Research: SCHRADER, Praxis Klinisch

Listed in Issue 56

Abstract

SCHRADER, Praxis Klinische Arzneimittelforschung, Pohlheim, Germany conducted a clinical trial comparing the effects of St Johns Wort with fluoxetine on mild -moderate depression.

Background

There is an increasing amount of evidence for the efficacy of St Johns Wort in treating mild-moderate depression. This study compares St Johns Wort with the conventional anti-depressant fluoxetine.

Methodology

Treatment with St John's wort extract tablets (hypericum Ze 117) and the commonly used slow serotonin re-uptake inhibitor (SSRI) fluoxetine was compared in patients with mild-moderate depression with entry Hamilton Depression Scale (HAM-D) (21-item) in the range 16-24, in a randomized, double-blind, parallel group comparison in 240 subjects; fluoxetine: 114 (48%), hypericum: 126 (52%).

Results

After 6 weeks' treatment, mean HAM-D at endpoint decreased to 11.54 on hypericum and to 12.20 on fluoxetine (P < 0.09), while mean Clinical Global Impression (CGI) item I (severity) was significantly (P < 0.03) superior on hypericum, as was the responder rate (P = 0.005). Hypericum safety was substantially superior to fluoxetine, with the incidence of adverse events being 23% on fluoxetine and 8% on hypericum. The commonest events on fluoxetine were agitation (8%), GI disturbances (6%), retching (4%), dizziness (4%), tiredness, anxiety/nervousness and erectile dysfunction (3% each), while on hypericum only GI disturbances (5%) had an incidence greater than 2%.

Conclusion

The authors concluded that hypericum and fluoxetine are equipotent with respect to all main parameters used to investigate antidepressants in this population. Although hypericum may be superior in improving the responder rate, the main difference between the two treatments is safety. Hypericum was superior to fluoxetine in overall incidence of side-effects, number of patients with side-effects and the type of side-effect reported.

References

Schrader E. Equivalence of St John's wort extract (Ze 117) and fluoxetine: a randomized, controlled study in mild-moderate depression. International Clinical Psychopharmacology 15(2): 61-8. 2000.

Comment

This is another clinical trial to be added to the significant and growing evidence confirming the efficacy of St Johns Wort in mild-moderate depression and its comparability and possible superiority to conventional medicines.

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