Health-Related Quality of Life, Mood, and Sexual Function in Polycystic Ovary Syndrome (PCOS): Assessing the Impact of Combined Oral Contraceptive Pills and Metformin Therapy (characters with spaces: 175, limit 125).

OBJECTIVE

To study the effects of combined oral contraceptive pills (COCPs), metformin, and their combination on health-related quality of life, depression, anxiety, and sexual function in women with hyperandrogenic polyendocrine metabolic ovarian syndrome (PMOS) and elevated BMI.

DESIGN

Secondary analysis of a double-blind, double-dummy, parallel, randomized controlled trial (COMET-PCOS).

SUBJECTS: 240 women aged 21-40 years with hyperandrogenic PMOS and BMI ≥25 kg/m2, randomized to COCP, metformin, or COCP+metformin; analyses were subset to subjects with a response at both baseline and end of study.

INTERVENTION: Six months of COCP (20μg ethinyl estradiol/0.15 mg desogestrel), metformin XR 2000 mg/day, or combination therapy.

MAIN OUTCOME MEASURES: Changes from baseline to study end in modified PCOS Health Related Quality of Life (mPCOSQ) domains, Center for Epidemiologic Studies Depression Scale (CES-D), State-Trait Anxiety Inventory (STAI Y-1 and Y-2), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS).

RESULTS

Compared to baseline, mPCOSQ scores improved across all domains in the combination group (n=60, p<0.01), COCP group (n=56, p<0.01, except menstrual health and acne domains), and metformin group (n=51, p<0.05, except body hair and weight domains). Depressive symptoms and depression prevalence were unchanged in the COCP and combined group but improved in the metformin group (p<0.001). State anxiety improved in the metformin and combined groups (p<0.01); trait anxiety improved across all groups (p<0.05). FSFI scores were lower in the COCP group for the desire (p<0.001) and arousal (p=0.03) domains with no difference in total score (p=0.07); however, sexual distress decreased in both the COCP (p=0.03) and metformin groups (p=0.03). There were no significant changes in the prevalence of sexual dysfunction in any group.

CONCLUSION

Although COCPs and metformin are commonly used to manage PMOS, limited data exist on their impact on mental and sexual health. Our study demonstrates favorable or neutral effects of these therapies on mental health and quality of life in women with hyperandrogenic PMOS and elevated BMI. Metformin improved depressive symptoms and anxiety, while COCPs produced modest reductions in sexual desire without increasing sexual distress or dysfunction. These findings provide clinically relevant data for counseling women with PMOS, a group at high risk for mental health disorders.