Efficacy and Safety of St. Joh'ns Wort Whole Extract (Ze117) in Patients with Depressive Symptomatology of Different Degrees

Author(s): Liske, E., Rosinus, V.

Abstract: Problem: The efficacy and safety of an antidepressant treatment with the St.John's wort whole extract, Ze117, in patients with depressive symptomatology of different degrees of severity was to be documented in general medical practice. In addition, the attempt was made to determine the various different symptoms and to assess the effect of the treatment on each of them. Study design: 'Me investigation was carried out as an open, multicentre treatment observation in four general medical practices. The patient data were collected by the treating physicians, using a documentation form of the SMGP (Schweizerische Medizinische Gesellschaft für Phytotherapie). In one practice an evaluation was also carried out by means of a Hamilton Scale for Depression (HAMD). Patients: In the four medical practices participating, a total of 170 patients with depressive symptomatology were included in the study, and the data on 163 of these patients (127 women and 36 men) were available for the evaluation. The pathologic findings of the patients were described by the doctors as masked, mild, moderately severe or severe depressions. Treatment: For an average treatment period of 66 days the patients received 2x1 tablet of the St.John's wort whole extract Ze117 per day, corresponding to a daily dose, in accordance with the monograph, of 500 mg extract (drug: extract ratio = 7:1 to 6:1, equivalent to 2-3,5 g drug), standardised to 1 mg total hypericin per day. Results: In the masked, mild and moderately severe depressions an average reduction of the depressive symptomatology by about 40%, in comparison with the baseline values, was observed (p<0.001). The patient's questionnaire contained a list of 22 typical symptoms, the severity of which could be followed in the course of the treatment. Statistically significant improvements were observed in all the symptoms (p < 0.001) in these three classifications of severity. In the severe depressions, on the other hand, the improvements were slight, not significantly different from the baseline situation and not clinically relevant. The evaluation by means of HAMD, in 84 patients, showed a statistically significant improvement of the depressive symptomatology in the course of the treatment (P < 0.001). 'Me efficacy and the tolerability of the drug were described by the doctors as 'good' to 'very good'. Conclusion: The results of this study confirm the knowledge on the effectiveness of St.John's wort obtained with other preparations containing this drug.

Keyword(s): Johanniskraut

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