United States Pharmacopeia Safety Review of Willow Bark.

Willow bark (Salix spp.) is an ingredient in some dietary supplements. No serious adverse effects were reported from trials of willow bark extracts delivering 120 - 240 mg salicin (the purported active constituent) daily for up to 8 weeks. All studies involved adults only; none involved special subpopulations such as pregnant or breastfeeding women, or children. The most common adverse effects associated with willow bark are gastrointestinal; a few allergic reactions were also reported. Some publications advise caution when taking willow bark. There is a risk of increased bleeding in vulnerable individuals, salicylates cross the placenta and are eliminated slowly in newborns, some persons are sensitive or allergic to aspirin, and children are at risk of Reye syndrome. Concurrent use with other salicylate-containing medicines increases these risks. Metabolism of 240 mg salicin from willow bark could yield 113 mg of salicylic acid, yet dietary supplement products are not required to be labeled with warnings. In contrast, over-the-counter low-dose aspirin (81 mg strength), which delivers 62 mg salicylic acid, is required by law to include cautions, warnings, and contraindications related to its use in pregnant and nursing women, children, and other vulnerable subpopulations, e.g., those using anticoagulants. In the interest of protecting public health, the United States Pharmacopeia has included a cautionary labeling statement in the United States Pharmacopeia Salix Species monograph as follows: "Dosage forms prepared with this article should bear the following statement: 'Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.'".

Safety and performance benefits of arginine supplements for military personnel: a systematic review.

CONTEXT: Dietary supplements are widely used by military personnel and civilians for promotion of health. OBJECTIVE: The objective of this evidence-based review was to examine whether supplementation with l-arginine, in combination with caffeine and/or creatine, is safe and whether it enhances athletic performance or improves recovery from exhaustion for military personnel. DATA SOURCES: Information from clinical trials and adverse event reports were collected from 17 databases and 5 adverse event report portals. STUDY SELECTION: Studies and reports were included if they evaluated the safety and the putative outcomes of enhanced performance or improved recovery from exhaustion associated with the intake of arginine alone or in combination with caffeine and/or creatine in healthy adults aged 19 to 50 years. DATA EXTRACTION: Information related to population, intervention, comparator, and outcomes was abstracted. Of the 2687 articles screened, 62 articles meeting the inclusion criteria were analyzed. Strength of evidence was assessed in terms of risk of bias, consistency, directness, and precision. RESULTS: Most studies had few participants and suggested risk of bias that could negatively affect the results. l-Arginine supplementation provided little enhancement of athletic performance or improvements in recovery. Short-term supplementation with arginine may result in adverse gastrointestinal and cardiovascular effects. No information about the effects of arginine on the performance of military personnel was available. CONCLUSIONS: The available information does not support the use of l-arginine, either alone or in combination with caffeine, creatine, or both, to enhance athletic performance or improve recovery from exhaustion. Given the information gaps, an evidence-based review to assess the safety or effectiveness of multi-ingredient dietary supplements was not feasible, and therefore the development of a computational model-based approach to predict the safety of multi-ingredient dietary supplements is recommended.

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.

INTRODUCTION: Little is known about the changes in prevalence of dietary supplement use in pregnancy, postpartum, and in a comparison group of nonpregnant women. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

Evidence-based evaluation of potential benefits and safety of beta-alanine supplementation for military personnel.

This Department of Defense-sponsored evidence-based review evaluates the safety and putative outcomes of enhancement of athletic performance or improved recovery from exhaustion in studies involving beta-alanine alone or in combination with other ingredients. Beta-alanine intervention studies and review articles were collected from 13 databases, and safety information was collected from adverse event reporting portals. Due to the lack of systematic studies involving military populations, all the available literature was assessed with a subgroup analysis of studies on athletes to determine if beta-alanine would be suitable for the military. Available literature provided only limited evidence concerning the benefits of beta-alanine use, and a majority of the studies were not designed to address safety. Overall, the strength of evidence in terms of the potential for risk of bias in the quality of the available literature, consistency, directness, and precision did not support the use of beta-alanine by military personnel. The strength of evidence for a causal relation between beta-alanine and paresthesia was moderate.

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.

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.

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. John's 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.

Integrative medicine in residency education: developing competency through online curriculum training.

INTRODUCTION: The Integrative Medicine in Residency (IMR) program, a 200-hour Internet-based, collaborative educational initiative was implemented in 8 family medicine residency programs and has shown a potential to serve as a national model for incorporating training in integrative/complementary/alternative medicine in graduate medical education. INTERVENTION: The curriculum content was designed based on a needs assessment and a set of competencies for graduate medical education developed following the Accreditation Council for Graduate Medical Education outcome project guidelines. The content was delivered through distributed online learning and included onsite activities. A modular format allowed for a flexible implementation in different residency settings. EVALUATION: TO ASSESS THE FEASIBILITY OF IMPLEMENTING THE CURRICULUM, A MULTIMODAL EVALUATION WAS UTILIZED, INCLUDING: (1) residents' evaluation of the curriculum; (2) residents' competencies evaluation through medical knowledge testing, self-assessment, direct observations, and reflections; and (3) residents' wellness and well-being through behavioral assessments. RESULTS: The class of 2011 (n  =  61) had a high rate of curriculum completion in the first and second year (98.7% and 84.2%) and course evaluations on meeting objectives, clinical utility, and functioning of the technology were highly rated. There was a statistically significant improvement in medical knowledge test scores for questions aligned with content for both the PGY-1 and PGY-2 courses. CONCLUSIONS: The IMR program is an advance in the national effort to make training in integrative medicine available to physicians on a broad scale and is a success in terms of online education. Evaluation suggests that this program is feasible for implementation and acceptable to residents despite the many pressures of residency.

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.

The role of nutrition in mental health.

A truly integrative approach to mental health includes a thorough assessment of dietary habits, level of exercise/physical activity, environmental exposures, medications, comorbid conditions, life stressors, level of social support, and family history. A complete physical exam and appropriate laboratory and imaging studies should be utilized to rule out underlying causes of depressed or anxious mood. Many patients will benefit from the use of specific dietary supplements, such as a multivitamin-mineral high in B-vitamins and omega-3 fatty acid. And no matter what the underlying cause of the mood disorder, patients should be counseled about the relationship between food and mood, for the evidence now substantiates what laypeople and medical professionals have long known intuitively: the way we eat affects the way we feel. The Western diet consumed in a growing number of countries is devoid of many of the key nutrients critical for the proper functioning of the central nervous system. When making dietary recommendations, clinicians should consider a low-glycemic, modified Mediterranean diet rich in fruits, vegetables, whole grains, and seafood (if not vegetarian) and low in processed, refined foods for optimizing mental health. A future article on the topic of nutrition and mental health will address the role of nutraceuticals and herbal medicines in mental health.