OBJECTIVE To evaluate the effects of Wenshen Huayu Anchong Recipe (WSAR) on spontaneous ovulation and menstrual recovery in patients with polycystic ovary syndrome (PCOS) characterized by kidney yang deficiency, phlegm-dampness, and blood stasis pattern.

METHODS From April 2023 to February 2025, a total of 64 women with kidney yang deficiency, phlegm-dampness, and blood stasis pattern PCOS who visited the Traditional Chinese Medicine Gynecology Clinic of Jiangxi University of Chinese Medicine Affiliated Hospital were enrolled. Participants were randomly assigned, using a random number table, to the treatment group (n=32) or the control group (n=32). The treatment group received the WSAR, while the control group received a placebo. Both groups were treated for 3 months, with a 1-month follow-up after treatment. During the study, 3 patients in the treatment group and 7 patients in the control group withdrew. Changes in traditional Chinese medicine syndrome scores, anxiety, and depression (HADS), sexual function (FSFI), and quality of life (PCOSQ) were evaluated before and after treatment. Clinical manifestations of hyperandrogenism, including hirsutism, acne, and hair loss, were also assessed. Serum sex hormone levels follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E₂), prolactin (PRL), and total testosterone (T) were measured using ELISA; fasting blood glucose (FBG), total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL-C), and low-density lipoprotein (LDL-C) were measured by enzymatic assay; fasting insulin (FINS) was measured by chemiluminescence immunoassay (CLIA), and the homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. Adverse events were monitored during treatment, and spontaneous ovulation was assessed after treatment.

RESULTS After 3 months of treatment, the treatment group showed significant improvement from baseline in TCM syndrome score, menstrual cycle length, acne score, LH, LH/FSH ratio, T, FINS, HOMA-IR, PCOSQ, and FSFI scores (P<0.01), whereas no significant changes were observed in the control group. Between-group comparisons indicated that the treatment group had a significantly higher monthly spontaneous ovulation rate and significantly higher PCOSQ and FSFI scores than the control group (P<0.05， P<0.01). Additionally, the treatment group had significantly lower TCM syndrome score, menstrual cycle length, acne score, LH, LH/FSH ratio, T, FINS, and HOMA-IR compared with the control group (P<0.05， P<0.01). No obvious adverse reactions were observed in either group during treatment.

CONCLUSION The WSAR effectively increases the spontaneous ovulation rate in women with PCOS characterized by kidney yang deficiency, phlegm-dampness, and blood stasis pattern, while improving serum hormone levels, reducing traditional Chinese medicine syndrome scores, alleviating insulin resistance, enhancing quality of life, and demonstrating good safety.