Posted by djmmm on April 10, 2002, at 7:23:18
St. John's Wort No Better Than Placebo for Depression
Laurie Barclay, MD
NEW YORK (MedscapeWire) Apr 10 — In an 8-week, randomized trial reported in the April 10 issue of The Journal of the American Medical Association, St. John's wort was no better than placebo in the treatment of major depression, and sertraline was better only on a secondary outcome measure. A second study and an editorial in the same issue of the journal stress the importance of placebo controls in trials of antidepressants.
"Major depression is treatable, but this research suggests that major depression of at least moderate severity should not be treated with St. John's wort," principal investigator Jonathan R. T. Davidson, MD, from Duke University in Durham, North Carolina, says in a news release. "It is vitally important to conduct well-designed studies to examine herbal supplements and other drugs for the treatment of depression."In this double-blind, parallel group study conducted at 12 academic or community clinics, 340 outpatients received St. John's wort 900 mg to 1500 mg daily, sertraline 50 mg to 100 mg daily, or placebo for 8 weeks, followed by up to 18 weeks of double-blind continuation treatment in responders. All subjects had a diagnosis of major depression, a score 20 or higher on the Hamilton Depression (HAM-D) scale, and a score 60 or lower on the Global Assessment of Functioning scale at baseline.
Neither St. John's wort nor sertraline proved to be more effective than placebo on primary measures of effectiveness including change on HAM-D score from baseline to 8 weeks and rate of full response on the Clinical Global Impressions scale (CGI) or HAM-D. Full response occurred in 31.9% of patients receiving placebo, 23.9% of those receiving St. John's wort, and 24.8% of patients receiving sertraline. Although sertraline was better than placebo on the CGI improvement scale (P=.02), a secondary outcome measure, St. John's wort showed no effectiveness on any measure.
The extract of St. John's wort used in this study (LI-160) was standardized to between 0.12% and 0.28% hypericin and was selected for the body of literature supporting its possible efficacy in depression.
Study coauthor Robert Califf, MD, from Duke Clinical Research Institute, emphasized possible interactions of St. John's wort and other herbal remedies with prescription medications, including antiretroviral therapy, certain cardiovascular drugs, and immunosuppressants. "Just because St. John's wort was found to be ineffective for this type of depression does not mean it is harmless to the body," Califf said. "As long as these types of products remain available to the public without the protection of adequate, controlled and unbiased studies, taking them is like playing Russian roulette with your health."
Pfizer provided sertraline and its matching placebo for this study and has financial relationships with some of the authors.
A meta-analysis in the same issue of JAMA notes that placebo response in published trials of antidepressants is highly variable, often substantial, and has increased significantly in recent years.
"Taken together, the two reports in this issue of The Journal return full circle to the placebo response and understanding its mechanisms of action and highlight the perplexing complexity of the placebo and its ability to cause 'mischief' in scientific inquiry," David J. Kupfer, MD, and Ellen Frank, PhD, from the University of Pittsburgh Medical School, write in an accompanying editorial. "This may be nature's way of providing clues to fundamental aspects of the healing process, even as advances in medicine and the discovery of new therapies take place. It is important to learn from, rather than dismiss, the variability of the therapeutic response."
A National Depressive and Manic-Depressive Association Consensus Statement on the use of placebo in clinical trials of mood disorders, published in the March issue of the Archives of General Psychiatry, concluded that findings of equivalence between a new drug and standard treatment are not evidence of efficacy unless the new drug is also significantly more effective than placebo.
JAMA. 2002;287(14):1807-1814, 1840-1847, 1853-1854
Reviewed by Gary D. Vogin, MD
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