| Autor: |
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 |
| Zdroj: |
JAMA: Journal of the American Medical Association; 4/10/2002, Vol. 287 Issue 14, p1807-1876, 10p |
| Abstrakt: |
Context: 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.Objective: To test the efficacy and safety of a well-characterized H perforatum extract (LI-160) in major depressive disorder.Design and Setting: Double-blind, randomized, placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States.Participants: 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.Interventions: 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.Main Outcome Measures: 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.Results: 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.Conclusion: 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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