Efficacy of Chinese patent medicine Tian Gui Capsule in patients with polycystic ovary syndrome: a randomized controlled trial.

BACKGROUND

Polycystic ovary syndrome (PCOS) is a complex hormonal disorder and one of the most common reproductive endocrinology abnormalities in women. Recently, many studies have been conducted assessing Chinese herbal medicine as an alternative treatment for women with PCOS, it is, therefore, worthwhile to analyze and observe the curative effects of traditional Chinese medicine treatment in PCOS.

OBJECTIVE

To evaluate the efficacy of the Chinese patent medicine Tian Gui Capsule, in women with PCOS and compare its effects with metformin and ethinyl estradiol plus cyproterone acetate (Diane-35).

DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A total of 47 PCOS outpatients from the Obstetrics and Gynecology Hospital of Fudan University were randomly divided into 3 groups. Patients in group A (n=19) were given Tian Gui Capsule, patients in group B (n=17) were given metformin, and patients in group C (n=11) were given Diane-35. The 3 groups of patients were treated for 3 months.

MAIN OUTCOME MEASURES

Serum testosterone (T), sex hormone binding globulin (SHBG) and dehydroepiandrosterone sulfate (DHEA-S) levels, free androgen index (FAI), fasting blood glucose (FPG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), insulin sensitive index (ISI) and left and right ovary volumes of the 3 groups were evaluated before and after treatment .

RESULTS

After 3 months of treatment, when compared with before treatment data, group A patients showed decreased serum T and SHBG levels, FAI, FINS, and left and right ovary volumes (P<0.05), and increased serum DHEA-S (P<0.05), while the FPG level showed no significant change. Although the level of serum T and FINS among the 3 groups after the treatment were similar, group A demonstrated better results than group B in reducing the FAI and increasing the serum SHBG, but less significant results than group C besides, group B was the only group showed improved insulin sensitivity. Although the level of FPG of the 3 groups after treatment were similar, group C had the most increased FPG.

CONCLUSION

The effects of Tian Gui Capsule on hyperandrogenism are not as significant as Diane-35, but more effective than metformin. The effects of Tian Gui Capsule on hyperinsulinemia are not as significant as metformin but better than Diane-35. Tian Gui Capsule treats PCOS by regulating ovarian functions and reducing blood insulin level without inhibiting the function of the hypothalamic-pituitary-ovarian axis. Further studies with larger sample size are needed to confirm the above results.