OBJECTIVETo observe the effect of Yishen Jianpi Yangxue Tongli Therapy (YJYTT) in treating polycystic ovary syndrome (PCOS) and to explore the therapeutic mechanism of YJYTT.

METHODSOne hundred and seven PCOS patients with syndrome differentiation of TCM as Pi-Shen Yang deficiency were randomly divided into two groups, the treated group (n = 76) was treated with Chinese herbal medicine, while the control group (n = 31) was treated by clomiphen. The therapeutic effect in both groups and the change of body mass index (BMI), Ferriman-Gallway (F-G) score, serum sex hormones and serum oral glucose tolerance test (OGTT) before and after treatment were observed.

RESULTSThe comparison of total effective rate between two groups was insignificantly different, but the pregnancy rate of the treated group (65.7%) was markedly higher than that of control group (25.0%, P < 0.01). Also, significant difference was shown in the aspect of BMI, F-G score, serum testosterone (T), luteinizing hormone (LH) and OGTT, etc. between the two groups (P < 0.05).

CONCLUSIONThe YJYTT could markedly improve the clinical symptoms and pregnancy rate of PCOS patients, particularly showing good effect to the clomiphen resistant patients. The mechanism possibly was due to its regulation on hypothalamus-pituitary-ovarium axis and reducing the insulin resistance.