To observe the clinical efficacy and safety of folic acid tablets combined with vitamin B₆ tablets as an adjuvant therapy for obese patients with polycystic ovary syndrome (PCOS).

Obese PCOS patients admitted to our hospital were divided into treatment group and control group according to the medication plan. The control group was treated with ethinylestradiol and cyproterone acetate tablets (taken orally before bedtime every night), metformin hydrochloride tablets (0.25 g, taken orally before breakfast and dinner), and orlistat capsules (60 mg, twice a day). The treatment group was treated with folic acid tablets (5 mg, once a day) and vitamin B₆ tablets (10 mg, once a day) in addition to control group. Compare clinical efficacy, glucose metabolism indicators, reproductive endocrine hormones, mean ovarian volume (MOV), mean number of follicles (MFN), inflammatory factors, serum homocysteine (Hcy), triglyceride (TG) levels and body measurement parameters between two groups, and evaluate their safety.

A total of 150 patients were included, with 73 in treatment group and 77 in control group. The total effective rates of treatment and control group were 90.41% (66 cases/73 cases) and 77.92% (60 cases/77 cases), respectively, and the difference was statistically significant (P<0.05). After treatment, the fasting plasma glucose (FPG) levels of treatment group and control group were (4.42±0.58) and (4.66±0.53) mmol·L^-1, respectively; the fasting insulin (FINS) levels were (9.16±1.77) and (10.03±2.06) mIU·L^-1, respectively; the homeostatic model assessment of insulin resistance (HOMA-IR) levels were 1.80±0.46 and 2.08±0.65, respectively; the anti-Müllerian hormone (AMH) levels were (4.03±1.19) and (4.63±1.32) ng·mL^-1, respectively; the inhibin B (INHB) levels were (102.33±14.54) and (108.81±17.63) pg·mL^-1, respectively; the MOV levels were (7.36±1.88) and (6.77±1.24) cm³, respectively; the numbers of MFN were (8.89±1.86) and (8.24±1.45) cell, respectively; the interleukin-6 (IL-6) levels were (16.87±3.22) and (18.34±3.67) pg·mL^-1, respectively; the tumor necrosis factor-alpha (TNF-α) levels were (10.19±3.06) and (11.83±3.22) pg·mL^-1, respectively; the Hcy levels were (14.78±3.52) and (16.16±3.64) μmol·L^-1, respectively; the TG levels were (3.49±0.61) and (4.15±0.66) mmol·L^-1, respectively; the body mass index (BMI) levels were (31.09±3.06) and (32.16±3.17) kg·m^-2, respectively; the body fat percentages were (31.42±3.24)% and (32.89±3.38)%, respectively; and the waist-to-hip ratio (WHR) levels were 0.92±0.21 and 1.01±0.26, respectively. There were statistically significant differences in the above indicators between treatment group and control group (P<0.05, P<0.01). The adverse drug reactions in treatment group were gastrointestinal discomfort, while those in control group were headache. The overall incidence rates of adverse drug reactions in treatment and control groups were 1.37% (1 case/73 cases) and 2.60% (2 cases/77 cases), respectively, with no statistically significant difference (P>0.05).

The adjuvant treatment of PCOS with folic acid combined with vitamin B₆ tablets has good clinical efficacy and safety. It can significantly reduce the levels of serum Hcy in patients and improve the insulin resistance status and lipid metabolism of patients.