title: Efficacy and tolerability of St. John's wort extract LI 160 versus imipramine in patients with severe depressive episodes according to ICD-10.
abstract: 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 treatment 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 result 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.
authors.affiliation: Department of Psychiatry and Psychotherapy, Ev. Krankenhaus Elisabethenstift, Darmstadt, Germany.
authors.forename: E U
authors.initials: EU
authors.lastname: Vorbach
authors.forename: K H
authors.initials: KH
authors.lastname: Arnoldt
authors.forename: W D
authors.initials: WD
authors.lastname: Hübner
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D020902:Hypericum; D007099:Imipramine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010569:Perylene / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010946:Plants, Medicinal; D011569:Psychiatric Status Rating Scales; D011794:Quercetin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014966:Xanthenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D000929:Antidepressive Agents, Tricyclic; D014966:Xanthenes; D010569:Perylene; D011794:Quercetin; D007099:Imipramine