Dietary supplements: What's in a name? What's in the bottle?

PubMed

Marcus, Donald M

2016-01-01

The Dietary Supplement Health and Education Act of 1994 (DSHEA), which arbitrarily classified herbals and other medicinal products as dietary supplements, obscured fundamental differences between two classes of products. Authentic supplements to the diet, such as multivitamins or calcium, have nutritional value and are safe. Herbals are used worldwide as medicines, they do not supplement the diet, they may cause severe adverse events, and they should be regulated as medicines. DSHEA also prevented the Food and Drug Administration (FDA) from effectively regulating herbal supplements as medicines. One consequence of weak FDA regulatory oversight is the poor quality of herbals. FDA inspections of manufacturing facilities have revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications. Moreover, many "all natural" herbals marketed for weight loss, enhancement of sexual health and improving sports performance are adulterated with prescription and over-the-counter medications that have caused adverse cardiovascular events. New procedures to authenticate the identity of plants used in herbals will neither detect adulteration by medications nor provide assurance of appropriate pharmacological activity or safety. Nonvitamin, nonmineral "supplements" should be regulated as medicines, but revision or repeal of DSHEA faces strong opposition in Congress. The marketing of botanical supplements is based on unfounded claims that they are safe and effective. Health professionals need to inform patients and the public that there is no reason to take herbal medicines whose composition and benefits are unknown, and whose risks are evident. Copyright © 2015 John Wiley & Sons, Ltd.

Determination of Oxalate Content in Herbal Remedies and Dietary Supplements Based on Plant Extracts.

PubMed

Siener, Roswitha; López-Mesas, Montserrat; Valiente, Manuel; Blanco, Francisco

2016-02-01

Lifestyle, especially diet, is a prominent risk factor that affects the formation of calcium oxalate stones. Urinary oxalate excretion is directly related to the amount of oral intake and intestinal absorption rate of oxalate. This work evaluated the possibility of increasing oxalate ingestion, which could lead to secondary hyperoxaluria, associated with the intake of herbal remedies and dietary supplements containing plant extracts. A wide variety of 17 commercially available drugs and dietary supplements were analyzed using ion chromatography. The results showed remarkable differences in oxalate contents of the extracts. Total oxalate concentrations ranged from 0.03 to 2.2 mg/g in solid samples and from 0.005 to 0.073 mg/mL in liquid samples. The selected herbal remedies and dietary supplements containing plant extracts represent only a low risk for calcium oxalate stone formers, if the recommended daily dose is not exceeded.

Mass spectrometric analysis of pharmaceutical adulterants in products labeled as botanical dietary supplements or herbal remedies: a review.

PubMed

Vaclavik, Lukas; Krynitsky, Alexander J; Rader, Jeanne I

2014-11-01

The increased availability and use of botanical dietary supplements and herbal remedies among consumers has been accompanied by an increased frequency of adulteration of these products with synthetic pharmaceuticals. Unscrupulous producers may add drugs and analogues of various classes, such as phosphodiesterase type 5 (PDE-5) inhibitors, weight loss, hypoglycemic, antihypertensive and anti-inflammatory agents, or anabolic steroids, to develop or intensify biological effects of dietary supplements or herbal remedies. The presence of such adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers. Analytical methods that allow rapid and reliable testing of dietary supplements for the presence of synthetic drugs are needed to address such fraudulent practices. Mass spectrometry (MS) and hyphenated techniques such as liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS) have become primary tools in this endeavor. The present review critically assesses the role and summarizes the applications of MS in the analysis of pharmaceutical adulterants in botanical dietary supplements and herbal remedies. The uses of MS techniques in detection, confirmation, and quantification of known pharmaceutical adulterants as well as in screening for and structure elucidation of unexpected adulterants and novel designer drugs are discussed.

Liver Injury from Herbal, Dietary, and Weight Loss Supplements: a Review

PubMed Central

Zheng, Elizabeth X.; Navarro, Victor J.

2015-01-01

Herbal and dietary supplement usage has increased steadily over the past several years in the United States. Among the non-bodybuilding herbal and dietary supplements, weight loss supplements were among the most common type of HDS implicated in liver injury. While drug induced liver injury is rare, its consequences are significant and on the rise. The purpose of this review is to highlight case reports of weight loss products such as Hydroxycut and OxyElite Pro as one form of HDS that have hepatotoxic potential and to characterize its clinical effects as well as pattern of liver injury. We also propose future strategies in the identification and study of potentially hepatotoxic compounds in an effort to outline a diagnostic approach for identifying any drug induced liver injury. PMID:26357638

Liver Injury from Herbal, Dietary, and Weight Loss Supplements: a Review.

PubMed

Zheng, Elizabeth X; Navarro, Victor J

2015-06-28

Herbal and dietary supplement usage has increased steadily over the past several years in the United States. Among the non-bodybuilding herbal and dietary supplements, weight loss supplements were among the most common type of HDS implicated in liver injury. While drug induced liver injury is rare, its consequences are significant and on the rise. The purpose of this review is to highlight case reports of weight loss products such as Hydroxycut and OxyElite Pro as one form of HDS that have hepatotoxic potential and to characterize its clinical effects as well as pattern of liver injury. We also propose future strategies in the identification and study of potentially hepatotoxic compounds in an effort to outline a diagnostic approach for identifying any drug induced liver injury.

Bleeding risks of herbal, homeopathic, and dietary supplements: a hidden nightmare for plastic surgeons?

PubMed

Wong, Wendy W; Gabriel, Allen; Maxwell, G Patrick; Gupta, Subhas C

2012-03-01

The utilization of complementary and alternative medicine has increased tremendously in the last two decades. Herbal products, homeopathic medicines, and dietary supplements are extremely popular and are available without a prescription (which likely contributes to their popularity). Despite their "natural" characteristics, these remedies have the potential to cause bleeding in patients who undergo surgery. The high use of these supplements among cosmetic surgery patients, coupled with increasing reports of hematomas associated with herbal and homeopathic medicines, prompted the authors to conduct a comprehensive review focused on bleeding risks of such products in an effort to raise awareness among plastic surgeons. This review focuses on 19 herbs, three herbal formulas, two herbal teas, and several other supplements that can cause bleeding perioperatively and postoperatively. In addition to being aware of such adverse effects, plastic surgeons must adequately screen all patients and educate them on the possible dangers associated with these treatments.

MedlinePlus: Herbs and Supplements

MedlinePlus

... T U V W XYZ 0-9 Browse dietary supplements and herbal remedies to learn about their effectiveness, ... C Calcium National Institutes of Health, Office of Dietary Supplements Calendula Natural Medicines Comprehensive Database Cancell/Cantron/Protocel ( ...

Adulteration of herbal sexual enhancers and slimmers: The wish for better sexual well-being and perfect body can be risky.

PubMed

Skalicka-Woźniak, Krystyna; Georgiev, Milen I; Orhan, Ilkay Erdogan

2017-10-01

The popularity of herbal medicines and dietary supplements is increasing all over the world due to the many side-effects assigned to synthetic drugs. Herbal remedies should be considered as safe, with no side-effects, but unfortunately, even if they are labelled as natural, large numbers of adulterants, not only with toxic heavy metals but also with undeclared synthetic substances, have been detected up to date. In this review, the most frequent instances of adulteration of herbal medicines and dietary supplements acting as sexual enhancers and slimming products are thoroughly discussed. The great success of synthetic phosphodiesterase type-5 (PDE-5) inhibitory drugs like sildenafil, vardenafil and tadalafil, used for the treatment of erectile dysfunction has made them, as well as their unapproved analogues, popular as adulterants in herbal dietary supplements. The second group among blockbuster products are herbal preparations for slimming purpose, as obesity and gaining weight are major problems worldwide. Here, sibutramine hydrochloride monohydrate, an anti-obesity drug which inhibits serotonergic and noradrenergic reuptake, seems to be the most common adulterant. Together with large numbers of its analogues, thyroid hormones, anorexigens, diuretics, stimulants, and laxative agents are also detected in most of tested diet supplements. Copyright © 2016 Elsevier Ltd. All rights reserved.

Over-the-Counter Medication and Herbal or Dietary Supplement Use in College: Dose Frequency and Relationship to Self-Reported Distress

ERIC Educational Resources Information Center

Stasio, Michael J.; Curry, Kim; Sutton-Skinner, Kelly M.; Glassman, Destinee M.

2008-01-01

Objective: A growing number of researchers have examined the use of over-the-counter (OTC) medications and herbal or dietary supplements among college students. There is concern about the efficacy and safety of these products, particularly because students appear to use them at a higher rate than does the general public. Participants and Methods:…

Review article: herbal and dietary supplement hepatotoxicity.

PubMed

Bunchorntavakul, C; Reddy, K R

2013-01-01

Herbal and dietary supplements are commonly used throughout the World. There is a tendency for underreporting their ingestion by patients and the magnitude of their use is underrecognised by Physicians. Herbal hepatotoxicity is not uncommonly encountered, but the precise incidence and manifestations have not been well characterised. To review the epidemiology, presentation and diagnosis of herbal hepatotoxicity. This review will mainly discuss single ingredients and complex mixtures of herbs marketed under a single label. A Medline search was undertaken to identify relevant literature using search terms including 'herbal', 'herbs', 'dietary supplement', 'liver injury', 'hepatitis' and 'hepatotoxicity'. Furthermore, we scanned the reference lists of the primary and review articles to identify publications not retrieved by electronic searches. The incidence rates of herbal hepatotoxicity are largely unknown. The clinical presentation and severity can be highly variable, ranging from mild hepatitis to acute hepatic failure requiring transplantation. Scoring systems for the causality assessment of drug-induced liver injury may be helpful, but have not been validated for herbal hepatotoxicity. Hepatotoxicity features of commonly used herbal products, such as Ayurvedic and Chinese herbs, black cohosh, chaparral, germander, greater celandine, green tea, Herbalife, Hydroxycut, kava, pennyroyal, pyrrolizidine alkaloids, skullcap, and usnic acid, have been individually reviewed. Furthermore, clinically significant herb-drug interactions are also discussed. A number of herbal medicinal products are associated with a spectrum of hepatotoxicity events. Advances in the understanding of the pathogenesis and the risks involved are needed to improve herbal medicine safety. © 2012 Blackwell Publishing Ltd.

Herbal Medicine

MedlinePlus

... used for its scent, flavor, or therapeutic properties. Herbal medicines are one type of dietary supplement. They are ... extracts, and fresh or dried plants. People use herbal medicines to try to maintain or improve their health. ...

Interaction of Carbamazepine with Herbs, Dietary Supplements, and Food: A Systematic Review

PubMed Central

Zuo, Zhong

2013-01-01

Background. Carbamazepine (CBZ) is a first-line antiepileptic drug which may be prone to drug interactions. Systematic review of herb- and food-drug interactions on CBZ is warranted to provide guidance for medical professionals when prescribing CBZ. Method. A systematic review was conducted on six English databases and four Chinese databases. Results. 196 out of 3179 articles fulfilled inclusion criteria, of which 74 articles were reviewed and 33 herbal products/dietary supplement/food interacting with CBZ were identified. No fatal or severe interactions were documented. The majority of the interactions were pharmacokinetic-based (80%). Traditional Chinese medicine accounted for most of the interactions (n = 17), followed by food (n = 10), dietary supplements (n = 3), and other herbs/botanicals (n = 3). Coadministration of 11 and 12 of the studied herbal products/dietary supplement/food significantly decreased or increased the plasma concentrations of CBZ. Regarding pharmacodynamic interaction, Xiao-yao-san, melatonin, and alcohol increased the side effects of CBZ while caffeine lowered the antiepileptic efficacy of CBZ. Conclusion. This review provides a comprehensive summary of the documented interactions between CBZ and herbal products/food/dietary supplements which assists healthcare professionals to identify potential herb-drug and food-drug interactions, thereby preventing potential adverse events and improving patients' therapeutic outcomes when prescribing CBZ. PMID:24023584

Identification of (antioxidative) plants in herbal pharmaceutical preparations and dietary supplements.

PubMed

Deconinck, Eric; Custers, Deborah; De Beer, Jacques Omer

2015-01-01

The standard procedures for the identification, authentication, and quality control of medicinal plants and herbs are nowadays limited to pure herbal products. No guidelines or procedures, describing the detection or identification of a targeted plant or herb in pharmaceutical preparations or dietary supplements, can be found. In these products the targeted plant is often present together with other components of herbal or synthetic origin. This chapter describes a strategy for the fast development of a chromatographic fingerprint approach that allows the identification of a targeted plant in herbal preparations and dietary supplements. The strategy consists of a standard chromatographic gradient that is tested for the targeted plant with different extraction solvents and different mobile phases. From the results obtained, the optimal fingerprint is selected. Subsequently the samples are analyzed according to the selected methodological parameters, and the obtained fingerprints can be compared with the one obtained for the pure herbal product or a standard preparation. Calculation of the dissimilarity between these fingerprints will result in a probability of presence of the targeted plant. Optionally mass spectrometry can be used to improve specificity, to confirm identification, or to identify molecules with a potential medicinal or antioxidant activity.

Composition of Lutein Ester Regioisomers in Marigold Flower, Dietary Supplement, and Herbal Tea.

PubMed

Abdel-Aal, El-Sayed M; Rabalski, Iwona

2015-11-11

Characterization of lutein and its esters in a health product is necessary for its efficacy. In the current study lutein ester regioisomers were quantified and identified in several dietary supplements and herbal teas in comparison with marigold flower, the commercial source of lutein. The products were extracted with three solvents and separated on a C30 column. The separated esters were identified/confirmed with LC-MS in APCI+ve mode with the use of synthetic lutein esters. The total content of lutein esters substantially varied among marigold flowers (167-5752 μg/g), supplements (88,000-110,700 μg/g), and herbal teas (12.4-91.3 μg/g). Lutein supplement had a lutein profile similar to that of marigold flower, whereas herbal tea showed an extremely different profile. Lutein dipalmitate was the dominant compound in supplements and marigold flowers followed by lutein 3'-O-myristate-3-O-palmitate and lutein 3'-O-palmitate-3-O-myristate. Lutein was the major compound in marigold herbal tea with small amounts of lutein mono- and diesters. Differences in the concentration and composition of lutein compounds among marigold products could indicate distinct product quality and lutein bioavailability.

Herbal hepatotoxicity: suspected cases assessed for alternative causes.

PubMed

Teschke, Rolf; Schulze, Johannes; Schwarzenboeck, Alexander; Eickhoff, Axel; Frenzel, Christian

2013-09-01

Alternative explanations are common in suspected drug-induced liver injury (DILI) and account for up to 47.1% of analyzed cases. This raised the question of whether a similar frequency may prevail in cases of assumed herb-induced liver injury (HILI). We searched the Medline database for the following terms: herbs, herbal drugs, herbal dietary supplements, hepatotoxic herbs, herbal hepatotoxicity, and herb-induced liver injury. Additional terms specifically addressed single herbs and herbal products: black cohosh, Greater Celandine, green tea, Herbalife products, Hydroxycut, kava, and Pelargonium sidoides. We retrieved 23 published case series and regulatory assessments related to hepatotoxicity by herbs and herbal dietary supplements with alternative causes. The 23 publications comprised 573 cases of initially suspected HILI; alternative causes were evident in 278/573 cases (48.5%). Among them were hepatitis by various viruses (9.7%), autoimmune diseases (10.4%), nonalcoholic and alcoholic liver diseases (5.4%), liver injury by comedication (DILI and other HILI) (43.9%), and liver involvement in infectious diseases (4.7%). Biliary and pancreatic diseases were frequent alternative diagnoses (11.5%), raising therapeutic problems if specific treatment is withheld; pre-existing liver diseases including cirrhosis (9.7%) were additional confounding variables. Other diagnoses were rare, but possibly relevant for the individual patient. In 573 cases of initially assumed HILI, 48.5% showed alternative causes unrelated to the initially incriminated herb, herbal drug, or herbal dietary supplement, calling for thorough clinical evaluations and appropriate causality assessments in future cases of suspected HILI.

UHPLC/HRMS analysis of African mango (Irvingia gabonensis) seeds, seed extracts, and African mango based dietary supplements

USDA-ARS?s Scientific Manuscript database

Dietary Supplements based on extract from Irvingia gabonensis (African Mango, or AM) seeds are one of the popular herbal weight loss dietary supplements in the US market. The extract from the AM seeds is believed to be a natural and healthy way to lose weight and improve overall health. However, the...

Liver injury induced by herbal complementary and alternative medicine.

PubMed

Navarro, Victor J; Seeff, Leonard B

2013-11-01

Herbal and dietary supplement use is common. Most marketed products consist of complex mixtures. Although they are perceived as safe, instances of hepatotoxicity attributable to these products underscore their potential for injury, but the exact component that is responsible for injury is difficult to discern. The lenient regulatory environment in the United States, which opens the possibility of adulteration and contamination, adds to the challenge of disease attribution. Although many different herbal and dietary supplements have been reported to cause liver injury, in the United States, products used for bodybuilding and weight loss are the most commonly implicated. Copyright © 2013 Elsevier Inc. All rights reserved.

Dietary Supplement Polypharmacy: An Unrecognized Public Health Problem?

PubMed Central

Gryzlak, Brian M.; Zimmerman, M. Bridget; Wallace, Robert B.

2010-01-01

Excessive and inappropriate use of medications, or ‘polypharmacy’, has been recognized as a public health problem. In addition, there is growing use of dietary supplements in the United States; however, little is known about the patterns of supplement use. Recent reports in the literature of cases of excessive or inappropriate use of herbal dietary supplements leading to the term ‘polyherbacy’. The clinical vignettes described in this article highlight the need for further research on the nature and extent of multiple and inappropriate dietary supplement use or ‘dietary supplement polypharmacy’. Clinical interviewing and population surveys both address this issue in complementary ways, and provide a further understanding of dietary supplement use patterns. PMID:18955288

A molecular docking study of phytochemical estrogen mimics from dietary herbal supplements.

PubMed

Powers, Chelsea N; Setzer, William N

2015-01-01

The purpose of this study is to use a molecular docking approach to identify potential estrogen mimics or anti-estrogens in phytochemicals found in popular dietary herbal supplements. In this study, 568 phytochemicals found in 17 of the most popular herbal supplements sold in the United States were built and docked with two isoforms of the estrogen receptor, ERα and ERβ (a total of 27 different protein crystal structures). The docking results revealed six strongly docking compounds in Echinacea, three from milk thistle (Silybum marianum), three from Gingko biloba, one from Sambucus nigra, none from maca (Lepidium meyenii), five from chaste tree (Vitex agnus-castus), two from fenugreek (Trigonella foenum-graecum), and two from Rhodiola rosea. Notably, of the most popular herbal supplements for women, there were numerous compounds that docked strongly with the estrogen receptor: Licorice (Glycyrrhiza glabra) had a total of 26 compounds strongly docking to the estrogen receptor, 15 with wild yam (Dioscorea villosa), 11 from black cohosh (Actaea racemosa), eight from muira puama (Ptychopetalum olacoides or P. uncinatum), eight from red clover (Trifolium pratense), three from damiana (Turnera aphrodisiaca or T. diffusa), and three from dong quai (Angelica sinensis). Of possible concern were the compounds from men's herbal supplements that exhibited strong docking to the estrogen receptor: Gingko biloba had three compounds, gotu kola (Centella asiatica) had two, muira puama (Ptychopetalum olacoides or P. uncinatum) had eight, and Tribulus terrestris had six compounds. This molecular docking study has revealed that almost all popular herbal supplements contain phytochemical components that may bind to the human estrogen receptor and exhibit selective estrogen receptor modulation. As such, these herbal supplements may cause unwanted side effects related to estrogenic activity.

Scientific evaluation of traditional Chinese medicine under DSHEA: a conundrum. Dietary Supplement Health and Education Act.

PubMed

Chang, J

1999-04-01

In the United States, traditional Chinese medicines (TCM) are currently sold as dietary supplements, as defined by The Dietary Supplement Health and Education Act (DSHEA). This legislation is unique to the United States and while "structure and function" claims are allowable under DSHEA, disease claims are not. The narrow definition, however, poses a challenge to designing appropriate clinical studies that can provide data for "structure and function" claim substantiation. The process of melding Chinese herbal medicines into the dietary supplement category is complex and there is a need to define a clinical trial paradigm carefully that addresses "structure and function claims" without sacrificing scientific rigor. It is frequently not recognized that TCM favors an amalgamation of several herbs to generate the putative clinical effect. Because of this historical multiherb approach, the reliance on retrospective data to support the potential health benefits of an herb extract has severe limitations. Notwithstanding the immense value of identifying the pharmacological activity of a TCM herb to a chemical suitable for pharmaceutical development, another approach to safe and efficacious herbal products is to develop a standardized herbal extract. This article highlights issues related to the latter approach and will discuss a research-based strategy that may be suitable for validating, in part, the putative health benefits of TCM.

Perioperative analgesia and the effects of dietary supplements.

PubMed

Abe, Andrew; Kaye, Alan David; Gritsenko, Karina; Urman, Richard D; Kaye, Adam Marc

2014-06-01

With over 50,000 dietary supplements available, resurgence in consumer interest over the past few decades has resulted in an explosion of use of these agents worldwide. Disillusionment with current medications and belief in "natural medicines" has resulted in a multibillion dollar industry. Active ingredients in a number of herbs are being tested for therapeutic potential, and some are efficacious, so herbal medicines cannot be dismissed. The prevalence of herbology is further encouraged by a relatively relaxed policy of the FDA regarding these compounds, which they consider foods. As herbal products are included in the "supplement" category, there is no existing protocol for standardization of these products. There are numerous examples of herbals that can adversely affect patient recovery and outcomes in anesthesia. The prudent anesthesia provider will make sure to obtain correct information as to accurate herbal usage of each patient and attempt to discontinue these products two to three weeks prior to the delivery of an anesthetic. Postoperative analgesia, bleeding, and level of sedation can be negatively impacted related to herbal products and herbal-drug interactions. Over 90 herbal products are associated with bleeding and this can be a specific problem intraoperatively or when considering placement of a regional anesthetic for postoperative pain management. Copyright © 2014 Elsevier Ltd. All rights reserved.

Utilization and Safety of Common Over-the-Counter Dietary/Nutritional Supplements, Herbal Agents, and Homeopathic Compounds for Disease Prevention.

PubMed

Trivedi, Ruchir; Salvo, Marissa C

2016-09-01

Dietary supplements are commonly used by patients as part of their medical care plan. Often clinicians may not be aware of their use, because patients do not always consider these to be medications. All clinicians need to continually ask patients about their use of dietary supplements when collecting a medication history. Dietary supplements and prescription medications often share similar enzymatic pathways for their metabolism. These interactions may lead to severe adverse reactions. This article reviews available evidence for a variety of dietary supplements in select disease categories. Copyright © 2016 Elsevier Inc. All rights reserved.

Herbal and Dietary Supplement Induced Liver Injury

PubMed Central

de Boer, Ynto S.; Sherker, Averell H.

2016-01-01

Summary The increase in the use of herbal and dietary supplements (HDS) over the last decades has been accompanied with an increase in the reports of HDS associated hepatotoxicity. The spectrum of HDS induced liver injury is diverse and the outcome may vary from transient liver test elevations to fulminant hepatic failure resulting in death or requiring liver transplantation. There are no validated standardized tools to establish the diagnosis, but some HDS products do have a typical clinical signature that may help to identify HDS induced liver injury. PMID:27842768

The incidence of vitamin, mineral, herbal, and other supplement use in facial cosmetic patients.

PubMed

Zwiebel, Samantha J; Lee, Michelle; Alleyne, Brendan; Guyuron, Bahman

2013-07-01

Dietary supplement use is common in the United States. Some herbal supplements may cause coagulopathy, hypertension, or dry eyes. The goal of this study is to reveal the incidence of herbal supplement use in the cosmetic surgery population. A retrospective chart review of 200 patients undergoing facial cosmetic surgery performed by a single surgeon was performed. Variables studied included patient age, sex, surgical procedure, herbal medication use, and intraoperative variables. Exclusion criteria were age younger than 15 years, noncosmetic procedures such as trauma, and incomplete preoperative medication form. Patients were subdivided into the supplement user group (herbal) and the supplement nonuser group (nonherbal). Statistical analysis included descriptive statistics, t test, and chi-square analysis. The incidence of supplement use was 49 percent in the 200 patients; 24.5 percent of patients used only vitamins or minerals, 2.5 percent of patients used only animal- and plant-based (nonvitamin/mineral) supplements, and 22 percent of patients used both types of supplements. In the herbal group, patients used an average of 2.8 supplements. The herbal and nonherbal groups differed significantly in sex (herbal, 89.8 percent female; nonherbal, 77.5 percent; p < 0.04) and age (herbal, 51.4 years; nonherbal, 38.5 years; p < 0.001). Herbal supplement use is prevalent in the facial cosmetic surgery population, especially in the older female population. Considering the potential ill effects of these products on surgery and recovery, awareness and careful documentation and prohibiting the patients from the consumption of these products will increase the safety and reduce the recovery following cosmetic procedures.

Attitudes, beliefs and behaviours of Australia dietitians regarding dietary supplements: A cross-sectional survey.

PubMed

Marx, Wolfgang; Kiss, Nicole; McKavanagh, Daniel; Isenring, Elisabeth

2016-11-01

The aim of this study was to investigate the attitudes, beliefs and behaviors of Australian dietitians regarding dietary supplements. An online survey was disseminated through the mailing lists of multiple healthcare organizations. There were 231 Australian dietitians that replied to the online survey. The results indicate that Australian dietitians are interested in dietary supplements (65%); however, the results also indicate that Australian dietitians are tentative about integrating dietary supplements into their dietetic practice. Concerns regarding potential drug-nutrient/herbal interactions were reported as the primary barrier (67%) to utilizing dietary supplements as part of clinical practice. In addition, there was a strong interest in additional training in dietary supplements (79%). In summary, Australian dietitians are interested in the use of dietary supplements; however, due to current barriers, few dietitians utilize dietary supplements as part of dietetic practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

Alternative Medicine and Your Child

MedlinePlus

... TCM practice of acupuncture may be combined with herbal medicine and qi gong. And Ayurveda includes the mind- ... complements to regular medical treatment, some therapies — particularly herbal ... (OTC) medicines, dietary supplements are not rigorously regulated by the ...

APPROACH FOR ASSESSING RISK OF ENVIRONMENTAL CONTAMINANTS PRESENT IN BOTANICAL DIETARY SUPPLEMENTS

EPA Science Inventory

Botanical dietary supplements have a long history of use in Europe and China, but they are becoming increasing popular in the United States. Since these products are classified as herbals, the United States Food and Drug Administration does not regulate nor monitor these suppleme...

Dietary Supplements in Children.

PubMed

Smolinske, Susan C

2017-12-01

High-quality systematic reviews of use of herbal or homeopathic remedies in children often suffer from design flaws, such as not following PRISMA guidelines, inconsistent outcome measurements, and paucity of high-quality studies. Herbal remedies have modest demonstrated benefits with insufficient evidence to recommend any particular supplement. Homeopathic remedies have no role in treatment of pediatric conditions, and have been associated with great harm in infants given homeopathic teething products. Two types of herbal supplements are associated with high risk in adolescents, energy drinks and adulterated weight-loss products. Parents should be counseled about risks of these products. Copyright © 2017 Elsevier Inc. All rights reserved.

Adverse Effects of Common Drugs: Dietary Supplements.

PubMed

Felix, Todd Matthew; Karpa, Kelly Dowhower; Lewis, Peter R

2015-09-01

Dietary supplement-induced adverse effects often resolve quickly after discontinuation of the offending product, especially in younger patients. The potential for unwanted outcomes can be amplified in elderly patients or those taking multiple prescription drugs, especially where interactions exist with drugs metabolized by cytochrome P450 enzymes. Attributing injury or illness to a specific supplement can be challenging, especially in light of multi-ingredient products, product variability, and variability in reporting, as well as the vast underreporting of adverse drug reactions. Clinicians prescribing a new drug or evaluating a patient with a new symptom complex should inquire about use of herbal and dietary supplements as part of a comprehensive evaluation. Clinicians should report suspected supplement-related adverse effects to the local or state health department, as well as the Food and Drug Administration's MedWatch program (available at https://www.safetyreporting.hhs.gov). Clinicians should consider discussing suspected adverse effects involving drugs, herbal products, or dietary supplements with their community- and hospital-based pharmacists, and explore patient management options with medical or clinical toxicology subspecialists. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

New drug information resources for pharmacists at the National Library of Medicine.

PubMed

Knoben, James E; Phillips, Steven J

2014-01-01

To provide an overview of selected drug information-related databases of the National Library of Medicine (NLM), with a focus on newer resources that support the professional information needs of pharmacists and other health care providers. NLM, which is the world's largest medical library, provides an array of bibliographic, factual, and evidence-based drug, herbal remedy, and dietary supplement information resources. Five of the more recently introduced online resources include areas of particular importance to pharmacists, including a repository of current product labeling/package inserts, with automated search links to associated information resources; a portal to drug information that allows pharmacists to search multiple databases simultaneously and link to related medication and health care information resources; authoritative information on the effects of medications, herbal remedies, and dietary supplements in nursing infants and their mothers; comprehensive information, including a case registry, on the potential for liver toxicity due to drugs, herbal remedies, and dietary supplements; and a pill identification system with two intuitive search methodologies. NLM provides several clinical-scientific drug information resources that are particularly useful in meeting the professional information needs of pharmacists.

Use and Factors Associated With Herbal/Botanical and Nonvitamin/Nonmineral Dietary Supplements Among Women of Reproductive Age: An Analysis of the Infant Feeding Practices Study II.

PubMed

Budzynska, Katarzyna; Filippelli, Amanda C; Sadikova, Ekaterina; Low Dog, Tieraona; Gardiner, Paula

2016-07-01

Little is known about the changes in prevalence of dietary supplement use in pregnancy, postpartum, and in a comparison group of nonpregnant women. We conducted a secondary analysis of the Infant Feeding Practices II study. The purpose of this study is to report the prevalence of herbal or botanical and nonvitamin, nonmineral dietary supplement use by US women with respect to demographic, behavioral, and health factors. We compared pregnant and postpartum women to a comparison group of nonpregnant women who had not given birth in the past 12 months. Our main outcome was the prevalence of dietary supplements. Multiple logistic regression models were used to examine factors associated with herbal or botanical and nonvitamin, nonmineral dietary supplement use during reproductive age, pregnancy, and postpartum. The total sample included 1444 women assessed during the prenatal period, 1422 from the postpartum period, and 1517 women in a comparison group. In terms of herb or botanical use, 15% of the prenatal group, 16% of the postpartum group, and 22% of the comparison group reported using herbs or botanicals. The most frequently used nonvitamin, nonmineral supplement was omega-3 fatty acid. Among the total prenatal group and comparison group, women eating 5 or more servings of fruits or vegetables were less likely to report using herbs or botanicals. Women in the comparison group self-identifying as black were 4 times as likely to report using herbs or botanicals compared to participants self-identifying as white. In addition, women identifying as a race other than white were almost twice as likely to report herb or botanical use across all study groups. This is one of the rare studies that shows the changing prevalence of herbs or botanicals and nonvitamin, nonmineral dietary supplement use in women in the reproductive stage of their lives. © 2016 by the American College of Nurse-Midwives.

Successful isolation and PCR amplification of DNA from National Institute of Standards and Technology herbal dietary supplement standard reference material powders and extracts.

PubMed

Cimino, Matthew T

2010-03-01

Twenty-four herbal dietary supplement powder and extract reference standards provided by the National Institute of Standards and Technology (NIST) were investigated using three different commercially available DNA extraction kits to evaluate DNA availability for downstream nucleotide-based applications. The material included samples of Camellia, Citrus, Ephedra, Ginkgo, Hypericum, Serenoa, And Vaccinium. Protocols from Qiagen, MoBio, and Phytopure were used to isolate and purify DNA from the NIST standards. The resulting DNA concentration was quantified using SYBR Green fluorometry. Each of the 24 samples yielded DNA, though the concentration of DNA from each approach was notably different. The Phytopure method consistently yielded more DNA. The average yield ratio was 22 : 3 : 1 (ng/microL; Phytopure : Qiagen : MoBio). Amplification of the internal transcribed spacer II region using PCR was ultimately successful in 22 of the 24 samples. Direct sequencing chromatograms of the amplified material suggested that most of the samples were comprised of mixtures. However, the sequencing chromatograms of 12 of the 24 samples were sufficient to confirm the identity of the target material. The successful extraction, amplification, and sequencing of DNA from these herbal dietary supplement extracts and powders supports a continued effort to explore nucleotide sequence-based tools for the authentication and identification of plants in dietary supplements. (c) Georg Thieme Verlag KG Stuttgart . New York.

Acute liver injury following Garcinia cambogia weight-loss supplementation: case series and literature review.

PubMed

Crescioli, Giada; Lombardi, Niccolò; Bettiol, Alessandra; Marconi, Ettore; Risaliti, Filippo; Bertoni, Michele; Menniti Ippolito, Francesca; Maggini, Valentina; Gallo, Eugenia; Firenzuoli, Fabio; Vannacci, Alfredo

2018-05-25

Herbal weight-loss supplements are sold as self-medication products, and are often used under the misconception that their natural origin guarantees their safety. Food supplements are not required to provide any benefit/risk profile evaluation before marketing; however, possible risks associated with use of herbal extracts in food supplements are becoming more and more documented in the literature. Some herbs are listed as the leading cause of herb-induced liver injury, with a severe or potentially lethal clinical course, and unpredictable herb-drug interactions. Garcinia cambogia (GC) extract and GC-containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we present four cases of acute liver failure in women taking GC extract for weight loss, and a literature review of clinical evidences about hepatic toxicity in patients taking dietary supplements containing GC extract.

Evaluation of herbal dietary supplements marketed on the internet for recreational use.

PubMed

Dennehy, Cathi E; Tsourounis, Candy; Miller, Amy E

2005-10-01

The Internet is a popular tool for marketing and purchasing herbal dietary supplements (DS). Various Web sites sell these products purely for recreational use. To describe the content of Web sites that advertise and market herbal DS for recreational use (ie, for the purpose of altering mood/behavior/or perception, "getting high," or as a substitute for a drug of abuse). Four major search engines and the search terms "buy herbal high" and "buy legal high" were used to identify Web sites selling herbal DS for recreational use. Web sites were evaluated for their country of origin and for compliance with the Dietary Supplement Health and Education Act (DSHEA). Products were evaluated for their ingredient lists, effect claims, comparisons with illicit drugs, adverse effects, drug interactions, and contraindications. Twenty-eight unique Web sites with 119 products were evaluated. Most sites were in the US (54%) and were in compliance with DSHEA. Forty-seven percent of the products were likened to illicit drugs, typically marijuana (48%) or 3-,4-methylene dioxyamphetamine (Ecstasy; 23%). The most common product ingredients were ephedra alkaloids (27%), Salvia divinorum (17%), kava (10%), guarana (10%), Acorus calamus (10%), and damiana (10%). Effect claims frequently involved the products' use as a hallucinogen (51%) or stimulant (39%). Sixty-four percent of the sites mentioned adverse effects, and 54% mentioned drug interactions. This study demonstrates that herbal DS are being marketed for use as legal alternatives to illicit drugs of abuse. Healthcare professionals need to be aware of this trend and the products that are involved.

Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study

PubMed Central

Block, Gladys; Jensen, Christopher D; Norkus, Edward P; Dalvi, Tapashi B; Wong, Les G; McManus, Jamie F; Hudes, Mark L

2007-01-01

Background Dietary supplement use in the United States is prevalent and represents an important source of nutrition. However, little is known about individuals who routinely consume multiple dietary supplements. This study describes the dietary supplement usage patterns, health, and nutritional status of long-term multiple dietary supplement users, and where possible makes comparisons to non-users and multivitamin/mineral supplement users. Methods Using a cross-sectional study design, information was obtained by online questionnaires and physical examination (fasting blood, blood pressure, body weight) from a convenience sample of long-term users of multiple dietary supplements manufactured by Shaklee Corporation (Multiple Supp users, n = 278). Data for non-users (No Supp users, n = 602) and multivitamin/mineral supplement users (Single Supp users, n = 176) were obtained from the National Health and Nutrition Examination Survey (NHANES) 2001–2002 and NHANES III 1988–1994. Logistic regression methods were used to estimate odds ratios with 95% confidence intervals. Results Dietary supplements consumed on a daily basis by more than 50% of Multiple Supp users included a multivitamin/mineral, B-complex, vitamin C, carotenoids, vitamin E, calcium with vitamin D, omega-3 fatty acids, flavonoids, lecithin, alfalfa, coenzyme Q10 with resveratrol, glucosamine, and a herbal immune supplement. The majority of women also consumed gamma linolenic acid and a probiotic supplement, whereas men also consumed zinc, garlic, saw palmetto, and a soy protein supplement. Serum nutrient concentrations generally increased with increasing dietary supplement use. After adjustment for age, gender, income, education and body mass index, greater degree of supplement use was associated with more favorable concentrations of serum homocysteine, C-reactive protein, high-density lipoprotein cholesterol, and triglycerides, as well as lower risk of prevalent elevated blood pressure and diabetes. Conclusion This group of long-term multiple dietary supplement users consumed a broad array of vitamin/mineral, herbal, and condition-specific dietary supplements on a daily basis. They were more likely to have optimal concentrations of chronic disease-related biomarkers, and less likely to have suboptimal blood nutrient concentrations, elevated blood pressure, and diabetes compared to non-users and multivitamin/mineral users. These findings should be confirmed by studying the dietary supplement usage patterns, health, and nutritional status of other groups of heavy users of dietary supplements. PMID:17958896

Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

PubMed Central

Avigan, Mark I.; Mozersky, Robert P.; Seeff, Leonard B.

2016-01-01

In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized. PMID:26950122

Consumer Health: CAM Claims

MedlinePlus

... over-the-counter medications can interact with certain dietary supplements. For example, the herbal supplement ginkgo can interact with the blood-thinning medication warfarin (Coumadin) and increase the risk of serious bleeding complications. Before surgery, tell your ...

UHPLC/HRMS Analysis of African Mango (Irvingia gabonensis) Seeds, Extract and Related Dietary Supplements

PubMed Central

Sun, Jianghao; Chen, Pei

2012-01-01

Dietary Supplements based on an extract from Irvingia gabonensis (African Mango, AM for abbreviation) seeds are one of the popular herbal weight loss dietary supplements in the US market. The extract is believed to be a natural and healthy way to lose weight and improve overall health. However, the chemical composition of African mango based-dietary supplements (AMDS) has never been reported. In this study, the chemical constituents of African mango seeds, African mango seeds extract (AMSE), and different kinds of commercially available African mango based dietary supplements (AMDS) have been investigated using an ultra high-performance liquid chromatography with high resolution mass spectrometry (UHPLC-HRMS) method. Ellagic acid, mono, di, tri-O methyl-ellagic acids and their glycosides were found as major components in African Mango seeds. These compounds may be used for quality control of African Mango extract and related dietary supplements. PMID:22880691

Analysis of the accuracy and readability of herbal supplement information on Wikipedia.

PubMed

Phillips, Jennifer; Lam, Connie; Palmisano, Lisa

2014-01-01

To determine the completeness and readability of information found in Wikipedia for leading dietary supplements and assess the accuracy of this information with regard to safety (including use during pregnancy/lactation), contraindications, drug interactions, therapeutic uses, and dosing. Cross-sectional analysis of Wikipedia articles. The contents of Wikipedia articles for the 19 top-selling herbal supplements were retrieved on July 24, 2012, and evaluated for organization, content, accuracy (as compared with information in two leading dietary supplement references) and readability. Accuracy of Wikipedia articles. No consistency was noted in how much information was included in each Wikipedia article, how the information was organized, what major categories were used, and where safety and therapeutic information was located in the article. All articles in Wikipedia contained information on therapeutic uses and adverse effects but several lacked information on drug interactions, pregnancy, and contraindications. Wikipedia articles had 26%-75% of therapeutic uses and 76%-100% of adverse effects listed in the Natural Medicines Comprehensive Database and/or Natural Standard. Overall, articles were written at a 13.5-grade level, and all were at a ninth-grade level or above. Articles in Wikipedia in mid-2012 for the 19 top-selling herbal supplements were frequently incomplete, of variable quality, and sometimes inconsistent with reputable sources of information on these products. Safety information was particularly inconsistent among the articles. Patients and health professionals should not rely solely on Wikipedia for information on these herbal supplements when treatment decisions are being made.

Dietary supplements and related products: a brief summary.

PubMed

Rapaka, Rao S; Coates, Paul M

2006-03-27

We were gratified by the interest expressed in publishing a large number of presentations from the NIDA organized Workshop on "Natureceuticals (Natural Products), Nutraceuticals, Herbal Botanicals, Psychoactives: Drug Discovery and Drug-Drug Interactions". The number of manuscripts received necessitated two volumes of proceedings. In this brief summary of the second volume, we present an introduction to the roles of organizations such as National Center for Complementary and Alternate Medicine and Office of Dietary Supplements, both at the National Institutes of Health, and the Food and Drug Administration. These agencies are involved in research and regulation of dietary supplements and related products. Next, a brief summary of each of the fifteen articles is provided. The first four articles are related to regulatory and standardization aspects: issues related to botanicals (Khan); USP and dietary supplements (Srinivasan); dietary supplement reference materials (Sander et al.); and proposed cGMPs and the scientific basis behind the proposed regulations by FDA (Melethil). The next three articles relate to the methodologies employed in research: LC/MS for the pharmacokinetic analysis polyphenols from dietary supplements (Barnes et al.); proteomic analysis of grape seed extract (Kim et al.); and a nematode model, C. elegans, in Alzheimer's and ginkgo biloba extract for mechanistic studies; another model, a hepatocyte tissue culture model for drug herbal interaction, is reviewed later and presented by Venkataramanan. The next four chapters are on specific dietary supplements: green tea and the polyphenolic catechins (Zaveri); curcumin (Maheswari et al.); tocotrienols (alpha-tocotrienol, Sen and Roy), gamma-tocotrienol (Sree Kumar et al.). This topic is followed by drug interaction studies: in vitro and in vivo assessment methodologies (Venkataramanan); flavonoid-drug interactions (Morris); MDR and CYP3A4-mediated drug-herb interaction (Pal and Mitra); and evidence-based examination of drug-herb interaction (Chavez and Chavez).

An overview of herbal supplement utilization with particular emphasis on possible interactions with dental drugs and oral manifestations.

PubMed

Abebe, Worku

2003-01-01

Herbal medication in the United States is a popular form of therapy. This paper provides an overview of the utilization of herbal supplements with particular emphasis on possible interactions with oral health drugs and oral manifestations. Herbal supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA), which limits their regulation by the U.S Food and Drug Administration (FDA). A number of studies indicate that there is a progressive increase in the utilization of herbal supplements. The majority of consumers of these products are white, middle-aged women who have some college education. Many of the consumers use pharmaceutical drugs concurrently, but most do not inform their health-care providers about their use of herbal supplements. Various herbal supplements have been reported or are suspected to interact with certain oral health drugs, the most important one being 1) bromelain, cayenne, chamomile, feverfew, dong quai, eleuthro/Seberian ginseng, garlic, ginkgo, ginger, ginseng and licorice interacting with aspirin; 2) aloe latex, ephedra, ginseng, rhubarb, cascara sagrada, licorice, and senna interacting with corticosteriods; 3) kava, St. John's wort, chamomile, and valerian interacting with central nervous system (CNS) depressant drugs; and 4) herbs acting on the gastrointestinal system, altering the absorption of several orally administered drugs. Further, the use of some herbal supplements has been reported to be associated with oral manifestations, including aphthous ulcers, lip and tongue irritation, and swelling with feverfew; gingival bleeding with feverfew and ginkgo; tongue numbness with echinacea; xerostomia with St. John's wort; oral and lingual dyskinesia with kava; and salivation with yohimbe. These potential effects of herbal supplements in conjunction with factors related to regulation restrictions suggest that the use of these products may be associated with various adverse reactions that can affect oral health and treatment. Dental hygienists should inform themselves about herbal supplements in order to offer appropriate oral health care to individuals who take these substances.

Emergency Department Visits for Adverse Events Related to Dietary Supplements.

PubMed

Geller, Andrew I; Shehab, Nadine; Weidle, Nina J; Lovegrove, Maribeth C; Wolpert, Beverly J; Timbo, Babgaleh B; Mozersky, Robert P; Budnitz, Daniel S

2015-10-15

Dietary supplements, such as herbal or complementary nutritional products and micronutrients (vitamins and minerals), are commonly used in the United States, yet national data on adverse effects are limited. We used nationally representative surveillance data from 63 emergency departments obtained from 2004 through 2013 to describe visits to U.S. emergency departments because of adverse events related to dietary supplements. On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement-related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits. An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements. Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults. (Funded by the Department of Health and Human Services.).

DNA barcode identification of black cohosh herbal dietary supplements.

PubMed

Baker, David A; Stevenson, Dennis W; Little, Damon P

2012-01-01

Black cohosh (Actaea racemosa) herbal dietary supplements are commonly consumed to treat menopausal symptoms, but there are reports of adverse events and toxicities associated with their use. Accidental misidentification and/or deliberate adulteration results in harvesting other related species that are then marketed as black cohosh. Some of these species are known to be toxic to humans. We have identified two matK nucleotides that consistently distinguish black cohosh from related species. Using these nucleotides, an assay was able to correctly identify all of the black cohosh samples in the validation set. None of the other Actaea species in the validation set were falsely identified as black cohosh. Of 36 dietary supplements sequenced, 27 (75%) had a sequence that exactly matched black cohosh. The remaining nine samples (25%) had a sequence identical to that of three Asian Actaea species (A. cimicifuga, A. dahurica, and A. simplex). Manufacturers should routinely test plant material using a reliable assay to ensure accurate labeling.

Implementing a "quality by design" approach to assure the safety and integrity of botanical dietary supplements.

PubMed

Khan, Ikhlas A; Smillie, Troy

2012-09-28

Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined.

Tanshinones as Effective Therapeutic Agents for Prostate Cancer

DTIC Science & Technology

2011-06-01

BW) and the routes of administration (oral gavaging with corn oil or dietary supplementation ) in inhibiting the growth of PC-3 tumors. We found...activity against PC3 tumors. Although dietary supplementation was labor-efficient, the intake of the active agents could not be controlled because the...basis for most modern pharmaceutical drugs. Herbal medicines usually contain multiple bioactive compo- nents with specific biological activities and

Inappropriate usage of dietary supplements in patients by miscommunication with physicians in Japan.

PubMed

Chiba, Tsuyoshi; Sato, Yoko; Nakanishi, Tomoko; Yokotani, Kaori; Suzuki, Sachina; Umegaki, Keizo

2014-11-26

Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements.

Inappropriate Usage of Dietary Supplements in Patients by Miscommunication with Physicians in Japan

PubMed Central

Chiba, Tsuyoshi; Sato, Yoko; Nakanishi, Tomoko; Yokotani, Kaori; Suzuki, Sachina; Umegaki, Keizo

2014-01-01

Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements. PMID:25431879

Safety issues with herbal products.

PubMed

Marrone, C M

1999-12-01

To review safety issues associated with the use of herbal products. Literature accessed through MEDLINE and other Internet search engines. Key search terms included herbs, dietary supplements, and safety. A misconception exists among consumers that herbal remedies are safe because they are natural. In an effort to provide healthcare practitioners with information necessary for a patient discussion, a review of safety concerns with herbal products was conducted. Several safety concerns exist with herbal products including lack of safety data, absence of quality-control requirements for potency and purity, and lenient labeling standards.

Incorporation of absorption and metabolism into liver toxicity prediction for phytochemicals: A tiered in silico QSAR approach.

PubMed

Liu, Yitong

2018-05-18

An increased use of herbal dietary supplements has been associated with adverse liver effects such as elevated serum enzymes and liver failure. The safety assessment for herbal dietary supplements is challenging since they often contain complex mixtures of phytochemicals, most of which have unknown pharmacokinetic and toxicological properties. Rapid tools are needed to evaluate large numbers of phytochemicals for potential liver toxicity. The current study demonstrates a tiered approach combining identification of phytochemicals in liver toxic botanicals, followed by in silico quantitative structure-activity relationship (QSAR) evaluation of these phytochemicals for absorption (e.g. permeability), metabolism (cytochromes P450) and liver toxicity (e.g. elevated transaminases). First, 255 phytochemicals from 20 botanicals associated with clinical liver injury were identified, and the phytochemical structures were subsequently used for QSAR evaluation. Among these identified phytochemicals, 193 were predicted to be absorbed and then used to generate metabolites, which were both used to predict liver toxicity. Forty-eight phytochemicals were predicted as liver toxic, either due to parent phytochemicals or metabolites. Among them, nineteen phytochemicals have previous evidence of liver toxicity (e.g. pyrrolizidine alkaloids), while the majority were newly discovered (e.g. sesquiterpenoids). These findings help reveal new toxic phytochemicals in herbal dietary supplements and prioritize future toxicological testing. Published by Elsevier Ltd.

A pilot study of complementary and alternative medicine use in patients with fibromyalgia syndrome

PubMed Central

Wall, Geoffrey C.; Krypel, Linda L.; Miller, Michael J.; Rees, Derek M.

Fibromyalgia syndrome (FMS) is a complex disorder, with primary symptoms of sleep disturbances, pain, and fatigue. FMS is one of the most common reasons for patient visits to a rheumatologist. Previous studies have suggested that complementary and alternative medicine (CAM) use in patients with rheumatic diseases is common, but such data specific to FMS patients is limited. Objective The following study sought to describe the prevalence of CAM use in a primary care practice of patients with FMS and assess whether these patients discuss CAM use with their physician, physician-extender, and/or pharmacist. Methods A one-group cross-sectional survey design was implemented in a large, community-based, private physician practice of patients diagnosed with FMS. A self-administered questionnaire was distributed during clinic visits. It solicited information related to demographic characteristics; FMS-specific health background; whether CAM use had been discussed with a health care provider; and the “ever-use” of common types of CAM. Respondents returned the questionnaire via US mail in a postage-paid, self-addressed envelope. Results A total of 115 surveys were distributed with 54 returned for analysis (47% completion rate). The sample was predominantly female, well educated and had a mean age of 55.6 years. All respondents were White. Most respondents (92.6%) reported using some type of CAM. Exercise (92.2%), chiropractic treatment (48.1%), lifestyle and diet (45.8%), relaxation therapy (44.9%), and dietary and herbal supplements (36.5%) were most commonly reported CAM therapies “ever-used” by respondents. Dietary and herbal supplements with the highest prevalence of “ever-use” were magnesium (19.2%), guaifenesin (11.5%), and methylsulfonylmethane (MSM) (9.6%). Respondents most commonly discussed CAM with the clinic rheumatologist and the primary care physician (53.7% and 38.9%, respectively). Only 14.8% of respondents discussed CAM with a pharmacist. However, a significantly higher proportion of respondents who “ever-used” dietary and herbal supplements discussed CAM with a pharmacist compared to those who never used dietary and herbal supplements [chi square=6.03, p=0.014]. Conclusion This pilot study suggests that CAM use is common in patients diagnosed with FMS. Compared to other healthcare providers, respondents were least likely to discuss CAM with a pharmacist. However, respondents who used dietary and herbal supplements were more likely to discuss CAM with a pharmacist compared to those who did not, suggesting the potential influence of pharmacist intervention. PMID:25170357

Complementary and alternative medicine for psoriasis: what the dermatologist needs to know.

PubMed

Talbott, Whitney; Duffy, Nana

2015-06-01

Complementary and alternative medicine (CAM) use is common among patients with psoriasis. CAM modalities include traditional Chinese medicine (TCM), herbal therapies, dietary supplements, climatotherapy, and mind/body interventions. In this review, evidence from clinical trials investigating the efficacy of CAM for psoriasis is reviewed. There is a large amount of evidence from controlled trials that have shown that the combination of TCM with traditional therapies for psoriasis is more efficacious than traditional therapies alone. Herbal therapies that have the most evidence for efficacy are Mahonia aquifolium and indigo naturalis, while there is a smaller amount of evidence for aloe vera, neem, and extracts of sweet whey. Dietary supplementation in patients with psoriasis demonstrates consistent evidence supporting the efficacy of fish oil supplements. Zinc supplementation has not been shown to be effective; however, some evidence is available (albeit conflicting) for vitamin D, vitamin B12, and selenium supplementation. Overwhelming evidence supports the effectiveness of Dead Sea climatotherapy. Finally, mindfulness-based stress reduction can be helpful as adjuvant treatment of psoriasis. There are potential benefits to these modalities, but also potential side issues. Concerns with CAM include, but are not limited to, contamination of TCM products with heavy metals or corticosteroids, systemic toxicity or contact dermatitis from herbal supplements, and ultraviolet light-induced carcinomas from climatotherapy. Dermatologists should be aware of these benefits and side effects to allow for informed discussions with their patients.

Yellow Oleander Seed, or "Codo de Fraile" (Thevetia spp.): A Review of Its Potential Toxicity as a Purported Weight-Loss Supplement.

PubMed

González-Stuart, Armando; Rivera, José O

2018-05-04

The Dietary Supplements and Health Education Act (DSHEA), passed by the United States Congress in October of 1994, defines herbal products as nutritional supplements, not medications. This opened the market for diverse products made from plants, including teas, extracts, essential oils, and syrups. Mexico and the United States share an extensive border, where diverse herbal products are available to the public without a medical prescription. Research undertaken in the neighboring cities of Ciudad Juarez, Mexico, and El Paso, Texas, USA, shows the use of herbs is higher in this border area compared to the rest of the United States. A portion of the population is still under the erroneous impression that "natural" products are completely safe to use and therefore lack side effects. We review the dangers of ingesting the toxic seed of Thevetia spp. (family Apocynaceae), commonly known as "yellow oleander" or "codo de fraile," misleadingly advertised on the Internet as an effective and safe dietary supplement for weight loss. Lack of proper quality control regarding herbs generates a great variability in the quantity and quality of the products' content. Herb-drug interactions occur between some herbal products and certain prescription pharmaceuticals. Certain herbs recently introduced into the U.S. market may not have been previously tested adequately for purity, safety, and efficacy. Due to the lack of reliable clinical data regarding the safe use of various herbal products currently available, the public should be made aware regarding the possible health hazards of using certain herbs for therapeutic purposes. The potentially fatal toxicity of yellow oleander seed is confirmed by cases reported from various countries, while the purported benefits of using it for weight loss have not been evaluated by any known clinical trials. For this reason, the use of yellow oleander seed as a dietary supplement should be avoided.

Effect of pre- and post-weaning dietary supplementation with Digestarom® herbal formulation on rabbit carcass traits and meat quality.

PubMed

Celia, C; Cullere, M; Gerencsér, Zs; Matics, Zs; Tasoniero, G; Dal Bosco, A; Giaccone, V; Szendrő, Zs; Dalle Zotte, A

2016-08-01

This study evaluated effects of Digestarom® (D) dietary inclusion before weaning (0-5weeks old; BW) and/or after weaning (5-12weeks old; AW) on growing rabbit carcass traits and meat quality. During BW, Pannon-Ka rabbits (does, kits) received two diets: a control diet (C) and one supplemented with 300mg Digestarom®/kg (D). At weaning, each group was divided into 3 dietary sub-groups: CC and DD received C and D diets from 5 to 12weeks of age, whereas DC was fed D from 5 to 8weeks and C from 8 to 12weeks of age (54 rabbits/group; AW). Rabbits were slaughtered at 12weeks of age. Digestarom® supplementation improved carcass yield and body mid part proportion only when administered BW. Rabbits fed D BW had higher hind leg meat cooking losses. Loin meat spiciness and rancidity increased with D both BW and AW. In conclusion, Digestarom(®) herbal formulation was ineffective in improving growing rabbit carcass traits or meat quality. Copyright © 2016 Elsevier Ltd. All rights reserved.

The effect of dietary Digestarom® herbal supplementation on rabbit meat fatty acid profile, lipid oxidation and antioxidant content.

PubMed

Mattioli, S; Dal Bosco, A; Szendrő, Zs; Cullere, M; Gerencsér, Zs; Matics, Zs; Castellini, C; Dalle Zotte, A

2016-11-01

The experiment tested the effect of Digestarom® herbal supplementation on the antioxidant content, lipid oxidation and fatty acid profile of rabbit meat. At kindling, rabbit does and litters were divided into two dietary groups (N=162 kits/dietary group) and fed either a control diet (C) or the C diet supplemented with Digestarom® (D: 300mg/kg). At weaning (35days) four experimental fattening groups (54 rabbits each) were considered: CC, CD, DC and DD. After slaughtering (12weeks of age), Longissimus thoracis et lumborum muscles were dissected from 20 rabbits/group and analyzed. Rabbit meat of DD group was enriched in essential C18:3 n-3 fatty acid and in other long-chain PUFA of n-3 series. Despite meat of DD group displayed the highest peroxidability index, TBARs value was the lowest. Meat antioxidant content followed the rank order: DD>CD>DC>CC. Digestarom® improved fatty acid composition and oxidative status of rabbit meat, particularly when administered from weaning throughout the growing period. Copyright © 2016. Published by Elsevier Ltd.

Herbal Dietary Supplements for Erectile Dysfunction: A Systematic Review and Meta-Analysis.

PubMed

Borrelli, Francesca; Colalto, Cristiano; Delfino, Domenico V; Iriti, Marcello; Izzo, Angelo A

2018-04-01

Erectile dysfunction (ED) is a common condition that significantly affects quality of life and interpersonal relationships. Our objective was to perform a systematic review and meta-analysis to evaluate the efficacy of herbal dietary supplements in the treatment of ED. We searched five databases to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of herbal medicines in ED. Quality was assessed and risk of bias was estimated using the Jadad score and the Cochrane risk-of-bias tool. In total, 24 RCTs, including 2080 patients with ED, were identified. Among these, 12 evaluated monopreparations (five ginseng [n = 399], three saffron [n = 397], two Tribulus terrestris [n = 202], and one each Pinus pinaster [n = 21] and Lepidium meyenii [n = 50]), seven evaluated formulations (n = 544), and five investigated dietary supplements in combination with pure compounds (n = 410). Ginseng significantly improved erectile function (International Index of Erectile Function [IIEF]-5 score: 140 ginseng, 96 placebo; standardized mean difference [SMD] 0.43; 95% confidence interval [CI] 0.15-0.70; P < 0.01; I 2  = 0), P. pinaster and L. meyenii showed very preliminary positive results, and saffron and T. terrestris treatment produced mixed results. Several herbal formulations were associated with a decrease of IIEF-5 or IIEF-15, although the results were preliminary. The quality of the included studies varied, with only seven having a prevalent low risk of bias. The median methodological quality Jadad score was three out of a maximum of five. Adverse events were recorded in 19 of 24 trials, with no significant differences between placebo and verum in placebo-controlled studies. Encouraging evidence suggests that ginseng may be an effective herbal treatment for ED. However, further, larger, and high-quality studies are required before firm conclusions can be drawn. Promising (although very preliminary) results have also been generated for some herbal formulations. Overall, more research in the field, adhering to the CONSORT statement extension for reporting trials, is justified before the use of herbal products in ED can be recommended.

Commonly Used Dietary Supplements on Coagulation Function during Surgery.

PubMed

Wang, Chong-Zhi; Moss, Jonathan; Yuan, Chun-Su

2015-09-01

Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information of potential complications of dietary supplements during perioperative management is important for physicians. Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John's wort, and valerian) and 4 other dietary supplements (coenzyme Q 10 , glucosamine and chondroitin sulfate, fish oil, and vitamins). Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John's wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet function are difficult to predict, it is prudent to advise their discontinuation before surgery.

First identification and quantification of lorcaserin in an herbal slimming dietary supplement.

PubMed

Hachem, Rabab; Malet-Martino, Myriam; Gilard, Véronique

2014-09-01

The weight-loss drug lorcaserin, a FDA approved anorectic drug, was isolated from the dietary supplement "Lose quickly" claimed to be a pure natural fast slimming diet pill. After its purification by means of preparative liquid chromatography, its structure was characterized using LC-UV, NMR, MS, MS/MS, and IR spectroscopy. The amount of lorcaserin measured by qNMR was 6.6mg/capsule. Copyright © 2014 Elsevier B.V. All rights reserved.

76 FR 31338 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... beneficiary's medications, including prescription and over-the-counter (OTC) medications, herbal therapies, and dietary supplements, which is intended to aid in assessing medication therapy and optimizing...

76 FR 60843 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... beneficiary's medications, including prescription and over-the-counter (OTC) medications, herbal therapies, and dietary supplements, which is intended to aid in assessing medication therapy and optimizing...

Commonly Used Dietary Supplements on Coagulation Function during Surgery

PubMed Central

Wang, Chong-Zhi; Moss, Jonathan; Yuan, Chun-Su

2015-01-01

Abstract Background Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information about the potential complications of dietary supplements during perioperative management is important for physicians. Methods Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Results Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John’s wort, and valerian) and four other dietary supplements (coenzyme Q10, glucosamine and chondroitin sulfate, fish oil, and vitamins). Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John’s wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. Conclusions To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet function are difficult to predict, it is prudent to advise their discontinuation before surgery. PMID:26949700

Epigenetic Programming of Breast Cancer and Nutrition Prevention

DTIC Science & Technology

2012-05-01

to control (Figure 2). Maternal dietary supplementation with Res reduced by ~60% DNMT1 occupancy on the BRCA-1 promoter, compared with TCDD exposed...2009;75:1227–30. [57] Jeuken A, Keser BJ, Khan E, Brouwer A, Koeman J, DenisonMS. Activation of the Ah receptor by extracts of dietary herbal ... supplements , vegetables, and fruits. J Agric Food Chem 2003;51:5478–87. [58] Amakura Y, Tsutsumi T, Sasaki K, Nakamura M, Yoshida T, Maitani T. Influence of

Prenatal Care

MedlinePlus

... and prescription medicines you are using. These include dietary or herbal supplements. Some medicines are not safe during pregnancy. At the same time, stopping medicines you need also can be harmful. Avoid contact with toxic substances or materials at ...

As You Age: You and Your Medicines

MedlinePlus

... dietary supplements, vitamins, and herbals you take. Your Pharmacist Can Help, Too One of the most important ... than English. What to Ask Your Doctor or Pharmacist What is the name of the medicine and ...

Tricuspid Atresia

MedlinePlus

... the-counter drugs, an herbal product or a dietary supplement, check with your doctor before using them during pregnancy. Avoid smoking or drinking alcohol during pregnancy. Either can increase the risk of congenital heart defects. Avoid chemical exposure, whenever ...

Rapid and reliable determination of illegal adulterant in herbal medicines and dietary supplements by LC/MS/MS.

PubMed

Liang, Qionglin; Qu, Jun; Luo, Guoan; Wang, Yiming

2006-02-13

In recent years, dietary supplements and herbal medicines are increasing in popularity all over the world. However, it is problematic that some manufacturers illegally included synthetic drugs in their products. Due to the extremely complex matrices of those products, most existing methods for screening illegal adulterations are time-consuming and liable to false positive. In this paper, a robust LC/MS/MS method for the high-throughput, sensitive and reliable determination of illegal adulterations from herbal medicines and dietary supplements was established. Minimal LC separation was employed and MRM was used to simultaneously monitor the three transitions under their respective optimal collision energy for each compound. Positive results were determined only if well-defined peaks appeared at all of the three transitions and the ratios among the peak areas were within given threshold. In this study, the method had been applied for the screening of nine most commonly adulterated therapeutic substances, such as sildenafil (Viagra) and famotidine, and the lower limits of detection of these compounds ranged from 0.05 to 1.5 ng/ml. Little sample preparation was needed for this method and the analysis time was less than 5 min/sample. The reliability has been demonstrated by the test with blank matrix. Over 200 products that were under suspicion by SDA of China had been assayed and till now no false negative or positive result was found. This method is rapid, simple, reliable and capable of screening multiple adulterants in one run.

Acute liver injury associated with a newer formulation of the herbal weight loss supplement Hydroxycut.

PubMed

Araujo, James L; Worman, Howard J

2015-05-06

Despite the widespread use of herbal and dietary supplements (HDS), serious cases of hepatotoxicity have been reported. The popular herbal weight loss supplement, Hydroxycut, has previously been implicated in acute liver injury. Since its introduction, Hydroxycut has undergone successive transformations in its formulation; yet, cases of liver injury have remained an ongoing problem. We report a case of a 41-year-old Hispanic man who developed acute hepatocellular liver injury with associated nausea, vomiting, jaundice, fatigue and asterixis attributed to the use of a newer formulation of Hydroxycut, SX-7 Clean Sensory. The patient required hospitalisation and improved with supportive therapy. Despite successive transformations in its formulation, potential liver injury appears to remain an ongoing problem with Hydroxycut. Our case illustrates the importance of obtaining a thorough medication history, including HDS, regardless of new or reformulated product marketing efforts. 2015 BMJ Publishing Group Ltd.

Acute liver injury associated with a newer formulation of the herbal weight loss supplement Hydroxycut

PubMed Central

Worman, Howard J

2015-01-01

Despite the widespread use of herbal and dietary supplements (HDS), serious cases of hepatotoxicity have been reported. The popular herbal weight loss supplement, Hydroxycut, has previously been implicated in acute liver injury. Since its introduction, Hydroxycut has undergone successive transformations in its formulation; yet, cases of liver injury have remained an ongoing problem. We report a case of a 41-year-old Hispanic man who developed acute hepatocellular liver injury with associated nausea, vomiting, jaundice, fatigue and asterixis attributed to the use of a newer formulation of Hydroxycut, SX-7 Clean Sensory. The patient required hospitalisation and improved with supportive therapy. Despite successive transformations in its formulation, potential liver injury appears to remain an ongoing problem with Hydroxycut. Our case illustrates the importance of obtaining a thorough medication history, including HDS, regardless of new or reformulated product marketing efforts. PMID:25948859

The Importance of Method Selection in Determining Product Integrity for Nutrition Research1234

PubMed Central

Mudge, Elizabeth M; Brown, Paula N

2016-01-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. PMID:26980823

The Importance of Method Selection in Determining Product Integrity for Nutrition Research.

PubMed

Mudge, Elizabeth M; Betz, Joseph M; Brown, Paula N

2016-03-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. © 2016 American Society for Nutrition.

Evaluation of “Dream Herb,” Calea zacatechichi, for Nephrotoxicity Using Human Kidney Proximal Tubule Cells

PubMed Central

Flynn, Thomas J.; Vohra, Sanah; Wiesenfeld, Paddy; Sprando, Robert L.

2016-01-01

A recent surge in the use of dietary supplements, including herbal remedies, necessitates investigations into their safety profiles. “Dream herb,” Calea zacatechichi, has long been used in traditional folk medicine for a variety of purposes and is currently being marketed in the US for medicinal purposes, including diabetes treatment. Despite the inherent vulnerability of the renal system to xenobiotic toxicity, there is a lack of safety studies on the nephrotoxic potential of this herb. Additionally, the high frequency of diabetes-associated kidney disease makes safety screening of C. zacatechichi for safety especially important. We exposed human proximal tubule HK-2 cells to increasing doses of this herb alongside known toxicant and protectant control compounds to examine potential toxicity effects of C. zacatechichi relative to control compounds. We evaluated both cellular and mitochondrial functional changes related to toxicity of this dietary supplement and found that even at low doses evidence of cellular toxicity was significant. Moreover, these findings correlated with significantly elevated levels of nephrotoxicity biomarkers, lending further support for the need to further scrutinize the safety of this herbal dietary supplement. PMID:27703475

Toxins in Botanical Dietary Supplements: Blue Cohosh Components Disrupt Cellular Respiration and Mitochondrial Membrane Potential

PubMed Central

Datta, Sandipan; Mahdi, Fakhri; Ali, Zulfiqar; Jekabsons, Mika B.; Khan, Ikhlas A.; Nagle, Dale G.; Zhou, Yu-Dong

2014-01-01

Certain botanical dietary supplements have been associated with idiosyncratic organ-specific toxicity. Similar toxicological events, caused by drug-induced mitochondrial dysfunction, have forced the withdrawal or U.S. FDA “Black Box” warnings of major pharmaceuticals. To assess the potential mitochondrial liability of botanical dietary supplements, extracts from 352 authenticated plant samples used in traditional Chinese, Ayurvedic, and Western herbal medicine were evaluated for the ability to disrupt cellular respiration. Blue cohosh (Caulophyllum thalictroides) methanol extract exhibited mitochondriotoxic activity. Used by some U.S. midwives to help induce labor, blue cohosh has been associated with perinatal stroke, acute myocardial infarction, congestive heart failure, multiple organ injury, and neonatal shock. The potential link between mitochondrial disruption and idiosyncratic herbal intoxication prompted further examination. The C. thalictroides methanol extract and three saponins, cauloside A (1), saponin PE (2), and cauloside C (3) exhibited concentration- and time-dependent mitochondriotoxic activities. Upon treatment, cell respiration rate rapidly increased and then dramatically decreased within minutes. Mechanistic studies revealed that C. thalictroides constituents impair mitochondrial function by disrupting membrane integrity. These studies provide a potential etiological link between this mitochondria-sensitive form of cytotoxicity and idiosyncratic organ damage. PMID:24328138

Herbal cancer cures on the Web: noncompliance with The Dietary Supplement Health and Education Act.

PubMed

Bonakdar, Robert Alan

2002-01-01

A significant portion of the US population uses the Internet to obtain health information; nearly half of Internet users admit that this information influences decisions about their health care and medical treatments. Concurrently, approximately one third of the population uses herbal supplements; a higher percentage is noted for subgroups of cancer patients. The Dietary Supplement Health and Education Act (DSHEA) of 1994 contained regulatory standards for herbal supplements, including restricting any claims for disease prevention, treatment, or cure. This study determined the degree of compliance with the DSHEA, as applied to Internet sites focusing on the subject of herbal supplements and cancer. Internet searches were conducted using six popular search engines and three master search engines in October-December 2000 using the linked terms herb and cancer. The Internet sites identified through this search process were examined for categories of information including claims regarding prevention, treatment, or cure; commercial nature; DSHEA and physician consultation warnings; country of origin; and use of research and testimonials. Additionally, commercial sites were reviewed to identify tactics used to promote products or services. Each of the six primary search engines provided between 11,730 and 58,605 matches for herb and cancer. Further cross matching with the three master search engines identified 70 non-repeating sites that appeared on all three master search engines. Of these 70 sites, nine were irrelevant matches or no longer functioning. Of the remaining 61, 34 (54%) were commercial sites (CS) and 27 (42.8%) were noncommercial sites (NCS). Of the CS surveyed, prevention, treatment, and cure were discussed 92%, 89%, and 58%, respectively. CS provided testimonials, physician consultation recommendations, and DSHEA warnings 89%, 38.8%, and 36.1% of the time, respectively. CS provided research with references 30.6% of the time versus 92.6% of the time in NCS. All international commercial sites surveyed claimed herbal cancer cures. Although the DSHEA was enacted and amended to decrease unlawful claims of disease prevention, treatment, and cure, the results of this study indicate that such claims are prevalent on commercial Internet sites. A majority of sites claim cancer cures through herbal supplementation with little regardfor current regulations, and such claims were more common on sites operated from outside the United States.

A vitamin, mineral, herb dietary supplement effect on blood glucose in uncontrolled type II diabetic subjects.

PubMed

González, Michael J; Ricart, Carlos M; Miranda-Massari, Jorge

2004-06-01

We tested a dietary supplement formulated with a synergistic combination of vitamins, minerals, herbals in a group of 15 patients with uncontrolled diabetes type II. The supplement was given for 30 days. Fasting blood glucose was measured prior to the supplementation and at the end of the 30 days treatment period. Blood glucose was significantly reduced in all patients with no adverse effects. This orthomolecular correction of faulty glucose metabolism with a combination of nontoxic, safe and fairly inexpensive nutraceuticals needs to be further substantiated. Nervertheless the idea of correcting metabolism with micronutrients is a new concept of genetic nutritioneering that seems appealing and cost effective.

Utilizing Integrative Medicine in the U.S. Army Medical Department

DTIC Science & Technology

2012-05-15

This first group can be considered ―complementary‖ to traditional Western medicine (TWM6), such as diet and herbal therapy, or mind-body medicine, in...categorized as: nutritional medicine (including dietary supplements ), botanical medicine, lifestyle medicine, mind-body medicine, manual medicine, traditional...focus on the body and the psyche‘s ability to restore themselves, aided by measures such as proper diet, healing spices, herbal therapy, meditation

The safety and regulation of natural products used as foods and food ingredients.

PubMed

Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

2011-10-01

The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

Efficient synthesis of dichlorodenafil, an unapproved sildenafil analogue appearing in non-prescription supplements.

PubMed

Kim, Jong Yup; Hwang, In Gyun; Oh, Jae Ho; Kang, Il Hyun; Kwon, Sung Won; Kim, Deukjoon

2013-01-01

We have developed an efficient synthesis of dichlorodenafil (4), an unapproved sildenafil analogue isolated from dietary supplements. Our sequence employs POCl(3)-mediated chlorination of readily available chloroacetyl compound 7 followed by selective hydrolysis of the chloro-heterocycle function. Our synthesis confirms the structure of the illegal additive, and will provide regulatory agencies with ready access to authentic standard samples of dichlorodenafil (4) to aid in their mission to protect the public from unapproved and potentially harmful erectile dysfunction (ED) drug analogues that are added to herbal and dietary supplements without providing users with appropriate toxicological or pharmacological information.

Detection of sibutramine in adulterated dietary supplements using attenuated total reflectance-infrared spectroscopy.

PubMed

Deconinck, E; Cauwenbergh, T; Bothy, J L; Custers, D; Courselle, P; De Beer, J O

2014-11-01

Sibutramine is one of the most occurring adulterants encountered in dietary supplements with slimming as indication. These adulterated dietary supplements often contain a herbal matrix. When customs intercept these kind of supplements it is almost impossible to discriminate between the legal products and the adulterated ones, due to misleading packaging. Therefore in most cases these products are confiscated and send to laboratories for analysis. This results inherently in the confiscation of legal, non-adulterated products. Therefore there is a need for easy to use equipment and techniques to perform an initial screening of samples. Attenuated total reflectance-infrared (ATR-IR) spectroscopy was evaluated for the detection of sibutramine in adulterated dietary supplements. Data interpretation was performed using different basic chemometric techniques. It was found that the use of ATR-IR combined with the k-Nearest Neighbours (k-NN) was able to detect all adulterated dietary supplements in an external test set and this with a minimum of false positive results. This means that a small amount of legal products will still be confiscated and analyzed in a laboratory to be found negative, but no adulterated samples will pass the initial ATR-IR screening. Copyright © 2014 Elsevier B.V. All rights reserved.

Associations of herbal and specialty supplements with lung and colorectal cancer risk in the VITamins And Lifestyle (VITAL) Study

PubMed Central

Satia, Jessie A.; Littman, Alyson; Slatore, Christopher G.; Galanko, Joseph A.; White, Emily

2010-01-01

Millions of Americans use dietary supplements with little knowledge about their benefits or risks. We examined associations of various herbal/specialty supplements with lung and colorectal cancer (CRC) risk. Men and women, 50-76y, in the VITAL (VITamins And Lifestyle) cohort completed a 24-page baseline questionnaire that captured duration (years) and frequency (days/week) of use of commonly used herbal/specialty supplements. Dose was not assessed due to lack of accurate potency information. Supplement exposure was categorized as “no use” or “any use” over the previous 10 years. Hazard ratios (HR) were estimated by multivariate Cox regression models. Incident lung (n=665) and CRC cancers (n=428) were obtained from the SEER cancer registry. Any use of glucosamine and chondroitin, which have anti-inflammatory properties, over the previous 10 years, was associated with significantly lower lung cancer risk: HR: 0.74 (95% CI: 0.58, 0.94) and HR: 0.72 (95% CI: 0.54, 0.96) and CRC risk: HR: 0.73 (95% CI: 0.54, 0.98) and HR: 0.65 (95% CI: 0.45, 0.93), respectively. There were also statistically significantly inverse associations of fish oil: HR: 0.65 (95% CI: 0.42, 0.99), methylsulfonylmethane (MSM): HR: 0.46 (95% CI: 0.23, 0.93), and St. John's wort: HR: 0.35 (95% CI: 0.14, 0.85) with CRC risk. In contrast, garlic pills were associated with a statistically significant 35% elevated CRC risk. These results suggest that some herbal/specialty supplements may be associated with lung and CRC risk; however, these products should be used with caution. Additional studies examining the effects of herbal/specialty supplements on risk for cancer/other diseases are needed. PMID:19423520

Components of an Anticancer Diet: Dietary Recommendations, Restrictions and Supplements of the Bill Henderson Protocol

PubMed Central

Mannion, Cynthia; Page, Stacey; Bell, Laurie Heilman; Verhoef, Marja

2010-01-01

The use of complementary and alternative medicines including dietary supplements, herbals and special diets to prevent or treat disease continues to be popular. The following paper provides a description of an alternative dietary approach to the self-management and treatment of cancer, the Bill Henderson Protocol (BHP). This diet encourages daily intake of raw foods, a combination of cottage cheese and flaxseed oil and a number of supplements. Some foods and food groups are restricted (e.g., gluten, meat, dairy). Early background theory that contributed to the protocol’s development is presented as is a summary of relevant evidence concerning the anti-cancer fighting properties of the individual components. Supplement intake is considered in relation to daily recommended intakes. Challenges and risks to protocol adherence are discussed. As with many complementary and alternative interventions, clear evidence of this dietary protocol’s safety and efficacy is lacking. Consumers of this protocol may require guidance on the ability of this protocol to meet their individual nutritional needs. PMID:22254073

Herbal and dietary supplements related to diarrhea and acute kidney injury: a case report.

PubMed

Wanitsriphinyo, Suphamat; Tangkiatkumjai, Mayuree

2017-03-01

Background There is very little evidence relating to the association of herbal medicine with diarrhea and the development of acute kidney injury (AKI). This study reports a case of diarrhea-induced AKI, possibly related to an individual ingesting copious amounts of homemade mixed fruit and herb puree. Case presentation A 45-year-old Thai man with diabetes had diarrhea for 2 days, as a result of taking high amounts of a puree made up of eight mixed fruits and herbs over a 3-day period. He developed dehydration and stage 2 AKI, with a doubling of his serum creatinine. He had been receiving enalapril, as a prescribed medication, over one year. After he stopped taking both the puree and enalapril, and received fluid replacement therapy, within a week his serum creatinine had gradually decreased. The combination of puree, enalapril and AKI may also have induced hyperkalemia in this patient. Furthermore, the patient developed hyperphosphatemia due to his worsening kidney function, exacerbated by regularly taking some dietary supplements containing high levels of phosphate. His serum levels of potassium and phosphate returned to normal within a week, once the patient stopped both the puree and all dietary supplements, and had begun receiving treatment for hyperkalemia. Results The mixed fruit and herb puree taken by this man may have led to his diarrhea due to its effect; particularly if the patient was taking a high concentration of such a drink. Both the puree and enalapril are likely to attenuate the progression of kidney function. The causal relationship between the puree and AKI was probable (5 scores) assessed by the modified Naranjo algorithm. This is the first case report, as far as the authors are aware, relating the drinking of a mixed fruit and herbal puree to diarrhea and AKI in a patient with diabetes. Conclusions This case can alert health care providers to the possibility that herbal medicine could induce diarrhea and develop acute kidney injury.

Complementary and Alternative Medicine (CAM) Treatments and Pediatric Psychopharmacology

ERIC Educational Resources Information Center

Rey, Joseph M.; Walter, Garry; Soh, Nerissa

2008-01-01

Children and adolescents often use complementary and alternative medicine (CAM) treatments outside their indications, particularly to lose weight. Some of the herbal remedies and dietary supplements that may of relevance for psychopharmacological practice are discussed with respect to CAM treatments.

Demographic, Lifestyle Factors, and Reasons for Use of Dietary Supplements by Air Force Personnel.

PubMed

Austin, Krista G; Price, Lori Lyn; McGraw, Susan M; Leahy, Guy; Lieberman, Harris R

2016-07-01

Dietary supplement (DS) use is common among U.S. Army personnel to purportedly improve health, provide energy, and increase strength. However, a comprehensive analysis of DS use among U.S. Air Force (USAF) personnel has not been conducted using the same survey instrument, which would permit direct comparisons to DS use by Army personnel. A standardized questionnaire was used to assess DS use, demographic factors, and reasons for use of DS by USAF personnel (N = 1750). Logistic regression models adjusted for age, sex, and rank were used to determine relationships among categories of DS (multivitamin and multimineral, individual vitamins and minerals, protein/amino acid supplements, combination products, herbal supplements, purported steroid analogs, and other) and demographic factors. Findings were compared to reports from other military services and civilian populations. DS were used by 68% of USAF personnel: 35% used 1-2 DS ≥ 1 time/wk, 13% 3-4 DS ≥ 1 time/wk, and 20% ≥ 5 DS ≥ 1 time/wk. There were 45% of personnel who used a multivitamin and mineral, 33% protein supplements, 22% individual vitamins/minerals, 22% combination products, and 7% herbals. Logistic regression demonstrated aerobic exercise duration and strength training were associated with increased DS use. Individuals who previously deployed were more likely to use DS. Like Army personnel, college students and athletes, USAF personnel use more DS than the general population and are more likely to use purported performance enhancing DS, such as protein supplements, and concurrently consume multiple DS. Austin KG, Price LL, McGraw SM, Leahy G, Lieberman HR. Demographic, lifestyle factors, and reasons for use of dietary supplements by Air Force personnel. Aerosp Med Hum Perform. 2016; 87(7):628-637.

Herbal medicines: challenges in the modern world. Part 2. European Union and Russia.

PubMed

Sammons, Helen M; Gubarev, Michael I; Krepkova, Lubov V; Bortnikova, Valentina V; Corrick, Fenella; Job, Kathleen M; Sherwin, Catherine Mt; Enioutina, Elena Y

2016-08-01

Herbal medicines (HMs) have been well known to people of the European Union (EU) and Russia for centuries. Currently, Western HMs can be classified into two categories, plant-derived conventional medicines and dietary supplements. Interest to HMs has grown rapidly in all countries during the past two decades. The main goal of this review article is to present the history of HMs in the EU and Russia, forms of modern HMs, including Oriental Medicines that are popular among consumers of both countries. Additional discussion points comprise safety and adulteration issues associated with HMs, including regulatory changes and new legislative measures undertaken by the authorities. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: Due to cultural diversities in the EU and Russia, traditional HMs of other regions, particularly Chinese Traditional and Ayurvedic medicines, are also popular. Recently, dietary supplements containing multiple herbal and other natural products have flooded the EU and Russian markets. Pharmacovigilance in these markets is challenging in terms of establishing quality and safety of ingredients, determining efficacy, and defining risks of herb-herb and herb-drug interactions. Both the EU and Russia have introduced new legislation aimed to overcome these deficiencies.

Evaluation of thin-layer chromatography methods for quality control of commercial products containing Aesculus hippocastanum, Turnera diffusa, Matricaria recutita, Passiflora incarnata, and Tilia occidentalis.

PubMed

Ramírez-Durón, Rosalba; Ceniceros-Almaguer, Lucía; Salazar-Aranda, Ricardo; Salazar-Cavazos, Ma de la Luz; Waksman de Torres, Noemi

2007-01-01

In Mexico, plant-derived products with health claims are sold as herbal dietary supplements, and there are no rules for their legal quality control. Aesculus hippocastanum, Turnera diffusa, Matricaria recutita, Passiflora incarnata, and Tilia occidentalis are some of the major commercial products obtained from plants used in this region. In this paper, we describe the effectiveness of thin-layer chromatography methods to provide for the quality control of several commercial products containing these plants. Standardized extracts were used. Of the 49 commercial products analyzed, only 32.65% matched the chromatographic characteristic of standardized extracts. A significant number of commercial products did not match their label, indicating a problem resulting from the lack of regulation for these products. The proposed methods are simple, sensitive, and specific and can be used for routine quality control of raw herbals and formulations of the tested plants. The results obtained show the need to develop simple and reliable analytical methods that can be performed in any laboratory for the purpose of quality control of dietary supplements or commercial herbal products sold in Mexico.

Data-Driven Identification of Structural Alerts for Mitigating the Risk of Drug-Induced Human Liver Injuries

DTIC Science & Technology

2015-02-11

the National Library of Medicine of the U.S. National Institutes of Health launched LiverTox, a data- base of ~700 medications associated with human... herbal remedies, and dietary supplements. Carefully curated and reviewed by experts in multiple disciplines, the database constitutes a valu- able resource...March 2014 via web access at http://livertox.nih.gov/. We then removed entries without chemical structures, such as some herbal extracts and vac

Anaphylactic reaction to a dietary supplement containing willow bark.

PubMed

Boullata, Joseph I; McDonnell, Patrick J; Oliva, Cynthia D

2003-06-01

To report a case of anaphylaxis resulting from the use of a willow bark-containing dietary supplement in a patient with a history of an aspirin allergy. A 25-year-old white woman presented to the emergency department of a community teaching hospital with anaphylaxis requiring epinephrine, diphenhydramine, methylprednisolone, and volume resuscitation to which she responded favorably. Medication history revealed that she had ingested 2 capsules of Stacker 2 (NVE Pharmaceuticals, Newton, NJ), a dietary supplement promoted for weight loss, prior to experiencing her initial symptoms. Among other active ingredients, this product contains willow bark. Of significance is that this patient also reported a history of allergy to acetylsalicylic acid. No other causes for anaphylaxis were identified. She continued to receive routine supportive care and the remaining hospital course was uncomplicated. Dietary supplements, including herbal products, are used by many individuals who consider them to be inherently safe despite limited regulatory oversight by the Food and Drug Administration. While there may be value to specific botanical ingredients, a potential for adverse effects also exists. The popular product consumed by our patient is used for weight loss and contains willow bark, a source of salicylates. Based on the Naranjo probability scale, it is probable that this case of anaphylaxis was due to this dietary supplement. The use of any willow bark-containing dietary supplement may present a risk of anaphylactic reaction to patients with a history of allergy to salicylates. Clinicians need to recognize the potential for adverse effects from dietary supplements.

Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements.

PubMed

Bonkovsky, Herbert L; Kleiner, David E; Gu, Jiezhun; Odin, Joseph A; Russo, Mark W; Navarro, Victor M; Fontana, Robert J; Ghabril, Marwan S; Barnhart, Huiman; Hoofnagle, Jay H

2017-04-01

Bile duct loss during the course of drug-induced liver injury is uncommon, but can be an indication of vanishing bile duct syndrome (VBDS). In this work, we assess the frequency, causes, clinical features, and outcomes of cases of drug-induced liver injury with histologically proven bile duct loss. All cases of drug-induced liver injury enrolled into a prospective database over a 10-year period that had undergone liver biopsies (n = 363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes, and outcomes. Twenty-six of the 363 patients (7%) with drug-, herbal-, or dietary-supplement-associated liver injury had bile duct loss on liver biopsy, which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50%-75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n = 3), temozolomide (n = 3), various herbal products (n = 3), azithromycin (n = 2), and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs. 47%), which was usually cholestatic and sometimes severe. Five patients died and 2 others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy. Bile duct loss during acute cholestatic hepatitis is an ominous early indicator of possible VBDS, for which at present there are no known means of prevention or therapy. (Hepatology 2017;65:1267-1277). © 2016 by the American Association for the Study of Liver Diseases.

Clinical Presentations and Outcomes of Bile Duct Loss caused by Drugs and Herbal and Dietary Supplements

PubMed Central

Bonkovsky, Herbert L.; Kleiner, David E.; Gu, Jiezhun; Odin, Joseph A.; Russo, Mark W.; Navarro, Victor M.; Fontana, Robert J.; Ghabril, Marwan S.; Barnhart, Huiman; Hoofnagle, Jay H.

2016-01-01

Bile duct loss during the course of drug induced liver injury is uncommon but can be an indication of vanishing bile duct syndrome. In this work we assess the frequency, causes, clinical features and outcomes of cases of drug induced liver injury with histologically proven bile duct loss. All cases of drug induced liver injury enrolled into a prospective database over a ten year period that had undergone liver biopsies (n=363) were scored for the presence of bile duct loss and assessed for clinical and laboratory features, causes and outcomes. 26 of the 363 patients (7%) with drug, herbal or dietary supplement associated liver injury had bile duct loss on liver biopsy which was moderate to severe (<50% of portal areas with bile ducts) in 14 and mild (50–75%) in 12. The presenting clinical features of the 26 cases varied, but the most common clinical pattern was a severe cholestatic hepatitis. The implicated agents included amoxicillin/clavulanate (n=3), temozolomide (n=3), various herbal products (n=3), azithromycin (n=2) and 15 other medications or dietary supplements. Compared to those without, those with bile duct loss were more likely to develop chronic liver injury (94% vs 47%), which was usually cholestatic and sometimes severe. Five patients died and two others underwent liver transplantation for progressive cholestasis despite treatment with corticosteroids and ursodiol. The most predictive factor of poor outcome was the degree of bile duct loss on liver biopsy. Conclusions Bile duct loss during acute cholestatic hepatitis is an ominous early indicator of possible vanishing bile duct syndrome, for which at present there are no known means of prevention or therapy. PMID:27981596

Perceived efficacy, indications, and information sources for medically indigent patients and their healthcare providers regarding dietary supplements.

PubMed

Clay, Patrick G; Glaros, Alan G; Clauson, Kevin A

2006-03-01

Evidence exists that medically indigent and minority patients use dietary supplements at rates as high or higher than that of the general population. Safety concerns regarding the use of dietary supplements are further exacerbated by a suboptimal level of patient disclosure and provider inquiry. To determine dietary supplement use, indications, perceived efficacy, and information sources of patients and providers using a pilot study in a clinic for the medically indigent. Five hundred self-administered patient surveys and 50 healthcare provider surveys were made available to any patient at a free health clinic in Kansas City, MO. Surveys were collected and descriptive analyses were performed. Three hundred eleven patient surveys were returned. Of the 37.3% (116/311) of respondents who had used dietary supplements, 13.8% (n = 16) had 10 comorbid conditions. Ninety-six dietary supplements were used for 8 medical condition categories. The 9 agents most frequently reported used were garlic (n = 32), aloe/green tea (n = 27 each), chamomile/echinacea (n = 24 each), St. John's wort (n = 22), ginseng (n = 18), and cranberry/Ginkgo biloba (n = 17 each). Patients reported a broad range of indications for taking dietary supplements. Patients reported (mean +/- SD) 2.37 +/- 4.23 agents as effective and 0.78 +/- 1.73 as ineffective or harmful. Provider surveys revealed that 60% (21/35) and 74% (26/35) were currently or had ever used dietary supplements, respectively. Fifty-seven percent (20/35) of providers reported attending educational programs on dietary supplements, and providers perceived patient supplement use to be most influenced by advertisements (40%) and friends (40%). The medically indigent population uses a wide variety of dietary supplements. There is little consistency in perceived indications, which may prevent clinicians from accurately predicting specific herbal use rationale given any individual's or population's set of comorbid conditions. Clinicians are encouraged to accurately determine their individual practice setting's use pattern.

Use of dietary supplements by elite figure skaters.

PubMed

Ziegler, Paula J; Nelson, Judy A; Jonnalagadda, Satya S

2003-09-01

The present study examined the prevalence of dietary supplement use among elite figure skaters, gender differences in supplement use, and differences in nutrient intake of supplement users versus non-users. Male (n = 46) and female (n = 59) figure skaters completed a supplement survey and 3-day food records. Descriptive analysis, chi-square test, and independent t tests were used to analyze the data. Sixty-five percent of male (n = 30) and 76% of female (n = 45) figure skaters reported use of supplements. Forty-seven percent of males and 55% of females reported daily use of supplements. Multivitamin-mineral supplements were the most popular dietary supplements consumed by figure skaters. Significant gender differences were observed in the use of multivitamin-mineral supplements (61% males vs. 83% females, p < .05). Echinacea and ginseng were popular herbal supplements used by these skaters. The 3 main reasons given by male figure skaters for taking supplements were: to provide more energy (41%), to prevent illness or disease (34%), and to enhance performance (21%). Among female figure skaters, the 3 main reasons given were: to prevent illness or disease (61%), to provide more energy (39%), and to make up for an inadequate diet (28%). Significant differences (p < .05) were observed in protein, total fat, saturated fat, polyunsaturated fat intakes, and % energy from carbohydrate and total fat of male supplement users versus non-users, with supplement users having higher intakes except for percent energy from carbohydrate. Sodium was the only nutrient significantly different (p < .05) among female supplement users versus non-users, with supplement users having lower intakes. Given the popularity of dietary supplements, it is important to understand the factors influencing athletes' use of supplements, their knowledge and attitudes regarding supplements, dosage of supplements used, and the effectiveness of these dietary supplements in meeting the goals of the athletes.

Aspirin for Reducing Your Risk of Heart Attack and Stroke: Know the Facts

MedlinePlus

... the medicines (prescription and over-the-counter) and dietary supplements, including vitamins and herbals, that you use — even if only occasionally. FACT: Aspirin is a drug If you are at risk for heart attack or stroke your doctor may ...

The Use of Herbal Medications and Dietary Supplements by People with Mental Illness

PubMed Central

Shatkin, Jess P.; Hamilton, Alison B.; Unützer, Jürgen; Klap, Ruth; Young, Alexander S.

2009-01-01

This study examined the relationship between herbal medication and dietary supplement (HMDS) use and mental health characteristics. Data are drawn from a national household survey of the United States’ civilian, non-institutionalized population (N = 9,585). Psychiatric medication and HMDS use, psychiatric diagnoses and treatment needs, utilization and satisfaction were assessed. Compared to non-users, HMDS users were more likely to perceive themselves as having mental health needs, to have received mental health and primary care treatment, and to be dissatisfied with their overall healthcare. Psychiatric medication use was not related to HMDS use, and in multivariate analyses, HMDS use was associated with perceived mental health needs. Differences in use of specific HMDS between those with and without a psychiatric disorder were also examined. The use of HMDS warrants particular attention in persons with perceived mental health problems as these individuals may be turning to HMDS use for treatment of their symptoms. PMID:19688594

Intersection of inflammation and herbal medicine in the treatment of osteoarthritis.

PubMed

Mobasheri, Ali

2012-12-01

Herbal remedies and dietary supplements have become an important area of research and clinical practice in orthopaedics and rheumatology. Understanding the risks and benefits of using herbal medicines in the treatment of arthritis, rheumatic diseases, and musculoskeletal complaints is a key priority of physicians and their patients. This review discusses the latest advances in the use of herbal medicines for treating osteoarthritis (OA) by focusing on the most significant trends and developments. This paper sets the scene by providing a brief introduction to ethnopharmacology, Ayurvedic medicine, and nutrigenomics before discussing the scientific and mechanistic rationale for targeting inflammatory signalling pathways in OA by use of herbal medicines. Special attention is drawn to the conceptual and practical difficulties associated with translating data from in-vitro experiments to in-vivo studies. Issues relating to the low bioavailability of active ingredients in herbal medicines are discussed, as also is the need for large-scale, randomized clinical trials.

Unmonitored use of herbal medicine by patients with breast cancer: reframing expectations.

PubMed

Samuels, Noah; Ben-Arye, Eran; Maimon, Yair; Berger, Raanan

2017-11-01

To identify the unmonitored use of herbal medicine by female patients with breast cancer, examining the impact of an integrative physician (IP) consultation on this practice. The files of 269 female patients with breast cancer following an IP consultation were surveyed retrospectively for use of herbal medicine for cancer-related goals. Expectations from the IP consultation and adherence to the IP-guided treatments were examined as well. Among the cohort, 111 (41.3%) reported using herbal medicine for cancer-related goals, unmonitored by their oncology healthcare professional. Factors predicting herbal medicine use were the adoption of dietary changes (odds ratio = 13.6, p < 0.001, CI 7.16-26.0) and the expectation that the IP consultation and treatments would address cancer-related goals (odds ratio = 3.29, p = 0.001, CI 1.64-6.6). Patients with metastatic disease were more likely to be using herbal medicine than non-users (34.5 vs. 22.8%; p = 0.088), as were those who had consulted with a complementary/alternative medicine practitioner (54.9 vs. 20.8%; p = 0.005). The IP advised 17 patients (15.3%) to stop taking specific herbal products due to safety-related concerns; and 10 patients to take dietary supplements for relief of specific symptoms. Herbal medicine users were less likely than non-users to adhere to the IP-recommended treatment program (34.7 vs. 48.3%; p = 0.037). Unmonitored use of herbal medicine by patients with breast cancer is more frequent among those adopting dietary changes for cancer-related goals. Integrative physicians provide evidence-based guidance on the safe and effective use of herbal products, and reframe patient expectations from cancer-related goals to reducing symptoms and improving quality of life.

Internet marketing of herbal products.

PubMed

Morris, Charles A; Avorn, Jerry

2003-09-17

Passage of the Dietary Supplement Health and Education Act in 1994 restricted the Food and Drug Administration's control over dietary supplements, leading to enormous growth in their promotion. The Internet is often used by consumers as a source of information on such therapies. To assess the information presented and indications claimed on the Internet for the 8 best-selling herbal products. We searched the Internet using the 5 most commonly used search engines. For each, we entered the names of the 8 most widely used herbal supplements (ginkgo biloba, St John's wort, echinacea, ginseng, garlic, saw palmetto, kava kava, and valerian root). We analyzed the health content of all Web sites listed on the first page of the search results. We analyzed all accessible, English-language Web sites that pertained to oral herbal supplements. A total of 522 Web sites were identified; of these, 443 sites met inclusion criteria for the analysis. The nature of the Web site (retail or nonretail), whether it was a sponsored link, and all references, indications, claims, and disclaimers were recorded. Two reviewers independently categorized medical claims as disease or nondisease according to Food and Drug Administration criteria. Among 443 Web sites, 338 (76%) were retail sites either selling product or directly linked to a vendor. A total of 273 (81%) of the 338 retail Web sites made 1 or more health claims; of these, 149 (55%) claimed to treat, prevent, diagnose, or cure specific diseases. More than half (153/292; 52%) of sites with a health claim omitted the standard federal disclaimer. Nonretail sites were more likely than retail sites to include literature references, although only 52 (12%) of the 443 Web sites provided referenced information without a link to a distributor or vendor. Consumers may be misled by vendors' claims that herbal products can treat, prevent, diagnose, or cure specific diseases, despite regulations prohibiting such statements. Physicians should be aware of this widespread and easily accessible information. More effective regulation is required to put this class of therapeutics on the same evidence-based footing as other medicinal products.

Total and inorganic arsenic in dietary supplement supplies in northern Mexico.

PubMed

García-Rico, Leticia; Tejeda-Valenzuela, Lourdes

2013-07-01

The aim of this study was to evaluate the presence of total and inorganic arsenic in dietary supplements composed of herbal plants and seaweed, and to determine the potential toxicological risk. Total arsenic was determined by dry ashing and hydride generation atomic absorption spectrometry, and inorganic arsenic was determined by acid digestion, solvent extraction, and hydride generation atomic absorption spectrometry. Total and inorganic arsenic in the supplements ranged from 0.07 to 8.31 mg kg(-1) dry weight and from 0.14 to 0.28 mg kg(-1) dry weight, respectively. Daily intake of total arsenic ranged from 0.05 to 12.46 μg day(-1). Inorganic arsenic intake ranged from 0.21 to 0.83 μg day(-1), values that are below the Benchmark Dose Lower Confidence Limit recommended by the Word Health Organization. Therefore, there appears to be a low risk of adverse effects resulting from excess inorganic arsenic intake from these supplements. This is the first study conducted in Mexico that investigates total and inorganic arsenic in dietary supplements. Although the results do not suggest toxicological risk, it is nonetheless important considering the toxicity of inorganic arsenic and the increasing number consumer preferences for dietary supplements. Moreover, it is important to improve and ensure the safety of dietary supplements containing inorganic arsenic.

Essiac/Flor Essence (PDQ®)—Health Professional Version

Cancer.gov

Essiac/Flor Essence are herbal tea mixtures that are marketed worldwide as dietary supplements, and sometimes used by cancer patients. No controlled data are available from human studies to suggest that they are effective in the treatment of patients with cancer. Learn more in this clinician summary.

Chromatographic fingerprint analysis of Pycnogenol® dietary supplements

USDA-ARS?s Scientific Manuscript database

French maritime bark (Pinus maritima) has been widely used as an herbal remedy for various degenerative diseases. A standardized bark extract is available that complies with its USP monograph and is derived from Pinus pinaster, Ait. (Pycnogenol®, Horphag Research Ltd., UK). The method specified in...

 Hepatoportal sclerosis related to the use of herbals and nutritional supplements. Causality or coincidence?

PubMed

Rios, Fernanda Ferreira; Rodrigues de Freitas, Luiz Antônio; Codes, Liana; Santos Junior, Genario Oliveira; Schinoni, Maria Isabel; Paraná, Raymundo

 Introduction and aim. Non-cirrhotic idiopathic portal hypertension (NCIPH), also known as hepatoportal sclerosis (HPS) is a disease of uncertain etiology. However, various pathophysiological mechanisms has been postulated, including chronic or recurrent infections and exposure to drugs or toxins. In this context, it appears to be of multifactorial etiology or resulting from a portal vascular endothelium aggression. It is important to consider whether the use of dietary supplements and herbs can trigger or contribute to the occurance of HPS. We report a possible association of HPS with the consumption of herbals and / or dietary supplements. We describe two cases of HPS in patients without known etiology causes associated with this disease. Both patients were females who were diagnosed with HPS following the consumption of Herbalife® products and putative anorexigenic agents in the form herbals infusions. Image-based analysis and the assessment of the histopathological alterations found in the livers confirmed the diagnosis. The histopatological analysis of liver samples from both patients showed portal tracts enlarged by fibrosis with disappearance or reduction in the diameter of the portal vein branches. In many portal tracts, portal veins branches were replaced by aberrant thin-walled fendiforme vessels. The bile ducts and branches of the hepatic artery show normal aspects. After the exclusion of other etiologic factors and a comprehensive analysis of clinical history, consumption of Herbalife® products and anorexigenic agents was pointed-out as a puttative predisposing factor for the development of the disease.

An overview of consumer attitudes and beliefs about plant food supplements.

PubMed

Egan, Bernadette; Hodgkins, Charo; Shepherd, Richard; Timotijevic, Lada; Raats, Monique

2011-12-01

The use of dietary supplements is increasing globally and this includes the use of plant food supplements (PFS). A variety of factors may be influencing this increased consumption including the increasing number of older people in society, mistrust in conventional medicine and the perception that natural is healthy. Consumer studies in this area are limited, with a focus on dietary supplements in general, and complicated by the use of certain plant food supplements as herbal medicines. Research indicates that higher use of dietary supplements has been associated with being female, being more educated, having a higher income, being white and being older, however the drivers for consumption of supplements are complex, being influenced by both demographic and health-related factors. The aim of this paper is to provide an overview of current knowledge about the users and the determinants of usage of plant food supplements. With growing consumption of these products, the need for effective risk-benefit assessment becomes ever more important and an insight into who uses these types of products and why is an important starting point for any future science-based decisions made by policy makers, PFS manufacturers and ultimately by consumers themselves.

Botanicals and Hepatotoxicity.

PubMed

Roytman, Marina M; Poerzgen, Peter; Navarro, Victor

2018-06-19

The use of botanicals, often in the form of multi-ingredient herbal dietary supplements (HDS), has grown tremendously in the past three decades despite their unproven efficacy. This is paralleled by an increase in dietary supplement-related health complications, notably hepatotoxicity. This article reviews the demographics and motivations of dietary supplement (DS) consumers and the regulatory framework for DS in the US and other developed countries. It examines in detail three groups of multi-ingredient HDS associated with hepatotoxicity: OxyElite Pro (two formulations), green tea extract-based DS, and "designer anabolic steroids." These examples illustrate the difficulties in identifying and adjudicating causality of suspect compound(s) of multi-ingredient HDS-associated liver injury in the clinical setting. The article outlines future directions for further study of HDS-associated hepatotoxicity as well as measures to safeguard the consumer against it. © 2018, The American Society for Clinical Pharmacology and Therapeutics.

Use and perception of herbal and dietary supplements in the Hutterites of South Dakota.

PubMed

Peters, Stacy; Shiyanbola, Olayinka

2013-12-01

South Dakota is home to 6,000 Hutterites, the largest population of Hutterites in the United States. Observation of frequent supplement use by this population prompted the current survey based study. Use of supplements is on the rise with around 53 percent of Americans reporting at least one herbal and dietary supplement (HDS). Use and perception of HDS has not previously been evaluated in the Hutterite population. Participants were 18 years of age and older and had to be present at the time of survey administration. Surveys were administered before and after an educational presentation at five colonies to volunteer participants. Survey data was analyzed using descriptive analysis and chi-square tests. One-hundred and six surveys were completed with 81.1 percent being female. Approximately 78 percent reported using at least one type of HDS, with an average of 2.7 (SD = 1.4) supplements per person. Women were more likely to report supplement use than men. Hutterites reported they felt HDS were safer than prescription medications. Education was effective on some aspects such as telling their doctor if they are taking HDS. Some study limitations included small sample size, possible lack of survey understanding, and the limited number of male participants. The frequency of HDS use in South Dakota Hutterites appears to be very high. Baseline knowledge on the safety and regulation of HDS reveals that education of this population is needed. Further investigation of HDS use in Hutterites is warranted.

A flow-injection mass spectrometry fingerprinting method for authentication and quality assessment of Scutellaria lateriflora-based dietary supplements

USDA-ARS?s Scientific Manuscript database

Scutellaria lateriflora, commonly known as skullcap, is used as an ingredient in numerous herbal products. However, it has been occasionally adulterated/contaminated with Teucrium canadense and/or Teucrium chamaedrys, commonly known as germander, due to the morphological similarities between the tw...

Coupling frontal elution paper chromatography with desorption corona beam ionization mass spectrometry for rapid analysis of chlorphenamine in herbal medicines and dietary supplements.

PubMed

Huang, Yun-Qing; You, Jing-Qing; Zhang, Junsheng; Sun, Wenjian; Ding, Li; Feng, Yu-Qi

2011-10-14

We developed a convenient method by coupling frontal elution paper chromatography with desorption corona beam ionization mass spectrometry (DCBI-MS) for rapid determination of chlorphenamine added in herbal medicines or dietary supplements. In this method, the ethanol extract of the herbal products was spotted directly onto an isosceles triangular filter paper sheet, and then the paper sheet was developed under strong elution condition with the sample zone migrating at the solvent front. The analyte was finally condensed at the V-shaped tip which could then be placed under the visible plasma beam of DCBI for ionization. The overall procedure took less than 5 min. The frontal elution paper chromatography on a triangular plate used in this work improved the signal intensity of chlorphenamine by 30-fold due to the analyte condensing at the tip and the reduction of the background suppression. Furthermore, the paper sheet also functioned as a filter in the analysis of solid or powder samples, which can increase the analytical throughput by omitting the step of centrifugation. The proposed method in current study was successfully applied in the determination of chlorphenamine in herbal medicines. Chlorphenamine was detected in four of the twelve types of herbal medicines examined in this study. The limit of detection was 200 ng/mL (2.0 ng absolute) in full-scan positive-ion mode and the linear range was from 5.0 μg/mL to 50 μg/mL with satisfactory linear coefficient (R(2) (the square of the correlation coefficient)=0.895). Good reproducibility was achieved with relative standard deviations (RSDs) less than 15.0% and the recoveries of chlorphenamine ranged from 84.3 to 90.6%. Copyright © 2011 Elsevier B.V. All rights reserved.

Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements

PubMed Central

Dara, Lily; Hewett, Jennifer; Lim, Joseph Kartaik

2008-01-01

Dietary supplements represent an increasingly common source of drug-induced liver injury. Hydroxycut is a popular weight loss supplement which has previously been linked to hepatotoxicity, although the individual chemical components underlying liver injury remain poorly understood. We report two cases of acute hepatitis in the setting of Hydroxycut exposure and describe possible mechanisms of liver injury. We also comprehensively review and summarize the existing literature on commonly used weight loss supplements, and their individual components which have demonstrated potential for liver toxicity. An increased effort to screen for and educate patients and physicians about supplement-associated hepatotoxicity is warranted. PMID:19058338

An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial.

PubMed

Boozer, C N; Nasser, J A; Heymsfield, S B; Wang, V; Chen, G; Solomon, J L

2001-03-01

To examine in overweight humans the short-term safety and efficacy for weight loss of an herbal supplement containing Ma Huang, Guarana and other ingredients. An 8 week randomized, double-blind placebo controlled study of a herbal dietary supplement (72 mg/day ephedrine alkaloids and 240 mg/day caffeine). Overweight men and women (body mass index, > or =29 and < or =35 kg/m2). The primary outcome variable was body weight change. Secondary variables included anthropometric, metabolic and cardiovascular changes. Sixty-seven subjects were randomized to either placebo (n=32) or active Ma Huang/Guarana (n=35). Twenty-four subjects in each group completed the study. Active treatment produced significantly (P<0.006) greater loss of weight (X+/-s.d.,-4.0+/-3.4 kg) and fat (-2.1+/-3.0% fat) over the 8-week treatment period than did placebo (-0.8+/-2.4 kg and 0.2+/-2.3% fat). Active treatment also produced greater reductions in hip circumference and serum triglyceride levels. Eight of the 35 actively treated subjects (23%) and none of the 32 placebo-treated control subjects withdrew from the protocol because of potential treatment-related effects. Dry mouth, insomnia and headache were the adverse symptoms reported most frequently by the herbal vs placebo group at the final evaluation visit. This herbal mixture of Ma Huang and Guarana effectively promoted short-term weight and fat loss. Safety with long-term use requires further investigation.

DO HERBAL AGENTS HAVE A PLACE IN THE TREATMENT OF SLEEP PROBLEMS IN LONG-TERM CARE?

PubMed Central

Shimazaki, Mark; Martin, Jennifer L.

2007-01-01

Sleep disruption is common in the long-term care setting. This paper discusses the available literature on two herbal approaches to sleep problems in long-term care. The largest body of evidence exists for the use of the dietary/herbal supplements valerian and melatonin. While these agents appear to have a modest positive effect on sleep quality among older adults, most studies were small in size and included only subjective assessments of sleep quality. In addition, it is unclear whether these agents pose risks to long-term care residents due to potential drug interactions. Additional research is needed prior to making conclusive recommendations about the use of these interventions for sleep in the long-term care setting. PMID:17498609

Overview of Botanical Status in EU, USA, and Thailand

PubMed Central

Mahady, Gail B.

2013-01-01

The botanical status in EU, USA, and Thailand is different owing to the regulatory status, the progress of science, and the influence of culture and society. In the EU, botanicals are positioned as herbal medicinal products and food supplements, in the US they are regulated as dietary supplements but often used as traditional medicines, and in Thailand, they are regulated and used as traditional medicines. Information for some of the most popular botanicals from each country is included in this review. PMID:24228061

A rapid ATR-FTIR spectroscopic method for detection of sibutramine adulteration in tea and coffee based on hierarchical cluster and principal component analyses.

PubMed

Cebi, Nur; Yilmaz, Mustafa Tahsin; Sagdic, Osman

2017-08-15

Sibutramine may be illicitly included in herbal slimming foods and supplements marketed as "100% natural" to enhance weight loss. Considering public health and legal regulations, there is an urgent need for effective, rapid and reliable techniques to detect sibutramine in dietetic herbal foods, teas and dietary supplements. This research comprehensively explored, for the first time, detection of sibutramine in green tea, green coffee and mixed herbal tea using ATR-FTIR spectroscopic technique combined with chemometrics. Hierarchical cluster analysis and PCA principle component analysis techniques were employed in spectral range (2746-2656cm -1 ) for classification and discrimination through Euclidian distance and Ward's algorithm. Unadulterated and adulterated samples were classified and discriminated with respect to their sibutramine contents with perfect accuracy without any false prediction. The results suggest that existence of the active substance could be successfully determined at the levels in the range of 0.375-12mg in totally 1.75g of green tea, green coffee and mixed herbal tea by using FTIR-ATR technique combined with chemometrics. Copyright © 2017 Elsevier Ltd. All rights reserved.

A critical evaluation of Internet marketing of products that contain ephedra.

PubMed

Ashar, Bimal H; Miller, Redonda G; Getz, Kelly J; Pichard, Carmen P

2003-08-01

To evaluate information contained within Internet sites that advertise and market dietary supplements containing ephedra. We conducted an Internet search to identify Web sites advertising weight-loss supplements that contained ephedra. Between July 7 and July 18, 2002, 4 search engines were used by entering the term herbal weight loss. Outcome measures included disclosure of potential adverse effects of or contraindications to ephedra-containing supplements, disclosure of ephedra alkaloid dosage, and presence of misleading or incorrect information. Thirty-two products and advertisements were identified and systematically evaluated for deviance from truth-in-advertising standards. Of the 32 Web sites analyzed, 13 (41%) failed to disclose potential adverse effects or contraindications to supplement use. Seventeen (53%) did not reveal the dosage of ephedra alkaloids that was recommended. More importantly, 11 sites (34%) contained incorrect or misleading statements, some of which could directly result in serious harm to consumers. If dietary supplements containing ephedra are to continue to be marketed freely, substantial reform in advertising regulation and enforcement is warranted.

Evaluation of effectiveness and safety of a herbal compound in primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes

PubMed Central

Palmieri, Giancarlo; Contaldi, Paola; Fogliame, Giuseppe

2017-01-01

Background and purpose Sleep disturbances and related daytime activities impairment are common diseases nowadays. General practitioners are often the first health care professional asked to alleviate sleep disturbances and primary insomnia symptoms. Beyond a wide class of hypnotic drugs, botanicals can represent an alternative treatment for those kinds of symptoms. The scope of the present study is to evaluate safety and effectiveness of a herbal compound composed of valerian, hop, and jujube (Vagonotte®) on primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes. Patients and methods One hundred and twenty subjects with sleep disturbances symptoms were randomized in two branches of 60 persons each, receiving the herbal compound or placebo at dosage of two pills per day 30 minutes before their scheduled bedtime. All subjects were screened for precise items related to sleep quality and daytime activity at the beginning, after 10 days, and after 20 days of consecutive dietary supplement (or placebo) consumption. The participants remained blind to group assignment until all of them completed the trial. Results Sleep onset, numbers of nocturnal awakenings, and overall nocturnal slept time were assessed. A statistically significant difference between the two groups emerged. The group receiving the herbal compound showed a lower time of sleep onset compared to placebo group, the same result was obtained for total slept time and night awakenings frequency (p<0.001). Daily symptom improvement in subjects receiving the herbal compound showed significant reduction in tension and irritability, difficulty in concentration, and fatigue intensity, if compared to placebo scores (p<0.001). None of the 60 subjects in the verum group reported adverse reaction related to the herbal compound, and 98% of subjects judged the product as having from good to excellent safety and tolerability. Conclusion Botanicals dietary supplement with relaxing and soothing properties can help practitioner to treat primary insomnia, especially when the risk/benefit profile of a patient does not sustain hypnotic drugs prescription. This clinical investigation on safety and effectiveness of a herbal compound made of valerian, hop, and jujube opens interesting perspectives on usage of herbal compound to manage primary insomnia. Further investigations could help in understanding herbal compounds’ effectiveness on sleep disturbances. PMID:28603433

Evaluation of effectiveness and safety of a herbal compound in primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes.

PubMed

Palmieri, Giancarlo; Contaldi, Paola; Fogliame, Giuseppe

2017-01-01

Sleep disturbances and related daytime activities impairment are common diseases nowadays. General practitioners are often the first health care professional asked to alleviate sleep disturbances and primary insomnia symptoms. Beyond a wide class of hypnotic drugs, botanicals can represent an alternative treatment for those kinds of symptoms. The scope of the present study is to evaluate safety and effectiveness of a herbal compound composed of valerian, hop, and jujube (Vagonotte ® ) on primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes. One hundred and twenty subjects with sleep disturbances symptoms were randomized in two branches of 60 persons each, receiving the herbal compound or placebo at dosage of two pills per day 30 minutes before their scheduled bedtime. All subjects were screened for precise items related to sleep quality and daytime activity at the beginning, after 10 days, and after 20 days of consecutive dietary supplement (or placebo) consumption. The participants remained blind to group assignment until all of them completed the trial. Sleep onset, numbers of nocturnal awakenings, and overall nocturnal slept time were assessed. A statistically significant difference between the two groups emerged. The group receiving the herbal compound showed a lower time of sleep onset compared to placebo group, the same result was obtained for total slept time and night awakenings frequency ( p <0.001). Daily symptom improvement in subjects receiving the herbal compound showed significant reduction in tension and irritability, difficulty in concentration, and fatigue intensity, if compared to placebo scores ( p <0.001). None of the 60 subjects in the verum group reported adverse reaction related to the herbal compound, and 98% of subjects judged the product as having from good to excellent safety and tolerability. Botanicals dietary supplement with relaxing and soothing properties can help practitioner to treat primary insomnia, especially when the risk/benefit profile of a patient does not sustain hypnotic drugs prescription. This clinical investigation on safety and effectiveness of a herbal compound made of valerian, hop, and jujube opens interesting perspectives on usage of herbal compound to manage primary insomnia. Further investigations could help in understanding herbal compounds' effectiveness on sleep disturbances.

Liver injury from herbal and dietary supplements.

PubMed

Navarro, Victor J; Khan, Ikhlas; Björnsson, Einar; Seeff, Leonard B; Serrano, Jose; Hoofnagle, Jay H

2017-01-01

Herbal and dietary supplements (HDS) are used increasingly both in the United States and worldwide, and HDS-induced liver injury in the United States has increased proportionally. Current challenges in the diagnosis and management of HDS-induced liver injury were the focus of a 2-day research symposium sponsored by the American Association for the Study of Liver Disease and the National Institutes of Health. HDS-induced liver injury now accounts for 20% of cases of hepatotoxicity in the United States based on research data. The major implicated agents include anabolic steroids, green tea extract, and multi-ingredient nutritional supplements. Anabolic steroids marketed as bodybuilding supplements typically induce a prolonged cholestatic but ultimately self-limiting liver injury that has a distinctive serum biochemical as well as histological phenotype. Green tea extract and many other products, in contrast, tend to cause an acute hepatitis-like injury. Currently, however, the majority of cases of HDS-associated liver injury are due to multi-ingredient nutritional supplements, and the component responsible for the toxicity is usually unknown or can only be suspected. HDS-induced liver injury presents many clinical and research challenges in diagnosis, identification of the responsible constituents, treatment, and prevention. Also important are improvements in regulatory oversight of nonprescription products to guarantee their constituents and ensure purity and safety. The confident identification of injurious ingredients within HDS will require strategic alignments among clinicians, chemists, and toxicologists. The ultimate goal should be to prohibit or more closely regulate potentially injurious ingredients and thus promote public safety. (Hepatology 2017;65:363-373). © 2016 by the American Association for the Study of Liver Diseases.

Liver Injury from Herbal and Dietary Supplements

PubMed Central

Navarro, Victor; Khan, Ikhlas; Björnsson, Einar; Seeff, Leonard B.; Serrano, Jose; Hoofnagle, Jay H.

2017-01-01

Herbal and dietary supplements (HDS) are used increasingly both in the United States and worldwide and HDS induced liver injury in the U.S. has increased proportionally. Current challenges in the diagnosis and management of HDS-induced liver injury were the focus of a 2-day research symposium sponsored by the American Association for the Study of Liver Disease and the National Institutes of Health. HDS-induced liver injury now accounts for 20% of cases of hepatotoxicity in the United States based on research data. The major implicated agents include anabolic steroids, green tea extract, and multi-ingredient nutritional supplements (MINS). Anabolic steroids marketed as bodybuilding supplements typically induce a prolonged cholestatic, but ultimately self-limiting liver injury that has a distinctive serum biochemical as well as histological phenotype. Green tea extract and many other products, in contrast, tend to cause an acute-hepatitis like injury. Currently, however, the majority of cases of HDS-associated liver injury are due to MINS, and the component responsible for the toxicity is usually unknown or can only be suspected. HDS-induced liver injury presents many clinical and research challenges, in diagnosis, identification of the responsible constituents, treatment and prevention. Also important are improvements in regulatory oversight of non-prescription products to guarantee their constituents and insure purity and safety. The confident identification of injurious ingredients within HDS will require strategic alignments among clinicians, chemists, and toxicologists. The ultimate goal should be to prohibit or more closely regulate potentially injurious ingredients and thus promote public safety. PMID:27677775

Dose-to-dose variations with single packages of counterfeit medicines and adulterated dietary supplements as a potential source of false negatives and inaccurate health risk assessments.

PubMed

Venhuis, B J; Zwaagstra, M E; Keizers, P H J; de Kaste, D

2014-02-01

In this report, we show three examples of how the variability in dose units in single packages of counterfeit medicines and adulterated dietary supplements may contribute to a false negative screening result and inaccurate health risk assessments. We describe a counterfeit Viagra 100mg blister pack and a box of an instant coffee both containing dose units with and without an active pharmaceutical ingredient (API). We also describe a purportedly herbal slimming product with capsules that mutually differed in API and impurities. The adulterated dietary supplements contained sibutramine, benzyl-sibutramine, N-desmethyl-sibutramine (DMS), N,N-didesmethyl-sibutramine (DDMS) and several other related impurities. Counterfeit medicines and adulterated dietary supplements are a health risk because their quality is unreliable. Health risks are even greater when such unreliability extends to fundamental differences between dose units in one package. Because dose-to-dose variability for these products is unpredictable, the confidence interval of a sample size is unknown. Consequently, the analyses of a selection of dose units may not be representative for the package. In the worst case, counterfeit or unauthorised medicines are not recognised as such or a health risk is not identified. In order to reduce erroneous results particular care should be taken when analysing a composite of dose units, when finding no API in a dietary supplement and when finding conformity in a suspect counterfeit medicine. Copyright © 2013 Elsevier B.V. All rights reserved.

Preanesthetic Assessment of Herbal and Dietary Supplement Use

DTIC Science & Technology

2000-10-01

anticoagulant therapy. Ginkgo has been reported to diminish the effectiveness of anticonvulsants such as carbamazepine, phenytoin , and phenobarbital by lowering...been implicated in drug interactions (DeSmet & D Arcy, 1996). Vitamin B6 can nullify the effects of L-dopa in patients with Parkinson disease...Intraoperative Parkinsonism has been associated with a neuroleptic malignant- like syndrome potentially creating unnecessary and inappropriate delay in

Hepatotoxicity by Dietary Supplements: A Tabular Listing and Clinical Characteristics

PubMed Central

García-Cortés, Miren; Robles-Díaz, Mercedes; Ortega-Alonso, Aida; Medina-Caliz, Inmaculada; Andrade, Raul J.

2016-01-01

Dietary supplements (DS) are extensively consumed worldwide despite unproven efficacy. The true incidence of DS-induced liver injury (DSILI) is unknown but is probably under-diagnosed due to the general belief of safety of these products. Reported cases of herbals and DS-induced liver injury are increasing worldwide. The aim of this manuscript is to report a tabular listing with a description of DS associated with hepatotoxicity as well as review the phenotype and severity of DSILI. Natural remedies related to hepatotoxicity can be divided into herbal product-induced liver injury and DS-induced liver injury. In this article, we describe different DS associated with liver injury, some of them manufactured DS containing several ingredients (Herbalife™ products, Hydroxycut™, LipoKinetix™, UCP-1 and OxyELITE™) while others have a single ingredient (green tea extract, linoleic acid, usnic acid, 1,3-Dimethylamylamine, vitamin A, Garcinia cambogia and ma huang). Additional DS containing some of the aforementioned ingredients implicated in liver injury are also covered. We have also included illicit androgenic anabolic steroids for bodybuilding in this work, as they are frequently sold under the denomination of DS despite being conventional drugs. PMID:27070596

Hepatotoxicity by Dietary Supplements: A Tabular Listing and Clinical Characteristics.

PubMed

García-Cortés, Miren; Robles-Díaz, Mercedes; Ortega-Alonso, Aida; Medina-Caliz, Inmaculada; Andrade, Raul J

2016-04-09

Dietary supplements (DS) are extensively consumed worldwide despite unproven efficacy. The true incidence of DS-induced liver injury (DSILI) is unknown but is probably under-diagnosed due to the general belief of safety of these products. Reported cases of herbals and DS-induced liver injury are increasing worldwide. The aim of this manuscript is to report a tabular listing with a description of DS associated with hepatotoxicity as well as review the phenotype and severity of DSILI. Natural remedies related to hepatotoxicity can be divided into herbal product-induced liver injury and DS-induced liver injury. In this article, we describe different DS associated with liver injury, some of them manufactured DS containing several ingredients (Herbalife™ products, Hydroxycut™, LipoKinetix™, UCP-1 and OxyELITE™) while others have a single ingredient (green tea extract, linoleic acid, usnic acid, 1,3-Dimethylamylamine, vitamin A, Garcinia cambogia and ma huang). Additional DS containing some of the aforementioned ingredients implicated in liver injury are also covered. We have also included illicit androgenic anabolic steroids for bodybuilding in this work, as they are frequently sold under the denomination of DS despite being conventional drugs.

Intermittent fasting combined with supplementation with Ayurvedic herbs reduces anxiety in middle aged female rats by anti-inflammatory pathways.

PubMed

Singh, Harpal; Kaur, Taranjeet; Manchanda, Shaffi; Kaur, Gurcharan

2017-08-01

Intermittent fasting-dietary restriction (IF-DR) is an increasingly popular intervention to promote healthy aging and delay age associated decline in brain functions. Also, the use of herbal interventions is gaining attention due to their non-pharmacological approach to treat several abnormalities and promote general health with least side effects. The present study was aimed to investigate the synergistic effects of IF-DR regimen with herbal supplementation on anxiety-like behavior and neuroinflammation in middle aged female rats. We used dried leaf powder of Withania somnifera and dried stem powder of Tinospora cordifolia for our study. The rats were divided into three groups: (1) Control group fed ad libitum (AL); (2) rats deprived of food for full day and fed ad libitum on every alternate day (IF-DR); and (3) IF-DR and herbal extract (DRH) group in which rats were fed ad libitum with herbal extract supplemented diet, every alternate day. Post regimen, the rats were tested for anxiety-like behavior and further used for study of key inflammatory molecules (NFκB, Iba1, TNFα, IL-1β, IL-6) and glial marker (GFAP) in hippocampus and piriform cortex regions of brain. The study was further extended to explore the effect of DRH regimen on stress response protein (HSP70) and calcium dependent regulators of synaptic plasticity (CaMKIIα, Calcineurin). Our data demonstrated that DRH regimen reduced anxiety-like behavior in middle age female rats and associated neuroinflammation by ameliorating key inflammatory cytokines and modulated stress response. The present data may provide scientific validation for anxiolytic and anti-inflammatory potential of herbal intervention combined with short term IF-DR regimen.

Preanesthetic Assessment of Herbal and Dietary Supplement Use

DTIC Science & Technology

2000-12-06

effectiveness of anticonvulsants such as carbamazepine, phenytoin , and phenobarbital by lowering the seizure threshold (Miller, 1998). Ginseng has been...DeSmet & D’Arcy, 1996). Vitamin B6 can nullify the effects of L-dopa in patients with Parkinson disease. Intraoperative Parkinsonism has been...Hall, 1996). Folic acid has been associated with decreased levels of phenytoin . Patients on phenytoin for control of seizures that are taking large

Long chain omega-3 dietary supplements: a review of the National Library of Medicine Herbal Supplement Database.

PubMed

Zargar, Atanaz; Ito, Matthew K

2011-08-01

Dietary fish oil supplements are increasingly used as an alternative to prescription-grade omega-3 fatty acids (P-OM3) for the treatment of hypertriglyceridemia. The content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in these supplement products varies widely and may result in a suboptimal response. The aim of this study was to review marketed fish oil supplements and to develop a reference for clinicians to compare products. The National Library of Medicine Herbal Supplement Database was systematically searched using fish oil, EPA, DHA, and omega-3 fatty acid as search terms. Daily doses needed to achieve the Food and Drug Administration (FDA)-approved dose (RxDose) (3,360 mg of combined EPA and DHA) were calculated from the milligrams of EPA and DHA per serving, and suggested retail prices were used to calculate monthly cost of each product. A "usage criteria" was set to highlight products at the RxDose with a monthly cost of <$50, daily servings <8, daily amount of vitamins A and D less than or equal to the U.S. Dietary Reference Intake upper limit defined as 10,000 and 4,000 IU, respectively, and if the product was U.S. Pharmacopeia verified. A total of 163 products were identified, and 102 nonliquid and liquid products met our entry criteria. The median amount of EPA and DHA per serving in the nonliquid products was 216 mg and 200 mg, respectively, and the median number of servings at the RxDose was 11.2 at a median monthly cost of $63.49. The median amount of EPA (460 mg) and DHA (400 mg) per serving in the liquid products was higher than the nonliquid products. Thus, the median number of servings at the RxDose was only 3.6 teaspoons and the median monthly cost of $13.60. Only 22% of products met our "usage criteria." The amount of EPA and DHA per recommended serving in these products was highly variable. Clinicians should heighten their scrutiny in terms of selection of the appropriate product.

Dietary supplement for energy and reduced appetite containing the β-agonist isopropyloctopamine leads to heart problems and hospitalisations.

PubMed

Bovee, Toine F H; Mol, Hans G J; Bienenmann-Ploum, Monique E; Heskamp, Henri H; Van Bruchem, Gerard D; Van Ginkel, Leendert A; Kooijman, Martin; Lasaroms, Johan J P; Van Dam, Ruud; Hoogenboom, Ron L A P

2016-05-01

In 2013 the Dutch authorities issued a warning against a dietary supplement that was linked to 11 reported adverse reactions, including heart problems and in one case even a cardiac arrest. In the UK a 20-year-old woman, said to have overdosed on this supplement, died. Since according to the label the product was a herbal mixture, initial LC-MS/MS analysis focused on the detection of plant toxins. Yohimbe alkaloids, which are not allowed to be present in herbal preparations according to Dutch legislation, were found at relatively high levels (400-900 mg kg(-1)). However, their presence did not explain the adverse health effects reported. Based on these effects the supplement was screened for the presence of a β-agonist, using three different biosensor assays, i.e. the validated competitive radioligand β2-adrenergic receptor binding assay, a validated β-agonists ELISA and a newly developed multiplex microsphere (bead)-based β-agonist assay with imaging detection (MAGPIX(®)). The high responses obtained in these three biosensors suggested strongly the presence of a β-agonist. Inspection of the label indicated the presence of N-isopropyloctopamine. A pure standard of this compound was bought and shown to have a strong activity in the three biosensor assays. Analysis by LC-full-scan high-resolution MS confirmed the presence of this 'unknown known' β3-agonist N-isopropyloctopamine, reported to lead to heart problems at high doses. A confirmatory quantitative analysis revealed that one dose of the preparation resulted in an intake of 40-60 mg, which is within the therapeutic range of this compound. The case shows the strength of combining bioassays with chemical analytical techniques for identification of illegal pharmacologically active substances in food supplements.

Knowledge and characteristics of herbal supplement usage among community pharmacy customers in a Malaysian population.

PubMed

Yeong, S W; Choong, Y C

2017-12-01

We investigated the knowledge and characteristics of herbal supplement usage of the customers of community pharmacies in a Malaysian population. Self-administered questionnaires (in English, Malay, or Chinese) were provided to customers at three community pharmacies in Malaysia (Ipoh, Perak). Questionnaire validation and translation validation were performed. A pilot study was conducted before actual questionnaire distribution. Informed consent was obtained from all participants. Total number of participants was 270 (99 males and 171 females) with majority from the 31-50 age group (41.5%). Among the participants, 45.6% were herbal users. The most commonly used herbal supplements were evening primrose oil (17.9%), ginkgo biloba (13.0%), and milk thistle (8.5%). The participants seemed to have sufficient knowledge regarding herbal supplements including safety, quality, and indication of use from medical literature. Participants obtained information about herbal supplements from pharmacists (26.9%), package inserts (25.2%), friends (20.5%), and the Internet (13.3%) more often than from their doctors (9.8%). Most herbal users did not inform their doctors about their usage of herbal supplements (68.3%) or the side effects (61.5%). Herbal supplement users also tended to be women, >50-year-old, and those with higher monthly household incomes. Community pharmacists have a vital role in educating their customers about the safe use of herbal supplements. The participants had sufficient knowledge about herbal supplement usage; therefore, customers of these community pharmacies may have benefitted from the advice of the pharmacists. Further studies could be carried out in future on the knowledge, skills and roles of community pharmacists in the safe use of herbal supplements. Copyright © 2017 Elsevier Ltd. All rights reserved.

Perspectives on the Market Globalization of Korean Herbal Manufacturers: A Company-Based Survey

PubMed Central

Kim, Dongsu; Ahn, Miyoung; Jung, Jeeyoun; Kwon, Soohyun; Park, Eun-Ji; Koo, Ki Hoon; Woo, Jong-Min

2015-01-01

The growth of herbal markets has increased substantially in South Korea, but the worldwide market share remains small despite significant governmental efforts. This study aimed to characterize manufacturing employment and identify employees' general perceptions of market expansion. A survey study covering 567 companies was conducted using face-to-face interviews in 2012. Data were analyzed using comparisons among three manufacturing groups (i.e., the herbal dietary supplement manufacturing group, the herbal medicine manufacturing group, and the personal care product manufacturing group) or among the manufacturers themselves. We found that the majority of the manufacturing employee respondents were regular permanent and production workers. The domestic distributors were primarily chain stores/direct outlets or retailers/wholesalers, and the dominant product was red ginseng (hongsam). Although the responding companies exhibited a variety of perspectives, “advertisement/public relations” was cited as the most important factor in the development of the herbal industry. In contrast, “low manpower/seeking business partners” were the most crucial limiting and challenging factors for market globalization. Our results can be used to design a proper national plan by reducing the gaps in perspective between herbal product producers and policy makers. PMID:26199635

Perspectives on the Market Globalization of Korean Herbal Manufacturers: A Company-Based Survey.

PubMed

Kim, Dongsu; Ahn, Miyoung; Jung, Jeeyoun; Kwon, Soohyun; Park, Eun-Ji; Koo, Ki Hoon; Woo, Jong-Min

2015-01-01

The growth of herbal markets has increased substantially in South Korea, but the worldwide market share remains small despite significant governmental efforts. This study aimed to characterize manufacturing employment and identify employees' general perceptions of market expansion. A survey study covering 567 companies was conducted using face-to-face interviews in 2012. Data were analyzed using comparisons among three manufacturing groups (i.e., the herbal dietary supplement manufacturing group, the herbal medicine manufacturing group, and the personal care product manufacturing group) or among the manufacturers themselves. We found that the majority of the manufacturing employee respondents were regular permanent and production workers. The domestic distributors were primarily chain stores/direct outlets or retailers/wholesalers, and the dominant product was red ginseng (hongsam). Although the responding companies exhibited a variety of perspectives, "advertisement/public relations" was cited as the most important factor in the development of the herbal industry. In contrast, "low manpower/seeking business partners" were the most crucial limiting and challenging factors for market globalization. Our results can be used to design a proper national plan by reducing the gaps in perspective between herbal product producers and policy makers.

Dietary supplements and prostate cancer: a systematic review of double-blind, placebo-controlled randomised clinical trials.

PubMed

Posadzki, Paul; Lee, Myeong Soo; Onakpoya, Igho; Lee, Hye Won; Ko, Byong Seob; Ernst, Edzard

2013-06-01

Dietary supplements are popular among patients with prostate cancer (PC). The objective of this systematic review was to critically examine double-blind, placebo-controlled randomised clinical trials (RCTs) of non-herbal dietary supplements and vitamins (NHDS) for evidence that prostate specific antigen (PSA) levels were reduced in PC patients. Five databases were searched from their inception through December 2012 to identify studies that met our inclusion criteria. Methodological quality was independently assessed by two reviewers using the Cochrane tool. Eight RCTs met the eligibility criteria and were of high methodological quality. The following supplements were tested: isoflavones (genistein, daidzein, and glycitein), minerals (Se) or vitamins (vitamin D) or a combination of antioxidants, bioflavonoids, carotenoids, lycopenes, minerals (Se, Zn, Cu, and Mg), phytoestrogens, phytosterols, vitamins (B2, B6, B9, B12, C, and E), and other substances (CoQ10 and n-acetyl-l cysteine). Five RCTs reported no significant effects compared with placebo. Two RCTs reported that a combination of antioxidants, isoflavones, lycopenes, minerals, plant oestrogens and vitamins significantly decreased PSA levels compared with placebo. One RCT did not report differences in PSA levels between the groups. In conclusion, the hypothesis that dietary supplements are effective treatments for PC patients is not supported by sound clinical evidence. There are promising data for only two specific remedies, which contained a mixture of ingredients, but even for these supplements, additional high quality evidence is necessary before firm recommendations would be justified. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Herbal supplements and skin testing: the lack of effect of commonly used herbal supplements on histamine skin prick testing.

PubMed

More, D R; Napoli, D C; Hagan, L L

2003-06-01

The use of herbal supplements is common, yet little is known about their pharmacologic properties. The purpose of this study was to assess the effects of 23 commonly used herbal supplements on histamine skin prick testing (SPT). Fifteen healthy volunteers participated in a double-blind, placebo-controlled, single-dose, crossover study. Wheal and flare responses to SPT with histamine phosphate (1 mg/ml) were measured before and 4 h after administration of each of the 23 popular herbal supplements, fexofenadine (60 mg) and placebo. Wheal and flare areas were recorded with tracings performed 10 min after the prick test and measured with a PC-digitizer using stereometric software. Fexofenadine significantly suppressed the wheal (P < 0.001) and flare (P = 0.02) areas compared with placebo. None of the herbal supplements caused significant suppression of the wheal and flare areas compared with placebo (P > 0.10). When taken in single-doses, the popular herbal supplements tested did not significantly affect the histamine skin response. Therefore, it seems unnecessary for clinicians to ask patients to discontinue these herbal supplements prior to allergy skin testing.

Assessment of the Authenticity of Herbal Dietary Supplements: Comparison of Chemical and DNA Barcoding Methods.

PubMed

Pawar, Rahul S; Handy, Sara M; Cheng, Raymond; Shyong, Nicole; Grundel, Erich

2017-07-01

About 7 % of the U. S. population reports using botanical dietary supplements. Increased use of such supplements has led to discussions related to their authenticity and quality. Reports of adulteration with substandard materials or pharmaceuticals are of concern because such substitutions, whether inadvertent or deliberate, may reduce the efficacy of specific botanicals or lead to adverse events. Methods for verifying the identity of botanicals include macroscopic and microscopic examinations, chemical analysis, and DNA-based methods including DNA barcoding. Macroscopic and microscopic examinations may fail when a supplement consists of botanicals that have been processed beyond the ability to provide morphological characterizations. Chemical analysis of specific marker compounds encounters problems when these compounds are not distinct to a given species or when purified reference standards are not available. Recent investigations describing DNA barcoding analysis of botanical dietary supplements have raised concerns about the authenticity of the supplements themselves as well as the appropriateness of using DNA barcoding techniques with finished botanical products. We collected 112 market samples of frequently consumed botanical dietary supplements of ginkgo, soy, valerian, yohimbe, and St. John's wort and analyzed each for specific chemical markers (i.e., flavonol glycosides, total isoflavones, total valerenic acids, yohimbine, and hypericins, respectively). We used traditional DNA barcoding techniques targeting the nuclear ITS2 gene and the chloroplast gene psb A- trn H on the same samples to determine the presence of DNA of the labelled ingredient. We compared the results obtained by both methods to assess the contribution of each in determining the identity of the samples. Georg Thieme Verlag KG Stuttgart · New York.

Essiac? and Flor-Essence? herbal tonics stimulate the in vitro growth of human breast cancer cells

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kulp, K S; Montgomery, J L; McLimans, B

People diagnosed with cancer often self-administer complementary and alternative medicines (CAMs) to supplement their conventional treatments, improve health, or prevent recurrence. Flor-Essence{reg_sign} and Essiac{reg_sign} Herbal Tonics are commercially available complex mixtures of herbal extracts sold as dietary supplements and used by cancer patients based on anecdotal evidence that they can treat or prevent disease. In this study, we evaluated Flor-Essence{reg_sign} and Essiac{reg_sign} for their effects on the growth of human tumor cells in culture. The effect of Flor-Essence{reg_sign} and Essiac{reg_sign} herbal tonics on cell proliferation was tested in MCF-7, MDA-MB-436, MDA-MB-231, and T47D cancer cells isolated from human breast tumors.more » Estrogen receptor (ER) dependent activation of a luciferase reporter construct was tested in MCF-7 cells. Specific binding to the ER was tested using an ICI 182,780 competition assay. Flor-Essence{reg_sign} and Essiac{reg_sign} herbal tonics at 1%, 2%, 4% and 8% stimulated cell proliferation relative to untreated controls and activated ER dependent luciferase activity in MCF-7 cells. A 10{sup -7} M concentration of ICI 870,780 inhibited the induction of ER dependent luciferase activity by Flor-Essence{reg_sign} and Essiac{reg_sign}, but did not affect cell proliferation. Flor-Essence{reg_sign} and Essiac{reg_sign} Herbal Tonics can stimulate the growth of human breast cancer cells through ER mediated as well as ER independent mechanisms of action. Cancer patients and health care providers can use this information to make informed decisions about the use of these CAMs.« less

UHPLC-UV method for the determination of flavonoids in dietary supplements and for evaluation of their antioxidant activities.

PubMed

Magiera, Sylwia; Baranowska, Irena; Lautenszleger, Anna

2015-01-01

A simple and rapid ultra-high performance liquid chromatographic (UHPLC) method coupled with an ultraviolet detector (UV) has been developed and validated for the separation and determination of 14 major flavonoids ((±)-catechin, (-)-epicatechin, glycitin, (-)-epicatechin gallate, rutin, quercitrin, hesperidine, neohesperidine, daidzein, glycitein, quercetin, genistein, hesperetin, and biochanin A) in herbal dietary supplements. The flavonoids have been separated on a Chromolith Fast Gradient Monolithic RP-18e column utilizing a mobile phase composed of 0.05% trifluoroacetic acid in water and acetonitrile in gradient elution mode. Under these conditions, flavonoids were separated in a 5 min run. The selectivity of the developed UHPLC-UV method was confirmed by comparison with ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) analysis. The validation parameters such as linearity, sensitivity, precision, and accuracy were found to be highly satisfactory. The optimized method was applied to determination of flavonoids in different dietary supplements. Additionally, the developed HPLC-UV method combined with 2,2-diphenyl-1-picrylhydrazyl radical (DPPH) assay was used in the evaluation of antioxidant activity of the selected flavonoids. Copyright © 2014 Elsevier B.V. All rights reserved.

Dietary supplement use among participants of a databank and biorepository at a comprehensive cancer centre

PubMed Central

Luc, LeQuyen; Baumgart, Charlotte; Weiss, Edward; Georger, Lesley; Ambrosone, Christine B; Zirpoli, Gary; McCann, Susan E

2015-01-01

Objective We assessed the prevalence, patterns and predictors of dietary supplement use among participants of the databank and biorepository (DBBR) at a comprehensive cancer centre in western New York. Design Archived epidemiological questionnaire data were obtained from the DBBR at Roswell Park Cancer Institute. Descriptive statistics and logistic regression explored the prevalence, patterns and predictors of lifetime use of four common supplements (multivitamins, vitamin C, vitamin E and calcium) and use of multivitamins, sixteen single vitamins/minerals and eighteen herbal/specialty supplements within the previous 10 years. Setting Western New York, USA. Subjects DBBR participants (n 8096) enrolled between December 2003 and July 2012 were included in these analyses: 66.9 % (n 5418) with cancer, 65.6 % (n 5309) women, mean age for patients ν. cancer-free controls 59.9 (sd 12.6) years and 50.7 (sd 15.4) years, respectively. Results Overall, 54.4 % of DBBR participants reported lifetime use of one or more supplements and 63.1 % reported use of one or more supplements within the previous 10 years (excluding multivitamins). Multivitamin use was high in this sample (lifetime: 64.1 %; 10 years: 71.3 %; current: 51.8 %). Supplementation was higher among cancer-free controls than cancer patients. Vitamin C, calcium and fish oil were the most common single vitamin, mineral and specialty product, respectively. Conclusions A consistently high and increasing proportion of dietary supplement use over time remains clear. Supplementation is prevalent among cancer patients and may even be higher than predicted in cancer-free individuals. Further studies should assess the safety and efficacy of specific supplements in reducing disease risk. PMID:24866812

Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

MedlinePlus

... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

Lone atrial fibrillation associated with creatine monohydrate supplementation.

PubMed

Kammer, Ryan T

2005-05-01

Atrial fibrillation in young patients without structural heart disease is rare. Therefore, when the arrhythmia is present in this population, reversible causes must be identified and resolved. Thyroid disorders, illicit drug or stimulant use, and acute alcohol intoxication are among these causes. We report the case of a 30-year-old Caucasian man who came to the emergency department in atrial fibrillation with rapid ventricular response. His medical history was unremarkable, except for minor fractures of the fingers and foot. Thyroid-stimulating hormone, magnesium, and potassium levels were within normal limits, urine drug screen was negative, and alcohol use was denied. However, when the patient was questioned about use of herbal products and supplements, the use of creatine monohydrate was revealed. The patient was admitted to the hospital, anticoagulated with unfractionated heparin, and given intravenous diltiazem for rate control and intravenous amiodarone for rate and rhythm control. When discharged less than 24 hours later, he was receiving metoprolol and aspirin, with follow-up plans for echocardiography and nuclear imaging to assess perfusion. Exogenous creatine is used by athletes to theoretically improve exercise performance. Vegetarians may also take creatine to replace what they are not consuming from meat, fish, and other animal products. Previous anecdotal reports have linked creatine to the development of arrhythmia. Clinicians must be diligent when interviewing patients about their drug therapy histories and include questions about their use of herbal products and dietary supplements. In addition, it is important to report adverse effects associated with frequently consumed supplements and herbal products to the Food and Drug Administration and in the literature.

Pharmacological activity of three commercial Hypericum perforatum preparations in mice.

PubMed

Jean, D; Pouligon, M; Henriot, A C

2006-08-01

St John's Wort (Hypericum perforatum) is the main herbal species used to treat depression. The products available on the pharmaceutical and dietary supplement markets are obtained by a variety of preparation processes and their pharmacological effects may differ significantly. The purpose of this study therefore was to investigate the effect of different St John's Wort commercial preparations available on the French market. Only one preparation gave significant results in the forced swimming test.

Acute liver injury induced by weight-loss herbal supplements.

PubMed

Chen, Gary C; Ramanathan, Vivek S; Law, David; Funchain, Pauline; Chen, George C; French, Samuel; Shlopov, Boris; Eysselein, Viktor; Chung, David; Reicher, Sonya; Pham, Binh V

2010-11-27

We report three cases of patients with acute liver injury induced by weight-loss herbal supplements. One patient took Hydroxycut while the other two took Herbalife supplements. Liver biopsies for all patients demonstrated findings consistent with drug-induced acute liver injury. To our knowledge, we are the first institute to report acute liver injury from both of these two types of weight-loss herbal supplements together as a case series. The series emphasizes the importance of taking a cautious approach when consuming herbal supplements for the purpose of weight loss.

Acute liver injury induced by weight-loss herbal supplements

PubMed Central

Chen, Gary C; Ramanathan, Vivek S; Law, David; Funchain, Pauline; Chen, George C; French, Samuel; Shlopov, Boris; Eysselein, Viktor; Chung, David; Reicher, Sonya; Pham, Binh V

2010-01-01

We report three cases of patients with acute liver injury induced by weight-loss herbal supplements. One patient took Hydroxycut while the other two took Herbalife supplements. Liver biopsies for all patients demonstrated findings consistent with drug-induced acute liver injury. To our knowledge, we are the first institute to report acute liver injury from both of these two types of weight-loss herbal supplements together as a case series. The series emphasizes the importance of taking a cautious approach when consuming herbal supplements for the purpose of weight loss. PMID:21173910

An evaluation of selected herbal reference texts and comparison to published reports of adverse herbal events.

PubMed

Haller, Christine A; Anderson, Ilene B; Kim, Susan Y; Blanc, Paul D

2002-01-01

There has been a recent proliferation of medical reference texts intended to guide practitioners whose patients use herbal therapies. We systematically assessed six herbal reference texts to evaluate the information they contain on herbal toxicity. We selected six major herbal references published from 1996 to 2000 to evaluate the adequacy of their toxicological information in light of published adverse events. To identify herbs most relevant to toxicology, we reviewed herbal-related calls to our regional California Poison Control System, San Francisco division (CPCS-SF) in 1998 and identified the 12 herbs (defined as botanical dietary supplements) most frequently involved in these CPCS-SF referrals. We searched Medline (1966 to 2000) to identify published reports of adverse effects potentially related to these same 12 herbs. We scored each herbal reference text on the basis of information inclusiveness for the target 12 herbs, with a maximal overall score of 3. The herbs, identified on the basis of CPCS-SF call frequency were: St John's wort, ma huang, echinacea, guarana, ginkgo, ginseng, valerian, tea tree oil, goldenseal, arnica, yohimbe and kava kava. The overall herbal reference scores ranged from 2.2 to 0.4 (median 1.1). The Natural Medicines Comprehensive Database received the highest overall score and was the most complete and useful reference source. All of the references, however, lacked sufficient information on management of herbal medicine overdose, and several had incorrect overdose management guidelines that could negatively impact patient care. Current herbal reference texts do not contain sufficient information for the assessment and management of adverse health effects of botanical therapies.

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

PubMed Central

2008-01-01

Introduction Herbal products have gained increasing popularity in the last decade, and are now used by approximately 20% of the population. Herbal products are complex mixtures of organic chemicals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Under the current law, herbs are defined as dietary supplements, and manufacturers can therefore produce, sell, and market herbs without first demonstrating safety and efficacy, as is required for pharmaceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many different side effects have been reported owing to active ingredients, contaminants, or interactions with drugs. Results Unfortunately, there is limited scientific evidence to establish the safety and efficacy of most herbal products. Of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy, but concerns over safety and a consideration of other medical therapies may temper the decision to use these products. Conclusions Herbal products are not likely to become an important alternative to standard medical therapies unless there are changes to the regulation, standardization, and funding for research of these products. PMID:18415652

Complementary and alternative medicine: is there a role in multiple sclerosis?

PubMed

Yadav, Vijayshree; Bourdette, Dennis

2006-05-01

Despite effective conventional therapies for multiple sclerosis (MS), many people with MS explore complementary and alternative medicine (CAM) therapies for their symptoms. Common CAM therapies that people use include dietary modification, nutritional and herbal supplementation, and mind-body therapies. There is a revival of interest among MS researchers about the therapeutic potential of low-fat diet and essential fatty acid supplementation in MS. The efficacy of specific vitamin supplementation remains unclear. Recently, cannabis and yoga have been studied in more controlled studies and have provided evidence that they may have some benefit. The research on CAM therapies in MS is still exploratory, but considering peoples' interest and common use of these therapies, further research in this area is clearly warranted.

Herbal supplement use among adult dental patients in a USA dental school clinic: prevalence, patient demographics, and clinical implications.

PubMed

Abebe, Worku; Herman, Wayne; Konzelman, Joseph

2011-03-01

This study assessed the frequency and patterns of utilization of herbal supplement products by adult dental patients at a USA dental school clinic. A self-reporting questionnaire was used to collect patient demographics and frequency of herbal supplement utilization along with other information. The questionnaire was distributed and collected at a dental visit. Herbal utilization was related to patient demographics using descriptive analysis. The clinical implications of the findings are discussed. Out of 1,240 questionnaires, 1,119 were returned as completed. Of these, 12.6% reported using ≥1 of 21 herbal products. The majority of the users were middle-aged educated caucasian women. Green tea, garlic, echinacea, ginkgo biloba, and ginseng were the top 5 products used. Mostly, supplements were consumed in combination with drugs. The type, prevalence, and frequency of herbal supplement utilization by adult dental patients in this USA dental clinic were generally similar to those reported for other population groups. This observation, coupled with the documented effects of the commonly used herbal products, should alert dental health caregivers to inquire about herbal supplement use when evaluating or treating their patients. Copyright © 2011 Mosby, Inc. All rights reserved.

Hepatotoxicity of herbal and dietary supplements: an update.

PubMed

Stickel, Felix; Shouval, Daniel

2015-06-01

Herbal and dietary supplements (HDS) have been used for health-related purposes since more than 5000 years, and their application is firmly anchored in all societies worldwide. Over last decades, a remarkable renaissance in the use of HDS can be noticed in affluent societies for manifold reasons. HDS are forms of complementary and alternative medicines commonly used to prevent or treat diseases, or simply as a health tonic. Another growing indication for HDS is their alleged benefit for weight loss or to increase physical fitness. Access is easy via internet and mail-order pharmacies, and their turnover reaches billions of dollars in the USA and Europe alone. However, HDS are generally not categorized as drugs and thus less strictly regulated in most countries. As a result, scientific evidence proving their beneficial effects is mostly lacking, although some HDS may have purported benefits. However, the majority lacks such proof of value, and their use is predominantly based on belief and hope. In addition to missing scientific evidence supporting their use, HDS are typically prone to batch-to-batch variability in composition and concentration, contamination, and purposeful adulteration. Moreover, numerous examples of preparations emerged which have been linked to significant liver injury. These include single ingredients, such as kava, germander, and several Chinese herbals. Other HDS products associated with liver toxicity consist of multiple, often ill-defined ingredients, such as Hydroxycut and Herbalife. Affirmative diagnostic tests are not available, and the assessment of liver injury ascribed to HDS depends on a thorough and proactive medical history, careful exclusion of other causes, and a search for available reports on similar events linked to the intake of the suspected preparation or ingredients contained therein.

Prevalence and Predictors of Herbal Medicine Use Among Adults in the United States.

PubMed

Rashrash, Mohamed; Schommer, Jon C; Brown, Lawrence M

2017-09-01

To describe the prevalence of herbal medicine use among US adults and to assess factors associated with and predictors of herbal use. The data for herbal products use were collected from the 2015 National Consumer Survey on the Medication Experience and Pharmacists' Roles. Chi-square test was used to analyz factors associated with herbal use, and predictors of herbal use were assessed with logistic regression analysis. Factors associated with herbal supplement use include age older than 70, having a higher than high school education, using prescription medications or over-the-counter (OTC) medications, and using a mail-order pharmacy." All Disease state associated significantly with herbal use. Approximately thirty-eight percent of those who used herbals used prescription medications and 42% of those who used herbals also used an OTC medication. The most frequent conditions associated with herbal supplement use were a stroke (48.7%), cancer (43.1%), and arthritis (43.0%). Among herbal product users, factors that predicted use included having higher than school education, using OTC medications, using mail-order pharmacy, stroke, obesity, arthritis, and breathing problems. More than one-third of respondents reported using herbal supplements. Older age and higher education were associated with a higher use of herbal supplements. People with chronic diseases are more likely to use herbal medicines than others. OTC drug users and patients with stroke are more likely to use herbal medicines than others.

New Insights into the Mechanisms of Chinese Herbal Products on Diabetes: A Focus on the “Bacteria-Mucosal Immunity-Inflammation-Diabetes” Axis

PubMed Central

Wu, Xuemin; Zhao, Xuemin

2017-01-01

Diabetes, especially type 2, has been rapidly increasing all over the world. Although many drugs have been developed and used to treat diabetes, side effects and long-term efficacy are of great challenge. Therefore, natural health product and dietary supplements have been of increasing interest alternatively. In this regard, Chinese herbs and herbal products have been considered a rich resource of product development. Although increasing evidence has been produced from various scientific studies, the mechanisms of action are lacking. Here, we have proposed that many herbal monomers and formulae improve glucose homeostasis and diabetes through the BMID axis; B represents gut microbiota, M means mucosal immunity, I represents inflammation, and D represents diabetes. Chinese herbs have been traditionally used to treat diabetes, with minimal side and toxic effects. Here, we reviewed monomers such as berberine, ginsenoside, M. charantia extract, and curcumin and herbal formulae such as Gegen Qinlian Decoction, Danggui Liuhuang Decoction, and Huanglian Wendan Decoction. This review was intended to provide new perspectives and strategies for future diabetes research and product. PMID:29164155

Herb use in pregnancy: what nurses should know.

PubMed

Born, Diane; Barron, Mary Lee

2005-01-01

During the last decade, there has been a dramatic rise in the availability and use of medicinal herbal preparations. Childbearing women are among those who are asking nurses about herbal use, and therefore nurses need to learn more about this topic. One of the most important points to understand is that in the United States herbs are classified as dietary supplements (not drugs), and manufacturers are therefore not required to provide proof of efficacy or safety before selling these substances. Few studies about effects of herbs have been conducted in the general population, and fewer still have been published about pregnancy use. Because the perinatal nurse has two patients to consider when caring for a pregnant woman, he or she has two equally important mandates: to help the mother without harming the fetus. This article provides an overview of key concepts underlying herbal use in general and also safety in pregnancy. Common herbs that can be safely be used in pregnancy are presented in detail to enable the nurse to better care for the pregnant woman who is considering herbal use.

Adverse events of herbal food supplements for body weight reduction: systematic review.

PubMed

Pittler, M H; Schmidt, K; Ernst, E

2005-05-01

Herbal weight-loss supplements are marketed with claims of effectiveness. Our earlier systematic review identified data from double-blind, randomized controlled trials for a number of herbal supplements. The aim of this systematic review was to assess all clinical evidence of adverse events of herbal food supplements for body weight reduction for which effectiveness data from rigorous clinical trials exist. We assessed Ephedra sinica, Garcinia cambogia, Paullinia cupana, guar gum, Plantago psyllium, Ilex paraguariensis and Pausinystalia yohimbe. Literature searches were conducted on Medline, Embase, Amed and The Cochrane Library. Data were also requested from the spontaneous reporting scheme of the World Health Organization. We hand-searched relevant medical journals and our own files. There were no restrictions regarding the language of publication. The results show that adverse events including hepatic injury and death have been reported with the use of some herbal food supplements. For herbal ephedra and ephedrine-containing food supplements an increased risk of psychiatric, autonomic or gastrointestinal adverse events and heart palpitations has been reported. In conclusion, adverse events are reported for a number of herbal food supplements, which are used for reducing body weight. Although the quality of the data does not justify definitive attribution of causality in most cases, the reported risks are sufficient to shift the risk-benefit balance against the use of most of the reviewed herbal weight-loss supplements. Exceptions are Garcinia cambogia and yerba mate, which merit further investigation.

Use of Herbal Dietary Supplement Si-Wu-Tang and Health-Related Quality of Life in Postpartum Women: A Population-Based Correlational Study

PubMed Central

Chang, Pei-Jen; Lin, Ching-Chun; Chen, Yi Chun; Chuang, Chao-Hua; Tseng, Yu-Ching; Hsieh, Wu-Shiun; Lin, Shio-Jean

2013-01-01

Objective. The aim of the study was to explore the association between women's use of herbal dietary supplement Si-Wu-Tang during the postpartum period and their health-related quality of life. Methods. This is a population-based correlational study. We used multistage, stratified, systematic sampling to recruit 24,200 pairs of postpartum women and newborns from the Taiwan National Birth Registry in 2005. A structured questionnaire was successfully administered to 87.8% of the sampled population. Trained interviewers performed home interviews 6 months after the women's deliveries between June 2005 and July 2006. The Medical Outcomes Study 36-item Short-Form (SF-36) was used to measure the quality of life of the women along with the frequency of Si-Wu-Tang use. Results. Si-Wu-Tang use after delivery improved women's score for bodily pain and also improved their score for mental health when used more than 10 times. In addition, there were increases in general health and vitality scores in the group who continuously used Si-Wu-Tang more than 10 times after using Sheng-Hua-Tang. Conclusion. Use of Si-Wu-Tang after delivery may be associated with women's health-related quality of life especially for those who previously used Sheng-Hua-Tang. These results are exploratory and need to be replicated. PMID:23476705

A Rare Case of Psychomotor Disturbances Linked to the Use of an Adulterated Dietary Supplement Containing Sibutramine.

PubMed

Shapira, Barak; Goldstein, Lee; Reshef, Amikam; Poperno, Alina

2016-01-01

Sibutramine, an oral anorexiant, is often found as an adulterant in various counterfeit herbal slimming products and dietary supplements. The use of sibutramine has been associated with various cardiovascular and psychiatric symptoms. Here, we report a rare case of psychomotor disturbances, in a patient with no previously diagnosed movement disorders. A 26-year-old woman developed abnormal behavior, visual hallucinations, hyperkinesia, facial flushing, and dizziness after taking a counterfeit dietary supplement which contained undeclared sibutramine and phenolphtalein. Laboratory work-up revealed microcytic anemia; leucopenia; and elevated erythrocyte sedimentation rate, C-reactive protein levels, and antistreptolysin O titer, but rheumatic fever was ruled out. After a neurologic examination, involuntary movements were classified as chorea. The psychiatric examination result was unremarkable. The patient responded well to haloperidol therapy. Body temperature, erythrocyte sedimentation rate, and C-reactive protein levels eventually normalized. The patient was discharged. This is the first report we are aware of about a transient, chorea-like psychomotor movement disorder associated with sibutramine. Although the causal relationship between sibutramine and the patient's symptoms cannot be proven definitely, the temporal dimension does suggest sibutramine initiation and termination led to onset and resolution of symptoms, respectively. Furthermore, because of the widespread availability of adulterated food supplements containing sibutramine, physicians should be more aware of their implications for patients.

Prevalence and Predictors of Herbal Medicine Use Among Adults in the United States

PubMed Central

Schommer, Jon C; Brown, Lawrence M

2017-01-01

Objective: To describe the prevalence of herbal medicine use among US adults and to assess factors associated with and predictors of herbal use. Design: The data for herbal products use were collected from the 2015 National Consumer Survey on the Medication Experience and Pharmacists’ Roles. Chi-square test was used to analyz factors associated with herbal use, and predictors of herbal use were assessed with logistic regression analysis. Results: Factors associated with herbal supplement use include age older than 70, having a higher than high school education, using prescription medications or over-the-counter (OTC) medications, and using a mail-order pharmacy.” All Disease state associated significantly with herbal use. Approximately thirty-eight percent of those who used herbals used prescription medications and 42% of those who used herbals also used an OTC medication. The most frequent conditions associated with herbal supplement use were a stroke (48.7%), cancer (43.1%), and arthritis (43.0%). Among herbal product users, factors that predicted use included having higher than school education, using OTC medications, using mail-order pharmacy, stroke, obesity, arthritis, and breathing problems. Conclusions: More than one-third of respondents reported using herbal supplements. Older age and higher education were associated with a higher use of herbal supplements. People with chronic diseases are more likely to use herbal medicines than others. OTC drug users and patients with stroke are more likely to use herbal medicines than others. PMID:28959715

Role of self-concept in answering survey questions on complementary and alternative medicine: challenges to and strategies for improving data quality.

PubMed

Willson, Stephanie; Stussman, Barbara; Maitland, Aaron; Nahin, Richard L

2009-12-01

The aim of this study was to assess the construct validity of survey questions about the use of herbal and other nonvitamin/nonmineral dietary supplements. We conducted one-on-one, in-depth cognitive interviews with 32 respondents to test questions from the complementary and alternative medicine (CAM) supplement for the 2007 National Health Interview Survey. Respondents were sampled purposively according to their use of CAM. Interviewers probed respondents for their understanding of the questions, and analysis was guided by grounded theory, an approach that generates explanations of response error that are closely tied to the empirical data. We found two sources of misinterpretation of CAM questions. First, some respondents did not have any pre-established definition of what constitutes an herbal supplement while others had interpretations that did not match the intended definitions. These problems are common to many survey questions. However, a second finding is that misinterpretation also arose when respondents incorporated notions of self-concept into the act of taking "natural herbs," and answered based on their understanding of this image rather than on actual behavior. There are several sources of misinterpretation of CAM questions. One of the most important sources is whether or not the respondent has created a concept of self-image that includes the use of herbal supplements. Common questionnaire design techniques such as providing definitions to respondents will not help to eliminate misinterpretation due to self-image. We found that careful question wording that does not evoke definitions of self, combined with visual aids that narrow the focus of the questions, can lead to more accurate answers.

Top-10 list of herbal and supplemental medicines used by cosmetic patients: what the plastic surgeon needs to know.

PubMed

Heller, Justin; Gabbay, Joubin S; Ghadjar, Kiu; Jourabchi, Mickel; O'Hara, Catherine; Heller, Misha; Bradley, James P

2006-02-01

Widespread use of herbal medications/supplements among the presurgical population may have a negative effect on perioperative patient care. Thus, the authors' goal was to identify the prevalence of such use in a cosmetic surgery patient population compared with use among the general public; to assess physician awareness of proper management of these herbal medications/supplements; and to review the literature to provide rational strategies for managing perioperative patients taking these remedies. To assess patient (n = 100) and general public (n = 100) usage rates, open-ended lists of (1) the most common herbal medications/supplements and (2) homeopathic treatments were compiled. Board-certified plastic surgeons (n = 20) were then given the same list of herbs/supplements and surveyed on their awareness of these treatments and perioperative side effects. The usage rate for cosmetic versus public surveys for herbal medicines/supplements was 55 percent versus 24 percent (p < 0.001), with 35 percent versus 8 percent (p < 0.001) engaging in homeopathic practices, respectively. Cosmetic patients' top four herbal/supplements of usage were chondroitin (18 percent), ephedra (18 percent), echinacea (14 percent), and glucosamine (10 percent). The top four used by the general public were echinacea (8 percent), garlic (6 percent), ginseng (4 percent), and ginger (4 percent). The physician survey demonstrated awareness of 54 percent of the listed supplements/herbal medicines, 85 percent of which were not suggested to be discontinued preoperatively, with only ephedra achieving 100 percent physician discontinuation preoperatively. Herbal medicines and supplements displayed greater prevalence in the cosmetic surgery population than in the population at large. Furthermore, side effects and potential complications warrant addressing these remedies as pharmaceuticals rather than as safe and "natural." Thus, a descriptive "top-10" list with perioperative recommendations was compiled for the plastic surgeon.

Antioxidant potentiality of three herbal teas consumed in Bandundu rural areas of Congo.

PubMed

Kapepula, Paulin Mutwale; Mbombo Mungitshi, Patricia; Franck, Thierry; Mouithys-Mickalad, Ange; Mumba Ngoyi, Dieudonné; Kalenda, Pascal Dibungi T; Kabamba Ngombe, Nadege; Serteyn, Didier; Tits, Monique; Frédérich, Michel; Tamfum Muyembe, Jean-Jacques

2017-08-01

The aim of this study was to evaluate and compare the cellular antioxidant activities of Lantana montevidensis, Lippia multiflora, and Ocimum gratissimum leaves often consumed as herbal teas in a rural area of Bandundu severely affected by konzo, which is related to oxidative damage. Consequently, dietary supplements with proven antioxidant potentialities could be of real interest to promote in this area. Phytochemical screening by TLC and HPLC-DAD of extracts revealed the presence of verbascoside as a major phenolic compound. Verbascoside in L. montevidensis and O. gratissimum is reported here for the first time. All extracts displayed high ABTS and DPPH radical-scavenging activities at the concentration range of 1-40 μg mL -1 according to order: L. multiflora > O. gratissimum > L. montevidensis. L. multiflora showed the best cellular antioxidant activity using DCFH-DA on HL-60 monocytes assay at 1-20 μg mL -1 . These herbal teas may be used as nutraceuticals for their potent antioxidant activity.

Activation of autoimmunity following use of immunostimulatory herbal supplements.

PubMed

Lee, Alice N; Werth, Victoria P

2004-06-01

Evidence for the scientific basis of purported therapeutic effects and adverse effects of herbal supplements continues to grow. Many herbal supplements are touted for their immunostimulatory properties, and both in vitro and in vivo experiments have supported this claim. Although this explains their beneficial effects in preventing or curtailing disease, to our knowledge, no immunostimulatory herbal supplements have been reported to exacerbate disorders of immune system overactivity. We describe 3 patients whose autoimmune disease onset and/or flares correlated with ingestion of herbal supplements with proven immunostimulatory effects. Echinacea and the alga Spirulina platensis are implicated in 2 patients' flares of pemphigus vulgaris, and a supplement containing the algae Spirulina platensis and Aphanizomenon flos-aquae was ingested by a third patient days before both onset and a severe flare of dermatomyositis. The third patient showed heterozygosity for a tumor necrosis factor alpha (TNF-alpha) promoter polymorphism (-308A), leading to increased production of TNF-alpha, which may have predisposed her to developing dermatomyositis. Immunostimulatory herbal supplements may exacerbate preexisting autoimmune disease or precipitate autoimmune disease in persons genetically predisposed to such disorders. Increased production of TNF-alpha may play a role, although more research is needed to clarify the mechanisms of such phenomena.

Over-the-Counter "Adrenal Support" Supplements Contain Thyroid and Steroid-Based Adrenal Hormones.

PubMed

Akturk, Halis Kaan; Chindris, Ana Maria; Hines, Jolaine M; Singh, Ravinder J; Bernet, Victor J

2018-03-01

To assess whether dietary supplements that are herbal and/or animal-derived products, marketed for enhancing metabolism or promoting energy, "adrenal fatigue," or "adrenal support," contain thyroid or steroid hormones. Twelve dietary adrenal support supplements were purchased. Pregnenolone, androstenedione, 17-hydroxyprogesterone, cortisol, cortisone, dehydroepiandrosterone sulfate, synthetic glucocorticoids (betamethasone, dexamethasone, fludrocortisone, megestrol acetate, methylprednisolone, prednisolone, prednisone, budesonide, and triamcinolone acetonide) levels were measured twice in samples in a blinded fashion. This study was conducted between February 1, 2016, and November 1, 2016. Among steroids, pregnenolone was the most common hormone in the samples. Budesonide, 17-hydroxyprogesterone, androstenedione, cortisol, and cortisone were the others in order of prevalence. All the supplements revealed a detectable amount of triiodothyronine (T3) (63-394.9 ng/tablet), 42% contained pregnenolone (66.12-205.2 ng/tablet), 25% contained budesonide (119.5-610 ng/tablet), 17% contained androstenedione (1.27-7.25 ng/tablet), 8% contained 17-OH progesterone (30.09 ng/tablet), 8% contained cortisone (79.66 ng/tablet), and 8% contained cortisol (138.5 ng/tablet). Per label recommended doses daily exposure was up to 1322 ng for T3, 1231.2 ng for pregnenolone, 1276.4 ng for budesonide, 29 ng for androstenedione, 60.18 ng for 17-OH progesterone, 277 ng for cortisol, and 159.32 ng for cortisone. All the supplements studied contained a small amount of thyroid hormone and most contained at least 1 steroid hormone. This is the first study that measured thyroid and steroid hormones in over-the-counter dietary "adrenal support" supplements in the United States. These results may highlight potential risks of hidden ingredients in unregulated supplements. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Spectroscopic and Spectrometric Methods Used for the Screening of Certain Herbal Food Supplements Suspected of Adulteration

PubMed Central

Mateescu, Cristina; Popescu, Anca Mihaela; Radu, Gabriel Lucian; Onisei, Tatiana; Raducanu, Adina Elena

2017-01-01

Purpose: This study was carried out in order to find a reliable method for the fast detection of adulterated herbal food supplements with sexual enhancement claims. As some herbal products are advertised as "all natural", their "efficiency" is often increased by addition of active pharmaceutical ingredients such as PDE-5 inhibitors, which can be a real health threat for the consumer. Methodes: Adulterants, potentially present in 50 herbal food supplements with sexual improvement claims, were detected using 2 spectroscopic methods - Raman and Fourier Transform Infrared - known for reliability, reproductibility, and an easy sample preparation. GC-MS technique was used to confirm the potential adulterants spectra. Results: About 22% (11 out of 50 samples) of herbal food supplements with sexual enhancement claims analyzed by spectroscopic and spectrometric methods proved to be "enriched" with active pharmaceutical compounds such as: sildenafil and two of its analogues, tadalafil and phenolphthalein. The occurence of phenolphthalein could be the reason for the non-relevant results obtained by FTIR method in some samples. 91% of the adulterated herbal food supplements were originating from China. Conclusion: The results of this screening highlighted the necessity for an accurate analysis of all alleged herbal aphrodisiacs on the Romanian market. This is a first such a screening analysis carried out on herbal food supplements with sexual enhancement claims. PMID:28761827

Spectroscopic and Spectrometric Methods Used for the Screening of Certain Herbal Food Supplements Suspected of Adulteration.

PubMed

Mateescu, Cristina; Popescu, Anca Mihaela; Radu, Gabriel Lucian; Onisei, Tatiana; Raducanu, Adina Elena

2017-06-01

Purpose: This study was carried out in order to find a reliable method for the fast detection of adulterated herbal food supplements with sexual enhancement claims. As some herbal products are advertised as "all natural", their "efficiency" is often increased by addition of active pharmaceutical ingredients such as PDE-5 inhibitors, which can be a real health threat for the consumer. Methodes: Adulterants, potentially present in 50 herbal food supplements with sexual improvement claims, were detected using 2 spectroscopic methods - Raman and Fourier Transform Infrared - known for reliability, reproductibility, and an easy sample preparation. GC-MS technique was used to confirm the potential adulterants spectra. Results: About 22% (11 out of 50 samples) of herbal food supplements with sexual enhancement claims analyzed by spectroscopic and spectrometric methods proved to be "enriched" with active pharmaceutical compounds such as: sildenafil and two of its analogues, tadalafil and phenolphthalein. The occurence of phenolphthalein could be the reason for the non-relevant results obtained by FTIR method in some samples. 91% of the adulterated herbal food supplements were originating from China. Conclusion: The results of this screening highlighted the necessity for an accurate analysis of all alleged herbal aphrodisiacs on the Romanian market. This is a first such a screening analysis carried out on herbal food supplements with sexual enhancement claims.

Herbal Treatment for Anxiety: Is It Effective?

MedlinePlus

... use, but can cause nausea and abdominal pain. Herbal supplements aren't monitored by the FDA the same ... mean safe. If you're considering taking any herbal supplement as a treatment for anxiety, talk to your ...

Evaluating the Role of Genetic Markers in Prostate Cancer Progression: A Multiethnic Cohort Experience

DTIC Science & Technology

2011-10-01

all vitamins, minerals, herbal and non- herbal supplements of any kind. _____ (2) No, GO TO Q. 26 _____ (1) Yes, Fairly regularly ______ (3)Yes, but...NOT regularly 25. Please list the names of any supplements (including vitamins, minerals and herbal supplements ), over-the-counter medications or...do you/did you smoke? _____________________ Fmr/Never smoker Go to Q.24 Currt smkr Go to Q.23 - 22 - MEDICATION/ SUPPLEMENT USE 24. Have

Hepatotoxicity of Herbal Supplements Mediated by Modulation of Cytochrome P450

PubMed Central

Chen, Taosheng

2017-01-01

Herbal supplements are a significant source of drug-drug interactions (DDIs), herb-drug interactions, and hepatotoxicity. Cytochrome P450 (CYP450) enzymes metabolize a large number of FDA-approved pharmaceuticals and herbal supplements. This metabolism of pharmaceuticals and supplements can be augmented by concomitant use of either pharmaceuticals or supplements. The xenobiotic receptors constitutive androstane receptor (CAR) and the pregnane X receptor (PXR) can respond to xenobiotics by increasing the expression of a large number of genes that are involved in the metabolism of xenobiotics, including CYP450s. Conversely, but not exclusively, many xenobiotics can inhibit the activity of CYP450s. Induction of the expression or inhibition of the activity of CYP450s can result in DDIs and toxicity. Currently, the United States (US) Food and Drug Administration does not require the investigation of the interactions of herbal supplements and CYP450s. This review provides a summary of herbal supplements that inhibit CYP450s, induce the expression of CYP450s, and/or whose toxicity is mediated by CYP450s. PMID:29117101

Enlarged Liver

MedlinePlus

... if you're not sure what's too much. Herbal supplements. Certain supplements, including black cohosh, ma huang and ... your doctor about the risks and benefits of herbal supplements before you take them. Some alternative medicine treatments ...

Ephedra Use in a Select Group of Adolescent Athletes

PubMed Central

P. Schaefer, Michael; Smith, Jay; L. Dahm, Diane; C. Sorenson, Matthew

2006-01-01

Ephedra-containing dietary supplements are consumed to improve sports performace, but may carry risks of cardiac and neurological adverse events. Little is known of their use by young athletes. Our aim was to determine the prevalence and patterns of ephedra use among high school athletes. An anonymous survey was performed in Rochester, Minnesota on high school athletes who participated in fall sports during 2003-04. Parental consent was obtained for athletes under age 18 years. Surveys were distributed at preparticipation examinations and in- school survey stations. The response rate to the survey was 68.2%, or 311 respondents out of a possible 456 with consent (or 26% of all 1197 athletes eligible prior to the consent process). Seven of 311 (2.3%) respondents used dietary supplements containing ephedra. Only one of seven users (14.3%) knew that the supplements they used contained ephedra. Ephedra use was more common in boys (five) than girls (two). Ephedra use was only found in 17 and 18-year-olds. The most common sports among ephedra users were football, track and field, and weightlifting. This study suggests that Ephedra use was infrequent among the young athletes in this population. However, ephedra users were generally unaware that the dietary supplements they consumed contained ephedra. Users were more likely to participate in football, track and field, and weightlifting. Ephedra users were likely to obtain supplements from their peers, and were largely uninformed of the content of their supplements. Key Points Ephedra is an herbal stimulant used as an ergogenic aide. Adolescent ephedra users most commonly obtain it from their friends. Adolescent athletes are likely to take ephedra unknowningly. PMID:24353458

Are patients with diabetes receiving the same message from dietitians and nurses?

PubMed

Venters, Jennifer Y; Hunt, Alice E; Pope, Janet F; Molaison, Elaine F

2004-01-01

The purpose of this study was to determine if registered dietitian (RD) and registered nurse (RN) certified diabetes educators (CDEs) provide similar recommendations regarding carbohydrates and dietary supplements to individuals with diabetes. A survey was mailed to CDEs in the southern United States. Participants were asked to indicate their recommendations for use of carbohydrates, fiber, artificial sweeteners, and 12 selected dietary and herbal supplements when counseling individuals with diabetes. The survey sample consisted of 366 CDEs: 207 were RNs and 159 were RDs. No statistically significant differences were found between RNs and RDs in typical carbohydrate recommendations for treatment of diabetes. However, RDs were more likely than RNs to make recommendations for fiber intake or use of the glycemic index. A significant difference also was found in the treatment of hypoglycemia: RNs were more likely than RDs to recommend consuming a carbohydrate source with protein to treat hypoglycemia. Although some differences existed, RD and RN CDEs are making similar overall recommendations in the treatment of individuals with diabetes.

Cytochrome P450 enzyme mediated herbal drug interactions (Part 1)

PubMed Central

Wanwimolruk, Sompon; Prachayasittikul, Virapong

2014-01-01

It is well recognized that herbal supplements or herbal medicines are now commonly used. As many patients taking prescription medications are concomitantly using herbal supplements, there is considerable risk for adverse herbal drug interactions. Such interactions can enhance the risk for an individual patient, especially with regard to drugs with a narrow therapeutic index such as warfarin, cyclosporine A and digoxin. Herbal drug interactions can alter pharmacokinetic or/and pharmacodynamic properties of administered drugs. The most common pharmacokinetic interactions usually involve either the inhibition or induction of the metabolism of drugs catalyzed by the important enzymes, cytochrome P450 (CYP). The aim of the present article is to provide an updated review of clinically relevant metabolic CYP-mediated drug interactions between selected herbal supplements and prescription drugs. The commonly used herbal supplements selected include Echinacea, Ginkgo biloba, garlic, St. John's wort, goldenseal, and milk thistle. To date, several significant herbal drug interactions have their origins in the alteration of CYP enzyme activity by various phytochemicals. Numerous herbal drug interactions have been reported. Although the significance of many interactions is uncertain but several interactions, especially those with St. John’s wort, may have critical clinical consequences. St. John’s wort is a source of hyperforin, an active ingredient that has a strong affinity for the pregnane xenobiotic receptor (PXR). As a PXR ligand, hyperforin promotes expression of CYP3A4 enzymes in the small intestine and liver. This in turn causes induction of CYP3A4 and can reduce the oral bioavailability of many drugs making them less effective. The available evidence indicates that, at commonly recommended doses, other selected herbs including Echinacea, Ginkgo biloba, garlic, goldenseal and milk thistle do not act as potent or moderate inhibitors or inducers of CYP enzymes. A good knowledge of the mechanisms of herbal drug interactions is necessary for assessing and minimizing clinical risks. These processes help prediction of interactions between herbal supplements and prescription drugs. Healthcare professionals should remain vigilant for potential interactions between herbal supplements/medicines and prescription drugs, especially for drugs with a narrow therapeutic index are used. PMID:26417265

Association of herbal/botanic supplement use with quality of life, recurrence, and survival in newly diagnosed stage II colon cancer patients: A 2-y follow-up study.

PubMed

Chen, Qiran; Xun, Pengcheng; Tsinovoi, Cari Lewis; Henschel, Beate; Fly, Alyce D; He, Ka

2018-02-13

Our objective was to investigate the association between herbal/botanic supplement use and perceived quality of life (QoL), cancer recurrence, and all-cause mortality in colon cancer patients. Patients (n = 453) newly diagnosed with stage II adenocarcinoma of the colon between 2009 and 2011 were recruited from the North Carolina Central Cancer Registry. Data including demographic variables, herbal medicine use and frequency, lifestyle, diet, cancer treatment, and QoL were collected by interviews at diagnosis (baseline) and 1 and 2 y after diagnosis. Mortality information was obtained via the National Death Index. The Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and Medical Outcomes Short Form 12 (SF-12) were used to evaluate QoL. At baseline, herbal/botanic supplement users were more likely to have a healthier lifestyle than non-users, including more physical activity (P <0.01), more fruit and vegetable consumption (P = 0.01), less smoking (P <0.01), and less energy intake from fat (P = 0.02). After adjustment for potential confounders, no significant association was found between herbal/botanic supplement use and QoL assessed by FACT-C and SF-12. Similarly, herbal/botanic supplement use was not associated with the risk of recurrence, all-cause mortality or the combined. In this study, patients with stage II colon cancer using herbal/botanic supplements had no significant improvement in their QoL and no difference in odds of colon cancer recurrence and all-cause mortality over 2 y after diagnosis compared with those who did not use herbs/botanicals. Further studies are warranted to confirm the findings and to focus on types of herbal/botanic supplements. Copyright © 2018 Elsevier Inc. All rights reserved.

A review of synthetic phosphodiesterase type 5 inhibitors (PDE-5i) found as adulterants in dietary supplements.

PubMed

Kee, Chee-Leong; Ge, Xiaowei; Gilard, Véronique; Malet-Martino, Myriam; Low, Min-Yong

2018-01-05

To date, there are 80 synthetic PDE-5i found as adulterants in dietary supplements. Analogues of sildenafil remain as the top list with 50 (62%) and are followed by analogues of tadalafil, 21 (26%), analogues of vardenafil, 7 (9%) and others, 2 (3%). The sildenafil group can be sub-categorized into sulphonamide-bonded (24, 48%), acetyl-bonded (11, 22%), carbonyl or thiocarbonyl-bonded (8, 16%) and other types (7, 14%) based on the functional group linked to pyrazolopyrimidine-one moieties. Meanwhile, analogues of tadalafil have become popularly found as adulterants in dietary supplements like beverages and herbal extracts from 2015 to 2016. The uptrend has been observed with the increase in number and complexity with more trans-oriented and dimerized tadalafil analogues being reported. Interestingly, there is no much increase for analogues of vardenafil. About two thirds of analogues have been reported from the Asian countries (67%), followed by Europe (22%) and North America (11%). South Korea and Singapore have reported the most number of analogues with a total number of 40 (50%). One plausible contributing factor to this trend is the convenient purchase of sexual enhancement dietary supplements, especially the on-line purchase. In terms of analytical methodologies, high performance liquid chromatography (HPLC) hyphenated to ultra-violet (UV) and/or mass spectrometry (MS) detection have been preferred in the screening analysis, i.e. 70 out of 77 compounds have been analysed by HPLC-UV. In addition, the electrospray ionization multistage fragmentation experiments (ESI-MS n ) for acquiring low- and high-resolution mass spectra have been successfully applied to detect and quantify PDE-5i in adulterated products simultaneously. Nuclear magnetic resonance (NMR) is another important technique in the structural elucidation of novel analogues. Copyright © 2017 Elsevier B.V. All rights reserved.

The Use of Dietary Supplements to Alleviate Androgen Deprivation Therapy Side Effects during Prostate Cancer Treatment

PubMed Central

Dueregger, Andrea; Heidegger, Isabel; Ofer, Philipp; Perktold, Bernhard; Ramoner, Reinhold; Klocker, Helmut; Eder, Iris E.

2014-01-01

Prostate cancer (PCa), the most commonly diagnosed cancer and second leading cause of male cancer death in Western societies, is typically androgen-dependent, a characteristic that underlies the rationale of androgen deprivation therapy (ADT). Approximately 90% of patients initially respond to ADT strategies, however many experience side effects including hot flashes, cardiotoxicity, metabolic and musculoskeletal alterations. This review summarizes pre-clinical and clinical studies investigating the ability of dietary supplements to alleviate adverse effects arising from ADT. In particular, we focus on herbal compounds, phytoestrogens, selenium (Se), fatty acids (FA), calcium, and Vitamins D and E. Indeed, there is some evidence that calcium and Vitamin D can prevent the development of osteoporosis during ADT. On the other hand, caution should be taken with the antioxidants Se and Vitamin E until the basis underlying their respective association with type 2 diabetes mellitus and PCa tumor development has been clarified. However, many other promising supplements have not yet been subjected large-scale clinical trials making it difficult to assess their efficacy. Given the demographic trend of increased PCa diagnoses and dependence on ADT as a major therapeutic strategy, further studies are required to objectively evaluate these supplements as adjuvant for PCa patients receiving ADT. PMID:25338271

Natural health product use in Canada.

PubMed

Troppmann, Leticia; Johns, Timothy; Gray-Donald, Katherine

2002-01-01

To quantify patterns of Natural Health Product (NHP) use in Canada. The Food Habits of Canadians surveyed 1,543 Canadian adults using a 24-hour recall to record dietary supplements. Prevalence of use by user profile was examined. Forty-six percent of women and 33% of men reported taking at least one Natural Health Product with a mean of 2.3 among users. The highest prevalence of supplement use, 57%, occurred among women aged 50-65. Supplement users were older, less likely to smoke and perceived their health as better than non-users. Among supplement users, men had higher rates of use of garlic and vitamin C while women used iron, calcium, B complex, evening primrose oil and glucosamine sulfate. Supplement use by Canadians, at 38% for nutrients and 15% for herbal products, was similar to the rate of uses in the U.S., although differences in the reporting of types of supplements underline aspects of consumer behaviour as well as methodological issues specific to NHPs. Investigation of the use of NHPs in the healthcare setting is important given the widespread use and the potential health care consequences associated with supplement use.

Effects of Herbal Essential Oil Mixture as a Dietary Supplement on Egg Production in Quail

PubMed Central

Çabuk, Metin; Eratak, Serdar; Alçicek, Ahmet; Bozkurt, Mehmet

2014-01-01

One hundred and eighty 7-week-old laying quail were fed various diets over a 12-week period. The diets included a control diet (without essential oil mixture (EOM) or antibiotics (ANTs)), a basal diet including EOM (24 mg/kg feed), and a basal diet including an ANT (avilamycin, 10 mg/kg feed). Each treatment comprised 4 replications with 4 cages (15 quail per cage), amounting to 60 quail per treatment group. Diets (in mash form) and water were provided for ad libitum consumption. EOM consisted of 6 different essential oils derived from the following herbs: oregano (Origanum sp.), laurel leaf (Laurus nobilis L.), sage leaf (Salvia triloba L.), myrtle leaf (Myrtus communis), fennel seeds (Foeniculum vulgare), and citrus peel (Citrus sp.). In comparison with the control diet, adding supplements such as EOM and ANTs to the basal diet increased egg production in quail (P < 0.001). However, egg production was similar between EOM and ANT treatment groups. Moreover, there were no differences between the treatment groups with regard to egg weight. Feed intake was not affected by EOM or ANT supplementation, whereas feed conversion ratio was significantly improved by EOM and ANT supplementation. Thus, we concluded that EOM has beneficial effects as a dietary supplement on egg production and feed conversion ratio. PMID:24587729

Herbal Supplements: Considerations for the Athletic Trainer.

ERIC Educational Resources Information Center

Winterstein, Andrew P.; Storrs, Cordial M.

2001-01-01

Examines common herbal supplements, exploring potential risks associated with herbal use and providing recommendations to athletic trainers regarding patient care issues. Data from searches of the MEDLINE, SPORT Discus, CINAHL, and Academic Search Elite databases indicate that athletes must understand that natural does not equal safe, and most…

Quality specifications for articles of botanical origin from the United States Pharmacopeia.

PubMed

Ma, Cuiying; Oketch-Rabah, Hellen; Kim, Nam-Cheol; Monagas, Maria; Bzhelyansky, Anton; Sarma, Nandakumara; Giancaspro, Gabriel

2018-06-01

In order to define appropriate quality of botanical dietary supplements, botanical drugs, and herbal medicines, the United States Pharmacopeia (USP) and the Herbal Medicines Compendium (HMC) contain science-based quality standards that include multiple interrelated tests to provide a full quality characterization for each article in terms of its identity, purity, and content. To provide a comprehensive description of the pharmacopeial tests and requirements for articles of botanical origin in the aforementioned compendia. Selective chromatographic procedures, such as high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC), are used as Identification tests in pharmacopeial monographs to detect species substitution or other confounders. HPLC quantitative tests are typically used to determine the content of key constituents, i.e., the total or individual amount of plant secondary metabolites that are considered bioactive constituents or analytical marker compounds. Purity specifications are typically set to limit the content of contaminants such as toxic elements, pesticides, and fungal toxins. Additional requirements highlight the importance of naming, definition, use of reference materials, and packaging/storage conditions. Technical requirements for each section of the monographs were illustrated with specific examples. Tests were performed on authentic samples using pharmacopeial reference standards. The chromatographic analytical procedures were validated to provide characteristic profiles for the identity and/or accurate determination of the content of quality markers. The multiple tests included in each monograph complement each other to provide an appropriate pharmacopeial quality characterization for the botanicals used as herbal medicines and dietary supplements. The monographs provide detailed specifications for identity, content of bioactive constituents or quality markers, and limits of contaminants, adulterants, and potentially toxic substances. Additional requirements such as labeling and packaging further contribute to preserve the quality of these products. Compliance with pharmacopeial specifications should be required to ensure the reliability of botanical articles used for health care purposes. Copyright © 2018. Published by Elsevier GmbH.

Drug-Induced Liver Injury Associated with Noni (Morinda citrifolia) Juice and Phenobarbital.

PubMed

Mrzljak, Anna; Kosuta, Iva; Skrtic, Anita; Kanizaj, Tajana Filipec; Vrhovac, Radovan

2013-01-01

Noni (Morinda citrifolia) juice is a popular herbal dietary supplement globally used for preventive or therapeutic purposes in a variety of ailments, claiming to exhibit hepatoprotective properties as well. Herein we present the case of a 38-year-old woman who developed acute liver injury associated with noni juice consumption on a long-term (9 months) anticonvulsant therapy. Clinical presentation and liver biopsy were consistent with severe, predominantly hepatocellular type of injury. Both agents were stopped and corticosteroids were initiated. Five months later the patient had fully recovered. Although in the literature the hepatotoxicity of noni juice remains speculative, sporadic but emerging cases of noni juice-associated liver injury address the need to clarify and investigate potential harmful effects associated with this supplement.

A Case of Hepatotoxicity Related to Kombucha Tea Consumption.

PubMed

Gedela, Maheedhar; Potu, Kalyan Chakravarthy; Gali, Vasantha L; Alyamany, Kimberlee; Jha, Lokesh K

2016-01-01

The use of herbal and dietary supplements (HDSs) is widespread and growing due to the popular notion that these products are of natural origins and safe. Kombucha (or "mushroom") tea is one HDS that is consumed by people for various perceived health benefits. Kombucha tea is a well-known health beverage made by fermenting sweet black tea with a round, flat, gray fungus for a week or longer. There is concern, however, from the evidence of a few case reports currently available, that it may pose life-threatening and/or adverse effects for users.

Hyaluronic Acid as a Target for Intervention in Prostate Cancer Metastases

DTIC Science & Technology

2011-06-01

Coumarin (HMC) is an inhibitor of hyaluronan synthase. It is commonly available in herbal supplements and, up to now, has been utilized mainly for...commonly available in herbal supplements and, up to now, has been utilized mainly for digestion complaints. We propose that it may be efficacious in the...metastatic prostate cancer cells. 7-Hydroxy-4-Methyl Coumarin (HMC) is an inhibitor of hyaluronan synthase. It is commonly available in herbal supplements

Hyaluronic Acid as a Target for Intervention in Prostate Cancer Metastases

DTIC Science & Technology

2012-06-01

hyaluronan synthase, commonly available in herbal supplements and, up to now, used mainly for digestion complaints. We proposed that it may be efficacious... herbal supplements and, up to now, has been utilized mainly for digestion complaints. We proposed that it may be efficacious in the prevention and...HAS. It is commonly available in herbal supplements and, up to now, has been utilized mainly in Europe for digestive complaints. We hypothesize that

Investigation of targeted pyrrolizidine alkaloids in traditional Chinese medicines and selected herbal teas sourced in Ireland using LC-ESI-MS/MS.

PubMed

Griffin, Caroline T; Gosetto, Francesca; Danaher, Martin; Sabatini, Stefano; Furey, Ambrose

2014-01-01

Publications linking hepatotoxicity to the use of herbal preparations are escalating. Herbal teas, traditional Chinese medicines (TCMs) and dietary supplements have been shown to contain pyrrolizidine alkaloids (PAs). Acute PA toxicosis of the liver can result in sinusoidal-obstruction syndrome, also known as veno-occlusive disease (VOD). This paper describes a sensitive and robust method for the detection of targeted PAs and their N-oxides (PANOs) in herbal products (selected herbal teas and TCMs) sourced within Ireland. The sample preparation includes a simple acidic extraction with clean-up via solid-phase extraction (SPE). Sample extracts were accurately analysed by using LC-ESI-MS/MS applying for the first time a pentafluorophenyl (PFP) core-shell column to the chromatographic separation of PAs and PANOs. The method was validated for selectivity, taking into consideration matrix effects, specificity, linearity, precision and trueness. Limits of detection (LOD) and limits of quantitation (LOQ) were quantified for all PAs and PANOs ranging from 0.4 to 1.9 µg kg⁻¹ and from 1.3 to 6.3 µg kg⁻¹, respectively. In this study 10 PAs and four PANOs were targeted because they are commercially available as reference standards. Therefore, this study can only report the levels of these PAs and PANOs analysed in the herbal teas and TCMs. The results reported represent the minimum levels of PAs and PANOs present in the samples analysed; commercially available herbal teas (n = 18) and TCMs (n = 54). A total of 50% herbal teas and 78% Chinese medicines tested positive for one or more PAs and/or PANOs included within this study, ranging from 10 to 1733 and from 13 to 3668 µg kg⁻¹, respectively.

Application of Traditional Chinese Herbal Medicine By-products as Dietary Feed Supplements and Antibiotic Replacements in Animal Production.

PubMed

Abdallah, Abedin; Zhang, Pei; Zhong, Qingzhen; Sun, Zewei

2018-05-22

Misuse of synthetic antibiotics in livestock leads to the transfer of antibiotic resistant pathogens into humans and deposits toxic residues in meat and milk. There is therefore an urgent need for safe and viable alternative approaches to improve the nutrition and wellbeing of farm animals. An alternative source that has been widely exploited is traditional Chinese herbal medicine (TCHM). These herbal medicines are an important part of the healthcare system in many Asian countries. Such herbs contain several but less toxic bioactive compounds which are generally regarded biodegradable. Recently, advances in knowledge on the importance of TCHM have led to a rapid increase in its production and hence, increasing the amount of by-products generated. Such by-products have become a serious environmental challenge because producers regard them as industrial waste and discard them directly. Incorporating TCHM by-products as feed additives to improve animal health and nutrition has been proposed because they contain high amounts of bioactive compounds which confer several health benefits to animals. TCHM by-products as feed additives apart from being a good alternative for synthetic antibiotics could also minimize the current environmental challenges associated with its disposal. This review summarizes scientific findings on the bioactive compounds in TCHM and TCHM by-products, discusses functional dietary patterns and outlines challenges that may hinder full utilization of TCHM by-products in animal production. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Acute oral intake of a higenamine-based dietary supplement increases circulating free fatty acids and energy expenditure in human subjects.

PubMed

Lee, Sang-Rok; Schriefer, Johnhenry M; Gunnels, Trint A; Harvey, Innocence C; Bloomer, Richard J

2013-10-21

Higenamine, also known as norcoclaurine, is an herbal constituent thought to act as a beta-2 adrenergic receptor agonist-possibly stimulating lipolysis. It was the purpose of this study to determine the impact of a higenamine-based dietary supplement on plasma free fatty acids and energy expenditure following acute oral ingestion. Sixteen healthy subjects (8 men; 26.1 ± 2.5 yrs; 8 women 22.4 ± 3.1 yrs) ingested a dietary supplement containing a combination of higenamine, caffeine (270 mg), and yohimbe bark extract or a placebo, on two separate occasions in a double-blind, randomized, cross-over design, separated by 6-8 days. Blood samples were collected immediately before ingestion, and at 30, 60, 120, and 180 minutes post ingestion, and analyzed for plasma free fatty acids (FFA) and glycerol. Breath samples were collected at the same times for a measure of kilocalorie expenditure and respiratory exchange ratio (RER) using indirect calorimetry. Heart rate and blood pressure were recorded at all times. Data collection occurred in the morning following a 10 hour overnight fast. A condition effect was noted for both FFA (p < 0.0001) and kilocalorie expenditure (p = 0.001), with values higher for supplement compared to placebo at 60, 120, and 180 minutes post ingestion. No statistically significant effects were noted for glycerol or RER (p > 0.05). A condition effect was noted for heart rate (p = 0.03) and systolic blood pressure (p < 0.0001), with values higher for supplement compared to placebo. Ingestion of a higenamine-based dietary supplement stimulates lipolysis and energy expenditure, as evidenced by a significant increase in circulating FFA and kilocalorie expenditure. The same supplement results in a moderate increase in heart rate (~3 bpm) and systolic blood pressure (~12 mmHg), which is consistent with previous studies evaluating moderate doses of caffeine and yohimbine, suggesting that higenamine contributes little to the increase in these hemodynamic variables. These findings are in reference to young, healthy and active men and women.

Acute oral intake of a higenamine-based dietary supplement increases circulating free fatty acids and energy expenditure in human subjects

PubMed Central

2013-01-01

Background Higenamine, also known as norcoclaurine, is an herbal constituent thought to act as a beta-2 adrenergic receptor agonist—possibly stimulating lipolysis. It was the purpose of this study to determine the impact of a higenamine-based dietary supplement on plasma free fatty acids and energy expenditure following acute oral ingestion. Methods Sixteen healthy subjects (8 men; 26.1 ± 2.5 yrs; 8 women 22.4 ± 3.1 yrs) ingested a dietary supplement containing a combination of higenamine, caffeine (270 mg), and yohimbe bark extract or a placebo, on two separate occasions in a double-blind, randomized, cross-over design, separated by 6–8 days. Blood samples were collected immediately before ingestion, and at 30, 60, 120, and 180 minutes post ingestion, and analyzed for plasma free fatty acids (FFA) and glycerol. Breath samples were collected at the same times for a measure of kilocalorie expenditure and respiratory exchange ratio (RER) using indirect calorimetry. Heart rate and blood pressure were recorded at all times. Data collection occurred in the morning following a 10 hour overnight fast. Results A condition effect was noted for both FFA (p < 0.0001) and kilocalorie expenditure (p = 0.001), with values higher for supplement compared to placebo at 60, 120, and 180 minutes post ingestion. No statistically significant effects were noted for glycerol or RER (p > 0.05). A condition effect was noted for heart rate (p = 0.03) and systolic blood pressure (p < 0.0001), with values higher for supplement compared to placebo. Conclusion Ingestion of a higenamine-based dietary supplement stimulates lipolysis and energy expenditure, as evidenced by a significant increase in circulating FFA and kilocalorie expenditure. The same supplement results in a moderate increase in heart rate (~3 bpm) and systolic blood pressure (~12 mmHg), which is consistent with previous studies evaluating moderate doses of caffeine and yohimbine, suggesting that higenamine contributes little to the increase in these hemodynamic variables. These findings are in reference to young, healthy and active men and women. PMID:24139127

Variable inhibitory effect of herbal supplements of different brands on human P450 CYP1A2

PubMed Central

Wanwimolruk, Sompon; Prachayasittikul, Virapong

2012-01-01

Herbal supplements are not governed by the same regulations as prescription drugs, we hypothesize that the content of their active ingredients may vary largely among different manufacturers. This may produce variable therapeutic outcomes. This study aims to examine this hypothesis on commonly used herbal supplements among cancer patients. CYP1A2 has been implicated in the activation of many carcinogens and alteration in its activity may be a mechanism associated with the protective effect of herbal products. Activity of human CYP1A2 was used to determine the effect of four herbal supplements of different brands, namely, black cohosh (BC), ginseng, grape seed extract (GSE) and green tea extract (GTE). The herbal content was extracted with methanol, and extract aliquots were used to determine their effect on CYP1A2. Human liver microsomes, the CYP1A2 probe (7-ethoxyresorufin) and NADPH in buffer were incubated with and without herbal extract. Metabolite (resorufin) formation was monitored by HPLC. Seven BC products caused a mild inhibition of CYP1A2, ranging from 2.4 % by GNC Plus to 21.9 % by Nature's Resource. Among nine ginseng products tested, the inhibitory effect varied from 4.2 % by Imperial to 44.6 % by Solarays. The effect of nine GSE brands also varied, ranging from 1.7 % (Country Life) to 26.5 % (Veg Life). Of twelve GTE products, the inhibitory effect varied from 2.9 % by Henry's to 46.6 % by GNC Plus. It appears that the inhibition of selected herbal supplements on CYP1A2 activity varies considerably among different brands of the products. This may be due to variations in the herbal products' active ingredients content. PMID:27298605

Dietary supplements: physician knowledge and adverse event reporting.

PubMed

Cellini, Matthew; Attipoe, Selasi; Seales, Paul; Gray, Robert; Ward, Andrew; Stephens, Mark; Deuster, Patricia A

2013-01-01

Dietary supplement (DS) use among US military personnel is widespread. Many consume several different DS with multiple ingredients one or more times each week, representing a potential public health concern. The overall purpose of the study was to assess the knowledge and behaviors of health professionals and physicians regarding patterns of DS use and possible adverse events (AE) associated with DS use. We also determined how providers address the issue of DS with patients and evaluated provider knowledge regarding reporting systems. Two prospective, cross-sectional, web-based questionnaires were administered. First, health care providers who accessed the Natural Medicines Comprehensive Database to gather evidenced-based information on DS and herbal products were queried. Second, physicians who had graduated from the Uniformed Services University were sent a web-based questionnaire regarding DS knowledge, AE knowledge and reporting, and communication with patients about DS. The frequencies of responses were evaluated. Although 60% of the military physicians who responded to the questionnaires believed they had observed AE in association with a DS, only 18% actually reported them. Three of four physician respondents (approximately 73%) did not know how or where to report AE associated with DS. The majority of physicians (66%) routinely asked most of their patients about DS use, and 65% did not have a reliable source of information for herbal and DS products. Information gaps in DS information and AE reporting were identified. A centralized AE reporting system could serve to identify potentially harmful DS for further evaluation. Health professionals need to remain vigilant for AE associated with DS use and better informed on how to report these events.

Dihydro-5,6-dehydrokavain (DDK) from Alpinia zerumbet: Its Isolation, Synthesis, and Characterization.

PubMed

Xuan, Tran Dang; Teschke, Rolf

2015-09-09

Dihydro-5,6-dehydrokavain (DDK) is the major and most promising component of the tropical plant Alpinia zerumbet (shell ginger), a species of the ginger family Zingiberaceae. Alpinia zerumbet is known for its human use as a traditional herbal medicine, food, and dietary supplement. With its α-lactone ring, DDK belongs to the large chemical group of kavalactones, which are also found in kava (Piper methysticum), another herbal medicine; DDK is characterized by a double-bond linkage at positions 5,6 and the absence of a double-bond linkage at positions 7,8. This dissociates DDK from other kavalactones with their linkages at positions 7,8 and 5,6 that are both either completely saturated or unsaturated, or may have an unsaturated bond at the position 7,8 as well as a saturated bond at the position 5,6. DDK is easily identified and quantified by HPLC and GC. DDK contents in fresh leaves, stems and rhizomes range from 80 to 410 mg/g, requiring solvent extraction procedures to ensure high DDK yield. This is best achieved by hexane extraction from fresh rhizomes that were previously boiled in water, allowing DDK yields of up to 424 mg/g. Successful synthesis of DDK can be achieved by asymmetric pathways, whereas its simple chemical structure facilitates the synthesis of DDK derivatives by HCl hydrolysis. Thus, all synthesized products may be used for various commercial purposes, including the potential development of promising antiobesity pharmaceutical drugs, preparation of specific and safe dietary supplements, and use as effective natural herbicides or fungicides.

Antiarrhythmics

MedlinePlus

... even over-the-counter medicines and vitamin or herbal supplements), so he or she can make you aware ... or interactions with other medicines and vitamin or herbal supplements. This information should not be used as medical ...

Nitrates

MedlinePlus

... your doctor about every medicine and vitamin or herbal supplement that you are taking, so he or she ... cough, cold, and flu medicines Over-the-counter herbal supplements for treating cough, cold, and flu While taking ...

Anticoagulants

MedlinePlus

... your doctor about every medicine and vitamin or herbal supplement that you are taking, so he or she ... or interactions with other medicines and vitamin or herbal supplements. This information should not be used as medical ...

[Quality control in herbal supplements].

PubMed

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

Penis Pump

MedlinePlus

... health conditions and any medications you take, including herbal supplements. This will help prevent potential problems. Side effects ... testicles or prostate What medications you take , including herbal supplements What erectile dysfunction treatments you've tried and ...

Biopsies

MedlinePlus

... taking, including blood thinners such as aspirin and herbal supplements, and whether you have any allergies – especially to ... doctor all medications that you are taking, including herbal supplements, and if you have any allergies, especially to ...

Atypical Antidepressants

MedlinePlus

... dangerous reactions when combined with certain medications or herbal supplements. Serotonin syndrome. Rarely, an antidepressant can cause high ... antidepressants, certain pain or headache medications, and the herbal supplement St. John's wort. Symptoms of serotonin syndrome include ...

Association Between Fish Oil Consumption and the Incidence of Mental Health Issues Among Active Duty Military Personnel

DTIC Science & Technology

2016-03-01

minerals, individual vitamins or minerals, antioxidants, legal body-building supplements, herbal supplements, weight loss products in the past twelve...minerals, individual vitamins or minerals, antioxidants, legal body-building supplements, herbal supplements, or weight loss products” (DOD 2011...These solutions they may be seeking could be medicinal or more alternative in health such as fish oil supplements. Finally, with regard to Navy

Blepharoplasty (Eyelid Surgery)

MedlinePlus

... also ask about your use of medications, vitamins, herbal supplements, alcohol, tobacco and drugs. Your expectations. An honest ... others), naproxen (Naprosyn), and any other medication or herbal supplement associated with increased bleeding. Ask your doctor how ...

Arm Lift (Brachioplasty)

MedlinePlus

... taken recently, including over-the-counter drugs and herbal supplements, as well as any surgeries you've had. ... to avoid taking aspirin, anti-inflammatory drugs and herbal supplements, which can increase bleeding. Arrange for help during ...

Face-Lift

MedlinePlus

... any medications, including over-the-counter drugs and herbal supplements, you're taking or have taken recently — especially ... to avoid taking aspirin, anti-inflammatory drugs and herbal supplements, which can increase bleeding. Also, if you're ...

Selective Serotonin Reuptake Inhibitors (SSRIs)

MedlinePlus

... dangerous reactions when combined with certain medications or herbal supplements. Serotonin syndrome. Rarely, an antidepressant can cause high ... antidepressants, certain pain or headache medications, and the herbal supplement St. John's wort. Signs and symptoms of serotonin ...

Tricyclic Antidepressants and Tetracyclic Antidepressants

MedlinePlus

... dangerous reactions when combined with certain medications or herbal supplements. Serotonin syndrome. Rarely, an antidepressant can cause high ... antidepressants, certain pain or headache medications, and the herbal supplement St. John's wort. Signs and symptoms of serotonin ...

Needle Biopsy of the Lung

MedlinePlus

... anesthesia. Discuss any medications you're taking, including herbal supplements and aspirin. You may be instructed not to ... doctor all medications that you are taking, including herbal supplements, and if you have any allergies, especially to ...

Prescription Nonsteroidal Anti-Inflammatory Medicines

MedlinePlus

... could be a drug-drug interaction. Vitamins and herbal supplements can affect the way your body processes medicines, ... This includes OTC and prescription medicines, vitamins, and herbal supplements. Also, talk to your doctor before you take ...

Detection and identification of multiple adulterants in plant food supplements using attenuated total reflectance-Infrared spectroscopy.

PubMed

Deconinck, E; Aouadi, C; Bothy, J L; Courselle, P

2018-04-15

Due to the rising popularity of dietary supplements, especially plant food supplements, and alternative herbal medicines, a whole market developed and these products became freely available through internet. Though several searches revealed that at least a part of these products, especially the ones obtained from websites disclosing their physical identity, are aldulterated with pharmaceutical compounds. This causes a threat for public health, since these compounds are not declared and therefore adverse effects will not immediately be related to the product. The more the adulterants can interfere with other medicinal treatments. Since the present active pharmaceutical ingredients are not declared on the package and the products are sold as 100% natural or herbal in nature, it is very difficult for custom personnel to discriminate between products to be confiscated or not. Therefore easy to apply analytical approaches to discriminate between adulterated and non-adulterated products are necessary. This paper presents an approach based on infrared spectroscopy combined with attenuated total reflectance (ATR) and partial least squares- discriminant analysis (PLS-DA) to easily differentiate between adulterated and non- adulterated plant food supplements and to get a first idea of the nature of the adulterant present. The performance of PLS-DA models based on Mid-IR and NIR data were compared as well as models based on the combined data. Further three preprocessing strategies were compared. The best performance was obtained for a PLS-DA model using Mid-IR data with the second derivative as preprocessing method. This model showed a correct classification rate of 98.3% for an external test set. Also eight real samples were screened using the model and for seven of these samples a correct classification was obtained. Generally it could be concluded that the obtained model and the presented approach could be used at customs to discriminate between adulterated and non-adulterated herbal food supplements and even get a first idea of the nature of the adulterant present. The more the presented approach hardly needs sample preparation. Copyright © 2018 Elsevier B.V. All rights reserved.

Herbal Hepatotoxicity: Clinical Characteristics and Listing Compilation

PubMed Central

Frenzel, Christian; Teschke, Rolf

2016-01-01

Herb induced liver injury (HILI) and drug induced liver injury (DILI) share the common characteristic of chemical compounds as their causative agents, which were either produced by the plant or synthetic processes. Both, natural and synthetic chemicals are foreign products to the body and need metabolic degradation to be eliminated. During this process, hepatotoxic metabolites may be generated causing liver injury in susceptible patients. There is uncertainty, whether risk factors such as high lipophilicity or high daily and cumulative doses play a pathogenetic role for HILI, as these are under discussion for DILI. It is also often unclear, whether a HILI case has an idiosyncratic or an intrinsic background. Treatment with herbs of Western medicine or traditional Chinese medicine (TCM) rarely causes elevated liver tests (LT). However, HILI can develop to acute liver failure requiring liver transplantation in single cases. HILI is a diagnosis of exclusion, because clinical features of HILI are not specific as they are also found in many other liver diseases unrelated to herbal use. In strikingly increased liver tests signifying severe liver injury, herbal use has to be stopped. To establish HILI as the cause of liver damage, RUCAM (Roussel Uclaf Causality Assessment Method) is a useful tool. Diagnostic problems may emerge when alternative causes were not carefully excluded and the correct therapy is withheld. Future strategies should focus on RUCAM based causality assessment in suspected HILI cases and more regulatory efforts to provide all herbal medicines and herbal dietary supplements used as medicine with strict regulatory surveillance, considering them as herbal drugs and ascertaining an appropriate risk benefit balance. PMID:27128912

The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

2016-01-01

Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47-88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) were evaluated before and after 12-week supplementation of BrainPower Advanced capsules (n = 47) or placebo (n = 51), using a 5-point memory questionnaire (1 = no/slight, 5 = severe). Objective memory function was evaluated using 3 subtests of visual/audio memory, abstraction, and memory recall that gave a combined total score. The BrainPower Advanced group had more cases of severe SML (severity ⩾ 3) (44/47) and severe SAD (43/47) than the placebo group (39/51 and 37/51, < 0.05, < 0.05, resp.) before the treatment. BrainPower Advanced intervention, however, improved a greater proportion of the severe SML (29.5%)(13/44) (P < 0.01) and SAD (34.9%)(15/43)(P < 0.01) than placebo (5.1% (2/39) and 13.5% (5/37), resp.). Thus, 3-month BrainPower Advanced supplementation appears to be beneficial to older adults with SMCs.

Comparative mass spectrometry & nuclear magnetic resonance metabolomic approaches for nutraceuticals quality control analysis: a brief review.

PubMed

Farag, Mohamed A

2014-01-01

The number of botanical dietary supplements in the market has recently increased primarily due to increased health awareness. Standardization and quality control of the constituents of these plant extracts is an important topic, particularly when such ingredients are used long term as dietary supplements, or in cases where higher doses are marketed as drugs. The development of fast, comprehensive, and effective untargeted analytical methods for plant extracts is of high interest. Nuclear magnetic resonance spectroscopy and mass spectrometry are the most informative tools, each of which enables high-throughput and global analysis of hundreds of metabolites in a single step. Although only one of the two techniques is utilized in the majority of plant metabolomics applications, there is a growing interest in combining the data from both platforms to effectively unravel the complexity of plant samples. The application of combined MS and NMR in the quality control of nutraceuticals forms the major part of this review. Finally I will look at the future developments and perspectives of these two technologies for the quality control of herbal materials.

Nurse Practitioners’ Experience With Herbal Therapy

DTIC Science & Technology

2000-05-01

supplements has also grown. Patient use, benefits, and potential adverse effects of herbal therapy have been well documented in the literature, but...established and a core variable emerged. Results identified nine theme categories related to knowledge, safety, validity and effectiveness , responsibility...decade. Advertisement and access to these supplements has also grown. Patient use, benefits, and potential adverse effects of herbal therapy have been

Home Parenteral Nutrition (HPN) Complication Chart

MedlinePlus

... you start any over-the-counter medications or herbal supplements. Hypoglycemia Symptoms: Cause: Immediate Action: Prevention: Sweating; pale ... if taking any over-the-counter medications or herbal supplements. Special thanks to the editors of this chart: ...

Sclerotherapy of Varicose Veins and Spider Veins

MedlinePlus

... conditions, allergies and medications you’re taking, including herbal supplements and aspirin. You may be advised to stop ... doctor all medications that you are taking, including herbal supplements, and if you have any allergies, especially to ...

Use of Herbal Supplements in Chronic Kidney Disease

MedlinePlus

... build up in your body. The herbal supplement market is a multi-million dollar business. You may ... Ginseng Bai Zhi (root) Bitter Melon (fruit, leaf) Black Mustard (leaf) Blessed Thistle Chervit (leaf) Chicory (leaf) ...

Alternative approaches to epilepsy treatment.

PubMed

McElroy-Cox, Caitlin

2009-07-01

Complementary and alternative medicine (CAM) is a diverse group of health care practices and products that fall outside the realm of traditional Western medical theory and practice and that are used to complement or replace conventional medical therapies. The use of CAM has increased over the past two decades, and surveys have shown that up to 44% of patients with epilepsy are using some form of CAM treatment. This article reviews the CAM modalities of meditation, yoga, relaxation techniques, biofeedback, nutritional and herbal supplements, dietary measures, chiropractic care, acupuncture, Reiki, and homeopathy and what is known about their potential efficacy in patients with epilepsy.

The merit of medicinal mushrooms from a pharmaceutical point of view.

PubMed

Lindequist, Ulrike

2013-01-01

Whereas pharmaceuticals prepared by extraction of medicinal plants constitute an important part of evidence-based medicine also in the Western Hemisphere, medicinal mushrooms are mainly used as dietary supplements without declaration of a medical indication. Scientific investigations and case studies from Asian medicine show that fungi have very promising pharmacological potential. This article provides an overview of the principles of authorization and market access of herbal drugs in Europe, with special reference to Germany. The current status regarding mushrooms is reported, with an aim toward supporting the development of legalized pharmaceutical preparations of medicinal mushrooms in Europe.

OTC Medicines: Know Your Risks, and Reduce Them

MedlinePlus

... something for just a short time. Include any herbal supplements, vitamins, and minerals you take. Once a year, ... you take. This includes OTC medicines, vitamins, and herbal supplements. Your doctor can tell you whether you are ...

Varicose Vein Treatment (Endovenous Ablation of Varicose Veins)

MedlinePlus

... conditions, allergies and medications you’re taking, including herbal supplements and aspirin. You may be advised to stop ... doctor all medications that you are taking, including herbal supplements, and if you have any allergies, especially to ...

Recent progress of research on medicinal mushrooms, foods, and other herbal products used in traditional Chinese medicine

PubMed Central

Lee, Kuo-Hsiung; Morris-Natschke, Susan L.; Yang, Xiaoming; Huang, Rong; Zhou, Ting; Wu, Shou-Fang; Shi, Qian; Itokawa, Hideji

2012-01-01

This article will review selected herbal products used in traditional Chinese medicine, including medicinal mushrooms (巴西蘑菇 bā xī mó gū; Agaricus blazei, 雲芝 yún zhī; Coriolus versicolor, 靈芝 líng zhī; Ganoderma lucidum, 香蕈 xiāng xùn; shiitake, Lentinus edodes, 牛樟芝 niú zhāng zhī; Taiwanofungus camphoratus), Cordyceps (冬蟲夏草 dōng chóng xià cǎo), pomegranate (石榴 shí liú; Granati Fructus), green tea (綠茶 lǜ chá; Theae Folium Non Fermentatum), garlic (大蒜 dà suàn; Allii Sativi Bulbus), turmeric (薑黃 jiāng huáng; Curcumae Longae Rhizoma), and Artemisiae Annuae Herba (青蒿 qīng hāo; sweet wormwood). Many of the discussed herbal products have gained popularity in their uses as dietary supplements for health benefits. The review will focus on the active constituents of the herbs and their bioactivities, with emphasis on the most recent progress in research for the period of 2003 to 2011. PMID:24716120

Herbal supplements: Research findings and safety.

PubMed

Pruitt, Rosanne; Lemanski, Ashley; Carroll, Adam

2018-05-17

Herbal supplements are used extensively worldwide without much awareness regarding their safety and efficacy. Extensive research to determine the safety, utility, and level of research support for commonly used herbs has culminated in an easily accessible summary chart for NP providers.

Complementary therapies in allergic rhinitis.

PubMed

Sayin, Ibrahim; Cingi, Cemal; Oghan, Fatih; Baykal, Bahadir; Ulusoy, Seckin

2013-01-01

Objective. To determine the prevalence of herbal treatment of allergic rhinitis. Methods. In this prospective study, patients who were diagnosed with perennial allergic rhinitis were questioned about their use of natural products/herbal therapies for their symptoms. Results. In total, 230 patients were enrolled. Overall, 37.3% of the patients stated that they had used natural products/herbal therapies at least once. Women were more likely than men to use herbal supplements (38.3% versus 32.4%). Ten different types of herbal supplements were identified, with stinging nettle (Urtica dioicath), black elderberry (Sambucus nigra), and Spirulina being the most common (12.6%, 6.1%, and 5.7%, resp.). Conclusion. This study found a high prevalence of herbal treatment usage for the relief of allergic rhinitis symptoms in Turkey. The herbal products identified in this study and in the literature are discussed.

Complementary Therapies in Allergic Rhinitis

PubMed Central

Sayin, Ibrahim; Cingi, Cemal; Baykal, Bahadir

2013-01-01

Objective. To determine the prevalence of herbal treatment of allergic rhinitis. Methods. In this prospective study, patients who were diagnosed with perennial allergic rhinitis were questioned about their use of natural products/herbal therapies for their symptoms. Results. In total, 230 patients were enrolled. Overall, 37.3% of the patients stated that they had used natural products/herbal therapies at least once. Women were more likely than men to use herbal supplements (38.3% versus 32.4%). Ten different types of herbal supplements were identified, with stinging nettle (Urtica dioicath), black elderberry (Sambucus nigra), and Spirulina being the most common (12.6%, 6.1%, and 5.7%, resp.). Conclusion. This study found a high prevalence of herbal treatment usage for the relief of allergic rhinitis symptoms in Turkey. The herbal products identified in this study and in the literature are discussed. PMID:24324897

A Case of Hepatotoxicity Induced by Adulterated "Tiger King", a Chinese Herbal Medicine Containing Sildenafil.

PubMed

Nissan, Ran; Poperno, Alina; Stein, Gideon Y; Shapira, Barak; Fuchs, Shmuel; Berkovitz, Ronny; Hess, Zipora; Arieli, Mickey

2016-01-01

Detection of Phosphodiesterase Type 5 (PDE-5) inhibitors and their analogues in "100% natural" or "herbal" supplements have been described in numerous reports. However, few reports have been published in relation to actual harm caused by counterfeit erectile dysfunction herbal supplements. We describe a case of a 65-year old male admitted to a tertiary hospital with acute liver toxicity, possibly induced by adulterated "Chinese herbal" supplement "Tiger King" for sexual enhancement. Chemical analysis of the tablets discovered the presence of therapeutic doses of sildenafil with no other herbal components. Other medications were excluded as potential causes of the hepatic impairment. According to the Naranjo adverse drug reaction scale and the Roussel Uclaf Causality Assessment Method (RUCAM) the probability of association of Hepatotoxicity with Sildenafil was "possible" and "probable" respectively (Naranjo score of 4, RUCAM score of 7). Within three days of admission, the patient's clinical status and liver function improved without any specific treatment. His liver function tests normalized 30 days post discharge. Further pharmacovigilance actions should be taken by regulatory authorities and pharmaceutical companies in order to determine the relation between sildenafil and hepatotoxicity. This case emphasizes the importance of raising public awareness on the potential dangers of "Tiger king" in particular, and other counterfeit medications or herbal supplements of unknown origin.

Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network.

PubMed

Navarro, Victor J; Barnhart, Huiman; Bonkovsky, Herbert L; Davern, Timothy; Fontana, Robert J; Grant, Lafaine; Reddy, K Rajender; Seeff, Leonard B; Serrano, Jose; Sherker, Averell H; Stolz, Andrew; Talwalkar, Jayant; Vega, Maricruz; Vuppalanchi, Raj

2014-10-01

The Drug-Induced Liver Injury Network (DILIN) studies hepatotoxicity caused by conventional medications as well as herbals and dietary supplements (HDS). To characterize hepatotoxicity and its outcomes from HDS versus medications, patients with hepatotoxicity attributed to medications or HDS were enrolled prospectively between 2004 and 2013. The study took place among eight U.S. referral centers that are part of the DILIN. Consecutive patients with liver injury referred to a DILIN center were eligible. The final sample comprised 130 (15.5%) of all subjects enrolled (839) who were judged to have experienced liver injury caused by HDS. Hepatotoxicity caused by HDS was evaluated by expert opinion. Demographic and clinical characteristics and outcome assessments, including death and liver transplantation (LT), were ascertained. Cases were stratified and compared according to the type of agent implicated in liver injury; 45 had injury caused by bodybuilding HDS, 85 by nonbodybuilding HDS, and 709 by medications. Liver injury caused by HDS increased from 7% to 20% (P < 0.001) during the study period. Bodybuilding HDS caused prolonged jaundice (median, 91 days) in young men, but did not result in any fatalities or LT. The remaining HDS cases presented as hepatocellular injury, predominantly in middle-aged women, and, more frequently, led to death or transplantation, compared to injury from medications (13% vs. 3%; P < 0.05). The proportion of liver injury cases attributed to HDS in DILIN has increased significantly. Liver injury from nonbodybuilding HDS is more severe than from bodybuilding HDS or medications, as evidenced by differences in unfavorable outcomes (death and transplantation). (Hepatology 2014;60:1399-1408). © 2014 by the American Association for the Study of Liver Diseases.

Liver injury from Herbals and Dietary Supplements in the US Drug Induced Liver Injury Network

PubMed Central

Navarro, Victor J.; Barnhart, Huiman; Bonkovsky, Herbert L.; Davern, Timothy; Fontana, Robert J.; Grant, Lafaine; Reddy, K. Rajender; Seeff, Leonard B.; Serrano, Jose; Sherker, Averell H.; Stolz, Andrew; Talwalkar, Jayant; Vega, Maricruz; Vuppalanchi, Raj

2014-01-01

Background The Drug-Induced Liver Injury Network (DILIN) studies hepatotoxicity due to conventional medications as well as herbals and dietary supplements (HDS). Rationale To characterize hepatotoxicity and its outcomes from HDS versus medications, patients with hepatotoxicity attributed to medications or HDS were enrolled prospectively between 2004 and 2013. The study took place among eight US referral centers that are part of the DILIN. Consecutive patients with liver injury referred to a DILIN center were eligible. The final sample comprised 130 (15.5%) of all subjects enrolled (839) who were judged to have experienced liver injury due to HDS. Hepatotoxicity due to HDS was evaluated by expert opinion. Demographic and clinical characteristics and outcome assessments including death and liver transplantation were ascertained. Cases were stratified and compared according to the type of agent implicated in liver injury; 45 had injury due to bodybuilding HDS, 85 due to non-bodybuilding HDS, and 709 due to medications. Main Results Liver injury due to HDS increased from 7% to 20% (p < 0.001) during the study period. Bodybuilding HDS caused prolonged jaundice (median 91 days) in young men but did not result in any fatalities or liver transplantation. The remaining HDS cases presented as hepatocellular injury, predominantly in middle-aged women and more frequently led to death or transplantation compared to injury from medications (13% vs. 3%, p < 0.05). Conclusions The proportion of liver injury cases attributed to HDS in DILIN has increased significantly. Liver injury from non-bodybuilding HDS is more severe than from bodybuilding HDS or medications, as evidenced by differences in unfavorable outcomes; death and transplantation. PMID:25043597

Standardization of Nomenclature and Causality Assessment in Drug-Induced Liver Injury: Summary of a Clinical Research Workshop

PubMed Central

Fontana, Robert J.; Seeff, Leonard B.; Andrade, Raúl J.; Björnsson, Einar; Day, Christopher P.; Serrano, Jose; Hoofnagle, Jay H.

2013-01-01

Idiosyncratic drug-induced liver injury (DILI) is an important but relatively infrequent cause of potentially severe acute and chronic liver injury. The aim of this clinical research workshop was to review and attempt to standardize the current nomenclature and terminology used in DILI research. Because DILI is a diagnosis of exclusion, selected elements of the medical history, laboratory tests, and previous reports were proposed to improve causality assessment. Definitions and diagnostic criteria regarding the onset of DILI, evolution of liver injury, risk factors, and mandatory testing versus optional testing for competing causes were reviewed. In addition, the role of intentional and inadvertent rechallenge, liver histology, and host genetic polymorphisms in establishing the diagnosis and prognosis of DILI were reviewed. Consensus was established regarding the need to develop a web-of-knowledge database that provides concise, reliable, and updated information on cases of liver injury due to drugs and herbal and dietary supplements. In addition, the need to develop drug-specific computerized causality assessment methods that are derived from prospectively phenotyped cases was a high priority. Proposed scales for grading DILI severity and assessing the likelihood of an agent causing DILI and written criteria for improving the reliability, accuracy, and reproducibility of expert opinion were reviewed. Finally, the unique challenges of assessing causality in children, patients with underlying liver disease, and subjects taking herbal and dietary supplements were discussed. Conclusion: Workshop participants concluded that multicenter referral networks enrolling patients with suspected DILI according to standardized methodologies are needed. These networks should also collect biological samples that may provide crucial insights into the mechanism(s) of DILI with the ultimate aim of preventing future cases of DILI. PMID:20564754

Use of complementary and alternative medicine in children with cancer: effect on survival.

PubMed

Karalı, Yasin; Demirkaya, Metin; Sevinir, Betül

2012-05-01

The objective of the present study was to determine the type, frequency, the reason why complementary and alternative medicine (CAM) treatments are used, the factors related with their use, and the effects of CAM usage on long-term survival. Families of a total of 120 children with cancer between 0-18 years of age, including 50 (41.7%) girls and 70 (58.3%) boys, participated in our study. The authors found that 88 patients (73.3%) used at least one CAM method, the most common (95.5%) of which was biologically based therapies. Most frequently used biologically based therapies were dietary supplements and herbal products. The most commonly used dietary supplement or herbal product was honey (43.2%) or stinging nettle (43.2%), respectively. We found that patients used such CAM methods as complementary to, but not instead of, conventional therapy. Sixty-nine out of 88 patient families (78.4%) shared the CAM method they used with their physicians. No statistically significant relation was found between socioeconomic, sociodemographic, or other factors or items and CAM use. The mean follow-up period of the CAM users and nonusers groups was 79.4 ± 36.7 (21.3-217.9) and 90.9 ± 50.3 (27.4-193.7) months, respectively. Five-year survival rates for CAM users and nonusers were found as 81.5% and 86.5%, respectively (P > .05). In conclusion, families of children with cancer use complementary and alternative treatment frequently. They do not attempt to replace conventional treatment with CAM. Higher rates of CAM use was found in families with higher educational level. CAM usage did not affect the long-term survival.

Hydroxybenzoic Acids Are Significant Contributors to the Antioxidant Effect of Borututu Bark, Cochlospermum angolensis Welw. ex Oliv.

PubMed Central

Abourashed, Ehab A.; Fu, Hao Wen

2017-01-01

Borututu (Cochlospermum angolensis) is an African tree whose bark has recently emerged as a herbal dietary supplement with claims for antioxidant activity. In order to substantiate the claimed activity of borututu supplements, we performed an activity-guided fractionation of the total extract utilizing a 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical scavenging assay. Subsequent flash and centrifugal chromatography resulted in the isolation of gallic acid (1) and protocatechuic acid (2) as the main antioxidant constituents. Two apocarotenoids and one flavonoid were also isolated from the chloroform fraction and were identified as cochloxanthin (3), dihydrocochloxanthin (4), and 7,4′-dimethyltaxifolin (5), respectively. A High-performance liquid chromatography (HPLC) method was also developed for fingerprinting borututu samples, with Compounds 1–4 suggested as chemical markers for quality control purposes. PMID:28134834

Principal component analysis of synthetic adulterants in herbal supplements advertised as weight loss drugs.

PubMed

Dastjerdi, Akram Ghasemi; Akhgari, Maryam; Kamali, Artin; Mousavi, Zahra

2018-05-01

Obesity is one of the major problems in many countries. Herbal drugs are widely used to treat obesity. Unfortunately the majority of herbal weight loss drugs are adulterated with active pharmaceutical ingredients. The purpose of the present study was to analyse herbal weight loss drugs for the general search for pharmaceuticals. sixty one herbal weight loss drugs that were collected from herb shops and internet in Kermanshah, Iran were analysed qualitatively using gas chromatography/mass spectrometry. Of the 61 weight loss products sampled, 72% were found to be adulterated with tramadol, caffeine, fluoxetine, rizatriptan, venlafaxine and methadone. Herbal weight loss products were adulterated with controlled and legitimate drugs. Patients should be aware of the danger of using adulterated supplements. Copyright © 2018 Elsevier Ltd. All rights reserved.

Toxicity and Carcinogenicity Studies of Ginkgo biloba extract in Rat and Mouse: Liver, Thyroid, and Nose are Targets

PubMed Central

Rider, Cynthia V.; Nyska, Abraham; Cora, Michelle C.; Kissling, Grace E.; Smith, Cynthia; Travlos, Gregory S.; Hejtmancik, Milton R.; Fomby, Laurene M.; Colleton, Curtis A.; Ryan, Michael J.; Kooistra, Linda; Morrison, James P.; Chan, Po C.

2014-01-01

Ginkgo biloba extract (GBE) is a popular herbal supplement that is used to improve circulation and brain function. In spite of widespread human exposure to relatively high doses over potentially long periods of time, there is a paucity of data from animal studies regarding the toxicity and carcinogenicity associated with GBE. In order to fill this knowledge gap, three-month and two-year toxicity and carcinogenicity studies with GBE administered by oral gavage to B6C3F1/N mice and F344/N rats were performed as part of the National Toxicology Program’s Dietary Supplements and Herbal Medicines Initiative. The targets of GBE treatment were the liver, thyroid, and nose. These targets were consistent across exposure period, sex, and species, albeit with varying degrees of effect observed among studies. Key findings included a notably high incidence of hepatoblastomas in male and female mice and evidence of carcinogenic potential in the thyroid gland of both mice and rats. Various nonneoplastic lesions were observed beyond control levels in the liver, thyroid gland, and nose of rats and mice administered GBE. Although these results cannot be directly extrapolated to humans, the findings fill an important data gap in assessing risk associated with GBE use. PMID:23960164

Botanical and Dietary Supplements for Menopausal Symptoms: What Works, What Doesn’t

PubMed Central

Geller, Stacie E.; Studee, Laura

2006-01-01

All women reach menopause and approximately two-thirds of women develop menopausal symptoms, primarily hot flashes. Hormone therapy long was considered the first line of treatment for vasomotor symptoms. However, given the results of the Women’s Health Initiative, many women are reluctant use exogenous hormones for symptomatic treatment and are turning to botanicals and dietary supplement (BDS) products for relief. Despite the fact that there is limited scientific evidence describing efficacy and long term safety of such products, many women find these “natural treatments” appealing. Peri- and postmenopausal women are amongst the highest users of these products, but 70% of women do not tell their health care providers about their use. Compounding this issue is the fact that few clinicians ask their patients about use of BDS, largely because they have not been exposed to alternative medical practices in their training and are unfamiliar with these products. This paper reviews the botanicals and dietary supplements commonly used in menopause, (such as black cohosh, red clover, soy products, among others) as well as the available data on efficacy and safety. We searched the MEDLINE database from 1966 to December 2004 using terms related to botanical and dietary supplements and menopausal symptoms for peri- or postmenopausal women. Abstracts from relevant meetings as well as reference books and websites on herbal supplements were also searched. Randomized-controlled trials (RCTs) were used if available; open trials and comparison group studies were used when RCTs were not available. The evidence to date suggests that black cohosh is safe and effective for reducing menopausal symptoms, primarily hot flashes and possibly mood disorders. Phytoestrogen extracts, including soy foods and red clover appear to have at best only minimal effect on menopausal symptoms but have positive health effects on plasma lipid concentrations and may reduce heart disease. St. John’s wort has been shown to improve mild to moderate depression in the general population and appears to show efficacy for mood disorders related to the menopausal transition. Other commonly used botanicals have limited evidence to demonstrate safety and efficacy for relief of symptoms related to menopause. PMID:16181020

DNA-Based Authentication of Botanicals and Plant-Derived Dietary Supplements: Where Have We Been and Where Are We Going?

PubMed

Coutinho Moraes, Denise F; Still, David W; Lum, Michelle R; Hirsch, Ann M

2015-06-01

Herbal medicines and botanicals have long been used as sole or additional medical aids worldwide. Currently, billions of dollars are spent on botanicals and related products, but minimal regulation exists regarding their purity, integrity, and efficacy. Cases of adulteration and contamination have led to severe illness and even death in some cases. Identifying the plant material in botanicals and phytomedicines using organoleptic means or through microscopic observation of plant parts is not trivial, and plants are often misidentified. Recently, DNA-based methods have been applied to these products because DNA is not changed by growth conditions unlike the chemical constituents of many active pharmaceutical agents. In recent years, DNA barcoding methods, which are used to identify species diversity in the Tree of Life, have been also applied to botanicals and plant-derived dietary supplements. In this review, we recount the history of DNA-based methods for identification of botanicals and discuss some of the difficulties in defining a specific bar code or codes to use. In addition, we describe how next generation sequencing technologies have enabled new techniques that can be applied to identifying these products with greater authority and resolution. Lastly, we present case histories where dietary supplements, decoctions, and other products have been shown to contain materials other than the main ingredient stipulated on the label. We conclude that there is a fundamental need for greater quality control in this industry, which if not self-imposed, that may result from legislation. Georg Thieme Verlag KG Stuttgart · New York.

Bearberry identification by a multidisciplinary study on commercial raw materials.

PubMed

Gallo, Francesca Romana; Multari, Giuseppina; Pagliuca, Giordana; Panusa, Alessia; Palazzino, Giovanna; Giambenedetti, Massimo; Petitto, Valentina; Nicoletti, Marcello

2013-04-01

Herbal species different from the official bearberry, Arctostaphylos uva-ursi, are sold through conventional markets and also through non-controlled Internet websites, putting consumer safety at risk owing to the lack of quality control. Recently, Arctostaphylos pungens has become one of the most used species as a raw material for herbal medicines and dietary supplements in the place of official bearberry, a plant used for the treatment of various urinary disorders. A fingerprint identification based on an integrated application of different analytical techniques (HPTLC, NMR, HPLC-DAD and LC-ESI-MS) is here described to distinguish A. uva-ursi from A. pungens. The HPTLC and HPLC-DAD fingerprints resulted the simplest methods to differentiate the two species, whereas LC-ESI-MS was more useful to quantify arbutin, the main component of bearberry, and to evaluate its different content in the two species. This multidisciplinary study showed for the first time a specific phytochemical fingerprint of the new species A. pungens.

Genotoxic alkenylbenzene flavourings, a contribution to risk assessment.

PubMed

Martins, Célia; Rueff, José; Rodrigues, António S

2018-06-15

Alkenylbenzenes, such as estragole, myristicin and eugenol, are present is several flavourings, functional foods, plant food supplements (PFS) and in complementary and alternative medicines (CAM) including herbal medicines. The increase in consumption in functional foods observed worldwide requires a strict analysis of the scientific validity of their benefits and risk-benefit ratio associated with their intake. Some instances of acute toxicity have been reported associated with the use of herbal medicines and PFS, in particular because quality control is poor, and this poses a risk especially in internet marketed products. In particular, chronic exposure to low levels of these constituents may pose a hazard. However, given the variability in dietary habits, plant properties, plant misidentification or interaction with pharmaceutical drugs or nutrients, the assessment of risk due to the intake of alkenylbenzenes is difficult. We herein review the regulatory status of the most common alkenylbenzenes and their genotoxic activity and potential carcinogenic activity. Copyright © 2018. Published by Elsevier Ltd.

Pyrrolizidine alkaloids (PAs) in honey and pollen-legal regulation of PA levels in food and animal feed required.

PubMed

Kempf, Michael; Reinhard, Annika; Beuerle, Till

2010-01-01

Pyrrolizidine alkaloids (PAs) are secondary plant constituents that comprise about 400 different structures and occur in two major forms, a tertiary form and the corresponding N-oxide. PAs containing a 1,2-double bond are pre-toxins and metabolically activated by the action of hepatic P-450 enzymes to toxic pyrroles. Besides the acute toxic effects, the genotoxic and tumorigenicity potential of PAs was demonstrated in some eukaryotic model systems. Recently, the potential PA contamination of food and feeding stuff attracted recurrent great deals of attention. Humans are exposed to these toxins by consumption of herbal medicine, herbal teas, dietary supplements or food containing PA plant material. In numerous studies the potential threat to human health by PAs is stated. In pharmaceuticals, the use of these plants is regulated. Considering the PA concentrations observed especially in authentic honey from PA producing plants and pollen products, the results provoke an international regulation of PAs in food.

Weight Loss Nutritional Supplements

NASA Astrophysics Data System (ADS)

Eckerson, Joan M.

Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry has responded by offering a variety of products that generates billions of dollars each year in sales. Most nutritional weight loss supplements are purported to work by increasing energy expenditure, modulating carbohydrate or fat metabolism, increasing satiety, inducing diuresis, or blocking fat absorption. To review the literally hundreds of nutritional weight loss supplements available on the market today is well beyond the scope of this chapter. Therefore, several of the most commonly used supplements were selected for critical review, and practical recommendations are provided based on the findings of well controlled, randomized clinical trials that examined their efficacy. In most cases, the nutritional supplements reviewed either elicited no meaningful effect or resulted in changes in body weight and composition that are similar to what occurs through a restricted diet and exercise program. Although there is some evidence to suggest that herbal forms of ephedrine, such as ma huang, combined with caffeine or caffeine and aspirin (i.e., ECA stack) is effective for inducing moderate weight loss in overweight adults, because of the recent ban on ephedra manufacturers must now use ephedra-free ingredients, such as bitter orange, which do not appear to be as effective. The dietary fiber, glucomannan, also appears to hold some promise as a possible treatment for weight loss, but other related forms of dietary fiber, including guar gum and psyllium, are ineffective.

Herbal Medicine

MedlinePlus

... Recipes Nutrition Information Prevention Guidelines Home > Health Library Herbal Medicine See related health topics and resources Diseases and ... to treat a specific condition, such as depression. Herbal supplements, unlike medicines, are not required to be standardized to ensure ...

Herbal medicine for sports: a review.

PubMed

Sellami, Maha; Slimeni, Olfa; Pokrywka, Andrzej; Kuvačić, Goran; D Hayes, Lawrence; Milic, Mirjana; Padulo, Johnny

2018-01-01

The use of herbal medicinal products and supplements has increased during last decades. At present, some herbs are used to enhance muscle strength and body mass. Emergent evidence suggests that the health benefits from plants are attributed to their bioactive compounds such as Polyphenols, Terpenoids, and Alkaloids which have several physiological effects on the human body. At times, manufacturers launch numerous products with banned ingredient inside with inappropriate amounts or fake supplement inducing harmful side effect. Unfortunately up to date, there is no guarantee that herbal supplements are safe for anyone to use and it has not helped to clear the confusion surrounding the herbal use in sport field especially. Hence, the purpose of this review is to provide guidance on the efficacy and side effect of most used plants in sport. We have identified plants according to the following categories: Ginseng, alkaloids, and other purported herbal ergogenics such as Tribulus Terrestris , Cordyceps Sinensis. We found that most herbal supplement effects are likely due to activation of the central nervous system via stimulation of catecholamines. Ginseng was used as an endurance performance enhancer, while alkaloids supplementation resulted in improvements in sprint and cycling intense exercises. Despite it is prohibited, small amount of ephedrine was usually used in combination with caffeine to enhance muscle strength in trained individuals. Some other alkaloids such as green tea extracts have been used to improve body mass and composition in athletes. Other herb (i.e. Rhodiola, Astragalus) help relieve muscle and joint pain, but results about their effects on exercise performance are missing.

Review of Ginkgo biloba-induced toxicity, from experimental studies to human case reports.

PubMed

Mei, Nan; Guo, Xiaoqing; Ren, Zhen; Kobayashi, Daisuke; Wada, Keiji; Guo, Lei

2017-01-02

Ginkgo biloba seeds and leaves have been used as a traditional herbal remedy for thousands of years, and its leaf extract has been consumed as a botanical dietary supplement for decades. Ginkgo biloba extract is a complex mixture with numerous components, including flavonol glycosides and terpene lactones, and is one of the most widely sold botanical dietary supplements worldwide. Concerns about potential health risks for the general population have been raised because of the widespread human exposure to Ginkgo biloba and its potential toxic and carcinogenic activities in rodents. The National Toxicology Program conducted 2-year gavage studies on one Ginkgo biloba leaf extract and concluded that there was clear evidence of carcinogenic activity of this extract in mice based on an increased incidence of hepatocellular carcinoma and hepatoblastoma. Recently, Ginkgo biloba leaf extract has been classified as a possible human carcinogen (Group 2B) by the International Agency for Research on Cancer. This review presents updated information on the toxicological effects from experimental studies both in vitro and in vivo to human case reports (caused by ginkgo seeds or leaves), and also summarizes the negative results from relatively large clinical trials.

Rapid on-site TLC-SERS detection of four antidiabetes drugs used as adulterants in botanical dietary supplements.

PubMed

Zhu, Qingxia; Cao, Yongbing; Cao, Yingying; Chai, Yifeng; Lu, Feng

2014-03-01

A novel facile method has been established for rapid on-site detection of antidiabetes chemicals used to adulterate botanical dietary supplements (BDS) for diabetes. Analytes and components of pharmaceutical matrices were separated by thin-layer chromatography (TLC) then surface-enhanced Raman spectroscopy (SERS) was used for qualitative identification of trace substances on the HPTLC plate. Optimization and standardization of the experimental conditions, for example the method used for preparation of silver colloids, the mobile phase, and the concentration of colloidal silver, resulted in a very robust and highly sensitive method which enabled successful detection when the amount of adulteration was as low as 0.001 % (w/w). The method was also highly selective, enabling successful identification of some chemicals in extremely complex herbal matrices. The established TLC-SERS method was used for analysis of real BDS used to treat diabetes, and the results obtained were verified by liquid chromatography-triple quadrupole mass spectrometry (LC-MS-MS). The study showed that TLC-SERS could be used for effective separation and detection of four chemicals used to adulterate BDS, and would have good prospects for on-site qualitative screening of BDS for adulterants.

Saw palmetto and lower urinary tract symptoms: what is the latest evidence?

PubMed

Avins, Andrew L; Bent, Stephen

2006-07-01

The use of dietary supplements for treating a wide range of health conditions has grown rapidly in the United States. In the field of men's health, the most common dietary supplement used is an extract of the berry of the saw palmetto plant, with which men commonly self-medicate in order to treat lower urinary tract symptoms. Throughout the past two decades, substantial literature has emerged examining the biologic and clinical effects of saw palmetto extracts. Several lines of evidence suggest that saw palmetto may exert physiologic effects consistent with a beneficial clinical effect on the mechanisms of benign prostatic hyperplasia. Although most clinical studies tend to suggest a modest efficacy benefit of saw palmetto, more recent studies are less consistent and the precise clinical value of saw palmetto for treating lower urinary tract symptoms remains undefined. Overall, there appear to be few safety concerns with short-term use of this herbal medicine, although large-scale and longer-term safety studies have not been performed. Higher-quality studies are currently underway to better define the potential benefits and risks of plant-based extracts for treating symptoms related to benign prostatic hyperplasia.

Herbal medications and plastic surgery: a hidden danger.

PubMed

Mohan, Arvind; Lahiri, Anindya

2014-04-01

Herbal medicine is a multibillion-pound industry, and surveys suggest that ~10% of the UK population uses herbal supplements concurrently with prescription medications. Patients and health care practitioners are often unaware of the adverse side effects of herbal medicines. In addition, because many of these herbal supplements are available over the counter, many patients do not disclose these when listing medications to health care providers. A 39-year-old nurse underwent an abdominoplasty with rectus sheath plication after weight loss surgery. Postoperatively, she experienced persistent drain output, and after discharge, a seroma developed requiring repeated drainage in the clinic. After scar revision 10 months later, the woman bled postoperatively, requiring suturing. Again, a seroma developed, requiring repeated drainage. It was discovered that the patient had been taking a herbal menopause supplement containing ingredients known to have anticoagulant effects. Complementary medicine is rarely taught in UK medical schools and generally not practiced in UK hospitals. Many supplements are known to have anticoagulant, cardiovascular, and sedative effects. Worryingly, questions about herbal medicines are not routinely asked in clinics, and patients do not often volunteer such information. With the number and awareness of complementary medications increasing, their usage among the population is likely to increase. The authors recommend specific questioning about the use of complementary medications and consideration of ceasing such medications before surgery. Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Management of psoriasis with nutraceuticals: An update.

PubMed

Raut, Gauravi; Wairkar, Sarika

2018-05-01

Psoriasis is a chronic skin disorder that speeds up the life cycle of skin cells, typically on the surface of the skin. Additional skin cells form thick scales and red fixes which are awfully itchy and sometimes painful. Although there are many therapeutic systems available to get symptomatic relief, unfortunately replete cure for psoriasis is not yet reported. Moreover, poor treatment outcomes as well as high toxicity profile of drugs makes these therapies more inconvenient to treat psoriasis. In search of alternative and complementary therapy for this disease, the focus has been shifted to nutraceuticals, few of them were reported since ages. It includes vitamins, herbal extracts, phytochemicals and dietary supplements. In this review, the attempt has been made to highlight key nutraceuticals for better management of psoriasis. Supplementation of appropriate nutraceutical may improve the quality of patient's life and have positive impact on overall state of disease. Copyright © 2018 Elsevier Ltd. All rights reserved.

Authentication of Herbal Supplements Using Next-Generation Sequencing

PubMed Central

Braukmann, Thomas W. A.; Borisenko, Alex V.; Zakharov, Evgeny V.

2016-01-01

Background DNA-based testing has been gaining acceptance as a tool for authentication of a wide range of food products; however, its applicability for testing of herbal supplements remains contentious. Methods We utilized Sanger and Next-Generation Sequencing (NGS) for taxonomic authentication of fifteen herbal supplements representing three different producers from five medicinal plants: Echinacea purpurea, Valeriana officinalis, Ginkgo biloba, Hypericum perforatum and Trigonella foenum-graecum. Experimental design included three modifications of DNA extraction, two lysate dilutions, Internal Amplification Control, and multiple negative controls to exclude background contamination. Ginkgo supplements were also analyzed using HPLC-MS for the presence of active medicinal components. Results All supplements yielded DNA from multiple species, rendering Sanger sequencing results for rbcL and ITS2 regions either uninterpretable or non-reproducible between the experimental replicates. Overall, DNA from the manufacturer-listed medicinal plants was successfully detected in seven out of eight dry herb form supplements; however, low or poor DNA recovery due to degradation was observed in most plant extracts (none detected by Sanger; three out of seven–by NGS). NGS also revealed a diverse community of fungi, known to be associated with live plant material and/or the fermentation process used in the production of plant extracts. HPLC-MS testing demonstrated that Ginkgo supplements with degraded DNA contained ten key medicinal components. Conclusion Quality control of herbal supplements should utilize a synergetic approach targeting both DNA and bioactive components, especially for standardized extracts with degraded DNA. The NGS workflow developed in this study enables reliable detection of plant and fungal DNA and can be utilized by manufacturers for quality assurance of raw plant materials, contamination control during the production process, and the final product. Interpretation of results should involve an interdisciplinary approach taking into account the processes involved in production of herbal supplements, as well as biocomplexity of plant-plant and plant-fungal biological interactions. PMID:27227830

Authentication of Herbal Supplements Using Next-Generation Sequencing.

PubMed

Ivanova, Natalia V; Kuzmina, Maria L; Braukmann, Thomas W A; Borisenko, Alex V; Zakharov, Evgeny V

2016-01-01

DNA-based testing has been gaining acceptance as a tool for authentication of a wide range of food products; however, its applicability for testing of herbal supplements remains contentious. We utilized Sanger and Next-Generation Sequencing (NGS) for taxonomic authentication of fifteen herbal supplements representing three different producers from five medicinal plants: Echinacea purpurea, Valeriana officinalis, Ginkgo biloba, Hypericum perforatum and Trigonella foenum-graecum. Experimental design included three modifications of DNA extraction, two lysate dilutions, Internal Amplification Control, and multiple negative controls to exclude background contamination. Ginkgo supplements were also analyzed using HPLC-MS for the presence of active medicinal components. All supplements yielded DNA from multiple species, rendering Sanger sequencing results for rbcL and ITS2 regions either uninterpretable or non-reproducible between the experimental replicates. Overall, DNA from the manufacturer-listed medicinal plants was successfully detected in seven out of eight dry herb form supplements; however, low or poor DNA recovery due to degradation was observed in most plant extracts (none detected by Sanger; three out of seven-by NGS). NGS also revealed a diverse community of fungi, known to be associated with live plant material and/or the fermentation process used in the production of plant extracts. HPLC-MS testing demonstrated that Ginkgo supplements with degraded DNA contained ten key medicinal components. Quality control of herbal supplements should utilize a synergetic approach targeting both DNA and bioactive components, especially for standardized extracts with degraded DNA. The NGS workflow developed in this study enables reliable detection of plant and fungal DNA and can be utilized by manufacturers for quality assurance of raw plant materials, contamination control during the production process, and the final product. Interpretation of results should involve an interdisciplinary approach taking into account the processes involved in production of herbal supplements, as well as biocomplexity of plant-plant and plant-fungal biological interactions.

Kidney toxicity related to herbs and dietary supplements: Online table of case reports. Part 3 of 5 series.

PubMed

Brown, Amy Christine

2017-09-01

No tabular summary of potentially life-threatening, kidney-toxic dietary supplements (DS; includes herbs) based on PubMed case reports is currently available online and continually updated to forewarn United States consumers, clinicians, and companies manufacturing DS. The purpose of this review was to create an online research summary table of kidney toxicity case reports related to DS. Documented PubMed case reports (1966 to May 2016, and cross-referencing) of DS appearing to contribute to kidney toxicity were listed in "DS Toxic Tables." Keywords included "herb" or "dietary supplement" combined with "kidney" to generate an overview list, and possibly "toxicity" to narrow the selection. Case reports were excluded if they involved herb combinations (some exceptions), Chinese herb mixtures, teas of mixed herb contents, mushrooms, poisonous plants, self-harm, excessive doses (except vitamins/minerals), legal or illegal drugs, drug-herbal interactions, and confounders of drugs or diseases. Since commercial DS often include a combination of ingredients, they were treated separately; so were foods. A few foods with kidney-toxic effects were listed in a fourth table. The spectrum of herbal or DS-induced kidney injuries included kidney stones, nephritis, nephrotic syndrome, necrosis, acute kidney injury (AKI; previously known as acute renal failure [ARF]), chronic kidney disease, kidney transplant, and death. Approximately 7 herbs (minus 4 no longer for sale) and 10 dietary supplements (minus 3 excluded due to excessive doses + germanium that is no longer sold) have been related to kidney injury case reports published in PubMed (+crosslisting) in the last 50 + years (1966 to May 2016). The implicated herbs include Chinese yew (Taxus celbica) extract, impila (Callilepis laureola), morning cypress (Cupressus funebris Endl), St. John's wort (Hypericum perforatum), thundergod vine (Tripterygium wilfordii hook F), tribulus (Tribulus terrestris) and wormwood (Artemisia herba-alba). No longer sold in the United States are chocolate vine or mu tong (Caulis aristolochiae), guang fang ji (Aristolochia fangchi), ma huang (Ephedra sinica), and Tenshin Tokishigyaku-ka-goshuyu-shokyo-to. The DS include bile (sheep), chlorella, chromium (Cr), CKLS, creatine, gallbladder (fish), glucosamine, hydrazine, N.O.-Xplode, Spanish fly, and excess intakes of vitamins A, C, and D. Germanium (Ge) is not available for sale. The top two DS with the largest number of reported publications, but not always case reports, in descending order, were the aristolochic acid-containing herbs guang fang ji (mistaken identity) and chocolate vine or mu tong. The remaining DS featured one to three publications over a 50+ year period. Numerous case reports were reported for kidney-toxic foods: djenkol bean, gallbladders (carp fish, pufferfish, & snake), and star fruit (only in chronic kidney disease patients), and uncooked yam powder or juice. This online "DS Toxic Table" provides clinicians, consumers, and manufacturers with a list of herbs that could potentially contribute to kidney injuries. Copyright © 2017 Elsevier Ltd. All rights reserved.

A dietary supplement for female sexual dysfunction, Avlimil, stimulates the growth of estrogen-dependent breast tumors (MCF-7) implanted in ovariectomized athymic nude mice.

PubMed

Ju, Young H; Doerge, Daniel R; Helferich, William G

2008-01-01

Avlimil, a dietary supplement advertised to ameliorate female sexual dysfunction, is a mixture of eleven herbal components, and some herbal constituents of Avlimil (including black cohosh, licorice, red raspberry, red clover and kudzu) contain phenolic compounds, which are suggested to have estrogenic, anti-estrogenic, or androgenic potential for relieving menopausal symptoms. We hypothesize that Avlimil could modulate the growth of estrogen receptor positive human breast cancer (MCF-7) cells in vitro and in vivo. A dimethylsulfoxide (DMSO) extract of Avlimil (0.001-100 microg Avlimil powder equivalents/mL media) was tested for its estrogenic and anti-estrogenic effects on the growth of MCF-7 cells in vitro. We observed that the DMSO extract of Avlimil at low concentrations (0.1-50 microg/mL media) dose-dependently increased MCF-7 cell proliferation in vitro, and Avlimil DMSO extract at 100 microg/mL inhibited the growth of MCF-7 cells in vitro. Avlimil and some constituents (black cohosh and licorice roots) of Avlimil were fractionated by using sequential solvent extraction (hexane, ethyl acetate, and methanol) and the activities of the fractions were monitored by effects on the growth of MCF-7 cells. Depending on dosage (0.1-100 microg/mL media) both stimulatory and inhibitory effects of the extracts on the growth of MCF-7 cells were observed. The effect of dietary Avlimil at dosages approximating human intake was evaluated using ovariectomized mice implanted with MCF-7 cells. Animals were fed diets containing 500 ppm or 1000 ppm Avlimil for 16 weeks. Dietary Avlimil at 500 ppm stimulated MCF-7 tumors, but Avlimil at 1000 ppm had no apparent effect on the growth of MCF-7 tumors. The observation of stimulated tumor growth in the absence of uterine wet weight gains suggest that estrogenic/anti-estrogenic effects of Avlimil we observed may be dosage- and target tissue-specific and that Avlimil may not be safe for women with estrogen-dependent breast cancer. The different biological effects of fractionated Avlimil components and the different concentration dependencies warrant further compound identification and dose-response studies, especially at recommended intake levels that could have estrogenic effects in women.

Herbal medicines: challenges in the modern world. Part 4. Canada and United States.

PubMed

Job, Kathleen M; Kiang, Tony K L; Constance, Jonathan E; Sherwin, Catherine M T; Enioutina, Elena Yu

2016-12-01

Similar to other nations North American people used herbs for thousands of years to treat diseases and purify their spirits. By the middle of the 1900s, evidence-based conventional medicine received wide acceptance in Canada and the United States (US). Nowadays, people are going back to their roots and actively using herbal medicines (HMs) and natural health products (NHPs). Areas covered: This article is focusing on use and regulation of the HMs and NHPs in Canada and the US, raises concerns regarding HM and NHP safety and efficacy, offers suggestions on how to overcome these problems. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: Use of HMs, especially dietary supplements is widespread among adults in Canada and US. HMs and NHPs are regulated in both countries, but minimum criteria for product approval and post-market surveillance have been set. Concerns of quality, contamination, adulteration, and efficacy in are of central importance in the discussion of HMs and NHPs. Detailed product description and research are of vital importance to ensure safety and efficacy of these products. Additionally, 'herbal' education of healthcare providers and patients is needed to guarantee further successful integration of HM and conventional medicines.

Herbal Formula HT048 Attenuates Diet-Induced Obesity by Improving Hepatic Lipid Metabolism and Insulin Resistance in Obese Rats.

PubMed

Lee, Yoon Hee; Jin, Bora; Lee, Sung Hyun; Song, MiKyung; Bae, HyeonHui; Min, Byung Jae; Park, Juyeon; Lee, Donghun; Kim, Hocheol

2016-10-25

It is well established that obesity causes a variety of chronic diseases such as cardiovascular diseases and diabetes. Despite the diligent scientific efforts to find effective ways to lower the level of obesity, the size of obese population grows continuously around the world. Here we present the results that show feeding diet containing HT048, a mixture of the extracts of Crataegus pinnatifida leaves and Citrus unshiu peel, two of the well-known traditional herbal medicines in Eastern Asia, decreases obesity in rats. We fed rats with five different diets for 10 weeks: chow diet (STD), high-fat diet (HFD), high-fat diet with 0.04% orlistat, a drug to treat obesity (HFD + Orlistat), high-fat diet with 0.2% HT048 ( w / w ; HFD + 0.2% HT048), and high-fat diet with 0.6% HT048 ( w / w ; HFD + 0.6% HT048). It was found that both body and total white adipose tissue weight of HT048 groups significantly decreased compared to those of the HFD group. Moreover, HT048 decreased serum insulin levels in HFD-fed obese rats. At the molecular level, HT048 supplementation downregulated genes involved in lipogenesis, gluconeogenesis, and adipogenesis, while the expression level of β-oxidation genes was increased. Supplementation-drug interactions are not likely as HFD and HT048-containing diet did not significantly induce genes encoding CYPs. Collectively, this study suggests that HT048 taken as dietary supplement helps to decrease obesity and insulin resistance in HFD-fed obese rats.

Pyranocoumarin Tissue Distribution, Plasma Metabolome and Prostate Transcriptome Impacts of Sub-Chronic Exposure to Korean Angelica Supplement in Mice.

PubMed

Zhang, Jinhui; Li, Li; Tang, Suni; Zhang, Yong; Markiewski, Maciej; Xing, Chengguo; Jiang, Cheng; Lü, Junxuan

2016-01-01

Herbal products containing Korean Angelica gigas Nakai (AGN) root extract are marketed as dietary supplements for memory enhancement, pain killing, and female menopausal symptom relief. We have shown the anticancer activities of AGN supplements in mouse models. To facilitate human anticancer translational research, we characterized the tissue distribution of AGN marker pyranocoumarin compounds decursin (D) and decursinol angelate (DA) ([Formula: see text]% in AGN) and their metabolite decursinol (DOH), assessed the safety of sub-chronic AGN dietary exposure in mice, and explored its impact on plasma aqueous metabolites and the prostate transcriptome. The data show that after a gavage dose, plasma contained readily detectable DOH, but little D and DA, mirroring patterns in the liver. Extra-hepatic tissues retained greater levels of DA and D than the liver did. For sub-chronic exposures, male mice were provided ad libitum AIN93M-pellet diets with 0.5 and 1% AGN for six weeks. No adverse effects were observed on the plasma biochemistry markers of liver and kidney integrity in spite of their enlargement. Histopathological examinations of the liver, kidney and other visceral organs did not reveal tissue abnormalities. Metabolomic assessment of plasma from mice fed the 1%-AGN diet suggested metabolic shifts of key amino acids especially in the methionine-cysteine cycle, purine cycle, and glycolysis-citrate cycle. Prostate transcriptomic profiling identified gene signature changes in the metabolisms of drugs, lipids and cellular energetics, neuro-muscular features, immunity and inflammation, and tumor suppressor/oncogene balance. The safety profile was corroborated with a daily [Formula: see text] injection of AGN extract (100-300[Formula: see text]mg/kg) for four weeks, which resulted in much greater systemic pyranocoumarin exposure than the dietary route did.

Pyranocoumarin tissue distribution, and plasma metabolome and prostate transcriptome impacts of sub-chronic exposure to Korean Angelica supplement in mice

PubMed Central

ZHANG, Jinhui; LI, Li; TANG, Suni; ZHANG, Yong; MARKIEWSKI, Maciej; XING, Chengguo; JIANG, Cheng; LÜ, Junxuan

2016-01-01

Herbal products containing Korean Angelica gigas Nakai (AGN) root extract are marketed as dietary supplements for memory enhancement, pain killing, and female menopausal symptom relief. We have shown anti-cancer activity of AGN supplement in mouse models. To facilitate human anti-cancer translational research, we characterized the tissue distribution of AGN marker pyranocoumarin compounds decursin (D) and decursinol angelate (DA) (~50% in AGN) and their metabolite decursinol (DOH), assessed safety of sub-chronic AGN dietary exposure in mice, and explored the impacts on the plasma aqueous metabolites and prostate transcriptome. The data show that after a gavage dose, plasma contained readily detectable DOH, but little D and DA, mirroring patterns in the liver. Extra-hepatic tissues retained greater level of DA and D than liver. For sub-chronic exposures, male mice were provided ad libitum AIN93M-pellet diet with 0.5 and 1% AGN for 6 weeks. No adverse effect was observed on plasma biochemistry markers of liver and kidney integrity in spite of their enlargement. Histopathological examination of liver, kidney and other visceral organs did not reveal tissue abnormalities. Metabolomic assessment of plasma from the mice fed 1%-AGN diet suggested metabolic shifts of key amino acids especially methionine-cysteine cycle, purine cycle and glycolysis-citrate cycle. Prostate transcriptomic profiling identified gene signature changes of metabolisms of drugs, lipids and cellular energetics, neuro-muscular features, immunity and inflammation, and tumor suppressor/oncogene balance. The safety profile was corroborated with daily i.p. injection of AGN extract (200 mg/kg) for 4 weeks, which resulted in much greater systemic pyranocoumarin exposure than dietary route. PMID:27080944

Heart Toxicity Related to Herbs and Dietary Supplements: Online Table of Case Reports. Part 4 of 5.

PubMed

Brown, Amy C

2017-10-05

The purpose of this review was to create an online research summary table of heart toxicity case reports related to dietary supplements (DS; includes herbs). Documented PubMed case reports of DS appearing to contribute to heart-related problems were used to create a "Toxic Table" that summarized the research (1966 to April, 2016, and cross-referencing). Keywords included "herb," "dietary supplement," and cardiac terms. Case reports were excluded if they were herb combinations (some exceptions), Chinese herb mixtures, teas of mixed herb contents, mushrooms, poisonous plants, self-harm (e.g. suicide), excess dose (except vitamins/minerals), drugs or illegal drugs, drug-herbal interactions, and confounders of drugs or diseases. The spectrum of heart toxicities included hypertension, hypotension, hypokalemia, bradycardia, tachycardia, arrhythmia, ventricular fibrillation, heart attack, cardiac arrest, heart failure, and death. Heart related problems were associated with approximately seven herbs: Four traditional Chinese medicine herbs - Don quai (Angelica sinensis), Jin bu huan (Lycopodium serratum), Thundergod vine or lei gong teng (Tripterygium wilfordii Hook F), and Ting kung teng (Erycibe henryi prain); one an Ayruvedic herb - Aswagandha, (Withania somnifera); and two North American herbs - blue cohosh (Caulophyllum thalictroides), and Yohimbe (Pausinystalia johimbe). Aconitum and Ephedra species are no longer sold in the United States. The DS included, but are not limited to five DS - bitter orange, caffeine, certain energy drinks, nitric oxide products, and a calming product. Six additional DS are no longer sold. Licorice was the food related to heart problems. The online "Toxic Table" forewarns clinicians, consumers and the DS industry by listing DS with case reports related to heart toxicity. It may also contribute to Phase IV post marketing surveillance to diminish adverse events that Government officials use to regulate DS.

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents).

PubMed

Calixto, J B

2000-02-01

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

Herbal Supplements for Prostate Enlargement: Current State of the Evidence.

PubMed

Nabavizadeh, Reza; Zangi, Mahdi; Kim, Michelle M; Yavari Bejestani, Maryam; Tabatabaei, Shahin

2018-02-01

To provide a comprehensive review of the current state of herbal supplement market for lower urinary tract symptoms (LUTS) and correlate the ingredients of each product with available scientific evidence. Twenty-seven products from Amazon.com that were advertised as herbal supplements for LUTS and had listed their active ingredients were selected. Active ingredients were reviewed on Google Scholar. Product price, warranty, and consumer review information were also collected. A total of 58 unique active ingredients were identified. The mean number of ingredients was 8.26 (standard deviation 5.25). Whereas 17 (63%) products had an ingredient with a systematic review to support their use, 20 (74%) had an ingredient with conflicting evidence based on systematic reviews. Out of the supplements that contained ingredients supported by literature, all (100%) products simultaneously had other ingredients with no, conflicting, or refuting evidence. There was no (0%) product that contained only scientifically proven ingredients. There is no scientific study to evaluate these supplements as a whole. Despite the widespread use of herbal supplements for LUTS, there is scant scientific evidence to support their safety and efficacy. Lack of adequate regulation and government support for research and development are some of the factors that disincentivize researchers to study safety and efficacy of these products. We encourage physicians to warn their patients on the lack of adequate evidence to support the safety and efficacy of many of these supplements. Copyright © 2017 Elsevier Inc. All rights reserved.

Predictors of Dietary Supplement Use by U.S. Coast Guard Personnel

PubMed Central

Austin, Krista G.; Price, Lori Lyn; McGraw, Susan M.; Lieberman, Harris R.

2015-01-01

Background Personnel in Armed Forces entities such as the US Coast Guard (USCG) engage in strenuous tasks requiring high levels of physiological and psychological fitness. Previous reports have found increased prevalence of dietary supplement (DS) use by military personnel to meet the demands of their occupation. Objective This study assessed DS prevalence and patterns of use in USCG personnel and compared these findings to reports from other Armed Forces personnel. Design Use of DS by USCG personnel (n = 1059) was assessed by survey at USCG installations. Data were weighted by age, sex, and rank to be representative of total USCG demographics. Results Seventy percent of USCG personnel reported using a DS at least 1 time/wk. Thirty-three percent used 1–2 DS ≤ 1 time/wk, 18% 3–4 DS ≥ 1 time/wk, and almost 19% ≥ 5 DS ≥ 1 time/wk. Average expenditure on DSs by UCSG personnel was $40/mo. More than 47% of USCG personnel used a multivitamin and mineral, 33% consumed protein supplements, 22% used individual vitamins and minerals, 23% reported taking combination products, and 9% consumed herbal supplements. Increased use of DS use was associated with high intensity operational occupations, participating in high volumes of aerobic exercise and strength training. Use of DS was not associated with age, education or body mass index. Conclusion Occupation is an important determinate of DS use. Prevalence of DS use by USCG personnel is greater than reported for other Armed Forces personnel and reflects high levels of participation in aerobic and strength training activities. PMID:26230407

Predictors of Dietary Supplement Use by U.S. Coast Guard Personnel.

PubMed

Austin, Krista G; Price, Lori Lyn; McGraw, Susan M; Lieberman, Harris R

2015-01-01

Personnel in Armed Forces entities such as the US Coast Guard (USCG) engage in strenuous tasks requiring high levels of physiological and psychological fitness. Previous reports have found increased prevalence of dietary supplement (DS) use by military personnel to meet the demands of their occupation. This study assessed DS prevalence and patterns of use in USCG personnel and compared these findings to reports from other Armed Forces personnel. Use of DS by USCG personnel (n = 1059) was assessed by survey at USCG installations. Data were weighted by age, sex, and rank to be representative of total USCG demographics. Seventy percent of USCG personnel reported using a DS at least 1 time/wk. Thirty-three percent used 1-2 DS ≤ 1 time/wk, 18% 3-4 DS ≥ 1 time/wk, and almost 19% ≥ 5 DS ≥ 1 time/wk. Average expenditure on DSs by UCSG personnel was $40/mo. More than 47% of USCG personnel used a multivitamin and mineral, 33% consumed protein supplements, 22% used individual vitamins and minerals, 23% reported taking combination products, and 9% consumed herbal supplements. Increased use of DS use was associated with high intensity operational occupations, participating in high volumes of aerobic exercise and strength training. Use of DS was not associated with age, education or body mass index. Occupation is an important determinate of DS use. Prevalence of DS use by USCG personnel is greater than reported for other Armed Forces personnel and reflects high levels of participation in aerobic and strength training activities.

Adverse interactions between herbal and dietary substances and prescription medications: a clinical survey.

PubMed

Bush, Thomas M; Rayburn, Keith S; Holloway, Sandra W; Sanchez-Yamamoto, Deanna S; Allen, Blaine L; Lam, Tiffany; So, Brian K; Tran, De H; Greyber, Elizabeth R; Kantor, Sophia; Roth, Larry W

2007-01-01

Patients often combine prescription medications with herbal and dietary substances (herein referred to as herbal medicines). A variety of potential adverse herb-drug interactions exist based on the pharmacological properties of herbal and prescription medications. To determine the incidence of potential and observed adverse herb-drug interactions in patients using herbal medicines with prescription medications. Consecutive patients were questioned about their use of herbal medicines in 6 outpatient clinics. Patients reporting use of these products provided a list of their prescription medications, which were reviewed for any potential adverse herb-drug interactions using a comprehensive natural medicine database. Any potential adverse herb-drug interactions prompted a review of the patient's chart for evidence of an observed adverse herb-drug interaction. The rate of potential and observed adverse herb-drug interactions. Eight hundred four patients were surveyed, and 122 (15%) used herbal medicines. Eighty-five potential adverse herb-drug interactions were found in 49 patients (40% of herbal medicine users). Twelve possible adverse herb-drug interactions in 8 patients (7% of herbal medicine users) were observed. In all 12 cases, the severity scores were rated as mild, including 8 cases of hypoglycemia in diabetics taking nopal (prickly pear cactus). A substantial number of potential adverse herb-drug interactions were detected and a small number of adverse herb-drug interactions observed, particularly in diabetics taking nopal. Screening for herbal medicine usage in 804 patients did not uncover any serious adverse interactions with prescription medications.

Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydropyrrolizidine alkaloids and aristolochic acid

USDA-ARS?s Scientific Manuscript database

In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids ...

CAM and Hepatitis C: A Focus on Herbal Supplements

MedlinePlus

... health/clinicaltrials/ Key References Dhiman RK, Chawla YK. Herbal medicines for liver diseases . Digestive Diseases and Sciences . 2005; ... double-blind, placebo-controlled trial. Annals of Internal Medicine ... TM, Szabo G, et al. Herbal product use by persons enrolled in the Hepatitis ...

Herbal hepatotoxicity: a tabular compilation of reported cases.

PubMed

Teschke, Rolf; Wolff, Albrecht; Frenzel, Christian; Schulze, Johannes; Eickhoff, Axel

2012-11-01

Herbal hepatotoxicity is a field that has rapidly grown over the last few years along with increased use of herbal products worldwide. To summarize the various facets of this disease, we undertook a literature search for herbs, herbal drugs and herbal supplements with reported cases of herbal hepatotoxicity. A selective literature search was performed to identify published case reports, spontaneous case reports, case series and review articles regarding herbal hepatotoxicity. A total of 185 publications were identified and the results compiled. They show 60 different herbs, herbal drugs and herbal supplements with reported potential hepatotoxicity, additional information including synonyms of individual herbs, botanical names and cross references are provided. If known, details are presented for specific ingredients and chemicals in herbal products, and for references with authors that can be matched to each herbal product and to its effect on the liver. Based on stringent causality assessment methods and/or positive re-exposure tests, causality was highly probable or probable for Ayurvedic herbs, Chaparral, Chinese herbal mixture, Germander, Greater Celandine, green tea, few Herbalife products, Jin Bu Huan, Kava, Ma Huang, Mistletoe, Senna, Syo Saiko To and Venencapsan(®). In many other publications, however, causality was not properly evaluated by a liver-specific and for hepatotoxicity-validated causality assessment method such as the scale of CIOMS (Council for International Organizations of Medical Sciences). This compilation presents details of herbal hepatotoxicity, assisting thereby clinical assessment of involved physicians in the future. © 2012 John Wiley & Sons A/S.

Control of Avian Coccidiosis: Future and Present Natural Alternatives

PubMed Central

Quiroz-Castañeda, Rosa Estela; Dantán-González, Edgar

2015-01-01

Numerous efforts to date have been implemented in the control of avian coccidiosis caused by the Eimeria parasite. Since the appearance of anticoccidial chemical compounds, the search for new alternatives continues. Today, no product is available to cope with the disease; however, the number of products commercially available is constantly increasing. In this review, we focus on natural products and their anticoccidial activity. This group comprises fatty acids, antioxidants, fungal and herbal extracts, and immune response modulators with proven anticoccidial activity, many of which exist as dietary supplements. Additionally, we offer an overview of the poultry industry and the economic cost of coccidiosis as well as the classical strategies used to control the disease. PMID:25785269

Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydopyrrolizidine alkaloids and aristolochic acid

USDA-ARS?s Scientific Manuscript database

In many countries, including the United States, herbal supplements, tisanes and vegetable products including traditional Chinese medicines are largely unregulated and their content is not registered, monitored or verified. Consequently potent plant toxins including dehydopyrrolizidine alkaloids and...

Pregnancy and herbal medicines: An unnecessary risk for women's health-A narrative review.

PubMed

Bruno, Luciana O; Simoes, Ricardo Santos; de Jesus Simoes, Manuel; Girão, Manoel João Batista Castello; Grundmann, Oliver

2018-05-01

The indiscriminate use of herbal medicines to prevent or to heal diseases or even the use for questionable purposes such as weight loss has received both interest and scrutiny from the scientific community and general public alike. An increasing number of women put their own and the unborn child's health at risk due to a lack of knowledge about the phytochemical properties and adequate use of herbal medicine (phytomedicines or herbal supplements) and lack of communication with their healthcare provider. The purpose of this narrative review was to summarize the use of herbal medicines during pregnancy and their potential toxic effects to highlight the importance of caution when prescribing herbal medicines or supplements for women, because, in addition to suffering interactions and a great amount of information obtained in preclinical predictive studies, assessment of nephrotoxicity, neurotoxicity, hepatotoxicity, genotoxicity, and teratogenicity of traditional medicinal herbs still remains scarce in the clinical setting. Copyright © 2018 John Wiley & Sons, Ltd.

Neurocognitive effects of multivitamin supplementation on the steady state visually evoked potential (SSVEP) measure of brain activity in elderly women.

PubMed

Macpherson, Helen; Silberstein, Richard; Pipingas, Andrew

2012-10-10

Growing evidence suggests that dietary supplementation with selected micronutrients and nutraceuticals may have the potential to improve cognition in older adults. Fewer studies have investigated the effects of these substances on brain activity. This study was a randomised, double-blind, placebo-controlled trial, conducted to explore the effects of 16 weeks supplementation with a combined multivitamin, mineral and herbal formula on the steady state visually evoked potential (SSVEP) measure of brain electrical activity. Participants were elderly women aged between 64 and 79 years, with subjective memory complaints. Baseline and post-treatment SSVEP data was obtained for 22 participants in the multivitamin group and 19 in the placebo group. A spatial working memory delayed response task (DRT) was performed during the recording of the SSVEP. The results revealed that when compared to placebo, multivitamin supplementation delayed SSVEP latency during retrieval, interpreted as an increase in inhibitory neural processes. Behavioural performance on the DRT was not improved by the multivitamin, however improved performance accuracy was associated with increased midline central SSVEP latency. There were no multivitamin-related effects on SSVEP amplitude. These findings indicate that in the elderly, multivitamin supplementation may enhance neural efficiency during memory retrieval. Copyright © 2012 Elsevier Inc. All rights reserved.

Herbs and alternative therapies: relevance to hypertension and cardiovascular diseases.

PubMed

Vora, Chaula K; Mansoor, George A

2005-08-01

Herbal remedies, supplements, and alternative therapeutic items are used by many patients with hypertension and cardiovascular diseases. Scientific knowledge about their efficacy and safety is lacking, and unfortunately, physicians are frequently not aware that patients are using these nontraditional forms of medical care. Patients may anticipate physicians' disapproval of their use, or not realize that it is important for the physician to know what they are taking. Therefore, it is imperative that patients are asked nonjudgmental questions about current and past use of herbals and alternative therapies. Even when physicians are aware of such use, they feel poorly trained to identify the constituents and effects. Although many such therapies are innocuous, several herbal or alternative therapeutic items can significantly elevate blood pressure or cause interactions with cardiovascular drugs. Practitioners in cardiovascular medicine should be competent and know current scientific evidence for the benefits and adverse effects of herbal supplements and provide patients reasonable advice. In this brief article, we review the epidemiology of alternative therapy use, and select several important herbal or other supplements that patients with hypertension and cardiovascular diseases may be taking. We discuss the therapies considered biological in nature as opposed to mind-body interventions or manipulative body or energy therapies.

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

DTIC Science & Technology

2012-09-01

NEY-1413 FINAL Version 8.05JAN2012 Page 5 of 45 ABBREVIATIONS AE Adverse Event AASM American Academy of Sleep Medicine BzRAs...Current use of statins, ketoconazole, prescription or over- the-counter medications or herbal supplements containing psychoactive properties or...Current use of statins, ketoconazole, prescription or over-the-counter medications or herbal supplements containing psychoactive properties or

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

DTIC Science & Technology

2014-09-01

46 NEY-1413 FINAL Version 10.30 JANUARY 2014 ABBREVIATIONS AE Adverse Event AASM American Academy of Sleep Medicine BzRAs Benzodiazepine...ketoconazole, prescription or over- the-counter medications or herbal supplements containing psychoactive properties or stimulants in the judgment of the...medical conditions; 12.) Current use of statins, ketoconazole, prescription or over-the-counter medications or herbal supplements containing

Herbs as an antioxidant arsenal for periodontal diseases

PubMed Central

Ramesh, Asha; Varghese, Sheeja Saji; Doraiswamy, Jayakumar Nadathur; Malaiappan, Sankari

2016-01-01

Herbal medicines have long been used as a traditional mode of therapy for various ailments in India. They are being used increasingly as dietary supplements to ward off common diseases. Periodontal diseases are highly prevalent and can affect up to 90% of the world population. Gingivitis is the mild form whereas periodontitis results in an irreversible loss of supporting structures of the teeth. Even though periodontal pathogens form a crucial component in the etiopathogenesis of periodontitis, there is a growing body of evidence suggesting oxidative stress playing a pivotal role in the disease initiation and progression. Studies have shown a direct correlation between increased levels of biomarkers for tissue damage induced by reactive oxygen species (ROS) to the severity of periodontal disease. Thus, the focus of attention has revolved back to herbal medicines due to their wide spectrum of biological and medicinal activities, lower costs, and higher safety margin. Internet databases Pubmed and Google Scholar were searched, and the most relevant articles were considered for review. This review briefly describes the various herbs with antioxidant capacity and their potency in the treating periodontal disease. PMID:27069730

Consumption and reasons for use of dietary supplements in an Australian university population.

PubMed

Barnes, Katelyn; Ball, Lauren; Desbrow, Ben; Alsharairi, Naser; Ahmed, Faruk

2016-05-01

The aim of this study was to examine the association between dietary supplement use and sociodemographic factors in an Australian university population. Additionally, reasons for use of specific dietary supplements were explored. A cross-sectional online questionnaire was completed by 1633 students and staff members of Griffith University, Queensland, Australia (76% female). The questionnaire collected information on sociodemographic characteristics, use of dietary supplements, and reasons for use of each dietary supplement reported. Multiple regression analyses were used to describe the relationship between demographic factors and dietary supplement use. Pearson χ(2) was used to identify correlations between frequency of dietary supplement use and selected demographic factors. Frequency distributions were used to explore the reasons for use of each dietary supplement reported. Vitamin or mineral use and use of "other" dietary supplements was reported by 69% and 63% of participants, respectively. Age, sex, ethnicity, and physical activity were independently associated with dietary supplement use. Age, sex, and income were associated with acute use of specific dietary supplements during illness or injury. The reasons for use of specific dietary supplements were closely aligned with marketed claims. Broad reasons of health were commonly reported for use of most dietary supplements. Use of dietary supplements in this population reflects that of other countries. Individuals were unsure of the benefits and risks associated with dietary supplementation. Health professionals should account for dietary supplements when assessing diet. These results also warrant consideration by regulating bodies and public health officers to ensure safe practices. Copyright © 2016 Elsevier Inc. All rights reserved.

The use of, and perceptions about, dietary supplements among patients with heart failure.

PubMed

Fan, Xiuzhen; Lee, Kyoung Suk; Frazier, Susan K; Lennie, Terry A; Moser, Debra K

2014-08-01

Dietary supplement use is widespread; patterns of use and perceptions about supplements in individuals with heart failure (HF) are not well understood. The purpose of this study was to describe the prevalence, patterns and reasons for use of dietary supplements, and to compare characteristics of, and perceptions about, safety and efficacy between dietary supplement user and non-user participants with HF. Patients with HF (n=99) completed a Dietary Supplement Questionnaire. Descriptive statistics were used to analyze the data. Independent sample t-tests, Fisher's exact test, and Chi square analyses compared dietary supplement users to non-users. More than half of the participants used at least one dietary supplement and almost all patients using dietary supplements reported they had informed their healthcare provider. Dietary supplements were taken to improve intake of dietary components and better individual health state. Participants thought that dietary supplements in general were safer and more effective than current evidence suggests. Users and non-users expressed similar perceptions. Patients who used dietary supplements were older (64±10 years vs 53±12 years) and had a lower body mass index (30.0±6.5 kg/m(2) vs 34.1±8.3 kg/m(2)) compared with patients who did not. Dietary supplement use was common in these participants with HF; global perceptions about safety and efficacy of dietary supplements were similar between users and non-users of dietary supplements. Systematic evaluation of dietary supplement use, with discussion about safety and efficacy may be constructive for patients with HF. © The European Society of Cardiology 2013.

76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related...; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,'' that... Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

The use of Stationary Phase Optimized Selectivity Liquid Chromatography for the development of herbal fingerprints to detect targeted plants in plant food supplements.

PubMed

Deconinck, E; Djiogo, C A Sokeng; Kamugisha, A; Courselle, P

2017-08-01

The consumption of plant food supplements is increasing steadily and more and more, these products are bought through internet. Often the products sold through internet are not registered or declared with a national authority, meaning that no or minimal quality control is performed and that they could contain herbs or plants that are regulated. Stationary Phase Optimized Selectivity Liquid Chromatography (SOS-LC) was evaluated for the development of specific fingerprints, to be used for the detection of targeted plants in plant food supplements. Three commonly used plants in plant food supplements and two regulated plants were used to develop fingerprints with SOS-LC. It was shown that for all plants specific fingerprints could be obtained, allowing the detection of these targeted plants in triturations with different herbal matrices as well as in real samples of suspicious supplements seized by the authorities. For three of the five plants a more specific fingerprint was obtained, compared to the ones developed on traditional columns described in literature. It could therefore be concluded that the combination of segments of different types of stationary phases, as used in SOS-LC, has the potential of becoming a valuable tool in the quality control and the identification of crude herbal or plant material and in the detection of regulated plants in plant food supplements or other herbal preparations. Copyright © 2017 Elsevier B.V. All rights reserved.

Alternative Medicine and Herbal Use among University Students

ERIC Educational Resources Information Center

Johnson, Susan K.; Blanchard, Anita

2006-01-01

In this study, the authors investigated the predictors of complementary and alternative medicine (CAM) and herbal supplement use among university students. They investigated demographic factors, trait affectivity, symptom reports, and individuals' worries about modernity as potential contributors to use of CAM and herbals. The authors surveyed 506…

Menopause in Latin America: Symptoms, attitudes, treatments and future directions in Costa Rica.

PubMed

Locklear, T D; Doyle, B J; Perez, A L; Wicks, S M; Mahady, G B

2017-10-01

Similar to their US counterparts, Costa Rican women enter menopause at ∼50 years of age, have similar symptoms, including hot flashes and night sweats, as well as an overall negative attitude toward the menopausal transition. One study of rural women in Monteverde reported that women knew little about the menopausal transition, as the subject was not discussed. Similar to other Latin American women, the use of hormone therapy by Costa Rican women is low and instead they use alternative therapies, including massage, dietary changes and herbal medicines. A wide variety of herbal therapies are used, and some of these herbs have estrogenic activities in vitro. However, clinical data on the safety and efficacy of any of these treatments is lacking. Recently, a disturbing increase in the incidence of human papilloma virus infections in menopausal women has been reported, due in part to more sexual freedom after menopause. Fortunately, the strain of HPV infecting these women is not associated with cervical cancer. Overall, there is a significant lack of scientific and medical research on menopausal women in Costa Rica. Considering the aging population, the high use of herbal medicines by menopausal women and the lack of clinical studies on these treatments, future research should focus on gaining a better understanding of menopause in this population. Furthermore, new educational programs for these women and the health professionals who serve them are necessary, as well as investigations of the safety and efficacy of the herbal supplements women use to manage their menopausal symptoms. Copyright © 2017 Elsevier B.V. All rights reserved.

Profiling the Use of Dietary Supplements by Brazilian Physical Education Professionals.

PubMed

Viana, Ricardo Borges; Silva, Maria Sebastiana; da Silva, Wellington Fernando; Campos, Mário Hebling; Andrade, Marília Dos Santos; Vancini, Rodrigo Luiz; Andre Barbosa de Lira, Claudio

2018-11-02

A survey was designed to examine the use of dietary supplements by Brazilian physical education professionals. The study included 131 Brazilian physical education professionals (83 men and 48 women). A descriptive statistical analysis was performed (mean, standard deviation, and absolute and relative frequencies). A chi-square test was applied to evaluate differences in use of dietary supplements according to particular variables of interest (p < .05). Forty-nine percent of respondents used dietary supplements. Approximately 59% of dietary supplement users took two or more kinds of supplements. Among users of supplements, men professionals (73%) consumed more dietary supplements than women (27%). The most-consumed dietary supplement was whey protein (80%). The results showed a higher use of dietary supplements by men. The most-consumed supplements were rich in protein. The consumption of dietary supplements by almost half of the participants in this study suggests that participants did not consider their dietary needs to be met by normal diet alone.

Phytochemical and Pharmacological Properties of Gymnema sylvestre: An Important Medicinal Plant

PubMed Central

Tiwari, Pragya; Mishra, B. N.; Sangwan, Neelam S.

2014-01-01

Gymnema sylvestre (Asclepiadaceae), popularly known as “gurmar” for its distinct property as sugar destroyer, is a reputed herb in the Ayurvedic system of medicine. The phytoconstituents responsible for sweet suppression activity includes triterpene saponins known as gymnemic acids, gymnemasaponins, and a polypeptide, gurmarin. The herb exhibits a broad range of therapeutic effects as an effective natural remedy for diabetes, besides being used for arthritis, diuretic, anemia, osteoporosis, hypercholesterolemia, cardiopathy, asthma, constipation, microbial infections, indigestion, and anti-inflammatory. G. sylvestre has good prospects in the treatment of diabetes as it shows positive effects on blood sugar homeostasis, controls sugar cravings, and promotes regeneration of pancreas. The herbal extract is used in dietary supplements since it reduces body weight, blood cholesterol, and triglyceride levels and holds great prospects in dietary as well as pharmacological applications. This review explores the transition of a traditional therapeutic to a modern contemporary medication with an overview of phytochemistry and pharmacological activities of the herb and its phytoconstituents. PMID:24511547

Phytochemical and pharmacological properties of Gymnema sylvestre: an important medicinal plant.

PubMed

Tiwari, Pragya; Mishra, B N; Sangwan, Neelam S

2014-01-01

Gymnema sylvestre (Asclepiadaceae), popularly known as "gurmar" for its distinct property as sugar destroyer, is a reputed herb in the Ayurvedic system of medicine. The phytoconstituents responsible for sweet suppression activity includes triterpene saponins known as gymnemic acids, gymnemasaponins, and a polypeptide, gurmarin. The herb exhibits a broad range of therapeutic effects as an effective natural remedy for diabetes, besides being used for arthritis, diuretic, anemia, osteoporosis, hypercholesterolemia, cardiopathy, asthma, constipation, microbial infections, indigestion, and anti-inflammatory. G. sylvestre has good prospects in the treatment of diabetes as it shows positive effects on blood sugar homeostasis, controls sugar cravings, and promotes regeneration of pancreas. The herbal extract is used in dietary supplements since it reduces body weight, blood cholesterol, and triglyceride levels and holds great prospects in dietary as well as pharmacological applications. This review explores the transition of a traditional therapeutic to a modern contemporary medication with an overview of phytochemistry and pharmacological activities of the herb and its phytoconstituents.

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

DTIC Science & Technology

2013-12-18

9.28MARCH2013 AE Adverse Event AASM American Academv of Sleep Medicine BzRAs B enzo diazepine Receptor A goni sts CRC Clinical Research Center CCRC University...medical conditions; 12.) Current use of statins, ketoconazole, prescription or over- the-counter medications or herbal supplements containing...medications or herbal supplements containing psychoactive properties or stimulants in the judgment of the Investigator-Sponsor or Medical Monitor; 13

Simultaneous determination of intestinal permeability and potential drug interactions of complex mixtures using Caco-2 cells and high-resolution mass spectrometry: Studies with Rauwolfia serpentina extract.

PubMed

Flynn, Thomas J; Vohra, Sanah N

2018-06-25

Caco-2 cells are a commonly used model for estimating the intestinal bioavailability of single chemical entity pharmaceuticals. Caco-2 cells, when induced with calcitriol, also express other biological functions such as phase I (CYP) and phase II (glucuronosyltransferases) drug metabolizing enzymes which are relevant to drug-supplement interactions. Intestinal bioavailability is an important factor in the overall safety assessment of products consumed orally. Foods, including herbal dietary supplements, are complex substances with multiple chemical components. Because of potential interactions between components of complex mixtures, more reliable safety assessments can be obtained by studying the commercial products "as consumed" rather than by testing individual chemical components one at a time. The present study evaluated the apparent intestinal permeability (P app ) of a model herbal extract, Rauwolfia serpentina, using both whole plant extracts and the individual purified Rauwolfia alkaloids. All test compounds, endpoint substrates, and their metabolites were quantified using liquid chromatography and high-resolution mass spectrometry. The P app values for individual Rauwolfia alkaloids were comparable whether measured individually or as components of the complete extract. Both Rauwolfia extract and all individual Rauwolfia alkaloids except yohimbine inhibited CYP3A4 activity (midazolam 1'-hydroxylation). Both Rauwolfia extract and all individual Rauwolfia alkaloids except corynanthine and reserpic acid significantly increased glucuronosyltransferase activity (glucuronidation of 4-methylumbelliferone). The positive control, ketoconazole, significantly inhibited both CYP3A4 and glucuronosyltransferase activities. These findings suggest that the Caco-2 assay is capable of simultaneously identifying both bioavailability and potentially hazardous intestinal drug-supplement interactions in complex mixtures. Published by Elsevier B.V.

Polysaccharide of Danggui Buxue Tang, an Ancient Chinese Herbal Decoction, Induces Expression of Pro-inflammatory Cytokines Possibly Via Activation of NFκB Signaling in Cultured RAW 264.7 Cells.

PubMed

Gong, Amy Gw; Zhang, Laura Ml; Lam, Candy Tw; Xu, Miranda L; Wang, Huai Y; Lin, H Q; Dong, Tina Tx; Tsim, Karl Wk

2017-02-01

Danggui Buxue Tang (DBT) is an ancient Chinese herbal decoction containing two herbs, Astragali Radix (AR) and Angelicae Sinensis Radix (ASR): this herbal decoction serves as dietary supplement for women during menopause. DBT has been known to modulate immune responses, and its polysaccharide is proposed to be one of the active components. However, the polysaccharide-induced signaling in immune activation is not revealed. Here, we are identifying that the immune activation, triggered by DBT, could be mediated by polysaccharide. In cultured macrophages (RAW 264.7 cells), the application of polysaccharide-enriched extract of DBT significantly increased the expressions of mRNA and protein levels of interleukin-1β, interleukin-6 and tumor necrosis factor. The induction was much stronger than the polysaccharide extract generated singly from AR, or from ASR, or from their simple mixture. The induced cytokine release in cultured macrophage was revealed to be triggered by activation of nuclear factor-kappa B (NF-κB) signaling, including (i) degradation of IkBα; (ii) translocation of NF-κB p65 from cytosol to nuclei; and (iii) activation of NF-κB transcriptional elements. These results verified the possible role of DBT polysaccharide in modulating immune responses. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Distribution, synthesis, and absorption of kynurenic acid in plants.

PubMed

Turski, Michal P; Turska, Monika; Zgrajka, Wojciech; Bartnik, Magdalena; Kocki, Tomasz; Turski, Waldemar A

2011-05-01

Kynurenic acid (KYNA) is an endogenous antagonist of the ionotropic glutamate receptors and the α7 nicotinic acetylcholine receptor as well as an agonist of the G-protein-coupled receptor GPR35. In this study, KYNA distribution and synthesis in plants as well as its absorption was researched. KYNA level was determined by means of the high-performance liquid chromatography with fluorescence detection. KYNA was found in leaves, flowers, and roots of tested medicinal herbs: dandelion (Taraxacum officinale), common nettle (Urtica dioica), and greater celandine (Chelidoniummajus). The highest concentration of this compound was detected in leaves of dandelion--a mean value of 0.49 µg/g wet weight. It was shown that KYNA can be synthesized enzymatically in plants from its precursor, L-kynurenine, or absorbed by plants from the soil. Finally, the content of KYNA was investigated in 21 herbal tablets, herbal tea, herbs in sachets, and single herbs in bags. The highest content of KYNA in a maximum daily dose of herbal medicines appeared in St. John's wort--33.75 µg (tablets) or 32.60 µg (sachets). The pharmacological properties of KYNA and its presence in high concentrations in medicinal herbs may suggest that it possesses therapeutic potential, especially in the digestive system and should be considered a new valuable dietary supplement. © Georg Thieme Verlag KG Stuttgart · New York.

Prebiotic Potential of Herbal Medicines Used in Digestive Health and Disease.

PubMed

Peterson, Christine Tara; Sharma, Vandana; Uchitel, Sasha; Denniston, Kate; Chopra, Deepak; Mills, Paul J; Peterson, Scott N

2018-03-22

The prebiotic potential of herbal medicines has been scarcely studied. The authors therefore used anaerobic human fecal cultivation to investigate whether three herbal medicines commonly used in gastrointestinal health and disease in Ayurveda alter the growth and abundance of specific bacterial species. Profiling of cultures supplemented with Glycyrrhiza glabra, Ulmus rubra, or triphala formulation by 16S rDNA sequencing revealed profound changes in diverse taxa in human gut microbiota. Principal coordinate analysis highlights that each herbal medicine drives the formation of unique microbial communities. The relative abundance of approximately one-third of the 299 species profiled was altered by all 3 medicines, whereas additional species displayed herb-specific alterations. Herb supplementation increased the abundance of many bacteria known to promote human health, including Bifidobacterium spp., Lactobacillus spp., and Bacteroides spp. Herb supplementation resulted in the reduced relative abundance of many species, including potential pathogens such as Citrobacter freundii and Klebsiella pneumoniae. Herbal medicines induced blooms of butyrate- and propionate-producing species. U. rubra and triphala significantly increased the relative abundance of butyrate-producing bacteria, whereas G. glabra induced the largest increase in propionate-producing species. To achieve greater insight into the mechanisms through which herbal medicines alter microbial communities, the authors assessed the shifts in abundance of glycosyl hydrolase families induced by each herbal medicine. Herb supplementation, particularly G. glabra, significantly increased the representation and potential expression of several glycosyl hydrolase families. These studies are novel in highlighting the significant prebiotic potential of medicinal herbs and suggest that the health benefits of these herbs are due, at least in part, to their ability to modulate the gut microbiota in a manner predicted to improve colonic epithelium function, reduce inflammation, and protect from opportunistic infection. Forthcoming studies in human clinical trials will test the concordance of the results generated in vitro and the predictions made by genome analyses.

Dietary Supplement Use, Knowledge, and Perceptions Among Student Pharmacists.

PubMed

Axon, David R; Vanova, Janka; Edel, Courtney; Slack, Marion

2017-06-01

Objective. To compare dietary supplement use between student pharmacists and the general population, and assess knowledge, attitudes toward use, and dietary supplement effectiveness; and to explore how student pharmacists view their education on dietary supplements. Methods. Paper questionnaires administered to student pharmacists collected data about their use, knowledge, and attitudes of dietary supplements. Use was compared to the 2007 National Health Interview survey findings. Results. Of 179 students who responded, 52% had used at least one dietary supplement in their lifetime versus 25% in the general population. Students perceived supplement label information as unhelpful, research into supplements inadequate, and supplements non-essential to health. Students thought supplement knowledge was important but their education was inadequate. Conclusion. Dietary supplement use was higher in this sample of student pharmacists than the general population. Student pharmacists had limited knowledge and need more education on dietary supplements.

Dietary Supplement Use, Knowledge, and Perceptions Among Student Pharmacists

PubMed Central

Vanova, Janka; Edel, Courtney; Slack, Marion

2017-01-01

Objective. To compare dietary supplement use between student pharmacists and the general population, and assess knowledge, attitudes toward use, and dietary supplement effectiveness; and to explore how student pharmacists view their education on dietary supplements. Methods. Paper questionnaires administered to student pharmacists collected data about their use, knowledge, and attitudes of dietary supplements. Use was compared to the 2007 National Health Interview survey findings. Results. Of 179 students who responded, 52% had used at least one dietary supplement in their lifetime versus 25% in the general population. Students perceived supplement label information as unhelpful, research into supplements inadequate, and supplements non-essential to health. Students thought supplement knowledge was important but their education was inadequate. Conclusion. Dietary supplement use was higher in this sample of student pharmacists than the general population. Student pharmacists had limited knowledge and need more education on dietary supplements. PMID:28720920

Nutritional supplements and the EU: is anyone happy?

PubMed

Eberhardie, Christine

2007-11-01

In 2000 an estimated pound sterling 335 x 106 was spent on food supplements and herbal remedies in the UK. Until recently, The Trades Description Act 1968, the Food Safety Act 1990 and The Food Labelling Regulations 1996 (amended 2004) were the only form of regulation available to protect the public. The medical community has been concerned about the risk to patients of inaccurate dosages and poor-quality products as well as drug-nutrient and nutrient-nutrient interactions. Following growing concern about the type and quality of food supplements and herbal remedies available in the EU, the European Commission has published directives regulating food supplements (2002/46/EC) and herbal remedies (2004/24/EC and 2004/27/EC) available within the EU. The directives came into force in 2005 and limit the number and quality of permitted food supplements through the creation of a 'positive list' of approved supplements. In the present paper the new regulatory frameworks and the implications for the food supplement manufacturers, traditional and complementary therapists, the healthcare professions and patients will be examined. It would appear that there is considerable dissatisfaction with the regulations in their present form. Several questions remain: is regulation the answer; who decides which nutrients go on the positive list; what effect has the regulation had on patient safety and patient choice?

Antioxidant enzyme activities, plasma hormone levels and serum metabolites of finishing broiler chickens reared under high ambient temperature and fed lemon and orange peel extracts and Curcuma xanthorrhiza essential oil.

PubMed

Akbarian, A; Golian, A; Kermanshahi, H; De Smet, S; Michiels, J

2015-02-01

The negative effects of high ambient temperature during some months of the year on poultry production have been of great concern in many countries. Dietary modifications are among the most practical ways to alleviate the effects of high temperature. Possible effects of dietary supplementation with 200 or 400 mg/kg feed of lemon peel extract (LPE), orange peel extract (OPE) and Curcuma xanthorrhiza essential oil (CXEO) under hot conditions (34 °C with 50% relative humidity for 5 h daily starting from day 28 until day 38 of age) on blood antioxidant enzyme activities, biochemical parameters and antibody titres of broiler chickens were investigated. All extracts are rich in phenolic compounds and highly available. Compared to control, supplementation with OPE at 400 mg/kg and CXEO significantly increased erythrocyte glutathione peroxidase and superoxide dismutase activity, plasma growth hormone concentrations and serum phosphorus, total protein and chloride concentrations and decreased serum low-density lipoprotein and cholesterol concentrations in chickens at 38 days of age. Regarding antibody titres, CXEO supplementation at 400 mg/kg caused a significant increase in bronchitis antibody titres. Supplementation with LPE and OPE gave more inconsistent results. Most interesting, 400 mg/kg LPE significantly increased 3,5,3'-triiodothyronine and GH concentration as compared to the control. In conclusion, the herbal extracts tested in this study, in particular CXEO at 400 mg/kg, may relieve some of the changes in blood composition induced by increased ambient temperatures. Journal of Animal Physiology and Animal Nutrition © 2014 Blackwell Verlag GmbH.

Phytochemical Assays of Commercial Botanical Dietary Supplements

PubMed Central

2004-01-01

The growing popularity of botanical dietary supplements (BDS) has been accompanied by concerns regarding the quality of commercial products. Health care providers, in particular, have an interest in knowing about product quality, in view of the issues related to herb-drug interactions and potential side effects. This study assessed whether commercial formulations of saw palmetto, kava kava, echinacea, ginseng and St. John's wort had consistent labeling and whether quantities of marker compounds agreed with the amounts stated on the label. We purchased six bottles each of two lots of supplements from nine manufacturers and analyzed the contents using established commercial methodologies at an independent laboratory. Product labels were found to vary in the information provided, such as serving recommendations and information about the herb itself (species, part of the plant, marker compound, etc.) With regard to marker compound content, little variability was observed between different lots of the same brand, while the content did vary widely between brands (e.g. total phenolic compounds in Echinacea ranged from 3.9–15.3 mg per serving; total ginsenosides in ginseng ranged from 5.3–18.2 mg per serving). Further, the amounts recommended for daily use also differed between brands, increasing the potential range of a consumer's daily dose. Echinacea and ginseng were the most variable, while St. John's wort and saw palmetto were the least variable. This study highlights some of the key issues in the botanical supplement market, including the importance of standardized manufacturing practices and reliable labeling information. In addition, health care providers should keep themselves informed regarding product quality in order to be able to appropriately advise patients utilizing both conventional and herbal medicines. PMID:15841264

Concomitant use of dietary supplements and medicines in patients due to miscommunication with physicians in Japan.

PubMed

Chiba, Tsuyoshi; Sato, Yoko; Suzuki, Sachina; Umegaki, Keizo

2015-04-16

We previously reported that some patients used dietary supplements with their medication without consulting with physicians. Dietary supplements and medicines may interact with each other when used concomitantly, resulting in health problems. An Internet survey was conducted on 2109 people who concomitantly took dietary supplements and medicines in order to address dietary supplement usage in people who regularly take medicines in Japan. A total of 1508 patients (two admitted patients and 1506 ambulatory patients) and 601 non-patients, who were not consulting with physicians, participated in this study. Purpose for dietary supplement use was different among ages. Dietary supplements were used to treat diseases in 4.0% of non-patients and 11.9% of patients, while 10.8% of patients used dietary supplements to treat the same diseases as their medication. However, 70.3% of patients did not declare dietary supplement use to their physicians or pharmacists because they considered the concomitant use of dietary supplements and medicines to be safe. A total of 8.4% of all subjects realized the potential for adverse effects associated with dietary supplements. The incidence of adverse events was higher in patients who used dietary supplements to treat their disease. Communication between patients and physicians is important for avoiding the adverse effects associated with the concomitant use of dietary supplements and medicines.

Concomitant Use of Dietary Supplements and Medicines in Patients due to Miscommunication with Physicians in Japan

PubMed Central

Chiba, Tsuyoshi; Sato, Yoko; Suzuki, Sachina; Umegaki, Keizo

2015-01-01

We previously reported that some patients used dietary supplements with their medication without consulting with physicians. Dietary supplements and medicines may interact with each other when used concomitantly, resulting in health problems. An Internet survey was conducted on 2109 people who concomitantly took dietary supplements and medicines in order to address dietary supplement usage in people who regularly take medicines in Japan. A total of 1508 patients (two admitted patients and 1506 ambulatory patients) and 601 non-patients, who were not consulting with physicians, participated in this study. Purpose for dietary supplement use was different among ages. Dietary supplements were used to treat diseases in 4.0% of non-patients and 11.9% of patients, while 10.8% of patients used dietary supplements to treat the same diseases as their medication. However, 70.3% of patients did not declare dietary supplement use to their physicians or pharmacists because they considered the concomitant use of dietary supplements and medicines to be safe. A total of 8.4% of all subjects realized the potential for adverse effects associated with dietary supplements. The incidence of adverse events was higher in patients who used dietary supplements to treat their disease. Communication between patients and physicians is important for avoiding the adverse effects associated with the concomitant use of dietary supplements and medicines. PMID:25894658

76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

77 FR 50699 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and.... Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and... reporting for dietary supplements and nonprescription drugs marketed without an approved application. The...

An analytical approach based on ESI-MS, LC-MS and PCA for the quali-quantitative analysis of cycloartane derivatives in Astragalus spp.

PubMed

Napolitano, Assunta; Akay, Seref; Mari, Angela; Bedir, Erdal; Pizza, Cosimo; Piacente, Sonia

2013-11-01

Astragalus species are widely used as health foods and dietary supplements, as well as drugs in traditional medicine. To rapidly evaluate metabolite similarities and differences among the EtOH extracts of the roots of eight commercial Astragalus spp., an approach based on direct analyses by ESI-MS followed by PCA of ESI-MS data, was carried out. Successively, quali-quantitative analyses of cycloartane derivatives in the eight Astragalus spp. by LC-ESI-MS(n) and PCA of LC-ESI-MS data were performed. This approach allowed to promptly highlighting metabolite similarities and differences among the various Astragalus spp. PCA results from LC-ESI-MS data of Astragalus samples were in reasonable agreement with both PCA results of ESI-MS data and quantitative results. This study affords an analytical method for the quali-quantitative determination of cycloartane derivatives in herbal preparations used as health and food supplements. Copyright © 2013 Elsevier B.V. All rights reserved.

Publishing scientifically sound papers in Traditional and Complementary Medicine.

PubMed

Isidoro, Ciro; Huang, Chia-Chi; Sheen, Lee-Yan

2016-01-01

Non-conventional medical practices that make use of dietary supplements, herbal extracts, physical manipulations, and other practices typically associated with folk and Traditional Medicine are increasingly becoming popular in Western Countries. These practices are commonly referred to by the generic, all-inclusive term "Complementary and Alternative Medicine." Scientists, practitioners, and medical institutions bear the responsibility of testing and proving the effectiveness of these non-conventional medical practices in the interest of patients. In this context, the number of peer-reviewed journals and published articles on this topic has greatly increased in the recent decades. In this editorial article, we illustrate the policy of the Journal of Traditional and Complementary Medicine for publishing solid and scientifically sound papers in the field of Traditional and Complementary Medicine.

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

Comparison of a Medication Inventory and a Dietary Supplement Interview in Assessing Dietary Supplement Use in the Hispanic Community Health Study/Study of Latinos

PubMed Central

Faurot, Keturah R.; Siega-Riz, Anna Maria; Gardiner, Paula; Rivera, José O.; Young, Laura A.; Poole, Charles; Whitsel, Eric A.; González, Hector M.; Chirinos-Medina, Diana A.; Talavera, Gregory A.; Castañeda, Sheila F.; Daviglus, Martha L.; Barnhart, Janice; Giacinto, Rebeca E.; Van Horn, Linda

2016-01-01

Although dietary supplement use is common, its assessment is challenging, especially among ethnic minority populations such as Hispanics/Latinos. Using the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) (n = 16,415), this report compares two strategies for capturing dietary supplement use over a 30-day period: a medication-based inventory and a nutrition-based dietary supplement interview. Age-standardized prevalence was calculated across multiple dietary supplement definitions, adjusted with survey/nonresponse weights. The prevalence of dietary supplement use was substantially higher as measured in the dietary supplement interview, compared to the medication inventory: for total dietary supplements (39% vs 26%, respectively), for nonvitamin, nonmineral supplements (24% vs 12%), and for botanicals (9.2% vs 4.5%). Concordance between the two assessments was fair to moderate (Cohen’s kappa: 0.31–0.52). Among women, inclusion of botanical teas increased the prevalence of botanical supplement use from 7% to 15%. Supplement assessment that includes queries about botanical teas yields more information about patient supplement use. PMID:26917949

Patient use of dietary supplements: a clinician's perspective.

PubMed

Sadovsky, Richard; Collins, Nancy; Tighe, Ann P; Brunton, Stephen A; Safeer, Richard

2008-04-01

The estimated prevalence of dietary-supplement use among US adults was 73% in 2002. Appropriate use of dietary supplements within the paradigm of evidence-based medicine may be a challenge for medical doctors and non-physician clinicians. Randomized, controlled, clinical trial data, which are considered the gold standard for evidence-based decision making, are lacking. Standardized guidelines for the use of dietary supplements are lacking, and dietary supplements can bear unsupported claims. This article is intended to review clinically-relevant issues related to the widespread use of dietary supplements, with emphasis on regulatory oversight and safety. Review articles and clinical trial articles published up until December 2007 were selected based on a search of the MEDLINE electronic database using PubMed. The Food and Drug Administration (FDA) Website was also used as a resource. We used the search terms dietary supplement(s), vitamin supplements, mineral supplements, and Dietary Supplement and Health Education Act. Articles discussing dietary supplements and their regulation, prevalence of use, prescription and nonprescription formulations, and/or adverse events were selected for review. Articles discussing one or more of these topics in adults were selected for inclusion. New FDA regulations require dietary-supplement manufacturers to evaluate the identity, purity, strength, and composition of their products. However, these regulations are not designed to demonstrate product efficacy and safety, and dietary-supplement manufacturers are not required to submit efficacy and safety data to the FDA prior to marketing. Product contamination and/or mislabeling may undermine the integrity of dietary-supplement formulations. The use of dietary supplements may be associated with adverse events. Although there are new regulatory requirements for dietary supplements, these products will not require FDA approval or submission of efficacy and safety data prior to marketing under the new regulation. A limitation to the literature used for this review is the lack of prospective, randomized clinical trials on the safety and efficacy of dietary supplements. Clinicians should be aware of all the dietary supplements that their patients consume, and help their patients make informed decisions appropriate to their medical care.

Herbal Products in Italy: The Thin Line between Phytotherapy, Nutrition and Parapharmaceuticals; A Normative Overview of the Fastest Growing Market in Europe

PubMed Central

Biagi, Marco; Pecorari, Rita; Appendino, Giovanni; Miraldi, Elisabetta; Magnano, Anna Rosa; Governa, Paolo; Cettolin, Giulia; Giachetti, Daniela

2016-01-01

The Italian herbal products market is the most prosperous in Europe. The proof is represented by the use of these products in several marketing categories, ranging from medicine to nutrition and cosmetics. Market and legislation in Italy are at the same time cause and consequence of this peculiar situation. In fact, the legislation on botanical food supplements in Italy is very permissive and at the same time the market shows an overall satisfaction of users and strong feedback in terms of consumption, which brings a widening use of medicinal plants, formerly the prerogative of pharmaceuticals, to other fields such as nutrition. This review summarizes the market and normative panorama of herbal products in Italy, highlighting the blurred boundaries of health indications, marketing authorizations and quality controls between herbal medicines and non pharmaceutical products, such as food supplements, cosmetics and other herbal-based “parapharmaceuticals”. PMID:27801865

Use of dietary supplements among people living with HIV/AIDS is associated with vulnerability to medical misinformation on the internet

PubMed Central

2012-01-01

Background Use of dietary supplements is common among people living with HIV/AIDS. Because dietary supplements are used in the context of other health behaviors, they may have direct and indirect health benefits. However, supplements may also be associated with vulnerability to medical misinformation and unfounded health claims. We examined use of dietary supplements among people living with HIV/AIDS (PLWH) and the association between use of dietary supplements and believing medical misinformation. Methods A convenience sample of 268 men and 76 women living with HIV was recruited from AIDS services and clinics in Atlanta, GA. Participants completed measures of demographic and health characteristics, dietary supplement use, beliefs about dietary supplements, internet use, and an internet evaluation task designed to assess vulnerability to medical misinformation. Results One out of four PLWH currently used at least one dietary supplement product excluding vitamins. Dietary supplement use was associated with higher education and greater use of the internet for health-related information. Dietary supplement users also endorsed greater believability and trust in unfounded claims for HIV cures. Conclusions Dietary supplement use is common among PLWH and is associated with a broad array of health information seeking behaviors. Interventions are needed to reduce the vulnerability of PLWH, particularly dietary supplement users, to medical misinformation propagated on the internet. PMID:22233928

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

Time To Talk About Dietary Supplements: 5 Things Consumers Need To Know

MedlinePlus

... 5 Tips: What Consumers Need To Know About Dietary Supplements Share: Many people take dietary supplements in an effort to be well and stay ... also called “natural products,” are one type of dietary supplement. Dietary supplements can come in the form of ...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

Safe Use of Complementary Health Products and Practices

MedlinePlus

... Mind and Body Practices for Children and Teens Dietary Supplement Safety Information Using Dietary Supplements Wisely Dietary Supplement ... Homeopathic Drugs Dietary Supplements—Adverse Event Reporting ( FDA ) Dietary Supplement Alerts and Advisories Alerts and Advisories Clinical Practice ...

Definitions of Health Terms: Minerals

MedlinePlus

... National Institutes of Health, Office of Dietary Supplements Dietary Supplements A dietary supplement is a product you take to supplement your ... safety. Source : National Institutes of Health, Office of Dietary Supplements Electrolytes Electrolytes are minerals in body fluids. They ...

Vitamin and Mineral Supplement Fact Sheets

MedlinePlus

... Dictionary of Dietary Supplement Terms Dietary Supplement Label Database (DSLD) Información en español Consumer information in Spanish ... Analytical Methods and Reference Materials Dietary Supplement Label Database (DSLD) Dietary Supplement Ingredient Database (DSID) Computer Access ...

Assessing patients' attitudes towards dietary supplements.

PubMed

Wierzejska, Regina; Jarosz, Mirosław; Siuba, Magdalena; Rambuszek, Michał

2014-01-01

There is currently many over the counter products on the market that exert nutritional or physiological effects on the human body. The differences between dietary supplements and non-prescription drugs are however poorly understood by the average consumer and may thus affect their expectations as to the desired effect produced on the body. To evaluate patients' knowledge and attitudes towards dietary supplements as compared to non-prescription drugs. Subjects were 335 patients of the Mazowiecki Voivodeship Hospital in Warsaw, Poland. The data were collected from a face-to-face interview using a single and multiple choice questionnaire with 10 questions on dietary supplements. Statistical analysis used the Chi-square (χ2) test. The majority of respondents were found to be familiar with the term 'dietary supplements', but had difficulties in classifying these products into appropriate categories. Over 55% do not consider dietary supplements to be foodstuffs and more than 40% considered such products to be drugs. Most respondents thought that the main purpose of taking dietary supplements is to improve nutrition, but over one third expected them to also treat disease. Over 70% declared taking notice to which category the non-prescription products they bought belongs to ie. whether non-prescription drugs (medicinal products) or dietary supplements. Many patients mistakenly believe that dietary supplements are drugs and can be used to treat disease and health disorders. dietary supplements, opinion on dietary supplements, nutrition, dietary supplement vs. medicinal product.

NIH and USDA Funding of Dietary Supplement Research, 1999–20071

PubMed Central

Regan, Karen S.; Wambogo, Edwina A.; Haggans, Carol J.

2011-01-01

Over one-half of U.S. adults use dietary supplements, so federally supported research into the safety and effectiveness of these compounds is important for the health of many Americans. Data collected in the Computer Access to Research on Dietary Supplements database, which compiles federally sponsored dietary supplement-related research, are useful to scientists in determining the type of dietary supplement research that federal agencies are currently funding and where research gaps exist. This article describes the dietary supplement-related research funded by the NIH and the USDA. Between fiscal years 1999 and 2007, the number of research projects and funding for dietary supplement research more than doubled. During that period, NIH funded 6748 dietary supplement-related projects at a cost of $1.9 billion and the USDA funded 2258 projects at a cost of $347 million. The top funded dietary supplement ingredient categories were vitamins and minerals, botanicals, phytochemicals, and fatty acids. Cancer was by far the most frequent health outcome in dietary supplement research funding, nearly double the next closest health outcome category. Other health outcomes with the greatest funding were cellular and molecular mechanisms, cardiovascular health, women’s reproductive health, and immune function. The greatest number of dietary supplement research projects are funded by the NIH National Cancer Institute, the NIH National Center for Complementary and Alternative Medicine, the NIH Office of Dietary Supplements, and the USDA Agricultural Research Service. PMID:21106929

Defining 'nutraceuticals': neither nutritious nor pharmaceutical.

PubMed

Aronson, Jeffrey K

2017-01-01

There are widespread inconsistencies and contradictions in the many published definitions of 'nutraceuticals' and 'functional foods', demonstrating wholesale uncertainty about what they actually are. Furthermore, in a 2014 lecture, the inventor of the term 'nutraceutical', confessing that nutraceuticals do not work, said that 'the quest to demonstrate whether … long-term supplementation [with nutraceuticals] can prevent serious diseases … has come to an end'. Definitions of 'nutraceuticals' and related terms, still widely used, should therefore be explored systematically. There are no internationally agreed definitions of 'nutraceuticals' and 'functional foods', or of similar terms, such as 'health foods', or of terms related to herbal products, which are sometimes referred to as 'nutraceuticals', compounding the confusion. 'Nutraceuticals' and 'functional foods' are vague, nondiscriminatory, unhelpful terms; the evidence suggests that they should be abandoned in favour of more precise terms. The term 'dietary supplement' is widely used to designate formulations that are also called 'nutraceuticals' but it would be better restricted to individual compounds used to treat or prevent deficiencies. 'Fortified foods', sometimes called 'designer foods', are foods to which compounds of proven therapeutic or preventive efficacy (e.g. folic acid) have been added. Other terms, such as 'food', 'foodstuffs', 'eat', 'drink', and 'nutrition', are well defined, as are 'medicinal products' and 'pharmaceutical formulations'. Dietary regimens, such as Mediterranean or nitrate-rich diets or vegetarianism, can affect health. A dietary regimen of this kind can be defined as a programme of food, of a defined kind and/or quantity, prescribed or adopted for the restoration or preservation of health. © 2016 The British Pharmacological Society.

Dietary supplement consumption among cardiac patients admitted to internal medicine and cardiac wards.

PubMed

Karny-Rahkovich, Orith; Blatt, Alex; Elbaz-Greener, Gabby Atalya; Ziv-Baran, Tomer; Golik, Ahuva; Berkovitch, Matityahu

2015-01-01

Dietary supplements may have adverse effects and potentially interact with conventional medications. They are perceived as "natural" products, free of side effects with no need for medical consultation. Little is known about consumption of dietary supplements by patients with cardiac diseases. The objective of this study was to investigate dietary supplement consumption among cardiac patients admitted to internal and cardiology wards. Potential drug-dietary supplement interactions were also assessed. During a period of 6 months, patients with cardiac disease hospitalized in the Internal Medicine and Cardiology Wards at Assaf Harofeh Medical Center were evaluated regarding their dietary supplement consumption. A literature survey examining possible drug-supplement interaction was performed. Out of 149 cardiac patients, 45% were dietary supplement consumers. Patients ad-mitted to the Internal Medicine Wards consumed more dietary supplements than those admit-ted to the Cardiology Division. Dietary supplement consumption was associated with older age (OR = 1.05, p = 0.022), female gender (OR = 2.94, p = 0.014) and routine physical activity (OR = 3.15, p = 0.007). Diabetes mellitus (OR = 2.68, p = 0.020), hematological diseases (OR = 13.29, p = 0.022), and the use of anti-diabetic medications (OR = 4.28, p = 0.001) were independently associated with dietary supplement intake. Sixteen potential moderate interactions between prescribed medications and dietary supplements were found. Consumption of dietary supplements is common among cardiac patients. It is more common in those admitted to Internal Medicine Departments than in those admitted to the Cardiology Wards. Due to the risk of various drug-supplement interactions consumed by patients with cardiac diseases, there is a need to increase awareness and knowledge among medical staff regarding the intake of dietary supplements.

Clinical safety assessment of oral higenamine supplementation in healthy, young men.

PubMed

Bloomer, R J; Schriefer, J M; Gunnels, T A

2015-10-01

Higenamine, an herbal agent also known as norcoclaurine, is thought to stimulate β-androgenic receptors and possess lipolytic activity. It is currently making its way into the dietary supplement market. To our knowledge, no studies have been conducted to determine the safety profile of oral higenamine when used alone and in conjunction with other commonly used lipolytic agents. Forty-eight men were assigned to ingest either a placebo, higenamine, caffeine, or higenamine + caffeine + yohimbe bark extract daily for a period of 8 weeks. Before and after 4 and 8 weeks of supplementation, the following variables were measured: resting respiratory rate, heart rate, blood pressure, urinalysis, complete blood count, metabolic panel, liver enzyme activity, and lipid panel. No interaction effects were noted for any variable (p > 0.05), with no changes of statistical significance occurring across time for any of the four conditions (p > 0.05). This is the first study to determine the safety profile of oral higenamine intake in human subjects. Our data indicate that 8 weeks of daily higenamine supplementation, either alone or in conjunction with caffeine and yohimbe bark extract, does not result in a statistically significant change in any of the measured outcome variables. Additional studies, inclusive of a larger sample size, are needed to extend these initial findings. © The Author(s) 2015.

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

Use and safety perceptions regarding herbal supplements: a study of older persons in southeast Idaho.

PubMed

Snyder, Frank J; Dundas, Mary L; Kirkpatrick, Carol; Neill, Karen S

2009-01-01

Herbal supplements (HS) are used by older persons and are often perceived as safe, although there is limited research that examines why this perception exists. A questionnaire was developed and pilot tested to investigate the use and perceived safety of HS among a convenience sample of 112 adults aged 60 to 92 in southeast Idaho. Fifty-five percent of the participants (n = 62) reported using HS in the past. Ninety-five percent (n = 59) of those using HS and 75% (n = 37) of nonusers reported they believed most or some HS were safe. Perception of herbal supplement safety was greatly influenced by family and friends, and HS users had a greater perception of safety than nonusers (p < or = .001). The top reasons for perceived safety given by HS users were that HS: (1) can be purchased without a prescription, (2) can be purchased in many locations, and (3) are natural.

Screening and determination of sibutramine in adulterated herbal slimming supplements by HPTLC-UV densitometry.

PubMed

Mathon, Caroline; Ankli, Anita; Reich, Eike; Bieri, Stefan; Christen, Philippe

2014-01-01

The adulteration of herbal supplements is of growing importance, especially when they contain undeclared compounds like sibutramine that are unsafe drugs. Sibutramine was withdrawn from US and European markets in 2010. In this study, an HPTLC-UV densitometric method was developed for the quantification of sibutramine in herbal diet foods. Sample extracts were directly applied onto HPTLC silica gel plates and separated with a mobile phase made of a toluene-methanol mixture. Sibutramine was quantified at 225 nm and its unequivocal identification was confirmed by MS using a TLC-MS interface. During two surveys, 52 weight loss supplements obtained via the Internet were screened. Half of those were adulterated with sibutramine at amounts reaching up to 35 mg per capsule. The results of this validated HPTLC method were compared with those obtained by HPLC-UV and HPLC-MS/MS. The results were not significantly different with the three methods.

Herbal hepatotoxicity: a critical review

PubMed Central

Teschke, Rolf; Frenzel, Christian; Glass, Xaver; Schulze, Johannes; Eickhoff, Axel

2013-01-01

This review deals with herbal hepatotoxicity, identical to herb induced liver injury (HILI), and critically summarizes the pitfalls associated with the evaluation of assumed HILI cases. Analysis of the relevant publications reveals that several dozens of different herbs and herbal products have been implicated to cause toxic liver disease, but major quality issues limit the validity of causality attribution. In most of these reports, discussions around quality specifications regarding herbal products, case data presentations and causality assessment methods prevail. Though the production of herbal drugs is under regulatory surveillance and quality aspects are normally not a matter of concern, low quality of the less regulated herbal supplements may be a critical issue considering product batch variability, impurities, adulterants and herb misidentifications. Regarding case data presentation, essential diagnostic information is often lacking, as is the use of valid and liver specific causality assessment methods that also consider alternative diseases. At present, causality is best assessed by using the Council for International Organizations of Medical Sciences scale ( CIOMS) in its original or updated form, which should primarily be applied prospectively by the treating physician when evaluating a patient rather than retrospectively by regulatory agencies. To cope with these problems, a common quality approach by manufacturers, physicians and regulatory agencies should strive for the best quality. We propose steps for improvements with impact on future cases of liver injury by herbs, herbal drugs and herbal supplements. PMID:22831551

Determinants of dietary supplement use--healthy individuals use dietary supplements.

PubMed

Kofoed, Christina L F; Christensen, Jane; Dragsted, Lars O; Tjønneland, Anne; Roswall, Nina

2015-06-28

The prevalence of dietary supplement use varies largely among populations, and previous studies have indicated that it is high in the Danish population compared with other European countries. The diversity in supplement use across countries indicates that cultural and environmental factors could influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54,948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements and lifestyle between 1993 and 1997. A health index including smoking, physical activity, alcohol and diet, and a metabolic risk index including waist circumference, urinary glucose and measured hypertension were constructed. Logistic regression was used to investigate these determinants in relation to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher likelihood of being user of any, more common and less common supplements, respectively. In the metabolic risk index, one additional point was associated with 17 and 16 % lower likelihood of being user of any supplement and more common supplements, respectively. No significant association was found for less common supplement use. In conclusion, those with the healthiest lifestyle were more likely to use dietary supplements. Thus, lifestyle and dietary composition should be considered as confounders on supplement use and health outcomes.

Dietary Supplements

MedlinePlus

... For Consumers Consumer Information by Audience For Women Dietary Supplements: Tips for Women Share Tweet Linkedin Pin it ... or 10877-382-4357. To Learn More about Dietary Supplements Information for Consumers on Using Dietary Supplements NIH ...

Causes, Clinical Features, and Outcomes From a Prospective Study of Drug-Induced Liver Injury in the United States

PubMed Central

Chalasani, Naga; Fontana, Robert J.; Bonkovsky, Herbert L.; Watkins, Paul B.; Davern, Timothy; Serrano, Jose; Yang, Hongqiu; Rochon, James

2013-01-01

Background & Aims Idiosyncratic drug-induced liver injury (DILI) is among the most common causes of acute liver failure in the United States, accounting for approximately 13% of cases. A prospective study was begun in 2003 to recruit patients with suspected DILI and create a repository of biological samples for analysis. This report summarizes the causes, clinical features, and outcomes from the first 300 patients enrolled. Methods Patients with suspected DILI were enrolled based on predefined criteria and followed up for at least 6 months. Patients with acetaminophen liver injury were excluded. Results DILI was caused by a single prescription medication in 73% of the cases, by dietary supplements in 9%, and by multiple agents in 18%. More than 100 different agents were associated with DILI; antimicrobials (45.5%) and central nervous system agents (15%) were the most common. Causality was considered to be definite in 32%, highly likely in 41%, probable in 14%, possible in 10%, and unlikely in 3%. Acute hepatitis C virus (HCV) infection was the final diagnosis in 4 of 9 unlikely cases. Six months after enrollment, 14% of patients had persistent laboratory abnormalities and 8% had died; the cause of death was liver related in 44% Conclusions DILI is caused by a wide array of medications, herbal supplements, and dietary supplements. Antibiotics are the single largest class of agents that cause DILI. Acute HCV infection should be excluded in patients with suspected DILI by HCV RNA testing. The overall 6-month mortality was 8%, but the majority of deaths were not liver related. PMID:18955056

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.

PubMed

Dodge, Tonya; Litt, Dana; Kaufman, Annette

2011-03-01

The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

A structured vocabulary for indexing dietary supplements in databases in the United States

USDA-ARS?s Scientific Manuscript database

Food composition databases are critical to assess and plan dietary intakes. Dietary supplement databases are also needed because dietary supplements make significant contributions to total nutrient intakes. However, no uniform system exists for classifying dietary supplement products and indexing ...

Beware of Fraudulent 'Dietary Supplements'

MedlinePlus

... Home For Consumers Consumer Updates Beware of Fraudulent Dietary Supplements Share Tweet Linkedin Pin it More sharing options ... phone at 1-800-FDA-1088 or online . Dietary Supplements and FDA Dietary supplements, in general, are not ...

Using Dietary Supplements Wisely

MedlinePlus

... T U V W X Y Z Using Dietary Supplements Wisely Share: On This Page Key Points About ... will help ensure coordinated and safe care. About Dietary Supplements Dietary supplements were defined in a law passed ...

A pilot study to assess students' perceptions, familiarity, and knowledge in the use of complementary and alternative herbal supplements in health promotion.

PubMed

Zimmerman, Caitlyn; Kandiah, Jay

2012-01-01

According to the National Center for Complementary and Alternative Medicine (NCCAM), use of herbal supplements is increasing and will continue to rise. With parents administering medicinal herbs to children as a preventive alternative to traditional drugs, the research team thought it would be interesting to assess the use of these products during the transition into adulthood through college life. This study examined participants' perceptions of, familiarity with, and knowledge of herbal supplements for health promotion. The research team invited participants to complete a 13-item Perception, Familiarity, and Knowledge Survey (PFKS). This online survey included questions regarding demographics, perceptions of complementary and alternative medicine, and familiarity with and knowledge of gingko, ginseng, St. John's wort, garlic, echinacea, and cinnamon. The study occurred at a Midwestern university. Two-hundred and eighty-six college students participated. The research team used the Chi-square test of association to examine the class rank (freshmen/sophomores, juniors/seniors, and graduate students) of students (frequency) and their gender in relation to their perceptions of, familiarity with, and knowledge of herbal supplements. Chi-square analysis showed that 80.8% of participants were familiar with complementary and alternative medicine (CAM) (P = .000). Of participants who were aware of the six herbs, a majority was familiar with ginkgo (82.4%), ginseng (96.1%), St. John's wort (78.4%), garlic (98.4%), echinacea (65.6%), and cinnamon (96.8%). Despite students' familiarity with the herbs, 45.1% to 74.1% of the participants were unsure of their effectiveness in preventing disease or promoting good health. Participants perceived the barriers to their CAM awareness as (1) insufficient education (26.0%), (2) a lack of scientific evidence (25.9%), and (3) a lack of trained professionals (17.5%). Many students (85.8%) desired educational courses on CAM therapies, with nutrition professors being ranked highest as the providers of this education by 88.0%. Over 60.0% of participants thought that conventional medicine could benefit from integration with CAM and that medical professionals should integrate CAM into health-care practices. College students appear to be highly familiar with CAM and herbal supplements but currently have little experience with and knowledge of herbal supplements.

Getting More Than You Paid For: Unauthorized "Natural" Substances in Herbal Food Supplements on EU Market.

PubMed

Zovko Končić, Marijana

2018-04-01

As the population in the industrialized world develops preference for what is perceived as a natural and holistic way of disease treatment, the popularity and the number of food supplements on the market, including herbal ones, is experiencing an unprecedented rise. However, unlike herbal medicinal products, intended for treating or preventing disease, current legislation classifies food supplements as products intended for achieving nutritional or physiological effect and to supplement the normal diet. Accordingly, most food supplements are not to be associated with specific health claims. However, either due to the subtle suggestions by the producers or the wishful thinking of the consumers, certain pharmacological effects from food supplements are often expected. Medicinal plants included in food supplements usually do not produce dramatic and instant pharmacological effects. Therefore, in order to meet the expectation of their customers, some producers have turned to the illicit and dangerous practice of adulterating their products with synthetic adulterants, including naturally occurring molecules, having the desired activity. Such practice is prevalent in, although not limited to, food supplements intended for use as weight-loss aids, as well as for sport performance and libido enhancement. The review is focusing on naturally occurring alkaloids, phenylethanolamines, and their semi-synthetic derivatives in food supplements in the European Union as reported by the Rapid Alert System for Food and Feed. Their desired and undesired pharmacological effects, as well as the methods for their detection and quantification in food supplements, will be reviewed. Georg Thieme Verlag KG Stuttgart · New York.

Progress in developing analytical and label-based dietary supplement databases at the NIH Office of Dietary Supplements

PubMed Central

Dwyer, Johanna T.; Picciano, Mary Frances; Betz, Joseph M.; Fisher, Kenneth D.; Saldanha, Leila G.; Yetley, Elizabeth A.; Coates, Paul M.; Milner, John A.; Whitted, Jackie; Burt, Vicki; Radimer, Kathy; Wilger, Jaimie; Sharpless, Katherine E.; Holden, Joanne M.; Andrews, Karen; Roseland, Janet; Zhao, Cuiwei; Schweitzer, Amy; Harnly, James; Wolf, Wayne R.; Perry, Charles R.

2013-01-01

Although an estimated 50% of adults in the United States consume dietary supplements, analytically substantiated data on their bioactive constituents are sparse. Several programs funded by the Office of Dietary Supplements (ODS) at the National Institutes of Health enhance dietary supplement database development and help to better describe the quantitative and qualitative contributions of dietary supplements to total dietary intakes. ODS, in collaboration with the United States Department of Agriculture, is developing a Dietary Supplement Ingredient Database (DSID) verified by chemical analysis. The products chosen initially for analytical verification are adult multivitamin-mineral supplements (MVMs). These products are widely used, analytical methods are available for determining key constituents, and a certified reference material is in development. Also MVMs have no standard scientific, regulatory, or marketplace definitions and have widely varying compositions, characteristics, and bioavailability. Furthermore, the extent to which actual amounts of vitamins and minerals in a product deviate from label values is not known. Ultimately, DSID will prove useful to professionals in permitting more accurate estimation of the contribution of dietary supplements to total dietary intakes of nutrients and better evaluation of the role of dietary supplements in promoting health and well-being. ODS is also collaborating with the National Center for Health Statistics to enhance the National Health and Nutrition Examination Survey dietary supplement label database. The newest ODS effort explores the feasibility and practicality of developing a database of all dietary supplement labels marketed in the US. This article describes these and supporting projects. PMID:25346570

Regulations applicable to plant food supplements and related products in the European Union.

PubMed

Silano, Vittorio; Coppens, Patrick; Larrañaga-Guetaria, Ainhoa; Minghetti, Paola; Roth-Ehrang, René

2011-12-01

This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin. Unlike food supplements, marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States. In fact, currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents. When the EU approach is compared with approaches adopted in some non-European countries to regulate these product categories, major differences become evident.

Dietitians use and recommend dietary supplements: report of a survey.

PubMed

Dickinson, Annette; Bonci, Leslie; Boyon, Nicolas; Franco, Julio C

2012-03-14

Dietary supplement use is common in the United States, with more than half of the population using such products. Nutrition authorities consistently advocate a "food first" approach to achieving nutritional adequacy but some, including the Academy of Nutrition and Dietetics (formerly the American Dietetic Association), also recognize that dietary supplements have a role to play in improving nutrient intake to support health and wellness. Surveys show that many health professionals use dietary supplements themselves and also recommend dietary supplements to their patients or clients. As one component of a series of surveys of healthcare professionals (the "Life...supplemented" HCP Impact Studies), 300 registered dietitians were surveyed in 2009 regarding their personal use of dietary supplements and whether they recommend dietary supplements to their clients. Respondents were registered dietitians whose business involved seeing clients in a private practice or at a clinic. Seventy-four percent of the dietitians surveyed said they were regular users of dietary supplements, while 22% said they used dietary supplements occasionally or seasonally. The primary reasons for using dietary supplements were for bone health (58%), overall health and wellness (53%), and to fill nutrient gaps (42%). When asked if they "ever recommend dietary supplements to clients," 97% of the respondents said they did. The primary reasons were for bone health (70%), to fill nutrient gaps (67%), and overall health and wellness (49%). Eighty-seven percent of the dietitians agreed with the statement, "There are gaps in clients' diets that could effectively be addressed with dietary supplements." The dietitians surveyed said they followed healthy habits including eating a balanced diet (96%), managing stress (92%), visiting their own healthcare professional regularly (86%), exercising regularly (83%), maintaining a healthy weight (80%), and getting a good night's sleep (72%). Nearly all respondents (95%) expressed an interest in continuing education about dietary supplements on a variety of topics. Many dietitians, like other health professionals, use dietary supplements regularly as part of their own approach to a healthy diet and lifestyle. They also recommend dietary supplements to their clients or patients, to promote health. © 2012 Dickinson et al; licensee BioMed Central Ltd.

Understanding the properties of common dietary supplements: clinical implications for healthcare practitioners.

PubMed

Zelig, Rena; Rigassio Radler, Diane

2012-12-01

Dietary supplement usage in the United States continues to increase. This article explores the background of dietary supplements and their regulations, discusses trends in usage patterns highlighting the properties of 10 popular dietary supplements, addresses safety concerns and drug-nutrient interactions, and discusses the role of the healthcare professional in assessing and recommending usage of dietary supplements. The authors reviewed the literature on dietary supplementation. Government websites were used to obtain background and regulatory information. Evidence-based databases were used to summarize popular dietary supplements in terms of their common uses, mechanisms of action, and clinical implications. The related literature was reviewed to discuss important factors for the healthcare professional to consider as well as the role of the healthcare professional in integrating dietary supplement use within patient care. Healthcare professionals need to be prepared to evaluate dietary supplement usage and make appropriate recommendations for an individualized plan of care. As the popularity of dietary supplements continues to grow, healthcare professionals will need to communicate with patients about their usage; educate themselves on their potential benefits, interactions, and contraindications; evaluate the literature; make recommendations; and document appropriately in a comprehensive and integrated plan of care.

A cross-sectional survey on dietary supplements consumption among Italian teen-agers.

PubMed

del Balzo, Valeria; Vitiello, Valeria; Germani, Alessia; Donini, Lorenzo M; Poggiogalle, Eleonora; Pinto, Alessandro

2014-01-01

In the last decades, dietary supplements consumption has increased in the Western world for all age groups. The long-term potentially dangerous effects related to an indiscriminate consumption of dietary supplements are still unknown and are becoming a matter of public health concern. Therefore, the aims of the present study were: to explore the contribution of dietary supplements to micronutrient daily intake, and to evaluate awareness and knowledge about dietary supplements. Participants (age ranging from 14 to 18 years) were recruited among students attending 8 high schools in the province of Frosinone (Italy). An anonymous questionnaire, composed of 12 multiple-choice items, was administered to all the participants. T-test and the analysis of variance (ANOVA) were performed to describe differences between means of the groups, while the chi-square test was used to compare observed and expected frequencies. The logistic regression model, aimed at identifying the characteristics of potential consumers of dietary supplements. A total of 686 teenagers (288 males and 398 females, average age: 17,89±0,91 years) participated in the study. The 83,6% of participants affirmed to be aware of dietary supplements. 239 participants consumed dietary supplements: 118 males and 121 females. 49,1% of females consumed dietary supplements less than twice a week, whereas 43,6% of males consumed dietary supplements from 2 to 5 times per week. Statistically significant differences emerged between the genders with respect to the source of information regarding dietary supplements, the perceived indications for their use, and the choice of the store/place to purchase them. Findings in the present study provide insight into the consumption of dietary supplements among young Italians, highlighting the need to foster further awareness among adolescents about the correct use of dietary supplements, especially in terms of indications and contraindications.

Dietary Supplements: What You Need to Know

MedlinePlus

... Products Food Home Food Resources for You Consumers Dietary Supplements: What You Need to Know Share Tweet Linkedin ... foods and nutrients you personally need. What are dietary supplements? Dietary supplements include such ingredients as vitamins, minerals, ...

Hepatitis C and Dietary Supplements: What the Science Says

MedlinePlus

... Health NCCIH Clinical Digest for health professionals Hepatitis C and Dietary Supplements: What the Science Says Share: ... Clinical Guidelines, Scientific Literature, Info for Patients: Hepatitis C and Dietary Supplements Dietary Supplements Milk Thistle Milk ...

Mutagenicity and Acute Oral Toxicity Test for Herbal Poultry Feed Supplements.

PubMed

Srinivasa Rao, Boddapati; Chandrasekaran, C V; Srikanth, H S; Sasikumar, Murugan; Edwin Jothie, R; Haseena, Begum; Bharathi, Bethapudi; Selvam, Ramasamy; Prashanth, D'Souza

2018-01-01

Herbal products are being used and trusted globally for thousands of years for their health benefits and limited side effects. Globally, a general belief amongst the consumers is that herbal supplements are always safe because they are "natural." But later, research reveals that they may not be safe. This raises concern on their safety and implications for their use as feed supplement or medicine. Toxicity testing can reveal some of the risks that may be associated with use of herbs, therefore avoiding potential harmful effects. The present study was designed to investigate five poultry feed supplements (PFS), EGMAX® (to revitalize ovarian activity), FEED-X ™ (feed efficiency enhancer), KOLIN PLUS ™ (natural replacer of synthetic choline chloride), PHYTOCEE® (natural defence enhancer), and STODI® (to prevent and control loose droppings), for their possible mutagenicity and toxicity. Bacterial reverse mutation (BRMT) and acute oral toxicity tests were employed to assess the PFS for their possible mutagenicity and toxicity. Results indicated that the PFS were devoid of mutagenic effects in BRMT and showed higher safety profile in rodent acute oral toxicity test.

Effects of Herbal Supplements on PTSD-Induced Changes in Rat Behavior & Brain Gene Expression

DTIC Science & Technology

2014-06-10

Corporation; 2008. 14. Bent S. Herbal medicine in the United States: review of efficacy, safety, and regulation: grand rounds at University of...Ceremuga, Thomas COL (Ret) USU Project Number: N10-P12 70. Bent S: Herbal medicine in the United States: review of efficacy, safety, and regulation...2012;177(7):814-822. 135. Ang-Lee MK, Moss J, Yuan CS. Herbal medicines and perioperative care. Jama. Jul 11 2001;286(2):208-216. 136. Jankowsi K

An RCT of Nurse Coaching vs. Herbal CAM for Soldier Weight Reduction

DTIC Science & Technology

2015-12-08

Coaching vs. Herbal CAM for Soldier Weight Reduction 5b. GRANT NUMBER HT9404-12-1-TS03 5c. PROGRAM ELEMENT NUMBER N/A 6. AUTHOR(S) 5d...coaching intervention and an herbal supplement for Service Member (SM) weight reduction over a 12-week period to evaluate their effectiveness...Title of Research Study or Evidence-Based Practice (EBP) Project An RCT of Nurse Coaching vs. Herbal CAM for Soldier Weight Reduction Period of Award

Dietary Supplement Intake and Associated Factors Among Gym Users in a University Community.

PubMed

Attlee, Amita; Haider, Amina; Hassan, Asma; Alzamil, Noura; Hashim, Mona; Obaid, Reyad Shaker

2018-01-02

Dietary supplement intake and associated factors among gym users in a university community in Sharjah, United Arab Emirates (UAE), were assessed using a structured, self-administered questionnaire in this cross-sectional study. Adults (N = 320) from five gyms in the University City of Sharjah participated in this cross-sectional study. The prevalence of dietary supplement intake was 43.8%. Statistically significant associations were found between the use of dietary supplements and sex (47.7% males, 28.1% females; p = .006), as well as weight lifting (88.6% taking supplements vs. 11.4% not taking supplements; p < .001), favoring male gym users. The reasons attributed to the use of dietary supplements varied between the sexes. Male exercisers used supplements to increase or maintain muscles mass, strength, and power and to boost exercise recovery. Females mainly used dietary supplements to increase energy, maintain their health, and prevent nutrition deficiency. Overall, protein supplements (whey proteins [48.6%] and protein powder [45.7%]) were among the most-consumed dietary supplements, followed by multivitamins (38.6%), branched-chain amino acids (36.4%), caffeine (35.0%), and creatine (29.3%). A widespread use of Internet-driven, self-prescribed dietary supplement intake was reported among gym users (60.7%). Only 12.8% of dietary supplement users sought information from dietitians. Practical implications suggest that gym instructors and coaches should be sufficiently trained to be able to provide accurate and scientifically sound information on dietary supplements to the exercisers in gyms in the university environment.

Chromatographic fingerprinting as a strategy to identify regulated plants in illegal herbal supplements.

PubMed

Custers, D; Van Praag, N; Courselle, P; Apers, S; Deconinck, E

2017-03-01

Erectile dysfunction (ED) is a sexual disorder characterized by the inability to achieve or maintain a sufficiently rigid erection. Despite the availability of non-invasive oral treatment options, many patients turn to herbal alternatives. Furthermore, herbal supplements are increasingly gaining popularity in industrialized countries and, as a consequence, quality control is a highly important issue. Unfortunately, this is not a simple task since plants are often crushed and mixed with other plants, which complicates their identification by usage of classical approaches such as microscopy. The aim of this study was to explore the potential use of chromatographic fingerprinting to identify plants present in herbal preparations intended for the treatment of ED. To achieve this goal, a HPLC-PDA and a HPLC-MS method were developed, using a full factorial experimental design in order to acquire characteristic fingerprints of three plants which are potentially beneficial for treating ED: Epimedium spp., Pausinystalia yohimbe and Tribulus terrestris. The full factorial design demonstrated that for all three plant references a C8 column (250mm×4.6mm; 5µm particle size) is best suited; methanol and an ammonium formate buffer (pH 3) were found to be the best constituents for the mobile phase. The suitability of this strategy was demonstrated by analysing several self-made triturations in three different botanical matrices, which mimic the influential effects that could be expected when analysing herbal supplements. To conclude, this study demonstrates that chromatographic fingerprinting could provide a useful means to identify plants in a complex herbal mixture. Copyright © 2016 Elsevier B.V. All rights reserved.

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

Herbal remedies and clinical biochemistry.

PubMed

Corns, Cathryn M

2003-09-01

The use of herbal products in the UK is increasing, and over-the-counter herbal supplements are perceived by the public as 'safe' and 'harmless'. Although the majority of them are safe, some herbal medicines carry risks. Heavy metal contamination, adulteration with Western pharmaceuticals and inclusion of prohibited animal and plant ingredients are regularly reported in ethnic medicines. Other herbs are hepato- or nephrotoxic and some interact with prescription medicines. Doctors should be made aware of the need to take a herbal as well as a drug history, and the clinical laboratory has a role in helping understanding of how herbal products may affect laboratory tests and in suggesting relevant lines of investigation in patients whose symptoms may be linked to the use of herbal products.

Oxidative stability of the meat of broilers supplemented with rosemary leaves, rosehip fruits, chokeberry pomace, and entire nettle, and effects on performance and meat quality.

PubMed

Loetscher, Y; Kreuzer, M; Messikommer, R E

2013-11-01

Prevention of lipid oxidation needs special attention because a high proportion of fatty acids in broiler meat are unsaturated. A feeding experiment was conducted to evaluate the antioxidant effect of dietary addition of rosemary, chokeberry pomace, rosehip, or nettle in comparison with vitamin E. Male Ross PM3 broilers caged in groups of 6 (4 replicated cages per treatment) were fed a balanced diet supplemented with 25 g/kg of herbal additive, 200 IU of α-tocopheryl acetate/kg, or without supplementation from d 7 to 35. Intake, performance, and with the help of excreta samples, apparent fiber digestibility, ME content, and metabolizability of nitrogen and energy were recorded per cage. Feed was analyzed for total phenols and tocopherols. In each bird (n = 24 per treatment), carcass weight and relative organ weights were recorded, and skin and liver color were assessed. Abdominal fat was analyzed for induction time (h) of lipid oxidation (Rancimat). Breast meat was analyzed for total tocopherol content (mg/kg) and development of TBA reactive substances (TBARS; μg of MDA/kg) over 9 d of storage. Data were subjected to ANOVA considering treatment and, where applicable, storage time. Rosemary supplementation reduced oxidation (TBARS d 9: 201; induction time: 2.48) and elevated tocopherol content (5.72) of the meat compared with control (470, 1.87, and 3.53, respectively). Rosemary-treated birds had a slightly lower carcass weight and a reduced nitrogen and energy metabolizability. Rosehip addition numerically decreased TBARS (319) and enhanced carcass weight (1.71 kg) compared with rosemary-treated birds (1.54 kg). Only a trend in antioxidant activity could be ascribed to chokeberry pomace, although dietary phenolic content was highest. Nettle did not improve oxidative stability (TBARS: 506; induction time: 1.91), although tocopherol content was elevated (6.51). Nettle treatment strongly intensified skin yellowness (b* of 20.6) compared with the control treatment (10.8). Clearly, rosemary is the most suitable dietary antioxidant investigated in this study, yet chokeberry and rosehip also exhibited interesting properties.

Response of irritable bowel syndrome with constipation patients administered a combined quebracho/conker tree/M. balsamea Willd extract.

PubMed

Brown, Kenneth; Scott-Hoy, Brandi; Jennings, Linda W

2016-08-06

The aim of this case series was to retrospectively examine the symptom response of irritable bowel syndrome with constipation (IBS-C) patients administered an herbal extract in a real-world setting. Twenty-four IBS-C patients in a community office practice were provided a combination over-the-counter dietary supplement composed of quebracho (150 mg), conker tree (470 mg) and M. balsamea Willd (0.2 mL) extracts (Atrantil™) and chose to take the formulation for a minimum of 2 wk in an attempt to manage their symptoms. Patient responses to the supplement were assessed by visual analogue scale (VAS) for abdominal pain, constipation and bloating at baseline and at 2 wk as part of standard-of-care. Patient scores from VAS assessments recorded in medical chart data were retrospectively compiled and assessed for the effects of the combined extract on symptoms. Sign tests were used to compare changes from baseline to 2 wk of taking the extract. Significance was defined as P < 0.05. Twenty-one of 24 patients (88%) responded to the dietary supplement as measured by individual improvements in VAS scores for abdominal pain, bloating and constipation symptoms comparing scores prior to administration of the extract against those reported after 2 wk. There were also significant improvements in individual as well as mean VAS scores after 2 wk of administration of the combined extract compared to baseline for abdominal pain [8.0 (6.5, 9.0) vs 2.0 (1.0, 3.0), P < 0.001], bloating [8.0 (7.0, 9.0) vs 1.0 (1.0, 2.0), P < 0.001] and constipation [6.0 (3.0, 8.0) vs 2.0 (1.0, 3.0), P < 0.001], respectively. In addition, 21 of 24 patients expressed improved quality of life while taking the formulation. There were no reported side effects to administration of the dietary supplement in this practice population suggesting excellent tolerance of the formulation. This pilot retrospective analysis of symptom scores from patients before and after consuming a quebracho/conker tree/M. balsamea Willd extract may support the formulation's use in IBS-C.

Response of irritable bowel syndrome with constipation patients administered a combined quebracho/conker tree/M. balsamea Willd extract

PubMed Central

Brown, Kenneth; Scott-Hoy, Brandi; Jennings, Linda W

2016-01-01

The aim of this case series was to retrospectively examine the symptom response of irritable bowel syndrome with constipation (IBS-C) patients administered an herbal extract in a real-world setting. Twenty-four IBS-C patients in a community office practice were provided a combination over-the-counter dietary supplement composed of quebracho (150 mg), conker tree (470 mg) and M. balsamea Willd (0.2 mL) extracts (Atrantil™) and chose to take the formulation for a minimum of 2 wk in an attempt to manage their symptoms. Patient responses to the supplement were assessed by visual analogue scale (VAS) for abdominal pain, constipation and bloating at baseline and at 2 wk as part of standard-of-care. Patient scores from VAS assessments recorded in medical chart data were retrospectively compiled and assessed for the effects of the combined extract on symptoms. Sign tests were used to compare changes from baseline to 2 wk of taking the extract. Significance was defined as P < 0.05. Twenty-one of 24 patients (88%) responded to the dietary supplement as measured by individual improvements in VAS scores for abdominal pain, bloating and constipation symptoms comparing scores prior to administration of the extract against those reported after 2 wk. There were also significant improvements in individual as well as mean VAS scores after 2 wk of administration of the combined extract compared to baseline for abdominal pain [8.0 (6.5, 9.0) vs 2.0 (1.0, 3.0), P < 0.001], bloating [8.0 (7.0, 9.0) vs 1.0 (1.0, 2.0), P < 0.001] and constipation [6.0 (3.0, 8.0) vs 2.0 (1.0, 3.0), P < 0.001], respectively. In addition, 21 of 24 patients expressed improved quality of life while taking the formulation. There were no reported side effects to administration of the dietary supplement in this practice population suggesting excellent tolerance of the formulation. This pilot retrospective analysis of symptom scores from patients before and after consuming a quebracho/conker tree/M. balsamea Willd extract may support the formulation’s use in IBS-C. PMID:27602249

Cancer chemoprevention by traditional chinese herbal medicine and dietary phytochemicals: targeting nrf2-mediated oxidative stress/anti-inflammatory responses, epigenetics, and cancer stem cells.

PubMed

Hun Lee, Jong; Shu, Limin; Fuentes, Francisco; Su, Zheng-Yuan; Tony Kong, Ah-Ng

2013-01-01

Excessive oxidative stress induced by reactive oxygen species (ROS), reactive nitrogen species (RNS), and reactive metabolites of carcinogens alters cellular homeostasis, leading to genetic/epigenetic changes, genomic instability, neoplastic transformation, and cancer initiation/progression. As a protective mechanism against oxidative stress, antioxidant/detoxifying enzymes reduce these reactive species and protect normal cells from endo-/exogenous oxidative damage. The transcription factor nuclear factor-erythroid 2 p45 (NF-E2)-related factor 2 (Nrf2), a master regulator of the antioxidative stress response, plays a critical role in the expression of many cytoprotective enzymes, including quinine oxidoreductase (NQO1), heme oxygenase-1 (HO-1), UDP-glucuronosyltransferase (UGT), and glutathione S-transferase (GST). Recent studies demonstrated that many dietary phytochemicals derived from various vegetables, fruits, spices, and herbal medicines induce Nrf2-mediated antioxidant/detoxifying enzymes, restore aberrant epigenetic alterations, and eliminate cancer stem cells (CSCs). The Nrf2-mediated antioxidant response prevents many age-related diseases, including cancer. Owing to their fundamental contribution to carcinogenesis, epigenetic modifications and CSCs are novel targets of dietary phytochemicals and traditional Chinese herbal medicine (TCHM). In this review, we summarize cancer chemoprevention by dietary phytochemicals, including TCHM, which have great potential as a safer and more effective strategy for preventing cancer.

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

The Prevalence of Dietary Supplement Use among College Students: A Nationwide Survey in Japan

PubMed Central

Kobayashi, Etsuko; Sato, Yoko; Umegaki, Keizo

2017-01-01

To clarify the prevalence of dietary supplement use among college students, we conducted Internet-based nationwide questionnaire surveys with 157,595 Japanese college students aged between 18 to 24 years old who were registrants of Macromill Inc. (Tokyo, Japan). Among the 9066 respondents (response rate 5.8%), 16.8% were currently using dietary supplements. The prevalence of dietary supplement use did not differ significantly between males (17.1%) and females (16.7%). However, it increased according to their grade (13.1% to 20.5%), and it was higher in medical and pharmaceutical college students (22.0%) compared to others (16.7%). The main purpose of dietary supplement use was for the health benefits in both males and females. Other reasons were to build muscle in males, and as a beauty supplement and for weight loss in females. According to the purpose of dietary supplement use, the most commonly-used dietary supplements were vitamin/mineral supplements in both males and females, then protein and weight loss supplements in males and females, respectively. Although most students obtained information about dietary supplements via the Internet, they typically purchased the supplements from drug stores. Of the students surveyed, 7.5% who were currently using or used to use dietary supplements experienced adverse effects, with no significant difference between genders (8.8% in male, 7.0% in female). In conclusion, the prevalence of dietary supplement use increased with grade among college students in Japan. Some of them experienced adverse effects. Education may be important to prevent adverse effects resulting from supplement use in college. PMID:29140269

Estimation of dietary supplements intake in a selected group of women over 50 and the risk assessment of interactions between the ingredients of dietary supplements and drugs

PubMed

Sadowska, Joanna; Bruszkowska, Magda

Concurrent use of dietary supplements and drugs may result in complications of pharmacotherapy due to possible interactions between their ingredients. The aim of the survey was to estimate the intake of dietary supplements in a group of women over 50 and to analyse the risk of interactions between the ingredients of dietary supplements and drugs taken by the women. The study was carried out among 146 women over 50 years of age. Questionnaire included detailed questions on the type of prescription drugs, OTC (over-the-counter) drugs, and dietary supplements taken. The risk of interactions was determined on the basis of chemical composition of the drugs and supplements specified by the manufacturer, by comparing the obtained data with literature reports on known interactions. The analysis has shown that 88.4% of respondents constantly took prescription drugs, 44.5% of them took OTC drugs, and 66.4% of respondents took dietary supplements throughout the survey period. It has been found that 71.3% of surveyed women taking prescription drugs, took dietary supplements as well. Among women taking supplements and drugs, 36.9% of respondents were taking them concurrently, 60.9% kept such an interval, but only 21.8% of them waited for at least two hours. It has been found that the drug-supplement interactions might occur in 35.8% women under the survey. The analysis of the obtained results has revealed that taking dietary supplements by the group under survey was frequent, and the risk of interactions between dietary supplements and drugs was significant. It is recommended that doctors ask their patients about taken supplements during regular check-ups, and inform them about possible interactions between dietary supplements and drugs. Moreover, appropriate would be to change the labelling of dietary supplements, so that the packaging provides information on possible interactions between their ingredients and drugs.

Term Coverage of Dietary Supplements Ingredients in Product Labels.

PubMed

Wang, Yefeng; Adam, Terrence J; Zhang, Rui

2016-01-01

As the clinical application and consumption of dietary supplements has grown, their side effects and possible interactions with prescribed medications has become a serious issue. Information extraction of dietary supplement related information is a critical need to support dietary supplement research. However, there currently is not an existing terminology for dietary supplements, placing a barrier for informatics research in this field. The terms related to dietary supplement ingredients should be collected and normalized before a terminology can be established to facilitate convenient search on safety information and control possible adverse effects of dietary supplements. In this study, the Dietary Supplement Label Database (DSLD) was chosen as the data source from which the ingredient information was extracted and normalized. The distribution based on the product type and the ingredient type of the dietary supplements were analyzed. The ingredient terms were then mapped to the existing terminologies, including UMLS, RxNorm and NDF-RT by using MetaMap and RxMix. The large gap between existing terminologies and ingredients were found: only 14.67%, 19.65%, and 12.88% of ingredient terms were covered by UMLS, RxNorm and NDF-RT, respectively.

Future development of global regulations of Chinese herbal products.

PubMed

Fan, Tai-Ping; Deal, Greer; Koo, Hoi-Lun; Rees, Daryl; Sun, He; Chen, Shaw; Dou, Jin-Hui; Makarov, Valery G; Pozharitskaya, Olga N; Shikov, Alexander N; Kim, Yeong Shik; Huang, Yi-Tsau; Chang, Yuan Shiun; Jia, William; Dias, Alberto; Wong, Vivian Chi-Woon; Chan, Kelvin

2012-04-10

GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims to collate data and draw comparison of these regulations. Case studies are also presented to illustrate the problems involved in registering TCM products in different regions worldwide. A collaborative network task force was established during the early stage of the GP-TCM project and operated through exchanges, teleconferences and focused discussions at annual meetings. The task force involved coordinators, academics who are actively involved with R&D of Chinese herbal medicines, experts on monographic standards of Chinese materia medica, representatives from regulatory agencies, experts from industries in marketing Chinese medicines/herbal medicines and natural products. The co-ordinators took turns to chair teleconferences, led discussions on specific issues at AGM discussion sessions, at joint workshops with other work-packages such as WP1 (quality issues), WP3 (toxicology issues) and WP6 (clinical trial issues). Collectively the authors were responsible for collating discussion outcomes and updating written information. A global overview of regulations on herbal registration has been compiled during the three years of the consortium. The regulatory requirements for registration of herbal products in the EU and China were compared, and this is extended to other regions/countries: Africa, Australia, Brazil, Canada, Japan, Russia, South Korea, Taiwan, and the United States. A wide variation of the regulations for the categories of herbal products exists: food (functional food, novel foods, dietary food for special medical purpose, foods for particular nutritional use, food supplement); cosmetic, traditional herbal medicine products; herbal medicines for human use and veterinary use. The regulatory issues for registration of herbal products are complicated among the countries and regions worldwide. The information summarised in the text is for reference only. Some regulations which are presented in this review are still in legislation process and may change in due course. Before taking any regulatory action, readers are advised to consult current official legislation and guidance and/or to seek appropriate professional advice. The lessons learnt from global regulation of TCM will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. The WHO is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Dietary supplements for dysmenorrhoea.

PubMed

Pattanittum, Porjai; Kunyanone, Naowarat; Brown, Julie; Sangkomkamhang, Ussanee S; Barnes, Joanne; Seyfoddin, Vahid; Marjoribanks, Jane

2016-03-22

Dysmenorrhoea refers to painful menstrual cramps and is a common gynaecological complaint. Conventional treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs), which both reduce myometrial activity (contractions of the uterus). A suggested alternative approach is dietary supplements. We used the term 'dietary supplement' to include herbs or other botanical, vitamins, minerals, enzymes, and amino acids. We excluded traditional Chinese medicines. To determine the efficacy and safety of dietary supplements for treating dysmenorrhoea. We searched sources including the Cochrane Gynaecology and Fertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, PsycINFO (all from inception to 23 March 2015), trial registries, and the reference lists of relevant articles. We included randomised controlled trials (RCTs) of dietary supplements for moderate or severe primary or secondary dysmenorrhoea. We excluded studies of women with an intrauterine device. Eligible comparators were other dietary supplements, placebo, no treatment, or conventional analgesia. Two review authors independently performed study selection, performed data extraction and assessed the risk of bias in the included trials. The primary outcomes were pain intensity and adverse effects. We used a fixed-effect model to calculate odds ratios (ORs) for dichotomous data, and mean differences (MDs) or standardised mean differences (SMDs) for continuous data, with 95% confidence intervals (CIs). We presented data that were unsuitable for analysis either descriptively or in additional tables. We assessed the quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. We included 27 RCTs (3101 women). Most included studies were conducted amongst cohorts of students with primary dysmenorrhoea in their late teens or early twenties. Twenty-two studies were conducted in Iran and the rest were performed in other middle-income countries. Only one study addressed secondary dysmenorrhoea. Interventions included 12 different herbal medicines (German chamomile (Matricaria chamomilla, M recutita, Chamomilla recutita), cinnamon (Cinnamomum zeylanicum, C. verum), Damask rose (Rosa damascena), dill (Anethum graveolens), fennel (Foeniculum vulgare), fenugreek (Trigonella foenum-graecum), ginger (Zingiber officinale), guava (Psidium guajava), rhubarb (Rheum emodi), uzara (Xysmalobium undulatum), valerian (Valeriana officinalis), and zataria (Zataria multiflora)) and five non-herbal supplements (fish oil, melatonin, vitamins B1 and E, and zinc sulphate) in a variety of formulations and doses. Comparators included other supplements, placebo, no treatment, and NSAIDs.We judged all the evidence to be of low or very low quality. The main limitations were imprecision due to very small sample sizes, failure to report study methods, and inconsistency. For most comparisons there was only one included study, and very few studies reported adverse effects. Effectiveness of supplements for primary dysmenorrhoea We have presented pain scores (all on a visual analogue scale (VAS) 0 to 10 point scale) or rates of pain relief, or both, at the first post-treatment follow-up. Supplements versus placebo or no treatmentThere was no evidence of effectiveness for vitamin E (MD 0.00 points, 95% CI -0.34 to 0.34; two RCTs, 135 women).There was no consistent evidence of effectiveness for dill (MD -1.15 points, 95% CI -2.22 to -0.08, one RCT, 46 women), guava (MD 0.59, 95% CI -0.13 to 1.31; one RCT, 151 women); one RCT, 73 women), or fennel (MD -0.34 points, 95% CI -0.74 to 0.06; one RCT, 43 women).There was very limited evidence of effectiveness for fenugreek (MD -1.71 points, 95% CI -2.35 to -1.07; one RCT, 101 women), fish oil (MD 1.11 points, 95% CI 0.45 to 1.77; one RCT, 120 women), fish oil plus vitamin B1 (MD -1.21 points, 95% CI -1.79 to -0.63; one RCT, 120 women), ginger (MD -1.55 points, 95% CI -2.43 to -0.68; three RCTs, 266 women; OR 5.44, 95% CI 1.80 to 16.46; one RCT, 69 women), valerian (MD -0.76 points, 95% CI -1.44 to -0.08; one RCT, 100 women), vitamin B1 alone (MD -2.70 points, 95% CI -3.32 to -2.08; one RCT, 120 women), zataria (OR 6.66, 95% CI 2.66 to 16.72; one RCT, 99 women), and zinc sulphate (MD -0.95 points, 95% CI -1.54 to -0.36; one RCT, 99 women).Data on chamomile and cinnamon versus placebo were unsuitable for analysis. Supplements versus NSAIDSThere was no evidence of any difference between NSAIDs and dill (MD 0.13 points, 95% CI -1.01 to 1.27; one RCT, 47 women), fennel (MD -0.70 points, 95% CI -1.81 to 0.41; one RCT, 59 women), guava (MD 1.19, 95% CI 0.42 to 1.96; one RCT, 155 women), rhubarb (MD -0.20 points, 95% CI -0.44 to 0.04; one RCT, 45 women), or valerian (MD points 0.62 , 95% CI 0.03 to 1.21; one RCT, 99 women),There was no consistent evidence of a difference between Damask rose and NSAIDs (MD -0.15 points, 95% CI -0.55 to 0.25; one RCT, 92 women).There was very limited evidence that chamomile was more effective than NSAIDs (MD -1.42 points, 95% CI -1.69 to -1.15; one RCT, 160 women). Supplements versus other supplementsThere was no evidence of a difference in effectiveness between ginger and zinc sulphate (MD 0.02 points, 95% CI -0.58 to 0.62; one RCT, 101 women). Vitamin B1 may be more effective than fish oil (MD -1.59 points, 95% CI -2.25 to -0.93; one RCT, 120 women). Effectiveness of supplements for secondary dysmenorrhoea There was no strong evidence of benefit for melatonin compared to placebo for dysmenorrhoea secondary to endometriosis (data were unsuitable for analysis). Safety of supplements Only four of the 27 included studies reported adverse effects in both treatment groups. There was no evidence of a difference between the groups but data were too scanty to reach any conclusions about safety. There is no high quality evidence to support the effectiveness of any dietary supplement for dysmenorrhoea, and evidence of safety is lacking. However for several supplements there was some low quality evidence of effectiveness and more research is justified.

Next-Gen Therapeutics for Skin Cancer: Nutraceuticals.

PubMed

Sreedhar, Annapoorna; Li, Jun; Zhao, Yunfeng

2018-05-15

Growing modernization and lifestyle changes with limited physical activity have impacted diet and health, leading to an increased cancer mortality rate worldwide. As a result, there is a greater need than before to develop safe and novel anticancer drugs. Current treatment options such as chemotherapy, radiotherapy and surgery, induce unintended side effects, compromising patient's quality of life, and physical well-being. Therefore, there has been an increased global interest in the use of dietary supplements and traditional herbal medicines for treatment of cancer. Recently, nutraceuticals or "natural" substances isolated from food have attracted considerable attention in the cancer field. Emerging research suggests that nutraceuticals may indeed prevent and protect against cancer. The intent of this article is to review some of the current spice-derived nutraceuticals in the treatment of melanoma and skin cancer.

Ischemic stroke after using over the counter products containing ephedra.

PubMed

Chen, Cassandra; Biller, Jose; Willing, Steven J; Lopez, Alfredo M

2004-01-15

Dietary supplements containing Ephedra used for weight loss and physical performance enhancement such as "herbal ecstasy" are widely available, and it is estimated that at least 1% of the adult population have taken these products. Ephedra products including Ephedra alkaloids such as phenylpropanolamine or other ephedrine compounds are sold under different names such as Metabolife 356, Ripped Fuel, Thermadrene, and Shape-Fast Plus. Over 2 years, five patients with ischemic infarctions associated with use of Ephedra products were evaluated at Indiana University Hospital. Ephedrine, like other sympathomimetic agents, predisposes patients to both ischemic and hemorrhagic strokes. People who take over the counter Ephedra products that claim to boost weight loss, increase energy, or bolster physical performance are at risk of adverse events including ischemic and hemorrhagic strokes.

Acute coronary syndrome presenting after pseudoephedrine use and regression with beta-blocker therapy

PubMed Central

Akay, Serhat; Ozdemir, Metehan

2008-01-01

Pseudoephedrine, a common ingredient in cold relief drugs, dietary supplements and Chinese herbal tea, has potent sympathomimetic effects, impacting the cardiovascular system. The chemical properties and clinical effects of pseudoephedrine are similar to those of ephedrine, and its main effect is caused by the release of endogenous norepinephrine. A 45-year-old man who presented with chest pain following ingestion of pseudoephedrine-containing prescription medication is described. The patient was initially diagnosed with inferior myocardial infarction based on an electrocardiogram, and intravenous metoprolol was started pending coronary artery angiography. Metoprolol reversed the ST segment elevation and relieved the symptoms, and coronary angiography showed normal coronary arteries. The present case highlights beta-blocker therapy as part of an initial intervention of pseudoephedrine-related cardiac symptoms. PMID:18987767

Acute coronary syndrome presenting after pseudoephedrine use and regression with beta-blocker therapy.

PubMed

Akay, Serhat; Ozdemir, Metehan

2008-11-01

Pseudoephedrine, a common ingredient in cold relief drugs, dietary supplements and Chinese herbal tea, has potent sympathomimetic effects, impacting the cardiovascular system. The chemical properties and clinical effects of pseudoephedrine are similar to those of ephedrine, and its main effect is caused by the release of endogenous norepinephrine. A 45-year-old man who presented with chest pain following ingestion of pseudoephedrine--containing prescription medication is described. The patient was initially diagnosed with inferior myocardial infarction based on an electrocardiogram, and intravenous metoprolol was started pending coronary artery angiography. Metoprolol reversed the ST segment elevation and relieved the symptoms, and coronary angiography showed normal coronary arteries. The present case highlights beta-blocker therapy as part of an initial intervention of pseudoephedrine-related cardiac symptoms.

Environmental influences: factors influencing a woman's decision to use dietary supplements.

PubMed

Conner, Mark; Kirk, Sara F L; Cade, Janet E; Barrett, Jennifer H

2003-06-01

Use of dietary supplements by women, particularly those over 40 years of age may be widespread in the United Kingdom. However, from surveillance data, there appears to be a disparity between nutrition and health needs and the rationale for and actual use of dietary supplements by women. This apparent paradox forms the basis for an inverse supplement hypothesis (i.e., supplement use in women appears to be most prevalent among those with least need). Little research has been done to examine the factors underlying the decision to use dietary supplements. Reasons for consuming dietary supplements are often complex, combining social, psychological, knowledge and economic factors. The theory of planned behavior is a widely used model for assessing factors influencing behavioral motivation and action that may be useful for assessing specific diet- and nutrition-related practices. It provided the basis for the development of a questionnaire to explore overall dietary supplement use in a cohort of women in the United Kingdom. The analysis of factors related to beliefs underlying dietary supplement use revealed differences between supplement users and nonusers. Differences included a stronger belief by users than nonusers that taking dietary supplements ensures against possible ill health. Both users and nonusers of supplements also perceived the media (books and magazines) to be a powerful influence on a person's decision to use supplements. These findings highlight the potential of the theory of planned behavior in exploring supplement-taking behavior while throwing light on the factors influencing an individual's motivations to use dietary supplements.

78 FR 4153 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

...; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION... dietary supplements to notify us that they are marketing a dietary supplement product that bears on its... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a...

Dietary Supplement Use in the United States, 2003–20061

PubMed Central

Bailey, Regan L.; Gahche, Jaime J.; Lentino, Cindy V.; Dwyer, Johanna T.; Engel, Jody S.; Thomas, Paul R.; Betz, Joseph M.; Sempos, Christopher T.; Picciano, Mary Frances

2011-01-01

Dietary supplement use has steadily increased over time since the 1970s; however, no current data exist for the U.S. population. Therefore, the purpose of this analysis was to estimate dietary supplement use using the NHANES 2003–2006, a nationally representative, cross-sectional survey. Dietary supplement use was analyzed for the U.S. population (≥1 y of age) by the DRI age groupings. Supplement use was measured through a questionnaire and was reported by 49% of the U.S. population (44% of males, 53% of females). Multivitamin-multimineral use was the most frequently reported dietary supplement (33%). The majority of people reported taking only 1 dietary supplement and did so on a daily basis. Dietary supplement use was lowest in obese adults and highest among non-Hispanic whites, older adults, and those with more than a high-school education. Between 28 and 30% reported using dietary supplements containing vitamins B-6, B-12, C, A, and E; 18–19% reported using iron, selenium, and chromium; and 26–27% reported using zinc- and magnesium-containing supplements. Botanical supplement use was more common in older than in younger age groups and was lowest in those aged 1–13 y but was reported by ~20% of adults. About one-half of the U.S. population and 70% of adults ≥ 71 y use dietary supplements; one-third use multivitamin-multimineral dietary supplements. Given the widespread use of supplements, data should be included with nutrient intakes from foods to correctly determine total nutrient exposure. PMID:21178089

Use of Iodine-Containing Dietary Supplements Remains Low among Women of Reproductive Age in the United States: NHANES 2011-2014.

PubMed

Gupta, Priya M; Gahche, Jaime J; Herrick, Kirsten A; Ershow, Abby G; Potischman, Nancy; Perrine, Cria G

2018-03-29

In the United States, the American Thyroid Association recommends that women take a dietary supplement containing 150 µg of iodine 3 months prior to conception and while pregnant and lactating to support fetal growth and neurological development. We used data from the National Health and Nutrition Examination Survey 2011–2014 to describe the use of dietary supplements with and without iodine in the past 30 days among 2155 non-pregnant, non-lactating (NPNL) women; 122 pregnant women; and 61 lactating women. Among NPNL women, 45.3% (95% Confidence Interval [CI]: 42.0, 48.6) used any dietary supplement and 14.8% (95% CI: 12.7, 16.8) used a dietary supplement with iodine in the past 30 days. Non-Hispanic black and Hispanic women were less likely to use any dietary supplement as well as one with iodine, than non-Hispanic white or non-Hispanic Asian women ( p < 0.05). Among pregnant women, 72.2% (95% CI: 65.8, 78.6) used any dietary supplement; however, only 17.8% (95% CI: 11.4, 24.3) used a dietary supplement with iodine. Among lactating women, 75.0% (95% CI: 63.0, 87.0) used a dietary supplement; however, only 19.0% (95% CI: 8.8, 29.2) used a dietary supplement with iodine. Among NPNL women using a supplement with iodine, median daily iodine intake was 75.0 µg. Self-reported data suggests that the use of iodine containing dietary supplements among pregnant and lactating women remains low in contrast with current recommendations.

Use of Iodine-Containing Dietary Supplements Remains Low among Women of Reproductive Age in the United States: NHANES 2011–2014

PubMed Central

Gupta, Priya M.; Gahche, Jaime J.; Herrick, Kirsten A.; Ershow, Abby G.; Potischman, Nancy; Perrine, Cria G.

2018-01-01

In the United States, the American Thyroid Association recommends that women take a dietary supplement containing 150 µg of iodine 3 months prior to conception and while pregnant and lactating to support fetal growth and neurological development. We used data from the National Health and Nutrition Examination Survey 2011–2014 to describe the use of dietary supplements with and without iodine in the past 30 days among 2155 non-pregnant, non-lactating (NPNL) women; 122 pregnant women; and 61 lactating women. Among NPNL women, 45.3% (95% Confidence Interval [CI]: 42.0, 48.6) used any dietary supplement and 14.8% (95% CI: 12.7, 16.8) used a dietary supplement with iodine in the past 30 days. Non-Hispanic black and Hispanic women were less likely to use any dietary supplement as well as one with iodine, than non-Hispanic white or non-Hispanic Asian women (p < 0.05). Among pregnant women, 72.2% (95% CI: 65.8, 78.6) used any dietary supplement; however, only 17.8% (95% CI: 11.4, 24.3) used a dietary supplement with iodine. Among lactating women, 75.0% (95% CI: 63.0, 87.0) used a dietary supplement; however, only 19.0% (95% CI: 8.8, 29.2) used a dietary supplement with iodine. Among NPNL women using a supplement with iodine, median daily iodine intake was 75.0 µg. Self-reported data suggests that the use of iodine containing dietary supplements among pregnant and lactating women remains low in contrast with current recommendations. PMID:29596306

77 FR 31622 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary... Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act--21 U.S.C. 379aa-1(b)(1) (OMB Control Number 0910- 0635)--Extension The Dietary Supplement and...

Why do Dutch people use dietary supplements? Exploring the role of socio-cognitive and psychosocial determinants.

PubMed

Pajor, E M; Eggers, S M; Curfs, K C J; Oenema, A; de Vries, H

2017-07-01

In the Netherlands, the prevalence of dietary supplement use has doubled (from 17 to 40 per cent) since the 1980s. Yet, limited data is available on which socio-cognitive factors are associated with dietary supplement use. Therefore, the purpose of the study is to explain dietary supplement use with determinants deriving from the Integrated Change Model (ICM) and from formative research. Socio-cognitive and psychosocial factors were measured among users and non-users of dietary supplements in a longitudinal survey study, with measurements at baseline (N = 1448) and at one-month follow-up (N = 1161). Negative binomial regression analysis was applied to de data. Intention emerged as the main predictor of dietary supplement use (OR = 1.99). Further predictors of dietary supplement use with smaller effect-sizes were: health regulatory focus (promotion, OR = 1.46), social modelling (OR = 1.44), attitude (pros, OR = 1.37), attitude (cons, OR = 0.87), health locus of control (OR = 0.77), and risk perception (chance of getting ill, OR = 1.22). Individuals tend to use dietary supplements if they are promotion oriented, notice dietary supplement users in their social environment, estimate their chances of getting ill higher, and have positive attitudes towards dietary supplements. In contrast, non-users believe that external factors affect their health, and hold negative attitudes towards dietary supplements. Mapping out individuals' socio-cognitive profile may contribute to the development of online health communication. Based on socio-cognitive and demographical factors, personalised advice can be given about dietary supplement use. Copyright © 2017 Elsevier Ltd. All rights reserved.

Dietary supplement research portfolio at the NIH, 2009-2011.

PubMed

Garcia-Cazarin, Mary L; Wambogo, Edwina A; Regan, Karen S; Davis, Cindy D

2014-04-01

The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009-2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement-related funding for FYs 2009-2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women's reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements.

An in vitro and in vivo study of a 4-herb formula on the management of diet-induced metabolic syndrome.

PubMed

Wat, Elaine; Wang, Yanping; Chan, Ken; Law, Hon Wai; Koon, Chi Man; Lau, Kit Man; Leung, Ping Chung; Yan, Choly; Lau, Clara Bik San

2018-03-15

Metabolic syndrome is the cluster of risk factors that leads to increased episodes of cardiovascular disease (CVD). These risk factors include but are not limited to obesity, non-alcoholic fatty liver (NAFLD), dyslipidemia, and type 2 diabetes. Since the pathogenesis of metabolic syndrome has multiple metabolic origins, there is no single treatment for it. Pharmacological approaches consist of separate drugs which target at individual risk factors which pose various side effects. Functional foods or nutraceuticals which have potentially important anti-obesity properties have thus attracted great attention. Schisandrae Fructus is a Chinese herb traditionally used as a liver tonic. Silymarin, an extract of the milk thistle (Silybum marianum), is a dietary supplement that is widely used in western society for the prevention and treatment of liver problems. Crataegus Fructus (hawthorn) is traditionally used to promote digestion and dissipate food stagnation. Momordica charantia (bitter melon) is traditionally used for treatment of diabetes in Ayurvedic Medicine. We aimed to develop a multi-targeted herbal formula to target on the multiple risk factors of metabolic syndrome using individual herbs. This proposed herbal formula include sylimarin and Schisandrae Fructus, for NAFLD; Crataegus Fructus for obesity and hyperlipidemia; and Momordica charantia for hyperglycemia. For in vitro study, we carried out insulin-induced 3T3-L1 adipocytes differentiation and fluorescent tagged cholesterol-treated Caco-2 cell assay to study for adipogenesis and cholesterol uptake into Caco-2 cells, respectively. Oleic acid-induced HepG2 cell assay was used to study for oleic acid-induced fatty liver, and brush border membrane vesicles (BBMV) assay was used to study for glucose uptake from the gut. For in vivo study, we performed an 8-week and a 12-week treatment studies, with each study comprising of 4 groups of C57Bl/6 male mice given: (i) Normal-chow diet; (ii)-(iv) High-fat diet (contains 21% fat and 0.15% cholesterol). After the initial 8 weeks of normal chow or high-fat diet feeding to induce obesity, animals were given: (i) Normal-chow diet; (ii) High-fat diet; (iii) High-fat diet + 2% herbal formula; or (iv) High-fat diet + 4% herbal formula as treatment for another 8 weeks or 12 weeks. Our in vitro results suggested Crataegus Fructus aqueous extract exerted potent inhibitory effects on 3T3-L1 preadipocytes differentiation and cholesterol uptake into Caco-2 cells. Schisandrae Fructus aqueous extract and milk thistle exerted inhibitory effects on oleic acid-induced fatty liver in HepG2 cells. Momordica charantia extract on the other hand, exerted significant inhibitory effect on glucose uptake into BBMV. Our in vivo results showed that our herbal formula exhibited a trend to reduce diet-induced increase in body weight and fat pad mass (epididymal, perirenal and inguinal fat); and significantly reduced diet-induced increase in liver weight, liver lipid, and plasma lipid dose-dependently. Besides, high-fat diet induced a significant reduction in adiponectin level which was significantly improved by herbal formula supplementation at 4%. There was however no significant effect of the herbal formula on diet-induced increase in plasma glucose or insulin levels at either dose. Herbal formula also significantly reduced diet-induced inflammation in the liver at both doses. Taken together, these data suggested the potential of our novel multi-targeted herbal formula to be used as a therapeutic agent for diet-induced metabolic syndrome, with special emphasis on NAFLD. Copyright © 2018. Published by Elsevier GmbH.

Use of dietary supplements by cardiologists, dermatologists and orthopedists: report of a survey

PubMed Central

2011-01-01

Background Dietary supplements are regularly used by a majority of the American population, and usage by health professionals is also common. There is considerable interest in usage patterns within the population and in the reasons for using dietary supplements. The "Life...supplemented" Healthcare Professionals 2008 Impact Study (HCP Impact Study) surveyed usage of dietary supplements by physicians in three specialties: cardiology, dermatology, and orthopedics. Methods The HCP Impact Study was conducted online by Ipsos Public Affairs for the Council for Responsible Nutrition (CRN), a trade association of the dietary supplement industry. Respondents were 900 physicians, including 300 each from three specialties - cardiology, dermatology, and orthopedics. Results Fifty-seven percent of cardiologists said they use dietary supplements at least occasionally, as did 75% of dermatologists and 73% of orthopedists. The product most commonly reported to be used was a multivitamin, but over 25% in each specialty said they used omega-3 fatty acids and over 20% said they used some botanical supplements. Regular dietary supplement use was reported by 37% of cardiologists, 59% of dermatologists, and 50% of orthopedists. Seventy-two percent of cardiologists, 66% of dermatologists, and 91% of orthopedists reported recommending dietary supplements to their patients. The primary reason given for recommending dietary supplements to patients was for heart health or lowering cholesterol for the cardiologists; benefits for skin, hair and nails for the dermatologists; and bone and joint health for the orthopedists. Conclusions Reported dietary supplement use was relatively common in this sample of physicians, and when they recommended dietary supplements to patients, they tended to do so for reasons related to their specialty. PMID:21371318

77 FR 17076 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription... information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). DATES: Submit...

75 FR 9232 - Office of Dietary Supplements (ODS) 2010-2014 Strategic Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

...-2014. SUMMARY: The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has..., entitled Strengthening Knowledge and Understanding of Dietary Supplements. The strategic plan is available... the federal government, academia, the dietary supplement industry, consumer advocacy and education...

The Association between Taking Dietary Supplements and Healthy Habits among Korean Adults: Results from the Fifth Korea National Health and Nutritional Examination Survey (2010-2012).

PubMed

Kim, Jin-Wook; Lee, So-Hye; Kim, Jung-Eun; Han, Kyung-Do; Kwack, Tae-Eung; Kim, Bo-Seon; Kim, Jeong-Eun; Jo, Eun-Bae; Park, Young-Kyu; Lee, Kyung-Shik

2016-05-01

Recently, the number of people interested in health in South Korea has increased, and the rate of dietary supplement use is rising. Researchers have hypothesized that the rate of practicing healthy habits is higher among those who use dietary supplements than those who do not. Therefore, this study aimed to discover the association between taking dietary supplements and practicing various healthy habits in the Korean, adult population. The sample included 15,789 adults over 19 years old who participated in the fifth Korea National Health and Nutrition Examination Survey. The user group was defined as those taking dietary supplements for more than 2 weeks during the previous year or once during the past month. Measures for the seven healthy habits were based on those included in the Alameda study and were analyzed accounting for the complex sampling design. The rate of taking dietary supplements was significantly higher in women, middle aged participants, urban residents, those with a higher income, those with a higher education level, and nonsmokers as well as among women with a moderate subjective health status, women who limited their alcohol content, and women with dyslipidemia. In the adjusted analysis, the rate of performing three of the 'Alameda 7' habits-eating breakfast regularly, restricting snacking, and limiting drinking-was higher in the female dietary supplement user group than in the other groups. Women practiced more healthy habits and had a higher dietary supplement intake rate than men. We found that taking dietary supplements in Korean adults is highly associated with demographic and social factors. Taking dietary supplements had a relationship with dietary habits, and there was no significant association between dietary supplement and other healthy habits. Thus in the health clinic, we suggest that taking dietary supplements complements a patient's healthy habits, with the exception of dietary habits, for health promotion.

The Association between Taking Dietary Supplements and Healthy Habits among Korean Adults: Results from the Fifth Korea National Health and Nutritional Examination Survey (2010–2012)

PubMed Central

Kim, Jin-Wook; Lee, So-Hye; Kim, Jung-Eun; Han, Kyung-Do; Kwack, Tae-Eung; Kim, Bo-Seon; Kim, Jeong-Eun; Jo, Eun-Bae; Park, Young-Kyu

2016-01-01

Background Recently, the number of people interested in health in South Korea has increased, and the rate of dietary supplement use is rising. Researchers have hypothesized that the rate of practicing healthy habits is higher among those who use dietary supplements than those who do not. Therefore, this study aimed to discover the association between taking dietary supplements and practicing various healthy habits in the Korean, adult population. Methods The sample included 15,789 adults over 19 years old who participated in the fifth Korea National Health and Nutrition Examination Survey. The user group was defined as those taking dietary supplements for more than 2 weeks during the previous year or once during the past month. Measures for the seven healthy habits were based on those included in the Alameda study and were analyzed accounting for the complex sampling design. Results The rate of taking dietary supplements was significantly higher in women, middle aged participants, urban residents, those with a higher income, those with a higher education level, and nonsmokers as well as among women with a moderate subjective health status, women who limited their alcohol content, and women with dyslipidemia. In the adjusted analysis, the rate of performing three of the 'Alameda 7' habits—eating breakfast regularly, restricting snacking, and limiting drinking—was higher in the female dietary supplement user group than in the other groups. Women practiced more healthy habits and had a higher dietary supplement intake rate than men. Conclusion We found that taking dietary supplements in Korean adults is highly associated with demographic and social factors. Taking dietary supplements had a relationship with dietary habits, and there was no significant association between dietary supplement and other healthy habits. Thus in the health clinic, we suggest that taking dietary supplements complements a patient's healthy habits, with the exception of dietary habits, for health promotion. PMID:27274390

Use of dietary supplements among gym trainees in Tanta city, Egypt.

PubMed

Abo Ali, Ehab A; Elgamal, Hanan H

2016-12-01

The use of dietary supplements has greatly increased in the past few years. Few studies described the prevalence of supplement use among gym trainees. The practices of most of the athletes and gym trainees in Egypt remain undocumented. This study aimed to assess the prevalence of dietary supplement use among gyms trainees in Tanta city, Egypt. A cross-sectional comparative study was carried out on 450 gym trainees aged more than or equal to 20 years in Tanta city, Egypt. Nine representative gyms (50 participants from each) were recruited in the study. Data on sociodemographic characteristics, health and lifestyle characteristics, type, underlying motive(s), and source(s) of information about dietary supplements were collected from each participant. Of the 450 participants, 38.2% reported using dietary supplements. Male participants and those with higher family incomes used dietary supplements more than female participants and those with lower family incomes (P<0.05). Female participants used vitamins/minerals, weight loss, and natural groups of dietary supplements more than male participants (P<0.05), whereas male participants used body-building group of supplements more than female participants (P<0.05). Participants of older ages (≥30) tended to use the natural group of dietary supplements more than younger ones (P<0.05). Female participants were more motivated to use dietary supplements for the prevention of nutritional and/or medical problems and for weight loss, whereas male participants used dietary supplements for muscle building/repair (P<0.05). Female participants mostly got their information about dietary supplements from health professionals and from the media more than male participants, whereas male participants got this information mainly from gym personnel. A considerable proportion of gym trainees use dietary supplements, mostly without professional consultation and frequently without any indication. It is very important to disseminate accurate information on these products in the sports environment.

Common use of dietary supplements for bipolar disorder: a naturalistic, self-reported study.

PubMed

Bauer, Michael; Glenn, Tasha; Conell, Jörn; Rasgon, Natalie; Marsh, Wendy; Sagduyu, Kemal; Munoz, Rodrigo; Lewitzka, Ute; Bauer, Rita; Pilhatsch, Maximilian; Monteith, Scott; Whybrow, Peter C

2015-12-01

Dietary supplements are taken by about half of Americans. Knowledge of dietary supplement use is important because they may interact with prescription drugs or other supplements, cause adverse reactions including psychiatric symptoms, or contain inherently toxic ingredients or contaminants. This study explores the use of dietary supplements by patients with bipolar disorder in the US. Data were obtained from an ongoing, naturalistic study of patients with bipolar disorder who received pharmacological treatment as usual. The patients self-reported their daily mood, sleep, and medications taken, including all drugs prescribed for bipolar disorder or that the patient felt impacted their mood. These included other prescribed drugs, over-the-counter drugs and dietary supplements. Drugs that received premarketing approval from the FDA were not included as dietary supplements. Patient demographics and daily medication use were characterized. Data were available from 348 patients in the US who returned a mean 249.5 days of data. In addition to prescribed psychiatric drugs, 101 of the 348 patients (29 %) used a dietary supplement for at least 7 days and 69 (20 %) used a supplement long term (for at least 50 % of days). Of the 101 supplement users, 72 (71.3 %) took one supplement daily. The 101 patients tried over 40 different supplements, and the long-term users took 19 different supplements. The most commonly taken supplements for both groups were fish oil, B vitamins, melatonin, and multivitamins. Patients using supplements were more likely to be white (p < 0.001), older (p = 0.009), and ill for more years (p = 0.025). Many patients with bipolar disorder use dietary supplements in addition to prescribed drugs. Physicians should obtain detailed information about all dietary supplements taken by patients with bipolar disorder.

Trends in Dietary Supplement Use in a Cohort of Postmenopausal Women From Iowa

PubMed Central

Park, Kyong; Jacobs, David R.

2009-01-01

Although it is widely known that use of dietary supplements is common in the United States, little is known about use patterns among older Americans. The authors examined trends in dietary supplement use and its contribution to total nutrient intake in the Iowa Women's Health Study cohort in 1986 (baseline) and 2004 (follow-up). The proportion of women who reported using dietary supplements increased substantially between baseline (66%) and follow-up (85%). Moreover, a substantial proportion of women reported using multiple dietary supplements, with 27% using 4 or more products in 2004. Dietary supplements contributed substantially to total intake of many nutrients at baseline, and their contribution became relatively greater at follow-up for most nutrients examined. For most nutrients, no decline in intake was observed, as might have been expected in an aging cohort. Rather, intake of many nutrients increased, primarily because of the rising use of dietary supplements. Use of dietary supplements by older individuals is of particular importance because of the potential benefits of maintaining nutrient intake levels despite potentially declining food intake. However, possible risks from obtaining a large proportion of purified nutrients from dietary supplements rather than deriving them from foods should be studied. PMID:19208725

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

Progress in development of an integrated dietary supplement ingredient database at the NIH Office of Dietary Supplements

PubMed Central

Dwyer, Johanna T.; Picciano, Mary Frances; Betz, Joseph M.; Fisher, Kenneth D.; Saldanha, Leila G.; Yetley, Elizabeth A.; Coates, Paul M.; Radimer, Kathy; Bindewald, Bernadette; Sharpless, Katherine E.; Holden, Joanne; Andrews, Karen; Zhao, Cuiwei; Harnly, James; Wolf, Wayne R.; Perry, Charles R.

2013-01-01

Several activities of the Office of Dietary Supplements (ODS) at the National Institutes of Health involve enhancement of dietary supplement databases. These include an initiative with US Department of Agriculture to develop an analytically substantiated dietary supplement ingredient database (DSID) and collaboration with the National Center for Health Statistics to enhance the dietary supplement label database in the National Health and Nutrition Examination Survey (NHANES). The many challenges that must be dealt with in developing an analytically supported DSID include categorizing product types in the database, identifying nutrients, and other components of public health interest in these products and prioritizing which will be entered in the database first. Additional tasks include developing methods and reference materials for quantifying the constituents, finding qualified laboratories to measure the constituents, developing appropriate sample handling procedures, and finally developing representative sampling plans. Developing the NHANES dietary supplement label database has other challenges such as collecting information on dietary supplement use from NHANES respondents, constant updating and refining of information obtained, developing default values that can be used if the respondent cannot supply the exact supplement or strength that was consumed, and developing a publicly available label database. Federal partners and the research community are assisting in making an analytically supported dietary supplement database a reality. PMID:25309034

Development of an Alert System to Detect Drug Interactions with Herbal Supplements using Medical Record Data.

PubMed

Archer, Melissa; Proulx, Joshua; Shane-McWhorter, Laura; Bray, Bruce E; Zeng-Treitler, Qing

2014-01-01

While potential medication-to-medication interaction alerting engines exist in many clinical applications, few systems exist to automatically alert on potential medication to herbal supplement interactions. We have developed a preliminary knowledge base and rules alerting engine that detects 259 potential interactions between 9 supplements, 62 cardiac medications, and 19 drug classes. The rules engine takes into consideration 12 patient risk factors and 30 interaction warning signs to help determine which of three different alert levels to categorize each potential interaction. A formative evaluation was conducted with two clinicians to set initial thresholds for each alert level. Additional work is planned add more supplement interactions, risk factors, and warning signs as well as to continue to set and adjust the inputs and thresholds for each potential interaction.

Dietary Supplement Research Portfolio at the NIH, 2009–201112

PubMed Central

Garcia-Cazarin, Mary L.; Wambogo, Edwina A.; Regan, Karen S.; Davis, Cindy D.

2014-01-01

The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009–2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement–related funding for FYs 2009–2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women’s reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements. PMID:24523489

Safety of herbal medicine in treatment of weight loss

PubMed Central

Najafian, Jamshid; Abdar-Esfahani, Morteza; Arab-Momeni, Morteza; Akhavan-Tabib, Afshan

2014-01-01

BACKGROUND Obesity is a common health problem in both developed and developing countries. There are many unconventional therapies, including herbal medicine, to treat this condition. Some people believe that herbal medicines are safe. This case and review is about adverse complication of treating obesity with some herbal medicine. CASE REPORT A 19 year old male with sever obesity (120 kg) used green tea (15 cups of green tea per day) and an intensive dietary regimen to lose weight. He lost 30 kg after 2 months. At that time, one day after usual exercise he suddenly lost consciousness due to left ventricular fibrillation. CONCLUSION Use of herbal medicine for weight reduction is not always safe. Moreover, for some herbal medicine the risk is sufficient to shift the risk-benefit balance against the use that medicine. PMID:24963315

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2012 CFR

2012-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2013 CFR

2013-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

78 FR 69095 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... a dietary supplement that contains an NDI, a manufacturer or distributor of dietary supplements or... upon which the manufacturer or distributor has based its conclusion that a dietary supplement... statutory provisions. Section 190.6(a) requires each manufacturer or distributor of a dietary supplement...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.260 - What must the batch record include?

Code of Federal Regulations, 2010 CFR

2010-04-01

..., LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements... dietary supplement; and (2) That you assign in accordance with § 111.415(f) for the following: (i) Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement; (ii...

Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

PubMed

Sax, Joanna K

2015-01-01

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Suspected dietary supplement injuries in special operations soldiers.

PubMed

Hughes, John; Shelton, Byron; Hughes, Teresa

2010-01-01

Evidence suggests that a number of Special Operations Soldiers are using dietary supplements to augment their physical training programs and that some of these supplements are not entirely benign. This article presents a series of case reports of Soldiers who suffered adverse effects that may be at least partially attributable to the use of dietary supplements. Given that many Special Operations Soldiers train at the same level as world class athletes and the use of supplements is common among world class athletes, the use of supplements is not likely to stop. To this end, the purpose of this article is to provide awareness of the problem, discuss some of the harmful effects of dietary supplements, make a recommendation for education to help reduce the number of injuries resulting from the use of dietary supplements, and recommend that scientific studies be done to prove the benefits and risks of taking dietary supplements. © 2010.

Reasons why Thai patients with chronic kidney disease use or do not use herbal and dietary supplements.

PubMed

Tangkiatkumjai, Mayuree; Boardman, Helen; Praditpornsilpa, Kearkiat; Walker, Dawn-Marie

2014-12-06

Despite a high prevalence of herbal and dietary supplement use (HDS) in pre-dialysis patients, the reasons are unknown as to why they decide to use HDS. Objectives of the cross-sectional and qualitative studies were to determine reasons for the use and non-use of HDS in Thai patients with chronic kidney disease (CKD). This prospective study recruited 421 patients with stage 3-5 CKD from two kidney clinics in Thailand, and 357 were followed up regarding their HDS use over 12 months. Patients receiving renal replacement therapy at baseline were excluded. Participants were interviewed at baseline and in the twelfth month regarding their HDS use, and reasons for their use or non-use of HDS. Among HDS users, 16 patients were enrolled in a qualitative study and were interviewed using eight-open ended questions about reasons for HDS use. Descriptive and thematic analyses were performed. Thirty-four percent of patients with CKD consistently used HDS over the 12 months and 17% of all patients intermittently took them during the follow-up period. At baseline, family or friends' recommendation was the most common reason for HDS use (35%), followed by having a perception of benefits from using HDS (24%). During the follow-up period, perceived benefits of HDS was a frequently reported reason for either continuing with HDS use (85%) or starting to use HDS (65%). Negative experience from using HDS influenced patients to stop using them (19%). Although the main reason for non-use of HDS was trust in a doctor or effectiveness of conventional medicine (32%), doubt about the benefits from HDS or concerns about negative effects were frequently reported reasons for non-use (23%). Doctor's recommendations to avoid using HDS were the main influence for non-users (19%) and for those who had stopped using HDS (23%). The media and patients' social network had an impact on HDS use. Patients who perceived benefits from HDS use were more likely to use HDS, whilst non-users had negative attitudes towards HDS. Health professionals therefore should educate patients and their relatives about the risks and benefits from using HDS.

Drug interaction study of flavonoids toward CYP3A4 and their quantitative structure activity relationship (QSAR) analysis for predicting potential effects.

PubMed

Li, Yannan; Ning, Jing; Wang, Yan; Wang, Chao; Sun, Chengpeng; Huo, Xiaokui; Yu, Zhenlong; Feng, Lei; Zhang, Baojing; Tian, Xiangge; Ma, Xiaochi

2018-05-09

The high risk of herb-drug interactions (HDIs) mediated by the herbal medicines and dietary supplements which containing abundant flavonoids had become more and more frequent in our daily life. In our study, the inhibition activities of 44 different structures of flavonoids toward human CYPs were systemically evaluated for the first time. According to our results, a remarkable structure-dependent inhibition behavior toward CYP3A4 was observed in vitro. Some flavonoids such as licoflavone (12) and irilone (30) exhibited the selective inhibition toward CYP3 A4 rather than other major human CYPs. To illustrate the interaction mechanism, the inhibition kinetics of various compounds was further performed. Sophoranone (1), apigenin (10), baicalein (11), 5,4'-dihydroxy-3,6,7,8,3'-pentamethoxyflavone (15), myricetin (23) and kushenol K (38) remarkably inhibited the CYP3 A4-catalyzed bufalin 5'-hydroxylation reaction, with K i values of 2.17 ± 0.29, 6.15 ± 0.39, 9.18 ± 3.40, 2.30 ± 0.36, 5.00 ± 2.77 and 1.35 ± 0.25 μM, respectively. Importantly, compounds 1, 11, 15, 23 and 38 could significantly inhibit the metabolism of some clinical drugs in vitro, and these drug-drug interactions (DDIs) of myricetin (23) or kushenol K (38) with clinical drug diazepam were further verified in human primary hepatocytes, respectively. Finally, a quantitative structure-activity relationship (QSAR) of flavonoids with their inhibitory effects toward CYP3 A4 was established using computational methods. Our findings illustrated the high risk of herb-drug interactions (HDIs) caused by flavonoids and revealed the vital structures requirement of natural flavonoids for the HDIs with clinical drugs eliminated by CYP3 A4. Our research provided the useful guidance to safely and rationally use herbal medicines and dietary supplements containing rich natural flavonoids components. Copyright © 2018 Elsevier B.V. All rights reserved.

76 FR 32214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-03

... a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to FDA upon which it has based its conclusion that a dietary supplement containing a new dietary... delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary...

78 FR 52773 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary... delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary...

Should You Take Dietary Supplements?

MedlinePlus

... August 2013 Print this issue Should You Take Dietary Supplements? A Look at Vitamins, Minerals, Botanicals and More ... half of all Americans take one or more dietary supplements daily or on occasion. Supplements are available without ...

Dental patients' self-reported use of dietary supplements on medical history questionnaires.

PubMed

Bakuri, Sarmad; Lanning, Sharon K; Best, Al M; Sabatini, Robert; Gunsolley, John; Waldrop, Thomas C

2016-01-01

Dietary supplement effects and drug interactions can lead to significant adverse health events, thus potentially impacting the safe delivery of oral healthcare. This study sought to determine the frequency of, and factors impacting, dietary supplement use among 209 dental patients and whether the design of a medical history questionnaire influences reporting of supplement use. Patients were randomly allocated to 1 of 2 groups in which they completed either a standard medical history questionnaire (n = 107) or the same questionnaire with an additional item about dietary supplement use (n = 102). All patients were then administered a survey with questions about their demographics, their use and knowledge of dietary supplements, and the person or persons who recommended dietary supplement use to the patient. While 62% of the total population (130/209) reported supplement use, specific prompting nearly doubled the number of supplements reported (mean with prompting: 1.53; mean without prompting: 0.76; P < 0.0001). Patients younger than 30 years of age reported significantly less dietary supplement use than all other age groups except the 30-40 age group (P = 0.0003). An estimated 70% of all respondents were not aware of potentially detrimental side effects of dietary supplement use or possible interactions with conventional drug therapies. Since patients tended to report a greater use of dietary supplements when specifically asked about their use on a medical history questionnaire, a checklist or set of designated questions may be a suitable first step toward gathering this essential information.

Dietary supplements in the setting of mohs surgery.

PubMed

Collins, Siobhan C; Dufresne, Raymond G

2002-06-01

The use of dietary supplements has become increasingly popular. While many are safe in small doses, others may have potentially harmful effects, particularly in surgical patients. To study the incidence of dietary supplement use in patients presenting for Mohs surgery. One hundred consecutive patients presenting for Mohs surgery completed a questionnaire providing all current medications. During the consultation, the patients were then asked specifically about their current use of any dietary supplements. Responses differing from those on the questionnaire were recorded. Forty-nine of 100 patients (49%) were currently taking dietary supplements. Of this group, 17 patients (35%) self-reported the use of supplements; 32 patients (65%) did not. Thirty women (59%) were currently using dietary supplements regularly compared to 19 men (39%). Women were also more likely to self-report the use of supplements compared to men: 14 women (47%) versus three men (15%). Forty-eight of the 100 study patients (48%) were currently taking anticoagulant medications such as aspirin, warfarin, nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel bisulfate. Fifty instances were noted where patients were taking one or more dietary supplements that have demonstrated anticoagulant properties. Of this group, 21 instances (42%) where patients took a combination of prescription and over-the-counter (OTC) anticoagulants and one or more dietary supplements shown to have effects on coagulation were recorded. Of the almost 50% of patients taking dietary supplements, one-third reported usage, while two-thirds did not. Women used dietary supplements more frequently than men and were more than three times more likely to offer this information. Furthermore, many supplements have been shown to have effects on coagulation, including vitamin E, garlic, ginkgo, feverfew, and fish oils. Use of these substances alone or in combination may potentiate the anticoagulant effects of each other or prescribed medications. It is therefore important for the dermatologic surgeon to communicate openly with patients regarding dietary supplements to avoid potential complications during or following surgery.

Dietary Crude Lecithin Increases Systemic Availability of Dietary Docosahexaenoic Acid with Combined Intake in Rats.

PubMed

van Wijk, Nick; Balvers, Martin; Cansev, Mehmet; Maher, Timothy J; Sijben, John W C; Broersen, Laus M

2016-07-01

Crude lecithin, a mixture of mainly phospholipids, potentially helps to increase the systemic availability of dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), such as docosahexaenoic acid (DHA). Nevertheless, no clear data exist on the effects of prolonged combined dietary supplementation of DHA and lecithin on RBC and plasma PUFA levels. In the current experiments, levels of DHA and choline, two dietary ingredients that enhance neuronal membrane formation and function, were determined in plasma and red blood cells (RBC) from rats after dietary supplementation of DHA-containing oils with and without concomitant dietary supplementation of crude lecithin for 2-3 weeks. The aim was to provide experimental evidence for the hypothesized additive effects of dietary lecithin (not containing any DHA) on top of dietary DHA on PUFA levels in plasma and RBC. Dietary supplementation of DHA-containing oils, either as vegetable algae oil or as fish oil, increased DHA, eicosapentaenoic acid (EPA), and total n-3 PUFA, and decreased total omega-6 PUFA levels in plasma and RBC, while dietary lecithin supplementation alone did not affect these levels. However, combined dietary supplementation of DHA and lecithin increased the changes induced by DHA supplementation alone. Animals receiving a lecithin-containing diet also had a higher plasma free choline concentration as compared to controls. In conclusion, dietary DHA-containing oils and crude lecithin have synergistic effects on increasing plasma and RBC n-3 PUFA levels, including DHA and EPA. By increasing the systemic availability of dietary DHA, dietary lecithin may increase the efficacy of DHA supplementation when their intake is combined.

Nutraceuticals and Dietary Supplements to Improve Quality of Life and Outcomes in Heart Failure Patients.

PubMed

Cicero, Arrigo F G; Colletti, Alessandro

2017-01-01

Heart failure (HF) is a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill or eject blood. It represents a major public health issue, with a prevalence of over 23 million worldwide. The lifetime risk of developing HF is one in five and the most important risk factors identified are ischemic heart disease, hypertension, smoking, obesity and diabetes. Preventive approaches are based on improvements of lifestyle, associated with pharmacological therapy. Several nutraceuticals have shown interesting clinical results in prevention of HF as well as in the treatment of the early stages of the disease, alone or in association with pharmacological therapy. The aim of this review is to resume the available clinical evidence on phytochemicals effect on HF prevention and/or treatment. A systematic search strategy was developed to identify trials in PubMed (January 1980 to April 2016). The terms 'nutraceuticals', 'dietary supplements', 'herbal drug' and 'heart failure' were incorporated into an electronic search strategy. Clinical trials reported that the intake of some nutraceuticals (hawthorn, coenzyme Q10, L-carnitine, Dribose, Carnosine, Vitamin D, Some probiotics, Omega-3 PUFAs, Beet nitrates) is associated with improvements in functional parameters such as ejection fraction, stroke volume and cardiac output in HF patients, with minimal side effects. These findings were sometimes reinforced by subsequent meta-analyses, which further concluded that benefits tended to be greater in earlier stage HF. The main mechanisms involved are antioxidant, antinflammatory, anti-ischemic and antiaggregant effects. Evidence suggests that the supplementation with nutraceuticals may be a useful option for effective management of HF, with the advantage of excellent clinical tolerance. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Nutritional Supplements and the Brain.

PubMed

Meeusen, Romain; Decroix, Lieselot

2018-03-01

Cognitive function plays an important role in athletic performance, and it seems that brain functioning can be influenced by nutrition and dietary components. Thus, the central nervous system might be manipulated through changes in diet or supplementation with specific nutrients including branched-chain amino acids, tyrosine, carbohydrates, and caffeine. Despite some evidence that branched-chained amino acids can influence ratings of perceived exertion and mental performance, several well-controlled studies have failed to demonstrate a positive effect on exercise performance. Evidence of an ergogenic benefit of tyrosine supplementation during prolonged exercise is limited. There is evidence that mild dehydration can impair cognitive performance and mood. The beneficial effect of carbohydrate supplementation during prolonged exercise could relate to increased substrate delivery for the brain, with numerous studies indicating that hypoglycemia affects brain function and cognitive performance. Caffeine can enhance performance and reduce perception of effort during prolonged exercise and will influence specific reward centers of the brain. Plant products and herbal extracts such as polyphenols, ginseng, ginkgo biloba, etc. are marketed as supplements to enhance performance. In several animal studies, positive effects of these products were shown, however the literature on their effects on sports performance is scarce. Polyphenols have the potential to protect neurons against injury induced by neurotoxins, suppress neuroinflammation, and to promote memory, learning, and cognitive function. In general, there remains a need for controlled randomized studies with a strong design, sufficient statistical power, and well-defined outcome measures before "claims" on its beneficial effects on brain functioning can be established.

Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

PubMed

Dodge, Tonya

2016-01-01

In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Four common herbs seen in dental practice: properties and potential adverse effects.

PubMed

Shankland, Wesley E

2009-04-01

The use of herbal supplements in North America is steadily growing and raises concerns about safety, efficacy, and how they affect safe patient care. The most notable and direct health risks associated with herbal supplements include hypertension, prolonged bleeding, and the potential for drug-herb interactions, which is of particular concern for patients undergoing anesthesia, both general and local anesthesia. In this article, four of the most commonly used herbs today in North America will be discussed: garlic, gingko, ginseng, and ginger. The pharmacology, benefits, and possible side effects of these herbs will be presented. Awareness of the rising use of herbs is important to prevent, recognize, and treat potential problems that can arise from herbal preparations taken alone or in conjunction with prescription medications.

21 CFR 111.1 - Who is subject to this part?

Code of Federal Regulations, 2014 CFR

2014-04-01

... HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.1 Who is subject to this part? (a..., package, label, or hold a dietary supplement, including: (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and (2) A dietary supplement imported or offered for import...

21 CFR 111.1 - Who is subject to this part?

Code of Federal Regulations, 2012 CFR

2012-04-01

... HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.1 Who is subject to this part? (a..., package, label, or hold a dietary supplement, including: (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and (2) A dietary supplement imported or offered for import...

78 FR 68453 - Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

... Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug... Dietary Supplements--21 CFR 111.75(a)(1)(ii) (OMB Control Number 0910-0608)-- Extension The Dietary... supplements. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if ``it has...

21 CFR 111.113 - What quality control operations are required for a material review and disposition decision?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or... or batches of a dietary supplement; or (5) A dietary supplement is returned. (b)(1) When there is a...

Systematic review of herbs and dietary supplements for glycemic control in diabetes.

PubMed

Yeh, Gloria Y; Eisenberg, David M; Kaptchuk, Ted J; Phillips, Russell S

2003-04-01

To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.

Cancer Chemoprevention by Traditional Chinese Herbal Medicine and Dietary Phytochemicals: Targeting Nrf2-Mediated Oxidative Stress/Anti-Inflammatory Responses, Epigenetics, and Cancer Stem Cells

PubMed Central

Hun Lee, Jong; Shu, Limin; Fuentes, Francisco; Su, Zheng-Yuan; Tony Kong, Ah-Ng

2013-01-01

Excessive oxidative stress induced by reactive oxygen species (ROS), reactive nitrogen species (RNS), and reactive metabolites of carcinogens alters cellular homeostasis, leading to genetic/epigenetic changes, genomic instability, neoplastic transformation, and cancer initiation/progression. As a protective mechanism against oxidative stress, antioxidant/detoxifying enzymes reduce these reactive species and protect normal cells from endo-/exogenous oxidative damage. The transcription factor nuclear factor-erythroid 2 p45 (NF-E2)-related factor 2 (Nrf2), a master regulator of the antioxidative stress response, plays a critical role in the expression of many cytoprotective enzymes, including NAD(P)H:quinine oxidoreductase (NQO1), heme oxygenase-1 (HO-1), UDP-glucuronosyltransferase (UGT), and glutathione S-transferase (GST). Recent studies demonstrated that many dietary phytochemicals derived from various vegetables, fruits, spices, and herbal medicines induce Nrf2-mediated antioxidant/detoxifying enzymes, restore aberrant epigenetic alterations, and eliminate cancer stem cells (CSCs). The Nrf2-mediated antioxidant response prevents many age-related diseases, including cancer. Owing to their fundamental contribution to carcinogenesis, epigenetic modifications and CSCs are novel targets of dietary phytochemicals and traditional Chinese herbal medicine (TCHM). In this review, we summarize cancer chemoprevention by dietary phytochemicals, including TCHM, which have great potential as a safer and more effective strategy for preventing cancer. PMID:24716158

[Whether the advertisement of dietary supplements is objective source of data about their impact on health? Analysis of broadcasting advertisements in the terms of the food law].

PubMed

Wierzejska, Regina

2016-01-01

Dietary supplements are intensively advertised in the media. Due to their form analogous to drugs many people don't notice differences between them, although it is fundamental. The dietary supplement, as the category of food don't have medicinal properties and suggesting such properties by producers is forbidden. The aim of this study was analysis of advertisements of dietary supplements, transmitted in the media in accordance with the law requirements, especially with the conditions of nutrition and health claims established in 2012. Advertisements of dietary supplements, transmitted in the period of one week (17-23 of September 2014 r.) into 5 radio and television channels. In the analysed period commercials of 27 assortments of the dietary supplement were being transmitted. Advertisements of 23 of them declared improvement the action of organs or concentration of biochemical indicators in the body. The strength of declarations about the benefits of action of dietary supplements was diversified, from expressions such as "support" to "treat" and "prevent". In some advertisements the authority of medical profession was being used. Moreover many advertisements emphasized the unique and comprehensive active ingredients of dietary supplement on the market. Advertisements of dietary supplements promise beneficial effect to the human body. In spite of more and more detailed legal requirements many of them are going beyond conditions established for food. It can cause incorrect opinion about the role of dietary supplements in curing medical disorders.

Prevalence, Knowledge and Attitudes Concerning Dietary Supplements among a Student Population in Croatia.

PubMed

Žeželj, Sandra Pavičić; Tomljanović, Ana; Jovanović, Gordana Kenđel; Krešić, Greta; Peloza, Olga Cvijanović; Dragaš-Zubalj, Nataša; Prokurica, Iva Pavlinić

2018-05-23

The aim of this study was to determine the prevalence of usage and the knowledge and attitudes towards dietary supplements among medical sciences and nonmedical sciences students from Croatia. The study was conducted based on a questionnaire about dietary supplement usage, knowledge and attitudes. The prevalence of dietary supplement use, among 910 university students was 30.5%. The most-used dietary supplements were vitamins (18.0% in medical sciences students and 9.8% in non-medical sciences students). For all students, the internet (66.1%) was the most common source of information, followed by healthcare professionals (33.2%). The most common reason for taking dietary supplements was to maintain good health (26.4%). Use of the internet rather than health professionals as a trusted information source should be revised among this young population. Supplement intake was significantly associated with body mass index (BMI) ( p = 0.016) and physical activity ( p = 0.050). Students with normal BMI (61.5%) and the most physically active students (37.7%) took significantly more dietary supplements. Results of this study could help medicine faculties to improve their curriculum and support the development of public health messages aimed at wise and safe use of dietary supplements.

Dietary Supplement Adverse Event Report Data From the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013.

PubMed

Timbo, Babgaleh B; Chirtel, Stuart J; Ihrie, John; Oladipo, Taiye; Velez-Suarez, Loy; Brewer, Vickery; Mozersky, Robert

2018-05-01

The Food and Drug Administration (FDA)'s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety of the nation's foods, dietary supplements, and cosmetic products. To present a descriptive analysis of the 2004-2013 dietary supplement adverse event report (AER) data from CAERS and evaluate the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act as pertaining to dietary supplements adverse events reporting. We queried CAERS for data from the 2004-2013 AERs specifying at least 1 suspected dietary supplement product. We extracted the product name(s), the symptom(s) reported, age, sex, and serious adverse event outcomes. We examined time trends for mandatory and voluntary reporting and performed analysis using SAS v9.4 and R v3.3.0 software. Of the total AERs (n = 15 430) received from January 1, 2004, through December 31, 2013, indicating at least 1 suspected dietary supplement product, 66.9% were mandatory, 32.2% were voluntary, and 0.9% were both mandatory and voluntary. Reported serious outcomes included death, life-threatening conditions, hospitalizations, congenital anomalies/birth defects and events requiring interventions to prevent permanent impairments (5.1%). The dietary supplement adverse event reporting rate in the United States was estimated at ~2% based on CAERS data. This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 period and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

A structured vocabulary for indexing dietary supplements in databases in the United States

PubMed Central

Saldanha, Leila G; Dwyer, Johanna T; Holden, Joanne M; Ireland, Jayne D.; Andrews, Karen W; Bailey, Regan L; Gahche, Jaime J.; Hardy, Constance J; Møller, Anders; Pilch, Susan M.; Roseland, Janet M

2011-01-01

Food composition databases are critical to assess and plan dietary intakes. Dietary supplement databases are also needed because dietary supplements make significant contributions to total nutrient intakes. However, no uniform system exists for classifying dietary supplement products and indexing their ingredients in such databases. Differing approaches to classifying these products make it difficult to retrieve or link information effectively. A consistent approach to classifying information within food composition databases led to the development of LanguaL™, a structured vocabulary. LanguaL™ is being adapted as an interface tool for classifying and retrieving product information in dietary supplement databases. This paper outlines proposed changes to the LanguaL™ thesaurus for indexing dietary supplement products and ingredients in databases. The choice of 12 of the original 14 LanguaL™ facets pertinent to dietary supplements, modifications to their scopes, and applications are described. The 12 chosen facets are: Product Type; Source; Part of Source; Physical State, Shape or Form; Ingredients; Preservation Method, Packing Medium, Container or Wrapping; Contact Surface; Consumer Group/Dietary Use/Label Claim; Geographic Places and Regions; and Adjunct Characteristics of food. PMID:22611303

Prevalence, Adverse Events, and Factors Associated with Dietary Supplement and Nutritional Supplement Use by US Navy and Marine Corps Personnel.

PubMed

Knapik, Joseph J; Trone, Daniel W; Austin, Krista G; Steelman, Ryan A; Farina, Emily K; Lieberman, Harris R

2016-09-01

About 50% of Americans and 60% to 70% of US military personnel use dietary supplements, some of which have been associated with adverse events (AEs). Nutritional supplements like sport drinks and sport bars/gels are also commonly used by athletes and service members. Previous dietary supplement and nutritional supplement surveys were conducted on Army, Air Force, and Coast Guard personnel. The aim of this cross-sectional study was to investigate dietary and nutritional supplement use in Navy and Marine Corps personnel, including the prevalence, types, factors associated with use, and AEs. A random sample of 10,000 Navy and Marine Corps personnel were contacted. Service members were asked to complete a detailed questionnaire describing their personal characteristics, supplement use, and AEs experienced. In total, 1,708 service members completed the questionnaire during August through December 2014, with 1,683 used for analysis. Overall, 73% reported using dietary supplements one or more times per week. The most commonly used dietary supplements (used one or more times per week) were multivitamins/multiminerals (48%), protein/amino acids (34%), combination products (33%), and individual vitamins and minerals (29%). About 31% of service members reported using five or more dietary supplements. Sport drinks and sport bars/gels were used by 45% and 23% of service members, respectively. Monthly expenditures on dietary supplements averaged $39; 31% of service members spent ≥$50/mo. Multivariate logistic regression modeling indicated that female sex (women/men; odds ratio [OR]=1.76, 95% CI 1.32 to 2.36), higher educational level (college degree/no college degree; OR=2.23, 95% CI 1.62 to 3.30), higher body mass index (calculated as kg/m(2)) (≥30/<25; OR=1.67, 95% CI 1.06 to 2.63), and a greater amount of resistance training (≥271/0 to 45 min/week; OR=2.85, 95% CI 1.94 to 4.17) were associated with dietary supplement use. Twenty-two percent of dietary supplement users and 6% of nutritional supplement users reported one or more AEs. For combination products alone, 29% of users reported one or more AEs. The prevalence of dietary supplement use in Navy and Marine Corps personnel was considerably higher than reported in civilian investigations for almost all types of dietary supplements, although similar to most other military services. Factors associated with dietary supplement use were similar to those reported in previous military and civilian investigations. Prevalence of self-reported AEs was very high, especially for combination products. Published by Elsevier Inc.

Gynaecomastia linked to the intake of a herbal supplement fortified with diethylstilbestrol.

PubMed

Toorians, A W F T; Bovee, T F H; De Rooy, J; Stolker, L A A M; Hoogenboom, R L A P

2010-07-01

This study reports the findings of a supplement marketed on the Internet for prostate problems. The supplement was orally taken by a 60-year-old man with divergent hormonal levels and who was surgically treated for gynaecomastia: development of abnormally large mammary glands in males. The supplement showed a strong effect in a yeast oestrogen bioassay, expressing a yeast-enhanced green fluorescent protein (yEGFP) upon exposure to oestrogens. Using both nuclear magnetic resonance (NMR) and a gradient liquid chromatographic time-of-flight mass spectrometric (LC/TOF-MS) method, the response was shown to be caused by very high levels of diethylstilbestrol, known for causing gynaecomastia. The gynaecomastia was most probably caused by this orally taken 'natural' herbal supplement, as the patient's hormonal levels also returned to normal again when stopping the use of it. This case demonstrates that physicians need to be aware of the use of supplements with illegal components that may be responsible for unwanted side-effects.

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification § 190.6 Requirement for premarket... dietary supplement that contains a new dietary ingredient that has not been present in the food supply as... manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of...

Herbal Energizers: Speed By Any Other Name.

ERIC Educational Resources Information Center

Jenkins, Andrew P.

This guide focuses on over-the-counter (OTC) stimulants sold to high school aged athletes and dieters as "herbal energizers," food supplements, and fatigue reducers. While advertising often makes them appear healthful and harmless, all of these stimulants belong in the class "sympathomimetic amines," so called because they…

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2011 CFR

2011-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2013 CFR

2013-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2012 CFR

2012-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2012 CFR

2012-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2011 CFR

2011-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2014 CFR

2014-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2013 CFR

2013-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2010 CFR

2010-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

Consumer attitudes about the role of multivitamins and other dietary supplements: report of a survey.

PubMed

Dickinson, Annette; MacKay, Douglas; Wong, Andrea

2015-07-02

U.S. nutrition surveys find that intakes of many nutrients fall short of recommendations. The majority of U.S. adults use multivitamins and other dietary supplements as one means of improving nutrient intakes. Some policy makers and health professionals appear reluctant to recommend routine use of dietary supplements to fill nutrient gaps in the diet, in part because they are concerned that people will view the supplements as a substitute for dietary improvement and that the use of supplements may lead to overconsumption of micronutrients. Surveys find that in fact users of dietary supplements tend to have better diets and adopt other healthy habits, suggesting that the supplements are viewed as one aspect of an overall effort to improve wellness. Furthermore, evidence demonstrates that the incidence of excess micronutrient intake is low. We report the results of a survey probing consumer attitudes about the role of dietary supplements. The Council for Responsible Nutrition funded a survey to measure consumer attitudes about the role of multivitamins, calcium and/or vitamin D supplements, and other supplements in improving dietary intakes. The research was designed and analyzed by FoodMinds and was fielded using Toluna's On-line Omnibus. The weighted sample of 2159 respondents is representative of U.S. adults. Nearly 90% of the survey respondents agreed that multivitamins and supplements of calcium and/or vitamin D can help meet nutrient needs when desirable intakes are not achieved through food alone. At the same time, 80% agreed that dietary supplements should not be used to replace healthy dietary or lifestyle habits, and 82% agreed that people considering taking a high dose, single nutrient supplement should talk with their physician. These results provide additional support for the conclusion that the vast majority of consumers recognize that multivitamins and other supplements can help fill nutrient gaps but should not be viewed as replacements for a healthy diet. This suggests that policy makers and health professionals could feel comfortable recommending rational dietary supplementation as one means of improving nutrient intakes, without being unduly concerned that such a recommendation would lead consumers to discount the importance of good dietary habits.

77 FR 35687 - Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer... of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) and the...

Drug-Induced Liver Injury Network Causality Assessment: Criteria and Experience in the United States.

PubMed

Hayashi, Paul H

2016-02-04

Hepatotoxicity due to drugs, herbal or dietary supplements remains largely a clinical diagnosis based on meticulous history taking and exclusion of other causes of liver injury. In 2004, the U.S. Drug-Induced Liver Injury Network (DILIN) was created under the auspices of the U.S. National Institute of Diabetes and Digestive and Kidney Diseases with the aims of establishing a large registry of cases for clinical, epidemiological and mechanistic study. From inception, the DILIN has used an expert opinion process that incorporates consensus amongst three different DILIN hepatologists assigned to each case. It is the most well-established, well-described and vigorous expert opinion process for DILI to date, and yet it is an imperfect standard. This review will discuss the DILIN expert opinion process, its strengths and weaknesses, psychometric performance and future.

Solid-phase microextraction technology for in vitro and in vivo metabolite analysis

PubMed Central

Zhang, Qihui; Zhou, Liandi; Chen, Hua; Wang, Chong-Zhi; Xia, Zhining; Yuan, Chun-Su

2016-01-01

Analysis of endogenous metabolites in biological samples may lead to the identification of biomarkers in metabolomics studies. To achieve accurate sample analysis, a combined method of continuous quick sampling and extraction is required for online compound detection. Solid-phase microextraction (SPME) integrates sampling, extraction and concentration into a single solvent-free step for chemical analysis. SPME has a number of advantages, including simplicity, high sensitivity and a relatively non-invasive nature. In this article, we reviewed SPME technology in in vitro and in vivo analyses of metabolites after the ingestion of herbal medicines, foods and pharmaceutical agents. The metabolites of microorganisms in dietary supplements and in the gastrointestinal tract will also be examined. As a promising technology in biomedical and pharmaceutical research, SPME and its future applications will depend on advances in analytical technologies and material science. PMID:27695152

Complementarity in dietary supplements and foods: are supplement users vegetable eaters?

PubMed

Kang, Hyoung-Goo; Joo, Hailey Hayeon; Choi, Kyong Duk; Lee, Dongmin; Moon, Junghoon

2017-01-01

Background : The consumption of fruits, vegetables, and dietary supplements correlate. Most previous studies have aimed to identify the determinants of supplement uses or the distinct features of supplement users; this literature lacks a discussion on dietary supplement consumption as a predictor of fruit and vegetable consumption. Objective : This study examines how dietary supplement consumption correlates with fruit and vegetable consumption by combining scanner data and surveys of Korean household grocery shopping. Methods : Propensity score matching (PSM) is used to identify the relationship between dietary supplement consumption and fruit and vegetable consumption in a household. A logit regression using supplement consumption as the dependent variable is used. Then, the supplement takers (the treatment group) are matched with non-takers (the control group) based on the propensity scores estimated in the logit regression. The fruit and vegetable consumption levels of the groups are then compared. Results : We found that dietary supplement use is associated with higher fruit and vegetable consumption. This supports the health consciousness hypothesis based on attention bias, availability heuristics, the focusing effect, and the consumption episode effect. It rejects the health substitute hypothesis based on economic substitutes and mental accounting. Conclusions : Future research on the health benefits of dietary supplements should address the complementary consumption of fruits/vegetables and their health benefits to avoid misstating the health effects of supplements.

Complementarity in dietary supplements and foods: are supplement users vegetable eaters?

PubMed Central

Kang, Hyoung-Goo; Joo, Hailey Hayeon; Choi, Kyong Duk; Lee, Dongmin; Moon, Junghoon

2017-01-01

ABSTRACT Background: The consumption of fruits, vegetables, and dietary supplements correlate. Most previous studies have aimed to identify the determinants of supplement uses or the distinct features of supplement users; this literature lacks a discussion on dietary supplement consumption as a predictor of fruit and vegetable consumption. Objective: This study examines how dietary supplement consumption correlates with fruit and vegetable consumption by combining scanner data and surveys of Korean household grocery shopping. Methods: Propensity score matching (PSM) is used to identify the relationship between dietary supplement consumption and fruit and vegetable consumption in a household. A logit regression using supplement consumption as the dependent variable is used. Then, the supplement takers (the treatment group) are matched with non-takers (the control group) based on the propensity scores estimated in the logit regression. The fruit and vegetable consumption levels of the groups are then compared. Results: We found that dietary supplement use is associated with higher fruit and vegetable consumption. This supports the health consciousness hypothesis based on attention bias, availability heuristics, the focusing effect, and the consumption episode effect. It rejects the health substitute hypothesis based on economic substitutes and mental accounting. Conclusions: Future research on the health benefits of dietary supplements should address the complementary consumption of fruits/vegetables and their health benefits to avoid misstating the health effects of supplements. PMID:28904529

Dangerous dietary supplements: Garcinia cambogia-associated hepatic failure requiring transplantation.

PubMed

Lunsford, Keri E; Bodzin, Adam S; Reino, Diego C; Wang, Hanlin L; Busuttil, Ronald W

2016-12-07

Commercial dietary supplements are marketed as a panacea for the morbidly obese seeking sustainable weight-loss. Unfortunately, many claims cited by supplements are unsupported and inadequately regulated. Most concerning, however, are the associated harmful side effects, often unrecognized by consumers. Garcinia cambogia extract and Garcinia cambogia containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we report the first known case of fulminant hepatic failure associated with this dietary supplement. One active ingredient in this supplement is hydroxycitric acid, an active ingredient also found in weight-loss supplements banned by the Food and Drug Administration in 2009 for hepatotoxicity. Heightened awareness of the dangers of dietary supplements such as Garcinia cambogia is imperative to prevent hepatoxicity and potential fulminant hepatic failure in additional patients.

Natural products modulating the hERG channel: heartaches and hope.

PubMed

Kratz, Jadel M; Grienke, Ulrike; Scheel, Olaf; Mann, Stefan A; Rollinger, Judith M

2017-08-02

Covering: 1996-December 2016The human Ether-à-go-go Related Gene (hERG) channel is a voltage-gated potassium channel playing an essential role in the normal electrical activity in the heart. It is involved in the repolarization and termination of action potentials in excitable cardiac cells. Mutations in the hERG gene and hERG channel blockage by small molecules are associated with increased risk of fatal arrhythmias. Several drugs have been withdrawn from the market due to hERG channel-related cardiotoxicity. Moreover, as a result of its notorious ligand promiscuity, this ion channel has emerged as an important antitarget in early drug discovery and development. Surprisingly, the hERG channel blocking profile of natural compounds present in frequently consumed botanicals (i.e. dietary supplements, spices, and herbal medicinal products) is not routinely assessed. This comprehensive review will address these issues and provide a critical compilation of hERG channel data for isolated natural products and extracts over the past two decades (1996-2016). In addition, the review will provide (i) a solid basis for the molecular understanding of the physiological functions of the hERG channel, (ii) the translational potential of in vitro/in vivo results to cardiotoxicity in humans, (iii) approaches for the identification of hERG channel blockers from natural sources, (iv) future perspectives for cardiac safety guidelines and their applications within phytopharmaceuticals and dietary supplements, and (v) novel applications of hERG channel modulation (e.g. as a drug target).

Exploring beliefs about dietary supplement use: focus group discussions with Dutch adults.

PubMed

Pajor, Emília Margit; Oenema, Anke; Eggers, Sander Matthijs; de Vries, Hein

2017-10-01

Although dietary supplement use is increasing in Europe and the USA, little research involving adults' beliefs regarding dietary supplements has been conducted. Therefore, the present study aimed to explore and compare users' and non-users' beliefs towards dietary supplements. Thirteen focus group discussions were conducted of which seven groups were dietary supplement users and six groups were non-users. Based on the socio-cognitive factors of the Integrated Change Model, a semi-structured topic guide was set up. The discussions were audio-recorded and subjected to qualitative content analysis, applying the framework approach. Data were collected in Maastricht, the Netherlands, in 2014 and 2015. In total fifty-six individuals participated in the study, of whom twenty-eight were dietary supplement users and twenty-eight non-users. The average age of participants was 42·9 years. Dietary supplement users' attitude beliefs were mainly related to mental and physical health enhancement, illness prevention and curative health benefits. Users were critical of the nutritional knowledge of health professionals and of the quality of food products. Non-users were convinced that the human body does not need any support and that regular food is enough to cover one's nutritional needs. Users and non-users held comparable beliefs regarding the definition and risks of dietary supplements, and perceived social influences. In their decision about dietary supplement use, both groups were guided by their own convictions to a great extent. Both groups would benefit from improved understanding of the health effects of dietary supplements to improve informed decision making.

Determinants of the use of dietary supplements among secondary and high school students

PubMed

Gajda, Karolina; Zielińska, Monika; Ciecierska, Anna; Hamułka, Jadwiga

All over the world, including Poland, the sale of dietary supplements is increasing. More and more often, people including children and youths, use dietary supplements on their own initiative and without any medical indications or knowledge in this field. Analysis of the conditions of using the dietary supplements with vitamins and minerals among secondary school and high school students in Poland. The study included 396 students aged 13-18 years (249 girls and 147 boys). Authors’ questionnaire was used to evaluate the intake of dietary supplements. The use of cluster analysis allowed to distinguish groups of students with similar socio-demographic characteristics and the frequency of use of dietary supplements. In the studied population of students three clusters were created that significantly differed in socio-demographic characteristics. In cluster 1 and 2, were mostly students who used dietary supplements (respectively, 56% of respondents and 100%). In cluster 1 there were mostly students coming from rural areas and small city, with a worse financial situation, mainly boys (56%), while cluster 2 was dominated by girls (81%) living in a big city, coming from families with a good financial situation and who were more likely to be underweight (28.8%). In cluster 3 there were mostly older students (62%), not taking dietary supplements. In comparison to cluster 2, they had lower frequency of breakfast consumption (55% vs. 69%), but higher frequency of the consumption of soft drinks, fast-food, coffee as well as salt use at the table. The results show that the use of dietary supplements in adolescence is a common phenomenon and slightly conditioned by eating behaviors. This unfavorable habit of common dietary supplements intake observed among students indicates the need for education on the benefits and risks of the supplements usage.

Nutrient intake and use of dietary supplements among US adults with disabilities.

PubMed

An, Ruopeng; Chiu, Chung-Yi; Andrade, Flavia

2015-04-01

Physical, mental, social, and financial hurdles in adults with disabilities may limit their access to adequate nutrition. To examine the impact of dietary supplement use on daily total nutrient intake levels among US adults 20 years and older with disabilities. Study sample came from 2007-2008 and 2009-2010 waves of the National Health and Nutrition Examination Survey, a nationally representative repeated cross-sectional survey. Disability was classified into 5 categories using standardized indices. Nutrient intakes from foods and dietary supplements were calculated from 2 nonconsecutive 24-hour dietary recalls. Two-sample proportion tests and multiple logistic regressions were used to examine the adherence rates to the recommended daily nutrient intake levels between dietary supplement users and nonusers in each disability category. The association between sociodemographic characteristics and dietary supplement use was assessed using multiple logistic regressions, accounting for complex survey design. A substantial proportion of the US adult population with disabilities failed to meet dietary guidelines, with insufficient intakes of multiple nutrients. Over half of the US adults with disabilities used dietary supplements. Dietary supplement use was associated with higher adherence rates for vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, calcium, copper, iron, magnesium, and zinc intake among adults with disabilities. Women, non-Hispanic Whites, older age, higher education, and higher household income were found to predict dietary supplement use. Proper use of dietary supplements under the guidance of health care providers may improve the nutritional status among adults with disabilities. Copyright © 2015 Elsevier Inc. All rights reserved.

Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling.

PubMed

Wang, Yefeng; Gunashekar, Divya R; Adam, Terrence J; Zhang, Rui

2017-01-01

The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Data-base (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements.

Health habits and other characteristics of dietary supplement users: a review

PubMed Central

2014-01-01

Dietary supplements are used by half to two-thirds of American adults, and the evidence suggests that this usage is one component of a larger effort to develop a healthier lifestyle. Dietary supplement users tend on average to be better educated and to have somewhat higher incomes than nonusers, and these factors may contribute to their health-consciousness. Dietary supplement use also tends to be more prevalent among women than among men, and the prevalence of use increases with age in both men and women. Numerous surveys document that users of dietary supplements are significantly more likely than nonusers to have somewhat better dietary patterns, exercise regularly, maintain a healthy weight, and avoid tobacco products. While supplement users tend to have better diets than nonusers, the differences are relatively small, their diets have some substantial nutrient shortfalls, and their supplement use has been shown to improve the adequacy of nutrient intakes. Overall, the evidence suggests that users of dietary supplements are seeking wellness and are consciously adopting a variety of lifestyle habits that they consider to contribute to healthy living. PMID:24499096

Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling

PubMed Central

Wang, Yefeng; Gunashekar, Divya R.; Adam, Terrence J.; Zhang, Rui

2018-01-01

The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Database (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements. PMID:29295169

Feasibility of including green tea products for an analytically verified dietary supplement database

USDA-ARS?s Scientific Manuscript database

The Dietary Supplement Ingredient Database (DSID) is a federally-funded, publically-accessible dietary supplement database that currently contains analytically derived information on micronutrients in selected adult and children’s multivitamin and mineral (MVM) supplements. Other constituents in di...

Surveillance of the armed forces as a sentinel system for detecting adverse effects of dietary supplements in the general population.

PubMed

Lieberman, Harris R; Austin, Krista G; Farina, Emily K

2018-04-01

Half the US population takes dietary supplements, but surveillance systems available to regulatory and public health authorities to determine whether specific dietary supplements present a risk are inadequate and numerous severe injuries and deaths have occurred from their consumption. Uniformed military personnel regularly use dietary supplements and are more likely to use potentially dangerous supplements than civilians. Recently, the supplement 1,3-dimethylamylamine (DMAA) was marketed for physical performance-enhancement and weight loss. However, after over 100 reports of illness attributed to DMAA, including six deaths, the Food and Drug Administration issued a warning to cease its sale. When DMAA was legal (2010-2011), we conducted, using convenience samples, supplement surveys of service members and determined prevalence of use and self-reported symptoms of DMAA use. We surveyed 4374 armed forces personnel using a standardized dietary supplement survey administered by local health-care professionals. Overall, 11 % of survey respondents used dietary supplements labelled as containing DMAA at least once/week. Regular users were over two times more likely to report tachycardia (P<0·0001), tremors (P<0·0001) and dizziness (P=0·0004), and over three times more likely to report numbness/tingling (P<0·0001) than non-users. Military services could readily monitor adverse events associated with dietary supplements using electronic surveys and medical records. Since armed forces personnel are much more likely than civilians to use potentially dangerous dietary supplements like DMAA, near real-time surveillance of them using electronic surveys and medical records would provide early warning to regulatory agencies and the medical and public health communities when high-risk dietary supplements are introduced.

Complementary medicine use among cancer patients receiving radiotherapy and chemotherapy: methods, sources of information and the need for counselling.

PubMed

Pihlak, R; Liivand, R; Trelin, O; Neissar, H; Peterson, I; Kivistik, S; Lilo, K; Jaal, J

2014-03-01

Complementary medicine (CM) use is common among cancer patients. However, little is known about CM products that are utilised during radiotherapy and/or chemotherapy. Out of 62 cancer patients who completed a specialised survey, 35 (56%) consumed some type of CM during active anti-cancer therapy. Cancer patients reported the use of herbal teas (52%), vitamins and other dietary supplements (45%), vegetables and juices (39%), special diets (19%), herbal medicines, including Chinese medicines (19%) and 'immunomodulators' (3%). Most of patients (86%) consumed CM products every day. However, nearly 47% of CM users did not admit this to their oncologists. Majority of CM users (85%) were convinced that supplementary products increase the efficacy of standard anti-cancer therapy and prolong their survival. Information about CM was mainly obtained through internet sources (36%), books and brochures (25%). Although most CM users (82%) trusted the received information, 73% of them admitted that additional information about CM methods would be necessary. Patients would like to receive additional information through a specialised consultation (60%), but also from brochures (44%) and the internet (20%). Adequate counselling of patients is of paramount importance since some CM methods may cause significant side effects and decrease the efficacy of radiotherapy and/or chemotherapy. © 2013 John Wiley & Sons Ltd.