Herbal medicine for the management of polycystic ovary syndrome (PCOS) and associated oligo/amenorrhoea and hyperandrogenism; a review of the laboratory evidence for effects with corroborative clinical findings
OBJECTIVE To investigate the effect of an herbal medicine, Shakuyaku-Kanzo-To (TJ-68), on endocrine variables in patients with polycystic ovarian disease (PCOD). SETTING Medical university hospital. PATIENTS AND INTERVENTIONS Thirty-four Japanese women with PCOD were treated daily with 7.5 g of TJ-68 for 24 weeks. Testosterone (T), free-testosterone (free-T), sex hormone binding globulin (SHBG), LH, FSH, estrone, 17 beta-estradiol, 3,4-dihydroxyphenylglycol (DOPEG), and 3, 4-dihydroxyphenylacetic acid (DOPAC) were examined. RESULTS No side effects were observed in any cases. At 4 weeks after initiation of treatment, serum T and free-T levels significantly decreased, while SHBG was not significantly elevated. Meanwhile, after 12 weeks of treatment, the mean serum T level of the patients who became pregnant decreased to 35% of that before the treatment, but levels did not change in the patients who failed to conceive. There was no significant difference in estrone/estradiol ratio before and after treatment, but the estradiol/testosterone ratio increased significantly after 4 weeks of treatment. The LH/FSH ratio after 24 weeks of treatment was significantly lower than that before treatment. DOPEG and the DOPEG/DOPAC ratio significantly decreased after 4 weeks of treatment. CONCLUSIONS It is suggested that TJ-68 acts directly on the ovary first, increasing the activity of aromatase, which promotes the synthesis of estradiol from testosterone, thus lowering serum T levels. Furthermore, the effect on catecholamines results in gradually improving the dissociate phenomenon of LH/FSH ratio. Therefore, TJ-68 is an effective herbal medicine for decreasing serum free-T levels and achieving pregnancy in patients with PCOD.