EFFICACY AND TOLERABILITY OF ST-JOHNS WORT EXTRACT LI-160 VERSUS IMIPRAMINE IN PATIENTS WITH SEVERE DEPRESSIVE EPISODES ACCORDING TO ICD-10

The special extract of St. John's wort, LI 160, exhibited a superior a ntidepressant efficacy compared to placebo in several controlled trial s. Two further trials demonstrated a similar reduction of depressive s ymptomatology under LI 160 compared to tricyclics. All these trials we re performed in mildly to moderately depressed patients. The present i nvestigation was a randomized, controlled, multicentre, 6-week trial c omparing 1800 mg LI 160/die to 150 mg imipramine/die in severely depre ssed patients according to ICD-10. The main efficacy parameter, a redu ction of the total score of the Hamilton Depression Scale, proved both treatment regimens very effective at the end of the 6 week treatmend period (mean values 25.3 to 14.5 in the LI 160 group and 26.1 to 13.6 in the imipramine group), but not statistically equivalent within a a- priori defined 25% interval of deviation. The analysis of subgroups wi th more than a 33% and 50% reduction of the HAMD total score justified the assumption of equivalence within a 25% deviation interval. This V iew was also supported by the global efficacy ratings from patients an d investigators. Regarding adverse events, the nonrejection of the non equivalence hypothesis denotes a superiority of the herbal antidepress ant. These main results indicate that LI 160 might be a treatment alte rnative to the synthetic tricyclic antidepressant imipramine in the ma jority of severe forms of depressions. However, more studies of this t ype must be performed before a stronger recommendation can be made.