Comparison of change in body weight between contraception containing 30-μg ethinylestradiol/2-mg chlormadinone acetate or 30-μg ethinylestradiol/3-mg drospirenone: a randomised controlled trial

Abstract

Objectives: The aim of this study was to compare changes in body weight in women using a combined oral contraceptive (COC) consisting of 30-μg ethinylestradiol (EE) and 2-mg chlormadinone acetate (CMA) or a COC consisting of 30-μg EE and 3-mg drospirenone (DRSP).

Methods: This randomised double-blind controlled trial (ClinicalTrials.gov NCT01608698) was conducted at a university hospital-based clinic in Thailand between June 2012 and September 2015. A total of 102 women were enrolled in the study, 99 of whom were randomised to EE/CMA (n = 45) or EE/DRSP (n = 54). Each participant was treated for six cycles. Body weight and other parameters as well as side effects were recorded at baseline and at the end of the third and sixth cycles of treatment.

Results: A significant difference was observed in mean body weight change between the EE/CMA and EE/DRSP groups from both baseline to third cycle (0.51 ± 1.36 kg vs –0.43 ± 1.56 kg; p = .003) and baseline to sixth cycle (1.00 ± 1.84 kg vs –0.20 ± 2.23 kg; p = .013). The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight. There was no significant difference in side effects between groups.

Conclusion: A COC containing 30-µg EE/3-mg DRSP tended to confer a significantly more favourable change in body weight over a 6-month period compared with a COC containing 30-µg EE/2-mg CMA, which was associated with an increase in body weight.

摘要

目的：本研究的目的是比较由30-μg炔雌醇（EE）和2-mg醋酸氯地孕酮（CMA）组成的联合口服避孕药（COC）或由30-μg炔雌醇（EE）和3-mg屈螺酮（DRSP）组成的COC对女性体重变化的影响。

方法：该随机双盲对照试验（临床试验编码NCT01608698）在2012年6月至2015年9月于泰国的一家大学医院诊所进行。 共纳入102名女性, 其中99名女性被随机分配至EE/CMA（n = 45）或EE/DRSP（n = 54）。每个参与者接受六个周期的治疗。在开始以及治疗的第三和第六周期结束时记录体重和其他参数以及副作用。

结果：EE/CMA和EE/DRSP组之间, 从基线到第三周期（0.51±1.36 kg vs –0.43±1.56 kg；p = .003）和基线至第六周期 （1.00±1.84 kg vs –0.20±2.23 kg；p = .013）的平均体重变化存在显着差异。体重指数和腰围的平均变化与体重的平均变化具有相似的趋势。两组之间的副作用没有显著差异。

结论：与含30-μg EE/2 mg CMA的COC组的体重增加相比, 含30-μg EE/3 mg DRSP的COC在6个月内倾向于带来明显更有利的体重变化。

Keywords:

• Body weight
• chlormadinone acetate
• combined oral contraceptives
• drospirenone
• randomised controlled trial

Acknowledgements

The authors would like to thank J. Inthawong and M. Vongsiri (Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University) for collecting data. The authors are also grateful to J. Pooliam (Clinical Epidemiology Unit, Faculty of Medicine Siriraj Hospital, Mahidol University) for assistance with the statistical analyses.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by a Siriraj grant for research development, Faculty of Medicine Siriraj Hospital, Mahidol University (no. R15532040).