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- Title
Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial.
- Authors
Hypericum Depression Trial Study Group; Davidson, Jonathan RT; Gadde, Kishore M; Fairbank, John A; Krishnan, K Ranga Rama; Califf, Robert M; Binanay, Cynthia; Parker, Corette B; Pugh, Norma; Hartwell, Tyler D; Vitiello, Benedetto; Ritz, Louise; Severe, Joanne; Cole, Jonathan O; de Battista, Charles; Doraiswamy, P Murali; Feighner, John P; Keck, Paul; Kelsey, Jeffrey; Lin, Khae-Ming
- Abstract
<bold>Context: </bold>Extracts of Hypericum perforatum (St John's wort) are widely used for the treatment of depression of varying severity. Their efficacy in major depressive disorder, however, has not been conclusively demonstrated.<bold>Objective: </bold>To test the efficacy and safety of a well-characterized H perforatum extract (LI-160) in major depressive disorder.<bold>Design and Setting: </bold>Double-blind, randomized, placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States.<bold>Participants: </bold>Adult outpatients (n = 340) recruited between December 1998 and June 2000 with major depression and a baseline total score on the Hamilton Depression Scale (HAM-D) of at least 20.<bold>Interventions: </bold>Patients were randomly assigned to receive H perforatum, placebo, or sertraline (as an active comparator) for 8 weeks. Based on clinical response, the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg. Responders at week 8 could continue blinded treatment for another 18 weeks.<bold>Main Outcome Measures: </bold>Change in the HAM-D total score from baseline to 8 weeks; rates of full response, determined by the HAM-D and Clinical Global Impressions (CGI) scores.<bold>Results: </bold>On the 2 primary outcome measures, neither sertraline nor H perforatum was significantly different from placebo. The random regression parameter estimate for mean (SE) change in HAM-D total score from baseline to week 8 (with a greater decline indicating more improvement) was -9.20 (0.67) (95% confidence interval [CI], -10.51 to -7.89) for placebo vs -8.68 (0.68) (95% CI, -10.01 to -7.35) for H perforatum (P =.59) and -10.53 (0.72) (95% CI, -11.94 to -9.12) for sertraline (P =.18). Full response occurred in 31.9% of the placebo-treated patients vs 23.9% of the H perforatum-treated patients (P =.21) and 24.8% of sertraline-treated patients (P =.26). Sertraline was better than placebo on the CGI improvement scale (P =.02), which was a secondary measure in this study. Adverse-effect profiles for H perforatum and sertraline differed relative to placebo.<bold>Conclusion: </bold>This study fails to support the efficacy of H perforatum in moderately severe major depression. The result may be due to low assay sensitivity of the trial, but the complete absence of trends suggestive of efficacy for H perforatum is noteworthy.
- Publication
JAMA: Journal of the American Medical Association, 2002, Vol 287, Issue 14, p1807
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.287.14.1807