Efficacy of Hypericum extract WS(®) 5570 compared with paroxetine in patients with a moderate major depressive episode - a subgroup analysis

Abstract

Objectives: efficacy and tolerability of WS(®) 5570 for the treatment of acute mild-to-moderate depression, has been demonstrated in various studies. Here, we present a subgroup analysis of a double blind, randomised trial to compare the therapeutic efficacy of WS(®) 5570 with paroxetine in patients suffering from a major depressive episode with moderate symptom intensity.

Methods: moderate depression was defined by a baseline Hamilton Depression Rating Scale (HAM-D) total score between 22 and 25. Patients received, after a single blind placebo run-in phase of 3-7 d, either 3 × 300 mg/d WS(®) 5570 or 20 mg/d paroxetine for six weeks. The change of the HAM-D total score was used to describe the efficacy of WS(®) 5570 compared with paroxetine in the subgroup of patients with moderate depression.

Results: the reductions of the HAM-D total score were significantly more pronounced in patients treated with 3 × 300 mg/d WS(®) 5570 compared to 20 mg/d paroxetine.

Conclusions: patients treated with WS(®) 5570 not only showed a reduction in depression severity score but also yielded greater response and remission rates compared with patients treated with paroxetine. Keypoints Various studies showed the efficacy and tolerability of WS(®) 5570 for the treatment of acute mild-to-moderate depression. Beneficial effects of WS(®) 5570 have been also shown in patients with moderate-to-severe depression. In this study reductions of the HAM-D total score were significantly more pronounced in patients with moderate depression treated with WS(®) 5570 compared with paroxetine. Patients treated with WS(®) 5570 not only showed a reduction in depression severity score but also yielded greater response and remission rates compared with patients treated with paroxetine.

Keywords: Hypericum extract; St. John’s wort; WS® 5570; moderate major depressive episode; paroxetine.

Figure 1.

Change of Hamilton Depression Rating Scale (HAM-D) total score during the course of the acute treatment phase [mean (SD) and p value of the two-sided t-test; pooled data; FAS, LOCF].

Figure 2.

Response and remission after six weeks of acute treatment [absolute (relative frequency) and p value of the two-sided χ² test; pooled data; FAS, LOCF].