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Effectiveness of St John's Wort in Major Depression
A Randomized Controlled Trial
Richard C. Shelton, MD;
Martin B. Keller, MD;
Alan Gelenberg, MD;
David L. Dunner, MD;
Robert Hirschfeld, MD;
Michael E. Thase, MD;
James Russell, MD;
R. Bruce Lydiard, MD,PhD;
Paul Crits-Christoph, PhD;
Robert Gallop, PhD;
Linda Todd;
David Hellerstein, MD;
Paul Goodnick, MD;
Gabor Keitner, MD;
Stephen M. Stahl, MD;
Uriel Halbreich, MD
JAMA. 2001;285:1978-1986.
Context Extracts of St John's wort are widely used to treat depression. Although more than 2 dozen clinical trials have been conducted with St John's wort, most have significant flaws in design and do not enable meaningful interpretation.
Objective To compare the efficacy and safety of a standardized extract of St John's wort with placebo in outpatients with major depression.
Design and Setting Randomized, double-blind, placebo-controlled clinical trial conducted between November 1998 and January 2000 in 11 academic medical centers in the United States.
Participants Two hundred adult outpatients (mean age, 42.4 years; 67.0% female; 85.9% white) diagnosed as having major depression and having a baseline Hamilton Rating Scale for Depression (HAM-D) score of at least 20.
Intervention Participants completed a 1-week, single-blind run-in of placebo, then were randomly assigned to receive either St John's wort extract (n = 98; 900 mg/d for 4 weeks, increased to 1200 mg/d in the absence of an adequate response thereafter) or placebo (n = 102) for 8 weeks.
Main Outcome Measures The primary outcome measure was rate of change on the HAM-D over the treatment period. Secondary measures included the Beck Depression Inventory (BDI), Hamilton Rating Scale for Anxiety (HAM-A), the Global Assessment of Function (GAF) scale, and the Clinical Global Impression–Severity and –Improvement scales (CGI-S and CGI-I).
Results The random coefficient analyses for the HAM-D, HAM-A, CGI-S, and CGI-I all showed significant effects for time but not for treatment or time-by-treatment interaction (for HAM-D scores, P<.001, P = .16, and P = .58, respectively). Analysis of covariance showed nonsignificant effects for BDI and GAF scores. The proportion of participants achieving an a priori definition of response did not differ between groups. The number reaching remission of illness was significantly higher with St John's wort than with placebo (P = .02), but the rates were very low in the full intention-to-treat analysis (14/98 [14.3%] vs 5/102 [4.9%], respectively). St John's wort was safe and well tolerated. Headache was the only adverse event that occurred with greater frequency with St John's wort than placebo (39/95 [41%] vs 25/100 [25%], respectively).
Conclusion In this study, St John's wort was not effective for treatment of major depression.
Author Affiliations: Department of Psychiatry, Vanderbilt University, Nashville, Tenn (Dr Shelton and Ms Todd); Department of Psychiatry, Brown University, Butler Hospital, Providence, RI (Dr Keller); Department of Psychiatry, University of Arizona Health Sciences Center, Tucson (Dr Gelenberg); Department of Psychiatry, University of Washington, Seattle (Dr Dunner); Department of Psychiatry, University of Texas, Galveston (Drs Hirschfeld and Russell); Department of Psychiatry, University of Pittsburgh, Western Psychiatric Institute and Clinic, Pittsburgh, Pa (Dr Thase); Department of Psychiatry, University of South Carolina, Charleston (Dr Lydiard); Department of Psychiatry, University of Pennsylvania, Philadelphia (Drs Crits-Christoph and Gallop); Department of Psychiatry, Beth Israel Medical Center, New York, NY (Dr Hellerstein); Department of Psychiatry, University of Miami School of Medicine, Miami, Fla (Dr Goodnick); Department of Psychiatry, Brown University, Rhode Island Hospital, Providence (Dr Keitner); Department of Psychiatry, University of California, San Diego (Dr Stahl); and Department of Psychiatry, University of Buffalo-State University of New York Clinical Center, Buffalo (Dr Halbreich).
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