Tieraona Low Dog

Safety of green tea extracts : a systematic review by the US Pharmacopeia.

Green tea [Camellia sinensis (L.) Kuntze] is the fourth most commonly used dietary supplement in the US. Recently, regulatory agencies in France and Spain suspended market authorization of a weight-loss product containing green tea extract because of hepatotoxicity concerns. This was followed by publication of adverse event case reports involving green tea products. In response, the US Pharmacopeia (USP) Dietary Supplement Information Expert Committee (DSI EC) systematically reviewed the safety information for green tea products in order to re-evaluate the current safety class to which these products are assigned. DSI EC searched PubMed (January 1966–June 2007) and EMBASE (January 1988–June 2007) for clinical case reports and animal pharmacological or toxicological information. Reports were also obtained from a diverse range of other sources, including published reviews, the US FDA MedWatch programme, USP’s MEDMARX® adverse event reporting system, the Australian Therapeutic Goods Administration, the UK Medicines and Healthcare products Regulatory Agency, and Health Canada’s Canadian Adverse Drug Reaction Monitoring Program. Case reports pertaining to liver damage were evaluated according to the Naranjo causality algorithm scale. In addition, the Committee analysed information concerning historical use, regulatory status, and current extent of use of green tea products. A total of 216 case reports on green tea products were analysed, including 34 reports concerning liver damage. Twenty-seven reports pertaining to liver damage were categorized as possible causality and seven as probable causality. Clinical pharmacokinetic and animal toxicological information indicated that consumption of green tea concentrated extracts on an empty stomach is more likely to lead to adverse effects than consumption in the fed state. Based on this safety review, the DSI EC determined that when dietary supplement products containing green tea extracts are used and formulated appropriately the Committee is unaware of significant safety issues that would prohibit monograph development, provided a caution statement is included in the labelling section. Following this decision, USP’s DSI ECs may develop monographs for green tea extracts, and USP may offer its verification programmes related to that dietary ingredient.

Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief.

ObjectiveThis comprehensive review examines the safety of Cimicifuga racemosa for the treatment of menopause symptoms, particularly in populations in which conventional menopause treatment regimens, including estrogen replacement, are contraindicated. DesignAn extensive database of information on Cimicifuga, which included all published literature pertaining to preclinical and clinical safety of various forms of Cimicifuga, the FDA and World Health Organization adverse-event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical anecdotal reports, was reviewed, and findings pertaining to the safety of Cimicifuga use for menopause treatment were reported. ResultsUncontrolled reports, postmarketing surveillance, and human clinical trials of more than 2,800 patients demonstrate a low incidence of adverse events (5.4%). Of the reported adverse events, 97% were minor and did not result in discontinuation of therapy, and the only severe events were not attributed to Cimicifuga treatment. ConclusionsAlthough the effects of Cimicifuga may be dependent on the specific extract preparation, this review clearly supports the safety of specific Cimicifuga extracts, particularly isopropanolic preparations, for use in women experiencing menopausal symptoms and as a safe alternative for women in whom estrogen therapy is contraindicated.

The North American Menopause Society recommendations for clinical care of midlife women

In celebration of the 25th anniversary of The North American Menopause Society (NAMS), the Society has compiled a set of key points and clinical recommendations for the care of midlife women. NAMS has always been a premier source of information about menopause for both healthcare providers and midli

The state of dietary supplement adverse event reporting in the United States

The Dietary Supplements Information Expert Committee (DSI‐EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP–National Formulary (USP–NF) quality monographs. Because the veracity of dietary supplement adverse event reports (DS AERs) directly affects DSI‐EC safety reviews, the Committee reviewed the current status of DS AER reporting in the US.

United States pharmacopeia safety evaluation of spirulina.

The Dietary Supplements Information Expert Committee (DSI-EC) of the United States Pharmacopeial Convention (USP) reviews the safety of dietary supplements and dietary supplement ingredients for the purpose of determining whether they should be admitted as quality monographs into the United States Pharmacopeia and National Formulary (USP–NF). The United States Food and Drug Administration (FDA) has enforcement authority to pursue a misbranding action in those instances where a dietary supplement product indicates that it conforms to USP standards but fails to so conform. Recently DSI-EC undertook a safety evaluation of spirulina, a widely used dietary ingredient. DSI-EC reviewed information from human clinical trials, animal studies, and regulatory and pharmacopeial sources and analyzed 31 adverse event reports regarding spirulina to assess potential health concerns. At the conclusion of this review, DSI-EC assigned a Class A safety rating for Spirulina maxima and S. platensis, thereby permitting the admission of quality monographs for these dietary supplement ingredients in USP–NF. DSI-EC continually monitors reports concerning the safety of dietary supplements and dietary supplement ingredients for which USP dietary supplement monographs are developed. The DSI-EC may revisit the safety classification of spirulina as new information on this dietary ingredient becomes available.

Systematic Review of Breastfeeding and Herbs

OBJECTIVES Despite popular and historical use, there has been little modern research conducted to determine the safety and efficacy of herb use during breastfeeding. The purpose of this study was to systematically review the clinical literature on herbal medicine and lactation. METHODS The databases PubMed, CAB Abstracts, Cochrane Central Register of Controlled Trials, HealthSTAR, Cumulative Index to Nursing and Allied Health Literature, and Reprotox were systematically searched for human trials from 1970 until 2010. Reference lists from relevant articles were hand-searched. RESULTS Thirty-two studies met the inclusion criteria. Clinical studies were divided into three categories: survey studies (n=11), safety studies (n=8), and efficacy studies (n=13). Six studies were randomized controlled trials. The most common herbs studied were St. Johns wort (Hypericum perforatum L.) (n=3), garlic (Allium sativum L.) extract (n=2), and senna (Cassia senna L.) (n=2). Studies were very heterogeneous with regard to study design, herbal intervention, and outcome measures. Overall, poor methodological quality predominated among the studies. CONCLUSIONS Our review concludes that further research is needed to assess the prevalence, efficacy, and safety of commonly used herbs during breastfeeding.

Developing and implementing core competencies for integrative medicine fellowships

The Consortium of Academic Health Centers for Integrative Medicine defines integrative medicine as “the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, health care professionals, and disciplines to achieve optimal health and healing.” Over the past three decades, the U.S. public increasingly has sought integrative medicine approaches. In an effort to train medical professionals to adequately counsel patients on the safe and appropriate use of these approaches, medical schools and residencies have developed curricula on integrative medicine for their trainees. In addition, integrative medicine clinical fellowships for postresidency physicians have emerged to provide training for practitioners interested in gaining greater expertise in this emerging field. Currently, 13 clinical fellowships in integrative medicine exist in the United States, and they are predominantly connected to academic medical centers or teaching affiliate hospitals. In 2010, the Consortium of Academic Health Centers for Integrative Medicine, represented by 56 member academic health care institutions with a shared commitment to advance the principles and practices of integrative medicine, convened a two-year task force to draft integrative medicine fellowship core competencies. These competencies would guide fellowship curriculum development and ensure that graduates possessed a common body of knowledge, skills, and attitudes. In this article, the authors discuss the competencies and the task force’s process to develop them, as well as associated teaching and assessment methods, faculty development, potential barriers, and future directions.

Concomitant use of prescription medications and dietary supplements in menopausal women: An approach to provider preparedness

Dietary supplements are becoming increasingly popular as therapies for symptom relief among menopause-age women in the United States. However, a large gap exists between research in the concomitant use of prescription medications and dietary supplements and provider preparedness to guide patient decision making. Many menopausal women take prescription medications, over the counter medications, and herbs and dietary supplements for climactic symptoms or other health conditions. With any drug, there is the potential for interactions. Women taking medications with a narrow therapeutic index, such as anticoagulants, anticonvulsants, and drugs for the treatment of chronic diseases, are at particular risk. Patients should be queried regarding their use of dietary supplements when starting or stopping a prescription drug, or if unexpected reactions occur. When counseling patients, one must carefully consider the risks and benefits of each supplement and medication being taken by each individual.

Complementary, Holistic, and Integrative Medicine: Advice for Clinicians on Herbs and Breastfeeding

The use of herbal remedies is a tradition held in many cultures throughout the world, and women may use herbal remedies during lactation. Because of the limitations of the current literature, it is difficult to develop accurate information on the safety and efficacy of specific herbs used during breastfeeding. It is critical that more research is conducted in this area, including national prevalence studies and safety and efficacy studies.

Response to Teschke et al.

Dear Editor, The review by Teschke et al.1 reanalyzed a selected group of 22 spontaneous reports from regulatory agencies for the causal relationship between the use of black cohosh–containing products and hepatotoxicity and concluded that an “updated” Council for International Organizations of Medical Sciences (CIOMS) scale should replace the liver-unspecific Naranjo scale. The “update” referred to by the author is not originated by the CIOMS but includes the authors’ modifications to the scale. On the basis of their new approach, the authors conclude that causality for black cohosh– mediated liver damage is “unlikely or excluded.” We would like to draw attention to some of the fundamental flaws with the authors’ analysis: