Efficacy and Tolerability of Ze 117 St. John's Wort Extract in Comparison with Placebo, Imipramine and Fluoxetine for the Treatment of Mild to Moderate Depression according to ICD-10. An Overview

In three randomised, double-blind, multi-centre clinical trials [ 1 ] [ 2 ] [ 3 ], the efficacy and tolerability of the St. John's wort (SJW) extract Ze 117 was examined in comparison with placebo, imipramine and fluoxetine for the treatment of mild to moderate states of depression according to ICD-10 (F32.0 mild; F32.1 moderate). Each study was performed for 6 weeks according to Good Clinical Practice (GCP). 162 patients (108 women, 54 men) were included in the first trial (a). The verum group received 2 × 1 tablet of SJW extract Ze 117 at 250 mg daily (ethanol 50 % (m/m); drug-extract ratio 4 - 7 : 1; 0.2 % total hypericin; < 1 % hyperforin). The placebo group was treated with 2 × 1 tablet of placebo daily. The main efficacy parameter was the change of baseline in the 21-item Hamilton Depression Score (HAMD). Response was defined as a decrease from baseline in the total HAMD score by over 50 % or a total score of at most 10 at the end of the therapy. Secondary outcome measures were the Clinical Global Impression Scale (GCI) and the Visual Analogue Scale (VAS). The two groups showed significant differences in their main and secondary outcome parameters. The mean HAMD scores improved from 20.13 to 10.53 points in the verum group, and from 18.76 to 17.89 (p < 0.001) in the placebo group (Fig. [ 1 ]). The responder rate for the verum group was 56 %, but only 15 % for the placebo group. The secondary parameters GCI and VAS also showed significant (p < 0.001) differences in favour of the Ze 117 group. Neither in the verum nor in the placebo group did any serious adverse events occur. In the imipramine trial (Fig. [ 2 ]), 324 patients were examined (230 women, 94 men) [ 3 ]. The Ze 117 group received 2 × 1 tablet of Ze 117 daily, and the imipramine group 2 × 75 mg imipramine daily (after initial titration). The main efficacy parameter was also the change from baseline according to the 21-item HAMD score. Equivalence of therapy was achieved when the difference of the HAMD score was not greater than 3.5 score points after 6 weeks. Secondary parameters were the Patients' Self Assessments of Global Improvement (PGI), Tolerability (TOL) and the Clinical Global Impression (CGI). Response was defined as a reduction of at least 50 % points of the HAMD scores after 6 weeks. The mean HAMD scores improved in the Ze 117 group from 22.4 to 12.0 and in the imipramine group from 22.1 to 12.75 (p < 0.20). In the primary parameters, the two therapies were statistically equivalent. The responder rate in the Ze 117 group was 43 % compared to 40 % in the imipramine group. Adverse events were reported by 39 % of the patients in the Ze 117 and 63 % in the imipramine group. The most common adverse events in the Hypericum group were dry mouth (8.3 %), headache (1.9 %), sweating (1.3 %). asthenia (1.3 %) and nausea (< 1 %). In the imipramine group, the most common adverse events were dry mouth (24.6 %), sweating (7.8 %), dizziness (7.2 %), nausea (7.2 %), asthenia (6.6 %) and headache (3.6 %). In the recent fluoxetine trial [ 1 ], 240 patients were included (157 women, 83 men). Once again, the Ze 117 group received 2 × 1 tablet of Ze 117 daily and the fluoxetine group 1 × 20 mg of fluoxetine daily. Equivalence of therapy was achieved when the difference of the HAMD score (main efficacy parameter) after 6 weeks was not greater than 3.0 score points. CGI and VAS were applied as secondary variables. Response was defined as a reduction of the HAMD score of at least 50 % or a reduction of at least 10 score points after 6 weeks. The mean HAMD scores improved from 19.65 to 11.54 in the Ze 117 group and from 19.5 to 12.2 in the fluoxetine group. Regarding the primary outcome parameters, both therapies were statistically equivalent (p < 0.09). The responder rate in the Ze 117 group was 60 % and in the fluoxetine group 40 %. Adverse events were reported by 14 % of the patients in the Ze 117 and 25 % in the fluoxetine group. The most common adverse events in the Ze 117 group were gastrointestinal disturbances (4.8 %) and in the fluoxetine group agitation (7.9 %), gastrointestinal disturbances (6.1 %), retching (4.4 %), dizziness (3.5 %), tiredness (2.6 %), anxiety and/or nervousness (2.6 %) and erectile dysfunction (2.6 %). These three clinical trials summarized in the present paper could clearly demonstrate the superiority of Ze 117 over placebo and its equivalence to imipramine and fluoxetine in its antidepressive effects for mild to moderate depression. SJW extract Ze 117 was clearly superior to imipramine and fluoxetine regarding side effects. With these results, Ze 117 SJW extract must be regarded as a real alternative to the chemical synthetic antidepressants in the therapy of mild to moderate depression. Fig. 1 Hypericum (Ze 117) vs. Placebo. HAMD-Score differences between begin and end of therapy (ITT-Analysis). Fig. 2 Hypericum (Ze 117) vs. Imipramine. HAMD-Score difference between begin and end of therapy (ITT-Analysis). Fig. 3 Hypericum (Ze 117) vs. Fluoxetine. HAMD-Score difference between begin and end of therapy (ITT-Analysis).

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