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BMJ. 2005 Mar 5;330(7490):503. Epub 2005 Feb 11.

Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort): randomised controlled double blind non-inferiority trial versus paroxetine.

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  • 1Charit√©-Universit√§tsmedizin Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy, Eschenallee 3, 14050 Berlin, Germany.

Erratum in

  • BMJ. 2005 Apr 2;330(7494):759. Dosage error in article text.

Abstract

OBJECTIVE:

To investigate the efficacy of hypericum extract WS 5570 (St John's wort) compared with paroxetine in patients with moderate to severe major depression.

DESIGN:

Randomised double blind, double dummy, reference controlled, multicentre non-inferiority trial.

SETTING:

21 psychiatric primary care practices in Germany.

PARTICIPANTS:

251 adult outpatients with acute major depression with total score > or = 22 on the 17 item Hamilton depression scale.

INTERVENTIONS:

900 mg/day hypericum extract WS 5570 three times a day or 20 mg paroxetine once a day for six weeks. In initial non-responders doses were increased to 1800 mg/day hypericum or 40 mg/day paroxetine after two weeks.

MAIN OUTCOME MEASURES:

Change in score on Hamilton depression scale from baseline to day 42 (primary outcome). Secondary measures were change in scores on Montgomery-Asberg depression rating scale, clinical global impressions, and Beck depression inventory.

RESULTS:

The Hamilton depression total score decreased by mean 14.4 (SD 8.8) points, corresponding to 56.6% (SD 34.3%) of the baseline value, in the hypericum group and by 11.4 (SD 8.6) points (44.8% (SD 33.5%) of baseline value) in the paroxetine group (intention to treat analysis; similar results were observed in the per protocol analysis). The intention to treat analysis (lower one sided 97.5% confidence limit 1.5 points for the difference hypericum minus paroxetine) and the per protocol analysis (lower confidence limit 0.7 points) showed non-inferiority of hypericum and statistical superiority over paroxetine. The lower limits in both cases exceeded the pre-specified non-inferiority margin of -2.5 points and the superiority margin of 0. The incidence of adverse events was 0.035 and 0.060 events per day of exposure for hypericum and paroxetine, respectively.

CONCLUSIONS:

In the treatment of moderate to severe major depression, hypericum extract WS 5570 is at least as effective as paroxetine and is better tolerated.

Comment in

PMID:
15708844
[PubMed - indexed for MEDLINE]
PMCID:
PMC552808
Free PMC Article
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