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NIH Studies St. John's Wort.
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The National Institutes of Health's Office of Complementary and Alternative Medicine (OCAM), the National Institute of Mental Health (NIMH), and the Office of Dietary Supplements (ODS) are collaborating to fund research to determine the potential benefits and risks of St. John's Wort (Hypericum perforatum L., Clusiaceae), for the treatment of depression. Hypericum, a wild-growing plant with yellow flowers (an introduced "weed" in North America), has recently generated media attention. An extract of Hypericum is widely used in some countries to treat mild to moderate depression. The goal of this OCAM-NIMH joint effort is to evaluate the efficacy and safety of SJW as a potential treatment for depression, in order to determine its role in helping many Americans afflicted with depressive conditions.

St. John's (SJW) Wort has become increasingly popular in Germany where physicians routinely prescribe herbal medicines to treat depression and other health conditions, such as anxiety and sleep disorders. An overview and meta-analysis of twenty-three clinical studies of SJW, which included a total of 1,757 outpatients diagnosed with mild to moderately severe depression, were reported in the August 3, 1996, issue of British Medical Journal (See HerbalGram #39, page 16). The report concluded that although Hypericum has antidepressive properties in cases of mild to moderate depression, more definitive, longer term studies are needed to explore SJW's potential as an effective antidepressant agent.

The impact of depression, a common illness that can occur in any family, is enormous in terms of human suffering and costs to the nation. In 1990, the leading cause of disability worldwide was clinical depression. Estimates of the yearly costs of depressive disorders in the United States range from $30-$44 billion dollars, including medical costs, loss of time and productivity, personnel replacement, and loss of life.

In response to public interest for more science-based information on complementary and alternative health care practices, the OCAM is planning to fund a study to evaluate the efficacy and safety of standardized extract of SJW in treating depression. The goal of this contract is to establish a full-service, centralized coordinating center to manage a multicenter clinical trial to evaluate the efficacy of this botanical product in patients with mild to moderate depression. The NIMH will provide scientific and clinical guidance on the conduct of a clinical trial on depression, in collaboration with the OCAM and the NIH ODS research.

A request for proposals (RFP) was issued June 6, 1997, with proposals due on July 21, 1997. NIMH proposed to issue an unrestrictive competitive solicitation for this requirement, and anticipates the award of a cost reimbursement contract for a period of three years. The RFP was made available electronically June 6, 1997, via the NIH Home Page, the NIH Gopher, or the NIMH Home Page.

Initial technical review of contracts received in response to the RFP was done by a team of outside experts on August 8, 1997, in Bethesda, Maryland. NIH officials said the clinical trial will be coordinated by Johathan Davidson, M.D., at Duke University Medical Center, which has received a three-year contract to conduct the $4.3 million study. Patient enrollment is expected to start next spring.

[NIH press release, June, 1997. NIH press release, October, 1997.]

Article copyright American Botanical Council.

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By Dawnelle Malone