OBJECTIVETo evaluate the clinical therapeutic effects and safety on infertility of polycystic ovary syndrome (PCOS) in the patients with ovulation induction with letrozole in the treatment with the formula for regulating menstruation and removing phlegm and electroacupuncture (EA).

METHODSA total of 120 patients of PCOS infertility were randomized into 3 groups, 40 cases in each one. In the group A, diane-35 was prescribed for oral administration (one tablet a day since the 5th day of menstruation, continuously for 21 days). After 1 course of treatment (3 months), letrozole was used (one tablet a day since the 5th day of menstruation, continuously for 5 days) for ovulation induction for another 1 course (3 months). In the group B, on the basis of the treatment as the group A, since the 5th day of menstruation, the Chinese herbal formula was combined to regulate menstruation and remove phlegm, one dose a day and discontinued during menstruation. In the group C, on the basis of the treatment as the group B, EA was added since the 5th day of menstruation. The main acupoints were Guanyuan (CV 4), Zusanli (ST 36) and Fenglong (ST 40), etc. EA was applied once every 2 days and discontinued during menstruation. In all of the 3 groups, the treatment for 3 months was as 1 course and the 2 courses were required continuously. Before and after treatment, the menstruation improvements, body weight, body mass index (BMI), serum sex hormones [luteal production hormone (LH), follicle stimulating hormone (FSH), LH/FSH, total testosterone (T) and estradiol (E)] were observed in the patients of each group. The enzyme linked immunosorbent assay was adopted to determine the content of anti-mullerian hormone (AMH) and inhibin B (IHNB). The therapeutic effects, safety, ovulation rate and pregnancy rate were compared among the 3 groups.

RESULTS(1) The differences were significant statistically in the total effective rate, ovulation rate and pregnancy rate in comparison of the 3 groups (all<0.05). The results in the group C were the best and those in the group B were the better in the comparison of the 3 groups. (2) After treatment, the menstrual cycle was remarkably shortened in the 3 groups (all<0.05). The result in the group C was better than that in the group A (<0.05). After treatment, the body weight in the group B and group C was all reduced (both<0.05). The reducing degree in the group C was better than that in the group A (<0.05). The differences in BMI were not significant statistically before and after treatment in each group as well as in comparison among the groups (all>0.05). (3) After treatment, the levels of LH and LH/FSH were all reduced remarkably in the 3 groups (all<0.05). The differences were not significant statistically in comparison among the three groups (all>0.05). After treatment, in the group B and group C, the levels of T and AMH were all reduced remarkably (all<0.05), in which, T value in the group C was lower than that in the group A and group B, that in the group B was lower than the group A (all<0.05). AMH value in the group C was lower than that in the group A (<0.05). The differences were not significant statistically in FSH, Eand IHNB before and after treatment in each group as well as in comparison among the 3 groups (all>0.05). (4) The luteinized unreuptured follicle syndrome (LUFS) did not happen in the group C. There were 3 cases of LUFS (7.5%) in the group B and 5 cases (12.5%) in the group A.

CONCLUSIONFor PCOS infertility patients receiving ovulation induction with letrozole, the combined treatment with the Chinese herbal formula for regulating menstruation and removing phlegm and EA remarkably improves the menstrual cycle, reduces body weight and the levels of LH, LH/FSH, T and AMH, improves ovulation and pregnancy rates. This therapy does not induce adverse reactions and the therapeutic effects are better than the simple application of letrozole or the combined therapy of letrozole and Chinese herbal medicine.