Analgesic effect of a herbal medicine for treatment of primary dysmenorrhea--a double-blind study.

We evaluated the analgesic effect of Toki-shakuyaku-san (TSS) in women who had a combination of "deficiency," of "Yin," "cold," and "stagnated blood" syndromes, and were suffering from dysmenorrhea. A diagnostic scoring system was used for determination of these conditions. We treated patients with either TSS or placebo during 2 menstrual cycles with a double-blind technique, and we followed them for 2 additional cycles. A significant alleviation of dysmenorrhea was observed in patients treated with TSS as compared to those treated with placebo. Our results suggest that TSS is effective for treatment of dysmenorrhea in patients with the above-mentioned conditions.