Pharmacopsychiatry 1997; 30: 81-85
DOI: 10.1055/s-2007-979524
Original Papers

© Georg Thieme Verlag Stuttgart · New York

Efficacy and Tolerability of St. John's Wort Extract LI 160 Versus Imipramine in Patients with Severe Depressive Episodes According to ICD-10

E. U. Vorbach1 , K. H. Arnoldt2 , W.-D. Hübner3
  • 1Department of Psychiatry and Psychotherapy, Ev. Krankenhaus Elisabethenstift, Darmstadt, Germany
  • 2CNS-Consultants, Research Institute of Neurology and Psychiatry, Darmstadt, Germany
  • 3Lichtwer Pharma GmbH, Berlin, Germany, Evaluation by: Biomathematical Institute D. Christl, Wiesbaden, Germany
Further Information

Publication History

Publication Date:
20 April 2007 (online)

The special extract of St. John's wort, LI 160, exhibited a superior antidepressant efficacy compared to placebo in several controlled trials. Two further trials demonstrated a similar reduction of depressive symptomatology under LI 160 compared to tricyclics. All these trials were performed in mildly to moderately depressed patients. The present investigation was a randomized, controlled, multicentre, 6-week trial comparing 1800 mg LI 160/die to 150 mg imipramine/die in severely depressed patients according to ICD-10. The main efficacy parameter, a reduction 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 with more than a 33 % and 50 % reduction of the HAMD total score justified the assumption of equivalence within a 25 % deviation interval. This view was also supported by the global efficacy ratings from patients and investigators. Regarding adverse events, the nonrejection of the nonequivalence hypothesis denotes a superiority of the herbal antidepressant. These main results indicate that LI 160 might be a treatment alternative to the synthetic tricyclic antidepressant imipramine in the majority of severe forms of depressions. However, more studies of this type must be performed before a stronger recommendation can be made.