Efficacy and safety of herbal medicine Yijin-tang on polycystic ovary syndrome: A single-arm pilot study

Polycystic ovary syndrome (PCOS) is one of the most common disorders in reproductive endocrinology among women of reproductive age. Recent studies suggest that complementary and alternative therapies can alleviate PCOS symptoms, but the evidence for its efficacy and safety is minimal. The objectives of this study were to examine the effect of Yijin-tang (YJT) on PCOS patients.A single-arm, prospective pilot study enrolled 15 PCOS women with oligomenorrhea at Kyung Hee University Hospital at Gangdong, Seoul. Each participant took YJT 3 times a day (1 h after meal), totaling 6 g of YJT (Pinellia ternata Breitenbach, Citrus unshiu Markovich, Poria cocos Wolf, Glycyrrhiza uralensis Fisch, and Zingiber officinale Roscoe) per day, for 12 weeks. The primary outcome was menstrual cycle length. The secondary outcomes were the levels of estradiol (E₂), luteinizing hormone (LH), follicle stimulating hormone (FSH), total testosterone, LH/FSH ratio, number of ovarian follicles, phlegm pattern questionnaire scores, body weight, and body mass index.The menstrual cycle length significantly decreased at week 12 compared to baseline (60.31 ± 15.61 to 44.40 ± 15.58; P = 0.002) without body weight reduction. Reduced menstrual cycle length was maintained at additional 12 weeks without treatment (60.31 ± 15.61 to 44.50 ± 15.70; P = 0.010). Number of ovarian follicles was reduced after 12-week treatment (12.33 ± 3.29 to 9.93 ± 2.79; P = 0.012). Levels of E₂, LH, FSH, and total testosterone and LH/FSH ratio did not show significant change at week 12 compared to baseline. No serious adverse events were reported during the study.This study demonstrated that YJT administration for 12 weeks improved oligomenorrhea and reduced follicle number of the ovary though there was not significant body weight reduction.