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QUESTION: Is agnus castus fruit (Vitex agnus castus L extract Ze 440) effective and safe for treatment of premenstrual syndrome?
Design
Randomised (allocation concealed), blinded (investigators and patients), placebo controlled trial with follow up until the end of the third consecutive menstrual cycle.
Setting
6 outpatient general medicine clinics.
Patients
178 women ≥18 years of age who met DSM-III-R criteria for premenstrual syndrome. Exclusion criteria were participation in other trials, concomitant psychotherapy, pregnancy or breast feeding, inadequate contraception, dementia, alcohol or drug dependence, serious medical condition, hypersensitivity to agnus castus, fever, pituitary disease, or sex hormone use. 170 women (96%) (mean age 37 y) were included in the intention to treat analysis.
Intervention
Women were allocated to receive agnus castus fruit, 20 mg dry tablet once daily (n=91) (60% ethanol m/m, extract ratio 6–12:1; standardised for …
Footnotes
Source of funding: Zeller AG, CH-8590 Switzerland through the Clinical Research Organisation Praxis Klinische Arzneimittelforschung, Polheim, Germany.
For correspondence: Dr R Schellenberg, Institute for Health Care and Science, 35625 Huttenberg, Germany. Fax +49 6403 72156.
A modified version of this abstract appears in Evidence-Based Mental Health.