Effect of 12-month treatment with metformin and/or oral contraceptives on health-related quality of life in polycystic ovary syndrome

Abstract

Health-related quality of life (HRQoL) is impaired in polycystic ovary syndrome (PCOS), but the effect of treatment with metformin (M) and/or oral contraceptives (OCP) is undetermined. To assess changes in HRQoL during 12-month randomized treatment with M, OCP or M + OCP in PCOS. Ninety women with PCOS were randomized to treatment with M, OCP or M + OCP. HRQoL was evaluated by a PCOS-specific visual analog scale (PCOS-VAS) regarding 1: Facial hair, 2: Body hair, 3: Acne, 4: Irregular menses, 5: Weight and 6: PCOS in general, and Short Form 36 (SF-36). PCOS-VAS1(facial hair) improved during treatment with OCP (n = 23) compared to M (n = 19), and during M + OCP (n = 23) compared to M treatment, whereas changes in PCOS-VAS2-6 and SF-36 scores were comparable between the three medical intervention groups. Pooled data (n = 65) showed improved PCOS-VAS scores during treatment (all p < .05), but changes in PCOS-VAS were unassociated with changes in BMI or FG-scores despite significant weight-loss during treatment with M (−3.0 kg (−10.3; 0.6)) and M + OCP (−1.9 kg (−4.9; 0.1)) and decreased FG-score during M + OCP treatment (median (quartiles)). PCOS-VAS scores improved significantly and to the same extent during treatment with M, OCP or M + OCP.

Chinese abstract

健康相关生活质量（HRQoL）在多囊卵巢综合征（PCOS）患者中是受损的, 但二甲双胍（M）和/或口服避孕药（OCP）治疗的效果尚未确定。我们评估多囊卵巢综合征患者经过十二个月二甲双胍、口服避孕药或二甲双胍联合口服避孕药治疗后HRQoL的改善。将90名患有PCOS的女性随机分到三组中。HRQoL通过PCOS特异性视觉模拟评分（PCOS-VAS）评估1：面部毛发, 2：体毛, 3：痤疮, 4：不规则月经, 5：体重, 6：PCOS一般表现, 以及简表36（SF-36）。与二甲双胍组（n = 19）相比, 用二甲双胍联合口服避孕药（n = 23）和口服避孕药（n = 23）治疗期间PCOS-VAS1（面部毛发）均有所改善, 而三个干预组的PCOS-VAS2-6和SF-36评分变化相当。汇总数据（n = 65）显示治疗期间PCOS-VAS评分改善（所有p <0.05）, 但是, 尽管在二甲双胍（ - 3.0kg（-10.3; 0.6））和二甲双胍联合口服避孕药（-1.9kg（-4.9; 0.1））治疗期间体重有显著减轻以及在二甲双胍联合口服避孕药治疗期间FG评分降低（中位数（四分位数））, PCOS-VAS的变化与BMI或FG评分的变化无关。在使用二甲双胍、口服避孕药或二甲双胍联合口服避孕药治疗期间, PCOS-VAS评分显著改善并程度相同。

Keywords:

• PCOS
• health-related quality of life
• metformin
• oral contraceptives

Acknowledgements

The authors thank Anne Mette Hangaard, Susanne Møller Pedersen, Geraldine Rasmussen and Thon Kowall Andersen for excellent technical assistance.

Disclosure statement

The authors have nothing to declare. Sandoz sponsored the tablets, but was not involved in the economy, planning of the project, or writing of the article.

Additional information

Funding

This work was supported by the Jacob Madsen’s and Olga Madsen’s Foundation, the Institute of Clinical research, Odense University Hospital, Kolding Hospital, A.P. Møller’s Foundation, Bernard and Marie Klein’s Foundation, the Novo Nordisk Foundation, and the Danish Medical Association. Oral contraceptive pills and metformin tablets were sponsored by Sandoz.