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The effect of Tokishakuyakusan, a Chinese herbal medicine, was examined, in vivo, in women with luteal insufficiency and in women with normal menstrual cycles. Luteal insufficiency was determined by daily measurement of basal body temperature and plasma progesterone levels. Tokishakuyakusan improved luteal insufficiency. Furthermore, the effects of Tokishakuyakusan on prolactin, gonadotropins, steroids, angiotensin II, ANP and renin levels in the blood of women with normal menstrual cycles were studied, as were the medicine's effects on estrogens, pregnenediol and LH in the urine of the same women. Tokishakuyakusan had no adverse effect on hormonal levels in either blood or urine. Furthermore, no clinical side effects were detected. These results suggest that Tokishakuyakusan improves luteal insufficiency in women but does not affect the hormonal levels of women with normal menstrual cycles.

The aim of the present investigation was to evaluate the clinical efficacy of Xiong-gui-tiao-xue-yin, a traditional Japanese herbal medicine, in stimulating lactation in the postpartum period. We enrolled 82 women who had a normal delivery in Osaka Medical College Hospital, and randomly assigned them to the following two groups: a group of 41 women who received Xiong-gui-tiao-xue-yin at a dose of 6.0 g/day (Group X), and a group of 41 women who received ergometrine (methylergometrine maleate) at a dose of 0.375 mg/day (Group E). Volume of lactation was determined daily until Day 6 postpartum. Plasma prolactin and oxytocin concentration were measured at Days 1 and 6 postpartum. The results showed that volume of lactation was significantly higher in Group X than in Group E at Days 4 (p = 0.042), 5 (p = 0.038), and 6 (p = 0.046). Significant differences between Groups X and E were noted in plasma prolactin concentration at Days 1 (157.9 ± 78.2 ng/ml and 129.1 ± 64.8 ng/ml; p = 0.037) and 6 (167.5 ± 95.4 ng/ml and 117.1 ± 53.6 ng/ml; p = 0.0042) postpartum. On the other hand, at Day 1, oxytocin concentration was significantly higher in Group E than in Group X (p = 0.0024). No adverse effects were observed in this study. The results of our study demonstrate the beneficial effects of Xiong-gui-tiao-xue-yin on lactation, with increase in prolactin level without increase in oxytocin level in the postpartum period. Therefore, Xiong-gui-tiao-xue-yin can be expected to improve lactation in women in the postpartum period. Further detailed bio-pharmacological studies and clinical trials to investigate the properties of this drug are warranted.