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Background Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders of reproductive age women with a prevalence of 4-12%. The study aimed to investigate the potential benefit of adding thymoquinone to metformin in alleviating symptoms of polycystic ovarian syndrome. Two hundred seven overweight and obese PCOS patients were divided into two groups. Patients in group A received metformin 500 mg three times daily for 6 months. Patients in group B received a combination of metformin 500 mg and thymoquinone in the form of black cumin oil 500 mg capsules three times daily for 6 months. Follow-up was done after 3 and 6 months from the beginning of the study for evaluation of menstrual cycle pattern, body mass index, waist circumference, hip circumference, and waist:hip ratio, oral glucose tolerance test, glycosylated hemoglobin A1C, superoxide dismutase activity, and malondialdehyde concentration. Results Patients who received a combination of black cumin oil capsules and metformin, showed a significant decrease in number of patients suffering from amenorrhea or oligomenorrhea ( P  = 0.031), significant ( P  = 0.00) weight reduction (reduced BMI), and body fat redistribution (reduced W/H ratio), regaining oxidative balance with significant increase of SOD activity ( P  = 0.00) and decrease of MDA concentrations ( P  = 0.03). Regarding the number of prediabetic patients, there was no statistically significant difference ( P  = 0.89) when both groups were compared at the end of study period. Conclusions Black cumin oil supplementation constitutes a beneficial added value to metformin in ameliorating PCOS-related disorders with resumption of menstrual regularity, weight reduction, change of body fat distribution, and regaining oxidative balance.

Amelioration of polycystic ovary syndrome-related disorders by supplementation of thymoquinone and metformin