A Double-blind, randomized trial of St John's wort, fluoxetine, and placebo in major depressive disorder.

Abstract

OBJECTIVE:

This study looks to compare the antidepressant efficacy and safety of a standardized extract of St John's wort with both placebo and fluoxetine.

METHOD:

After a 1-week single-blind washout, patients with major depressive disorder diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition were randomized to 12 weeks of double-blind treatment with LI-160 St John's wort extract (900 mg/d), fluoxetine (20 mg/d), or placebo. The 17-item Hamilton Rating Scale for Depression (HAMD-17) was the primary efficacy measure, and analysis of covariance was used to compare differences in end point HAMD-17 scores across the 3 treatment groups, treating the baseline HAMD-17 as the covariate.

RESULTS:

One hundred thirty-five patients (57% women; mean age, 37.3 +/- 11.0; mean HAMD-17, 19.7 +/- 3.2) were randomized to double-blind treatment and were included in the intent-to-treat analyses. Analysis of covariance analyses showed lower mean HAMD-17 scores at end point in the St John's wort group (n = 45; mean +/- SD, 10.2 +/- 6.6) compared with the fluoxetine group (n = 47; 13.3 +/- 7.3; P < 0.03) and a trend toward a similar finding relative to the placebo group (n = 43; 12.6 +/- 6.4; P = 0.096). There was also a trend toward higher rates of remission (HAMD-17 <8) in the St John's wort group (38%) compared with the fluoxetine group (30%) and the placebo group (21%). Overall, St John's wort appeared to be safe and well tolerated.

CONCLUSION:

St John's wort was significantly more effective than fluoxetine and showed a trend toward superiority over placebo. A (25%) smaller than planned sample size is likely to account for the lack of statistical significance for the advantage (indicating a moderate effect size, d = 0.45) of St John's wort over placebo.

• Authors: Maurizio Fava, Jonathan Alpert, Andrew A Nierenberg, David Mischoulon, Michael W Otto, John Zajecka, Harald Murck, Jerrold F Rosenbaum
• Journal: Journal of clinical psychopharmacology (J Clin Psychopharmacol) Vol. 25 Issue 5 Pg. 441-7 (Oct 2005) ISSN: 0271-0749 [Print] United States
• PMID: 16160619 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antidepressive Agents, Second-Generation
• Plant Extracts
• Fluoxetine

Topics

• Adolescent
• Adult
• Aged
• Antidepressive Agents, Second-Generation (adverse effects, therapeutic use)
• Depressive Disorder, Major (drug therapy, psychology)
• Double-Blind Method
• Endpoint Determination
• Female
• Fluoxetine (adverse effects, therapeutic use)
• Humans
• Hypericum
• Male
• Middle Aged
• Phytotherapy (adverse effects)
• Plant Extracts (therapeutic use)
• Psychiatric Status Rating Scales