respond to an adequate trial of an SSRI. These results are preliminary, and future controlled studies are required to test the efficacy of rescue pharmacotherapy with duloxetine. Trial Registration

  16. Duloxetine-bupropion combination for treatment-resistant atypical depression: a double-blind, randomized, placebo-controlled trial.

    PubMed

    Fornaro, Michele; Martino, Matteo; Mattei, Chiara; Prestia, Davide; Vinciguerra, Valentina; De Berardis, Domenico; De Pasquale, Concetta; Iasevoli, Felice; Mungo, Sergio; Fornaro, Pantaleo

    2014-08-01

    The efficacy, safety, and tolerability of combined bupropion versus placebo using duloxetine as active reference drug, in patients with a DSM-IV diagnosis of major depression with atypical features and a history of treatment resistance, were evaluated in this preliminary six-week study. Patients (n=46) had a baseline Hamilton Depression Scale (HAM-D) ≥14 and were randomly assigned to 150/300 mg/day bupropion vs. placebo, which was added to 60 to 120 mg/day duloxetine depending on baseline depression severity. Atypical features of depression were assessed using the additional eight-item module of the Structured Interview Guide for the HAM-D with the Atypical Depression Supplement. By week 6, only five (21.7%) patients receiving duloxetine+placebo vs. six (26.1%) patients on the bupropion combination achieved response. No significant difference in final HAM-D scores between the two groups was observed between those patients achieving response. The presence of a higher number of atypical features significantly predicted non-response, with the relevant binary logistic regression model correctly classifying 17 out 22 (77.3%) of non-responders [Exp(B)=0.294; p=0.016] vs. 17 out 23 (73.9%) [Exp(B)=0.353; p=0.028] non-responder cases in the "+placebo" and "+bupropion" groups, respectively. In those patients receiving bupropion, treatment-emergent adverse events leading to withdrawal were more common among those receiving lower doses of the combination drug, and no life-threating dangers were noted. Additional studies, including an adequate course of duloxetine trial, are nonetheless aimed to allow a firm conclusion about the usefulness of the combination of duloxetine and bupropion for treatment-resistant cases of major depression with atypical features. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  17. Antinociceptive Effects of the Serotonin and Noradrenaline Reuptake Inhibitors Milnacipran and Duloxetine on Vincristine-Induced Neuropathic Pain Model in Mice.

    PubMed

    Katsuyama, Soh; Aso, Hiromu; Otowa, Akira; Yagi, Tomomi; Kishikawa, Yukinaga; Komatsu, Takaaki; Sakurada, Tsukasa; Nakamura, Hitoshi

    2014-01-01

    Vincristine is an anticancer drug used to treat a variety of cancer types, but it frequently causes peripheral neuropathy. Neuropathic pain is often associated with the appearance of abnormal sensory signs, such as allodynia. Milnacipran and duloxetine, serotonin/noradrenaline reuptake inhibitors, have shown efficacy against several chronic pain syndromes. In this study, we investigated the attenuation of vincristine-induced mechanical allodynia in mice by milnacipran and duloxetine. To induce peripheral neuropathy, vincristine was administered once per day (0.1 mg/kg, intraperitoneally (i.p.)) for 7 days. Mechanical allodynia was evaluated by measuring the withdrawal response to stimulation with a von Frey filament. In vincristine-treated mice, mechanical allodynia was observed on days 3-28 of vincristine administration. A single administration of milnacipran (40 mg/kg, i.p.) or duloxetine (20 mg/kg, i.p.) had no effect on vincristine-induced mechanical allodynia. However, repeated administration of milnacipran (20 or 40 mg/kg, once per day, i.p.) or duloxetine (5, 10, or 20 mg/kg, once per day, i.p.) for 7 days significantly reduced vincristine-induced mechanical allodynia. These results suggest that chronic vincristine administration induces mechanical allodynia, and that repeated milnacipran and duloxetine administration may be an effective approach for the treatment of neuropathic pain caused by vincristine treatment for cancer.

  18. Early discontinuation and suboptimal dosing of duloxetine treatment in patients with major depressive disorder: analysis from a US third-party payer perspective.

    PubMed

    Cui, Zhanglin; Faries, Douglas E; Gelwicks, Steven; Novick, Diego; Liu, Xianchen

    2012-01-01

    Little is known about early discontinuation of duloxetine therapy or the effect that initial dose has on discontinuation in patients with major depressive disorder (MDD). Data from a private payer insurance claim database included 6132 patients with MDD who started duloxetine between 7/1/2005 and 6/30/2006, had no prescription for duloxetine in the previous 3 months, and were enrolled for 12 months before and after initiation. Chi-square tests, t-tests, and logistic regression were used to compare demographic, clinical, and healthcare cost data stratified by length of continuation. Early discontinuation was defined as continuation ≤30 days. Healthcare costs, persistence, and adherence were compared between patients with suboptimal initial dose (<40 mg/day) and those with recommended initial dose (40-60 mg/day). Discontinuation rates were 16.8% at ≤30 days, 16.7% at 31-90 days, 14.9% at 91-180 days, and 51.6% at >180 days. Suboptimal initial dose, younger age, male gender, prior benzodiazepine use, insomnia, psychiatric disorders, infectious diseases, digestive disorders, genitourinary disorders, and injury/poisoning increased the likelihood of early discontinuation (Odds ratios [ORs]: 1.18-2.16), while recent use of SSRIs or venlafaxine XR decreased the likelihood (ORs: 0.67-0.68). Compared with patients who persisted with therapy for >180 days, patients who discontinued early had more hospital admissions, longer hospital stays, and more ER visits during the 1-year follow-up (all p-values <0.01). Patients with an initial dose <40 mg/day had shorter persistence (p < 0.001) and lower rates of adherence (p < 0.001) compared with patients with an initial dose of 40-60 mg/day. Limitations of this study were those of all analyses based on data from insurance claim databases. Early discontinuation was associated with increased healthcare utilization. Demographic and clinical predictors of early discontinuation were identified that may help target care

  19. Synthesis and characterization of pharmaceutical surfactant templated mesoporous silica: Its application to controlled delivery of duloxetine

    SciTech Connect

    Mani, Ganesh; Pushparaj, Hemalatha; Peng, Mei Mei; Muthiahpillai, Palanichamy; Udhumansha, Ubaidulla; Jang, Hyun Tae

    2014-03-01

    Graphical abstract: - Highlights: • Usefulness of dual pharmaceutical surfactants in silica synthesis was evaluated. • Effects of concentration of secondary template (Tween-40) were studied. • Effects of fixed solvothermal condition on mesostructure formation were studied. • Duloxetine drug loading capability was studied. • Sustained release of duloxetine was evaluated. - Abstract: A new group of mesoporous silica nanoparticles (MSNs) were synthesized using combination pharmaceutical surfactants, Triton X-100 and Tween-40 as template and loaded with duloxetine hydrochloride (DX), for improving the sustained release of DX and patterns with high drug loading. Agglomerated spherical silica MSNs were synthesized by sol–gel and solvothermal methods. The calcined and drug loaded MSNs were characterized using X-ray diffraction (XRD), Braunner–Emmett–Teller (BET), thermogravimetric analysis (TGA), Fourier-transform infrared (FT-IR) spectroscopy, scanning electron microscopy (SEM), differential scanning calorimetry (DSC), diffuse reflectance ultraviolet–visible (DRS-UV–vis) spectroscopy. MSNs with high surface area and pore volume were selected and studied for their DX loading and release. The selected MSNs can accommodate a maximum of 34% DX within it. About 90% was released at 200 h and hence, the synthesized MSNs were capable of engulfing DX and sustain its release. Further form the Ritger and Peppas, Higuchi model for mechanism drug release from all the MSN matrices follows anomalous transport or Non-Fickian diffusion with the ‘r’ and ‘n’ value 0.9 and 0.45 < n < 1, respectively. So, from this study it could be concluded that the MSNs synthesized using pharmaceutical templates were better choice of reservoir for the controlled delivery of drug which requires sustained release.

  20. Comparative Packaging Study

    NASA Technical Reports Server (NTRS)

    Perchonok, Michele; Antonini, David

    2008-01-01

    This viewgraph presentation describes a comparative packaging study for use on long duration space missions. The topics include: 1) Purpose; 2) Deliverables; 3) Food Sample Selection; 4) Experimental Design Matrix; 5) Permeation Rate Comparison; and 6) Packaging Material Information.

  1. Improvement with Duloxetine in an Adult ADHD Patient

    ERIC Educational Resources Information Center

    Tourjman, Smadar Valerie; Bilodeau, Mathieu

    2009-01-01

    Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a common and disabling disorder among adults and is treated with stimulant and non stimulant medication. Objective: To report the case of a patient with ADHD showing good clinical response to duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Case…

  2. Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP

    PubMed Central

    2013-01-01

    Background The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This article describes the aims and design of a study to evaluate effects and costs of collaborative care with the antidepressant duloxetine for patients with pain symptoms and a depressive disorder, compared to collaborative care with placebo and compared to duloxetine alone. Methods/Design This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. In the collaborative care conditions a) and b), a care-manager provides Problem Solving Treatment and integrated symptom management guidance with a self-help manual, monitors depressive and pain symptoms, and refers patients to a physiotherapist for

  3. Economic evaluation of duloxetine as a first-line treatment for painful diabetic peripheral neuropathy in Mexico.

    PubMed

    Carlos, Fernando; Ramírez-Gámez, Jocelyn; Dueñas, Héctor; Galindo-Suárez, Rosa María; Ramos, Elisa

    2012-01-01

    To perform an economic evaluation of duloxetine, pregabalin, and both branded and generic gabapentin for managing pain in patients with painful diabetic peripheral neuropathy (PDPN) in Mexico. The analysis was conducted using a 3-month decision model, which compares duloxetine 60 mg once daily (DUL), pregabalin 150 mg twice daily (PGB), and gabapentin 600 mg three-times daily (GBP) for PDPN patients with moderate-to-severe pain. A systematic review was performed and placebo-adjusted risk ratios for achieving good pain relief (GPR), adverse events (AE), and withdrawal owing to intolerable AE were calculated. Direct medical costs included drug acquisition and additional visits due to lack of efficacy (poor pain relief) or intolerable AE. Unit costs were taken from local sources. Adherence rates were used to estimate the expected drug costs. All costs are expressed in 2010 Mexican Pesos (MXN). Utility values drawn from published literature were applied to health states. The proportion of patients with GPR and quality-adjusted life years (QALY) were assessed. Branded-GBP was dominated by all the other options. PGB was more costly and less effective than DUL. Compared with branded-GBP and PGB, DUL led to savings of 1.01 and 1.74 million MXN (per 1000 patients). The incremental cost per QALY gained with DUL used instead of generic-GBP was $102 433 MXN. This amount is slightly lower than the estimated gross domestic product per capita in Mexico for 2010. During a second-order Monte Carlo simulation, DUL had the highest probability of being cost-effective (61%), followed by generic-GBP (25%) and PGB (14%). Study limitations include a short timeframe and using data from different dosage schemes for GBP and PGB. This study suggests that DUL provides overall savings and better health outcomes compared with branded-GBP and PGB. Administering DUL rather than generic-GBP is a cost-effective intervention to manage PDPN in Mexico.

  4. Agomelatine and duloxetine synergistically modulates apoptotic pathway by inhibiting oxidative stress triggered intracellular calcium entry in neuronal PC12 cells: role of TRPM2 and voltage-gated calcium channels.

    PubMed

    Akpinar, Abdullah; Uğuz, Abdülhadi Cihangir; Nazıroğlu, Mustafa

    2014-05-01

    Calcium ion (Ca(2+)) is one of the universal second messengers, which acts in a wide range of cellular processes. Results of recent studies indicated that ROS generated by depression leads to loss of endoplasmic reticulum-Ca(2+) homeostasis, oxidative stress, and apoptosis. Agomelatine and duloxetine are novel antidepressant and antioxidant drugs and may reduce oxidative stress, apoptosis, and Ca(2+) entry through TRPM2 and voltage-gated calcium channels. We tested the effects of agomelatine, duloxetine, and their combination on oxidative stress, Ca(2+) influx, mitochondrial depolarization, apoptosis, and caspase values in the PC-12 neuronal cells. PC-12 neuronal cells were exposed in cell culture and exposed to appropriate non-toxic concentrations and incubation times for agomelatine were determined in the neurons by assessing cell viability. Then PC-12 cells were incubated with agomelatine and duloxetine for 24 h. Treatment of cultured PC-12 cells with agomelatine, duloxetine, and their combination results in a protection on apoptosis, caspase-3, caspase-9, mitochondrial membrane depolarization, cytosolic ROS production, glutathione peroxidase, reduced glutathione, and lipid peroxidation, values. Ca(2+) entry through non-specific TRPM2 channel blocker (2-APB) and voltage-gated Ca(2+) channel blockers (verapamil and diltiazem) was modulated by agomelatine and duloxetine. However, effects of duloxetine on the Ca(2+) entry through TRPM2 channels were higher than in agomelatine. Results of current study suggest that the agomelatine and duloxetine are useful against apoptotic cell death and oxidative stress in PC-12 cells, which seem to be dependent on mitochondrial damage and increased levels of intracellular Ca(2+) through activation of TRPM2 and voltage-gated Ca(2+) channels.

  5. Effects of Duloxetine Treatment on Cognitive Flexibility and BDNF Expression in the mPFC of Adult Male Mice Exposed to Social Stress during Adolescence.

    PubMed

    Xu, Hang; Zhang, Yu; Zhang, Fan; Yuan, San-Na; Shao, Feng; Wang, Weiwen

    2016-01-01

    Early stress is a significant risk factor for the onset of mood disorders such as depression during adulthood. Impairments in cognitive flexibility mediated by prefrontal cortex (PFC) dysfunction are increasingly recognized as important etiological and pathological factors in the development of depression. Our previous study demonstrated that social defeat stress during early adolescence produced delayed deficits in cognitive flexibility in adult mice. The potential molecular mechanisms underlying these long-term consequences remain unclear. One candidate molecule is brain-derived neurotrophic factor (BDNF), which plays a vital role in neural development and synaptic plasticity. In this study, we initially examined the effects of adolescent social stress on cognitive flexibility and PFC BDNF expression within a week after the last stress exposure and 6 weeks later during adulthood. Adolescent (PND 28) male mice were subjected to stress or control manipulation for 10 days. The attentional set-shifting task (AST) was used to assess cognitive flexibility. Levels of BDNF mRNA and protein in the PFC were examined after behavioral testing. The results demonstrated that previously stressed mice exhibited delayed extra-dimensional set-shifting deficits in AST when tested as adults but not when tested as adolescents. Consistent with the cognitive alterations, adolescent stress induced dynamic alterations in BDNF expression in the medial PFC (mPFC), with a transient increase observed shortly after the stress, followed by a decrease 6 weeks later during adulthood. Next, we further determined the effects of chronic treatment with the antidepressant duloxetine during early adulthood on cognitive and molecular alterations induced by adolescent stress. Compared with the controls, duloxetine treatment reversed the cognitive deficits and increased the BDNF protein expression in the mPFC during adulthood in previously stressed mice. These findings demonstrated that BDNF expression

  6. Effects of Duloxetine Treatment on Cognitive Flexibility and BDNF Expression in the mPFC of Adult Male Mice Exposed to Social Stress during Adolescence

    PubMed Central

    Xu, Hang; Zhang, Yu; Zhang, Fan; Yuan, San-na; Shao, Feng; Wang, Weiwen

    2016-01-01

    Early stress is a significant risk factor for the onset of mood disorders such as depression during adulthood. Impairments in cognitive flexibility mediated by prefrontal cortex (PFC) dysfunction are increasingly recognized as important etiological and pathological factors in the development of depression. Our previous study demonstrated that social defeat stress during early adolescence produced delayed deficits in cognitive flexibility in adult mice. The potential molecular mechanisms underlying these long-term consequences remain unclear. One candidate molecule is brain-derived neurotrophic factor (BDNF), which plays a vital role in neural development and synaptic plasticity. In this study, we initially examined the effects of adolescent social stress on cognitive flexibility and PFC BDNF expression within a week after the last stress exposure and 6 weeks later during adulthood. Adolescent (PND 28) male mice were subjected to stress or control manipulation for 10 days. The attentional set-shifting task (AST) was used to assess cognitive flexibility. Levels of BDNF mRNA and protein in the PFC were examined after behavioral testing. The results demonstrated that previously stressed mice exhibited delayed extra-dimensional set-shifting deficits in AST when tested as adults but not when tested as adolescents. Consistent with the cognitive alterations, adolescent stress induced dynamic alterations in BDNF expression in the medial PFC (mPFC), with a transient increase observed shortly after the stress, followed by a decrease 6 weeks later during adulthood. Next, we further determined the effects of chronic treatment with the antidepressant duloxetine during early adulthood on cognitive and molecular alterations induced by adolescent stress. Compared with the controls, duloxetine treatment reversed the cognitive deficits and increased the BDNF protein expression in the mPFC during adulthood in previously stressed mice. These findings demonstrated that BDNF expression

  7. A selective α2 B adrenoceptor agonist (A-1262543) and duloxetine modulate nociceptive neurones in the medial prefrontal cortex, but not in the spinal cord of neuropathic rats.

    PubMed

    Chu, K L; Xu, J; Frost, J; Li, L; Gomez, E; Dart, M J; Jarvis, M F; Meyer, M D; McGaraughty, S

    2015-05-01

    The noradrenergic system contributes to pain modulation, but the roles of its specific adrenoceptors are still being defined. We have identified a novel, potent (rat EC50  = 4.3 nM) and selective α2B receptor agonist, A-1262543, to further explore this adrenoceptor subtype's contribution to pathological nociception. Systemic administration of A-1262543 (1-10 mg/kg, intraperitoneal) dose-dependently attenuated mechanical allodynia in animals with a spinal nerve ligation injury. To further explore its mechanism of action, the activity of nociceptive neurones in the spinal cord and medial prefrontal cortex (mPFC) were examined after injection of 3 mg/kg of A-1262543 (intravenous, i.v.). These effects were compared with duloxetine (3 mg/kg, i.v.), a dual noradrenaline (NA) and serotonin (5-HT) reuptake inhibitor. Systemic administration of A-1262543 or duloxetine did not alter the spontaneous or evoked firing of spinal wide dynamic range and nociceptive-specific neurones in the neuropathic rats, indicating that neither compound engaged spinal, peripheral or descending pathways. In contrast to the lack of effect on spinal neurones, both A-1262543 and duloxetine reduced the evoked and spontaneous firing of 'pain-responsive' (PR) neurones in the mPFC. Duloxetine, but not A-1262543, also inhibited the firing of pain non-responsive (nPR) neurones in the mPFC probably reflecting duloxetine's contribution to modulating non-pain endpoints. These data highlight that activation of the α2B adrenoceptor as well as inhibiting NA and 5-HT reuptake can result in modulating the ascending nociceptive system, and in particular, dampening the firing of PR neurones in the mPFC. © 2014 European Pain Federation - EFIC®

  8. [Combination of dialectic and behavioral therapy (DBT) and duloxetin in kleptomania].

    PubMed

    Rudel, Astrid; Hubert, Cornelia; Juckel, Georg; Edel, Marc-Andreas

    2009-09-01

    Kleptomania is characterized by repetitive stealing of things not needed for personal use. Comorbidity with affective disorders, personality disorders and attention deficit hyperactivity disorder (ADHD) is often described. Pharmacological treatment options are serotonin reuptake inhibitors, naltrexone or mood stabilizers. There are no controlled studies for cognitive-behavioral (CBT) and psychodynamic psychotherapies. However, literature suggests that patients respond to CBT, especially when combined with pharmacological strategies. Dialectical behavioral therapy (DBT) is successfully applied in the treatment of borderline personality disorder. and, in a modified manner, of ADHD. We report a treatment of an in-patient with kleptomania, depressive episode, combined personality disorder and ADHD. Under combined treatment with DBT, which has been successfully used in the treatment of impulsive disorders, and duloxetine, the patient's urge to steal decreased markedly, and no corresponding actions were detectable in follow-up examinations. Particularly for the kleptomania subtype with comorbid ADHD and / or personality disorder, DBT may be a promising approach. In addition, duloxetine as a serotonin-epinephrine reuptake inhibitor (SNRI) might fit into a complementary treatment strategy.

  9. The Use of Duloxetine in Chronic Bulimia Nervosa

    PubMed Central

    Averbuch, Robert N.

    2009-01-01

    Selective serotonin reuptake inhibitors are routinely prescribed as off-label treatments for bulimia nervosa. There is, however, a paucity of literature addressing the efficacy of the serotonin norepinephrine reuptake inhibitors in the pharmacologic management of this disorder. This article describes a clinical situation in which duloxetine, a serotonin norepinephrine reuptake inhibitor, effectively treated a patient with long-standing bulimia nervosa, purging type, and comorbid generalized anxiety disorder. PMID:19763204

  10. Operations dashboard: comparative study

    NASA Astrophysics Data System (ADS)

    Ramly, Noor Nashriq; Ismail, Ahmad Zuhairi; Aziz, Mohd Haris; Ahmad, Nurul Haszeli

    2011-10-01

    In this present days and age, there are increasing needs for companies to monitor application and infrastructure health. Apart from having proactive measures to secure their application and infrastructure, many see monitoring dashboards as crucial investment in disaster preparedness. As companies struggle to find the best solution to cater for their needs and interest for monitoring their application and infrastructure's health, this paper summarizes the studies made on several known off-the-shelf operations dashboard and in-house developed dashboard. A few criteria of good dashboard are collected from previous studies carried out by several researchers and rank them according to importance and business needs. The finalized criteria that will be discussed in later sections are data visualization, performance indicator, dashboard personalization, audit capability and alert/ notification. Comparative studies between several popular dashboards were then carried out to determine whether they met these criteria that we derived from the first exercise. The findings hopefully can be used to educate and provide an overview of selecting the best IT application and infrastructure operations dashboard that suit business needs, thus become the main contribution of this paper.

  11. Vortioxetine for major depressive disorder: An indirect comparison with duloxetine, escitalopram, levomilnacipran, sertraline, venlafaxine, and vilazodone, using number needed to treat, number needed to harm, and likelihood to be helped or harmed.

    PubMed

    Citrome, Leslie

    2016-05-15

    Vortioxetine is approved for the treatment of major depressive disorder and differs from other antidepressants in terms of its pharmacodynamic profile. Given the limited number of head-to-head studies comparing vortioxetine with other antidepressants, indirect comparisons using effect sizes observed in other trials can be helpful to discern potential differences in clinical outcomes. Data sources were the clinical trial reports for the pivotal short-term double-blind trials for vortioxetine and from publicly available sources for the pivotal short-term double-blind trials for two commonly used generic serotonin specific reuptake inhibitor antidepressants (sertraline, escitalopram), two commonly used generic serotonin-norepinephrine reuptake inhibitor antidepressants (venlafaxine, duloxetine), and two recently introduced branded antidepressants (vilazodone, levomilnacipran). Response was the efficacy outcome of interest, defined as a≥50% reduction from baseline on the Montgomery-Asberg Depression Rating Scale or Hamilton Depression Rating Scale. The tolerability outcome of interest was discontinuation because of an adverse event. Number needed to treat (NNT) and number needed to harm (NNH) for these outcomes vs. placebo were calculated, as well as likelihood to be helped or harmed (LHH) to contrast efficacy vs. tolerability. The analysis included 8 studies for duloxetine, 3 studies for escitalopram, 5 studies for levomilnacipran, 1 study for sertraline, 4 studies for venlafaxine, 2 studies for vilazodone, and 11 studies for vortioxetine. NNTs for response vs. placebo were 6 (95% CI 5-8), 7 (5-11), 10 (8-16), 6 (4-13), 6 (5-9), 8 (6-16), and 9 (7-11), respectively. NNHs for discontinuation because of an adverse event vs. placebo were 25 (17-51), 31 (19-92), 19 (14-27), 7 (5-12), 8 (7-11), 27 (15-104), and 43 (28-91), respectively. LHH values contrasting response vs. discontinuation because of an adverse event were 4.3, 4.6, 1.8, 1.2, 1.4, 3.3, and 5.1 respectively

  12. Catechol-O-methyltransferase Val158Met genotype and the clinical responses to duloxetine treatment or plasma levels of 3-methoxy-4-hydroxyphenylglycol and homovanillic acid in Japanese patients with major depressive disorder

    PubMed Central

    Atake, Kiyokazu; Yoshimura, Reiji; Hori, Hikaru; Katsuki, Asuka; Nakamura, Jun

    2015-01-01

    Purpose This study investigated the relationships among the plasma levels of catecholamine metabolites, the clinical response to duloxetine treatment, and Val158Met polymorphism of the catechol-O-methyltransferase (COMT) gene. Subjects and methods Sixty-four patients and 30 healthy control subjects were recruited. Major depressive episodes were diagnosed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria. The severity of depression was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD17). Patients whose HAMD17 scores were 15 or greater were enrolled in the study. Blood sampling and clinical evaluation were performed at week 0 and week 8. The levels of plasma catecholamine metabolites were measured using high-performance liquid chromatography with electrochemical detection. Genotyping was performed using direct sequencing. Results Thirty of 45 patients (67%) responded to duloxetine treatment during the 8 weeks of treatment. The baseline plasma levels of 3-methoxy-4-hydroxyphenylglycol (MHPG), but not homovanillic acid (HVA), were lower in patients with major depressive disorder (MDD) who had the Val/Val genotype than in patients who were Met-carriers. Patients with MDD and the Val/Val genotype, but not Met carriers, had increased plasma levels of MHPG after 8 weeks of duloxetine treatment. The baseline plasma MHPG levels in healthy control subjects with the Val/Val genotype were significantly higher than those in patients with MDD. Among the subjects in the MDD group with the Val/Val genotype, the plasma MHPG levels increased to the same degree as in the healthy control subjects with the Val/Val genotype after 8 weeks of duloxetine treatment. Conclusion The relationship among the COMT Val158Met polymorphism, plasma levels of catecholamine metabolites, and responses to duloxetine is complex. Nevertheless, our results suggest that patients with MDD and the

  13. The efficacy of duloxetine, non-steroidal anti-inflammatory drugs, and opioids in osteoarthritis: a systematic literature review and meta-analysis

    PubMed Central

    2014-01-01

    Background This meta-analysis assessed the efficacy of duloxetine versus other oral treatments used after failure of acetaminophen for management of patients with osteoarthritis. Methods A systematic literature review of English language articles was performed in PUBMED, EMBASE, MedLine In-Process, Cochrane Library, and ClinicalTrials.gov between January 1985 and March 2013. Randomized controlled trials of duloxetine and all oral non-steroidal anti-inflammatory drugs and opioids were included if treatment was ≥12 weeks and the Western Ontario and McMaster Universities Index (WOMAC) total score was available. Studies were assessed for quality using the assessment tool from the National Institute for Health and Clinical Excellence guidelines for single technology appraisal submissions. WOMAC baseline and change from baseline total scores were extracted and standardized. A frequentist meta-analysis, meta-regression, and indirect comparison were performed using the DerSimonian-Laird and Bucher methods. Bayesian analyses with and without adjustment for study-level covariates were performed using noninformative priors. Results Thirty-two publications reported 34 trials (2 publications each reported 2 trials) that met inclusion criteria. The analyses found all treatments except oxycodone (frequentist) and hydromorphone (frequentist and Bayesian) to be more effective than placebo. Indirect comparisons to duloxetine found no significant differences for most of the compounds. Some analyses showed evidence of a difference with duloxetine for etoricoxib (better), tramadol and oxycodone (worse), but without consistent results between analyses. Forest plots revealed positive trends in overall efficacy improvement with baseline scores. Adjusting for baseline, the probability duloxetine is superior to other treatments ranges between 15% to 100%. Limitations of this study include the low number of studies included in the analyses, the inclusion of only English language

  14. Comparative Packaging Study

    NASA Technical Reports Server (NTRS)

    Perchonok, Michele H.; Oziomek, Thomas V.

    2009-01-01

    Future long duration manned space flights beyond low earth orbit will require the food system to remain safe, acceptable and nutritious. Development of high barrier food packaging will enable this requirement by preventing the ingress and egress of gases and moisture. New high barrier food packaging materials have been identified through a trade study. Practical application of this packaging material within a shelf life test will allow for better determination of whether this material will allow the food system to meet given requirements after the package has undergone processing. The reason to conduct shelf life testing, using a variety of packaging materials, stems from the need to preserve food used for mission durations of several years. Chemical reactions that take place during longer durations may decrease food quality to a point where crew physical or psychological well-being is compromised. This can result in a reduction or loss of mission success. The rate of chemical reactions, including oxidative rancidity and staling, can be controlled by limiting the reactants, reducing the amount of energy available to drive the reaction, and minimizing the amount of water available. Water not only acts as a media for microbial growth, but also as a reactant and means by which two reactants may come into contact with each other. The objective of this study is to evaluate three packaging materials for potential use in long duration space exploration missions.

  15. The role of the NMDA receptors and l-arginine-nitric oxide-cyclic guanosine monophosphate pathway in the antidepressant-like effect of duloxetine in the forced swimming test.

    PubMed

    Zomkowski, Andréa D E; Engel, Daiane; Cunha, Mauricio P; Gabilan, Nelson H; Rodrigues, Ana Lúcia S

    2012-12-01

    Duloxetine is a selective serotonin and noradrenaline reuptake inhibitor used as antidepressant. However, its mechanisms of action are not fully understood. This study investigated the effect of duloxetine in the mouse forced swimming test (FST) and in the tail suspension test (TST) and the involvement of the NMDA receptors and the l-arginine-NO-cGMP pathway in its effect in the FST. Duloxetine reduced the immobility time both in the FST and in the TST (dose range of 1-30mg/kg, i.p.), without changing locomotion in an open-field. Duloxetine administered orally (1-30mg/kg) also reduced the immobility time in the FST. The effect of duloxetine (10mg/kg, p.o.) in the FST was prevented by pre-treatment with NMDA (0.1pmol/site, i.c.v.), d-serine (30μg/site, i.c.v.), (l-arginine (750mg/kg, i.p.), S-nitroso-N-acetyl-penicillamine (SNAP, 25μg/site, i.c.v) or sildenafil (5mg/kg, i.p.). The administration of MK-801 (0.001mg/kg, i.p.), 7-nitroindazole (50mg/kg, i.p.), methylene blue (20mg/kg, i.p.) or 1H-[1,2,4]oxadiazole[4,3-a]quinoxalin-1-one (ODQ) (30pmol/site i.c.v.) in combination with a sub-effective dose of duloxetine (0.3mg/kg, p.o.) reduced the immobility time in the FST. Moreover, the administration of duloxetine (10mg/kg) produced a reduction in NOx levels in the hippocampus and cerebral cortex. Altogether the results suggest that the effect of duloxetine in the FST is dependent on either a blockade of NMDA receptors or an inhibition of NO. In addition, our results further reinforce the role of NMDA receptors and l-arginine-NO-cGMP pathway, besides the monoaminergic systems, in the mechanism of action of current prescribed antidepressant agents.

  16. [A case of Paclitaxel-induced peripheral neuropathy successfully treated with duloxetine].

    PubMed

    Nagashima, Satoshi; Kiba, Takayoshi; Ogawa, Yoshikazu; Mura, Takuya; Kajiume, Sayoko; Okada, Yuuko; Morii, Nao; Takahashi, Hirotoshi; Ichiba, Yasunori; Yamashiro, Hiroyasu

    2015-05-01

    Here, we report about a 60-year-old woman with metastatic breast cancer who was successfully treated for paclitaxelinduced peripheral neuropathy with duloxetine. She was administered trastuzumab plus paclitaxel(PTX)combination therapy that was ultimately discontinued because of grade 3 peripheral neuropathy detected on day 15, according to the CTCAE (v4.0). She was administered duloxetine on day 90 after the end of the previous therapy because of the peripheral neuropathy. Thereafter, the peripheral neuropathy decreased to grade 1, which enabled PTX administration on her request. Further trials are required to confirm the efficacy of duloxetine.

  17. Temperature and concentration dependences of density and refraction of aqueous duloxetine solutions

    NASA Astrophysics Data System (ADS)

    Deosarkar, S. D.; Deoraye, S. M.; Kalyankar, T. M.

    2014-07-01

    Present paper reports the measured densities (ρ) and refractive indices ( n D) of aqueous solutions of Duloxetine drug in wide range of molal concentrations ( m = 0.0101-0.1031 mol kg-1) and at different temperatures (297.15, 302.15, and 307.15 K). Apparent molar volumes (φv) of drug were calculated from density data and fitted to Masson's relation and partial molar volumes (φ{v/0}) were evaluated at different temperatures. Concentration dependence of refractive index ( n D = Kc + n {D/0}) at experimental temperature has been studied. Density and refractive index data has been used for the calculation of specific refractions ( R D). Experimental (ρ and n D) and calculated (φv, φ{v/0}, and R D) properties have been interpreted in terms of concentration and temperature effects on structural fittings and drug-water interactions.

  18. Duloxetine for the treatment of mood disorder in cancer patients: a 12-week case-control clinical trial.

    PubMed

    Torta, Riccardo; Leombruni, Paolo; Borio, Roberto; Castelli, Lorys

    2011-01-01

    The aim of this study was to investigate the efficacy and tolerability of duloxetine in cancer patients with mood disorder (MD) by means of a comparison with a matched control group of patients with MD without medical illness. Fifty-nine consecutive patients with MD were enrolled in this prospective case-control study and received duloxetine 60/120 mg per day for 12 weeks. Twenty-seven patients were affected by cancer, whereas 32 had an MD without cancer. All the patients were assessed by means of efficacy and effectiveness tolerability scales for depression (Montgomery-Asberg Depression Rating Scale and Hospital Anxiety and Depression Scale), anxiety (State-Trait Anxiety Inventory-Y1/Y2) and severity of symptoms (Clinical Global Impression (CGI)-Severity) at baseline (T0), after 4 weeks (T1) and 12 weeks (T2). The CGI-Improvement, CGI-Effectiveness Index and Dosage Record Treatment Emergent Symptom Scale were administered at T1 and T2. A significant global improvement in all the efficacy measures was found. The results showed no significant interaction 'Time X Group', suggesting a similar improvement in efficacy scores for cancer-depressed patients and depressed patients without cancer. No difference was found between the two groups with regard to drop-out percentage, effectiveness and tolerability. Although the results of this case-control study are preliminary, they suggest that duloxetine can be considered a good option for the treatment of MD in cancer patients. Copyright © 2011 John Wiley & Sons, Ltd.

  19. Does early improvement in depressive symptoms predict subsequent remission in patients with depression who are treated with duloxetine?

    PubMed Central

    Sueki, Akitsugu; Suzuki, Eriko; Takahashi, Hitoshi; Ishigooka, Jun

    2016-01-01

    Purpose In this prospective study, we examined whether early reduction in depressive symptoms predicts later remission to duloxetine in the treatment of depression, as monitored using the Montgomery–Asberg Depression Rating Scale (MADRS). Patients and methods Among the 106 patients who were enrolled in this study, 67 were included in the statistical analysis. A clinical evaluation using the MADRS was performed at weeks 0, 4, 8, 12, and 16 after commencing treatment. For each time point, the MADRS total score was separated into three components: dysphoria, retardation, and vegetative scores. Results Remission was defined as an MADRS total score of ≤10 at end point. From our univariate logistic regression analysis, we found that improvements in both the MADRS total score and the dysphoria score at week 4 had a significant interaction with subsequent remission. Furthermore, age and sex were significant predictors of remission. There was an increase of approximately 4% in the odds of remission for each unit increase in age, and female sex had an odds of remission of 0.318 times that of male sex (remission rate for men was 73.1% [19/26] and for women 46.3% [19/41]). However, in the multivariate model using the change from baseline in the total MADRS, dysphoria, retardation, and vegetative scores at week 4, in which age and sex were included as covariates, only sex retained significance, except for an improvement in the dysphoria score. Conclusion No significant interaction was found between early response to duloxetine and eventual remission in this study. Sex difference was found to be a predictor of subsequent remission in patients with depression who were treated with duloxetine, with the male sex having greater odds of remission. PMID:27307739

  20. Experience and challenges presented by a multicenter crossover study of combination analgesic therapy for the treatment of painful HIV-associated polyneuropathies

    PubMed Central

    Harrison, Taylor; Miyahara, Sachiko; Lee, Anthony; Evans, Scott; Bastow, Barbara; Simpson, David; Gilron, Ian; Dworkin, Robert; Daar, Eric S.; Wieclaw, Linda; Clifford, David B.

    2014-01-01

    Objective There is limited evidence for efficacy of analgesics as monotherapy for neuropathic pain associated with HIV-associated polyneuropathies, in spite of demonstrated efficacy in other neuropathic pain conditions. We evaluated the tolerability and analgesic efficacy of duloxetine, methadone, and the combination of duloxetine-methadone compared to placebo. Design This study was a phase II, randomized, double blind, placebo-controlled, four-period crossover multi-center study of analgesic therapy for patients with at least moderate neuropathic pain due to HIV-associated polyneuropathy. Duloxetine, methadone, combination duloxetine-methadone, and placebo were administered in four different possible sequences. The primary outcome measure was mean pain intensity (MPI) measured daily in a study-supplied pain diary. Results A total of 15 patients were enrolled from 8 study sites and 8 patients completed the entire trial. Study treatments failed to show statistically significant change in MPI compared to placebo. Adverse events were frequent and associated with high rates of drug discontinuation and study drop-out. Conclusions Challenges with participant recruitment and poor retention precluded trial completion to its planned targets, limiting our evaluation of the analgesic efficacy of the study treatments. Challenges to successful completion of this study and lessons learned are discussed. PMID:23565581

  1. Validated spectrophotometric method for the determination, spectroscopic characterization and thermal structural analysis of duloxetine with 1,2-naphthoquinone-4-sulphonate

    NASA Astrophysics Data System (ADS)

    Ulu, Sevgi Tatar; Elmali, Fikriye Tuncel

    2012-03-01

    A novel, selective, sensitive and simple spectrophotometric method was developed and validated for the determination of the antidepressant duloxetine hydrochloride in pharmaceutical preparation. The method was based on the reaction of duloxetine hydrochloride with 1,2-naphthoquinone-4-sulphonate (NQS) in alkaline media to yield orange colored product. The formation of this complex was also confirmed by UV-visible, FTIR, 1H NMR, Mass spectra techniques and thermal analysis. This method was validated for various parameters according to ICH guidelines. Beer's law is obeyed in a range of 5.0-60 μg/mL at the maximum absorption wavelength of 480 nm. The detection limit is 0.99 μg/mL and the recovery rate is in a range of 98.10-99.57%. The proposed methods was validated and applied to the determination of duloxetine hydrochloride in pharmaceutical preparation. The results were statistically analyzed and compared to those of a reference UV spectrophotometric method.

  2. Frontal regional homogeneity increased and temporal regional homogeneity decreased after remission of first-episode drug-naïve major depressive disorder with panic disorder patients under duloxetine therapy for 6 weeks.

    PubMed

    Lai, Chien-Han; Wu, Yu-Te

    2012-02-01

    We designed this study to investigate the changes of regional homogeneity (ReHo) after a 6-week duloxetine therapy in first-episode drug-naïve major depressive disorder with panic disorder (FEMDDPD) patients. 3T magnetic resonance imaging (MRI) scanning and ReHo functional MRI analysis were performed on 15 patients (male: 5; female: 10; age: 35.87±9.59 years old) at baseline and remitted status (sixth week) compared with 15 healthy control subjects (male: 4; female: 11; age: 34.30±9.87 years old) which were scanned twice within 6 weeks. The ReHo was analyzed by the REST toolbox (resting-state functional MRI data analysis toolbox). The ReHos of different time-points were compared by using paired t test function of REST. ReHo increased in right superior frontal cortex, right medial frontal cortex and decreased in right superior temporal cortex (uncorrected p<0.00005, cluster threshold>20, surface connected theory) after remission of symptoms in these FEMDDPD patients within 6 weeks (improvements of clinician rating and self rating scale scores; post-hoc corrected p<0.001). No significant changes of ReHo were observed in the controls within 6 weeks (uncorrected p<0.1, no cluster threshold setting, surface connected theory). The changes of ReHo value were mildly correlated with improvements of clinical rating scales with age, gender, depression and anxiety severity as covariates. Our study suggested that differential modulations inside the default mode network probably were associated with remission of FEMDDPD symptoms after duloxetine therapy. Copyright © 2011 Elsevier B.V. All rights reserved.

  3. Duloxetine and 8-OH-DPAT, but not fluoxetine, reduce depression-like behaviour in an animal model of chronic neuropathic pain.

    PubMed

    Hu, Bing; Doods, Henri; Treede, Rolf-Detlef; Ceci, Angelo

    2016-04-21

    The current study assessed whether antidepressant and/or antinociceptive drugs, duloxetine, fluoxetine as well as (±)-8-hydroxy-2-[di-n-propylamino] tetralin (8-OH-DPAT), are able to reverse depression-like behaviour in animals with chronic neuropathic pain. Chronic constriction injury (CCI) of the sciatic nerve in rats was selected as neuropathic pain model. Mechanical hypersensitivity and depression-like behaviour were evaluated 4 weeks after surgery by "electronic algometer" and forced swimming test (FST), which measured the time of immobility, and active behaviours climbing and swimming. The selective noradrenergic and serotonergic uptake blocker duloxetine (20mg/kg) and the selective 5-HT1A agonist 8-OH-DPAT (0.5mg/kg) significantly reversed both mechanical hypersensitivity and depression-like behaviour in CCI animals. Duloxetine significantly reversed depression-like behaviour in CCI rats by increasing the time of climbing and swimming, while 8-OH-DPAT attenuated depression-like behaviour mainly by increasing the time of swimming. However, the selective serotonergic uptake blocker fluoxetine (20mg/kg) failed to attenuate mechanical hypersensitivity and depression-like behaviour, possibly due to confounding pro-nociceptive actions at 5-HT3 receptors. These data suggest to target noradrenergic and 5-HT1A receptors for treatment of chronic pain and its comorbidity depression.

  4. Development and validation of a HPTLC method for Estimation of Duloxetine Hydrochloride in Bulk Drug and in Tablet Dosage Form.

    PubMed

    Dhaneshwar, Suneela S; Deshpande, P; Patil, M; Vadnerkar, G; Dhaneshwar, S R

    2008-01-01

    Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11+/-0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot), precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46-1.59%), accuracy (98.72+/-0.20) and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation.

  5. Development and validation of a HPTLC method for Estimation of Duloxetine Hydrochloride in Bulk Drug and in Tablet Dosage Form

    PubMed Central

    Dhaneshwar, Suneela S.; Deshpande, P.; Patil, M.; Vadnerkar, G.; Dhaneshwar, S. R.

    2008-01-01

    Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11±0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot), precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46-1.59%), accuracy (98.72±0.20) and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation. PMID:20046720

  6. Duloxetine prevents the effects of prenatal stress on depressive-like and anxiety-like behavior and hippocampal expression of pro-inflammatory cytokines in adult male offspring rats.

    PubMed

    Zhang, Xiaosong; Wang, Qi; Wang, Yan; Hu, Jingmin; Jiang, Han; Cheng, Wenwen; Ma, Yuchao; Liu, Mengxi; Sun, Anji; Zhang, Xinxin; Li, Xiaobai

    2016-12-01

    Stress during pregnancy may cause neurodevelopmental and psychiatric disorders. However, the mechanisms are largely unknown. Currently, pro-inflammatory cytokines have been identified as a risk factor for depression and anxiety disorder. Unfortunately, there is very little research on the long-term effects of prenatal stress on the neuroinflammatory system of offspring. Moreover, the relationship between antidepressant treatment and cytokines in the central nervous system, especially in the hippocampus, an important emotion modulation center, is unclear. Therefore, the aim of this study was to determine the effects of prenatal chronic mild stress during development on affective-like behaviors and hippocampal cytokines in adult offspring, and to verify whether antidepressant (duloxetine) administration from early adulthood could prevent the harmful consequences. To do so, prenatally stressed and non-stressed Sprague-Dawley rats were treated with either duloxetine (10mg/kg/day) or vehicle from postnatal day 60 for 21days. Adult offspring were divided into four groups: 1) prenatal stress+duloxetine treatment, 2) prenatal stress+vehicle, 3) duloxetine treatment alone, and 4) vehicle alone. Adult offspring were assessed for anxiety-like behavior using the open field test and depression-like behavior using the forced swim test. Brains were analyzed for pro-inflammatory cytokine markers in the hippocampus via real-time PCR. Results demonstrate that prenatal stress-induced anxiety- and depression-like behaviors are associated with an increase in hippocampal inflammatory mediators, and duloxetine administration prevents the increased hippocampal pro-inflammatory cytokine interleukin-6 and anxiety- and depression-like behavior in prenatally stressed adult offspring. This research provides important evidence on the long-term effect of PNS exposure during development in a model of maternal adversity to study the pathogenesis of depression and its therapeutic interventions

  7. Self-Limited Kleptomania Symptoms as a Side Effect of Duloxetine

    PubMed Central

    Gallagher, Keith E.

    2016-01-01

    Introduction. Impulse control disorders (ICDs) have been described as a side effect of dopamine agonists, frequently used in neurodegenerative conditions affecting the nigrostriatal pathway. Serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine) have dose-dependent differential affinity for monoaminergic transporters, inhibiting the dopamine transporter at higher doses, thus increasing availability of synaptic dopamine, with the potential for similar impulse control side effects. Case Presentation. A 19-year-old Asian-American female with a history of depression developed new-onset stealing behaviors after an increase in her dose of duloxetine from 60 mg to 90 mg; she described these actions as “compulsive” and irresistible, later experiencing either relief or guilt, features compatible with an ICD. Her symptoms eventually subsided with continued use of 90 mg of duloxetine. Discussion. To the knowledge of the authors, this is the first report of a patient developing new-onset ICD behaviors after being placed on a higher dose of duloxetine, which can inhibit the dopamine transporter and cause difficulty with impulse control. The self-resolving nature of the symptoms may result from compensatory upregulation of dopamine transporters, increasing reuptake of dopamine. Asian populations may be at a higher risk due to the frequent occurrence of CYP2D6 polymorphisms, which decrease the conversion of duloxetine to its inactive metabolites. PMID:28018697

  8. Successful treatment by adding duloxetine to pregabalin for peripheral neuropathy induced by paclitaxel.

    PubMed

    Takenaka, Motoyasu; Iida, Hiroki; Matsumoto, Shigemi; Yamaguchi, Shinobu; Yoshimura, Noritaka; Miyamoto, Maki

    2013-11-01

    Although paclitaxel is a commonly used anticancer drug, peripheral neuropathy may develop as a side effect. Worsening of the symptoms with time may cause patients who receive paclitaxel to give up their chemotherapy. Duloxetine, a serotonin- and norepinephrine-reuptake inhibitor, has been used to treat peripheral neuropathic pain. We report the case of a 68-year-old man with gastric cancer, who underwent gastrectomy and then received 8 cycles of chemotherapy involving weekly administrations of paclitaxel. Under this paclitaxel treatment, he complained of severe peripheral neuropathy, leading to a diminished quality of life. Following treatment with a combination of duloxetine and pregabalin, a remission of his symptoms was achieved. Duloxetine plus pregabalin therapy may be useful for the peripheral neuropathy induced by paclitaxel.

  9. Rapid Management of Trigeminal Neuralgia and Comorbid Major Depressive Disorder With Duloxetine.

    PubMed

    Hsu, Chung-Chih; Chang, Chun-Wei; Peng, Chia-Ho; Liang, Chih-Sung

    2014-08-01

    To describe a case of a patient diagnosed with major depressive disorder whose trigeminal neuralgia was unexpectedly but rapidly and efficiently responsive to duloxetine. A 37-year-old woman was diagnosed with trigeminal neuralgia, and the initial treatment with carbamazepine 800 mg/d did not improve her pain. In the following 3 years, she was poorly responsive to the combination therapy with several medications, including carbamazepine, valproate, baclofen, diclofenac, and acetaminophen. The repeated gamma knife radiosurgery still did not relieve her symptoms. She developed clinically significant depressive symptoms, and a diagnosis of major depressive disorder was made. Duloxetine 30 mg/d was initiated for the management of depression, with the dose gradually increased to 60 mg/d. Unexpectedly, at the dose of 60 mg/d, the patient reported remarkable relief in her trigeminal neuralgia within the first week. Her depressed mood gradually improved in the following 3 weeks. At the 4-year follow-up, she was gradually tapered off her medications, and her depression and trigeminal neuralgia were well managed on duloxetine 60 mg/d and carbamazepine 600 mg/d. The mechanisms may be related to duloxetine's ability to modulate norepinephrine and serotonin and antagonize N-methyl-d-aspartate (NMDA) receptors. The ignition hypothesis is a proposed etiology of trigeminal neuralgia, in that any individual hyperexcitable neuron can spread its discharge quickly to activate the entire population of neurons. We suggest that duloxetine exerts desynchronizing effects through its NMDA antagonism, modulating the hyperexcitable state of the trigeminal afferents. Duloxetine may be an adjuvant in treatment-resistant trigeminal neuralgia. © The Author(s) 2014.

  10. Duloxetine in the treatment of burning mouth syndrome refractory to conventional treatment: A case report.

    PubMed

    Kim, Yeon-Dong; Lee, Ji-Hye; Shim, Jee-Hoon

    2014-06-01

    Patients with burning mouth syndrome (BMS) report burning sensation and pain involving the tongue and oral mucosa without any apparent medical or dental cause. The pathogenesis of this syndrome remains unclear and there is currently no standard treatment. BMS is, therefore, often misdiagnosed and its management is complex. This lack of clinical expertise may result in decreased health-related quality of life and increased psychological distress among patients with BMS. The present case report involves a 77-year-old female patient with BMS refractory to conventional treatment with nerve block and medication, who was successfully treated with duloxetine. Duloxetine may become a new therapeutic option in the management of BMS.

  11. Multicolor holography: a comparative study

    NASA Astrophysics Data System (ADS)

    Oliveira, Rosa M.; Bernardo, Luis M.; Pinto, Joao L.

    2000-10-01

    A multicolor holography study case will be presented with emphasis on color control in different silver-halide materials. It has been systematized in order to compare the results obtained with Agfa 8E 75HD to those with Slavich PFG-01. Some experiments were made and the emulsion was manipulated before exposure to achieve high quality multicolored white light reflection holograms. This work has therefore been developed in order to obtain the various colors in a very well controlled way.

  12. Predictors of duloxetine response in patients with oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial - CALGB/alliance 170601.

    PubMed

    Smith, E M L; Pang, H; Ye, C; Cirrincione, C; Fleishman, S; Paskett, E D; Ahles, T; Bressler, L R; Le-Lindqwister, N; Fadul, C E; Loprinzi, C; Shapiro, C L

    2017-03-01

    Duloxetine is an effective treatment for oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN). However, predictors of duloxetine response have not been adequately explored. The objective of this secondary and exploratory analysis was to identify predictors of duloxetine response in patients with painful oxaliplatin-induced CIPN. Patients (N = 106) with oxaliplatin-induced painful CIPN were randomised to receive duloxetine or placebo. Eligible patients had chronic CIPN pain and an average neuropathic pain score ≥4/10. Duloxetine/placebo dose was 30 mg/day for 7 days, then 60 mg/day for 4 weeks. The Brief Pain Inventory-Short Form and the EORTC QLQ-C30 were used to assess pain and quality of life, respectively. Univariate and multiple logistic regression analyses were performed to identify demographic, physiologic and psychological predictors of duloxetine response. Higher baseline emotional functioning predicted duloxetine response (≥30% reduction in pain; OR 4.036; 95% CI 0.999-16.308; p = 0.050). Based on the results from a multiple logistic regression using patient data from both the duloxetine and placebo treatment arms, duloxetine-treated patients with high emotional functioning are more likely to experience pain reduction (p = 0.026). In patients with painful, oxaliplatin-induced CIPN, emotional functioning may also predict duloxetine response. ClinicalTrials.gov, Identifier NCT00489411.

  13. [Comparative studies of face recognition].

    PubMed

    Kawai, Nobuyuki

    2012-07-01

    Every human being is proficient in face recognition. However, the reason for and the manner in which humans have attained such an ability remain unknown. These questions can be best answered-through comparative studies of face recognition in non-human animals. Studies in both primates and non-primates show that not only primates, but also non-primates possess the ability to extract information from their conspecifics and from human experimenters. Neural specialization for face recognition is shared with mammals in distant taxa, suggesting that face recognition evolved earlier than the emergence of mammals. A recent study indicated that a social insect, the golden paper wasp, can distinguish their conspecific faces, whereas a closely related species, which has a less complex social lifestyle with just one queen ruling a nest of underlings, did not show strong face recognition for their conspecifics. Social complexity and the need to differentiate between one another likely led humans to evolve their face recognition abilities.

  14. Duloxetine in treatment of refractory chronic tennis elbow: Two case reports

    PubMed Central

    Wani, Zaid Ahmad; Dhar, Shabir Ahmad; Butt, Mohammad Farooq; Rather, Yasir Hassan; Sheikh, Shano

    2008-01-01

    Introduction Tennis elbow is a common musculoskeletal disorder; management options include physiotherapeutic, medical, surgical, and other forms of intervention. Some patients remain symptomatic despite best efforts. We present two patients who did not respond to medical and surgical treatments, and whose symptoms were relieved with duloxetine. This is the first report on the use of duloxetine to treat tennis elbow. Case presentation Two mentally healthy young Asian women aged 32 and 27 years, each with tennis elbow of about 18 months duration continued to suffer pain despite treatment with analgesics, local steroid injections, physiotherapy, cryotherapy, ultrasound, and surgical release, among other interventions. Both showed substantial improvement within 4 to 6 weeks of receiving monotherapy with duloxetine 60 mg/day. Both were pain-free with continued treatment at a 6-month follow-up. Conclusion Duloxetine may be a useful treatment option in patients with chronic tennis elbow, even those who have failed conventional medical, physiotherapeutic, surgical, and other forms of management. PMID:18798992

  15. Syndrome of inappropriate antidiuretic hormone secretion: a story of duloxetine-induced hyponatraemia.

    PubMed

    Amoako, Adae Opoku; Brown, Carina; Riley, Timothy

    2015-04-24

    Hyponatraemia is the most commonly encountered electrolyte abnormality in clinical practice. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) accounts for nearly 60% of all hyponatraemias. Selective serotonin reuptake inhibitors (SSRIs) are well known to have side effects of SIADH. There have been few reported cases of serotonin norepinephrine reuptake inhibitors (SNRIs) causing SIADH-induced hyponatraemia. Duloxetine is one type of SNRI used to treat several conditions, including depression and diabetic neuropathy. We present a case of a 76-year-old woman with a history of fibromyalgia who had recently been prescribed duloxetine for her condition. On admission to the hospital, her sodium decreased to a low of 118 mmol/L. Evaluation for other causes of hyponatraemia yielded negative results. Duloxetine was discontinued and after 3 days the patient's sodium increased to 130 mmol/L. The purpose of this case report is to highlight the importance of having suspicion for rare but real side effects of medications such as duloxetine.

  16. Comparative study of embedding methods.

    PubMed

    Cellucci, C J; Albano, A M; Rapp, P E

    2003-06-01

    Embedding experimental data is a common first step in many forms of dynamical analysis. The choice of appropriate embedding parameters (dimension and lag) is crucial to the success of the subsequent analysis. We argue here that the optimal embedding of a time series cannot be determined by criteria based solely on the time series itself. Therefore we base our analysis on an examination of systems that have explicit analytic representations. A comparison of analytically obtained results with those obtained by an examination of the corresponding time series provides a means of assessing the comparative success of different embedding criteria. The assessment also includes measures of robustness to noise. The limitations of this study are explicitly delineated. While bearing these limitations in mind, we conclude that for the examples considered here, the best identification of the embedding dimension was achieved with a global false nearest neighbors argument, and the best value of lag was identified by the mutual information function.

  17. Sex work: a comparative study.

    PubMed

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status.

  18. Vortioxetine promotes maturation of dendritic spines in vitro: A comparative study in hippocampal cultures.

    PubMed

    Waller, Jessica A; Chen, Fenghua; Sánchez, Connie

    2016-04-01

    Cognitive dysfunction is prevalent in patients with major depressive disorder (MDD), and cognitive impairments can persist after relief of depressive symptoms. The multimodal-acting antidepressant vortioxetine is an antagonist at 5-HT3, 5-HT7, and 5-HT1D receptors, a partial agonist at 5-HT1B receptors, an agonist at 5-HT1A receptors, and an inhibitor of the serotonin (5-HT) transporter (SERT) and has pro-cognitive properties. In preclinical studies, vortioxetine enhances long-term potentiation (LTP), a cellular correlate of neuroplasticity, and enhances memory in various cognitive tasks. However, the molecular mechanisms by which vortioxetine augments LTP and memory remain unknown. Dendritic spines are specialized, actin-rich microdomains on dendritic shafts and are major sites of most excitatory synapses. Since dendritic spine remodeling is implicated in synaptic plasticity and spine size dictates the strength of synaptic transmission, we assessed if vortioxetine, relative to other antidepressants including ketamine, duloxetine, and fluoxetine, plays a role in the maintenance of dendritic spine architecture in vitro. We show that vortioxetine, ketamine, and duloxetine induce spine enlargement. However, only vortioxetine treatment increased the number of spines in contact with presynaptic terminals. In contrast, fluoxetine had no effect on spine remodeling. These findings imply that the various 5-HT receptor mechanisms of vortioxetine may play a role in its effect on spine dynamics and in increasing the proportion of potentially functional synaptic contacts. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Effect of duloxetine, a norepinephrine and serotonin reuptake inhibitor, on sneeze-induced urethral continence reflex in rats.

    PubMed

    Miyazato, Minoru; Kaiho, Yasuhiro; Kamo, Izumi; Chancellor, Michael B; Sugaya, Kimio; de Groat, William C; Yoshimura, Naoki

    2008-07-01

    We investigated the effect of duloxetine, a norepinephrine (NE) and serotonin (5-HT) reuptake inhibitor, on the neurally evoked urethral continence reflex induced by sneezing in rats. To clarify the role of noradrenergic and serotonergic mechanisms in preventing stress urinary incontinence (SUI) during sneezing, we examined the effect of duloxetine followed by intrathecal (it) methiothepin maleate (5-HT receptor and alpha1-adrenoceptor antagonist) or terazosin or idazoxan (selective alpha1- and alpha2-adrenoceptor antagonists, respectively). Amplitude of urethral pressure responses during sneezing (A-URS), urethral baseline pressure (UBP) at the midurethra, and sneeze-induced leak point pressure (S-LPP) were measured in normal adult female rats and rats with SUI induced by vaginal distension (VD). In normal and VD rats, intravenous application of duloxetine (1 mg/kg) increased A-URS by 35% and 34% and UBP by 21% and 34%, respectively. Sneezing-induced fluid leakage from the urethral orifice was observed in VD rats but not in normal rats. S-LPP was increased from 39.1 to 92.2 cmH2O by intravenous duloxetine in incontinent VD rats. Duloxetine-mediated enhancement of A-URS was inhibited by terazosin but not methiothepin maleate (it). In addition, simultaneous intrathecal application of methiothepin and terazosin induced a reduction in A-URS during sneezing, which was not increased by intravenous duloxetine. However, the reduced A-URS after intrathecal application of methiothepin and terazosin returned to the control level when duloxetine (iv) was applied after intrathecal idazoxan administration. These results indicate that duloxetine can prevent SUI by facilitating noradrenergic and serotonergic systems in the spinal cord to enhance the sneeze-induced active urethral closure mechanism.

  20. Impaired noradrenaline homeostasis in rats with painful diabetic neuropathy as a target of duloxetine analgesia

    PubMed Central

    2013-01-01

    Background Painful diabetic neuropathy (PDN) is a serious complication of diabetes mellitus that affects a large number of patients in many countries. The molecular mechanisms underlying the exaggerated nociception in PDN have not been established. Recently, duloxetine (DLX), a serotonin and noradrenaline re-uptake inhibitor, has been recommended as one of the first-line treatments of PDN in the United States Food and Drug Administration, the European Medicines Agency and the Japanese Guideline for the Pharmacologic Management of Neuropathic pain. Because selective serotonin re-uptake inhibitors show limited analgesic effects in PDN, we examined whether the potent analgesic effect of DLX contributes toward improving the pathologically aberrant noradrenaline homeostasis in diabetic models. Results In streptozotocin (STZ) (50 mg/kg, i.v.)-induced diabetic rats that exhibited robust mechanical allodynia and thermal hyperalgesia, DLX (10 mg/kg, i.p.) significantly and markedly increased the nociceptive threshold. The analgesic effect of DLX was nullified by the prior administration of N-(2-chloroethyl)-N-ethyl-2-bromobenzylamine (DSP-4) (50 mg/kg, i.p.), which drastically eliminated dopamine-beta-hydroxylase- and norepinephrine transporter-immunopositive fibers in the lumbar spinal dorsal horn and significantly reduced the noradrenaline content in the lumbar spinal cord. The treatment with DSP-4 alone markedly lowered the nociceptive threshold in vehicle-treated non-diabetic rats; however, this pro-nociceptive effect was occluded in STZ-treated diabetic rats. Furthermore, STZ-treated rats exhibited a higher amount of dopamine-beta-hydroxylase- and norepinephrine transporter-immunopositive fibers in the dorsal horn and noradrenaline content in the spinal cord compared to vehicle-treated rats. Conclusions Impaired noradrenaline-mediated regulation of the spinal nociceptive network might underlie exaggerated nociception in PDN. DLX might exert its analgesic effect by

  1. An open treatment trial of duloxetine in elderly patients with dysthymic disorder

    PubMed Central

    Kerner, Nancy; D’Antonio, Kristina; Pelton, Gregory H; Salcedo, Elianny; Ferrar, Jennifer; Roose, Steven P

    2014-01-01

    Objective: We evaluated the efficacy and side effects of the selective serotonin and norepinephrine reuptake inhibitor antidepressant duloxetine in older adults with dysthymic disorder. Methods: Patients ≥ 60 years old with dysthymic disorder received flexible dose duloxetine 20–120 mg daily in an open-label 12-week trial. The main outcomes were change from baseline to 12 weeks in 24-item Hamilton Depression Rating Scale scores and Treatment Emergent Symptoms Scale scores. Response required ≥ 50% decline in Hamilton Depression Rating Scale scores with a Clinical Global Impression of much improved or better, and remission required final Hamilton Depression Rating Scale ≤ 6. Intent-to-treat analyses were conducted with the last observation carried forward. Results: In 30 patients, the mean age was 70.7 (standard deviation (SD) = 7.6) years and 56.7% were female. In intent-to-treat analyses, there were 16 responders (53.3%) and 10 remitters (33.3%). Of these, 19 patients completed the trial. The mean maximum dose was 76.3 mg (SD = 38.5) in the total sample and 101 mg (SD = 17.9) in completers. In the total sample, the mean final dose was 51 mg (SD = 27.2) and correlated significantly with decline in Hamilton Depression Rating Scale (p < .03); decline in Hamilton Depression Rating Scale correlated significantly with decline in Treatment Emergent Symptoms Scale (p < .001). Daily doses above 60 mg were associated with greater improvement and well tolerated. This result was partly confounded by early dropouts having received low doses. Demographic and medical comorbidities, including cardiac disease and hypertension, were not related to response. Somatic side effects were common prior to duloxetine treatment and improved rather than worsened with duloxetine. There were no serious adverse events. Conclusion: Duloxetine at relatively high doses showed moderate efficacy in elderly patients with dysthymic disorder and was well tolerated in successful completers

  2. Comparative Studies in Special Education.

    ERIC Educational Resources Information Center

    Mazurek, Kas, Ed.; Winzer, Margret A., Ed.

    This text presents 26 case studies which examine special education provisions for children in the world today. The reports focus on the current state of special education in selected nations and major issues and controversies in the field of special education within those nations. Each case study addresses the following themes: (1) prevalence of…

  3. Comparative study of silicon detectors

    SciTech Connect

    Allier, C.P.; Valk, H.; Huizenga, J.; Bom, V.R.; Hollander, R.W.; Eijk, C.W.E. van

    1998-06-01

    The authors studied three different types of silicon sensors: PIN diodes, circular drift detectors, both made at the Delft University of Technology (DUT), and Hamamatsu S5345 avalanche photodiodes. Measurements have been carried out in the same optimized experimental setup, both at room temperature and at low temperatures. Comparison is made for direct X-ray detection and CsI(Tl) scintillation light readout.

  4. Comparison of neurogenic effects of fluoxetine, duloxetine and running in mice

    PubMed Central

    Marlatt, Michael W.; Lucassen, Paul J.; van Praag, Henriette

    2010-01-01

    Hippocampal neurogenesis can be regulated by extrinsic factors, such as exercise and antidepressants. While there is evidence that the serotonin re-uptake inhibitor (SSRI) fluoxetine (Prozac) enhances neurogenesis, the new dual serotonin/noradrenaline reuptake inhibitor (SNRI) duloxetine has not been evaluated in this context. In addition, it is unclear whether effects of antidepressants and running on cell genesis and behavior are of similar magnitude in mice. Here,we assessed neurogenesis and open field behavior in 2 month old female C57Bl/6 mice after 28 days of treatment with either fluoxetine (18 mg/kg), duloxetine (2, 6 or 18 mg/kg) or exercise. New cell survival, as measured by 5-bromo-2´-deoxyuridine (BrdU) labeled cells, was enhanced by 200% in the running group only. Both running and fluoxetine, but not duloxetine, increased the percentage of new cells that became neurons. In the open field test, animals treated with either drug spent less time in the center than controls and runners. In addition, fluoxetine treatment resulted in reduced locomotor activity. Together, these data not only show that the neurogenic response to exercise is much stronger than to antidepressants, but also imply a low likelihood that reported effects of these two drugs on anxiety are mediated by adult neurogenesis in C57Bl/6 mice. PMID:20381469

  5. Delirium associated with concomitant use of duloxetine and bupropion in an elderly patient.

    PubMed

    Ma, Szu-Pin; Tsai, Chia-Jui; Chang, Cheng-Chen; Hsu, Wen-Yu

    2017-03-01

    Delirium is common in daily practice. Drug-induced delirium constitutes approximately one-third of all cases of delirium. In cases characterized by the limited efficacy of a single antidepressant, a combination of two antidepressants is required, which may induce a complex drug-drug interaction. We reviewed a case of duloxetine- and bupropion-related delirium in an elderly male patient in our clinical practice. The patient was diagnosed with major depressive disorder and was treated with duloxetine. However, he developed delirium 10 days after bupropion was added to his treatment regimen. Three days after the cessation of bupropion, his delirious condition gradually improved. Duloxetine and bupropion are both cytochrome P450 2D6 inhibitors that may result in a higher level of hydroxybupropion. An increased level of hydroxybupropion may cause the elevation of dopamine and a risk of subsequent delirium. We should be aware of the risk of delirium induced by drug-drug interactions. © 2016 The Authors. Psychogeriatrics © 2016 Japanese Psychogeriatric Society.

  6. Comparative pyrolysis studies of ethylarsines

    NASA Astrophysics Data System (ADS)

    Li, S. H.; Larsen, C. A.; Stringfellow, G. B.

    1991-01-01

    The pyrolysis of triethylarsine (TEAs), diethylarsine (DEAsH), and monoethylarsine (MEAsH 2) has been studied at atmospheric pressure in a flow tube reactor using mass spectrometry. He and D 2 were selected as the carrier gases to determine ambient effects and to isotopically label the pyrolysis products. For some experiments, supplemental C 2H 5 and CH 3 radicals, produced from pyrolysis of the co-reactants azoethane ((C 2H 5) 2N 2) and azomethane ((CH 3) 2N 2), were added to investigate the roles of C 2H 5 and CH 3 in the reactions. Significant D 2 effects have been observed for pyrolysis of TEAs but not for DEAsH and MEAsH 2. Pyrolysis of the latter could be enhanced by adding C 2H 5 radicals while the TEAs was nearly unaffected. With the presence of supplemental CH 3 radicals, 85% decomposition was induced for each precursor. The products included DEAsD, rather than DEAsH, for TEAs pyrolysis in D 2. However, DEAsH pyrolysis produced TEAs, and MEAsH 2 decomposed to yield DEAsH and arsine, in both ambients. This suggests that a β-elimination reaction is not a major step for any of the ethylarsine precursors. More likely, radical reactions occur. When trimethylgallium (TMGa) was added, the ethylarsine pyrolysis rates were accelerated due to the CH 3 radicals produced from TMGa pyrolysis. In addition, heterogeneous reactions have been observed for pyrolysis of ethylarsines, especially when a GaAs surface was involved.

  7. Predictors of duloxetine response in patients with oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial – CALGB/alliance 170601

    PubMed Central

    SMITH, E.M.L.; PANG, H.; YE, C.; CIRRINCIONE, C.; FLEISHMAN, S.; PASKETT, E.D.; AHLES, T.; BRESSLER, L.R.; LE-LINDQWISTER, N.; FADUL, C.E.; LOPRINZI, C.; SHAPIRO, C.L.

    2016-01-01

    Duloxetine is an effective treatment for oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN). However, predictors of duloxetine response have not been adequately explored. The objective of this secondary and exploratory analysis was to identify predictors of duloxetine response in patients with painful oxaliplatin-induced CIPN. Patients (N = 106) with oxaliplatin-induced painful CIPN were randomised to receive duloxetine or placebo. Eligible patients had chronic CIPN pain and an average neuropathic pain score ≥4/10. Duloxetine/placebo dose was 30 mg/day for 7 days, then 60 mg/day for 4 weeks. The Brief Pain Inventory-Short Form and the EORTC QLQ-C30 were used to assess pain and quality of life, respectively. Univariate and multiple logistic regression analyses were performed to identify demographic, physiologic and psychological predictors of duloxetine response. Higher baseline emotional functioning predicted duloxetine response (≥30% reduction in pain; OR 4.036; 95% CI 0.999–16.308; p = 0.050). Based on the results from a multiple logistic regression using patient data from both the duloxetine and placebo treatment arms, duloxetine-treated patients with high emotional functioning are more likely to experience pain reduction (p = 0.026). In patients with painful, oxaliplatin-induced CIPN, emotional functioning may also predict duloxetine response. ClinicalTrials.gov, Identifier NCT00489411 PMID:26603828

  8. Neuropathic pain phenotyping as a predictor of treatment response in painful diabetic neuropathy: data from the randomized, double-blind, COMBO-DN study.

    PubMed

    Bouhassira, Didier; Wilhelm, Stefan; Schacht, Alexander; Perrot, Serge; Kosek, Eva; Cruccu, Giorgio; Freynhagen, Rainer; Tesfaye, Solomon; Lledó, Alberto; Choy, Ernest; Marchettini, Paolo; Micó, Juan Antonio; Spaeth, Michael; Skljarevski, Vladimir; Tölle, Thomas

    2014-10-01

    Sensory profiles are heterogeneous in neuropathic pain disorders, and subgroups of patients respond differently to treatment. To further explore this, patients in the COMBO-DN study were prospectively assessed by the Neuropathic Pain Symptom Inventory (NPSI) at baseline, after initial 8-week therapy with either duloxetine or pregabalin, and after subsequent 8-week combination/high-dose therapy. Exploratory post hoc cluster analyses were performed to identify and characterize potential subgroups through their scores in the NPSI items. In patients not responding to initial 60 mg/d duloxetine, adding 300 mg/d pregabalin for combination treatment was particularly effective regarding the dimensions pressing pain and evoked pain, whereas maximizing the duloxetine dose to 120 mg/d appeared more beneficial regarding paresthesia/dysesthesia. In contrast, adding 60 mg/d duloxetine to 300 mg/d pregabalin in case of nonresponse to initial pregabalin led to numerically higher decreases in all NPSI dimensions/items compared to maximizing the pregabalin dose to 600 mg/d. Cluster analysis revealed 3 patient clusters (defined by baseline scores for the 10 NPSI sensory items) with different pain profiles, not only in terms of overall pain severity, but also across NPSI items. Mean Brief Pain Inventory average pain improved in all clusters during combination/high-dose therapy. However, in patients with severe pain, the treatment effect showed a trend in favor of high-dose monotherapy, whereas combination therapy appeared to be more beneficial in patients with moderate and mild pain (not significant). These complementary exploratory analyses further endorse the idea that sensory phenotyping might lead to a more stratified treatment and potentially to personalized pain therapy. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  9. Effects of milnacipran, duloxetine and indomethacin, in polyarthritic rats using the Randall-Selitto model.

    PubMed

    Mico, Juan Antonio; Berrocoso, Esther; Vitton, Olivier; Ladure, Philippe; Newman-Tancredi, Adrian; Bardin, Laurent; Depoortère, Ronan

    2011-09-01

    Milnacipran, a serotonin and noradrenalin reuptake inhibitor (SNRI), is efficacious in rodents in various models of acute or chronic pain (traumatic, neuropathic, inflammatory, visceral). However, its activity against arthritic pain has never been explored. Here, we assessed the activity of acute treatment with milnacipran in a polyarthritic rat model. Rats were injected in the tail base with complete Freund's adjuvant to induce a state of polyarthritis. Analgesic effects of acute treatment with intraperitoneal administration of milnacipran were then evaluated, using the Randall-Selitto model, against two levels of pressure applied to both hind paws (a lower one, addressing mechanical allodynia and a higher one, addressing mechanical hyperalgesia). The other SNRI duloxetine and the nonsteroidal anti-inflammatory drug indomethacin were tested as positive controls. Milnacipran was significantly and dose dependently active against the decrease of paw withdrawal threshold produced by complete Freund's adjuvant for low (minimum effective dose=5 mg/kg, range tested: 2.5-10 mg/kg) and high (minimum effective dose=10 mg/kg, range tested: 5-20 mg/kg)-pressure levels. Duloxetine (20 mg/kg, intraperitoneally) was significantly active against low pressure only. Indomethacin (3 mg/kg per os) was efficacious against both pressure levels. These rodent data suggest that milnacipran should be efficacious in painful conditions associated with chronic inflammatory states, such as arthritis.

  10. Comparative Environmental Threat Analysis: Three Case Studies.

    ERIC Educational Resources Information Center

    Latour, J. B.; Reiling, R.

    1994-01-01

    Reviews how carrying capacity for different environmental problems is operationalized. Discusses whether it is possible to compare threats, using the exceeding of carrying capacity as a yardstick. Points out problems in comparative threat analysis using three case studies: threats to European groundwater resources, threats to ecosystems in Europe,…

  11. Comparative Environmental Threat Analysis: Three Case Studies.

    ERIC Educational Resources Information Center

    Latour, J. B.; Reiling, R.

    1994-01-01

    Reviews how carrying capacity for different environmental problems is operationalized. Discusses whether it is possible to compare threats, using the exceeding of carrying capacity as a yardstick. Points out problems in comparative threat analysis using three case studies: threats to European groundwater resources, threats to ecosystems in Europe,…

  12. Rapid onset of syndrome of inappropriate antidiuretic hormone secretion induced by duloxetine in an elderly type 2 diabetic patient with painful diabetic neuropathy.

    PubMed

    Kamei, Shinji; Kaneto, Hideaki; Tanabe, Akihito; Irie, Shintaro; Hirata, Yurie; Shimoda, Masashi; Kohara, Kenji; Mune, Tomoatsu; Kaku, Kohei

    2015-05-01

    Diabetic neuropathy is the most common diabetic complication. Duloxetine, a serotonin noradrenaline reuptake inhibitor (SNRI), is widely used for the treatment of diabetic painful neuropathy (DPN) because of the efficacy and safety profile. Syndrome of inappropriate antidiuretic hormone secretion, which is strongly associated duloxetine, is a rare but occasionally life-threatening adverse effect. Here, we report a case of syndrome of inappropriate antidiuretic hormone secretion that rapidly developed after starting duloxetine in an elderly Japanese female type 2 diabetes mellitus patient. Furthermore, we discuss the possible relationship between the onset of syndrome of inappropriate antidiuretic hormone secretion and the gene polymorphism of cytochrome P450 isoform 1A2 and 2D6, both of which are responsible for duloxetine metabolism.

  13. Comparative Review of Elementary Social Studies Textbooks.

    ERIC Educational Resources Information Center

    Waters, Barbara A.

    Four elementary social studies textbook series are reviewed and compared with particular attention paid to the extent to which the textbooks are globally oriented. The trend of emphasizing global education in the social studies also is discussed. As used in this paper, "global education" includes the study of world geography, world…

  14. World Studies through a Comparative Constitutional Prism.

    ERIC Educational Resources Information Center

    Robinson, Donald

    1992-01-01

    Emphasizes the importance of understanding the development of democracy around the world by comparative study of constitutions. Uses the development of the Japanese constitution after World War II as a case study. Describes the work of the team appointed by General Douglas MacArthur and the significance of the clause guaranteeing equal rights for…

  15. Efficacy of Duloxetine in the Early Management of Urinary Continence after Radical Prostatectomy

    PubMed Central

    Alan, Cabir; Eren, Ali E.; Ersay, Ahmet R.; Kocoglu, Hasan; Basturk, Gokhan; Demirci, Emrah

    2015-01-01

    Aim To evaluate the efficacy of early duloxetine therapy in stress urinary incontinence occurring after radical prostatectomy (RP). Material and Method Patients that had RP were randomly divided into 2 groups following the removal of the urinary catheter. Group A patients (n = 28) had pelvic floor exercise and duloxetine therapy. Group B patients (n = 30) had only pelvic floor exercise. The incontinence status of the patients and number of pads were recorded and 1-hour pad test and Turkish validation of International Consultation on Incontinence Questionnaire-Short Form test were applied to the patients at the follow-up. Results When the dry state of the patients was evaluated, 5, 17, 3, and 2 of 28 Group A patients stated that they were completely dry in the 3rd, 6th, 9th and 12th month respectively and pad use was stopped. There was no continence in 30 Group B in the first 3 months. Twelve, 6, and 8 patients stated that they were completely dry in the 6th, 9th and 12th month, respectively. But 3 of 4 patients in whom dryness could not be provided were using a mean of 7.6 pads in the first day and a mean of 1.3 pads after 1 year. When pad use of the patients was evaluated, the mean monthly number of pad use was determined to be 6.2 (4-8) in the initial evaluation, 2.7 (0-5) in the in 3rd month, 2 (0-3) in the 6th month and 1.6 (0-2) pad/d in the 9th month in the group taking medicine. The mean monthly number of pads used was determined to be 5.8 (4-8) in the initial evaluation, 4.3 (3-8) in the 3rd month, 3 (0-6) in the 6th month and 1.6 (0-6) pad/d in the 9th month in the group not taking medicine. Conclusion According to the results, early duloxetine therapy in stress urinary incontinence that occurred after RP provided early continence. PMID:26195963

  16. The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders.

    PubMed

    Farrar, John T; Pritchett, Yili L; Robinson, Michael; Prakash, Apurva; Chappell, Amy

    2010-02-01

    Data on 1,700 patients pooled from 5 randomized, placebo-controlled duloxetine studies (3 in diabetic peripheral neuropathic pain and 2 in fibromyalgia) were analyzed to determine clinically important differences (CIDs) in the 0 to 10 Numeric Rating Scale-Pain Intensity (NRS-PI) for patient-reported "worst" and "least" pain intensity while validating the previously published level for "average" pain. The correspondence between the baseline-to-endpoint raw and percentage change in the NRS-PI for the worst, least, and average pain were compared to patients' perceived improvements at endpoint as measured by the 7-point Patient Global Impression of Improvement (PGI-I) scales. Stratification by baseline pain separated the raw but not the percent change scores. The PGI-I category of "much better" or above was our a priori definition of a CID. Cutoff points for the NRS-PI change scores were determined using a receiver operator curve analysis. A consistent relationship between the worst and average NRS-PI percent change and the PGI-I was demonstrated regardless of the study, pain type, age, sex, or treatment group with a reduction of approximately 34%. The least pain item CID was slightly higher at 41%. Raw change CID cutoff points were approximately -2, -2.5 and -3 for least, average, and worst pain respectively. We determined an anchor-based value for the change in the worst, least, and average pain intensity items of the Brief Pain Inventory that best represents a clinically important difference. Our findings support a standard definition of a clinically important difference in clinical trials of chronic-pain therapies. Copyright 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.

  17. Species comparative studies and cognitive development.

    PubMed

    Gómez, Juan-Carlos

    2005-03-01

    The comparative study of infant development and animal cognition brings to cognitive science the promise of insights into the nature and origins of cognitive skills. In this article, I review a recent wave of comparative studies conducted with similar methodologies and similar theoretical frameworks on how two core components of human cognition--object permanence and gaze following--develop in different species. These comparative findings call for an integration of current competing accounts of developmental change. They further suggest that evolution has produced developmental devices capable at the same time of preserving core adaptive components, and opening themselves up to further adaptive change, not only in interaction with the external environment, but also in interaction with other co-developing cognitive systems.

  18. The Student Teaching Experience: A Comparative Study.

    ERIC Educational Resources Information Center

    Butler, Judy D.

    This paper describes a 1996 study that compared the student teaching experiences of a traditional and a nontraditional student to ascertain what differences in their experiences might imply about teacher preparation. The two students kept journals that could be written in at any time of the day. They recorded their impressions of their situation…

  19. The antidepressant drugs fluoxetine and duloxetine produce anxiolytic-like effects in a schedule-induced polydipsia paradigm in rats: enhancement of fluoxetine's effects by the α2 adrenoceptor antagonist yohimbine.

    PubMed

    Prus, Adam J; Mooney-Leber, Sean M; Berquist, Michael D; Pehrson, Alan L; Porter, Nicholas P; Porter, Joseph H

    2015-08-01

    Similar to the time-course for treating depression, several weeks of administration are required for serotonin (5-HT) reuptake inhibitors to produce anxiolytic effects. Previous studies with the schedule-induced polydipsia paradigm (a putative preclinical anxiety model) have shown that repeated administration of antidepressant drugs is necessary to produce a suppression of polydipsia, which is interpreted as an anxiolytic-like effect. The present study sought to expand past findings by evaluating the selective 5-HT reuptake inhibitor (SSRI) fluoxetine and the 5-HT-norepinephrine reuptake inhibitor duloxetine in the schedule-induced polydipsia paradigm with rats. Dose combinations of the α2 adrenoceptor antagonist yohimbine with fluoxetine were also explored to determine whether α2 adrenoceptor antagonism could enhance the anxiolytic-like effects produced by an SSRI. Fluoxetine and duloxetine significantly reduced water intake over the course of daily administrations. Daily treatment with the combination of fluoxetine and yohimbine produced a significantly greater reduction in water intake than fluoxetine alone. The present results confirmed previous findings that inhibition of 5-HT reuptake reduces water consumption in this paradigm. The results for the α2 antagonist yohimbine (in combination with fluoxetine) also indicate that α2 adrenoceptor antagonism may significantly enhance anxiolytic-like effects of SSRIs.

  20. Evaluation of genetic models for response in a randomized clinical trial of duloxetine in major depressive disorder.

    PubMed

    Houston, John P; Zou, Wei; Aris, Virginie; Fijal, Bonnie; Chen, Peining; Heinloth, Alexandra N; Martinez, James

    2012-11-30

    In self-identified white patients with major depressive disorder (N=126) treated with open-label duloxetine (60-120 mg/d), a significant association of (P=0.020) of a composite risk score (based on SLC6A2 rs5569 [G1287A] AA, HTR1A rs6295 [C(-1019)G] GG, and COMT rs174697 AA/AG) with 17-item Hamilton Depression Rating Scale total score change from baseline to 12 weeks was observed.

  1. Evaluating synteny for improved comparative studies

    PubMed Central

    Ghiurcuta, Cristina G.; Moret, Bernard M. E.

    2014-01-01

    Motivation: Comparative genomics aims to understand the structure and function of genomes by translating knowledge gained about some genomes to the object of study. Early approaches used pairwise comparisons, but today researchers are attempting to leverage the larger potential of multi-way comparisons. Comparative genomics relies on the structuring of genomes into syntenic blocks: blocks of sequence that exhibit conserved features across the genomes. Syntenic blocs are required for complex computations to scale to the billions of nucleotides present in many genomes; they enable comparisons across broad ranges of genomes because they filter out much of the individual variability; they highlight candidate regions for in-depth studies; and they facilitate whole-genome comparisons through visualization tools. However, the concept of syntenic block remains loosely defined. Tools for the identification of syntenic blocks yield quite different results, thereby preventing a systematic assessment of the next steps in an analysis. Current tools do not include measurable quality objectives and thus cannot be benchmarked against themselves. Comparisons among tools have also been neglected—what few results are given use superficial measures unrelated to quality or consistency. Results: We present a theoretical model as well as an experimental basis for comparing syntenic blocks and thus also for improving or designing tools for the identification of syntenic blocks. We illustrate the application of the model and the measures by applying them to syntenic blocks produced by three different contemporary tools (DRIMM-Synteny, i-ADHoRe and Cyntenator) on a dataset of eight yeast genomes. Our findings highlight the need for a well founded, systematic approach to the decomposition of genomes into syntenic blocks. Our experiments demonstrate widely divergent results among these tools, throwing into question the robustness of the basic approach in comparative genomics. We have taken

  2. A study on comparative efficacyof hypolipidemic drugs.

    PubMed

    Sher, A; Ullah, A; Mateen, A

    1995-01-01

    A study was carried out on the comparative efficacy of Lopid, Mevacor, Bezalip and Lasona in sixteen hyperlipidemic subjects. All the subjects were on Lopid at least for the last 15 days. Lopid therapy was discontinued after determining blood lipid profile of the subjects on day zero (day of 1st contact). The subjects were divided into three groups and after a washout period of 15 days, they were given three different drugs for the next 15 days. Subjects in group a (6), b (5) and c (5) received Mevacor, Bezalip and lasona respectively. In the present study mevacor was found to be the most potent hypolipidemic drug in lowering blood cholesterol and Low density lipoprotein (LDL) while lopid was most effective in keeping blood Triglycerides (TG) and High density lipoproteins (HDL) level within the desired limits. Bezalip and Lasona were also sufficiently effective in changing blood lipid profile, but lasona showed a negligible effect on HDL rise as compared with Bezalip or any other drug used in this study.

  3. Comparative study of INPIStron and spark gap

    NASA Technical Reports Server (NTRS)

    Han, Kwang S.; Lee, Ja H.

    1993-01-01

    An inverse pinch plasma switch, INPIStron, was studied in comparison to a conventional spark gap. The INPIStron is under development for high power switching applications. The INPIStron has an inverse pinch dynamics, opposed to Z-pinch dynamics in the spark gap. The electrical, plasma dynamics and radiative properties of the closing plasmas have been studied. Recently the high-voltage pulse transfer capabilities or both the INPIStron and the spark gap were also compared. The INPIStron with a low impedance Z = 9 ohms transfers 87 percent of an input pulse with a halfwidth of 2 mu s. For the same input pulse the spark gap of Z = 100 ohms transfers 68 percent. Fast framing and streak photography, taken with an TRW image converter camera, was used to observe the discharge uniformity and closing plasma speed in both switches. In order to assess the effects of closing plasmas on erosion of electrode material, emission spectra of two switches were studied with a spectrometer-optical multi channel analyzer (OMA) system. The typical emission spectra of the closing plasmas in the INPIStron and the spark gap showed that there were comparatively weak carbon line emission in 658.7 nm and copper (electrode material) line emissions in the INPIStron, indicating low erosion of materials in the INPIStron.

  4. The Economics of Comparative Effectiveness Studies

    PubMed Central

    Meltzer, David; Basu, Anirban; Conti, Rena

    2013-01-01

    Comparative effectiveness research (CER) can provide valuable information for patients, providers and payers. These stakeholders differ in their incentives to invest in CER. To maximize benefits from public investments in CER, it is important to understand the value of CER from the perspectives of these stakeholders and how that affects their incentives to invest in CER. This article provides a conceptual framework for valuing CER, and illustrates the potential benefits of such studies from a number of perspectives using several case studies. We examine cases in which CER provides value by identifying when one treatment is consistently better than others, when different treatments are preferred for different subgroups, and when differences are small enough that decisions can be made based on price. We illustrate these findings using value-of-information techniques to assess the value of research, and by examining changes in pharmaceutical prices following publication of a comparative effectiveness study. Our results suggest that CER may have high societal value but limited private return to providers or payers. This suggests the importance of public efforts to promote the production of CER. We also conclude that value-of-information tools may help inform policy decisions about how much public funds to invest in CER and how to prioritize the use of available public funds for CER, in particular targeting public CER spending to areas where private incentives are low relative to social benefits. PMID:20831292

  5. Comparative study of hydrogenated and lithiated superhalogens

    NASA Astrophysics Data System (ADS)

    Xu, Li-Na; Li, Ying; Liu, Jia-Yuan; Wu, Di; Sun, Yan-Bo; Li, Zhi-Ru

    2016-09-01

    The structural features, properties and stability of two kinds of representative superhalogen compounds, namely hydrogenated superhalogens and lithiated superhalogens, are theoretically studied in detail, providing further insight into the behavior of superhalogens. According to topological analysis of the electron localization function, most of superhalogen clusters as a whole combine with Li atom through ionic bond(s). In contrast, the H atom tends to bind with superhalogen by covalent bond although a portion of superhalogens are broken upon hydrogenation. In addition, the electric properties of these superhalogen compounds are also obtained and compared with those of traditional acid and salt molecules.

  6. EFQPSK Versus CERN: A Comparative Study

    NASA Technical Reports Server (NTRS)

    Borah, Deva K.; Horan, Stephen

    2001-01-01

    This report presents a comparative study on Enhanced Feher's Quadrature Phase Shift Keying (EFQPSK) and Constrained Envelope Root Nyquist (CERN) techniques. These two techniques have been developed in recent times to provide high spectral and power efficiencies under nonlinear amplifier environment. The purpose of this study is to gain insights into these techniques and to help system planners and designers with an appropriate set of guidelines for using these techniques. The comparative study presented in this report relies on effective simulation models and procedures. Therefore, a significant part of this report is devoted to understanding the mathematical and simulation models of the techniques and their set-up procedures. In particular, mathematical models of EFQPSK and CERN, effects of the sampling rate in discrete time signal representation, and modeling of nonlinear amplifiers and predistorters have been considered in detail. The results of this study show that both EFQPSK and CERN signals provide spectrally efficient communications compared to filtered conventional linear modulation techniques when a nonlinear power amplifier is used. However, there are important differences. The spectral efficiency of CERN signals, with a small amount of input backoff, is significantly better than that of EFQPSK signals if the nonlinear amplifier is an ideal clipper. However, to achieve such spectral efficiencies with a practical nonlinear amplifier, CERN processing requires a predistorter which effectively translates the amplifier's characteristics close to those of an ideal clipper. Thus, the spectral performance of CERN signals strongly depends on the predistorter. EFQPSK signals, on the other hand, do not need such predistorters since their spectra are almost unaffected by the nonlinear amplifier, Ibis report discusses several receiver structures for EFQPSK signals. It is observed that optimal receiver structures can be realized for both coded and uncoded EFQPSK

  7. Comparative Study of Vented vs. Unvented Crawlspaces

    SciTech Connect

    Biswas, Kaushik; Christian, Jeffrey E; Gehl, Anthony C

    2011-10-01

    There has been a significant amount of research in the area of building energy efficiency and durability. However, well-documented quantitative information on the impact of crawlspaces on the performance of residential structures is lacking. The objective of this study was to evaluate and compare the effects of two crawlspace strategies on the whole-house performance of a pair of houses in a mixed humid climate. These houses were built with advanced envelope systems to provide energy savings of 50% or more compared to traditional 2010 new construction. One crawlspace contains insulated walls and is sealed and semi-conditioned. The other is a traditional vented crawlspace with insulation in the crawlspace ceiling. The vented (traditional) crawlspace contains fiberglass batts installed in the floor chase cavities above the crawl, while the sealed and insulated crawlspace contains foil-faced polyisocyanurate foam insulation on the interior side of the masonry walls. Various sensors to measure temperatures, heat flux through crawlspace walls and ceiling, and relative humidity were installed in the two crawlspaces. Data from these sensors have been analyzed to compare the performance of the two crawlspace designs. The analysis results indicated that the sealed and insulated crawlspace design is better than the traditional vented crawlspace in the mixed humid climate.

  8. A Comparative Study of Mammalian Diversification Pattern

    PubMed Central

    Yu, Wenhua; Xu, Junxiao; Wu, Yi; Yang, Guang

    2012-01-01

    Although mammals have long been regarded as a successful radiation, the diversification pattern among the clades is still poorly known. Higher-level phylogenies are conflicting and comprehensive comparative analyses are still lacking. Using a recently published supermatrix encompassing nearly all extant mammalian families and a novel comparative likelihood approach (MEDUSA), the diversification pattern of mammalian groups was examined. Both order- and family-level phylogenetic analyses revealed the rapid radiation of Boreoeutheria and Euaustralidelphia in the early mammalian history. The observation of a diversification burst within Boreoeutheria at approximately 100 My supports the Long Fuse model in elucidating placental diversification progress, and the rapid radiation of Euaustralidelphia suggests an important role of biogeographic dispersal events in triggering early Australian marsupial rapid radiation. Diversification analyses based on family-level diversity tree revealed seven additional clades with exceptional diversification rate shifts, six of which represent accelerations in net diversification rate as compared to the background pattern. The shifts gave origin to the clades Muridae+Cricetidae, Bovidae+Moschidae+Cervidae, Simiiformes, Echimyidae, Odontoceti (excluding Physeteridae+Kogiidae+Platanistidae), Macropodidae, and Vespertilionidae. Moderate to high extinction rates from background and boreoeutherian diversification patterns indicate the important role of turnovers in shaping the heterogeneous taxonomic richness observed among extant mammalian groups. Furthermore, the present results emphasize the key role of extinction on erasing unusual diversification signals, and suggest that further studies are needed to clarify the historical radiation of some mammalian groups for which MEDUSA did not detect exceptional diversification rates. PMID:22457604

  9. Comparative study of methods for WHPA delineation.

    PubMed

    Paradis, Daniel; Martel, Richard; Karanta, Gilbert; Lefebvre, René; Michaud, Yves; Therrien, René; Nastev, Miroslav

    2007-01-01

    Human activities, whether agricultural, industrial, commercial, or domestic, can contribute to ground water quality deterioration. In order to protect the ground water exploited by a production well, it is essential to develop a good knowledge of the flow system and to adequately delineate the area surrounding the well within which potential contamination sources should be managed. Many methods have been developed to delineate such a wellhead protection area (WHPA). The integration of more information on the geologic and hydrogeologic characteristics of the study area increases the precision of any given WHPA delineation method. From a practical point of view, the WHPA delineation methods allowing the simplest and least expensive integration of the available information should be favored. This paper presents a comparative study in which nine different WHPA delineation methods were applied to a well and a spring in an unconfined granular aquifer and to a well in a confined highly fractured rock aquifer. These methods range from simple approaches to complex computer models. Hydrogeological mapping and numerical modeling with MODFLOW-MODPATH were used as reference methods to respectively compare the delineation of the zone of contribution and the zone of travel obtained from the various WHPA methods. Although applied to simple ground water flow systems, these methods provided a relatively wide range of results. To allow a realistic delineation of the WHPA in aquifers of variable geometry, a WHPA delineation method should ensure a water balance and include observed or calculated regional flow characteristics.

  10. Brain region-specific effects of short-term treatment with duloxetine, venlafaxine, milnacipran and sertraline on monoamine metabolism in rats.

    PubMed

    Muneoka, Katsumasa; Shirayama, Yukihiko; Takigawa, Morikuni; Shioda, Seiji

    2009-03-01

    We examined brain region-specific changes in monoamines and metabolites, and their ratios, after short-term administration of antidepressants to rats. Serotonin noradrenaline reuptake inhibitors (SNRIs; duloxetine, venlafaxine, milnacipran) and a serotonin-selective reuptake inhibitor (SSRI; sertraline) elevated serotonin (5-HT) levels in the midbrain (MB). Duloxetine and venlafaxine increased 5-HT levels in the brainstem and 5-HT terminal areas, whereas milnacipran and sertraline increased levels in the brainstem only. Significant reductions in 5-HT turnover were observed in various forebrain regions, including the hippocampus and hypothalamus, after treatment with all of the tested drugs except for milnacipran. In addition, there was reduced 5-HT turnover in the dorsolateral frontal cortex (dlFC), the medial prefrontal cortex (mPFC), and both the dlFC and the mPFC after treatment with duloxetine, sertraline, and venlafaxine, respectively. Venlafaxine significantly increased dopamine (DA) levels in the nucleus accumbens (NAc) and the substantia nigra and decreased DA turnover in the NAc. Similar changes were observed after treatment with duloxetine and sertraline in the NAc, whereas milnacipran increased DA levels in the mPFC. Limited increases in noradrenaline levels were detected after treatment with duloxetine, venlafaxine, or sertraline, but not after treatment with milnacipran. These results show that SNRIs and SSRIs induced region-specific monoaminergic changes after short-term treatment.

  11. A comparative study of teenage pregnancy.

    PubMed

    Mahavarkar, S H; Madhu, C K; Mule, V D

    2008-08-01

    Teenage pregnancy is a global problem and is considered a high-risk group, in spite of conflicting evidence. Our objective was to compare obstetric outcomes of pregnancy in teenagers and older women. This was a retrospective study of case records of pregnancies from August 2000 to July 2001. Girls aged < or =19 years were compared with pregnancy outcomes in older women (19-35 years) in the same hospital. The study took place in the Government General Hospital, Sangli, India, a teaching hospital in rural India, with an annual delivery rate of over 3,500. A total of 386 teenage pregnancies were compared with pregnancies in 3,326 older women. Socioeconomic data, age, number of pregnancies, antenatal care and complications, mode of delivery, and neonatal outcomes were considered. The incidence of teenage pregnancy in the study was 10%. A significant proportion of teenage pregnant mothers were in their first pregnancies. The teenage mothers were nearly three times more at risk of developing anaemia (OR = 2.83, 95% CI = 2.2-3.7, p < 0.0001) and delivering pre-term (OR = 2.97, 95% CI = 2.4-3.7, p < 0.0001). Teenage mothers were twice as likely to develop hypertensive problems in pregnancy (OR = 2.2, 95% CI = 1.5-3.2, p < 0.0001) and were more likely to deliver vaginally with no significant increase in the risk of assisted vaginal delivery or caesarean section. Young mothers were nearly twice at risk of delivering low birth weight babies (OR = 1.8, 95% CI = 1.5-2.2, p < 0.0001) and 50% less likely to have normal birth weight babies (OR = 0.5, 95% CI = 1.2-2.9, p < 0.0001). The outcome of this study showed that teenage pregnancies are still a common occurrence in rural India in spite of various legislations and government programmes and teenage pregnancy is a risk factor for poor obstetric outcome in rural India. Cultural practices, poor socioeconomic conditions, low literacy rate and lack of awareness of the risks are some of the main contributory factors. Early booking

  12. Scatterometry or imaging overlay: a comparative study

    NASA Astrophysics Data System (ADS)

    Hsu, Simon C. C.; Pai, Yuan Chi; Chen, Charlie; Yu, Chun Chi; Hsing, Henry; Wu, Hsing-Chien; Kuo, Kelly T. L.; Amir, Nuriel

    2015-03-01

    Most fabrication facilities today use imaging overlay measurement methods, as it has been the industry's reliable workhorse for decades. In the last few years, third-generation Scatterometry Overlay (SCOL™) or Diffraction Based Overlay (DBO-1) technology was developed, along another DBO technology (DBO-2). This development led to the question of where the DBO technology should be implemented for overlay measurements. Scatterometry has been adopted for high volume production in only few cases, always with imaging as a backup, but scatterometry overlay is considered by many as the technology of the future. In this paper we compare imaging overlay and DBO technologies by means of measurements and simulations. We outline issues and sensitivities for both technologies, providing guidelines for the best implementation of each. For several of the presented cases, data from two different DBO technologies are compared as well, the first with Pupil data access (DBO-1) and the other without pupil data access (DBO-2). Key indicators of overlay measurement quality include: layer coverage, accuracy, TMU, process robustness and robustness to process changes. Measurement data from real cases across the industry are compared and the conclusions are also backed by simulations. Accuracy is benchmarked with reference OVL, and self-consistency, showing good results for Imaging and DBO-1 technology. Process sensitivity and metrology robustness are mostly simulated with MTD (Metrology Target Designer) comparing the same process variations for both technologies. The experimental data presented in this study was done on ten advanced node layers and three production node layers, for all phases of the IC fabrication process (FEOL, MEOL and BEOL). The metrology tool used for most of the study is KLA-Tencor's Archer 500LCM system (scatterometry-based and imaging-based measurement technologies on the same tool) another type of tool is used for DBO-2 measurements. Finally, we conclude that

  13. A comparative study on monitored anesthesia care.

    PubMed

    Sen, Jayashree; Sen, Bitan

    2014-01-01

    The aim of this study is to compare the effectiveness, hemodynamic changes and duration of sedation and analgesia between combinations of fortwin-phenergan-midazolam (FPM) and ketamine - midazolam (KM) along with local anesthesia for the surgeries done under the umbrella of monitored anesthesia care. A total of 50 patients undergoing surgeries as tympanoplasty, septoplasty, lip repair, dacrocystectomy and cataract under local anesthesia, randomly received either intravenous (IV) fortwin 0.3 mg/kg over 1 min followed by IV midazolam 0.04 mg/kg plus IV phenergan 12.5 mg (Group FPM) or IV ketamine 0.3 mg/kg over 1 min plus IV midazolam 0.04 mg/kg (Group KM). Sedation was titrated to Ramsay sedation score (RSS) of 3. Patients' mean arterial pressure (MAP), heart rate (HR), saturation peripheral pulse, duration of sedation and need for intraoperative rescue sedation/analgesic were recorded and compared. Satisfaction of patients (using a 1-7 point Likert verbal rating scale) and readiness for discharge towards (time to Aldrete score of 10) were also determined. Group KM had significant rise in HR (20-25%) and MAP (25-30%) from 30 min after the bolus dose given until the end of the surgery in contrast to Group FPM. The target sedation level (RSS ≥ 3) was higher in Group FPM (n = 23 [92%]) as compared with Group KM (n = 12 [48%]). Time until need for rescue sedation was 66.96 ± 17.19 min in FPM and 32.80 ± 8.90 min in KM group. The patient satisfaction (Likert scale) is more with the FPM group (6.12 ± 0.83 vs. 4.40 ± 1.20). We found that the combination of FPM is superior to the KM combination as per the hemodynamic changes, duration of analgesia, patients' satisfaction and efficacy of the drugs are concerned.

  14. A comparative study of physiologic intracranial calcifications.

    PubMed

    Abbassioun, K; Aarabi, B; Zarabi, M

    1978-04-01

    It has been the impression of clinicians that pineal calcification is infrequent in Shiraz, Iran. In order to evaluate this clinical impression 2000 consecutive skul X-rays taken at Saadi Hospital, Shiraz, Iran, were reviewed for the presence of physiologic intracranial calcifications. The incidence of these clasifications in male and female in consecutive age groups of 10 years from 0 to over 70 years of age were assessed and compared with previous reports from other countries. The average incidence of pineal calcification for those over 20 years of age was 18.29% in this study compared with 55% in the U.S.A. The incidence of calcification in the choroid plexus and the falx cerebri was also considerably less than previously reported. The literature is reviewed and the possible causes for the geographical differences in the reported frequency of physiologic intracranial calcifications is discussed. It is possible that racial and dietary factors may be significant in the variation in the incidence of pineal and other cranial calcifications noted in different countries. Within a population group, age and sex are additional factors.

  15. Comparative Study of Airfoil Flow Separation Criteria

    NASA Astrophysics Data System (ADS)

    Laws, Nick; Kahouli, Waad; Epps, Brenden

    2015-11-01

    Airfoil flow separation impacts a multitude of applications including turbomachinery, wind turbines, and bio-inspired micro-aerial vehicles. In order to achieve maximum performance, some devices operate near the edge of flow separation, and others use dynamic flow separation advantageously. Numerous criteria exist for predicting the onset of airfoil flow separation. This talk presents a comparative study of a number of such criteria, with emphasis paid to speed and accuracy of the calculations. We evaluate the criteria using a two-dimensional unsteady vortex lattice method, which allows for rapid analysis (on the order of seconds instead of days for a full Navier-Stokes solution) and design of optimal airfoil geometry and kinematics. Furthermore, dynamic analyses permit evaluation of dynamic stall conditions for enhanced lift via leading edge vortex shedding, commonly present in small flapping-wing flyers such as the bumblebee and hummingbird.

  16. Comparative microscopy study of Vibrio cholerae flagella

    NASA Astrophysics Data System (ADS)

    Konnov, Nikolai P.; Baiburin, Vil B.; Zadnova, Svetlana P.; Volkov, Uryi P.

    1999-06-01

    A fine structure of bacteria flagella is an important problem of molecular cell biology. Bacteria flagella are the self-assembled structures that allow to use the flagellum protein in a number of biotechnological applications. However, at present, there is a little information about high resolution scanning probe microscopy study of flagellum structure, in particular, about investigation of Vibrio cholerae flagella. In our lab have been carried out the high resolution comparative investigation of V. cholerae flagella by means of various microscopes: tunneling (STM), scanning force (SFM) and electron transmission. As a scanning probe microscope is used designed in our lab versatile SPM with replaceable measuring heads. Bacteria were grown, fixed and treated according to the conventional techniques. For STM investigations samples were covered with Pt/Ir thin films by rotated vacuum evaporation, in SFM investigations were used uncovered samples. Electron microscopy of the negatively stained bacteria was used as a test procedure.

  17. Comparative study of boundary conditions with helix

    NASA Astrophysics Data System (ADS)

    Pillay, Shamini; Kumar, Deepak; Phua, Y. N.

    2016-11-01

    This paper presents a comparative study of dispersion characteristics of the circular waveguide with helical windings. Our waveguide is doubly unconventional in the choice of reverse boundary condition, in the choice of normal boundary condition and further with the presence of sheath helix between the core and cladding parameters. Two methods of winding the helix between the core and cladding are considered namely from right to left and left to right. Through mathematical analysis using field components and boundary conditions the modal characteristics are derived for both conditions. Normal boundary condition and reverse boundary conditions are used respectively to represent the helical windings. Here the characteristic equation is obtained in the form of Bessel and modified Bessel for both waveguides. Using the modal characteristic equation the dispersion curves are plotted for numerous angles and wavelengths. We find that the method of wrapping the helical material has significant effect on the dispersion properties with regards to the way the modes propagate.

  18. Comparative studies on ecotoxicology of synthetic detergents.

    PubMed

    Lal, H; Misra, V; Viswanathan, P N; Krishna Murti, C R

    1983-12-01

    To predict the comparative toxicological response of synthetic detergents on aquatic ecosystems, the effects of various concentrations of neutralized alkyl benzene sulfonate were studied. The median tolerance limit at 48 hr, 95% confidence limit, slope function, presumable harmless concentration, and rate of survival of different species of aquatic fauna such as water fleas (Daphnia magna), mosquito larvae (Culex pipiens), slug worms (Tubifex rivulorum), snails (Lymnaea vulgaris), tadpoles (Rana cyanophlyctis), and fish fingerlings (Cirrhina mrigala) were followed at 0, 24, 48, 72, and 96 hr. Any effect on quality of the water was also tested after the addition of various concentrations of detergents. The results showed that water fleas are more susceptible to detergent toxicity than fish fingerlings, tadpoles, slug worms, snails, and mosquito larvae. Behavioral changes were also observed as an index for detergent toxicity. The relative toxicity of the detergents to various species is discussed in relation to selective ecotoxicological response.

  19. COSMOS - a study comparing peripheral intravenous systems.

    PubMed

    López, Juan Luis González; Del Palacio, Encarnación Ferenández; Marti, Carmen Benedicto; Corral, Javier Olivares; Portal, Pilar Herrera; Vilela, Ana Arribi

    In many areas of the world, safety peripheral intravenous systems have come into widespread use. The Madrid region was the first in Spain to adopt such an approach. These systems, though initially introduced to protect users from sharps injuries, have now evolved to include patient protection features as well. Patient protection, simply stated, means closing the system to pathogen entry. The authors' purpose was to investigate, in a prospective and randomized study, the clinical performance of a closed safe intravenous system versus an open system (COSMOS - Compact Closed System versus Mounted Open System). COSMOS is designed to provide definitive answers, from a nursing perspective, to many topics related to peripheral venous catheterization, which have important implications in intravenous therapy and which have not been validated scientifically. Furthermore, it forms pioneering research in that it is the first clinical trial on medical devices in a legislated environment carried out entirely by nurses and whose promoter and principal investigator is a nurse. The objectives of COSMOS are to compare the effectiveness (as defined by time of survival without complications) and rates of catheter-related complications, such as phlebitis, pain, extravasation, blockage and catheter-related infections. It also looks at rates of catheter colonization, the ease of handling of both systems and overall costs. This article outlines the authors' approach, both in preparing hospital units for such an evaluation as well as in the choice of parameters and their method of study. Further articles will detail the results and findings of the study.

  20. [Terconazol in vaginal candidiasis. Comparative study].

    PubMed

    Llaca Rodríguez, V; Carrión Tizcareño, H; Arguelles Domenzain, P

    1990-11-01

    The antimycotic action and tolerance to terconazole in patients with vaginal candidiasis, were evaluated in a blind study. The medication was given in vaginal ovules (VO) 240 mg, one dose per day, and 80 mg one daily dose for three days; as compared to chlotrimazole, VO 200 mg, daily dose for three days. The patients presented with vaginal candidiasis demonstrated by Nickerson culture medium. Sixty patients were studied in three equivalent groups. The mates of patients treated with terconazole had no treatment; and the mates of patients treated with chlotrimazole received urinary acidifying medication. Symptomatology and mycologic findings were evaluated at 10 and 28 days post treatment. Mycological cure rates at 10 days were: 90 per cent for the terconazole group, 240 mg, one dose; and 95 per cent for patients with terconazole, 80 mg, daily dose for three days; or chlotrimazole, 200 mg, daily dose for three days. Twenty eight days post-treatment, laboratory tests were positive again: 50%, 40% and 15%, respectively. Recidive in patients treated with terconazole, is explained by lack of treatment in mates. In conclusion, terconazole offers a high percentage of clinical and mycological cure in vaginal candidiasis, and it is indispensable treatment for the mate, in order to avoid recidives.

  1. [Terconazole in vaginal candidiasis. A comparative study].

    PubMed

    Llaca Rodríguez, V; Carrión Tizcareño, H; Arguelles Domenzain, P

    1990-11-01

    The antimycotic action and tolerance to terconazole in patients with vaginal candidiasis, were evaluated in a blind study. The medication was given in vaginal ovules (VO)240 mg, one dose per day, and 80 mg one daily dose for three days; as compared to chlotrimazole, VO 200 mg, daily dose for three days. The patients presented with vaginal candidiasis demonstrated by Nickerson culture medium. Sixty patients were studied in three equivalent groups. The mates of patients treated with terconazole had no treatment; and the mates of patients treated with chlotrimazole received urinary acidifying medication. Symptomatology and mycologic findings were evaluated at 10 and 28 days post treatment. Mycological cure rates at 10 days were: 90 per cent for the terconazole group, 240 mg, one dose; and 95 per cent for patients with terconazole, 80 mg, daily dose for three days; or chlotrimazole, 200 mg, daily dose for three days. Twenty eight days post-treatment, laboratory tests were positive again: 50%, 40% and 15%, respectively. Recidive in patients treated with terconazole, is explained by lack of treatment in mates. In conclusion, terconazole offers a high percentage of clinical and mycological cure in vaginal candidiasis, and it is indispensable treatment for the mate, in order to avoid recidives.

  2. Intentional burns in Nepal: a comparative study.

    PubMed

    Lama, Bir Bahadur; Duke, Janine M; Sharma, Narayan Prasad; Thapa, Buland; Dahal, Peeyush; Bariya, Nara Devi; Marston, Wendy; Wallace, Hilary J

    2015-09-01

    Intentional burns injuries are associated with high mortality rates, and for survivors, high levels of physical and psychological morbidity. This study provides a comprehensive assessment of intentional burn admissions to the adult Burns Unit at Bir Hospital, Kathmandu, Nepal, during the period 2002-2013. A secondary data analysis of de-identified data of patients hospitalized at Bir Hospital, Kathmandu, with a burn during the period of 1 January 2002 to 31 August 2013. Socio-demographic, injury and psychosocial factors of patients with intentional and unintentional burns are described and compared. Chi-square tests, Fisher's exact test and Wilcoxon rank sum tests were used to determine statistical significance. There were a total of 1148 burn admissions of which 329 (29%) were for intentional burn, 293 (26%) were self-inflicted and 36 (3%) were due to assault. Mortality rates for intentional burns were approximately three times those for unintentional burns (60 vs. 22%). When compared to unintentional burns, patients with intentional burns were more likely to be female (79 vs. 48%), married (84 vs. 67%), younger (25 vs. 30 years), have more extensive burns (total body surface area, %: 55 vs. 25) and higher mortality (60 vs. 22%). Intentional burns were more likely to occur at home (95 vs. 67%), be caused by fire (96 vs. 77%), and kerosene was the most common accelerant (91 vs. 31%). A primary psychosocial risk factor was identified in the majority of intentional burn cases, with 60% experiencing adjustment problems/interpersonal conflict and 32% with evidence of a pre-existing psychological condition. A record of alcohol/substance abuse related to the patient or other was associated with a greater proportion of intentional burns when compared with unintentional burns (17 vs. 4%). The majority of intentional burn patients were female. Almost all intentional burns occurred in the home and were caused by fire, with kerosene the most common accelerant used. Underlying

  3. Comparative study of selected parallel tempering methods

    NASA Astrophysics Data System (ADS)

    Malakis, A.; Papakonstantinou, T.

    2013-07-01

    We review several parallel tempering schemes and examine their main ingredients for accuracy and efficiency. The present study covers two selection methods of temperatures and several choices for the exchange of replicas, including a recent novel all-pair exchange method. We compare the resulting schemes and measure specific heat errors and efficiency using the two-dimensional (2D) Ising model. Our tests suggest that an earlier proposal for using numbers of local moves related to the canonical correlation times is one of the key ingredients for increasing efficiency, and protocols using cluster algorithms are found to be very effective. Some of the protocols are also tested for efficiency and ground state production in 3D spin-glass models where we find that a simple nearest-neighbor approach using a local n-fold-way algorithm is the most effective. Finally, we present evidence that the asymptotic limits of the ground state energy for the isotropic case and for an anisotropic case of the 3D spin-glass model are very close and may even coincide.

  4. Biosafe alternative to xylene: A comparative study

    PubMed Central

    Negi, Amita; Puri, Abhiney; Gupta, Rakhi; Chauhan, Isha; Nangia, Rajat; Sachdeva, Alisha

    2013-01-01

    Background: Xylene in one of the non-substitutable chemical used in histology laboratories. However, it is known to have many toxic effects. The toxic effects of xylene include heart and kidney injuries, some fatal blood dyscrasia and other less dangerous problems, such as skin erythema, drying, scaling and secondary infections. The exposure and handling of xylene is maximum during deparaffinizing tissue sections. Aims: The aim of this study was to evaluate the efficacy of 1.7% dishwashing soap (DWS) solution as a deparaffinizing agent for hematoxylin and eosin (H and E) staining and compare it with xylene. Materials and Methods: Sixty sections of 4 μm were obtained from 30 formalin-fixed paraffin-embedded (FFPE) tissues and were considered in two different groups, groups A and B. Slides in group A were stained with routine H and E staining procedure; whereas, slides in group B were stained using 1.7% DWS as a deparaffinizing agent. Statistical Analysis Used: Wilcoxon matched-pairs signed rank test was used to calculate the test of significance (P-value significant at ≤0.05). Results and Conclusion: 1.7% DWS was found to be an effective alternative deparaffinizing agent to xylene and meanwhile facilitating as less biohazardous, economical and a faster deparaffinizing agent. PMID:24574653

  5. Assays for mammalian tyrosinase: a comparative study

    SciTech Connect

    Jara, J.R.; Solano, F.; Lozano, J.A.

    1988-01-01

    This work describes a comparative study of the tyrosinase activity determined using three methods which are the most extensively employed; two radiometric assays using L-tyrosine as substrate (tyrosine hydroxylase and melanin formation activities) and one spectrophotometric assay using L-dopa (dopa oxidase activity). The three methods were simultaneously employed to measure the activities of the soluble, melanosomal, and microsomal tyrosinase isozymes from Harding-Passey mouse melanoma through their purification processes. The aim of this study was to find any correlation among the tyrosinase activities measured by the three different assays and to determine whether that correlation varied with the isozyme and its degree of purification. The results show that mammalian tyrosinase has a greater turnover number for L-dopa than for L-tyrosine. Thus, enzyme activity, expressed as mumol of substrate transformed per min, is higher in assays using L-dopa as substrate than those using L-tyrosine. Moreover, the percentage of hydroxylated L-tyrosine that is converted into melanin is low and is affected by several factors, apparently decreasing the tyrosinase activity measured by the melanin formation assay. Bearing these considerations in mind, average interassay factors are proposed. Their values are 10 to transform melanin formation into tyrosine hydroxylase activity, 100 to transform tyrosine hydroxylase into dopa oxidase activity, and 1,000 to transform melanin formation into dopa oxidase activity. Variations in these values due to the presence in the tyrosinase preparations of either inhibitors or regulatory factors in melanogenesis independent of tyrosinase are also discussed.

  6. A Comparative Study Of Dust Devils

    NASA Astrophysics Data System (ADS)

    Lange, C. F.; Prieto, L. E.

    2005-12-01

    computational models. This was accomplished by examining features of the dust devils in the form of three main flow parameters: the ratio of the inflow layer height h to the updraft radius r_0 (aspect ratio), the radial Reynolds number characterizing the updraft zone, and the ratio of the tangential velocity to the mean radial velocity (swirl ratio) at the radius of the updraft zone, r_0. The detailed analysis of the numerical flow solutions led to a simple definition of h and r_0, valid for the types of model flows analyzed. This study is a necessary part of a larger effort to examine and compare both numerical and laboratory simulations of atmospheric vortices in terrestrial and Martian conditions. References [1] R. Greeley et al., XXXII Lunar and Planetary Science, 2001. [2] D. E. Lund and J. T. Snow, The Tornado: Its Structure, Dynamics, Prediction, and Hazards, 1993, p. 297--306. [3] N. B. Ward, J. Atmos. Sci., 1972, 1194--1204.

  7. Comparative Study of Two Automatic Registration Algorithms

    NASA Astrophysics Data System (ADS)

    Grant, D.; Bethel, J.; Crawford, M.

    2013-10-01

    The Iterative Closest Point (ICP) algorithm is prevalent for the automatic fine registration of overlapping pairs of terrestrial laser scanning (TLS) data. This method along with its vast number of variants, obtains the least squares parameters that are necessary to align the TLS data by minimizing some distance metric between the scans. The ICP algorithm uses a "model-data" concept in which the scans obtain differential treatment in the registration process depending on whether they were assigned to be the "model" or "data". For each of the "data" points, corresponding points from the "model" are sought. Another concept of "symmetric correspondence" was proposed in the Point-to-Plane (P2P) algorithm, where both scans are treated equally in the registration process. The P2P method establishes correspondences on both scans and minimizes the point-to-plane distances between the scans by simultaneously considering the stochastic properties of both scans. This paper studies both the ICP and P2P algorithms in terms of their consistency in registration parameters for pairs of TLS data. The question being investigated in this paper is, should scan A be registered to scan B, will the parameters be the same if scan B were registered to scan A? Experiments were conducted with eight pairs of real TLS data which were registered by the two algorithms in the forward (scan A to scan B) and backward (scan B to scan A) modes and the results were compared. The P2P algorithm was found to be more consistent than the ICP algorithm. The differences in registration accuracy between the forward and backward modes were negligible when using the P2P algorithm (mean difference of 0.03 mm). However, the ICP had a mean difference of 4.26 mm. Each scan was also transformed by the forward and backward parameters of the two algorithms and the misclosure computed. The mean misclosure for the P2P algorithm was 0.80 mm while that for the ICP algorithm was 5.39 mm. The conclusion from this study is

  8. Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form

    PubMed Central

    Chhalotiya, Usmangani K.; Bhatt, Kashyap K.; Shah, Dimal A.; Baldania, Sunil L.

    2010-01-01

    The objective of the present work was to develop a stability-indicating RP-HPLC method for duloxetine hydrochloride (DUL) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid hydrolysis. The drug was found to be stable to dry heat, photodegradation, oxidation and basic condition attempted. Successful separation of the drug from the degradation products formed under acidic stress conditions was achieved on a Hypersil C-18 column (250 mm × 4.6 mm id, 5μm particle size) using acetonitrile: 0.01 M potassium dihydrogen phosphate buffer (pH 5.4 adjusted with orthophosphoric acid) (50:50, v/v) as the mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with photodiode array detection at 229 nm over the concentration range 1–25 μg/ml with range of recovery 99.8–101.3 % for DUL by the RP-HPLC method. Statistical analysis proved the method to be repeatable, specific, and accurate for estimation of DUL. It can be used as a stability-indicating method due to its effective separation of the drug from its degradation products, PMID:21179321

  9. Counseling in Costa Rica: A Comparative Study

    ERIC Educational Resources Information Center

    Collier, Crystal

    2013-01-01

    With one of the world's most comprehensive universal healthcare systems, medical tourism in Costa Rica has increased significantly over the past few decades. American tourists save up to 80% of comparative costs for procedures, from heart surgery to root canal treatment. Although many Costa Rican healthcare professionals receive training in North…

  10. Counseling in Costa Rica: A Comparative Study

    ERIC Educational Resources Information Center

    Collier, Crystal

    2013-01-01

    With one of the world's most comprehensive universal healthcare systems, medical tourism in Costa Rica has increased significantly over the past few decades. American tourists save up to 80% of comparative costs for procedures, from heart surgery to root canal treatment. Although many Costa Rican healthcare professionals receive training in North…

  11. Flip This Classroom: A Comparative Study

    ERIC Educational Resources Information Center

    Unruh, Tiffany; Peters, Michelle L.; Willis, Jana

    2016-01-01

    The purpose of this research was to compare the beliefs and attitudes of teachers using the flipped versus the traditional class model. Survey and interview data were collected from a matched sample of in-service teachers representing both models from a large suburban southeastern Texas school district. The Attitude Towards Technology Scale, the…

  12. Flip This Classroom: A Comparative Study

    ERIC Educational Resources Information Center

    Unruh, Tiffany; Peters, Michelle L.; Willis, Jana

    2016-01-01

    The purpose of this research was to compare the beliefs and attitudes of teachers using the flipped versus the traditional class model. Survey and interview data were collected from a matched sample of in-service teachers representing both models from a large suburban southeastern Texas school district. The Attitude Towards Technology Scale, the…

  13. Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

    PubMed

    de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

    2013-05-24

    The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive

  14. Comparative study of some new EPR dosimeters

    NASA Astrophysics Data System (ADS)

    Alzimami, K. S.; Maghraby, Ahmed M.; Bradley, D. A.

    2014-02-01

    Investigations have been made of four new radiation dosimetry EPR candidates from the same family of materials: sulfamic acid, sulfanillic acid, homotaurine, and taurine. Mass energy attenuation coefficients, mass stopping power values and the time dependence of the radiation induced radicals are compared. Also investigated are the microwave saturation behavior and the effect of applied modulation amplitude on both peak-to-peak line width (WPP) and peak-to-peak signal height (HPP). The dosimeters are characterized by simple spectra and stable radiation-induced radicals over reasonable durations, especially in taurine dosimeters. Sulfamic acid dosimeters possessed the highest sensitivity followed by taurine and homotaurine and sulfanillic.

  15. Comparative transport studies of ``1212'' superconductors

    SciTech Connect

    GAPUD,ALBERT; WU,JUDY; YAN,SHAOLIN; XIE,YI-YUAN; KANG,BYEONGWON; SIEGAL,MICHAEL P.; OVERMYER,DONALD L.

    2000-05-17

    HgBa{sub 2}CaCu{sub 2}O{sub 6+{delta}} (Hg-1212) thin films were fabricated by exchanging the TI cations in TlBa{sub 2}CaCu{sub 2}O{sub 7-{delta}} (Tl-1212) thin films with Hg cations, causing a 30-K increase in Tc. To determine how this exchange effects such a Tc increase, the irreversibility lines, temperature dependence of critical current density, and temperature dependence of Hall angle of Hg-1212 and T1-1212 thin films were measured and then compared. The results strongly suggest that the Tc shift is caused by a doubling of charge carrier density.

  16. Genetic network models: a comparative study

    NASA Astrophysics Data System (ADS)

    van Someren, Eugene P.; Wessels, Lodewyk F. A.; Reinders, Marcel J. T.

    2001-06-01

    Currently, the need arises for tools capable of unraveling the functionality of genes based on the analysis of microarray measurements. Modeling genetic interactions by means of genetic network models provides a methodology to infer functional relationships between genes. Although a wide variety of different models have been introduced so far, it remains, in general, unclear what the strengths and weaknesses of each of these approaches are and where these models overlap and differ. This paper compares different genetic modeling approaches that attempt to extract the gene regulation matrix from expression data. A taxonomy of continuous genetic network models is proposed and the following important characteristics are suggested and employed to compare the models: inferential power; predictive power; robustness; consistency; stability and computational cost. Where possible, synthetic time series data are employed to investigate some of these properties. The comparison shows that although genetic network modeling might provide valuable information regarding genetic interactions, current models show disappointing results on simple artificial problems. For now, the simplest models are favored because they generalize better, but more complex models will probably prevail once their bias is more thoroughly understood and their variance is better controlled.

  17. Sensor management simulation and comparative study

    NASA Astrophysics Data System (ADS)

    McIntyre, Gregory A.; Hintz, Kenneth J.

    1997-07-01

    Within the framework of a command and control system, vast amounts of data are being collected and processed from a variety of dissimilar sensors. Through sensor management, sensor usage is integrated to accomplish specific and often dynamic mission objectives. Every opportunity a sensor has to measure the environment can be equated to a reduction in uncertainty in its state, and hence a quantifiable amount of information. A difficulty arises when the data from sensors is not directly comparable as in the case of kinematic and nonkinematic sensors. This paper expands on our previous work, in which a modest multiple sensor, multiple threat simulation model was built to demonstrate the use of Information Theory in sensor management. The simulation model was used to demonstrate the use of Information Theory to effectively deal with the target tracking and target search decision problem. This paper builds upon that work by implementing the OGUPSA sensor scheduling algorithm in the simulation model with more fidelity by replacing the unit interval tasks by appropriate non-unit interval tasks and compares several sensor management methods including minimum position error and maximum information.

  18. Advertisement Analysis: A Comparative Critical Study

    ERIC Educational Resources Information Center

    Abdelaal, Noureldin Mohamed; Sase, Amal Saleh

    2014-01-01

    This study aimed at analyzing two advertisements, and investigating how advertisers use discourse and semiotics to make people and customers buy into their ideas, beliefs, or simply their products. The two advertisements analyzed are beauty products which have been selected from internet magazines. The methodology adopted in this study is…

  19. Comparative results of 327 chemical carcinogenicity studies.

    PubMed Central

    Haseman, J K; Huff, J E; Zeiger, E; McConnell, E E

    1987-01-01

    The National Cancer Institute (NCI) and the National Toxicology Program (NTP) have carried out a number of laboratory animal carcinogenicity studies and presented the results of these experiments in a series of Technical Reports. This paper tabulates the results of the 327 NCI/NTP studies carried out to date on 308 distinct chemicals, and discusses certain issues relevant to the evaluation of carcinogenicity in these experiments. This compilation of results from NCI/NTP carcinogenicity experiments provides a large database that can be used to study structure-activity correlations, interspecies concordance, and associations between laboratory animal carcinogenicity and other toxicological effects. PMID:3691430

  20. A Comparative Study of Landmine Detection Techniques

    NASA Astrophysics Data System (ADS)

    Kasban, H.; Zahran, O.; Elaraby, Sayed M.; El-Kordy, M.; Abd El-Samie, F. E.

    2010-09-01

    Several countries suffer from the existence of millions of buried landmines in their territories. These landmines have indefinite life, and may still cause horrific personal injuries and economic dislocation for decades after a war has finished. Therefore, there is a growing demand by these countries for reliable landmine inspection systems. There are several landmine detection techniques that can be used for this purpose. Each technique is suitable for detection under some conditions depending on the type of the landmine case, the explosive material, and the soil. This paper presents an overview of some of the existing landmine detection techniques. These techniques are briefly described and their merits and drawbacks are highlighted and compared. The purpose of this comparison is to shows the ideal conditions and the challenges for each technique. Furthermore, a comparison between landmine detection techniques from the points of view of cost, complexity, speed, safety, false alarm rate and effect of environmental conditions is presented.

  1. Comparative Study of Light Sources for Household

    NASA Astrophysics Data System (ADS)

    Pawlak, Andrzej; Zalesińska, Małgorzata

    2017-03-01

    The article describes test results that provided the ground to define and evaluate basic photometric, colorimetric and electric parameters of selected, widely available light sources, which are equivalent to a traditional incandescent 60-Watt light bulb. Overall, one halogen light bulb, three compact fluorescent lamps and eleven LED light sources were tested. In general, it was concluded that in most cases (branded products, in particular) the measured and calculated parameters differ from the values declared by manufacturers only to a small degree. LED sources prove to be the most beneficial substitute for traditional light bulbs, considering both their operational parameters and their price, which is comparable with the price of compact fluorescent lamps or, in some instances, even lower.

  2. Comparative biochemical studies of carotenoids in catfishes.

    PubMed

    Tsushima, M; Ikuno, Y; Nagata, S; Kodama, K; Matsuno, T

    2002-11-01

    The carotenoids of 12 species of Siluriformes fishes (eight families) were investigated from a comparative biochemical point of view. The patterns of carotenoids in catfishes belonging to the family Siluridae were quite different from those of the other seven families of catfishes (Bagridae, Amblycipitidae, Clariidae, Plotosidae, Ictaluridae, Callichthyidae and Malapteruridae). 7, 8-Dihydro-beta-carotene; 7, 8, 7', 8'- and 7, 8, 9, 10-tetrahydro-beta-carotene; (3R)-7', 8'-dihydro-beta-cryptoxanthin; 7, 8-dihydrolutein A; 7, 8-dihydrolutein B; parasiloxanthin; 7', 8'-dihydroparasiloxanthin; and 4 or 4'-hydroxyparasiloxanthin were characteristic carotenoids found in only one family, Siluridae, and these carotenoids accounted for 24-60% of total carotenoids. In catfishes belonging to the other seven families except Siluridae, the carotenoid patterns were very similar and the most predominant carotenoid was zeaxanthins (23-56%). Copyright 2002 Elsevier Science Inc.

  3. A comparative study of staff removal algorithms.

    PubMed

    Dalitz, Christoph; Droettboom, Michael; Pranzas, Bastian; Fujinaga, Ichiro

    2008-05-01

    This paper presents a quantitative comparison of different algorithms for the removal of stafflines from music images. It contains a survey of previously proposed algorithms and suggests a new skeletonization based approach. We define three different error metrics, compare the algorithms with respect to these metrics and measure their robustness with respect to certain image defects. Our test images are computer-generated scores on which we apply various image deformations typically found in real-world data. In addition to modern western music notation our test set also includes historic music notation such as mensural notation and lute tablature. Our general approach and evaluation methodology is not specific to staff removal, but applicable to other segmentation problems as well.

  4. Comparative in vitro study in new cephalosporins.

    PubMed Central

    Bodey, G P; Fainstein, V; Hinkle, A M

    1981-01-01

    Three new cephalosporins, ceftazidime, ceftizoxime, and cefotiam, were evaluated in vitro against clinical isolates, and their activities were compared with those of other cephalosporins, mezlocillin, and tobramycin. All three new cephalosporins were very active against gram-positive cocci (except enterococci), but mezlocillin was more active against Streptococcus ssp. Cefotiam and cefamandole were the most active antibiotics against Streptococcus aureus. Ceftazidime had broad-spectrum activity against all gram-negative bacilli tested, except Enterobacter spp. Ceftizoxime was active against all, except Enterobacter spp. and Pseudomonas aeruginosa. Although cefotiam was quite active against Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, it was inactive against indole-positive Proteus spp., Serratia spp, and P. aeruginosa. The in vitro activity suggests that ceftazidime should prove useful as a broad-spectrum antibiotic, in those settings in which the most likely pathogens are gram-negative bacilli. PMID:7283419

  5. Pharmacodynamics of norepinephrine reuptake inhibition: Modeling the peripheral and central effects of atomoxetine, duloxetine, and edivoxetine on the biomarker 3,4-dihydroxyphenylglycol in humans.

    PubMed

    Kielbasa, William; Lobo, Evelyn

    2015-12-01

    Norepinephrine, a neurotransmitter in the autonomic sympathetic nervous system, is deaminated by monoamine oxidase to 3,4-dihydroxyphenylglycol (DHPG). Inhibition of the NE transporter (NET) using DHPG as a biomarker was evaluated using atomoxetine, duloxetine, and edivoxetine as probe NET inhibitors. Pharmacokinetic and pharmacodynamic data were obtained from healthy subjects (n = 160) from 5 clinical trials. An indirect response model was used to describe the relationship between drug plasma concentration and DHPG concentration in plasma and cerebrospinal fluid (CSF). The baseline plasma DHPG concentration (1130-1240 ng/mL) and Imax (33%-37%) were similar for the 3 drugs. The unbound plasma drug IC50 (IC50U ) based on plasma DHPG was 0.973 nM for duloxetine, 0.136 nM for atomoxetine, and 0.041 nM for edivoxetine. The baseline CSF DHPG concentration (1850-2260 ng/mL) was similar for the 3 drugs, but unlike plasma DHPG, the Imax for DHPG was 38% for duloxetine, 53% for atomoxetine, and75% for edivoxetine. The IC50U based on CSF DHPG was 2.72 nM for atomoxetine, 1.22 nM for duloxetine, and 0.794 nM for edivoxetine. These modeling results provide insights into the pharmacology of NET inhibitors and the use of DHPG as a biomarker.

  6. Comparative Anticonvulsant Study of Epoxycarvone Stereoisomers.

    PubMed

    Salgado, Paula Regina Rodrigues; da Fonsêca, Diogo Vilar; Braga, Renan Marinho; de Melo, Cynthia Germoglio Farias; Andrade, Luciana Nalone; de Almeida, Reinaldo Nóbrega; de Sousa, Damião Pergentino

    2015-10-29

    Stereoisomers of the monoterpene epoxycarvone (EC), namely (+)-cis-EC, (-)-cis-EC, (+)-trans-EC, and (-)-trans-EC, were comparatively evaluated for anticonvulsant activity in specific methodologies. In the pentylenetetrazole (PTZ)-induced anticonvulsant test, all of the stereoisomers (at 300 mg/kg) increased the latency to seizure onset, and afforded 100% protection against the death of the animals. In the maximal electroshock-induced seizures (MES) test, prevention of tonic seizures was also verified for all of the isomers tested. However, the isomeric forms (+) and (-)-trans-EC showed 25% and 12.5% inhibition of convulsions, respectively. In the pilocarpine-induced seizures test, all stereoisomers demonstrated an anticonvulsant profile, yet the stereoisomers (+) and (-)-trans-EC (at 300 mg/kg) showed a more pronounced effect. A strychnine-induced anticonvulsant test was performed, and none of the stereoisomers significantly increased the latency to onset of convulsions; the stereoisomers probably do not act in this pathway. However, the stereoisomers (+)-cis-EC and (+)-trans-EC greatly increased the latency to death of the animals, thus presenting some protection. The four EC stereoisomers show promise for anticonvulsant activity, an effect emphasized in the isomers (+)-cis-EC, (+)-trans-EC, and (-)-trans-EC for certain parameters of the tested methodologies. These results serve as support for further research and development of antiepileptic drugs from monoterpenes.

  7. LES versus DNS: A comparative study

    NASA Technical Reports Server (NTRS)

    Shtilman, L.; Chasnov, J. R.

    1992-01-01

    We have performed Direct Numerical Simulations (DNS) and Large Eddy Simulations (LES) of forced isotropic turbulence at moderate Reynolds numbers. The subgrid scale model used in the LES is based on an eddy viscosity which adjusts instantaneously the energy spectrum of the LES to that of the DNS. The statistics of the large scales of the DNS (filtered DNS field or fDNS) are compared to that of the LES. We present results for the transfer spectra, the skewness and flatness factors of the velocity components, the PDF's of the angle between the vorticity and the eigenvectors of the rate of strain, and that between the vorticity and the vorticity stretching tensor. The above LES statistics are found to be in good agreement with those measured in the fDNS field. We further observe that in all the numerical measurements, the trend was for the LES field to be more gaussian than the fDNS field. Future research on this point is planned.

  8. Children's Friendship Development: A Comparative Study

    ERIC Educational Resources Information Center

    Yu, SeonYeong; Ostrosky, Michaelene M.; Fowler, Susan A.

    2011-01-01

    Establishing friendships is an important developmental goal of early childhood, but little research has addressed ways in which parents support the friendship development of their young children with disabilities. The purpose of this survey study was to explore the support strategies that parents use to facilitate their children's friendships.…

  9. Comparative U.S.-Mexico Border Studies.

    ERIC Educational Resources Information Center

    Stoddard, Ellwyn R., Ed.

    Four United States universities, one from each American state having a common boundary with Mexico, organized the Border-State University Consortium for Latin America. The organization emerged as an attempt to focus collectively on problems and situations immediately accessible for study in a series of publications entitled "Occasional…

  10. Social Studies. Language Arts: Comparative World Religions.

    ERIC Educational Resources Information Center

    Moore, John A.

    The elective (7-9) course in world religions outlined in this guide is designed to fit the quinmester organization of schools. The course is described as a study of world religions, focusing on religion as an institution in society. It includes effects of religion on people, governments, and internal relations. The guide is divided according to:…

  11. Metacognition and Group Differences: A Comparative Study

    ERIC Educational Resources Information Center

    Al-Hilawani, Yasser A.

    2014-01-01

    In this study, metacognition refers to performing visual analysis and discrimination of real life events and situations in naïve psychology, naïve physics, and naïve biology domains. It is used, along with measuring reaction time, to examine differences in the ability of four groups of students to select appropriate pictures that correspond with…

  12. Comparative U.S.-Mexico Border Studies.

    ERIC Educational Resources Information Center

    Stoddard, Ellwyn R., Ed.

    Four United States universities, one from each American state having a common boundary with Mexico, organized the Border-State University Consortium for Latin America. The organization emerged as an attempt to focus collectively on problems and situations immediately accessible for study in a series of publications entitled "Occasional…

  13. Implicature, Pragmatics, and Documentation: A Comparative Study

    ERIC Educational Resources Information Center

    Wright, David

    2008-01-01

    This study investigates the link between the linguistic principles of implicature and pragmatics and software documentation. When implicatures are created in conversation or text, the listener or reader is required to fill in missing information not overtly stated. This information is usually filled in on the basis of previous knowledge or…

  14. Metacognition and Group Differences: A Comparative Study

    ERIC Educational Resources Information Center

    Al-Hilawani, Yasser A.

    2014-01-01

    In this study, metacognition refers to performing visual analysis and discrimination of real life events and situations in naïve psychology, naïve physics, and naïve biology domains. It is used, along with measuring reaction time, to examine differences in the ability of four groups of students to select appropriate pictures that correspond with…

  15. Articulation of Quality Teaching: A Comparative Study

    ERIC Educational Resources Information Center

    Sakarneh, Mohammad

    2015-01-01

    The aim of this study is to describe and then contrast the New South Wales Department of Education and Training's model of quality teaching with the Jordanian Ministry of Education's conception of quality teaching, looking particularly at potential differences in interpretation. A content analysis methodology was used. Each perspective has been…

  16. [Eating and affective disorders: a comparative study].

    PubMed

    Behar, Rosa; Arriagada, María Inés; Casanova, Dunny

    2005-12-01

    The relationship between eating disorders and affective disorders still remains unclear. Eating disordered patients may have affective disorders and vice versa, depressed and maniac patients may experience eating problems. To compare eating symptoms, attitudes and behaviors in patients with affective disorders and normal subjects. A structured clinical interview, the Eating Attitudes Test (EAT-40) and the Eating Disorder Inventory (EDI) were administered to 194 patients that fulfilled the DSM-IV diagnostic criteria for eating disorders, to 45 patients with affective disorders and to 82 normal female students. Patients with eating disorders ranked significantly higher on the EAT-40 and on the EDI and its factors (p <0.001). Patients with affective disorders ranked between eating disordered patients and the students (p <0.001). Compulsive-purgative type of anorectics and purgative type of bulimics showed the highest scores on these measures (p <0.001). Restrictive type of anorectics scored significantly highest on EDI maturity fears item (p <0.001). Not significant difference was observed on the EDI ineffectiveness item, between purgative bulimics and depressive patients and between the latter and compulsive-purgative anorexics, on the EDI interpersonal distrust item. Compulsive-purgative type of anorectics and purgative type of bulimics showed the more severe psychological and behavioral disturbances. Restrictive types of anorectics were the most immature. Both purgative bulimics and depressive patients showed feelings of general inadequacy, and both compulsive-purgative anorexics and depressive patients displayed an interpersonal distrust. As a whole, patients with affective disorders did not show the core eating disordered behaviors and attitudes as seen in patients suffering from eating problems.

  17. Earthquake correlations and networks: A comparative study

    SciTech Connect

    Krishna Mohan, T. R.; Revathi, P. G.

    2011-04-15

    We quantify the correlation between earthquakes and use the same to extract causally connected earthquake pairs. Our correlation metric is a variation on the one introduced by Baiesi and Paczuski [M. Baiesi and M. Paczuski, Phys. Rev. E 69, 066106 (2004)]. A network of earthquakes is then constructed from the time-ordered catalog and with links between the more correlated ones. A list of recurrences to each of the earthquakes is identified employing correlation thresholds to demarcate the most meaningful ones in each cluster. Data pertaining to three different seismic regions (viz., California, Japan, and the Himalayas) are comparatively analyzed using such a network model. The distribution of recurrence lengths and recurrence times are two of the key features analyzed to draw conclusions about the universal aspects of such a network model. We find that the unimodal feature of recurrence length distribution, which helps to associate typical rupture lengths with different magnitude earthquakes, is robust across the different seismic regions. The out-degree of the networks shows a hub structure rooted on the large magnitude earthquakes. In-degree distribution is seen to be dependent on the density of events in the neighborhood. Power laws, with two regimes having different exponents, are obtained with recurrence time distribution. The first regime confirms the Omori law for aftershocks while the second regime, with a faster falloff for the larger recurrence times, establishes that pure spatial recurrences also follow a power-law distribution. The crossover to the second power-law regime can be taken to be signaling the end of the aftershock regime in an objective fashion.

  18. Comparative study on computed tomography algorithms

    NASA Astrophysics Data System (ADS)

    Zayed, Nasser; Lawton, Bryan

    1994-09-01

    This study uses Computed Tomography (CT) for reconstructing images of solid propellant rocket motors during static firing tests. Implementation, verification and comparison of four CT algorithms are presented. These four algorithms are: Algebraic Reconstruction Technique, Linear Superposition with Compensation, and Fourier Convolution technique with parallel beams and fan-beam. The phantom used in the comparison between algorithms is similar in cross-section to a solid propellant rocket motor. Comparison between algorithms on the ability to detect artifacts is made. Also, a comparison is made using data obtained by optical tomography of the absorption coefficient inside a 20 mm gas gun barrel. Finally, a comparison of the running time versus number of projections, number of ray sums, and resolution is studied.

  19. Conjunctivitis in the newborn- a comparative study.

    PubMed

    Wadhwani, Meenakshi; D'souza, Pamela; Jain, Rajesh; Dutta, Renu; Saili, Arvind; Singh, Abha

    2011-01-01

    Conjunctivitis of the newborn is defined as hyperemia and eye discharge in the neonates and is a common infection occurring in the neonates in the first month of life. In the United States, the incidence of neonatal conjunctivitis ranges from 1-2%, in India, the prevalence is 0.5-33% and varies in the world from 0.9-21% depending on the socioeconomic status. To study the organisms causing conjunctivitis of the newborn and to correlate the etiology with the mode of delivery. Single center, prospective, observational study. A total of 300 mothers and their newborns, born over a period of one year, were included in the study. Of these 200 newborns were delivered through vaginal route (Group A) and 100 (Group B) delivered by lower segment caesarean section (LSCS). At the time of labour, high vaginal swabs were taken from the mothers. Two conjunctival swabs each from both eyes of the newborn were collected at birth and transported to Microbiology department in a candle jar immediately. Eight babies in Group A, developed conjunctivitis at birth. None of the babies in Group B developed conjunctivitis, this difference was statistically highly significant (P<0.000). The organisms found in the conjunctiva of the newborns in Group A were Coagulase negative Staphylococcus, α hemolytic Streptococcus, Escherichia coli and Pseudomonas spps. However, the commonest organism leading to conjunctivitis in the newborn in this study was Coagulase negative Staphylococcus. It was observed that the mothers of 5 out of 8 babies (60%) developing conjunctivitis gave history of midwife interference and premature rupture of membranes so the presence of risk factors contribute to the occurrence of conjunctivitis in the newborn. It is inferred that the mode of delivery and the presence of risk factors is responsible for conjunctivitis in the newborn.

  20. Comparative study on dermatoglyphics in alcoholic patients.

    PubMed

    Devcić, Sanja; Mihanović, Mate; Milicić, Jasna; Glamuzina, Ljubomir; Silić, Ante

    2009-12-01

    According to the world's prevalence rate, alcoholism is in the third place after heart and blood vessel diseases and malignant tumors. With the development of neuroscience, the causes of alcoholism's biological etiologic sources are still being studied. Considering that dermatoglyphics are highly determined by heritage, we contemplated the possibilities of their discrimination in alcoholic patients in relation to phenotypically healthy subjects. We analyzed the quantitative and qualitative dermatoglyphics properties of 100 alcoholic patients without psychiatric comorbidity, who have been cured in the Psychiatric Hospital Sveti Ivan two or more times, and those of 100 phenotypically healthy men. Through the t-test we evaluated the heterogeneity of the examined groups. Results showed a statistically significant difference on five examined variables. In the calculation of fluctuating asymmetry measure, we found no statistically significant differences in the correlation of values of the right and the left hand on the tested variables, beside one. Chi-square tests showed that there is no relation between the dermatoglyphic qualitative properties of alcoholic patients and those of the examinees from the comparison group. Despite the indisputable genetic role in the genesis of alcoholism, the analysis of the dermatoglyphics carried out in our study did not show any etiological connection between the results of the test on dermatoglyphics and the appearance of alcoholism.

  1. A comparative study of crested gibbons (Nomascus).

    PubMed

    Mootnick, Alan R; Fan, Peng-Fei

    2011-02-01

    Crested gibbons (Nomascus) are in the rarest genus of the family Hylobatidae, with the Hainan gibbon (Nomascus hainanus) being the rarest primate in the world. In the past, the number of species in this genus has been at the center of much controversy, in part, because their color changes during immaturity as well as other factors, such as physical similarities in genitalia, creating difficulties in accurately determining the sex of individuals. Furthermore, owing to their rarity, illusiveness, and the rough terrain that comprises their native habitat, Nomascus is one of the least studied Hylobatidae. This article represents the most comprehensive dissemination of visual characteristics of the genus Nomascus to assist in the accurate identification of captive and wild crested gibbons. Through differences in pelage color, skeletal anatomy, dentition, vocalizations, behavior, distribution, and genetic studies, we are able to determine more accurately whether or not a subspecies should be elevated to species level. From the current data, there are six species and one subspecies in the genus Nomascus. However, reports of a recently identified light-cheeked gibbon (Nomascus sp.) in northeast Cambodia, Central Vietnam, and South Lao PDR, will add additional taxa to this genus.

  2. Low reflectance EUV materials - A comparative study

    NASA Technical Reports Server (NTRS)

    Jelinsky, Patrick; Jelinsky, Sharon

    1987-01-01

    A study has been undertaken of the performance characteristics of a variety of surfaces and surface treatments for use on baffle materials in Extreme UV Explorer instrumentation, in order to ascertain which materials performed with the least overall scattering between 300 and 1200 A and thereby minimize this important background source. Seven scattering samples were measured: bead-blasted aluminum treated with alodine 600, bead-blasted aluminum, Kel-f, etched molybdenum, nickel-plated etched molybdenum, bead-blasted 304 stainless steel, and bead-blasted aluminum painted with Chemglaze Z-306. Attention is given to total reflectance of each material plotted against the graze angle for 304, 584, and 1216 A.

  3. Neurodevelopmental treatment after stroke: a comparative study

    PubMed Central

    Hafsteinsdottir, T; Algra, A; Kappelle, L; Grypdonck, M; on, b

    2005-01-01

    Background: Neurodevelopmental treatment (NDT) is a rehabilitation approach increasingly used in the care of stroke patients, although no evidence has been provided for its efficacy. Objective: To investigate the effects of NDT on the functional status and quality of life (QoL) of patients with stroke during one year after stroke onset. Methods: 324 consecutive patients with stroke from 12 Dutch hospitals were included in a prospective, non-randomised, parallel group study. In the experimental group (n = 223), nurses and physiotherapists from six neurological wards used the NDT approach, while conventional treatment was used in six control wards (n = 101). Functional status was assessed by the Barthel index. Primary outcome was "poor outcome", defined as Barthel index <12 or death after one year. QoL was assessed with the 30 item version of the sickness impact profile (SA-SIP30) and the visual analogue scale. Results: At 12 months, 59 patients (27%) in the NDT group and 24 (24%) in the non-NDT group had poor outcome (corresponding adjusted odds ratio = 1.7 (95% confidence interval, 0.8 to 3.5)). At discharge the adjusted odds ratio was 0.8 (0.4 to 1.5) and after six months it was 1.6 (0.8 to 3.2). Adjusted mean differences in the two QoL measures showed no significant differences between the study groups at six or 12 months after stroke onset. Conclusions: The NDT approach was not found effective in the care of stroke patients in the hospital setting. Health care professionals need to reconsider the use of this approach. PMID:15897499

  4. Neurodevelopmental treatment after stroke: a comparative study.

    PubMed

    Hafsteinsdóttir, T B; Algra, A; Kappelle, L J; Grypdonck, M H F

    2005-06-01

    Neurodevelopmental treatment (NDT) is a rehabilitation approach increasingly used in the care of stroke patients, although no evidence has been provided for its efficacy. To investigate the effects of NDT on the functional status and quality of life (QoL) of patients with stroke during one year after stroke onset. 324 consecutive patients with stroke from 12 Dutch hospitals were included in a prospective, non-randomised, parallel group study. In the experimental group (n = 223), nurses and physiotherapists from six neurological wards used the NDT approach, while conventional treatment was used in six control wards (n = 101). Functional status was assessed by the Barthel index. Primary outcome was "poor outcome", defined as Barthel index <12 or death after one year. QoL was assessed with the 30 item version of the sickness impact profile (SA-SIP30) and the visual analogue scale. At 12 months, 59 patients (27%) in the NDT group and 24 (24%) in the non-NDT group had poor outcome (corresponding adjusted odds ratio = 1.7 (95% confidence interval, 0.8 to 3.5)). At discharge the adjusted odds ratio was 0.8 (0.4 to 1.5) and after six months it was 1.6 (0.8 to 3.2). Adjusted mean differences in the two QoL measures showed no significant differences between the study groups at six or 12 months after stroke onset. The NDT approach was not found effective in the care of stroke patients in the hospital setting. Health care professionals need to reconsider the use of this approach.

  5. Comparative study of fixation density maps.

    PubMed

    Engelke, Ulrich; Liu, Hantao; Wang, Junle; Le Callet, Patrick; Heynderickx, Ingrid; Zepernick, Hans-Jürgen; Maeder, Anthony

    2013-03-01

    Fixation density maps (FDM) created from eye tracking experiments are widely used in image processing applications. The FDM are assumed to be reliable ground truths of human visual attention and as such, one expects a high similarity between FDM created in different laboratories. So far, no studies have analyzed the degree of similarity between FDM from independent laboratories and the related impact on the applications. In this paper, we perform a thorough comparison of FDM from three independently conducted eye tracking experiments. We focus on the effect of presentation time and image content and evaluate the impact of the FDM differences on three applications: visual saliency modeling, image quality assessment, and image retargeting. It is shown that the FDM are very similar and that their impact on the applications is low. The individual experiment comparisons, however, are found to be significantly different, showing that inter-laboratory differences strongly depend on the experimental conditions of the laboratories. The FDM are publicly available to the research community.

  6. Deformation of metal brackets: a comparative study.

    PubMed

    Flores, D A; Choi, L K; Caruso, J M; Tomlinson, J L; Scott, G E; Jeiroudi, M T

    1994-01-01

    The purpose of this study was to determine the effect of material and design on the force and stress required to permanently deform metal brackets. Fourteen types of metal brackets were categorized according to raw material composition, slot torque degree, and wing type. Five types of raw materials, three types of slot torque degree, and four types of wing design were tested using an archwire torque test developed by Flores. An analysis of variance (ANOVA) and t-test showed that all three categories had a significant effect on the force and stress needed to permanently deform metal brackets. Of the three, raw material had the greatest effect on the amount of force. Results showed that 17-4PH and 303S had higher yield strengths and regular twin brackets had higher resistance to deformation. Also, as slot torque degree increased, brackets deformed with less force. Result confirmed that brackets requiring the greatest stress to permanently deform were made of steel with the greatest hardness.

  7. COMPARATIVE STUDIES OF HERPETOMONADS AND LEISHMANIAS

    PubMed Central

    Noguchi, Hideyo

    1926-01-01

    . culicidarum. This organism ferments thirteen sugars, including amygdalin which no other organism of the series attacks. One of the most striking phenomena observed was the entire lack of fermentative faculty on the part of Herpetomonas ctenocephali and Trypanosoma rotatorium. Neither of these organisms was affected by any of the immune sera prepared with other flagellates. The serological specificity of Leishmania tropica, L. brasiliensis, and L. donovani, and the close relation between L. donovani and L. infantum were confirmed in the present study. These organisms could not, however, be differentiated by fermentation tests. The data presented suggest that the biological characteristics of flagellates of the Herpetomonas group may be utilized with advantage for identification of a species which occurs in different environments and for separation of different species when they are found in the same environment. If the leishmania parasites pass the flagellated or herpetomonad stage of their life history in some invertebrate host, it may be possible by tests of the sort described to distinguish them from the non-pathogenic herpetomonads which are so widely distributed among insects and plants. PMID:19869187

  8. Comparative mirror cleaning study: a study on removing particulate contamination

    NASA Astrophysics Data System (ADS)

    Houston, Karrie D.

    2006-08-01

    A mirror cleaning study was conducted to assess the effectiveness of three cleaning methods in their ability to remove particulate contamination from reflective mirror surfaces. Presently, the detergent bath, solvent rinse, and CO II snow cleaning methods are the most commonly used optical cleaning techniques within the optics industry. These techniques are also commonly used by the Optics Branch/Code 551 at Goddard Space Flight Center (GSFC) to remove particulate contamination from optical surfaces. In this experimental study, the above-mentioned cleaning methods were used to clean twelve uncoated silicon wafers, twelve gold coated silicon wafers, and twelve gold coated silicon wafers with a silicon oxide protective coating. CO II snow cleaning had an average removal percentage of 84%, followed by the solvent rinse at 74%, and the detergent bath at 61%. In addition to the average removal percentage, this comparative study was designed to: (1) determine the cleaning ability of each method based on the number and size of removed particles; (2) assess the risk of surface damage for each cleaning procedure; (3) evaluate each cleaning method as a function of its initial "qualitative" contamination level ("fairly clean", "dirty", and "very dirty"). The particulate cleanliness of all wafers was characterized using Image Analysis and Image-Pro Plus 5.0 software. In addition, the experimental design and experimental results were analyzed using JMP/Statistical Analytical Software Version 6.0.

  9. What Do We Compare When We Compare Religions? Philosophical Remarks on the Psychology of Studying Comparative Religion Abroad

    ERIC Educational Resources Information Center

    Irvine, Andrew

    2015-01-01

    The issue of comparison is a vexing one in religious and theological studies, not least for teachers of comparative religion in study abroad settings. We try to make familiar ideas fresh and strange, in settings where students may find it hard not to take "fresh" and "strange" as signs of existential threat. The author explores…

  10. A Comparative Study of Defense Reforms in Eastern European Nations

    DTIC Science & Technology

    2010-12-01

    NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA MBA PROFESSIONAL REPORT A Comparative Study of Defense Reforms in Eastern...2010 3. REPORT TYPE AND DATES COVERED MBA Professional Report 4. TITLE AND SUBTITLE A Comparative Study of Defense Reforms in Eastern European...to Comparative Public Administration (Aldershot: Edward Elgar, 1995), ix. 7. John Clarke and Janet Newman, The Managerial State (Oxford: Sage, 1997

  11. Duloxetine, a Selective Noradrenaline Reuptake Inhibitor, Increased Plasma Levels of 3-Methoxy-4-hydroxyphenylglycol but Not Homovanillic Acid in Patients with Major Depressive Disorder

    PubMed Central

    Atake, Kiyokazu; Hori, Hikaru; Katsuki, Asuka; Ikenouchi-Sugita, Atsuko; Umene-Nakano, Wakako; Nakamura, Jun

    2014-01-01

    Objective We investigated the effects of duloxetine on the plasma levels of catecholamine metabolites and serum brain-derived neurotrophic factor (BDNF) in 64 patients with major depressive disorder (MDD). Methods Major depressive episode was diagnosed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV) according to the DSM-IV text revision (DSM-IV-TR) criteria. The severity of depression was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD-17). Blood sampling and clinical evaluation were performed on days 0, 28, and 56. Results Duloxetine treatment for 8 weeks significantly increased the plasma 3-methoxy-4-hydroxyphenylglycol (MHPG) levels but not the homovanillic acid (HVA) levels in responders with MDD. Conclusion These results imply that noradrenaline plays an important role in alleviating depressive symptoms. PMID:24851119

  12. [Comparative Migration Studies and Comparative Politics.] Fulbright-Hays Summer Seminars Abroad, 1997 (India).

    ERIC Educational Resources Information Center

    Ireland, Patrick

    This paper addresses how the experience of the Fulbright Seminar in India has allowed the participant to enrich his teaching in comparative migration studies and comparative politics. The paper describes specifically how each course has changed as a result of the international experience. The report suggests questions for consideration as the…

  13. Does Duloxetine Improve Cognitive Function Independently of Its Antidepressant Effect in Patients with Major Depressive Disorder and Subjective Reports of Cognitive Dysfunction?

    PubMed Central

    Greer, Tracy L.; Sunderajan, Prabha; Grannemann, Bruce D.; Kurian, Benji T.; Trivedi, Madhukar H.

    2014-01-01

    Introduction. Cognitive deficits are commonly reported by patients with major depressive disorder (MDD). Duloxetine, a dual serotonin/noradrenaline reuptake inhibitor, may improve cognitive deficits in MDD. It is unclear if cognitive improvements occur independently of antidepressant effects with standard antidepressant medications. Methods. Thirty participants with MDD who endorsed cognitive deficits at screening received 12-week duloxetine treatment. Twenty-one participants completed treatment and baseline and posttreatment cognitive testing. The Cambridge Neuropsychological Test Automated Battery was used to assess the following cognitive domains: attention, visual memory, executive function/set shifting and working memory, executive function/spatial planning, decision making and response control, and verbal learning and memory. Results. Completers showed significant cognitive improvements across several domains on tasks assessing psychomotor function and mental processing speed, with additional improvements in visual and verbal learning and memory, and affective decision making and response control. Overall significance tests for executive function tasks were also significant, although individual tasks were not, perhaps due to the small sample size. Most notably, cognitive improvements were observed independently of symptom reduction on all domains except verbal learning and memory. Conclusions. Patients reporting baseline cognitive deficits achieved cognitive improvements with duloxetine treatment, most of which were independent of symptomatic improvement. This trial is registered with NCT00933439. PMID:24563781

  14. Technology-Enhanced Consultation in Counselling: A Comparative Study

    ERIC Educational Resources Information Center

    Astramovich, Randall L.; Jones, W. Paul; Coker, J. Kelly

    2004-01-01

    Two quasi-experimental studies comparing technology-enhanced counselling consultation were conducted with a sample of 147 students enrolled in an undergraduate counselling and consultation course for elementary and secondary teachers. Study 1 (N = 76) compared the effectiveness of counselling consultation using telephone, text chat, or text chat…

  15. Global Harmonization of Comparator Products for Bioequivalence Studies.

    PubMed

    Gwaza, Luther; Gordon, John; Leufkens, Hubert; Stahl, Matthias; García-Arieta, Alfredo

    2017-05-01

    Comparator products should be the products that were shown to be safe and efficacious in pivotal clinical trials to ensure prescribability of generics. The use of a common comparator ensures switchability between generics. The selection of the comparator is a national responsibility and may be different between countries. This paper discusses the current recommendations on selection of comparators, the associated problems, and the possibility of harmonization. Most countries follow the World Health Organization (WHO) recommendations for selecting comparator products and require the comparator product to be obtained from their national markets to ensure switchability between the local comparator and their generics. These recommendations are only feasible in the few countries where the repetition of the bioequivalence study is economically feasible, but they are impracticable in all other countries. Furthermore, the exclusive use of the local comparator to ensure switchability is ethically and scientifically questionable. The innovator product from well-regulated markets should be the global comparator. This harmonization is feasible as the concept already applies in the WHO prequalification program. It is ineffectual to harmonize only the requirements for performing bioequivalence studies, if such a study has to be repeated for every single country simply because of the different comparator products.

  16. Comparative Mirror Cleaning Study: 'A Study on Removing Particulate Contamination'

    NASA Technical Reports Server (NTRS)

    Houston, Karrie

    2007-01-01

    The cleanliness of optical surfaces is recognized as an industry-wide concern for the performance of optical devices such as mirrors and telescopes, microscopes and lenses, lasers and interferometers, and prisms and optical filters. However, no standard has been established for optical cleaning and there is no standard definition of a 'clean' optical element. This study evaluates the effectiveness of commonly used optical cleaning techniques based on wafer configuration, contamination levels, and the number and size of removed particles. It is concluded that cleaning method and exposure time play a significant factor in obtaining a high removal percentage. The detergent bath and solvent rinse method displayed an increase in effective removal percentage as the contamination exposure increased. Likewise, CO2 snow cleaning showed a relatively consistent cleaning effectiveness. The results can help ensure mission success to flight projects developed for the NASA Origins Program. Advantages and disadvantages of each of the optical cleaning methods are described.

  17. From Comparative Education to Comparative Pedagogy: A Physical Education Case Study

    ERIC Educational Resources Information Center

    Georgakis, Steve; Graham, Jessica

    2016-01-01

    In the last two decades forces of globalization and the rise of and access to information technology have transformed the nature of educational research. Traditional disciplines such as comparative education have not been immune to these transformational impacts. Although one might expect globalization to promote the study of comparative…

  18. From Comparative Education to Comparative Pedagogy: A Physical Education Case Study

    ERIC Educational Resources Information Center

    Georgakis, Steve; Graham, Jessica

    2016-01-01

    In the last two decades forces of globalization and the rise of and access to information technology have transformed the nature of educational research. Traditional disciplines such as comparative education have not been immune to these transformational impacts. Although one might expect globalization to promote the study of comparative…

  19. Are comparative studies of extinction risk useful for conservation?

    PubMed

    Cardillo, Marcel; Meijaard, Erik

    2012-03-01

    Large-scale, comparative studies of species extinction risk have become common in conservation science, but their influence on conservation practice appears limited. The link between such studies and the practice of conservation breaks down in two key places. First, results of comparative studies are often ambiguous, inconsistent and difficult to translate into policy. Second, conservation as currently practiced emphasizes the rescue and protection of currently threatened biodiversity, whereas comparative studies are often better suited to a proactive approach that anticipates and prevents future species declines. Scientists should make their research more accessible by addressing the first issue. Policymakers and managers, in turn, could make better use of comparative studies by moving towards more preventative approaches to conservation planning. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

  20. Mobile Learning vs. Traditional Classroom Lessons: A Comparative Study

    ERIC Educational Resources Information Center

    Furió, D.; Juan, M.-C.; Seguí, I.; Vivó, R.

    2015-01-01

    Different methods can be used for learning, and they can be compared in several aspects, especially those related to learning outcomes. In this paper, we present a study in order to compare the learning effectiveness and satisfaction of children using an iPhone game for learning the water cycle vs. the traditional classroom lesson. The iPhone game…

  1. Important Questions of Comparative Studies in Asian Countries

    ERIC Educational Resources Information Center

    Pazyura, Natalia

    2015-01-01

    The issue of the "identity" of comparative education as a field of study or a discipline has been discussed for decades. Yet a kind of systematic structure that provides the basic principles for a coherent exposition of the field remains open. "Comparative education" is no longer conceived as an imaginary field's coherence but,…

  2. A Comparative Study of Croatian and Hungarian EFL Students

    ERIC Educational Resources Information Center

    Mihaljevic Djigunovic, Jelena; Nikolov, Marianne; Otto, Istvan

    2008-01-01

    This comparative research aims to provide insights into how Croatian and Hungarian 8th graders' proficiency in English as a foreign language (EFL) compares to one another in relation to organizational macro factors. A total of 717 14-year-old students participated in the study in two neighboring regions and towns of Croatia and Hungary examining…

  3. A Comparative Study of Document Retrieval Systems of Nursing Interest.

    ERIC Educational Resources Information Center

    Saba, Virginia Kathleen Joseph

    Intended to provide the nursing community with a comparative analysis of four major computerized document retrieval systems and one manual system providing coverage of the nursing literature, this study compares the indexing vocabulary, database coverage, and retrieval performance of the Educational Resource Information Center (ERIC),…

  4. Comparatively Knowing: Making a Case for the Vertical Case Study

    ERIC Educational Resources Information Center

    Vavrus, Frances; Bartlett, Lesley

    2006-01-01

    This article enters into contemporary debates regarding methodology and training in comparative and international education by addressing epistemological questions about "what" can be known of the world and how it can be known through comparative research. We contend that debates over qualitative versus quantitative methods or area studies versus…

  5. Development Studies and Comparative Education: Context, Content, Comparison and Contributors.

    ERIC Educational Resources Information Center

    Little, Angela

    2000-01-01

    Examines the context and content of articles in "Comparative Education," 1977-98. Explores the parallel literature of development studies, focusing on themes of importance to comparative education: modernization, human capital theory, and the "dependency" of poor countries. A shared commitment to understanding the role of…

  6. Important Questions of Comparative Studies in Asian Countries

    ERIC Educational Resources Information Center

    Pazyura, Natalia

    2015-01-01

    The issue of the "identity" of comparative education as a field of study or a discipline has been discussed for decades. Yet a kind of systematic structure that provides the basic principles for a coherent exposition of the field remains open. "Comparative education" is no longer conceived as an imaginary field's coherence but,…

  7. Mobile Learning vs. Traditional Classroom Lessons: A Comparative Study

    ERIC Educational Resources Information Center

    Furió, D.; Juan, M.-C.; Seguí, I.; Vivó, R.

    2015-01-01

    Different methods can be used for learning, and they can be compared in several aspects, especially those related to learning outcomes. In this paper, we present a study in order to compare the learning effectiveness and satisfaction of children using an iPhone game for learning the water cycle vs. the traditional classroom lesson. The iPhone game…

  8. Male and Female High School Principals: A Comparative Study.

    ERIC Educational Resources Information Center

    Paddock, Susan C.

    Differences in the personal and career characteristics of men and women secondary principals were examined by comparing data from a study of women high school principals with data from a National Association of Secondary School Principals (NASSP) study on the secondary school principalship. Data for the study of women principals were provided by…

  9. Teacher Leader Human Relations Skills: A Comparative Study

    ERIC Educational Resources Information Center

    Roby, Douglas E.

    2012-01-01

    In this study, 142 graduate school teachers working in schools throughout southwestern Ohio assessed their human relation skills. A human relations survey was used for the study, and results were compared with colleagues assessing the teachers in the study. The survey was developed using a Likert-type scale, and was based on key elements affecting…

  10. Teacher Leader Human Relations Skills: A Comparative Study

    ERIC Educational Resources Information Center

    Roby, Douglas E.

    2012-01-01

    In this study, 142 graduate school teachers working in schools throughout southwestern Ohio assessed their human relation skills. A human relations survey was used for the study, and results were compared with colleagues assessing the teachers in the study. The survey was developed using a Likert-type scale, and was based on key elements affecting…

  11. Male and Female High School Principals: A Comparative Study.

    ERIC Educational Resources Information Center

    Paddock, Susan C.

    Differences in the personal and career characteristics of men and women secondary principals were examined by comparing data from a study of women high school principals with data from a National Association of Secondary School Principals (NASSP) study on the secondary school principalship. Data for the study of women principals were provided by…

  12. A Comparative Study of Japanese and English Sublanguage Patterns

    DTIC Science & Technology

    1988-06-01

    A Comparative Study of Japanese and English Sublanguage Patterns Lr) Virginia Teller *, Michiko Kosaka**, and Ralph Grishman PROTEUS Project...85-K-0163 from the Office of Naval Research. A COMPARATIVE STUDY OF JAPANESE AND ENGLISH SUBLANGUAGE PATTERNS . NTI3 C .:, [,:C T,: Virginia Teller L...argument framework, we have proposed a novel design for a machine translation system (Kosaka, Teller & Grishman, 1988). A central claim of our proposal is

  13. Comparative Study of Microstrip Patch Antenna Feed Network (PREPRINT)

    DTIC Science & Technology

    2014-10-09

    patch antenna can achieve a gain of 9dB. Simply a patch can be seen as a pair of imaginary dipoles in parallel separated by the width of the patch. The...Comparative Study of Microstrip Patch Antenna Feed Network Behnam Jamali School of Electrical & Electronic Engineering The University of Adelaide...paper presents a comparative study of patch antenna feed structures. That includes microstrip line feed, inset feed, coaxial feed, aperture coupled

  14. Information Technology Diffusion: A Comparative Case Study of Intranet Adoption

    DTIC Science & Technology

    1999-07-01

    Information Technology Diffusion: A Comparative Case Study of Intranet Adoption George A. Zolla Jr. Naval Postgraduate School, Monterey, CA 93943...unfreezing”. Cooper and Zmud [4] defined IT implementation as “an organizational effort directed toward diffusing appropriate information technology within a...1999 4. TITLE AND SUBTITLE Information Technology Diffusion: A Comparative Case Study of Intranet Adoption 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c

  15. A comparative study of centbucridine and lidocaine in dental extraction.

    PubMed

    Vacharajani, G N; Parikh, N; Paul, T; Satoskar, R S

    1983-01-01

    A randomized double-blind study comparing the efficacy and tolerability of centbucridine (0.5%) with those of lidocaine (2%) as an anaesthetic agent was conducted in the dental outpatient department on patients attending for dental extraction. One hundred and twenty patients were studied. The degree of analgesia attained with centbucridine compared well with that obtained with lidocaine. The compound was well tolerated with no significant changes in the cardiovascular parameters and no serious side-effects.

  16. A review of the suitability of duloxetine and venlafaxine for use in patients with depression in primary care with a focus on cardiovascular safety, suicide and mortality due to antidepressant overdose

    PubMed Central

    Lenox-Smith, Alan; Bradley, Andrew

    2013-01-01

    Depression and anxiety disorders are among the most common disorders treated by general practitioners (GPs) in the UK. Since both disorders are associated with a significantly increased risk of suicide, including with antidepressant overdose, the safety of antidepressants in overdose is of paramount importance. Numerous updates relating to antidepressant safety have been issued by regulators in the UK which may have eroded GP confidence in antidepressants. Venlafaxine, a serotonin nor adrenaline reuptake inhibitor (SNRI) had primary care prescribing restrictions placed on it in 2004 due to concerns about cardiotoxicity and mortality in overdose. Although a review of the evidence led to a reversal of the majority of restrictions in 2006, evidence suggests GPs may still be cautious in their prescribing of venlafaxine and possibly other SNRI antidepressants for patients with depression and anxiety disorders. This paper reviews the evidence pertaining to the safety of SNRI antidepressants from a perspective of cardiovascular safety and overdose. The currently available evidence suggests a marginally higher toxicity of venlafaxine in overdose compared with another SNRI duloxetine and the selective serotonin reuptake inhibitors (SSRIs), although this may be related to differential patterns of prescribing in high-risk patients. Based on this review SNRIs have a positive risk benefit profile in the treatment of depression and generalized anxiety disorder in primary care, especially as second-line agents to SSRIs. PMID:24167687

  17. Sustaining and Improving Study Abroad Experiences Through Comparative Evaluation.

    PubMed

    Johanson, Linda S

    Researchers have related participation in study abroad experiences to many positive outcomes for nursing students; however, educators are faced with the task of not only developing meaningful study abroad opportunities but sustaining and improving them as well. Educators can evaluate repeat study abroad programs by comparing experiences, looking for trends, and conjecturing rationales. To illustrate this process, an example of a study abroad opportunity that has been repeated over 11 years is presented. The first six years have been compared to the most recent five years, revealing three categories of change for evaluation and the resulting course improvements.

  18. Comparative Study of Bio-implantable Acoustic Generator Architectures

    NASA Astrophysics Data System (ADS)

    Christensen, D.; Roundy, S.

    2013-12-01

    This paper is a comparative study of the design spaces of two bio-implantable acoustically excited generator architectures: the thickness-stretch-mode circular piezoelectric plate and the bending-mode unimorph piezoelectric diaphragm. The generators are part of an acoustic power transfer system for implanted sensors and medical devices such as glucose monitors, metabolic monitors, drug delivery systems, etc. Our studies indicate that at small sizes the diaphragm architecture outperforms the plate architecture. This paper will present the results of simulation studies and initial experiments that explore the characteristics of the two architectures and compare their performance.

  19. Living With and Learning about Radioactivity: A Comparative Conceptual Study.

    ERIC Educational Resources Information Center

    Alsop, Steve

    2001-01-01

    Documents a quasi-scientific comparative study of two groups of 'recent school leavers' in the UK. Studies non-science university undergraduates and explores whether people living with the immediacy and relevance of higher-than-average levels of radioactivity were more knowledgeable and emotionally detached than a similar group removed from this…

  20. A Comparative Study of Teaching Typing Skills on Microcomputers.

    ERIC Educational Resources Information Center

    Lindsay, Robert M.

    A 4-week experimental study was conducted with 105 high school students in 4 introductory typewriting classes of a large urban school in British Columbia during the 1981 spring semester. The purpose of the study was to compare the effectiveness of teaching the skill-building components of typewriting speed and accuracy using either the…

  1. A Comparative Study of Students' Achievement in Botany and Zoology

    ERIC Educational Resources Information Center

    Tamir, P.

    1974-01-01

    A comparative study of student achievement in botany and zoology based on data of 10 studies conducted in 20 countries. Up to age 14, students achieve better in zoology; after age 14, students achieve better in botany. Based on the findings, recommendations are suggested regarding curriculum planning, laboratory work and the need for specific…

  2. Entrepreneurial Training: A Comparative Study across Fifteen European Countries

    ERIC Educational Resources Information Center

    Matricano, Diego

    2014-01-01

    This paper arises from the contents of the Lisbon Strategy, a set of cooperation policies stressing the role of education and training. The findings from a comparative study of the influence that entrepreneurial training--classified as formal or informal--can have on start-up expectations are analysed. The study covers fifteen European countries…

  3. Sustainability of Social Programs: A Comparative Case Study Analysis

    ERIC Educational Resources Information Center

    Savaya, Riki; Spiro, Shimon; Elran-Barak, Roni

    2008-01-01

    The article reports on the findings of a comparative case study of six projects that operated in Israel between 1980 and 2000. The study findings identify characteristics of the programs, the host organizations, and the social and political environment, which differentiated programs that are sustained from those that are not. The findings reaffirm…

  4. Political Ideology: A Comparative Study of Three Chicano Youth Organizations.

    ERIC Educational Resources Information Center

    Garcia, Richard A.

    The study investigated the political ideology of three Chicano youth groups in El Paso, Texas: Mexican American Youth Association (MAYA), Mexican American Political Association (MAPA), and the Alianza. Purpose of the study was to identify and compare the political ideas and attitudes of the three organizations. Questionnaires were administered to…

  5. Political Ideology: A Comparative Study of Three Chicano Youth Organizations.

    ERIC Educational Resources Information Center

    Garcia, Richard A.

    The study investigated the political ideology of three Chicano youth groups in El Paso, Texas: Mexican American Youth Association (MAYA), Mexican American Political Association (MAPA), and the Alianza. Purpose of the study was to identify and compare the political ideas and attitudes of the three organizations. Questionnaires were administered to…

  6. Entrepreneurial Training: A Comparative Study across Fifteen European Countries

    ERIC Educational Resources Information Center

    Matricano, Diego

    2014-01-01

    This paper arises from the contents of the Lisbon Strategy, a set of cooperation policies stressing the role of education and training. The findings from a comparative study of the influence that entrepreneurial training--classified as formal or informal--can have on start-up expectations are analysed. The study covers fifteen European countries…

  7. A Comparative Study of Students' Achievement in Botany and Zoology

    ERIC Educational Resources Information Center

    Tamir, P.

    1974-01-01

    A comparative study of student achievement in botany and zoology based on data of 10 studies conducted in 20 countries. Up to age 14, students achieve better in zoology; after age 14, students achieve better in botany. Based on the findings, recommendations are suggested regarding curriculum planning, laboratory work and the need for specific…

  8. Living With and Learning about Radioactivity: A Comparative Conceptual Study.

    ERIC Educational Resources Information Center

    Alsop, Steve

    2001-01-01

    Documents a quasi-scientific comparative study of two groups of 'recent school leavers' in the UK. Studies non-science university undergraduates and explores whether people living with the immediacy and relevance of higher-than-average levels of radioactivity were more knowledgeable and emotionally detached than a similar group removed from this…

  9. A Comparative Study of Learning Organisation Practices of Indian Businesses

    ERIC Educational Resources Information Center

    Bhattacharya, Sonali; Neelam, Netra; Behl, Abhishek; Acharya, Sabyasachi

    2017-01-01

    Purpose: In this study we compared the learning organisation practices of Indian Businesses across sectors. Methodology: The study is based on a sample of 406 managers of banking, information technology and information technology enabled services (IT/ITES), manufacturing, hotel & hospitality and hospital and healthcare sectors. Learning…

  10. Comparative genomics approaches to study organism similarities and differences

    SciTech Connect

    Wei, Liping; Liu, Yueyi; Dubchak, Inna; Shon, John; Park, John

    2002-06-01

    Comparative genomics is a large-scale, holistic approach that compares two or more genomes to discover the similarities and differences between the genomes and to study the biology of the individual genomes. Comparative studies can be performed at different levels of the genomes to obtain multiple perspectives about the organisms. We discuss in detail the type of analyses that offer significant biological insights in the comparisons of (1) genome structure including overall genome statistics, repeats, genome rearrangement at both DNA and gene level, synteny, and breakpoints; (2) coding regions including gene content, protein content, orthologs, and paralogs; and (3) noncoding regions including the prediction of regulatory elements. We also briefly review the currently available computational tools in comparative genomics such as algorithms for genome-scale sequence alignment, gene identification, and nonhomology-based function prediction.

  11. A comparative study between shielded and open coplanar waveguide discontinuities

    NASA Technical Reports Server (NTRS)

    Dib, Nihad I.; Harokopus, W. P., Jr.; Ponchak, G. E.; Katehi, L. P. B.

    1993-01-01

    A comparative study between open and shielded coplanar waveguide (CPW) discontinuities is presented. The space domain integral equation method is used to characterize several discontinuities such as the open-end CPW and CPW series stubs. Two different geometries of CPW series stubs (straight and bent stubs) are compared with respect to resonant frequency and radiation loss. In addition, the encountered radiation loss due to different CPW shunt stubs is evaluated experimentally. The notion of forced radiation simulation is presented, and the results of such a simulation are compared to the actual radiation loss obtained rigorously. It is shown that such a simulation cannot give reliable results concerning radiation loss from printed circuits.

  12. Diagnosis of bone metastasis: recent comparative studies of imaging modalities.

    PubMed

    Talbot, J N; Paycha, F; Balogova, S

    2011-08-01

    Various imaging modalities are currently available to diagnose bone metastasis. The two main anatomical modalities are computed tomography (CT) and magnetic resonance imaging (MRI), with many variants proposed for the MRI procedure, including diffusion-weighted imaging. The two main functional modalities are scintigraphy and PET, also with many variants in the radiopharmaceutical, from the "all purpose" 99mTc labelled bisphosphonates to very selective radiopharmaceuticals for rare neoplasia. The diagnostic strategy will become more and more individually tailored according to the patient's clinical and biological data (primary cancer type, phase of the evolution, markers of aggressiveness, serum levels of biological tracers of bone metabolism, circulating or disseminating tumour cells …). If imaging is indicated, the diagnostic strategy will also depend on the availability and the diagnostic performance of the imaging modalities. Assessment of diagnostic performance requires comparative studies, performed with an adequate methodology. The main methodological weaknesses encountered in studies intending to compare imaging modalities for diagnosing bone metastasis are summarised. Comparative studies have been reviewed, which address the initial diagnosis of skeletal metastases in solid tumours except primary bone cancers. The results of more than 140 such comparative studies are then summarised and briefly commented, according to the type of the primary cancer, and according to the compared imaging modalities.

  13. "Lies, damned lies ..." and observational studies in comparative effectiveness research.

    PubMed

    Albert, Richard K

    2013-06-01

    A new federal initiative has allocated $1.1 billion to comparative effectiveness research, and many have emphasized the importance of including observational studies in this effort. The rationale for using observational studies to assess comparative effectiveness is based on concerns that randomized controlled trials (RCTs) are not "real world" because they enroll homogeneous patient populations, measure study outcomes that are not important to patients, use protocols that are overly complex, are conducted in specialized centers, and use study treatments that are not consistent with usual care, and that RCTs are not always feasible because of a lack of equipoise, the need to assess delayed endpoints, and concerns that they take years to complete and are expensive. This essay questions the validity of each of these proposed limitations, summarizes concerns raised about the accuracy of results generated by observational studies, provides some examples of discrepancies between results of observational studies and RCTs that pertain to pulmonary and critical care, and suggests that using observational studies for comparative effectiveness research may increase rather than decrease the cost of health care and may harm patients.

  14. Comparative study on direct burning of oil shale and coal

    NASA Astrophysics Data System (ADS)

    Hammad, Ahmad; Al Asfar, Jamil

    2017-07-01

    A comparative study of the direct burning processes of oil shale and coal in a circulating fluidized bed (CFB) was done in this study using ANSYS Fluent software to solve numerically the governing equations of continuity, momentum, energy and mass diffusion using finite volume method. The model was built based on an existing experimental combustion burner unit. The model was validated by comparing the theoretical results of oil shale with proved experimental results from the combustion unit. It was found that the temperature contours of the combustion process showed that the adiabatic flame temperature was 1080 K for oil shale compared with 2260 K for coal, while the obtained experimental results of temperatures at various locations of burner during the direct burning of oil shale showed that the maximum temperature reached 962 K for oil shale. These results were used in economic and environmental analysis which show that oil shale may be used as alternative fuel for coal in cement industry in Jordan.

  15. Comparative and Developmental Study of the Immune System in Xenopus

    PubMed Central

    Robert, Jacques; Ohta, Yuko

    2010-01-01

    Xenopus laevis is the model of choice for evolutionary, comparative, and developmental studies of immunity, and invaluable research tools including MHC-defined clones, inbred strains, cell lines, and monoclonal antibodies are available for these studies. Recent efforts to use Silurana (Xenopus) tropicalis for genetic analyses have led to the sequencing of the whole genome. Ongoing genome mapping and mutagenesis studies will provide a new dimension to the study of immunity. Here we review what is known about the immune system of X. laevis integrated with available genomic information from S. tropicalis. This review provides compelling evidence for the high degree of similarity and evolutionary conservation between Xenopus and mammalian immune systems. We propose to build a powerful and innovative comparative biomedical model based on modern genetic technologies that takes take advantage of X. laevis and S. tropicalis, as well as the whole Xenopus genus. PMID:19253402

  16. Rodents for comparative aging studies: from mice to beavers

    PubMed Central

    Bozzella, Michael J.; Seluanov, Andrei

    2008-01-01

    After humans, mice are the best-studied mammalian species in terms of their biology and genetics. Gerontological research has used mice and rats extensively to generate short- and long-lived mutants, study caloric restriction and more. Mice and rats are valuable model organisms thanks to their small size, short lifespans and fast reproduction. However, when the goal is to further extend the already long human lifespan, studying fast aging species may not provide all the answers. Remarkably, in addition to the fast-aging species, the order Rodentia contains multiple long-lived species with lifespans exceeding 20 years (naked mole-rat, beavers, porcupines, and some squirrels). This diversity opens great opportunities for comparative aging studies. Here we discuss the evolution of lifespan in rodents, review the biology of slow-aging rodents, and show an example of how the use of a comparative approach revealed that telomerase activity coevolved with body mass in rodents. PMID:19424861

  17. Reverse engineering of gene regulatory networks: a comparative study.

    PubMed

    Hache, Hendrik; Lehrach, Hans; Herwig, Ralf

    2009-01-01

    Reverse engineering of gene regulatory networks has been an intensively studied topic in bioinformatics since it constitutes an intermediate step from explorative to causative gene expression analysis. Many methods have been proposed through recent years leading to a wide range of mathematical approaches. In practice, different mathematical approaches will generate different resulting network structures, thus, it is very important for users to assess the performance of these algorithms. We have conducted a comparative study with six different reverse engineering methods, including relevance networks, neural networks, and Bayesian networks. Our approach consists of the generation of defined benchmark data, the analysis of these data with the different methods, and the assessment of algorithmic performances by statistical analyses. Performance was judged by network size and noise levels. The results of the comparative study highlight the neural network approach as best performing method among those under study.

  18. Comparative Study of Student Support Services of AIOU and UKOU

    ERIC Educational Resources Information Center

    Choudhry, Amtul Hafeez; Gujjar, Aijaz Ahmed; Hafeez, Muhammad Rashid

    2008-01-01

    This paper attempts to compare the availability, quality, similarities and differences of student support services in Allama Iqbal Open University (AIOU) and United Kingdom Open University (UKOU) and also to identify and enlist the deficiencies that AIOU students are facing in the student support services. The study found out that student support…

  19. Research Governance and the Role of Evaluation: A Comparative Study

    ERIC Educational Resources Information Center

    Molas-Gallart, Jordi

    2012-01-01

    Through a comparative study of the United Kingdom and Spain, this article addresses the effect of different research governance structures on the functioning and uses of research evaluation. It distinguishes three main evaluation uses: distributive, improvement, and controlling. Research evaluation in the United Kingdom plays important…

  20. Comparative Study on Inclusive and Special Education Curricula in Hungary

    ERIC Educational Resources Information Center

    Gita, Szilvia; Bognar, Jozsef; Kalbli, Katalin; Dorogi, Laszlo

    2008-01-01

    Study aim: To compare the National Core Curriculum (NCC) and the special education curriculum regarding how much they are suitable for children with disabilities in the field of physical education and sports. Material and methods: Content analysis of Hungarian NCC and of 5 special schools curricula was employed to obtain information on specific…

  1. A Comparative Study of Students' Attitudes Toward Education.

    ERIC Educational Resources Information Center

    Quintanar, Rosalinda

    The comparative analysis of students' attitudes included Mexican American, Anglo, and Asian students (from Thailand, Taiwan, and the Philippines). A Likert scale was used to measure all attitudes. All analysis performed utilized cross tabulation and chi square. The attitudes studied were reasons for going to college; concept of an educated person…

  2. Research Governance and the Role of Evaluation: A Comparative Study

    ERIC Educational Resources Information Center

    Molas-Gallart, Jordi

    2012-01-01

    Through a comparative study of the United Kingdom and Spain, this article addresses the effect of different research governance structures on the functioning and uses of research evaluation. It distinguishes three main evaluation uses: distributive, improvement, and controlling. Research evaluation in the United Kingdom plays important…

  3. Different Underlying Neurocognitive Deficits in Developmental Dyslexia: A Comparative Study

    ERIC Educational Resources Information Center

    Menghini, D.; Finzi, A.; Benassi, M.; Bolzani, R.; Facoetti, A.; Giovagnoli, S.; Ruffino, M.; Vicari, S.

    2010-01-01

    The aim of this study was to investigate the role of several specific neurocognitive functions in developmental dyslexia (DD). The performances of 60 dyslexic children and 65 age-matched normally reading children were compared on tests of phonological abilities, visual processing, selective and sustained attention, implicit learning, and executive…

  4. The Social Sciences and the Comparative Study of Educational Systems.

    ERIC Educational Resources Information Center

    Fischer, Joseph, Ed.

    Aiming at the comprehension of schools as social, political, economic, and cultural systems, this book suggests that education does not constitute a separate academic discipline but is dependent upon the social sciences for its elucidation and for its comparative study. The book emphasizes interdisciplinary approaches within four social sciences…

  5. A Comparative Study of Learning Networks in the United States.

    ERIC Educational Resources Information Center

    Lewis, George Robert

    This comparative study examines learning networks from an historical perspective and, in addition to determining the state-of-the-art after seven years of independent development, provides operational definitions of the major critical elements needed to assure the development of a successful learning network model. Learning networks are discussed…

  6. Comparative Studies on Sino-Canadian Higher Education

    ERIC Educational Resources Information Center

    Yang, Hong

    2008-01-01

    Today education is internationalization. Both China and Canada have their own strong merits of higher education. This paper approaches comparative studies on differences of Sino-Canadian higher education from new points, so as to achieve an inspiration to the development of Chinese higher education: preserve relative independence between higher…

  7. Comparative Study on Inclusive and Special Education Curricula in Hungary

    ERIC Educational Resources Information Center

    Gita, Szilvia; Bognar, Jozsef; Kalbli, Katalin; Dorogi, Laszlo

    2008-01-01

    Study aim: To compare the National Core Curriculum (NCC) and the special education curriculum regarding how much they are suitable for children with disabilities in the field of physical education and sports. Material and methods: Content analysis of Hungarian NCC and of 5 special schools curricula was employed to obtain information on specific…

  8. Using Comparative Online Media to Study the Iraq War

    ERIC Educational Resources Information Center

    Eaton, Jana Sackman

    2004-01-01

    The war in Iraq and the aftermath are receiving media attention around the globe. A plethora of media reports from many other countries is now available online in English. This article recommends possible approaches to developing comparative media studies and provides URLs to specific sources. The NCSS standards addressed by these lessons include:…

  9. Generation 1.5 Written Error Patterns: A Comparative Study

    ERIC Educational Resources Information Center

    Doolan, Stephen M.; Miller, Donald

    2012-01-01

    In an attempt to contribute to existing research on Generation 1.5 students, the current study uses quantitative and qualitative methods to compare error patterns in a corpus of Generation 1.5, L1, and L2 community college student writing. This error analysis provides one important way to determine if error patterns in Generation 1.5 student…

  10. A Comparative Study of Two Acoustic Measures of Hypernasality

    ERIC Educational Resources Information Center

    Vogel, Adam P.; Ibrahim, Hasherah M.; Reilly, Sheena; Kilpatrick, Nicky

    2009-01-01

    Purpose: This study aimed to compare 2 quantitative acoustic measures of nasality in children with cleft lip and palate (CLP) and healthy controls using formalized perceptual assessment as a guide. Method: Fifty participants (23 children with CLP and 27 age- and gender-matched healthy controls) aged between 4 and 12 years produced a variety of…

  11. The spectrum of NeH. A comparative isoelectronic study

    NASA Astrophysics Data System (ADS)

    Martin, I.; Pérez-Delgado, Y.; Lavín, C.

    1999-05-01

    Einstein coefficients and oscillator strengths for Rydberg-ground and Rydberg-Rydberg transitions in the rare-gas excimer NeH have been calculated with the quantum defect orbital (QDO) method. A comparative study of analogous transitions in NeH and in some of its isoelectronic Rydberg radicals has revealed clear similarities between them.

  12. Midlife Women in Continuing Education: A Comparative Study.

    ERIC Educational Resources Information Center

    Traupmann, Jane

    Developmental theorists have suggested recently that at midlife women often want to reduce responsibilities to family and concentrate on self-development and growth, which earlier in their lives would have seemed to them selfish and therefore not acceptable. The aim of this comparative study was to determine if women returning to school at midlife…

  13. Spanish and American Turn-Taking Styles: A Comparative Study.

    ERIC Educational Resources Information Center

    Berry, Anne

    A comparative study of turn-taking in North American and Spanish conversation investigated (1) differences in styles for the two cultures and (2) any resulting misinterpretation of communicative intentions. Data for the first were drawn from two dinner parties, one with four American women, conducted in English, and one with four Spanish-speaking…

  14. A Comparative Study of Two Acoustic Measures of Hypernasality

    ERIC Educational Resources Information Center

    Vogel, Adam P.; Ibrahim, Hasherah M.; Reilly, Sheena; Kilpatrick, Nicky

    2009-01-01

    Purpose: This study aimed to compare 2 quantitative acoustic measures of nasality in children with cleft lip and palate (CLP) and healthy controls using formalized perceptual assessment as a guide. Method: Fifty participants (23 children with CLP and 27 age- and gender-matched healthy controls) aged between 4 and 12 years produced a variety of…

  15. Homeless Adolescents' Perceptions of Positive Development: A Comparative Study

    ERIC Educational Resources Information Center

    Nott, Brooke Dolenc; Vuchinich, Samuel

    2016-01-01

    Background: While some recent research has addressed homeless youth from a strengths-based approach, comparative studies of homeless and non-homeless youth from a strengths perspective are few; research that includes youth's views on positive youth development are also limited. Objective: Addressing these gaps and using an inductive approach,…

  16. A Comparative Study of the Adjustment of Secondary School Students

    ERIC Educational Resources Information Center

    Devika R.

    2014-01-01

    Education is the ability to meet one's life. How the child adjusts with varying situations determines the success of life. The child's adjustment is determined by a number of factors like Home, Social, Educational and Financial adjustment. The investigator here aims to make a comparative study on the adjustment of secondary school students. The…

  17. Scandinavian Approaches to Gender Equality in Academia: A Comparative Study

    ERIC Educational Resources Information Center

    Nielsen, Mathias Wullum

    2017-01-01

    This study investigates how Denmark, Norway, and Sweden approach issues of gender equality in research differently. Based on a comparative document analysis of gender equality activities in six Scandinavian universities, together with an examination of the legislative and political frameworks surrounding these activities, the article provides new…

  18. The Social Sciences and the Comparative Study of Educational Systems.

    ERIC Educational Resources Information Center

    Fischer, Joseph, Ed.

    Aiming at the comprehension of schools as social, political, economic, and cultural systems, this book suggests that education does not constitute a separate academic discipline but is dependent upon the social sciences for its elucidation and for its comparative study. The book emphasizes interdisciplinary approaches within four social sciences…

  19. Comparative Study of Bacterial Growth in Magnet Fields

    NASA Astrophysics Data System (ADS)

    Smith, Derek; Masood, Samina

    It has been shown that magnetic fields affect bacterial growth. A comparative study of growth rates for gram-positive and gram-negative bacteria with different types of magnetic fields is done. Special focus is placed upon growth within liquid media, and the effect of magnetic fields relative to the chosen growth medium is considered.

  20. Homeless Adolescents' Perceptions of Positive Development: A Comparative Study

    ERIC Educational Resources Information Center

    Nott, Brooke Dolenc; Vuchinich, Samuel

    2016-01-01

    Background: While some recent research has addressed homeless youth from a strengths-based approach, comparative studies of homeless and non-homeless youth from a strengths perspective are few; research that includes youth's views on positive youth development are also limited. Objective: Addressing these gaps and using an inductive approach,…

  1. Laser stapedotomy: a comparative study of prostheses and seals.

    PubMed

    Perkins, R; Curto, F S

    1992-12-01

    During the past 13 years, a number of prostheses of differing design and tissue seals have been used in laser stapedotomy for otosclerosis. This study compares the results of three different configurations of prostheses and tissue seals in a series of 53 patients. In 19, a platinum wire Teflon piston was placed in the laser stapedotomy fenestra and crimped on the long process of the incus; autologous venous blood was infiltrated into the oval window niche as a sealing mechanism. In 8 patients, a stainless steel bucket-handle-type prosthesis was used with a blood tissue seal. In 26 patients, a segment of autogenous vein was clad onto the bucket-handle-type prosthesis and placed into the laser fenestra. Two tissue seals (blood and vein) were also compared. The results were compared with regard to several audiometric parameters. It would appear that the bucket handle/vein configuration improves air-bone gap closure in the low- and mid-frequency speech range and also shows an advantage for air-bone gap closure to 10 dB or less compared to the other configurations in this study. Mean postoperative gaps were significantly less for vein compared to the blood tissue seal. Physiologic and surgical implications are discussed, and the vein-clad technique is illustrated.

  2. Comparative study of texture detection and classification algorithms

    NASA Astrophysics Data System (ADS)

    Koltsov, P. P.

    2011-08-01

    A description and results of application of the computer system PETRA (performance evaluation of texture recognition algorithms) are given. This system is designed for the comparative study of texture analysis algorithms; it includes a database of textured images and a collection of software implementations of texture analysis algorithms. The functional capabilities of the system are illustrated using texture classification examples. Test examples are taken from the Brodatz album, MeasTech database, and a set of aerospace images. Results of a comparative evaluation of five well-known texture analysis methods are described—Gabor filters, Laws masks, ring/wedge filters, gray-level cooccurrence matrices (GLCMs), and autoregression image model.

  3. A Study of Comparative Management Styles in Japan and Korea.

    DTIC Science & Technology

    1982-06-01

    elders. The cardinal virtue of filial piety was combination of loyalty and reverence. He taught that, in order to gain a well-ordered society, five...NAVAL POSTGRADUATE SCHOOL Monterey, California THESIS A STUDY OF COMPARATIVE MANAGEMENT STYLES IN JAPAN AND KOREA by Kwang Sop Choe June 1982-JJ...coveREDA La~y of Comparative Management Styles Master’s Thesis in Japan and Korea June 1982 4. PERFORMING COG. REPORT NuffUER 7. AUTHWO 11. COwYRACY OR

  4. Study comparing midazolam and nitrous oxide in dental anxiety control.

    PubMed

    Pereira-Santos, Darklilson; Brêda-Júnior, Marcus Antônio; Ferraz, Emanuela Prado; Crippa, Grasiele Edilaine; de Oliveira, Fabíola Singaretti; da Rocha-Barros, Valdemar Mallet

    2013-09-01

    The purpose of this study is to comparatively assess the effect of midazolam and nitrous oxide associated with oxygen, in lower third molar extractions, on the change in the anxiety level of patients by salivary cortisol dosage. Twenty-eight male patients underwent lower third molar extraction under sedation with midazolam and nitrous oxide. Objective (salivary cortisol dosage) and subjective (Corah Dental Anxiety Scale) data have been obtained. By salivary cortisol, 40 minutes after midazolam administration, there has been a statistically significant difference compared with the mean baseline value. Midazolam was the most effective sedation method for reducing salivary cortisol level.

  5. Comparative study of semilocal density functionals on solids and surfaces

    NASA Astrophysics Data System (ADS)

    Mo, Yuxiang; Tian, Guocai; Tao, Jianmin

    2017-08-01

    Recently, Tao and Mo (TM) proposed an accurate nonempirical meta-generalized gradient approximation (meta-GGA). To better understand the performance of this functional, here we make a comparative study of the combinations of the TM exchange part with the original TPSS correlation (TMTPSS) and the modified TPSS correlation (TM) on a variety of solids and surfaces. Specifically, we compare the performance of these two functionals on 22 lattice constants and bulk moduli, 30 band gaps of semiconductors, 7 cohesive energies, and surface exchange-correlation energies of simple metals with rs ranging from 2 to 3 bohr.

  6. Comparing classification methods for longitudinal fMRI studies.

    PubMed

    Schmah, Tanya; Yourganov, Grigori; Zemel, Richard S; Hinton, Geoffrey E; Small, Steven L; Strother, Stephen C

    2010-11-01

    We compare 10 methods of classifying fMRI volumes by applying them to data from a longitudinal study of stroke recovery: adaptive Fisher's linear and quadratic discriminant; gaussian naive Bayes; support vector machines with linear, quadratic, and radial basis function (RBF) kernels; logistic regression; two novel methods based on pairs of restricted Boltzmann machines (RBM); and K-nearest neighbors. All methods were tested on three binary classification tasks, and their out-of-sample classification accuracies are compared. The relative performance of the methods varies considerably across subjects and classification tasks. The best overall performers were adaptive quadratic discriminant, support vector machines with RBF kernels, and generatively trained pairs of RBMs.

  7. Comparative study of lung functions in swimmers and runners.

    PubMed

    Sable, Meenakshi; Vaidya, S M; Sable, S S

    2012-01-01

    In the present study pulmonary function tests of two different groups of athletes, swimmers and runners were studied and compared. Thirty swimmers who used to swim a distance of two to three kilometers per day regularly were compared with age, sex, height, and weight matched thirty middle distance runners. Runners and swimmers selected for this study were undergoing training since last three years. Tidal Volume (TV), forced Vital Capacity (FVC). Forced expiratory volume in one second (FEV1) and maximum voluntary ventilation (MVV) were higher in swimmers than runners. Swimming exercise affects lung volume measurements as respiratory muscles including diaphragm of swimmers are required to develop greater pressure as a consequence of immersion in water during respiratory cycle, thus may lead to functional improvement in these muscles and also alterations in elasticity of lung and chest wall or of ventilatory muscles, leading to an improvement in forced vital capacity and other lung functions of swimmers than runners.

  8. Transvaginal hydrolaparoscopy compared with laparoscopy for the evaluation of infertile women: a prospective comparative blind study.

    PubMed

    Darai, E; Dessolle, L; Lecuru, F; Soriano, D

    2000-11-01

    Standard diagnostic laparoscopy is considered the gold standard to investigate tubo-peritoneal infertility. It requires general anaesthesia and full operative facilities. Due to the risk of complications, laparoscopy is frequently postponed to the final stage of infertility evaluation or even after treatment trials have failed. Transvaginal hydrolaparoscopy (THL) is based on vaginal access using a needle puncture technique and saline for distention. THL can be performed on an outpatient basis under local anaesthesia. However, little data exist concerning the accuracy of THL in comparison with laparoscopy. We conducted a prospective comparative blind trial to assess the feasibility and accuracy of THL compared with diagnostic laparoscopy in infertile women. Sixty women were assigned to undergo THL immediately prior to laparoscopy. Different operators evaluated the findings of the two procedures. In order to evaluate the accuracy of THL, findings in terms of tubal pathology, endometriosis and adhesions were analysed. The success rate of accessing the pouch of Douglas was 90.2%. Complication rate was 1.6%. THL diagnosis was correlated with that of laparoscopy in 92.3% of cases. In cases of abnormal findings by THL, there were no normal laparoscopies. Our pilot study suggests that THL is a safe and reproducible method. Retroverted uterus should be considered as a relative contraindication to THL. When a complete evaluation by THL is available, it is a highly accurate technique in comparison with the laparoscopy.

  9. Comparative chemical study of MTA and Portland cements.

    PubMed

    Oliveira, Marília Gerhardt de; Xavier, Cristina Braga; Demarco, Flávio Fernando; Pinheiro, Antônio Luis Barbosa; Costa, Aline Tempel; Pozza, Daniel Humberto

    2007-01-01

    Portland cement has been analyzed and compared to mineral trioxide aggregate (MTA) because of their chemical similarity. The possibility of using this material as a less expensive alternative to MTA in dental practice should be considered. In view of this, the present study compared the components of a Portland cement (Votoran) to two commercial brands of MTA (Pro-Root and MTA-Angelus). Twelve specimens of each material were fabricated and examined by scanning electron microscopy (SEM) with energy dispersive spectroscopy (EDS) to obtain their percentage of chemical elements. The means of the chemical elements found in each material was compared by descriptive statistics. Bismuth was present only in MTA cements to provide radiopacity. In conclusion, the tested cements have similar components, which supports, as far as composition is concerned, the possible clinical use of Portland as an option to MTA.

  10. Ergonomic intervention, workplace exercises and musculoskeletal complaints: a comparative study

    PubMed Central

    Mehrparvar, Amir Houshang; Heydari, Mohammad; Mirmohammadi, Seyyed Jalil; Mostaghaci, Mehrdad; Davari, Mohammad Hossein; Taheri, Mahmoud

    2014-01-01

    Background: Musculoskeletal disorders are among the most prevalent occupational disorders in different jobs such as office work. Some interventions such as ergonomic modifications and workplace exercises are introduced as the methods for alleviating these disorders. In this study we compared the effect of ergonomic modifications and workplace exercises on musculoskeletal pain and discomfort in a group of office workers. Methods: In an interventional study on office workers, the effect of two interventions was compared. Ergonomic modification consisted of correcting the arrangement of workstation and changing some equipment; workplace exercises included stretching exercises focusing on neck, shoulders, low back, and hand and wrist. Musculoskeletal complaints were assessed and compared before and after 1 month interventions. Results: The frequency of musculoskeletal complaints was high before the study. Both interventions significantly reduced complaints in a similar manner except for low back pain which was reduced in exercise group more than the other group. Conclusion: In this study we found a beneficial short-term effect for both ergonomic modifications and stretching work-place exercises on reducing musculoskeletal pain in office workers. PMID:25405134

  11. Ergonomic intervention, workplace exercises and musculoskeletal complaints: a comparative study.

    PubMed

    Mehrparvar, Amir Houshang; Heydari, Mohammad; Mirmohammadi, Seyyed Jalil; Mostaghaci, Mehrdad; Davari, Mohammad Hossein; Taheri, Mahmoud

    2014-01-01

    Musculoskeletal disorders are among the most prevalent occupational disorders in different jobs such as office work. Some interventions such as ergonomic modifications and workplace exercises are introduced as the methods for alleviating these disorders. In this study we compared the effect of ergonomic modifications and workplace exercises on musculoskeletal pain and discomfort in a group of office workers. In an interventional study on office workers, the effect of two interventions was compared. Ergonomic modification consisted of correcting the arrangement of workstation and changing some equipment; workplace exercises included stretching exercises focusing on neck, shoulders, low back, and hand and wrist. Musculoskeletal complaints were assessed and compared before and after 1 month interventions. The frequency of musculoskeletal complaints was high before the study. Both interventions significantly reduced complaints in a similar manner except for low back pain which was reduced in exercise group more than the other group. In this study we found a beneficial short-term effect for both ergonomic modifications and stretching work-place exercises on reducing musculoskeletal pain in office workers.

  12. Analytical lessons learned from selected therapeutic protein drug comparability studies.

    PubMed

    Federici, Marcia; Lubiniecki, Anthony; Manikwar, Prakash; Volkin, David B

    2013-05-01

    The successful implementation of process and product changes for a therapeutic protein drug, both during clinical development and after commercialization, requires a detailed evaluation of their impact on the protein's structure and biological functionality. This analysis is called a comparability exercise and includes a data driven assessment of biochemical equivalence and biological characterization using a cadre of analytical methodologies. This review focuses on describing analytical results and lessons learned from selected published therapeutic protein comparability case studies both for bulk drug substance and final drug product. An overview of the currently available analytical methodologies typically used is presented as well as a discussion of new emerging analytical techniques. The potential utility of several novel analytical approaches to comparability studies is discussed including distribution and stability of protein drugs in vivo, and enhanced evaluation of higher-order protein structure in actual formulations using hydrogen/deuterium exchange mass spectrometry, two-dimensional nuclear magnetic resonance fingerprinting or empirical phase diagrams. In addition, new methods for detecting and characterizing protein aggregates and particles are presented as these degradants are of current industry-wide concern. The critical role that analytical methodologies play in elucidating the structure-function relationships for therapeutic protein products during the overall assessment of comparability is discussed.

  13. A comparative study of orphan drug prices in Europe

    PubMed Central

    Young, Katherine Eve; Soussi, Imen; Hemels, Michiel; Toumi, Mondher

    2017-01-01

    ABSTRACT Background and Objective: This study assessed price differences by comparing annual treatment costs of similarly available orphan drugs in France, Germany, Italy, Norway, Spain, Sweden, and UK. Methods: Annual treatment costs per drug were calculated using ex-factory prices from IHS POLI and country price databases. The treatment cost in the comparator country was compared to the UK and ratios were analysed. Subanalyses were done on disease areas and UK cost quartiles. Results: 120 orphan drugs were included. Compared to the UK, the average costs were more expensive in France (1.13), Germany (1.11), Italy (1.08), Spain (1.07), and were cheaper in Sweden (0.99) and Norway (0.88). The average ratios offered a restrictive view as ratios were greatly heterogeneous (0.26 to 1.92) which was also seen in the different disease areas. The averaged ratios varied minimally among the cost quartiles which shows that cost differences were similar for the most expensive and least expensive orphan drugs in the UK. Conclusions: Individual orphan drug prices can vary widely across European countries, although on average these differences are relatively minor. This study suggests that in Europe, we may not be able predict which country may have higher or lower prices for orphan drugs. PMID:28473887

  14. A Comparative Study between Carcinoma and Sarcoma Using Raman Spectroscopy

    NASA Astrophysics Data System (ADS)

    Dehghani-Bidgoli, Z.; Baygi, M. H. Miran; Kabir, E.; Malekfar, R.

    2014-01-01

    The purpose of this study was to find discriminating Raman spectral features between two major types of cancer, i.e., carcinoma and sarcoma. To this end, Raman spectra from adenocarcinoma, liposarcoma and fibrosarcoma samples were compared. A Raman system was used for the tissue Raman spectroscopic measurements at 785-nm laser excitation. After pre-processings, the Raman spectra were investigated, in major bands associated with protein and lipids, in the adenocarcinoma, liposarcoma, and fibrosarcoma groups. Principal component analysis and nonnegative matrix factorization were performed for finding most significant features in discriminating the spectra of carcinoma from those of sarcoma samples. The findings of this study show that the lipid content in the sarcoma samples decreases compared with the carcinoma samples. The achieved accuracy in discriminating carcinoma from sarcoma by linear discriminant analysis is 93.75 % and 90.63 % using the first nine principal components and nonnegative matrix factorization analysis, respectively.

  15. Comparative study of infrared wavefront sensing solutions for adaptive optics

    NASA Astrophysics Data System (ADS)

    Plantet, C.; Fusco, T.; Guerineau, N.; Derelle, S.; Robert, C.

    2016-07-01

    The development of new low-noise infrared detectors, such as RAPID (CEA LETI/Sofradir) or SAPHIRA (Selex), has given the possibility to consider infrared wavefront sensing at low ux. We propose here a comparative study of near infrared (J and H bands) wavefront sensing concepts for mid and high orders estimation on a 8m- class telescope, relying on three existing wavefront sensors: the Shack-Hartmann sensor, the pyramid sensor and the quadri-wave lateral shearing interferometer. We consider several conceptual designs using the RAPID camera, making a trade-off between background flux, optical thickness and compatibility with a compact cryostat integration. We then study their sensitivity to noise in order to compare them in different practical scenarios. The pyramid provides the best performance, with a gain up to 0.5 magnitude, and has an advantageous setup.

  16. Comparative study of turbulence models in predicting hypersonic inlet flows

    NASA Technical Reports Server (NTRS)

    Kapoor, Kamlesh; Anderson, Bernhard H.; Shaw, Robert J.

    1992-01-01

    A numerical study was conducted to analyze the performance of different turbulence models when applied to the hypersonic NASA P8 inlet. Computational results from the PARC2D code, which solves the full two-dimensional Reynolds-averaged Navier-Stokes equation, were compared with experimental data. The zero-equation models considered for the study were the Baldwin-Lomax model, the Thomas model, and a combination of the Baldwin-Lomax and Thomas models; the two-equation models considered were the Chien model, the Speziale model (both low Reynolds number), and the Launder and Spalding model (high Reynolds number). The Thomas model performed best among the zero-equation models, and predicted good pressure distributions. The Chien and Speziale models compared very well with the experimental data, and performed better than the Thomas model near the walls.

  17. [Fatal child abuse in Japan and Germany. Comparative retrospective study].

    PubMed

    Ohtsuji, M; Ohshima, T; Kondo, T; Godoy, M R; Oehmichen, M

    1998-01-01

    In this study a record for comparative international epidemiological studies on autopsy cases of child abuse is introduced. The form was proved in a retrospective comparative survey of cases of fatal child abuse at the Department of Legal Medicine in Kanazawa (Japan) and Institute of Legal Medicine of Lübeck (Germany). A total of 33 cases were included. The following data were evaluated: age and gender of victims and assailants, relationship between victims and assailants, causes and methods of abuse, chief autopsy findings, and causes of death. The results were leading into two directions between Kanazawa and Lübeck: (1) In the years of 1981-1996 in Kanazawa 23 cases of fatal child abuse were autopsied while during the same period in Lübeck only 10 cases were registered. (2) While sexual abuse was not registered in Kanazawa, it was recorded twice in Lübeck.

  18. Comparative study of turbulence models in predicting hypersonic inlet flows

    NASA Technical Reports Server (NTRS)

    Kapoor, Kamlesh; Anderson, Bernhard H.; Shaw, Robert J.

    1992-01-01

    A numerical study was conducted to analyze the performance of different turbulence models when applied to the hypersonic NASA P8 inlet. Computational results from the PARC2D code, which solves the full two-dimensional Reynolds-averaged Navier-Stokes equation, were compared with experimental data. The zero-equation models considered for the study were the Baldwin-Lomax model, the Thomas model, and a combination of the Baldwin-Lomax and Thomas models; the two-equation models considered were the Chien model, the Speziale model (both low Reynolds number), and the Launder and Spalding model (high Reynolds number). The Thomas model performed best among the zero-equation models, and predicted good pressure distributions. The Chien and Speziale models compared wery well with the experimental data, and performed better than the Thomas model near the walls.

  19. Positioning for Endovenous Laser Ablation: Comparative Study with Thigh Stripping

    PubMed Central

    Masaki, Hisao; Yunoki, Yasuhiro; Watanabe, Yoshiko; Furukawa, Hiroshi; Yamasawa, Takahiko; Takiuchi, Hiroki; Honda, Takeshi; Kuwada, Noriaki; Kojima, Kenji; Tanemoto, Kazuo

    2016-01-01

    We performed a comparative study of surgical outcomes and venous functions between endovenous laser ablation with a 980-nm diode laser (EV group) and thigh stripping (ST group). There were no severe complications and initial success rates were 100% in both groups. In the EV group, preoperative symptoms improved in 94.3% of cases, the venous occlusion rate was 98%, and endovenous heat induced thrombosis had occurred in 11.9% (Class 3: 0.7%) at 12 months after the operation. Although comparative study of postoperative venous function by air plethysmography showed significant improvement in both groups, there was less recovery of postoperative venous function in the EV than in the ST group. (This article is a translation of J Jpn Coll Angiol 2015; 55: 13–20.) PMID:27738455

  20. A comparative study of primary and secondary stereotypies.

    PubMed

    Ghosh, Debabrata; Rajan, Prashant V; Erenberg, Gerald

    2013-12-01

    This study compares primary stereotypies (repetitive, self-stimulating, and seemingly nonsensical movements that can occur within typically developing children) and secondary stereotypies (those occurring within autistic or mentally retarded children). Utilizing a retrospective chart review from 1995 to 2010, the current study compares primary and secondary stereotypies by the application of a classification system that organizes the movement by its type (motor only, phonic only, mixed) and complexity. In addition, it investigates other parameters associated with the movements such as duration, frequency, age, functional impairment, and progression. The sample group consisted of 28 primary and 28 secondary cases. Primary stereotypies were predominantly motor, simple, of shorter duration, and of less frequency, whereas secondary stereotypies had more vocalization, complexity, longer durations, and higher frequencies. Moreover, functional impairment due to stereotypies was noted in 3 primary and 7 secondary cases, and worsening of stereotypies was noted in 70% of primary versus 44% of secondary cases.

  1. Magnetic field effect on indole exciplexes: a comparative study

    NASA Astrophysics Data System (ADS)

    Sengupta, Tamal; Basu, Samita

    2004-04-01

    A comparative magnetic field effect (MFE) study was done on indole exciplexes with various acceptors, anthracene, pyrene, all-s- trans-1,4-diphenylbuta-1,3-diene and 9-cyanophenanthrene. A surprisingly low magnetic field effect was detected for the 9-cyanophenanthrene exciplexes and was correlated with exciplex geometry. The wavelength dependence of magnetic field effect confirms the presence of single charge-transfer complex for all the exciplexes with 1,2-dimethylindole.

  2. What is AIDS in Guadeloupe? A descriptive and comparative study.

    PubMed

    Elenga, Narcisse; Georger-Sow, Marie-Thérèse; Messiaen, Thierry; Lamaury, Isabelle; Favre, Isabelle; Nacher, Mathieu; Beaucaire, Gilles

    2014-03-01

    Since the pathogen ecology differs between Caribbean regions, specific differences in the most frequent clinical presentations of acquired immunodeficiency syndrome (AIDS) may be expected. We therefore conducted the present retrospective cohort study in order to describe the main AIDS-defining events in Guadeloupe and to compare them with those observed in Metropolitan France and in French Guiana. We discuss the local pathogen ecology, the diagnostic limitations of hospitals in overseas territories and the drivers of the epidemic.

  3. Comparative Statistical Study of Some SAP UI Technologies

    NASA Astrophysics Data System (ADS)

    Berdie, Adela; Osaci, Mihaela; Dan Lemle, Ludovic

    2011-09-01

    The goal of this paper is to present a comparative study on some web UI (User Interface) technologies that involve the creation of web applications on the platform SAP Net Weaver AS 7.01 of the integrated SAP (System Application Products) system. The attention will be directed mainly to the ABAP (Advanced Business Application Programing) development environment and to the Web Dynpro (WD) technologies, Floor Plan Manager (FPM) and Web Client UI. Through this study, we make an assesment regarding the decision of choosing a technology for the realisation of a project which consists of a web application.

  4. Image based 3D city modeling : Comparative study

    NASA Astrophysics Data System (ADS)

    Singh, S. P.; Jain, K.; Mandla, V. R.

    2014-06-01

    3D city model is a digital representation of the Earth's surface and it's related objects such as building, tree, vegetation, and some manmade feature belonging to urban area. The demand of 3D city modeling is increasing rapidly for various engineering and non-engineering applications. Generally four main image based approaches were used for virtual 3D city models generation. In first approach, researchers were used Sketch based modeling, second method is Procedural grammar based modeling, third approach is Close range photogrammetry based modeling and fourth approach is mainly based on Computer Vision techniques. SketchUp, CityEngine, Photomodeler and Agisoft Photoscan are the main softwares to represent these approaches respectively. These softwares have different approaches & methods suitable for image based 3D city modeling. Literature study shows that till date, there is no complete such type of comparative study available to create complete 3D city model by using images. This paper gives a comparative assessment of these four image based 3D modeling approaches. This comparative study is mainly based on data acquisition methods, data processing techniques and output 3D model products. For this research work, study area is the campus of civil engineering department, Indian Institute of Technology, Roorkee (India). This 3D campus acts as a prototype for city. This study also explains various governing parameters, factors and work experiences. This research work also gives a brief introduction, strengths and weakness of these four image based techniques. Some personal comment is also given as what can do or what can't do from these softwares. At the last, this study shows; it concluded that, each and every software has some advantages and limitations. Choice of software depends on user requirements of 3D project. For normal visualization project, SketchUp software is a good option. For 3D documentation record, Photomodeler gives good result. For Large city

  5. Comparative inhalation studies with American and Estonian oil shale

    SciTech Connect

    Holland, L.M.; Vigil, E.A.; Gonzales, M.; Tillery, M.I.

    1981-01-01

    This paper presents interim findings on studies comparing the effects of long-term inhalation of quartz, Estonian kukersite, or American Green River shales in rats. No tumors have been observed in the exposed animals. In the studies with Green River shales, the rate of death increased as the animals approached 2 years of exposure. Varying degrees of lung fibrosis has been noted in these animals also. Animals in the kukersite group exhibited only mild changes with some alveolar thickening, and increased macrophages and collagen. Quartz exposed animals suffered severe fibrosis after several months exposure and died after 12 to 15 months.

  6. Comparative study of some commercial samples of naga bhasma.

    PubMed

    Wadekar, Mrudula; Gogte, Viswas; Khandagale, Prasad; Prabhune, Asmita

    2004-04-01

    Naga bhasma is one of those reputed ayurvedic bhasmas which are claimed to possess some extraordinary medical properties. However, identification of a genuine sample of naga bhasma is a challenging problem. Because at present naga bhasma is manufactured by different ayurvedic pharmacies, by following different methods, these products are not standardised either from chemical and structural point of view. Therefore, comparative study of these samples using modern analytical techniques is important and necessary to understand their current status. In this communication, such study of naga bhasma from chemical and structural point of view is reported by using XRD, IR and UV spectroscopy and thermogravimetry.

  7. A comparative study of fluoride release from two different sealants.

    PubMed

    Ananda, Shimoga-Raju; Mythri, Halappa

    2014-12-01

    The introduction of fluoride releasing sealants and glass ionomer cements as fissure sealants adds another dimension to prevention of pit and fissure caries. The ability of resin sealants and glass ionomer cements to release fluoride on a long term basis to the sealed enamel and the adjacent unsealed pit and fissure and cuspal incline enamel may allow for further reduction in pit and fissure caries experience for children. Hence, the study was conducted to compare the amount of fluoride release in the plaque after placing fluoride releasing pit and fissure sealants and glass ionomer fissure sealants used in Atraumatic Restorative Treatment (ART) approach. To compare the fluoride release of both the materials at the different time intervals. A total of 60 school going children were included in this study. Before application of the sealants, baseline plaque fluoride levels were estimated from all the study subjects. After application of sealants again the same was estimated at an interval of 24 hour, 9 days, 2 weeks and 4 weeks. The peak plaque fluoride levels were achieved at 24 hours after application of fissure sealants in all the groups. Within the limitation of the study, the present study indicated that fluoride releasing fissure sealants may act as a source of fluoride in plaque which will help in preventing pit and fissure and smooth surface caries in the tooth sealed with fissure sealants. Key words:Plaque fluoride, pit and fissures sealants, dental caries.

  8. A comparative study of fluoride release from two different sealants

    PubMed Central

    Ananda, Shimoga-Raju

    2014-01-01

    Objectives: The introduction of fluoride releasing sealants and glass ionomer cements as fissure sealants adds another dimension to prevention of pit and fissure caries. The ability of resin sealants and glass ionomer cements to release fluoride on a long term basis to the sealed enamel and the adjacent unsealed pit and fissure and cuspal incline enamel may allow for further reduction in pit and fissure caries experience for children. Hence, the study was conducted to compare the amount of fluoride release in the plaque after placing fluoride releasing pit and fissure sealants and glass ionomer fissure sealants used in Atraumatic Restorative Treatment (ART) approach. To compare the fluoride release of both the materials at the different time intervals. Material and Methods: A total of 60 school going children were included in this study. Before application of the sealants, baseline plaque fluoride levels were estimated from all the study subjects. After application of sealants again the same was estimated at an interval of 24 hour, 9 days, 2 weeks and 4 weeks. Results: The peak plaque fluoride levels were achieved at 24 hours after application of fissure sealants in all the groups. Conclusions: Within the limitation of the study, the present study indicated that fluoride releasing fissure sealants may act as a source of fluoride in plaque which will help in preventing pit and fissure and smooth surface caries in the tooth sealed with fissure sealants. Key words:Plaque fluoride, pit and fissures sealants, dental caries. PMID:25674315

  9. Comparative photodynamic therapy study using two phthalocyanine derivatives

    PubMed Central

    YSLAS, EDITH INÉS; MILLA, LAURA NATALIA; ROMANINI, SILVIA; DURANTINI, EDGARDO NÉSTOR; BERTUZZI, MABEL; RIVAROLA, VIVIANA ALICIA

    2010-01-01

    In the present study, a comparative photodynamic therapy (PDT) study was performed using the phthalocyanine derivatives, ZnPc(OCH3)4 and ZnPc(CF3)4, in a mouse tumor model, under identical experimental procedures. We studied the ablation of tumors induced by PDT. The end-point was to compare the photodynamic efficacy of ZnPc(OCH3)4 and ZnPc(CF3)4. ZnPc(OCH3)4 and ZnPc(CF3)4 were administered intraperitoneally at a dose of 0.2 mg/kg body weight. The injections of drugs were carried out in Balb/c mice bearing subcutaneously inoculated LM2 mouse mammary adenocarcinoma. Histological examination and serum biochemical parameters were used to evaluate hepatic and renal toxicity and function. Phototherapeutic studies were achieved employing a light intensity of 210 J/cm2. After PDT, tumoral regression analyses were carried out, and the degree of tumor cell death was measured utilizing the vital stain Evan’s blue. In this pilot study, we revealed that the cytotoxic effect of ZnPc(OCH3)4 after PDT led to a higher success rate compared to ZnPc(CF3)4-PDT when both were intraperitoneally injectioned. Both phthalocynanine derivatives were able to induce ablation in the tumors. In summary, these results demonstrate the feasibility of ZnPc(OCH3)4- or ZnPc(CF3)4-PDT and its potential as a treatment for small tumors. PMID:22993594

  10. Comparative experimental study of argon plasma and bipolar coagulation techniques.

    PubMed

    Riegel, T; Tirakotai, W; Mennel, H D; Hellwig, D; Sure, U; Bertalanffy, H; Celik, I

    2006-07-01

    Argon plasma coagulation (APC) is based on the principle of ionised argon creating conductive plasma between an activating electrode and tissue surface and is used as an effective alternative coagulation technique in various surgical disciplines. This trial aims to compare thermal injury in rat brain caused by APC and conventional bipolar coagulation technique. A controlled study design with constant power setting and application time was established. Twenty rats were randomised into the APC and bipolar groups. Each group of ten rats had 20 treated lesions. Early and late histopathological changes, as well as maximum extent of the lesion after 48 hours (h) and 12 days were studied in overall 20 lesions. Although the maximum depth of the lesions was different in APC (2.2 mm) and bipolar (1.8 mm) groups after 48 h, this did not achieve statistical significance (p=0.151). The superficially coagulated area was significantly larger after APC compared with the bipolar technique at the 48 h time point (p=0.032). After twelve days there were no differences in penetration depth (p=0.310) or coagulated area (p=0.222). Tissue defects after APC application on rat brains were comparable to conventional bipolar technique in this trial. The results suggest that argon plasma coagulation (APC) is an effective coagulation technique.

  11. A comparative clinical study on the Carisolv caries removal method.

    PubMed

    Kakaboura, Afrodite; Masouras, Costas; Staikou, Olga; Vougiouklakis, George

    2003-04-01

    Carisolv is a relatively new chemomechanical method for caries removal. The aim of this clinical study was to compare Carisolv with the conventional drilling technique. Forty-five volunteers, ages 18 to 55 years, each with two contralateral primary coronal mesio-occlusal or disto-occlusal carious lesions, similar in extent, participated in the study. Two calibrated operators treated all lesions. One operator treated both lesions in one visit (one lesion with Carisolv and the other with conventional drilling). Following the filling procedure, the opinion of each patient regarding each caries removal method was recorded. The need for drilling in addition to the Carisolv application, the time required for caries removal, the need for anesthesia, and the gingival reaction to the Carisolv gel were recorded by each operator for each case. The patients found Carisolv treatment more pleasant (82%) and preferable (88%) to drilling. Of the patients treated with drilling, 40% required anesthesia compared to the 8% treated with Carisolv. Additional drilling for complete caries removal was needed in 10% of Carisolv-treated lesions. Carisolv induced no gingival reaction. Significantly longer times were required for caries removal with Carisolv (12.2 +/- 4.1 minutes) compared to drilling (6.8 +/- 2.8 minutes). The Carisolv technique was: (a) accepted by the majority of patients, (b) efficient for caries removal, (c) considered a time-consuming technique for the dentists, and (d) considered less dependent on local anesthesia.

  12. Comparative study of gabapentin and isoflavone in menopausal vasomotor symptoms

    PubMed Central

    Singhal, Savita Rani; Shullai, Wansalan Kuru

    2016-01-01

    Objective: This study was planned to compare the effects of gabapentin and isoflavones in menopausal vasomotor symptoms. Materials and Methods: This prospective comparative study was conducted on 100 patients with complaints of hot flashes, divided into two groups of 50 each. Group I received 900 mg of gabapentin and Group II received 60 mg of isoflavones daily for 3 months. The patients were interviewed to calculate hot flash, global and depression scores and were rescored after 2, 4, 8, and 12 weeks. The primary outcome measure was a change in the hot flash score from baseline. The secondary outcome was an improvement in sleep, depression, and lipid profile. Data were analyzed using Chi-square test and Student's t-test. Results: Both groups showed significant improvement in hot flash score at the end of 12 weeks (82% Group I, 74% Group II; P = 0.076). Statistically significant difference was seen at 12 weeks in sleep quality in favor of gabapentin (P = 0.011) and in depression in favor of isoflavones (0.026). Isoflavone had significant improvement in cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides profiles after 12 weeks (P < 0.001, 0.009, 0.024 and <0.001, respectively) as compared to gabapentin. Conclusion: Isoflavone and gabapentin are equally effective in the treatment of hot flashes; however, isoflavones have better response in patients who have associated with complaints of depression and gabapentin is better who have associated sleep disturbance. PMID:27721641

  13. Comparing protein VEGF inhibitors: In vitro biological studies

    SciTech Connect

    Yu, Lanlan; Liang, Xiao Huan; Ferrara, Napoleone

    2011-05-06

    Highlights: {yields} VEGF is a mediator of angiogenesis. {yields} VEGF inhibitors have clinical applications in cancer and eye disorders. {yields} Five protein VEGF inhibitors were compared for their ability to inhibit. {yields} VEGF-induced activities in cultured endothelial cells. -- Abstract: VEGF inhibitors are widely used as a therapy for tumors and intravascular neovascular disorders, but limited and conflicting data regarding their relative biological potencies are available. The purpose of the study is to compare different protein VEGF inhibitors for their ability to inhibit VEGF-stimulated activities. We tested ranibizumab, the full-length variant of ranibizumab (Mab Y0317), bevacizumab, the VEGF-TrapR1R2 and Flt(1-3)-IgG in bioassays measuring VEGF-stimulated proliferation of bovine retinal microvascular endothelial cells or chemotaxis of human umbilical vein endothelial cells (HUVEC). The inhibitors were also compared for their ability to inhibit MAP kinase activation in HUVECs following VEGF addition. Ranibizumab, VEGF-TrapR1R2 and Flt(1-3)-IgG had very similar potencies in the bioassays tested. Bevacizumab was over 10-fold less potent than these molecules. Mab Y0317 was over 30-fold more potent than bevacizumab. The findings reported in this manuscript describe important intrinsic characteristics of several VEGF inhibitors that may be useful to design and interpret preclinical or clinical studies.

  14. Comparative inter-institutional study of stress among dentists.

    PubMed

    Pozos-Radillo, Blanca E; Galván-Ramírez, Ma Luz; Pando, Manuel; Carrión, Ma De los Angeles; González, Guillermo J

    2010-01-01

    Dentistry is considered to be a stressful profession due to different factors caused by work, representing a threat to dentists'health. The objectives of this work were to identify and compare chronic stress in dentists among the different health institutions and the association of stress with risk factors. The study in question is observational, transversal and comparative; 256 dentists were included, distributed among five public health institutions in the city of Guadalajara, Jalisco, Mexico, namely: the Mexican Institute of Social Security (IMSS), the Ministry of Health (SS), the Integral Development of the Family (DIF), the Social Security Services Institute for the Workers (ISSSTE) and the University of Guadalajara (U. de G) Data were obtained by means of the census technique. Stress was identified using the Stress Symptoms Inventory and the statistical analysis was performed using the Odds Ratio (O.R.) and the chi-square statistic. From the total population studied, 219 subjects presented high levels of chronic stress and 37, low levels. In the results of comparative analysis, significant differences were found between IMSS and U. de G and likewise between IMSS and SS. However, in the analysis of association, only U. de G was found to be associated with the high level of chronic stress.

  15. Comparative study of convective heat transfer characteristics of nanofluids

    NASA Astrophysics Data System (ADS)

    Muryam, Hina; Ramzan, Naveed; Umer, Asim; Awan, Gul Hameed; Hassan, Ali

    2017-02-01

    The present research is about to draw a comparison between heat transfer characteristics of gold/deionized water (DIW) and silver/DIW based nanofluid under same heat flux for laminar flow. Experiments are performed on both nanofluid by using different concentrations (0.015, 0.045, 0.0667%) of nano-particles (NPs) in DIW as a base fluid. The experimental study concludes that an appreciable intensification in heat transfer coefficient (HTC) of both nanofluid has been attained as compare to base fluid. However, gold/DIW based nanofluid exhibit better convective heat transfer intensification compared with silver/DIW based nanofluid but Shah correlation cannot predict as much augmentation as in experimental work for both nanofluid. It is also noticed that the anomalous enhancement in Nusselt number and HTC is not only due to the accession in thermal properties but also by the formation of thinner thermal boundary layer at the entrance of the tube due to NPs.

  16. A comparative study of three methods for robot kinematics.

    PubMed

    Aspragathos, N A; Dimitros, J K

    1998-01-01

    Three methods for the formulation of the kinematic equations of robots with rigid links are presented in this paper. The first and most common method in the robotics community is based on 4x4 homogeneous matrix transformation, the second one is based on Lie algebra, and the third one on screw theory expressed via dual quaternions algebra. These three methods are compared in this paper for their use in the kinematic analysis of robot arms. The basic theory and the transformation operators, upon which every method is based, are referenced. Three analytic algorithms are presented for the solution of the direct kinematic problem corresponding to each method, and the geometric significance of the transformation operators and parameters is explained. Finally, a comparative study on the computation and storage requirements for the three methods is worked out.

  17. Comparative study of convective heat transfer characteristics of nanofluids

    NASA Astrophysics Data System (ADS)

    Muryam, Hina; Ramzan, Naveed; Umer, Asim; Awan, Gul Hameed; Hassan, Ali

    2017-07-01

    The present research is about to draw a comparison between heat transfer characteristics of gold/deionized water (DIW) and silver/DIW based nanofluid under same heat flux for laminar flow. Experiments are performed on both nanofluid by using different concentrations (0.015, 0.045, 0.0667%) of nano-particles (NPs) in DIW as a base fluid. The experimental study concludes that an appreciable intensification in heat transfer coefficient (HTC) of both nanofluid has been attained as compare to base fluid. However, gold/DIW based nanofluid exhibit better convective heat transfer intensification compared with silver/DIW based nanofluid but Shah correlation cannot predict as much augmentation as in experimental work for both nanofluid. It is also noticed that the anomalous enhancement in Nusselt number and HTC is not only due to the accession in thermal properties but also by the formation of thinner thermal boundary layer at the entrance of the tube due to NPs.

  18. Comparative studies of industrial grade carbon black powders

    NASA Astrophysics Data System (ADS)

    Chawla, Komal; Chauhan, Alok P. S.

    2016-05-01

    Comparative studies of two dissimilar industrial grade Carbon Black (CB) powders (N375 and N405) were conducted. The structure, surface area and particle size are the three important characteristics of CB powder that determine their processability and application as filler in preparing rubber compounds. The powders were characterized for their structure using dibutyl phthalate absorption (DBPA), particle size via laser particle size analyzer and surface area by nitrogen adsorption method. The structural characterization showed that N405 had lower DBPA in comparison to N375, confirming low structure of N405 grade CB powder. It was observed from the particle size analysis that N375 was coarser than N405 grade CB. The total surface area values were determined by the BET method based on the cross sectional area of the nitrogen molecule. N375, a coarse grade CB powder with high structure, depicted less surface area as compared to N405.

  19. A comparative study of bifidobacteria in human babies and adults

    PubMed Central

    KHONSARI, Shadi; SUGANTHY, Mayuran; BURCZYNSKA, Beata; DANG, Vu; CHOUDHURY, Manika; PACHENARI, Azra

    2015-01-01

    The composition and diversity of the gut microbiota are known to be different between babies and adults. The aim of this project was to compare the level of bifidobacteria between babies and adults and to investigate the influence of lifestyle factors on the level of this bacterium in the gut. During this study, the levels of bifidobacteria in 10 human babies below 2 years of age were compared with that of 10 human adults above 40 years. The level of bifidobacteria proved to be significantly higher in babies in comparison with adults. This investigation concluded that a combination of several factors, such as age, diet, and BMI, has an important effect on the level of bifidobacteria in adults, while in babies, a combination of diet and age may influence the level of intestinal bifidobacteria. PMID:27200263

  20. Comparative studies of industrial grade carbon black powders

    SciTech Connect

    Chawla, Komal Chauhan, Alok P. S. E-mail: alok.chauhan@alumni.stonybrook.edu

    2016-05-06

    Comparative studies of two dissimilar industrial grade Carbon Black (CB) powders (N375 and N405) were conducted. The structure, surface area and particle size are the three important characteristics of CB powder that determine their processability and application as filler in preparing rubber compounds. The powders were characterized for their structure using dibutyl phthalate absorption (DBPA), particle size via laser particle size analyzer and surface area by nitrogen adsorption method. The structural characterization showed that N405 had lower DBPA in comparison to N375, confirming low structure of N405 grade CB powder. It was observed from the particle size analysis that N375 was coarser than N405 grade CB. The total surface area values were determined by the BET method based on the cross sectional area of the nitrogen molecule. N375, a coarse grade CB powder with high structure, depicted less surface area as compared to N405.

  1. Assessing analytical comparability of biosimilars: GCSF as a case study.

    PubMed

    Nupur, Neh; Singh, Sumit Kumar; Narula, Gunjan; Rathore, Anurag S

    2016-10-01

    The biosimilar industry is witnessing an unprecedented growth with the newer therapeutics increasing in complexity over time. A key step towards development of a biosimilar is to establish analytical comparability with the innovator product, which would otherwise affect the safety/efficacy profile of the product. Choosing appropriate analytical tools that can fulfil this objective by qualitatively and/or quantitatively assessing the critical quality attributes (CQAs) of the product is highly critical for establishing equivalence. These CQAs cover the primary and higher order structures of the product, product related variants and impurities, as well as process related impurities, and host cell related impurities. In the present work, we use such an analytical platform for assessing comparability of five approved Granulocyte Colony Stimulating Factor (GCSF) biosimilars (Emgrast, Lupifil, Colstim, Neukine and Grafeel) to the innovator product, Neupogen(®). The comparability studies involve assessing structural homogeneity, identity, secondary structure, and product related modifications. Physicochemical analytical tools include peptide mapping with mass determination, circular dichroism (CD) spectroscopy, reverse phase chromatography (RPC) and size exclusion chromatography (SEC) have been used in this exercise. Bioactivity assessment include comparison of relative potency through in vitro cell proliferation assays. The results from extensive analytical examination offer robust evidence of structural and biological similarity of the products under consideration with the pertinent innovator product. For the most part, the biosimilar drugs were found to be comparable to the innovator drug anomaly that was identified was that three of the biosimilars had a typical variant which was reported as an oxidized species in the literature. But, upon further investigation using RPC-FLD and ESI-MS we found that this is likely a conformational variant of the biotherapeutic been

  2. Bilateral Breast Reduction Without Opioid Analgesics: A Comparative Study.

    PubMed

    Parsa, Fereydoun Don; Cheng, Justin; Stephan, Brad; Castel, Nikki; Kim, Leslie; Murariu, Daniel; Parsa, Alan A

    2017-03-03

    Breast reduction has traditionally been performed under general anesthesia with adjunct opioid use. However, opioids are associated with a wide variety of adverse effects, including nausea, vomiting, constipation, postoperative sedation, dizziness, and addiction. This study compares bilateral breast reduction using a multimodal opioid-free pain management regimen vs traditional general anesthesia with adjunct opioids. A total of 83 female patients were enrolled in this study. Group 1 includes a retrospective series of 39 patients that underwent breast reduction via general anesthesia with adjunct opioid use. This series was compared to 2 prospective groups of patients who did not receive opioids either preoperatively or intraoperatively. In group 2, twenty-six patients underwent surgery under intravenous sedation and local anesthesia. In group 3, eighteen patients underwent surgery with general anesthesia. All patients in groups 2 and 3 received preoperative gabapentin and celecoxib along with infiltration of local anesthetics during the operation and prior to discharge to the Post-Anesthesia Care Unit (PACU). Primary outcome measures included the duration of surgery, time from end of operation to discharge home, postoperative opioid and antiemetic use, and unplanned postoperative hospitalizations. When compared to group 1, groups 2 and 3 experienced a shorter time from end of operation to discharge home (P < 0.05), fewer unplanned hospital admissions (P < 0.05), and highly significant decrease in postoperative opioid use (P < 0.001). This multimodal approach allows patients to safely undergo opioid-free bilateral breast reduction either under local or general anesthesia as an outpatient. This method resulted in significantly less morbidity, use of opioids postoperatively, as well as unplanned hospital admissions compared to "traditional" breast reduction under general anesthesia with the use of opioids.

  3. A Comparative Study on Emerging Electric Vehicle Technology Assessments

    SciTech Connect

    Ford, Jonathan; Khowailed, Gannate; Blackburn, Julia; Sikes, Karen

    2011-03-01

    Numerous organizations have published reports in recent years that investigate the ever changing world of electric vehicle (EV) technologies and their potential effects on society. Specifically, projections have been made on greenhouse gas (GHG) emissions associated with these vehicles and how they compare to conventional vehicles or hybrid electric vehicles (HEVs). Similar projections have been made on the volumes of oil that these vehicles can displace by consuming large amounts of grid electricity instead of petroleum-based fuels. Finally, the projected rate that these new vehicle fleets will enter the market varies significantly among organizations. New ideas, technologies, and possibilities are introduced often, and projected values are likely to be refined as industry announcements continue to be made. As a result, over time, a multitude of projections for GHG emissions, oil displacement, and market penetration associated with various EV technologies has resulted in a wide range of possible future outcomes. This leaves the reader with two key questions: (1) Why does such a collective range in projected values exist in these reports? (2) What assumptions have the greatest impact on the outcomes presented in these reports? Since it is impractical for an average reader to review and interpret all the various vehicle technology reports published to date, Sentech Inc. and the Oak Ridge National Laboratory have conducted a comparative study to make these interpretations. The primary objective of this comparative study is to present a snapshot of all major projections made on GHG emissions, oil displacement, or market penetration rates of EV technologies. From the extensive data found in relevant publications, the key assumptions that drive each report's analysis are identified and 'apples-to-apples' comparisons between all major report conclusions are attempted. The general approach that was taken in this comparative study is comprised of six primary steps: (1

  4. Discourse Formation in Comparative Education. 4th, Revised Edition. Comparative Studies Series. Volume 10

    ERIC Educational Resources Information Center

    Schriewer, Jurgen, Ed.

    2012-01-01

    New theories and theory-based methodological approaches have found their way into Comparative Education--just as into Comparative Social Science more generally--in increasing number in the recent past. The essays of this volume express and critically discuss quite a range of these positions such as, inter alia, the theory of self-organizing social…

  5. Discourse Formation in Comparative Education. 4th, Revised Edition. Comparative Studies Series. Volume 10

    ERIC Educational Resources Information Center

    Schriewer, Jurgen, Ed.

    2012-01-01

    New theories and theory-based methodological approaches have found their way into Comparative Education--just as into Comparative Social Science more generally--in increasing number in the recent past. The essays of this volume express and critically discuss quite a range of these positions such as, inter alia, the theory of self-organizing social…

  6. A Comparative Study between Universal Eclectic Septoplasty Technique and Cottle.

    PubMed

    Amaral Neto, Odim Ferreira do; Mizoguchi, Flavio Massao; Freitas, Renato da Silva; Maniglia, João Jairney; Maniglia, Fábio Fabrício; Maniglia, Ricardo Fabrício

    2017-07-01

    Introduction  Since the last century surgical correction of nasal septum deviation has been improved. The Universal Eclectic Technique was recently reported and there are still few studies dedicated to address this surgical approach. Objective  The objective of this study is to compare the results of septal deviation correction achieved using the Universal Eclectic Technique (UET) with those obtained through Cottle's Technique. Methods  This is a prospective study with two consecutive case series totaling 90 patients (40 women and 50 men), aged between 18 and 55 years. We divided patients into two groups according to the surgical approach. Fifty-three patients underwent septoplasty through Universal Eclectic Technique (UET) and thirty-seven patients were submitted to classical Cottle's septoplasty technique. All patients have answered the Nasal Obstruction Symptom Evaluation Scale (NOSE) questionnaire to assess pre and postoperative nasal obstruction. Results  Statistical analysis showed a significantly shorter operating time for the UET group. Nasal edema assessment performed seven days after the surgery showed a prevalence of mild edema in UET group and moderate edema in Cottle's technique group. In regard to complication rates, UET presented a single case of septal hematoma while in Cottle's technique group we observed: 02 cases of severe edemas, 01 case of incapacitating headache, and 01 complaint of nasal pain. Conclusion  The Universal Eclectic Technique (UET) has proven to be a safe and effective surgical technique with faster symptomatic improvement, low complication rates, and reduced surgical time when compared with classical Cottle's technique.

  7. A comparative study of ICU patient diaries vs. hospital charts.

    PubMed

    Egerod, Ingrid; Christensen, Doris

    2010-10-01

    Intensive care survivors often suffer from memory disorders, and some go on to develop anxiety, depression, and posttraumatic stress. Since the 1980s nurses have written diaries for intensive care patients to help them understand their illness and come to terms with their experiences after discharge. The central question we posed in this study was: Why do nurses write diaries in addition to conventional charting in the medical record? To answer this question, we compared intensive care diaries and hospital charts using textual analysis and narrative theory. The aims of our study were to compare patient diaries and hospital charts to explore (a) what each documentation instrument has to offer patients in their quest to make sense of their illness, and (b) why it is worthwhile for nurses to sustain the practice of writing diaries. The study findings show that the diary is coherent, personal, and supportive, whereas the hospital chart is fragmented, impersonal, and technical. The diary tells a comprehensive story that might help the patient to construct or reconstruct his or her own illness narrative.

  8. Comparative study of clinical pulmonary surfactants using atomic force microscopy

    PubMed Central

    Zhang, Hong; Fan, Qihui; Wang, Yi E.; Neal, Charles R.; Zuo, Yi Y.

    2016-01-01

    Clinical pulmonary surfactant is routinely used to treat premature newborns with respiratory distress syndrome, and has shown great potential in alleviating a number of neonatal and adult respiratory diseases. Despite extensive study of chemical composition, surface activity, and clinical performance of various surfactant preparations, a direct comparison of surfactant films is still lacking. In this study, we use atomic force microscopy to characterize and compare four animal-derived clinical surfactants currently used throughout the world, i.e., Survanta, Curosurf, Infasurf and BLES. These modified-natural surfactants are further compared to dipalmitoyl phosphatidylcholine (DPPC), a synthetic model surfactant of DPPC:palmitoyl-oleoyl phosphatidylglycerol (POPG) (7:3), and endogenous bovine natural surfactant. Atomic force microscopy reveals significant differences in the lateral structure and molecular organization of these surfactant preparations. These differences are discussed in terms of DPPC and cholesterol contents. We conclude that all animal-derived clinical surfactants assume a similar structure of multilayers of fluid phospholipids closely attached to an interfacial monolayer enriched in DPPC, at physiologically relevant surface pressures. This study provides the first comprehensive survey of the lateral structure of clinical surfactants at various surface pressures. It may have clinical implications on future application and development of surfactant preparations. PMID:21439262

  9. [Laparoscopic versus open surgery for colorectal cancer. A comparative study].

    PubMed

    Arribas-Martin, Antonio; Díaz-Pizarro-Graf, José Ignacio; Muñoz-Hinojosa, Jorge Demetrio; Valdés-Castañeda, Alberto; Cruz-Ramírez, Omar; Bertrand, Martin Marie

    2014-01-01

    Laparoscopic surgery for colorectal cancer is currently accepted and widespread worldwide. However, according tol the surgical experience on this approach, surgical and short-term oncologic results may vary. Studies comparing laparoscopic vs. open surgery in our population are scarce. To determine the superiority of the laparoscopic vs. open technique for colorectal cancer surgery. This retrospective and comparative study collected data from patients operated on for colorectal cancer between 1999 and 2011 at the Angeles Lomas Hospital, Mexico. A total of 82 patients were included in this study; 47 were operated through an open approach and 35 laparoscopically. Mean operative time was significantly lower in the open approach group (p= 0.008). There were no significant difference between both techniques for intraoperative bleeding (p= 0.3980), number of lymph nodes (p= 0.27), time to initiate oral feeding (p= 0.31), hospital stay (p= 0.12), and postoperative pain (p= 0.19). Procedure-related complications rate and type were not significantly different in both groups (p= 0.44). Patients operated laparoscopically required significantly less analgesic drugs (p= 0.04) and less need for epidural postoperative analgesia (p= 0.01). Laparoscopic approach is as safe as the traditional open approach for colorectal cancer. Early oncological and surgical results confirm its suitability according to this indication.

  10. Comparative study of clinical pulmonary surfactants using atomic force microscopy.

    PubMed

    Zhang, Hong; Fan, Qihui; Wang, Yi E; Neal, Charles R; Zuo, Yi Y

    2011-07-01

    Clinical pulmonary surfactant is routinely used to treat premature newborns with respiratory distress syndrome, and has shown great potential in alleviating a number of neonatal and adult respiratory diseases. Despite extensive study of chemical composition, surface activity, and clinical performance of various surfactant preparations, a direct comparison of surfactant films is still lacking. In this study, we use atomic force microscopy to characterize and compare four animal-derived clinical surfactants currently used throughout the world, i.e., Survanta, Curosurf, Infasurf and BLES. These modified-natural surfactants are further compared to dipalmitoyl phosphatidylcholine (DPPC), a synthetic model surfactant of DPPC:palmitoyl-oleoyl phosphatidylglycerol (POPG) (7:3), and endogenous bovine natural surfactant. Atomic force microscopy reveals significant differences in the lateral structure and molecular organization of these surfactant preparations. These differences are discussed in terms of DPPC and cholesterol contents. We conclude that all animal-derived clinical surfactants assume a similar structure of multilayers of fluid phospholipids closely attached to an interfacial monolayer enriched in DPPC, at physiologically relevant surface pressures. This study provides the first comprehensive survey of the lateral structure of clinical surfactants at various surface pressures. It may have clinical implications on future application and development of surfactant preparations. Copyright © 2011 Elsevier B.V. All rights reserved.

  11. Randomized study comparing inflammatory response after tonsillectomy versus tonsillotomy.

    PubMed

    Kordeluk, Sofia; Goldbart, Aviv; Novack, Lena; Kaplan, Daniel Michael; El-Saied, Sabri; Alwalidi, Musa; Shapira-Parra, Angelica; Segal, Nili; Slovik, Yuval; Max, Puterman; Joshua, Ben-Zion

    2016-11-01

    To determine if there was a difference in the inflammatory reaction after tonsil surgery with "traditional" techniques (tonsillectomy and adenoidectomy or TA) compared to partial intracapsular tonsillectomy and adenoidectomy (PITA). Randomized, double-blind study. tertiary care academic hospital. Children under the age of 16 years with a diagnosis of obstructive sleep disordered breathing were randomly allocated into three study groups: TA with electrocautery (n = 34), PITA with CO2 laser (n = 30) and PITA with debrider (n = 28). All of the children underwent adenoidectomy with a current at the same surgical procedure. c-reactive protein level (CRP) was the primary endpoint. In addition, the following were assessed: white blood cells (WBC), neutrophils (NEU), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Pre- and post-procedure measurements were compared between the groups. Parents filled out a questionnaire daily during the first postoperative week assessing pain, swallowing and snoring. CRP levels ascended higher in the PITA groups after surgery (p = 0.023), WBC and NEU showed the same pattern, IL-6 levels were higher in PITA group and there was no difference in TNF-alpha levels between the two types of procedures. Postoperative pain and postoperative hemorrhage were significantly lower in the PITA groups as compared to the TA group (p = 0.01 and 0.048). PITA in comparison to TA is associated with lower morbidity; however, the inflammatory response does not differ significantly in the first 24 h after surgery. Additional long-term studies assessing efficacy of PITA are warranted. Level 1, prospective randomized controlled trial.

  12. Comparative studies on the efficacy of brotizolam and nitrazepam

    PubMed Central

    Lohmann, H.; Von Delbrück, Orla; Findeisen, P.

    1983-01-01

    1 Efficacy and tolerability of brotizolam (0.25 and 0.5 mg) were compared over a 6-day period with nitrazepam (5.0 mg) in middle-aged patients (less than 65 years) with sleep disturbances requiring medication. The study was double-blind and randomised with a cross-over design. 2 Each preparation reduced sleep onset latency and frequency of awakenings, and improved quality and duration of sleep as well as subjective condition on awakening. Brotizolam 0.25 mg was found to be equally effective as 0.5 mg, and so the lower dose is recommended for the middle aged. PMID:6362699

  13. Comparative study of minutiae selection algorithms for ISO fingerprint templates

    NASA Astrophysics Data System (ADS)

    Vibert, B.; Charrier, C.; Le Bars, J.-M.; Rosenberger, C.

    2015-03-01

    We address the selection of fingerprint minutiae given a fingerprint ISO template. Minutiae selection plays a very important role when a secure element (i.e. a smart-card) is used. Because of the limited capability of computation and memory, the number of minutiae of a stored reference in the secure element is limited. We propose in this paper a comparative study of 6 minutiae selection methods including 2 methods from the literature and 1 like reference (No Selection). Experimental results on 3 fingerprint databases from the Fingerprint Verification Competition show their relative efficiency in terms of performance and computation time.

  14. Comparative Study of Edge Detectors in case of Echocardiographic Images

    NASA Astrophysics Data System (ADS)

    Saini, Kalpana; Dewal, M. L.; Rohit, Manoj Kumar

    2010-11-01

    In this paper we compare different edge detectors based on peak signal to noise ratio on Echocardiographic images. Edge detection is a critical element in image processing, since edges contain a major function of image information. The function of edge detection is to identify the boundaries of homogeneous regions in an image based on properties such as intensity and texture.We have taken Perwitt edge detector, Robarts edge detector, LoG edge detector, Canny edge detector, and Sobel edge detector for this comparison and study.

  15. Radioactivity of natural and artificial building materials - a comparative study.

    PubMed

    Szabó, Zs; Völgyesi, P; Nagy, H É; Szabó, Cs; Kis, Z; Csorba, O

    2013-04-01

    Building materials and their additives contain radioactive isotopes, which can increase both external and internal radioactive exposures of humans. In this study Hungarian natural (adobe) and artificial (brick, concrete, coal slag, coal slag concrete and gas silicate) building materials were examined. We qualified 40 samples based on their radium equivalent, activity concentration, external hazard and internal hazard indices and the determined threshold values of these parameters. Absorbed dose rate and annual effective dose for inhabitants living in buildings made of these building materials were also evaluated. The calculations are based on (226)Ra, (232)Th and (40)K activity concentrations determined by gamma-ray spectrometry. Measured radionuclide concentrations and hence, calculated indices and doses of artificial building materials show a rather disparate distribution compared to adobes. The studied coal slag samples among the artificial building materials have elevated (226)Ra content. Natural, i.e. adobe and also brick samples contain higher amount of (40)K compared to other artificial building materials. Correlation coefficients among radionuclide concentrations are consistent with the values in the literature and connected to the natural geochemical behavior of U, Th and K elements. Seven samples (coal slag and coal slag concrete) exceed any of the threshold values of the calculated hazard indices, however only three of them are considered to be risky to use according to the fact that the building material was used in bulk amount or in restricted usage. It is shown, that using different indices can lead to different conclusions; hence we recommend considering more of the indices at the same time when building materials are studied. Additionally, adding two times their statistical uncertainties to their values before comparing to thresholds should be considered for providing a more conservative qualification. We have defined radon hazard portion to point

  16. A comparative study of ketanserin and metoprolol in essential hypertension.

    PubMed

    Kane, J A; Tooley, M; Sibbald, B; Gould, S E

    1986-04-01

    The efficacy and tolerability of ketanserin was compared with metoprolol in a double-blind parallel group study. After a 4-week placebo run-in on no treatment patients with a diastolic blood pressure (BP) of 95 mmHg or more received ketanserin 40 mg (n = 16) or metoprolol 100 mg (n = 17) twice daily. Blood pressure was measured in duplicate using a Hawksley random zero sphygmomanometer. Both blood pressure and heart rate were recorded after 5 min supine and 1 min standing. Patients visited after 2, 4, 8 and 12 weeks of treatment. Systolic, diastolic and mean arterial BPs, both supine and standing, were significantly reduced from week 2 by both treatments (P less than 0.05, Student's t-test). The mean (+/- s.e.m.) changes in supine BP at 3 months compared with baseline were -15.7 (3.6) mmHg systolic and -13.9 (2.7) mmHg diastolic in the ketanserin group and -26.6 (7.9) mmHg systolic and -15.2 (2.7) mmHg diastolic in the metoprolol group. There was a tendency for the fall in systolic BP to be greater in the metoprolol group, but this did not reach statistical significance except for the standing systolic BP at 1 month. Metoprolol caused a significant fall in heart rate compared with baseline values throughout the study, and the metoprolol group was significantly different from the ketanserin group at 2 months for the supine heart rate and at all time points for standing heart rate.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. Comparative study of two commercially pure titanium casting methods

    PubMed Central

    RODRIGUES, Renata Cristina Silveira; FARIA, Adriana Claudia Lapria; ORSI, Iara Augusta; de MATTOS, Maria da Gloria Chiarello; MACEDO, Ana Paula; RIBEIRO, Ricardo Faria

    2010-01-01

    The interest in using titanium to fabricate removable partial denture (RPD) frameworks has increased, but there are few studies evaluating the effects of casting methods on clasp behavior. Objective This study compared the occurrence of porosities and the retentive force of commercially pure titanium (CP Ti) and cobalt-chromium (Co-Cr) removable partial denture circumferential clasps cast by induction/centrifugation and plasma/vacuum-pressure. Material and Methods 72 frameworks were cast from CP Ti (n=36) and Co-Cr alloy (n=36; control group). For each material, 18 frameworks were casted by electromagnetic induction and injected by centrifugation, whereas the other 18 were casted by plasma and injected by vacuum-pressure. For each casting method, three subgroups (n=6) were formed: 0.25 mm, 0.50 mm, and 0.75 mm undercuts. The specimens were radiographed and subjected to an insertion/removal test simulating 5 years of framework use. Data were analyzed by ANOVA and Tukey's to compare materials and cast methods (α=0.05). Results Three of 18 specimens of the induction/centrifugation group and 9 of 18 specimens of plasma/vacuum-pressure cast presented porosities, but only 1 and 7 specimens, respectively, were rejected for simulation test. For Co-Cr alloy, no defects were found. Comparing the casting methods, statistically significant differences (p<0.05) were observed only for the Co-Cr alloy with 0.25 mm and 0.50 mm undercuts. Significant differences were found for the 0.25 mm and 0.75 mm undercuts dependent on the material used. For the 0.50 mm undercut, significant differences were found when the materials were induction casted. Conclusion Although both casting methods produced satisfactory CP Ti RPD frameworks, the occurrence of porosities was greater in the plasma/vacuum-pressure than in the induction/centrifugation method, the latter resulting in higher clasp rigidity, generating higher retention force values. PMID:21085805

  18. Comparative activity of carbapenem testing (the COMPACT study) in Turkey

    PubMed Central

    2012-01-01

    Background Recent evidence indicates that Gram-negative bacterial pathogens, the most common of which are Pseudomonas spp., Enterobacteriaceae, and Acinetobacter baumannii, are frequent causes of hospital-acquired infections. This study aims to evaluate the in vitro activity of doripenem and comparator carbapenem antibiotics against Gram-negative clinical isolates collected from COMParative Activity of Carbapenem Testing (COMPACT) study centres in Turkey. Methods Ten centres in Turkey were invited to submit Pseudomonas aeruginosa, Enterobacteriaceae, and other Gram-negative isolates from intensive care unit (ICU)/non-ICU patients with complicated intra-abdominal infections, bloodstream infections, or nosocomial pneumonia, including ventilator-associated pneumonia, between May and October 2008. Susceptibility was determined by each centre using E-test. A central laboratory performed species confirmation as well as limited susceptibility and quality-control testing. Results Five hundred and ninety six isolates were collected. MIC90 values for doripenem, meropenem, and imipenem, respectively, were 32, ≥ 64, and ≥ 64 mg/L against Pseudomonas spp.; 0.12, 0.12, and 0.5 mg/L against Enterobacteriaceae; and ≥ 64 mg/L for each against other Gram-negative isolates. In determining the susceptibility of hospital isolates of selected Gram-negative pathogens to doripenem, imipenem, and meropenem, we found that against all pathogens combined, the MIC90 for ICU compared with non-ICU isolates was higher. Conclusions Doripenem showed similar or slightly better activity than meropenem and better activity than imipenem against the Gram-negative pathogens collected in Turkey. PMID:22340940

  19. Comparative study of ring and random cavities for fiber lasers.

    PubMed

    Fernandez-Vallejo, Montserrat; Rota-Rodrigo, Sergio; Lopez-Amo, Manuel

    2014-06-01

    An experimental comparison of three fiber laser structures with the same Raman gain medium is presented in order to establish the main pros and cons of each basic scheme. The first fiber laser is based on a hybrid ring-random fiber laser, the second one is a pure ring fiber laser, and the last one is a random fiber laser. Several aspects have been taken into account in the study. First, from the optical point of view, the parameters of interest compared are output power, lasing threshold, slope efficiency, power fluctuations, and the longitudinal modes have been analyzed. Second, the possible utilization of fiber lasers in digital modulated optical communication systems is also studied.

  20. Comparative studies of energy sources in gynecologic laparoscopy.

    PubMed

    Law, Kenneth S K; Lyons, Stephen D

    2013-01-01

    Energy sources incorporating "vessel sealing" capabilities are being increasingly used in gynecologic laparoscopic surgery although conventional monopolar and bipolar electrosurgery remain popular. The preference for one device over another is based on a combination of factors, including the surgeon's subjective experience, availability, and cost. Although comparative clinical studies and meta-analyses of laparoscopic energy sources have reported small but statistically significant differences in volumes of blood loss, the clinical significance of such small volumes is questionable. The overall usefulness of the various energy sources available will depend on a number of factors including vessel burst pressure and seal time, lateral thermal spread, and smoke production. Animal studies and laboratory-based trials are useful in providing a controlled environment to investigate such parameters. At present, there is insufficient evidence to support the use of one energy source over another.

  1. A Comparative Study on Automotive Brake Testing Standards

    NASA Astrophysics Data System (ADS)

    Kumbhar, Bhau Kashinath; Patil, Satyajit Ramchandra; Sawant, Suresh Maruti

    2016-06-01

    Performance testing of automotive brakes involves determination of stopping time, distance and deceleration level. Braking performance of an automobile is required to be ensured for various surfaces like dry, wet, concrete, bitumen etc. as well as for prolonged applications. Various brake testing standards are used worldwide to assure vehicle and pedestrian safety. This article presents methodologies used for automotive service brake testing for two wheelers. The main contribution of this work lies in comparative study of three main brake testing standards; viz. Indian Standards, Federal Motor Vehicle Safety Standards and European Economic Commission Standards. This study shall help the policy makers to choose the best criteria out of these three while formulating newer edition of testing standards.

  2. A Comparative Study on Automotive Brake Testing Standards

    NASA Astrophysics Data System (ADS)

    Kumbhar, Bhau Kashinath; Patil, Satyajit Ramchandra; Sawant, Suresh Maruti

    2017-08-01

    Performance testing of automotive brakes involves determination of stopping time, distance and deceleration level. Braking performance of an automobile is required to be ensured for various surfaces like dry, wet, concrete, bitumen etc. as well as for prolonged applications. Various brake testing standards are used worldwide to assure vehicle and pedestrian safety. This article presents methodologies used for automotive service brake testing for two wheelers. The main contribution of this work lies in comparative study of three main brake testing standards; viz. Indian Standards, Federal Motor Vehicle Safety Standards and European Economic Commission Standards. This study shall help the policy makers to choose the best criteria out of these three while formulating newer edition of testing standards.

  3. Comparative study of Waste Isolation Pilot Plant (WIPP) transportation alternatives

    SciTech Connect

    Not Available

    1994-02-01

    WIPP transportation studies in the Final Supplement Environmental Impact Statement for WIPP are the baseline for this report. In an attempt to present the most current analysis, this study incorporates the most relevant data available. The following three transportation options are evaluated for the Disposal Phase, which is assumed to be 20 years: Truck shipments, consisting of a tractor and trailer, with three TRUPACT-IIs or one RH-72B; Regular commercial train shipments consisting of up to three railcars carrying up to 18 TRUPACT-IIs or up to six RH-72Bs; Dedicated train shipments consisting of a locomotive, an idle car, railcars carrying 18 TRUPACT-IIs or six RH-72Bs, another idle car, and a caboose or passenger car with an emergency response specialist. No other cargo is carried. This report includes: A consideration of occupational and public risks and exposures, and other environmental impacts; A consideration of emergency response capabilities; and An extimation of comparative costs.

  4. Comparative study on the topological structure of China Education Network

    NASA Astrophysics Data System (ADS)

    Yu, Ming-Min; Zhang, Ning; Mao, Guo-Yong

    2017-07-01

    China Education Network (CEN) of year 2014 was studied as a complex network object. By searching the domain of “.edu.cn” and filtering some unexpected results, we finally get a network with 14,100,628 pages and 213,513,401 links. The topology of this network was studied to get the features such as out-degree distribution, in-degree distribution and average shortest path length. These features were compared with that of year 2007 and 2004 to observe the evolution mechanisms of CEN. According to the statistical results, it is found that some topology features of CEN such as out-degree distribution, in-degree distribution and average shortest path have changed a lot and the related reasons for these changes are given in this paper.

  5. A comparative study on glyoxalase II from vertebrata.

    PubMed

    Principato, G B; Rosi, G; Talesa, V; Giovannini, E; Norton, S J

    1987-01-01

    S-2-hydroxyacylglutathione hydrolase (glyoxalase II) from the liver of animals belonging to the various vertebrate classes (Oryctolagus cuniculus, Gallus gallus, Python molurus, Rana esculenta, Esox lucius) have been purified from 100,000 g supernatants of liver homogenates, using acetone fractionation and affinity chromatography. Subsequent comparative studies were concerned with some molecular and kinetic properties. Isoelectric focusing gave evidence for a single form of liver glyoxalase II in O. cuniculus, P. molurus and E. lucius, while the enzyme from G. gallus and R. esculenta showed respectively two and three forms with different pI values. All studied enzymes are basic proteins. The relative molecular mass values range from 18,000 to 23,000. The various glyoxalases II do not display markedly different Kn or Ki values. Their stability behavior at different temperatures is also quite similar.

  6. A comparative study of Raman enhancement in capillaries

    NASA Astrophysics Data System (ADS)

    Eftekhari, Fatemeh; Irizar, Juan; Hulbert, Laila; Helmy, Amr S.

    2011-06-01

    This work reports on the comparative studies of Raman enhancement in liquid core waveguides (LCWs). The theoretical considerations that describe Raman enhancement in LCWs is adapted to analyze and compare the performance of hollow core photonic crystal fibers (HCPCFs) to conventional Teflon capillary tubes. The optical losses in both platforms are measured and used to predict their performance for different lengths. The results show that for an optimal waveguide length, two orders of magnitude enhancement in the Raman signal can be achieved for aqueous solutions using HCPCFs. This length, however, cannot be achieved using normal capillary effects. By integrating the interface of the fluidic pump and the HCPCF into a microfluidic chip, we are able to control fluid transport and fill longer lengths of HCPCFs regardless of the viscosity of the sample. The long-term stability and reproducibility of Raman spectra attained through this platform are demonstrated for naphthalenethiol, which is a well-studied organic compound. Using the HCPCF platform, the detection limit of normal Raman scattering in the range of micro-molars has been achieved. In addition to the higher signal-to-noise ratio of the Raman signal from the HCPCF-platform, more Raman modes of naphthalenethiol are revealed using this platform.

  7. Stress management and erectile dysfunction: a pilot comparative study.

    PubMed

    Kalaitzidou, I; Venetikou, M S; Konstadinidis, K; Artemiadis, A K; Chrousos, G; Darviri, C

    2014-08-01

    Erectile dysfunction (ED) is a complex disorder with various biopsychosocial implications leading the individual into a state of chronic stress that further worsens ED symptoms. The aim of this study is to investigate the effects of a 8-week stress management programme on erectile dysfunction (ED). A convenience sample of 31 newly diagnosed men with ED, aged between 20 and 55 years, was recruited during a period of 5 months to receive either tadalafil (12 patients) or tadalafil and the 8-week stress management programme. Both groups showed statistical significant improvement of both perceived stress and erectile function scores. Men practising stress management showed a statistical significant reduction in perceived stress score compared with men receiving tadalafil alone. No other statistical significant differences were noted between the two groups, although the stress management group showed a lower daily exposure to cortisol compared with the control group after 8 weeks. Finally, perceived stress and cortisol showed some interesting correlations with sexual function measurements. These findings provide important insight into the role of stress management, as part of the recommended biopsychosocial approach, in ED. Future studies should focus on randomised, controlled trials with larger samples and longer follow-up time.

  8. Outpatient- and inpatient-based buckling surgery: a comparative study

    PubMed Central

    Lee, Jin Cheol; Kim, Yu Cheol

    2014-01-01

    Purpose To evaluate the clinical outcomes of ambulatory buckling surgery, comparing outpatient- with inpatient-based surgery. Methods The authors performed a retrospective study of 80 consecutive cases of rhegmato genous retinal detachment from January 2009 to December 2011 treated by scleral buckling surgery. Two groups of patients were defined according to inpatient (group 1) or outpatient (group 2) surgery, and a comparison of several parameters between these two groups was performed. Results Of the 80 subjects in this study, the average age of group 1 (50 patients) was 49.7 years, and that of group 2 (30 patients) was 47.5 years. There were no statistically significant differences in the average logarithm of the minimum angle of resolution-visual acuity, the condition of the lens, or the presence of retinal lattice degeneration prior to the surgery between the groups. There were no statistically significant differences in the patterns of tear or retinal detachment or in surgical procedure between the groups. Comparing the best-corrected visual acuity after 6 months with that prior to the surgery, the changes in group 1 and group 2 were 0.26 and 0.31, respectively. The functional success rates of group 1 and group 2 after 6 months were 90% and 93%, respectively, and the anatomical success rates of group 1 and group 2 after 6 months were 94% and 96%, respectively, but these were also statistically insignificant. Conclusion Hospitalization is not essential for buckling surgery in uncomplicated rhegmatogenous retinal detachment surgery. PMID:24812485

  9. A comparative Study of Circulation Patterns at Active Lava Lakes

    NASA Astrophysics Data System (ADS)

    Lev, Einat; Oppenheimer, Clive; Spampinato, Letizia; Hernandez, Pedro; Unglert, Kathi

    2016-04-01

    Lava lakes present a rare opportunity to study magma dynamics in a large scaled-up "crucible" and provide a unique natural laboratory to ground-truth dynamic models of magma circulation. The persistence of lava lakes allows for long-term observations of flow dynamics and of lava properties, especially compared to surface lava flows. There are currently five persistent lava lakes in the world: Halemaumau in Kilauea (Hawaii, USA), Erta Ale (Ethiopia), Nyiragongo (Congo), Erebus (Antarctica), and Villarica (Chile). Marum and Benbow craters of Ambrym volcano (Vanuatu) and Masaya (Nicaragua) have often hosted lava lakes as well. We use visible-light and thermal infrared time-lapse and video footage collected at all above lakes (except Villarica, where the lake is difficult to observe), and compare the circulation patterns recorded. We calculate lake surface motion from the footage using the optical flow method (Lev et al., 2012) to produce 2D velocity fields. We mined both the surface temperature field and the surface velocity field for patterns using machine learning techniques such as "self-organizing maps (SOMs)" and "principle component analysis (PCA)". We use automatic detection technique to study the configuration of crustal plates at the lakes' surface. We find striking differences among the lakes, in flow direction, flow speed, frequency of changes in flow direction and speed, location and consistency of upwelling and downwelling, and crustal plate configuration. We relate the differences to lake size, shallow conduit geometry, lava viscosity, crystal and gas content, and crust integrity.

  10. Return to work after general surgery: A comparative study.

    PubMed

    Hermoso, J; Duran, E; Sanchez-Pradell, C; Comajuncosas, J; Gris, P; Jimeno, J; Orbeal, R; Vallverdú, H; Urgellés, J; Lopez-Negre, J-L; Estalella, L; Parés, D

    2015-01-01

    There is scarce information on the time to return to work after general surgery. The aim of this study was to analyze time off work after elective cholecystectomy and to compare the results with those in patients undergoing other surgical interventions. Observational and comparative study. Inclusion criteria were: being of working age and undergoing elective laparoscopic cholecystectomy (group 1) or unilateral inguinal hernia or haemorrhoidectomy (group 2). 36 patients were included: 18 patients in each group. Overall, return to work occurred at a mean of 35.7 days, with no significant differences (p=0.656) between groups (group 1: 36.6 days vs. group 2: 35.44 days). The reasons for not returning to work earlier were fear of complications (37.5%), pain control (37.5%), surgeon recommendation (12.5%), and general practitioner recommendation (12.5%). Time to recovery after laparoscopic cholecystectomy is prolonged. No statistically significant differences with less complex surgical procedures were detected. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  11. Programming PHREEQC calculations with C++ and Python a comparative study

    USGS Publications Warehouse

    Charlton, Scott R.; Parkhurst, David L.; Muller, Mike

    2011-01-01

    The new IPhreeqc module provides an application programming interface (API) to facilitate coupling of other codes with the U.S. Geological Survey geochemical model PHREEQC. Traditionally, loose coupling of PHREEQC with other applications required methods to create PHREEQC input files, start external PHREEQC processes, and process PHREEQC output files. IPhreeqc eliminates most of this effort by providing direct access to PHREEQC capabilities through a component object model (COM), a library, or a dynamically linked library (DLL). Input and calculations can be specified through internally programmed strings, and all data exchange between an application and the module can occur in computer memory. This study compares simulations programmed in C++ and Python that are tightly coupled with IPhreeqc modules to the traditional simulations that are loosely coupled to PHREEQC. The study compares performance, quantifies effort, and evaluates lines of code and the complexity of the design. The comparisons show that IPhreeqc offers a more powerful and simpler approach for incorporating PHREEQC calculations into transport models and other applications that need to perform PHREEQC calculations. The IPhreeqc module facilitates the design of coupled applications and significantly reduces run times. Even a moderate knowledge of one of the supported programming languages allows more efficient use of PHREEQC than the traditional loosely coupled approach.

  12. COMPARATIVE STUDIES OF FRANCISELLA TULARENSIS AND FRANCISELLA NOVICIDA

    PubMed Central

    Owen, C. R.; Buker, E. O.; Jellison, W. L.; Lackman, D. B.; Bell, J. F.

    1964-01-01

    Owen, C. R. (U.S. Public Health Service, Rocky Mountain Laboratory, Hamilton, Mont.), E. O. Buker, W. L. Jellison, D. B. Lackman, and J. F. Bell. Comparative studies of Francisella tularensis and Francisella novicida. J. Bacteriol. 87:676–683. 1964.—Comparative studies of various properties of Francisella tularensis (= Pasteurella tularensis) and F. novicida were performed. The two organisms are very similar morphologically. Growth of both was markedly enhanced by addition of cystine to media, but F. novicida is less fastidious than F. tularensis. The virulence of F. novicida for mice and cavies is lower than that of fresh isolates of F. tularensis. In complement-fixation tests, some cross-reaction occurred when rabbit antisera were used; complement-fixation tests with cavy antisera were specific. Agglutination tests with sera from both rabbits and cavies were specific. Nonliving vaccines of the two organisms (extracts, whole dead cells) conferred no cross-protection to mice; living attenuated vaccines conferred cross-protection which was more transitory than was specific protection. Passive cutaneous anaphylaxis (PCA) tests were highly specific. Absorption of antisera with homologous organisms removed all PCA reactivity, while absorption with heterologous organisms left it almost intact. Hemagglutination and hemagglutination-inhibition tests were specific. It was concluded that the two organisms are sufficiently similar to belong in the same genus but sufficiently different to be retained in separate species. Images PMID:14127585

  13. Cutaneous chemical burns in children - a comparative study.

    PubMed

    Hardwicke, Joseph; Bechar, Janak; Bella, Husam; Moiemen, Naiem

    2013-12-01

    Exposure to chemicals is an unusual causation of cutaneous burns in children. The aim of this study is to look at childhood chemical burns and compare this to adult chemical burns from the same population. A total of 2054 patients were referred to the pediatric burns unit during the study period. This included 24 cutaneous chemical burns, equating to an incidence of 1.1%. Over half of the injuries occurred in the domestic setting. The mean total body surface area (TBSA) affected was 1.9%. When compared to a cohort of adult patients from the same population with cutaneous chemical burns, the TBSA affected was identical (1.9%) but distribution favored the buttock and perineum in children, rather than the distal lower limb in adults. Children presented earlier, had lower rates of surgical intervention and had a shorter length of stay in hospital (p < 0.001). Children also had a lower rate of appropriate first aid treatment. Chemical burns in children are rare, but are becoming more common in our region. It is important to be aware of the characteristic distribution, etiology and need to identify children at risk of child protection issues. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  14. A comparative phylogenetic study of genetics and folk music.

    PubMed

    Pamjav, Horolma; Juhász, Zoltán; Zalán, Andrea; Németh, Endre; Damdin, Bayarlkhagva

    2012-04-01

    Computer-aided comparison of folk music from different nations is one of the newest research areas. We were intrigued to have identified some important similarities between phylogenetic studies and modern folk music. First of all, both of them use similar concepts and representation tools such as multidimensional scaling for modelling relationship between populations. This gave us the idea to investigate whether these connections are merely accidental or if they mirror population migrations from the past. We raised the question; does the complex structure of musical connections display a clear picture and can this system be interpreted by the genetic analysis? This study is the first to systematically investigate the incidental genetic background of the folk music context between different populations. Paternal (42 populations) and maternal lineages (56 populations) were compared based on Fst genetic distances of the Y chromosomal and mtDNA haplogroup frequencies. To test this hypothesis, the corresponding musical cultures were also compared using an automatic overlap analysis of parallel melody styles for 31 Eurasian nations. We found that close musical relations of populations indicate close genetic distances (<0.05) with a probability of 82%. It was observed that there is a significant correlation between population genetics and folk music; maternal lineages have a more important role in folk music traditions than paternal lineages. Furthermore, the combination of these disciplines establishing a new interdisciplinary research field of "music-genetics" can be an efficient tool to get a more comprehensive picture on the complex behaviour of populations in prehistoric time.

  15. [Generations of Italian nurses compared: an exploratory study].

    PubMed

    Stevanin, Simone; Gregori, Dario; Poletti, Piera

    2015-01-01

    The influence that generations have on complex nursing work environment have not been investigated yet in Italy. The majority of studies realized on this topic up to now has a small sample size and is monocentric. None Italian study has directly investigated nursing multigenerational workforce. The study aimed to investigate the existence of generational differences in Italian nurses professional within the italian context and describe their characteristics. A 33 items questionnaire devised for the purpose was administred to a sample of 317 nurses of two major Italian North-East hospital. Five dimensions were analyzed: professional space, professional role, professional culture, orientation to care, relationships among generations. Data showed statistically significant differences among nurses generations in 9 items. The dimensions with the greatest number of significant items were found to be relationship among generations (6 items), followed by orientation to care, professional space and professional role (1 item each). Results highlighted the existence of generational differences and give some information on perceptions and relationships between italian nurses generations. Being the first exploratory study on Italian nurses, it is currently impossible to compare these results with those of previous studies. Further investigation is needed to make more comparisons with international literature.

  16. [Comparative clinical study of 2 surgical techniques for trapeziometacarpal osteoarthritis].

    PubMed

    Martínez-Martínez, F; García-Hortelano, S; García-Paños, J P; Moreno-Fernández, J M; Martín-Ferrero, M Á

    2016-01-01

    In trapeziometacarpal osteoarthritis (or rhizarthrosis), there is great controversy over the surgical technique to choose: simple trapeziectomy, resection-interposition arthroplasty, interposition arthroplasty suspension-or arthroplasty with implant or prosthesis. These latter 2 are the most used without consensus in the literature on the technique to choose and without sufficient comparative studies. The objective is to compare the 2 techniques most used today: suspension-interposition arthroplasty and arthroplasty with prosthesis. A prospective study was conducted on 15 patients diagnosed with grade 2-3 rhizarthrosis treated with interposition arthroplasty-suspension (group 1) and 15 with prosthesis (group 2) showing clinical outcomes, advantages and disadvantages of each. The study variables were the visual analogue scale (VAS), the DASH questionnaire, the grip strength, the strength of end to end and end-lateral clamp, the joint balance adduction-abduction and preemption-retropositioning, and the opposition. The 2 groups are from 2 different hospitals operated on by a hand surgeon from the Hand Unit. The follow-up time for all patients included in the study was 12 months. The VAS, DASH and grip strength at 12 months did not show significant differences. As regards the strength of end to end and end-lateral clamp, group 2 showed the highest values in all follow-up periods with statistically significant differences. Patient selection and surgical experience is essential, given the satisfactory results of both techniques. Arthroplasty prosthesis is reserved for grades 2 and 3, middle-aged patients, good trapezium architecture, and experienced surgeons. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.

  17. Comparative study of visual pathways in owls (Aves: Strigiformes).

    PubMed

    Gutiérrez-Ibáñez, Cristián; Iwaniuk, Andrew N; Lisney, Thomas J; Wylie, Douglas R

    2013-01-01

    Although they are usually regarded as nocturnal, owls exhibit a wide range of activity patterns, from strictly nocturnal, to crepuscular or cathemeral, to diurnal. Several studies have shown that these differences in the activity pattern are reflected in differences in eye morphology and retinal organization. Despite the evidence that differences in activity pattern among owl species are reflected in the peripheral visual system, there has been no attempt to correlate these differences with changes in the visual regions in the brain. In this study, we compare the relative size of nuclei in the main visual pathways in nine species of owl that exhibit a wide range of activity patterns. We found marked differences in the relative size of all visual structures among the species studied, both in the tectofugal and the thalamofugal pathway, as well in other retinorecipient nuclei, including the nucleus lentiformis mesencephali, the nucleus of the basal optic root and the nucleus geniculatus lateralis, pars ventralis. We show that the barn owl (Tyto alba), a species widely used in the study of the integration of visual and auditory processing, has reduced visual pathways compared to strigid owls. Our results also suggest there could be a trade-off between the relative size of visual pathways and auditory pathways, similar to that reported in mammals. Finally, our results show that although there is no relationship between activity pattern and the relative size of either the tectofugal or the thalamofugal pathway, there is a positive correlation between the relative size of both visual pathways and the relative number of cells in the retinal ganglion layer. Copyright © 2012 S. Karger AG, Basel.

  18. Methylphenidate in Pregnancy: A Multicenter, Prospective, Comparative, Observational Study.

    PubMed

    Diav-Citrin, Orna; Shechtman, Svetlana; Arnon, Judy; Wajnberg, Rebecka; Borisch, Cornelia; Beck, Evelin; Richardson, Jonathan Luke; Bozzo, Pina; Nulman, Irena; Ornoy, Asher

    2016-09-01

    Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attention-deficit disorder with or without hyperactivity (ADD/ADHD). Data on its use in human pregnancy are limited. The primary objective of the study was to evaluate the risk of major congenital anomalies after pregnancy exposure to methylphenidate for medical indications. In a prospective, comparative, multicenter observational study performed in 4 participating Teratology Information Services (in Jerusalem, Berlin, Newcastle upon Tyne, and Toronto) between 1996 and 2013, methylphenidate-exposed pregnancies were compared with pregnancies counseled for nonteratogenic exposure (NTE) after matching by maternal age, gestational age, and year at initial contact. 382 methylphenidate-exposed pregnancies (89.5% in the first trimester) were followed up. The overall rate of major congenital anomalies was similar between the groups (10/309 = 3.2% [methylphenidate] vs 13/358 = 3.6% [NTE], P = .780). The rates of major congenital anomalies (6/247 = 2.4% [methylphenidate] vs 12/358 = 3.4% [NTE], P = .511) and cardiovascular anomalies (2/247 = 0.8% [methylphenidate] vs 3/358 = 0.8% [NTE], P = .970) were also similar after exclusion of genetic or cytogenetic anomalies and limiting methylphenidate exposure to the period of organogenesis (weeks 4-13 after the last menstrual period). There was a higher rate of miscarriages and elective terminations of pregnancy in the methylphenidate group. Significant predictors for the miscarriages using Cox proportional hazards model were methylphenidate exposure (adjusted hazard ratio [HR] = 1.98; 95% CI, 1.23-3.20; P = .005) and past miscarriage (adjusted HR = 1.35; 95% CI, 1.18-1.55; P < .001). The present study suggests that methylphenidate does not seem to increase the risk for major malformations. Further studies are required to establish its pregnancy safety and its possible association with miscarriages.

  19. Comparative Study of Algorithms for Automated Generalization of Linear Objects

    NASA Astrophysics Data System (ADS)

    Azimjon, S.; Gupta, P. K.; Sukhmani, R. S. G. S.

    2014-11-01

    Automated generalization, rooted from conventional cartography, has become an increasing concern in both geographic information system (GIS) and mapping fields. All geographic phenomenon and the processes are bound to the scale, as it is impossible for human being to observe the Earth and the processes in it without decreasing its scale. To get optimal results, cartographers and map-making agencies develop set of rules and constraints, however these rules are under consideration and topic for many researches up until recent days. Reducing map generating time and giving objectivity is possible by developing automated map generalization algorithms (McMaster and Shea, 1988). Modification of the scale traditionally is a manual process, which requires knowledge of the expert cartographer, and it depends on the experience of the user, which makes the process very subjective as every user may generate different map with same requirements. However, automating generalization based on the cartographic rules and constrains can give consistent result. Also, developing automated system for map generation is the demand of this rapid changing world. The research that we have conveyed considers only generalization of the roads, as it is one of the indispensable parts of a map. Dehradun city, Uttarakhand state of India was selected as a study area. The study carried out comparative study of the generalization software sets, operations and algorithms available currently, also considers advantages and drawbacks of the existing software used worldwide. Research concludes with the development of road network generalization tool and with the final generalized road map of the study area, which explores the use of open source python programming language and attempts to compare different road network generalization algorithms. Thus, the paper discusses the alternative solutions for automated generalization of linear objects using GIS-technologies. Research made on automated of road network

  20. Evaluation systems for clinical governance development: a comparative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  1. [User benefit of modern hearing aids. A comparative study].

    PubMed

    Kießling, J; Kreikemeier, S

    2013-08-01

    In the face of the rapid development of hearing aid system technology it is helpful to regularly study the user benefit of the current generation. To contribute to the question on how the user benefit of current hearing aids compares with the benefit of the previous generation of hearing aids, a multicentre study was carried out in cooperation with 79 hearing aid acoustics companies in Germany. The user benefit of modern hearing aids in everyday life was assessed by asking end users to participate in a survey by completing a questionnaire. The questionnaire consisted of 20 items, 10 of which were taken from validated international inventories (SSQ: Speech, Spatial and Qualities of Hearing scale, IOI-HA: International Outcome Inventory for Hearing Aids) and the other 10 were formulated particularly for this purpose. A total of 664 usable questionnaires were returned whereby 421 responders were first time users and 243 responders were previous hearing aid users. The results of the present study showed that modern hearing aid system technology provides significant extra benefits at the 5 % level relative to the previous generation of hearing aids for all variables tested in this study. Even though the amount of gain in terms of user benefit may be overestimated due to well-known placebo effects, an obvious net effect was evident. Correlations between the level of hearing aid benefit and possible influencing factors, such as age, gender, subjects own hearing aid, duration of use or hearing loss, could not be identified.

  2. A comparative study of road traffic accidents in West Malaysia.

    PubMed Central

    Silva, J. F.

    1978-01-01

    The problem of road traffic accidents in developing countries is now becoming a cause for concern. This is more so as preventive measures have not kept pace with economic progress and development. This paper reviews the present situation in West Malaysia, one of the better developed countries of the East, during the period 1970 to 1975. A comparative study has been made between the United States and Malaysia. To enable the urgency of the problem in developing countries to be appreciated the increases in the country's population and in the number of vehicles in use and their relation to the lesser increase in road mileage over the period of study have been discussed. The study has considered every aspect of the causative factors leading to traffic accidents, such as the effects of weather, seasonal variation, and road and lighting conditions. The common human errors leading to accidents have been discussed. Other factors, such as the ethnic distribution in Malaysia, and their relation to road accidents have shown the effect of the social structure on the problems. The data evaluated in this study make it clear that preventive measures are very necessary in underdeveloped as well as in developed countries. PMID:718073

  3. A comparative study of road traffic accidents in West Malaysia.

    PubMed

    Silva, J F

    1978-11-01

    The problem of road traffic accidents in developing countries is now becoming a cause for concern. This is more so as preventive measures have not kept pace with economic progress and development. This paper reviews the present situation in West Malaysia, one of the better developed countries of the East, during the period 1970 to 1975. A comparative study has been made between the United States and Malaysia. To enable the urgency of the problem in developing countries to be appreciated the increases in the country's population and in the number of vehicles in use and their relation to the lesser increase in road mileage over the period of study have been discussed. The study has considered every aspect of the causative factors leading to traffic accidents, such as the effects of weather, seasonal variation, and road and lighting conditions. The common human errors leading to accidents have been discussed. Other factors, such as the ethnic distribution in Malaysia, and their relation to road accidents have shown the effect of the social structure on the problems. The data evaluated in this study make it clear that preventive measures are very necessary in underdeveloped as well as in developed countries.

  4. Institutions and national development in Latin America: a comparative study.

    PubMed

    Portes, Alejandro; Smith, Lori D

    We review the theoretical and empirical literatures on the role of institutions on national development as a prelude to present a more rigorous and measurable definition of the concept and a methodology to study this relationship at the national and subnational levels. The existing research literature features conflicting definitions of the concept of "institutions" and empirical tests based mostly on reputational indices, with countries as units of analysis. The present study's methodology is based on a set of five strategic organizations studied comparatively in five Latin American countries. These include key federal agencies, public administrative organizations, and stock exchanges. Systematic analysis of results show a pattern of differences between economically-oriented institutions and those entrusted with providing basic services to the general population. Consistent differences in institutional quality also emerge across countries, despite similar levels of economic development. Using the algebraic methods developed by Ragin, we test six hypotheses about factors determining the developmental character of particular institutions. Implications of results for theory and for methodological practices of future studies in this field are discussed.

  5. Epidural analgesia during labor vs no analgesia: A comparative study

    PubMed Central

    Mousa, Wesam Farid; Al-Metwalli, Roshdi; Mostafa, Manal

    2012-01-01

    Background: Epidural analgesia is claimed to result in prolonged labor. Previous studies have assessed epidural analgesia vs systemic opioids rather than to parturients receiving no analgesia. This study aimed to evaluate the effect of epidural analgesia on labor duration compared with parturients devoid of analgesia. Methods: One hundred sixty nulliparous women in spontaneous labor at full term with a singleton vertex presentation were assigned to the study. Parturients who request epidural analgesia were allocated in the epidural group, whereas those not enthusiastic to labor analgesia were allocated in the control group. Epidural analgesia was provided with 20 mL bolus 0.5% epidural lidocaine plus fentanyl and maintained at 10 mL for 1 h. Duration of the first and second stages of labor, number of parturients receiving oxytocin, maximal oxytocin dose required for each parturient, numbers of instrumental vaginal, vacuum-assisted, and cesarean deliveries and neonatal Apgar score were recorded. Results: There was no statistical difference in the duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores less than 7 between both groups and number of parturients receiving oxytocin, however, the maximal oxytocin dose was significantly higher in the epidural group. Conclusion: Epidural analgesia by lidocaine (0.5%) and fentanyl does not prolong labor compared with parturients without analgesia; however, significant oxytocin augmentation is required during the epidural analgesia to keep up the aforementioned average labor duration. PMID:22412775

  6. Texture analysis of multiple sclerosis: a comparative study.

    PubMed

    Zhang, Jing; Tong, Longzheng; Wang, Lei; Li, Ning

    2008-10-01

    The difficulty of using magnetic resonance imaging (MRI) to support early diagnosis of multiple sclerosis (MS) stems from the subtle pathological changes in the central nervous system (CNS). In this study, texture analysis was performed on MR images of MS patients and normal controls and a combined set of texture features were explored in order to better discriminate tissues between MS lesions, normal appearing white matter (NAWM) and normal white matter (NWM). Features were extracted from gradient matrix, run-length (RL) matrix, gray level co-occurrence matrix (GLCM), autoregressive (AR) model and wavelet analysis, and were selected based on greatest difference between different tissue types. The results of the combined set of texture features were compared with our previous results of GLCM-based features alone. The results of this study demonstrated that (1) with the combined set of texture features, classification was perfect (100%) between MS lesions and NAWM (or NWM), less successful (88.89%) among the three tissue types and worst (58.33%) between NAWM and NWM; (2) compared with GLCM-based features, the combined set of texture features were better at discriminating MS lesions and NWM, equally good at discriminating MS lesions and NAWM and at all three tissue types, but less effective in classification between NAWM and NWM. This study suggested that texture analysis with the combined set of texture features may be equally good or more advantageous than the commonly used GLCM-based features alone in discriminating MS lesions and NWM/NAWM and in supporting early diagnosis of MS.

  7. A Comparative Study between Universal Eclectic Septoplasty Technique and Cottle

    PubMed Central

    Amaral Neto, Odim Ferreira do; Mizoguchi, Flavio Massao; Freitas, Renato da Silva; Maniglia, João Jairney; Maniglia, Fábio Fabrício; Maniglia, Ricardo Fabrício

    2017-01-01

    Introduction  Since the last century surgical correction of nasal septum deviation has been improved. The Universal Eclectic Technique was recently reported and there are still few studies dedicated to address this surgical approach. Objective  The objective of this study is to compare the results of septal deviation correction achieved using the Universal Eclectic Technique (UET) with those obtained through Cottle's Technique. Methods  This is a prospective study with two consecutive case series totaling 90 patients (40 women and 50 men), aged between 18 and 55 years. We divided patients into two groups according to the surgical approach. Fifty-three patients underwent septoplasty through Universal Eclectic Technique (UET) and thirty-seven patients were submitted to classical Cottle's septoplasty technique. All patients have answered the Nasal Obstruction Symptom Evaluation Scale (NOSE) questionnaire to assess pre and postoperative nasal obstruction. Results  Statistical analysis showed a significantly shorter operating time for the UET group. Nasal edema assessment performed seven days after the surgery showed a prevalence of mild edema in UET group and moderate edema in Cottle's technique group. In regard to complication rates, UET presented a single case of septal hematoma while in Cottle's technique group we observed: 02 cases of severe edemas, 01 case of incapacitating headache, and 01 complaint of nasal pain. Conclusion  The Universal Eclectic Technique (UET) has proven to be a safe and effective surgical technique with faster symptomatic improvement, low complication rates, and reduced surgical time when compared with classical Cottle's technique. PMID:28680499

  8. Comparative micromorphological study of wild and micropropagated Dioscorea bulbifera Linn.

    PubMed Central

    Sonibare, Mubo A.; Adeniran, Adedapo A.

    2014-01-01

    Objective To study the leaf epidermis of wild and micropropagated Dioscorea bulbifera Linn. (D. bulbifera) in order to document useful diagnostic features that may be employed for correct crude drug identification and to clear any taxonomic uncertainties in the micropropagated medicinal plant. Methods Growth responses of micropropagated D. bulbifera were observed on Murashige Skoog medium supplemented with 6-benzylamino purine (1.0 mg/L)+α-naphthaleneacetic acid (0.2 mg/L)+cysteine (20 mg/L) using nodal segments as explants. Leaves of the wild and micropropagated plants were studied microscopically. Results More than 80% shoot regeneration and formation of 10%-30% whitish-brown callus were observed within 3 weeks. The highest root proliferation was obtained from Murashige Skoog medium of 6-benzylamino purine (0.05 mg/L) and α-naphthaleneacetic acid (0.01 mg/L) with mean root length of (27.00±1.25) mm and elongated single shoot of mean length (38.00±11.09) mm. Leaf epidermal features that revealed similarities between the wild and micropropagated plants included amphistomatic condition, presence of mucilage, glandular unicellular trichome with multicellular head, polygonal cells with smooth walls, stomata type and shape. Slight variations included thick cuticular wall with closed stomata in wild plant compared to thin walled opened stomata in the in vitro plant. Opening of stomata accounted for larger average stomata sizes of (7.68±0.38) µm and (6.14±0.46) µm on the adaxial and abaxial surfaces, respectively of the micropropagated plant compared to the wild. Conclusions The diagnostic features obtained in the study could serve as a basis for proper identification for quality control for standardization of the medicinal plant. PMID:25182434

  9. Comparative study of muscle regeneration following cardiotoxin and glycerol injury.

    PubMed

    Mahdy, Mohamed A A; Lei, Hsiao Yin; Wakamatsu, Jun-Ichi; Hosaka, Yoshinao Z; Nishimura, Takanori

    2015-11-01

    In the present study, we examined muscle regeneration following two types of chemical injuries, cardiotoxin (CTX) and glycerol, in order to compare their effect on the morphological characteristics during muscle regeneration, in addition we studied the structural changes of the intramuscular connective tissue (IMCT) during the regeneration process, by scanning electron microscopy (SEM) after digestion of the cellular elements of the muscle with sodium hydroxide. Tibialis anterior (TA) muscles of adult male mice were injected either with CTX or glycerol. Muscle degeneration was greater in the CTX-injured model than in the glycerol-injured model at day 4 post injection. Muscle regeneration started at day 7 in both the CTX and glycerol models. However, the CTX-injured model showed a higher myotube density and larger myotube diameter than the glycerol-injured model at days 10 and 14 post injection. On other hand, adipocyte infiltration was detected in the glycerol-injured model. In contrast, no adipocytes could be detected in the CTX-injured model. Furthermore, ultrastructural analysis showed a significant difference in myofiber damage and regeneration between the two models. SEM of the IMCT showed a transient increase in endomysial collagen deposition at early stages of regeneration in the CTX-injured model. In contrast, glycerol-injured model showed slight endomysial collagen deposition. Our results suggest that changes in IMCT affect the efficiency of muscle regeneration. Studying the three dimensional structure of IMCT may help clinical therapies to reduce skeletal muscle fibrosis. To our knowledge this is the first time the changes in IMCT following CTX and glycerol injury using SEM-cell maceration technique have been compared.

  10. Antiamoebic chemoprophylaxis using quinfamide in children: a comparative study.

    PubMed

    Padilla, Nicolas; Diaz, Rosalinda; Alarcon, Alfonso; Barreda, Roberto

    2002-04-20

    This study sought to examine whether the administration of quinfamide at 3- or 6-month intervals diminished the frequency of Entamoeba histolytica cysts in stool samples compared to controls. The prospective, longitudinal, randomized, single-blind study examined children from six primary schools in Celaya and Neutla, Guanajuato. Of the 1,524 students in these schools, we selected participants for the study as follows: Children were included in the study if their parents agreed in writing to the study and if the children demonstrated evidence of E. histolytica cysts after a parasitoscopic analysis by concentration (PSC) in three samples over consecutive days using Faust"s method. Those included in the study received a single 4.3-g/kg dose of quinfamide, and we performed PSC on days 5, 6, and 7 following dose administration to examine whether quinfamide had affected the presence of the cysts. The study participants who tested negative for cysts were divided into three groups: Group 1 had 102 patients who underwent quinfamide treatment and three CPS analyses after the 12 months of the study; Group 2 had 98 subjects who underwent the quinfamide treatment and three CPS analyses at months 3, 6, 9, and 12 after their entrance into the study; and Group 3 had 102 patients, who underwent the quinfamide treatment and series of three CPS analyses at months 6 and 12 of the study. All participants received the dose of quinfamide after providing stool samples and after a clinical gastrointestinal history was obtained. Further clinical gastrointestinal data were collected 5 days after the quintamide dose was administered. We used EpiInfo 6.0 for statistical analysis, calculating c2 and p values for the clinical data and the CPS data after the 12 months concluded. Of the initial samples of 1,524 subjects, 308 (20.2%) had Entamoebic cysts. Of these, six were further eliminated because they did not meet the inclusion requirements. At the conclusion of the study, Group 1 presented

  11. Comparative study on diagonal equivalent methods of masonry infill panel

    NASA Astrophysics Data System (ADS)

    Amalia, Aniendhita Rizki; Iranata, Data

    2017-06-01

    ratio of height to width of 1 to 1.5. Load used in the experiment was based on Uniform Building Code (UBC) 1991. Every method compared was calculated first to get equivalent diagonal strut width. The second step was modelling method using structure analysis software as a frame with a diagonal in a linear mode. The linear mode was chosen based on structure analysis commonly used by structure designers. The frame was loaded and for every model, its load and deformation values were identified. The values of load - deformation of every method were compared to those of experimental test specimen by Mehrabi and open frame. From comparative study performed, Holmes' and Bazan-Meli's equations gave results the closest to the experimental test specimen by Mehrabi. Other equations that gave close values within the limit (by comparing it to the open frame) are Saneinejad-Hobbs, Stafford-Smith, Bazan-Meli, Liauw Kwan, Paulay and Priestley, FEMA 356, Durani Luo, Hendry, Papia and Chen-Iranata.

  12. Contrasting tropical estuarine ecosystem functioning and stability: A comparative study

    NASA Astrophysics Data System (ADS)

    Villanueva, Maria Ching

    2015-03-01

    A comparative study of the Sine-saloum (Senegal) and Gambia (The Gambia) estuaries was performed based on trophic model outputs that describe the system structure and functioning. These trophic models were constructed such as to differentiate main energetic flows in the systems and express how climate change may have impacted ecosystem resilience to change. Estuarine fish assemblages are highly resilient despite exposure to vast hydrodynamic variations and stress. Coupled with strong anthropogenic-driven stresses such as fisheries and climate change, ecosystems may undergo severe regime shifts that may weaken their resilience and stability. Taxonomically related and morphologically similar species do not necessarily play similar ecological roles in these two ecosystems. Biomass and production in the Sine-saloum are concentrated at trophic levels (TLs) 2 and 3, while for the Gambia, both are concentrated at TL3. Higher TL biomasses in Gambia compared to Sine-Saloum may be explained by the latter ecosystem being characterized by inverse hypersalinity. Higher TL of production in Sine-Saloum is due to higher exploitations compared to Gambia where fishing activities are still less developed. High production and consumption rates of some groups in both ecosystems indicate high system productivity. Elevated productivity may be due to higher abundance of juvenile fishes in most groups that utilize the latter as refuge and/or nursery zones. Both ecosystems are phytoplankton-driven. Differences in group trophic and ecological roles are mainly due to adaptive responses of these species to seasonal and long-term climate and anthropogenic stressors. System indicators suggest different levels of ecosystem resilience and stability as a function of biodiversity. Relevance of other observations on ecosystem functioning and indicators in relation to perturbation is discussed.

  13. Values in nursing students and professionals: An exploratory comparative study.

    PubMed

    Jiménez-López, F Rosa; Roales-Nieto, Jesus Gil; Seco, Guillermo Vallejo; Preciado, Juan

    2016-02-01

    Many studies have explored personal values in nursing, but none has assessed whether the predictions made by the theory of intergenerational value change are true for the different generations of nursing professionals and students. This theory predicts a shift in those personal values held by younger generations towards ones focussed on self-expression. The purpose of the study was to identify intergenerational differences in personal values among nursing professionals and nursing students and to determine whether generational value profiles fit the predictions made by the theory. An exploratory comparative design with a cross-sectional survey method was used. Participants were recruited from four public hospitals and 10 Primary Care Centres in medium-size cities in Spain. A sample of 589 nurses and 2295 nursing students participated in the study. An open survey method was used to collect data that were classified grouping reported values into categories following a method of value lexicon construction and analysed by contingency tables with Pearson's χ (2) and standardized residuals. Approval to conduct the study was obtained from the Deans of the nursing schools and the Directors of Nursing of the institutions. Anonymity was guaranteed, participation was voluntary and participants were informed of the purpose of the study. The results can be synthesized in two age-related trends in the reporting of values among three groups of participants. First, among younger nurses and students, some nursing core values (e.g. ethical and professional) decreased in importance, while other values centred on social relationships and personal well-being increased. This study shows intergenerational change in personal values among both nursing students and young nursing professionals. Findings suggest the need to pay more attention to value training and professional socialization during the schooling period. © The Author(s) 2014.

  14. Erythrophagocytosis in Entamoeba histolytica and Entamoeba dispar: A Comparative Study

    PubMed Central

    Talamás-Lara, Daniel; Chávez-Munguía, Bibiana; González-Robles, Arturo; Talamás-Rohana, Patricia; Salazar-Villatoro, Lizbeth; Durán-Díaz, Ángel; Martínez-Palomo, Adolfo

    2014-01-01

    Entamoeba histolytica is the causative agent of human intestinal and liver amebiasis. The extraordinary phagocytic activity of E. histolytica trophozoites has been accepted as one of the virulence mechanisms responsible for their invasive capacity. The recognition of the noninvasive Entamoeba dispar as a different species has raised the question as to whether the lack of pathogenic potential of this ameba correlates with a limited phagocytic capacity. We have therefore compared the process of erythrophagocytosis in both species by means of light and video microscopy, hemoglobin measurement, and the estimation of reactive oxygen species (ROS). In the present study, we confirmed that E. dispar has lower erythrophagocytic capacity. We also observed by video microscopy a new event of erythrocyte opsonization-like in both species, being more characteristic in E. histolytica. Moreover, E. dispar showed a lower capacity to produce ROS compared with the invasive species and also showed a large population of amoebae that did not engulf any erythrocyte over time. Our results demonstrate that E. histolytica has a higher phagocytic capacity than E. dispar, including a higher rate of production of ROS in the course of ingesting red blood cells. PMID:25003123

  15. Erythrophagocytosis in Entamoeba histolytica and Entamoeba dispar: a comparative study.

    PubMed

    Talamás-Lara, Daniel; Chávez-Munguía, Bibiana; González-Robles, Arturo; Talamás-Rohana, Patricia; Salazar-Villatoro, Lizbeth; Durán-Díaz, Ángel; Martínez-Palomo, Adolfo

    2014-01-01

    Entamoeba histolytica is the causative agent of human intestinal and liver amebiasis. The extraordinary phagocytic activity of E. histolytica trophozoites has been accepted as one of the virulence mechanisms responsible for their invasive capacity. The recognition of the noninvasive Entamoeba dispar as a different species has raised the question as to whether the lack of pathogenic potential of this ameba correlates with a limited phagocytic capacity. We have therefore compared the process of erythrophagocytosis in both species by means of light and video microscopy, hemoglobin measurement, and the estimation of reactive oxygen species (ROS). In the present study, we confirmed that E. dispar has lower erythrophagocytic capacity. We also observed by video microscopy a new event of erythrocyte opsonization-like in both species, being more characteristic in E. histolytica. Moreover, E. dispar showed a lower capacity to produce ROS compared with the invasive species and also showed a large population of amoebae that did not engulf any erythrocyte over time. Our results demonstrate that E. histolytica has a higher phagocytic capacity than E. dispar, including a higher rate of production of ROS in the course of ingesting red blood cells.

  16. [Stereoscopic neuroanatomy: comparative study between anaglyphic and light polarization techniques].

    PubMed

    Meneses, Murilo Sousa; Cruz, André Vieira; Castro, Izara Almeida; Pedrozo, Ari A

    2002-09-01

    The need of didactic material is increasing in medical science nowadays. The lack of anatomical specimens, and the toxicity of conservators, have originated an intense search for alternative ways of demonstrating the human anatomy. As a solution for this difficulty, three-dimensional (3-D) images may be used, facilitating the learning process. This study aims at comparing and describing two techniques of reproduction of bi-dimensional images into three dimensions, which is called stereoscopy. The methods evaluated are filter of colors (anaglyphic) and polarized light. Techniques were analyzed for clearness and 3-D effect. Fourteen images were evaluated by 5 people, with scores ranging from 0 to 4. Total mean scores of polarized light was superior compared to the anaglyphic technique. Both methods use the codification of the image, which means separation and exclusivity with each eye seeing its corresponding image. After several photographic essays and gradual adaptation to a better technique, based on optical physics, photography and neuroanatomical knowledge, we concluded that both techniques are suitable means for production of 3-D images. The best technique, however, considering the final quality of image was polarized light, which did not alter the natural color of the specimen, conserving clearness of images with lower cost.

  17. Comparative Study between Standard and Totally Tubeless Percutaneous Nephrolithotomy.

    PubMed

    Yun, Sung Il; Lee, Yoon Hyung; Kim, Jae Soo; Cho, Sung Ryong; Kim, Bum Soo; Kwon, Joon Beom

    2012-11-01

    Several recent studies have reported the benefits of tubeless percutaneous nephrolithotomy (PNL). Postoperatively, tubeless PNL patients have an indwelling ureteral stent placed, which is often associated with stent-related morbidity. We have performed totally tubeless (tubeless and stentless) PNL in which no nephrostomy tube or ureteral stent is placed postoperatively. We evaluated the safety, effectiveness, and feasibility of totally tubeless PNL. From March 2008 to February 2012, 57 selected patients underwent standard or totally tubeless PNL. Neither a nephrostomy tube nor a ureteral stent was placed in the totally tubeless PNL group. We compared patient and stone characteristics, operation time, length of hospitalization, analgesia requirements, stone-free rate, blood loss, change in creatinine, and perioperative complications between the standard and totally tubeless PNL groups. There were no significant differences in preoperative patient characteristics, postoperative complications, or the stone-free rate between the two groups, but the totally tubeless PNL group showed a shorter hospitalization and a lesser analgesic requirement compared with the standard PNL group. Blood loss and change in creatinine were not significantly different between the two groups. Totally tubeless PNL appears to be a safe and effective alternative for the management of renal stone patients and is associated with a decrease in length of hospital stay.

  18. Comparative Study between Standard and Totally Tubeless Percutaneous Nephrolithotomy

    PubMed Central

    Yun, Sung Il; Lee, Yoon Hyung; Kim, Jae Soo; Cho, Sung Ryong; Kim, Bum Soo

    2012-01-01

    Purpose Several recent studies have reported the benefits of tubeless percutaneous nephrolithotomy (PNL). Postoperatively, tubeless PNL patients have an indwelling ureteral stent placed, which is often associated with stent-related morbidity. We have performed totally tubeless (tubeless and stentless) PNL in which no nephrostomy tube or ureteral stent is placed postoperatively. We evaluated the safety, effectiveness, and feasibility of totally tubeless PNL. Materials and Methods From March 2008 to February 2012, 57 selected patients underwent standard or totally tubeless PNL. Neither a nephrostomy tube nor a ureteral stent was placed in the totally tubeless PNL group. We compared patient and stone characteristics, operation time, length of hospitalization, analgesia requirements, stone-free rate, blood loss, change in creatinine, and perioperative complications between the standard and totally tubeless PNL groups. Results There were no significant differences in preoperative patient characteristics, postoperative complications, or the stone-free rate between the two groups, but the totally tubeless PNL group showed a shorter hospitalization and a lesser analgesic requirement compared with the standard PNL group. Blood loss and change in creatinine were not significantly different between the two groups. Conclusions Totally tubeless PNL appears to be a safe and effective alternative for the management of renal stone patients and is associated with a decrease in length of hospital stay. PMID:23185671

  19. [Classification statistical techniques: an applied and comparative study].

    PubMed

    Richard's, María Marta; Solanas, Antonio; Ledesma, Rubén D; Introzzi, Isabel M; López Ramón, María Fernanda

    2008-11-01

    The aim of this article is to assess and compare three classification statistical techniques--logistic regression, discriminant analysis and classification trees--to identify the personality characteristics associated with the risk of suffering from ischemic cardiovascular acute episodes (ICAE). The sample comprised 313 participants, men and women, aged from 36 to 80. Participants were divided into two groups: a clinical group of patients (n = 143) who were diagnosed as suffering from ICAE, and a control group (n = 170). Both groups were equated in gender, age, socio-economic and educational level. In view of the comparative study of the analytical procedures, we recommend classification trees as the best choice, as it was the most accurate for the individuals in the clinical group, a simple data analysis and a meaningful clinical interpretation. The predictive validity analysis of the MCMI-II allowed the construction of a reduced version made up of 9 personality scales from the 22 scales in the original version. Thus, we could identify the patients with a higher probability of suffering from ICAE, and additionally, generate an empirical model comprising seven and five personality profiles associated, respectively, with the increase and the decrease of the probability of suffering from ICAE.

  20. A comparative study of cardiovascular stress during different swimming strokes.

    PubMed

    Gupta, S; Goswami, A

    2001-04-01

    The study was aimed: (i) to compare maximum heart rate during exhaustive running (HRmasr) and swimming (HRmaxs), (ii) to compare heart rate (HR) in various modes of swimming-front crawl (FC), butterfly (BF), breast stroke (BRS) and back stroke (BS). HRmaxr (192.3 +/- 4.9 beats/min) of the swimmers (N = 7) was higher, although not significantly (P < 0.05), than their HRmaxs (183.7 +/- 3.8). Peak HR of the swimmers in FC, BF, BRS and BS (each of 100 m distance) were 179.9 +/- 7.2, 180.3 +/- 7, 178.6 +/- 6.2 and 177.3 +/- 5.4 beats/min respectively. Average HR in the respective events were 167.3 +/- 15.8, 166.6 +/- 14.1, 163.3 +/- 13.5 and 165.8 +/- 14.6 beats/min. Differences were not significant between any two modes, either in peak HR or mean HR. The results conclude that: (i) maximum HR in swimming is approximately 8 beats/min lower than maximal running and (ii) when the effort is maximum, cardiovascular stress remains unaltered in different swimming modes.

  1. Early parenting styles and sexual offending behavior: A comparative study.

    PubMed

    Sigre-Leirós, Vera; Carvalho, Joana; Nobre, Pedro J

    2016-01-01

    Sexual offenders, in general, report problematic rearing practices from their parents, lacking however more empirical research on this topic regarding particular subtypes of offenders. The current study examined the relationship between early parenting styles and different types of sexual offending. A total of 113 sexual offenders (rapists, pedophilic and nonpedophilic child molesters), and 51 nonsexual offenders completed the EMBU (My Memories of Upbringing), the Brief Symptom Inventory, and the Socially Desirable Response Set Measure. Results showed that rapists were less likely to remember their fathers as being emotionally warm compared with nonsexual offenders and pedophilic child molesters. In addition, compared with rapists, pedophilic offenders perceived their mothers as having been less emotionally warm to them. Overall, results showed that certain developmental experiences with parents were able to distinguish between subtypes of offenders supporting an association between distal interpersonal factors and sexual offending. These findings may have important implications for early intervention and prevention of sexual crimes. Further research using larger samples of pedophilic child molesters is recommended. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Colloidal Dispersions for the Delivery of Acyclovir: A Comparative Study

    PubMed Central

    Cortesi, Rita; Ravani, Laura; Menegatti, Enea; Drechsler, M.; Esposito, Elisabetta

    2011-01-01

    This paper describes a comparative study on the performances of ethosomes and solid lipid nanoparticle as delivery systems for acyclovir. Ethosomes were spontaneously produced by dissolution of phosphatidylcholine and acyclovir in ethanol followed by addition of an aqueous buffer while solid lipid nanoparticle were produced by homogenization and ultrasonication. Both colloidal systems were morphologically characterized by cryo-transmission electron microscopy. The encapsulation efficiency was 94.2±2.8% for ethosomes and 53.2±0.2% for solid lipid nanoparticle. Concerning Z potential, both formulations are close to neutrality. The diffusion coefficients of the drug from ethosomes and solid lipid nanoparticle, determined by a Franz cell method, were 9.4 and 1.2-fold lower as compared to the free acyclovir in solution, thus evidencing the ability of both colloidal systems in enhancing the diffusion of the drug. The antiviral activity against HSV-1 of both systems was tested by plaque reduction assay in monolayer cultures of Vero cells. Data showed that no significant differences in the antiviral activity were observed by acyclovir in the free or loaded forms. Taken together these results, colloidal systems could be interesting to mediate the penetration of acyclovir within Vero cells. PMID:23112407

  3. Colloidal dispersions for the delivery of acyclovir: a comparative study.

    PubMed

    Cortesi, Rita; Ravani, Laura; Menegatti, Enea; Drechsler, M; Esposito, Elisabetta

    2011-11-01

    This paper describes a comparative study on the performances of ethosomes and solid lipid nanoparticle as delivery systems for acyclovir. Ethosomes were spontaneously produced by dissolution of phosphatidylcholine and acyclovir in ethanol followed by addition of an aqueous buffer while solid lipid nanoparticle were produced by homogenization and ultrasonication. Both colloidal systems were morphologically characterized by cryo-transmission electron microscopy. The encapsulation efficiency was 94.2±2.8% for ethosomes and 53.2±0.2% for solid lipid nanoparticle. Concerning Z potential, both formulations are close to neutrality. The diffusion coefficients of the drug from ethosomes and solid lipid nanoparticle, determined by a Franz cell method, were 9.4 and 1.2-fold lower as compared to the free acyclovir in solution, thus evidencing the ability of both colloidal systems in enhancing the diffusion of the drug. The antiviral activity against HSV-1 of both systems was tested by plaque reduction assay in monolayer cultures of Vero cells. Data showed that no significant differences in the antiviral activity were observed by acyclovir in the free or loaded forms. Taken together these results, colloidal systems could be interesting to mediate the penetration of acyclovir within Vero cells.

  4. Manual tracing versus smartphone application (app) tracing: a comparative study.

    PubMed

    Sayar, Gülşilay; Kilinc, Delal Dara

    2017-11-01

    This study aimed to compare the results of conventional manual cephalometric tracing with those acquired with smartphone application cephalometric tracing. The cephalometric radiographs of 55 patients (25 females and 30 males) were traced via the manual and app methods and were subsequently examined with Steiner's analysis. Five skeletal measurements, five dental measurements and two soft tissue measurements were managed based on 21 landmarks. The durations of the performances of the two methods were also compared. SNA (Sella, Nasion, A point angle) and SNB (Sella, Nasion, B point angle) values for the manual method were statistically lower (p < .001) than those for the app method. The ANB value for the manual method was statistically lower than that of app method. L1-NB (°) and upper lip protrusion values for the manual method were statistically higher than those for the app method. Go-GN/SN, U1-NA (°) and U1-NA (mm) values for manual method were statistically lower than those for the app method. No differences between the two methods were found in the L1-NB (mm), occlusal plane to SN, interincisal angle or lower lip protrusion values. Although statistically significant differences were found between the two methods, the cephalometric tracing proceeded faster with the app method than with the manual method.

  5. Comparing the Leadership Styles of Two Heads of Department at Carnelian School: Comparative Case Studies

    ERIC Educational Resources Information Center

    Parascandalo, Marthese

    2014-01-01

    The purpose of this dissertation was to compare and contrast the Leadership Styles of two Heads of Department who work at Carnelian Secondary School (anonymized). It augments a previous paper (Parascandalo 2011) which examined the role of the middle leader in secondary schools in educational literature. The investigation by means of two…

  6. A comparative study of two stochastic mode reduction methods

    SciTech Connect

    Stinis, Panagiotis

    2005-09-01

    We present a comparative study of two methods for thereduction of the dimensionality of a system of ordinary differentialequations that exhibits time-scale separation. Both methods lead to areduced system of stochastic differential equations. The novel feature ofthese methods is that they allow the use, in the reduced system, ofhigher order terms in the resolved variables. The first method, proposedby Majda, Timofeyev and Vanden-Eijnden, is based on an asymptoticstrategy developed by Kurtz. The second method is a short-memoryapproximation of the Mori-Zwanzig projection formalism of irreversiblestatistical mechanics, as proposed by Chorin, Hald and Kupferman. Wepresent conditions under which the reduced models arising from the twomethods should have similar predictive ability. We apply the two methodsto test cases that satisfy these conditions. The form of the reducedmodels and the numerical simulations show that the two methods havesimilar predictive ability as expected.

  7. A comparative study of two different clear aligner systems

    PubMed Central

    2014-01-01

    Background This study aims to compare the ‘Nuvola®’ system with ‘Fantasmino®’ system, examine their material properties, and define the indications for use of the aligners. Methods Two groups of patients were selected and were respectively treated with Nuvola® aligner and Fantasmino® system. Results The goal of treatment has been achieved with the two systems. Conclusions The two types of aligners have shown differences during the treatment. Fantasmino® system has elastic properties of high performance, but its size does not encourage compliance throughout the day. Nuvola® system determines good tooth movement and its size facilitates the patient’s collaboration. In both aligner systems, difficulties were found in the correction of torque information and rotations. PMID:24934094

  8. Comparative studies in series of cytochrome c oxidase models.

    PubMed

    Melin, F; Trivella, A; Lo, M; Ruzié, C; Hijazi, I; Oueslati, N; Wytko, J A; Boitrel, B; Boudon, C; Hellwig, P; Weiss, J

    2012-03-01

    This study compares the behavior as cytochrome c oxidase (CcO) functional and structural models of a series of reported and unreported ligands that provide either a binding site for copper without a built-in proximal base, or both a flexible binding site for copper and a built-in proximal base, or a fixed binding site for copper with a built-in proximal base. The comparisons of the models show that the relative position of the two metal sites is not only a crucial parameter in the control of the catalytic behavior but also essential in mimicking other features of the enzyme such as CO exchange between the ferrous heme a(3) and the cuprous Cu(B) center.

  9. Anatomopathological findings in scars: comparative study between different specimens.

    PubMed

    Munteanu, Andrada Despina; Bedereag, Ştefan Iulian; NiŢescu, Cristian; Florescu, Ioan Petre

    2015-01-01

    In spite of the remarkable progress science and medicine have experienced, many facts concerning healing processes and pathological scars are still unknown or incompletely explained. This paper is part of a larger study (research for a PhD thesis) concerning new approaches in the prevention and treatment of pathological post-burn scars. We present and analyze the cases of some patients who developed abnormal scars in order to understand and point out the characteristics, that different types of pathological scars have in common and how we can differentiate them. Knowing what issue to address is the key to any successful therapy. Thus, the information we obtained will help us in applying more appropriate and efficient methods of treatment and in our further research: comparing the efficiency of newer therapies to that of older ones.

  10. A Comparative Study of Random Patterns for Digital Image Correlation

    NASA Astrophysics Data System (ADS)

    Stoilov, G.; Kavardzhikov, V.; Pashkouleva, D.

    2012-06-01

    Digital Image Correlation (DIC) is a computer based image analysis technique utilizing random patterns, which finds applications in experimental mechanics of solids and structures. In this paper a comparative study of three simulated random patterns is done. One of them is generated according to a new algorithm, introduced by the authors. A criterion for quantitative evaluation of random patterns after the calculation of their autocorrelation functions is introduced. The patterns' deformations are simulated numerically and realized experimentally. The displacements are measured by using the DIC method. Tensile tests are performed after printing the generated random patterns on surfaces of standard iron sheet specimens. It is found that the new designed random pattern keeps relatively good quality until reaching 20% deformation.

  11. Advanced general aviation comparative engine/airframe integration study

    NASA Technical Reports Server (NTRS)

    Huggins, G. L.; Ellis, D. R.

    1981-01-01

    The NASA Advanced Aviation Comparative Engine/Airframe Integration Study was initiated to help determine which of four promising concepts for new general aviation engines for the 1990's should be considered for further research funding. The engine concepts included rotary, diesel, spark ignition, and turboprop powerplants; a conventional state-of-the-art piston engine was used as a baseline for the comparison. Computer simulations of the performance of single and twin engine pressurized aircraft designs were used to determine how the various characteristics of each engine interacted in the design process. Comparisons were made of how each engine performed relative to the others when integrated into an airframe and required to fly a transportation mission.

  12. A Comparative Study of Distribution System Parameter Estimation Methods

    SciTech Connect

    Sun, Yannan; Williams, Tess L.; Gourisetti, Sri Nikhil Gup

    2016-07-17

    In this paper, we compare two parameter estimation methods for distribution systems: residual sensitivity analysis and state-vector augmentation with a Kalman filter. These two methods were originally proposed for transmission systems, and are still the most commonly used methods for parameter estimation. Distribution systems have much lower measurement redundancy than transmission systems. Therefore, estimating parameters is much more difficult. To increase the robustness of parameter estimation, the two methods are applied with combined measurement snapshots (measurement sets taken at different points in time), so that the redundancy for computing the parameter values is increased. The advantages and disadvantages of both methods are discussed. The results of this paper show that state-vector augmentation is a better approach for parameter estimation in distribution systems. Simulation studies are done on a modified version of IEEE 13-Node Test Feeder with varying levels of measurement noise and non-zero error in the other system model parameters.

  13. A Comparative Study of Phenols in Apulian Italian Wines.

    PubMed

    Ragusa, Andrea; Centonze, Carla; Grasso, Maria E; Latronico, Maria F; Mastrangelo, Pier F; Sparascio, Federica; Fanizzi, Francesco P; Maffia, Michele

    2017-03-24

    Nutraceutics is a growing research field in which researchers study and attempt to improve the biological properties of metabolites in food. Wine is one of the most consumed products in the world and contains a plethora of molecules biologically relevant to human health. In this article, several polyphenols with potential antioxidant activity were measured in wines from Apulia, in Southeast Italy. Hydroxytyrosol, gallic and syringic acids, luteolin, quercetin, and trans-resveratrol were identified and quantified by HPLC. The amount of the analyzed metabolites in wines were largely dependent on their color, with red ones being the richest compared to white and rose wines. Gallic acid was the most abundant polyphenol, followed by syringic acid and luteolin. Nevertheless, significant amounts of hydroxytyrosol, quercetin, and trans-resveratrol were also found. The average concentration of polyphenols found in these wines could have potential health-promoting effects, especially if consumed in moderate quantities on a regular basis.

  14. MRI compatibility of robot actuation techniques--a comparative study.

    PubMed

    Fischer, Gregory S; Krieger, Axel; Iordachita, Iulian; Csoma, Csaba; Whitcomb, Louis L; Gabor, Fichtinger

    2008-01-01

    This paper reports an experimental evaluation of the following three different MRI-compatible actuators: a Shinsei ultrasonic motor a Nanomotion ultrasonic motor and a pneumatic cylinder actuator. We report the results of a study comparing the effect of these actuators on the signal to noise ratio (SNR) of MRJ images under a variety of experimental conditions. Evaluation was performed with the controller inside and outside the scanner room and with both 1.5T and 3T MRI scanners. Pneumatic cylinders function with no loss of SNR with controller both inside and outside of the scanner room. The Nanomotion motor performs with moderate loss of SNR when moving during imaging. The Shinsei is unsuitable for motion during imaging. All may be used when motion is appropriately interleaved with imaging cycles.

  15. A Comparative Characteristic Study of Jatropha and Cardanol Biodiesel Blends

    NASA Astrophysics Data System (ADS)

    Pugazhenthi, R.; Chandrasekaran, M.; Muthuraman, R. K.; Vivek, P.; Parthiban, A.

    2017-03-01

    The demand in fuel needs and the depleting fossil fuels raised the need towards bio-fuels. The emerging trend in research field is highly focused on biodiesel production and their characteristic analysis. Since pollution is a major threat to the environment, emission parameter analyses are much important to be concentrated. As the entire world contains plenty of biofuels, it is necessary to explore them for its efficiency and analyze their parameters. In this experimental work jatropha and cashew nut shell biodiesel (Cardanol) was extracted and they were blended with diesel. The characteristics of jatropha and cardanol biodiesel were studied in the DI diesel engine by varying the load at the same speed. In brief, this experimental analysis is carried out to compare the emission characteristics between Jatropha biodiesel at 20% (B20) and 40% (B40) and Cardanol biodiesel blends at 20% (C20) and 40% (C40).

  16. Sibling relationships in individuals with Angelman syndrome: a comparative study.

    PubMed

    Love, Victoria; Richters, Lotte; Didden, Robert; Korzilius, Hubert; Machalicek, Wendy

    2012-01-01

    Investigating the impact of Angelman syndrome on the sibling relationship. This study explored differences in sibling relationships between children with a typically-developing sibling (n = 55) and children with a sibling with Angelman syndrome (n = 44). Sibling relationships were compared on four factors and 16 sub-scales of the Sibling Relationship Questionnaire-Revised. Results showed significant differences in mean scores on each of the four factors (i.e. Warmth/Closeness, Conflict, Rivalry and Dominance/Nurturance) and most of the sub-scales. ANCOVAs showed that demographic variables (number of siblings, living in a two-parent vs single parent household, gender, participant's age, place of residence) did not influence significant differences in sibling relationships between the two groups. Having a brother or sister with Angelman syndrome may influence the way in which the sibling perceives the sibling relationship. This may have important implications for family-centred intervention for this population.

  17. A Comparative Study of Phenols in Apulian Italian Wines

    PubMed Central

    Ragusa, Andrea; Centonze, Carla; Grasso, Maria E.; Latronico, Maria F.; Mastrangelo, Pier F.; Sparascio, Federica; Fanizzi, Francesco P.; Maffia, Michele

    2017-01-01

    Nutraceutics is a growing research field in which researchers study and attempt to improve the biological properties of metabolites in food. Wine is one of the most consumed products in the world and contains a plethora of molecules biologically relevant to human health. In this article, several polyphenols with potential antioxidant activity were measured in wines from Apulia, in Southeast Italy. Hydroxytyrosol, gallic and syringic acids, luteolin, quercetin, and trans-resveratrol were identified and quantified by HPLC. The amount of the analyzed metabolites in wines were largely dependent on their color, with red ones being the richest compared to white and rose wines. Gallic acid was the most abundant polyphenol, followed by syringic acid and luteolin. Nevertheless, significant amounts of hydroxytyrosol, quercetin, and trans-resveratrol were also found. The average concentration of polyphenols found in these wines could have potential health-promoting effects, especially if consumed in moderate quantities on a regular basis. PMID:28338616

  18. A Comparative Study on Cutting Electrodes for Batteries with Lasers

    NASA Astrophysics Data System (ADS)

    Luetke, Matthias; Franke, Volker; Techel, Anja; Himmer, Thomas; Klotzbach, Udo; Wetzig, Andreas; Beyer, Eckhard

    E-mobility is still one of the most discussed topics within the automotive industry. Electric powered vehicles can drive emissionfree and present consequently the future propulsion. Nearly all global players in the automotive industry are making great efforts to develop cost-efficient electric drives, which are suitable for series production. The national governments support this evolution progressively. For example the mobility research programme of the Federal Republic of Germany looks at the production of Li- Ion cells in its entirety. Within this programme the cutting of electrodes for Li-Ion cells by lasers is an issue, too. This paper provides a comparative study on cutting materials relevant for Li-Ion cells with beam sources operating in a cw mode and a pulsed mode respectively.

  19. Primate phylogeny studied by comparative determinant analysis. A preliminary report.

    PubMed

    Bauer, K

    1993-01-01

    In this preliminary report the divergence times for the major primate groups are given, calculated from a study by comparative determinant analysis of 69 proteins (equaling 0.1% of the whole genetic information). With an origin of the primate order set at 80 million years before present, the ages of the last common ancestors (LCAs) of man and the major primate groups obtained this way are as follows: Pan troglodytes 5.2; Gorilla gorilla 7.4; Pongo pygmaeus 19.2; Hylobates lar 20.3; Old World monkeys 31.4; Lagothrix lagotricha 46.0; Cebus albifrons 59.5; three lemur species 67.0, and Galago crassicaudatus 73.3 million years. The LCA results and the approach are shortly discussed. A full account of this extended investigation including results on nonprimate mammals and on the determinant structures and the immunologically derived evolutionary rates of the proteins analyzed will be published elsewhere.

  20. Interpreting odours in hermit crabs: A comparative study

    NASA Astrophysics Data System (ADS)

    Tricarico, Elena; Breithaupt, Thomas; Gherardi, Francesca

    2011-01-01

    Odours of different sources can indicate to hermit crabs the availability of empty shells, crucial resources for the life cycle of almost all of them. Here, we compared Clibanarius erythropus and Pagurus bernhardus for the intensity of investigative behaviour exhibited towards an empty, well-fitting shell in the presence of (1) plain seawater as control and seawater conditioned by (2) dead and live snails, (3) dead and live conspecifics, (4) live predators, and (5) food. During 10 min of observation, we recorded latency (the time until the first contact with the shell), and the number and duration of shell investigation bouts. The two species behaved similarly when exposed to the odours of food, live snails, and predators, while a more intense shell investigation was induced by dead snail odour in C. erythropus and by dead or live conspecific odour in P. bernhardus. Further studies should investigate the influence of phylogeny and ecology on this interspecific difference.

  1. Writer identification: A comparative study across three world major languages.

    PubMed

    Tan, Gloria Jennis; Sulong, Ghazali; Rahim, Mohd Shafry Mohd

    2017-10-01

    This paper presents a review on the state of the art in offline text-independent writer identification methods for three major languages, namely English, Chinese and Arabic, which were published in literatures from 2011 till 2016. For ease of discussions, we grouped the techniques into three categories: texture-, structure-, and allograph-based. Results are analysed, compared and tabulated along with datasets used for fair and just comparisons. It is observed that during that period, there are significant progresses achieved on English and Arabic; however, the growth on Chinese is rather slow and far from satisfactory in comparison to its wide usage. This is due to its complex writing structure. Meanwhile, issues on datasets used by previous studies are also highlighted because the size matter - accuracy of the writer identification deteriorates as database size increases. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Comparative study of heuristic evaluation and usability testing methods.

    PubMed

    Thyvalikakath, Thankam Paul; Monaco, Valerie; Thambuganipalle, Himabindu; Schleyer, Titus

    2009-01-01

    Usability methods, such as heuristic evaluation, cognitive walk-throughs and user testing, are increasingly used to evaluate and improve the design of clinical software applications. There is still some uncertainty, however, as to how those methods can be used to support the development process and evaluation in the most meaningful manner. In this study, we compared the results of a heuristic evaluation with those of formal user tests in order to determine which usability problems were detected by both methods. We conducted heuristic evaluation and usability testing on four major commercial dental computer-based patient records (CPRs), which together cover 80% of the market for chairside computer systems among general dentists. Both methods yielded strong evidence that the dental CPRs have significant usability problems. An average of 50% of empirically-determined usability problems were identified by the preceding heuristic evaluation. Some statements of heuristic violations were specific enough to precisely identify the actual usability problem that study participants encountered. Other violations were less specific, but still manifested themselves in usability problems and poor task outcomes. In this study, heuristic evaluation identified a significant portion of problems found during usability testing. While we make no assumptions about the generalizability of the results to other domains and software systems, heuristic evaluation may, under certain circumstances, be a useful tool to determine design problems early in the development cycle.

  3. Vitreous Microparticle Shedding in Retinal Detachment: A Prospective Comparative Study.

    PubMed

    Tumahai, Perle; Saas, Philippe; Ricouard, Fanny; Biichlé, Sabéha; Puyraveau, Marc; Laheurte, Caroline; Delbosc, Bernard; Saleh, Maher

    2016-01-01

    Microparticles (MPs) are membrane-derived vesicles measuring less than 1 μm in diameter. They are shed from nearly every activated or preapoptotic cell and may exhibit biologic activities in inflammation or apoptosis settings. The main purpose of this study was to determine whether MP shedding was higher in the vitreous of patients with retinal detachment (RD). This was a prospective, comparative study. Levels of vitreous MPs (including phosphatidylserine [PS]-expressing MPs, photoreceptor cell-derived MPs, and photoreceptor cell-derived MPs expressing PS) and soluble proinflammatory factors (i.e., monocyte chemoattractant protein-1, intercellular adhesion molecule-1, and IL-6) were analyzed by flow cytometry. Samples were obtained from 49 eyes undergoing RD surgery and 41 control eyes. Vitreous levels of all the MPs studied were significantly increased in the RD group. Vitreous MP levels were correlated with levels of at least one proinflammatory factor depending on MP subsets. Concerning clinical parameters, vitreous PS-expressing MP and PS-expressing photoreceptor cell-derived MP levels were higher depending on the duration of RD at surgery, the detached retina surface, and the macula status and were found more sensitive than proinflammatory factors only for the duration of RD at surgery. Vitreous concentrations of MPs (mainly derived from photoreceptor cells) are higher after rhegmatogenous RD and found to be correlated with soluble proinflammatory factors.

  4. Modelling effects of internalized antibody: a simple comparative study

    PubMed Central

    2014-01-01

    Background The modelling framework is proposed to study protection properties of antibodies to neutralize the effects of the plant toxin (ricin). The present study extends our previous work by including (i) the model of intracellular transport of toxin to the Endoplasmic Reticulum and (ii) the model of the internalised antibodies (when antibody is delivered directly into the cytosol). Method Simulation of the receptor-toxin-antibody interaction is implemented by solving the systems of PDEs (advection-diffusion models) or ODEs (rate models) for the underlying transport coupled with mass-action kinetics. Results As the main application of the enhanced framework we present a comparative study of two kinds (external and internalised) of antibodies. This comparison is based on calculation of the non-dimensional protection factor using the same set of parameters (geometry, binding constants, initial concentrations of species, and total initial amount of the antibody). Conclusion This research will provide a framework for consistent evaluation and comparison of different types of antibodies for toxicological applications. PMID:24521456

  5. Primary dysmenorrhoea: a comparative study on Australian and Chinese women.

    PubMed

    Zhu, Xiaoshu; Bensoussan, Alan; Zhu, Lin; Qian, Jing; Xu, Meiyan; Zhou, Chunxiang; Chao, Peixia; Lo, Singkai

    2009-06-01

    To explore the extent to which traditional Chinese medicine (TCM) diagnostic categories for primary dysmenorrhoea are useful in describing the clinical presentation of this condition in Australian women in comparison with Chinese women, and therefore the potential usefulness of these categories in guiding TCM treatment of Australian women. A comparative study of 120 Australian and 122 Chinese women aged from 18 to 45 years with primary dysmenorrhoea. Modified valid TCM diagnostic protocol. Difference in menstruation and menstrual pain profiles between the two groups of women found in the same study did not translate into differences in the underlying syndrome according to TCM diagnostic categories. The study found that Australian and Chinese women were represented in broadly similar proportions across the defined five diagnostic categories. Some evidence suggests that although the clinical presentation of symptoms in Australian and Chinese women is different, the distribution of women across the diagnostic categories in TCM is similar. Therefore, the TCM protocol used to diagnose primary dysmenorrhoea and guide treatment is unlikely to require adaptation for use with Australian women.

  6. Emergency medical kits on board commercial aircraft: a comparative study.

    PubMed

    Sand, Michael; Gambichler, Thilo; Sand, Daniel; Thrandorf, Christina; Altmeyer, Peter; Bechara, Falk G

    2010-11-01

    In cases of critical medical situations on board commercial aircraft, access to emergency medical kits can be lifesaving. Thus, this comparative study investigated acute care medication and equipment supplied in emergency medical kits on board both low-cost carriers and full-service carriers. Thirty-two European airlines (sixteen low-cost carriers and sixteen full-service-carriers) were asked to provide anonymous data on the contents of their emergency medical kits. All emergency medical equipment and medication carried on board were subject to a descriptive analysis with regards to International Civil Aviation Organization (ICAO) standards for emergency medical kits, as well as variation and differences between low-cost carriers and full-service carriers. A total of twelve airlines (seven full-service carriers and five low-cost carriers) participated in this study. None complied with ICAO standards. Emergency medical kits from both full-service carriers and low-cost carriers exhibited a high degree of variability. Two European low-cost carriers were assessed as being insufficiently equipped for a medical emergency requiring acute care. This study demonstrates the high degree of variability in the contents of emergency medical kits. Additionally, some airlines were equipped insufficiently for a critical medical situation on board their aircraft. Frequent checks of national authorities and further evaluation of acute care equipment are required to prepare for potentially life-threatening critical conditions occurring in special environments, such as in airplane during flight. Copyright © 2010 Elsevier Ltd. All rights reserved.

  7. Psychological profile of women with infertility: A comparative study

    PubMed Central

    Poddar, Shuvabrata; Sanyal, Nilanjana; Mukherjee, Urbi

    2014-01-01

    Background: An endeavour to probe into the psychological profile of infertile women in a comparative stance with the fertile women is not very common. This study is an attempt to explore the possible non-apparent personality factors which contribute to the unexplained pain of infertility. Methods: The main objectives of the present study were (a) to examine whether infertile women are different from fertile women in terms of selected psychological variables- narcissistic components, dimensions of attachment style and uses of defensive manoeuvres; and (b) whether the primary infertile women (n=18) are different from the secondary infertile women (n=12) with respect to those variables. A total of 60 individuals (30 infertile women and 30 matched fertile women) were assessed through Attachment Style Questionnaire (ASQ), Narcissistic Personality Inventory (NPI) and Defense Style Questionnaire (DSQ-40). General Health Questionnaire (GHQ) was administered on to the fertile women to rule out the psychiatric morbidity. Results: Findings revealed that infertile women group differed from fertile women group with respect to narcissism, dimensions of attachment style and uses of defense mechanism. The primary infertile group also showed marked difference from the secondary infertile group with respect to those variables. Conclusions: This study endeavours to enrich the knowledge regarding the personality dynamics of infertile women to design psychotherapeutic programme to aid their well-being, help them to cherish the flavour of parenthood and improve their quality of life. PMID:25788801

  8. Institutions and national development in Latin America: a comparative study

    PubMed Central

    Portes, Alejandro; Smith, Lori D.

    2013-01-01

    We review the theoretical and empirical literatures on the role of institutions on national development as a prelude to present a more rigorous and measurable definition of the concept and a methodology to study this relationship at the national and subnational levels. The existing research literature features conflicting definitions of the concept of “institutions” and empirical tests based mostly on reputational indices, with countries as units of analysis. The present study’s methodology is based on a set of five strategic organizations studied comparatively in five Latin American countries. These include key federal agencies, public administrative organizations, and stock exchanges. Systematic analysis of results show a pattern of differences between economically-oriented institutions and those entrusted with providing basic services to the general population. Consistent differences in institutional quality also emerge across countries, despite similar levels of economic development. Using the algebraic methods developed by Ragin, we test six hypotheses about factors determining the developmental character of particular institutions. Implications of results for theory and for methodological practices of future studies in this field are discussed. PMID:26543407

  9. The comparative study of solvents to expedite removal of bitumen.

    PubMed

    Iuchi, Manabu; Sugiyama, Masahide; Oyatsu, Yasuyuki; Fukai, Takao

    2009-03-01

    Hot-bitumen burn is a unique case in all types of burns. This melting substance is difficult to remove when it adheres to the skin and solidifies. It causes burns and sticks to the skin when it is cooled to the skin temperature. Some reports are available on many kinds of solvents for the removal of solid bitumen. However, there have thus far been no comparative studies. It is necessary to seek for an optimum method to remove bitumen without consuming so much time and with minimum injury to the skin. The selected solvents in this study were petrolatum, olive oil, salad oil, butter, Neosporin ointment and De-solv-it. They were often reported as being effective for hot-bitumen burn injuries with little irritation for a damaged skin. It is easy to purchase them commercially. Each solvent was poured over the bitumen in a test tube. Afterwards, the concentrations of the bitumen in the solvents were quantified with the fluorescence measurement technique. We consider De-solv-it is the one of the best solvent for the removal of bitumen and highly recommended for hot-bitumen burns. The results of this study suggest that dressing change should be done every 4 to 8 h or as frequently as needed until the bitumen is entirely removed.

  10. Skin condition assessment: a comparative study of techniques

    NASA Astrophysics Data System (ADS)

    Bindra, Ravindar M.; Wong, Joretta K.; Andrew, Jeremy J.; Xiao, Peng; Zhang, Bufa; Imhof, Robert E.

    1996-05-01

    We report the results of a study aimed at comparing Opto-Thermal Transient Emission Radiometry (OTTER) with established techniques of assessing skin condition, namely evaporimetry (TEWL), skin dielectric constant measurement, ATR-FTIR and clinical assessment. Comparisons were made during a week-long study of the effects of intensive washing on the volar forearms of 14 subjects. The study also provided a comparison of skin condition after washing with two different cleansers, a mild isethionate betaine cleansing bar and a soap bar. The subject-averaged results from OTTER and TEWL were found to correlate with the clinical assessments, namely that intensive washing with the soap bar produces greater skin damage than with the isethionate betaine bar. Skin dielectric constant measurements were found to be sensitive to changes of skin condition other than hydration, as evidenced by a daily oscillation that dominate the results. The ATR-FTIR measurements proved difficult to evaluate, because of interfering calcium deposits from the soap bar. On the practical side, OTTER and skin dielectric constant measurements were found to be quicker and more convenient to use than TEWL and ATR-FTIR.

  11. Comparative studies of brain activation with MEG and functional MRI

    SciTech Connect

    George, J.S.; Aine, C.J.; Sanders, J.A.; Lewine, J.D.; Caprihan, A.

    1993-12-31

    The past two years have witnessed the emergence of MRI as a functional imaging methodology. Initial demonstrations involved the injection of a paramagnetic contrast agent and required ultrafast echo planar imaging capability to adequately resolve the passage of the injected bolus. By measuring the local reduction in image intensity due to magnetic susceptibility, it was possible to calculate blood volume, which changes as a function of neural activation. Later developments have exploited endogenous contrast mechanisms to monitor changes in blood volume or in venous blood oxygen content. Recently, we and others have demonstrated that it is possible to make such measurements in a clinical imager, suggesting that the large installed base of such machines might be utilized for functional imaging. Although it is likely that functional MRI (fMRI) will subsume some of the clinical and basic neuroscience applications now touted for MEG, it is also clear that these techniques offer different largely complementary, capabilities. At the very least, it is useful to compare and cross-validate the activation maps produced by these techniques. Such studies will be valuable as a check on results of neuromagnetic distributed current reconstructions and will allow better characterization of the relationship between neurophysiological activation and associated hemodynamic changes. A more exciting prospect is the development of analyses that combine information from the two modalities to produce a better description of underlying neural activity than is possible with either technique in isolation. In this paper we describe some results from initial comparative studies and outline several techniques that can be used to treat MEG and fMRI data within a unified computational framework.

  12. Perfluorocarbon oxygen transport. A comparative study of four oxygenator designs.

    PubMed

    Ferguson, E R; Clymer, J J; Spruell, R D; Holman, W L

    1994-01-01

    Improvements made in current generation perfluorocarbon emulsions (PFCEs) warrant renewed interest in PFCEs as an oxygen (O2) carrying substance during cardiopulmonary bypass (CPB). Before embarking on in vivo studies of PFCEs during CPB, an in vitro study was designed to: 1) demonstrate increased O2 content attributable to PFCEs, and 2) compare O2 transfer to a PFCE crystalloid mixture by four oxygenator designs (one bubble oxygenator, two hollow fiber membrane oxygenators, and one silastic membrane oxygenator). A circuit was designed to circulate fluid between a deoxygenating device and a test oxygenator. In protocol I, either a crystalloid solution or a crystalloid PFCE mixture was circulated through bubble oxygenators at flows ranging from 0.5 to 3 l/min, and at temperatures of 4, 20, 30, or 40 degrees C. In protocol II, a crystalloid PFCE mixture was circulated at flows ranging from 0.5 to 6 l/min at temperatures of 4, 20, 30, or 40 degrees C. Four different oxygenator designs were compared using the in vitro test circuit. The comparison variables for protocols I and II were arterovenous oxygen (AVO2) difference and O2 transfer rate measured at each flow for each temperature. Protocol I showed that the AVO2 differences and O2 transfer rates were higher in the crystalloid PFCE mixture than in the crystalloid solution, although statistical comparison was precluded by the small sample size. In protocol II, the hollow fiber and silastic membrane oxygenators had higher (P < 0.05) AVO2 differences and oxygen transfer rates than the bubble oxygenators at all flows and temperatures tested. Future trials to evaluate PFCEs during cardiopulmonary bypass should use hollow fiber or silastic membrane oxygenators, rather than bubble oxygenators, to maximize transfer of O2 to the PFCE.

  13. Extreme storm surges: a comparative study of frequency analysis approaches

    NASA Astrophysics Data System (ADS)

    Hamdi, Y.; Bardet, L.; Duluc, C.-M.; Rebour, V.

    2014-08-01

    In France, nuclear facilities were designed around very low probabilities of failure. Nevertheless, some extreme climatic events have given rise to exceptional observed surges (outliers) much larger than other observations, and have clearly illustrated the potential to underestimate the extreme water levels calculated with the current statistical methods. The objective of the present work is to conduct a comparative study of three approaches to extreme value analysis, including the annual maxima (AM), the peaks-over-threshold (POT) and the r-largest order statistics (r-LOS). These methods are illustrated in a real analysis case study. All data sets were screened for outliers. Non-parametric tests for randomness, homogeneity and stationarity of time series were used. The shape and scale parameter stability plots, the mean excess residual life plot and the stability of the standard errors of return levels were used to select optimal thresholds and r values for the POT and r-LOS method, respectively. The comparison of methods was based on (i) the uncertainty degrees, (ii) the adequacy criteria and tests, and (iii) the visual inspection. It was found that the r-LOS and POT methods have reduced the uncertainty on the distribution parameters and return level estimates and have systematically shown values of the 100 and 500-year return levels smaller than those estimated with the AM method. Results have also shown that none of the compared methods has allowed a good fit at the right tail of the distribution in the presence of outliers. As a perspective, the use of historical information was proposed in order to increase the representativeness of outliers in data sets. Findings are of practical relevance, not only to nuclear energy operators in France, for applications in storm surge hazard analysis and flood management, but also for the optimal planning and design of facilities to withstand extreme environmental conditions, with an appropriate level of risk.

  14. Extreme storm surges: a comparative study of frequency analysis approaches

    NASA Astrophysics Data System (ADS)

    Hamdi, Y.; Bardet, L.; Duluc, C.-M.; Rebour, V.

    2013-11-01

    In France, nuclear facilities were designed to very low probabilities of failure. Nevertheless, exceptional climatic events have given rise to surges much larger than observations (outliers) and had clearly illustrated the potential to underestimate the extreme water levels calculated with the current statistical methods. The objective of the present work is to conduct a comparative study of three approaches including the Annual Maxima (AM), the Peaks-Over Threshold (POT) and the r-Largest Order Statistics (r-LOS). These methods are illustrated in a real analysis case study. All the data sets were screened for outliers. Non-parametric tests for randomness, homogeneity and stationarity of time series were used. The shape and scale parameters stability plots, the mean excess residual life plot and the stability of the standard errors of return levels were used to select optimal thresholds and r values for the POT and r-LOS method, respectively. The comparison of methods was based on: (i) the uncertainty degrees, (ii) the adequacy criteria and tests and (iii) the visual inspection. It was found that the r-LOS and POT methods have reduced the uncertainty on the distributions parameters and return level estimates and have systematically shown values of the 100 and 500 yr return levels smaller than those estimated with the AM method. Results have also shown that none of the compared methods has allowed a good fitting at the right tail of the distribution in the presence of outliers. As a perspective, the use of historical information was proposed in order to increase the representativity of outliers in data sets. Findings are of practical relevance not only to nuclear energy operators in France, for applications in storm surge hazard analysis and flood management, but also for the optimal planning and design of facilities to withstand extreme environmental conditions, with an appropriate level of risk.

  15. Systemic Inflammation in Cardiovascular and Periodontal Disease: Comparative Study

    PubMed Central

    Glurich, Ingrid; Grossi, Sara; Albini, Boris; Ho, Alex; Shah, Rashesh; Zeid, Mohamed; Baumann, Heinz; Genco, Robert J.; De Nardin, Ernesto

    2002-01-01

    Epidemiological studies have implicated periodontal disease (PD) as a risk factor for the development of cardiovascular disease (CVD). These studies addressed the premise that local infection may perturb the levels of systemic inflammatory mediators, thereby promoting mechanisms of atherosclerosis. Levels of inflammatory mediators in the sera of subjects with only PD, only CVD, both diseases, or neither condition were compared. Subjects were assessed for levels of C-reactive protein (CRP), serum amyloid A (SAA), ceruloplasmin, α1-acid-glycoprotein (AAG), α1-antichymotrypsin (ACT), and the soluble cellular adhesion molecules sICAM-1 and sVCAM by enzyme-linked immunoabsorbent and/or radial immunodiffusion assays. CRP levels in subjects with either condition alone were elevated twofold above subjects with neither disease, whereas a threefold increase was noted in subjects with both diseases (P = 0.0389). Statistically significant increases in SAA and ACT were noted in subjects with both conditions compared to those with one or neither condition (P = 0.0162 and 0.0408, respectively). Ceruloplasmin levels were increased in subjects with only CVD (P = 0.0001). Increases in sVCAM levels were noted in all subjects with CVD (P = 0.0054). No differences in sICAM levels were noted among subject groups. A trend toward higher levels of AAG was noted in subjects with both conditions and for ACT in subjects with only PD. Immunohistochemical examination of endarterectomy specimens of carotid arteries from subjects with atherosclerosis documented SAA and CRP deposition in association with atheromatous lesions. The data support the hypothesis that localized persistent infection may influence systemic levels of inflammatory mediators. Changes in inflammatory mediator levels potentially impact inflammation-associated atherosclerotic processes. PMID:11874889

  16. Comparative Study of Endoscope Assisted Myringoplasty and Microscopic Myringoplasty.

    PubMed

    Lakpathi, G; Sudarshan Reddy, L; Anand

    2016-06-01

    To study and compare the outcomes of the endoscopic versus microscopic approach to Myringoplasty in 60 patients. In this prospective study, the outcomes of 60 ears of 60 patients (40 male and 20 female) who underwent Myringoplasty were evaluated. The age range of the patients was 15-55 years. Group 1 underwent Myringoplasty with an endoscopic technique (n = 30), and Group 2 underwent Myringoplasty with the conventional microscopic technique (n = 30). A temporalis fascia graft was used in both groups. The outcomes were analyzed in terms of the hearing gain, duration of surgery, graft success rate and advantages and disadvantages of endoscopic versus microscopic approach to Myringoplasty. In both groups, the postoperative air-bone gap (ABG) was significantly lower than the preoperative ABG. There were no significant differences between the preoperative and postoperative ABG values (in dB) in either group. The mean operative duration in Group 1 (96.32 min) was significantly lower than that in Group 2 (136.09 min). In the preoperative evaluation of patients in Group 1 had small, medium, large perforations are 16 (53 %), 12 (40 %), and 02 (7 %), respectively. In Group 2, had small, medium, large perforations are 12 (40 %), 15 (50 %), and 03 (10 %), respectively. Perforations (wet ear) were detected in 10 (33 %), 06 (20 %), and 04 (12 %) of the patients in Group 1 at postoperative months 1, 3, and 6, respectively. Perforations (wet ear) were detected 09 (30 %), 06 (20 %) and 03 (10 %) patients in Group 2 at postoperative months 1, 3, and 6. At 6 months postoperatively, there were smaller perforations and reduced rate of perforations as compared to 1st and 3rd month in Group 1 and Group 2. The difference between the perforation conditions (larger vs. smaller) was not significant in either group. The preoperative and postoperative increases in the ABG were associated. At the end of 6 months all (100 %) patients in the Group 1 rated their cosmetic

  17. A comparative study of QT prolongation with serotonin reuptake inhibitors.

    PubMed

    Ojero-Senard, Ana; Benevent, Justine; Bondon-Guitton, Emmanuelle; Durrieu, Geneviève; Chebane, Leila; Araujo, Melanie; Montastruc, Francois; Montastruc, Jean-Louis

    2017-08-03

    QT interval prolongations were described with citalopram and escitalopram. However, the effects of the other serotonin reuptake inhibitors (SRIs) remained discussed. In order to identify a putative signal with other SRIs, the present study investigates the reports of QT interval prolongation with SRIs in two pharmacovigilance databases (PVDB). Two kinds of investigations were performed: (1) a comparative study in VigiBase®, the WHO PVDB, where notifications of QT prolongation with six SRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) were selected. Cases with overdose or pregnancy were excluded. The relationship between the "suspected" SRI and occurrence of QT prolongation was assessed by calculating reporting odds ratio (ROR) in a case/non-case design. (2) A descriptive study of QT prolongation reports with citalopram and escitalopram in the French FPVD. In VigiBase®, 855 notifications were identified (mean age 56.2 years, mainly women 73%). Among them, 172 (20.1%) were associated to escitalopram; 299 (35.0%), to citalopram; 186 (21.8%), to fluoxetine; 94 (11.0%), to sertraline; 66 (7.7%), to paroxetine; and 38 (4.4%) to fluvoxamine. A significant ROR value (higher than 1) was only found for citalopram (3.35 CI95% [2.90-3.87]) or escitalopram (2.50 [2.11-2.95]). In the FPVD, eight reports of QT prolongation were found with citalopram and 27 with escitalopram, mainly in women (77.1%) with a mean age of 73.2 years. In 23 cases (66%), SRIs were associated with other suspected drugs, mainly cardiotropic or psychotropic ones. Hypokalemia was associated in six patients. This study, performed in real conditions of life, shows a clear signal of QT prolongation with only two SRIs, citalopram and escitalopram, indicating that QT prolongation is not a SRI class effect.

  18. An open multicenter comparative randomized clinical study on chitosan.

    PubMed

    Mo, Xiaohui; Cen, John; Gibson, Elaine; Wang, Robin; Percival, Steven L

    2015-01-01

    Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next-generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management

  19. [Optimizing electrotherapy--a comparative study of 3 different currents].

    PubMed

    Crevenna, Richard; Posch, Martin; Sochor, Andrea; Keilani, Mohammad; Wiesinger, Günther; Nuhr, Martin; Kollmitzer, Josef; Nicolakis, Peter; Fialka-Moser, Veronika; Quittan, Michael

    2002-06-14

    Neuromuscular electrical stimulation can be used to increase strength of skeletal muscle. In neuromuscular electrical stimulation of innervated skeletal muscle, the application of the highest possible intensities of electricity is an important determinant of therapeutic success with regard to strength training. The therapeutic goal of "strengthening muscles" is opposed to the side effect of discomfort through the application of electricity. The aim of the present study was to compare three forms of electric current with respect to subjective tolerance and maximum achievable muscular strength. Twenty-nine healthy male volunteers were included in a single-blind study in which three forms of electric current were applied in a randomized fashion. The following types were compared: a short monophasic form, a biphasic form that was twice as long in terms of impulse duration, and a long monophasic form with an equal impulse duration than tht of the biphasic form and with an impulse form that corresponded to the short monophasic current. Stimulation was administered via surface electrodes placed on the knee extensors in the lower extremity on the right side. The intensity of the current was increased to the individual limit of tolerance or to a maximum of 100 mA. The main target parameter used to determine the success of treatment was the maximum electrically induced strength as a percentage of maximal voluntary contraction. The short monophasic form of electricity was associated with much less discomfort than the long monophasic and biphasic forms (p < 0.0001, p = 0.0062). Furthermore, the biphasic form was better tolerated (and therefore had a larger therapeutic range of application) than the long monophasic form (p = 0.041). The biphasic and long monophasic forms produced higher values for maximum electrically induced strength than did the short monophasic form (p = 0.0001, p = 0.0010). To summarize: the biphasic form had a larger range of therapeutic application than

  20. Comparative studies on nitrogen budgets of closed shrimp polyculture systems

    NASA Astrophysics Data System (ADS)

    Qi, Zhen-Xiong; Li, De-Shang; Zhang, Man-Ping; Dong, Shuang-Lin

    2001-09-01

    April to October, 1997 comparative studies on the nitrogen budgets of closed shrimp polyculture systems showed that, in all the studied polyculture systems, nitrogen from feeds and fertilizers were the main input items, which comprised 70.7% 83.9% of the total input nitrogen 3.2% 7.4% of which was provided by nitrogen fixation. It was in monoculture enclosures (Y-4, Y-11 and Y-12) that the percentage reached the maximum value. The output nitrogen in harvested products comprised 10.8% 24.6% of total input nitrogen, and the highest percentage, 24.6%, was found in shrimp-fish-tagelus polyculture systems. In shrimp monoculture and shrimp-fish polyculture systems, they were 19.1% and 21.9% respectively. The nitrogen utilization efficiency was different and varied from 12.2% was found in shrimp-tagelus polyculture systems. The lowest, 12.2%, was found in shrimp monoculture systems. All the nitrogen utilization efficiencies in shrimp-fish systems or shrimp-scallop systems seemed to be higher than that of the monoculture system, but they showed little statistical difference. The main outputs of nitrogen were found in sediment mud, and comprised 48.2% 60.8% of the total, input, the lowest percentage was found in shrimp-fish-tagelus polyculture systems, and the highest percentage in shrimp-scallop systems. During the experiment, nitrogen lost through denitrification and ammonia volatilization comprised 1.9% 6. 2%, averaged 2.8%, of the total input, and the loss through seepage comprised 5.9% 8.9% of the total. The estimated nitrogen attached to the enclosure wall comprised 3.7% 13.3% of the total, and was highest in shrimp monoculture systems. Compared with the classic shrimp farming industry, the closed shrimp polyculture systems may improve the nitrogen utilization efficiency, and hence reduce the environmental impacts on coastal waters. The nitrogen discharging rates for all the studied polyculture systems ranged from 3.0% to 6. 0% of total input nitrogen.