DIETARY SUPPLEMENT, HERBAL MEDICINE EFFICACY STUDY METHODOLOGIES

DIETARY SUPPLEMENT, HERBAL MEDICINE EFFICACY STUDY METHODOLOGIES will be considered at a meeting jointly sponsored by the National Institutes of Health's Office of Alternative Medicine (OAM) and Office of Medical Applications of Research (OMAR). The technology assessment conference, which is expected to take place in July or August, will address testing methodologies for a number of "alternative medicine" therapies including dietary supplements and herbal products. Discussing the upcoming conference at a meeting of OAM's Ad Hoc Panel on Alternative Medicine on April 1-2 in Herndon, Va., OMAR Director John Ferguson, MD, said that the conference will be a collaborative effort between the two offices to determine appropriate methods of conducting studies to determine whether non-traditional medical therapies work and are safe. Ferguson said the meeting could address cross-over studies, outcome studies, meta-analyses and surveys. OMAR was established to hold consensus conferences on matters of public health significance that may be controversial. The meetings consist of investigators who present data to a panel which is "screened very rigidly to be not involved, not to have published, or to have publicly held opinions on the issues" discussed at the conference, Ferguson noted. The panel then comes to a conclusion based on data presented and any public comment. Mandated by the HHS appropriations bill for fiscal 1992, OAM represents the first official government attempt to study alternative medicine. The office operates under $ 2 mil. each for FY 1992 and 1993, which is approximately .02% of the overall NIH budget. The NIH reauthorization bill (HR 4/S 1), currently in conference committee, would provide permanent statutory authority for the office's activities. OAM issued its first request for applications on March 26. The RFA solicits applications for collaborations between alternative medicine practitioners and conventional researchers, and for "small-scale studies designed to obtain preliminary data relevant to the evaluation of alternative medicine." The RFA explains that such studies are necessary because, "despite the large number of people using alternative medicine treatments, relatively little scientific data are available to demonstrate convincingly whether or not a particular treatment is safe, efficacious, beneficial, helpful, or leads to a positive outcome." Types of interventions that could be studied, the RFA suggests, include: "diet, nutrition and lifestyle changes" such as macrobiotics, megavitamins and diets; "traditional and ethnomedicines" such as herbal medicine, homeopathic medicine, Native American medicine, natural products, traditional Oriental medicine and acupuncture; and "pharmacological and biological treatments" such as antioxidants, cell treatments, chelation therapy, metabolic therapy and oxidizing agents. OAM Deputy Director Daniel Eskinazi, DDS/PhD, told the alternative medicine panel that up to 20, one-year awards would be made for a maximum of $ 30,000 each. OAM anticipates making the awards by Sept. 30.