Differential Therapy of mild to moderate Depressive Episodes
(ICD-10 F 32.0; F 32.1) with St. John's Wort

The purpose of this report was to evaluate specific depressive symptoms that are most suitable for a therapy with the Ze 117 St. John's wort extract. We examined the antidepressant efficacy and drug safety of Ze 117 and fluoxetine in a multicentric prospective randomized double-blind parallel group comparison according to generally accepted guidelines such as the Declaration of Helsinki and GCP [15]. We treated outpatients (n = 240; Ze 117: 126; fluoxetine: 114) with mild to moderate depressive episodes (ICD-10: F 32.0, F 32.1; HAMD range: 16 - 24) with either two tablets St John's wort (Ze 117; 500 mg extract/day) or fluoxetine (20 mg/day) for 6 weeks. Antidepressant efficacy was evaluated with the validated HAMD psychometric method. A validated analysis of HAMD subscores was made to verify the efficacy for certain depressive symptoms.

The main results were:

• The HAMD responder rate [1] was 60 % in the Ze 117 group compared to 40 % in the fluoxetine group (p = 0.005).

• Particularly, there was a marked decrease of depressive agitation (pre-post comparison: 46 %) and anxiety symptoms (44 %) during the therapy with St. John's wort. Depressive obstruction (44 %) and sleep disorders (43 %) were reduced during the treatment, too. There were no statistically significant differences between the treatment groups.

• Adverse events occurred in 28 patients (25 %) in the fluoxetine group and in 18 (14 %) of the St. John's wort group (p < 0.07).

St. John's wort extract is a clinically effective equivalent to fluoxetine regarding overall depressive symptoms and main symptoms of depressive episodes. An especially interesting overall observation is that Ze 117 is particularly effective in depressive patients suffering from anxiety symptoms. St. John's wort revealed better safety and tolerability data than fluoxetine.

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