The effect of different progestogens on sleep in postmenopausal women: a randomized trial

Abstract

Background: While progesterone affects sleep, different types of it might affect sleep differently.

Methods: One hundred Thai women, who complained of insomnia, visited the Menopause Clinic at Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand from February 2014 to March 2015, and were divided randomly into two groups. Both groups received daily hormonal treatment that included estradiol valerate (progynova) at 1 mg. The first group also received dydrogesterone (duphaston^®) at 10 mg and the second group micronized progesterone (utrogestran^®) at 100 mg. The clinical symptoms and Pittsburgh Sleep Quality Index (PSQI) were recorded for three consecutive months after treatment. This study was registered with clinicaltrial.gov (code number NCT02086032).

Results: Sleep quality improved in both groups (10.52 ± 4.27 to 4.91 ± 3.15 in the dydrogesterone group and 10.16 ± 3.60 to 6.27 ± 3.04 in the micronized progesterone group, p value 0.08). Women in the micronized progesterone group had fewer overall side effects than those in the dydrogesterone group.

Conclusion: Sleep quality of peri-postmenopausal women with insomnia improved dramatically after the first month of hormonal treatment. However, more participating patients are necessary to ascertain the differences in sleep quality from dydrogesterone and micronized progesterone treatment.

Trial registration: ClinicalTrial.gov identifier: NCT02086032.

Chinese abstract

背景：孕激素影响睡眠, 药物种类不同, 作用效果不一。

方法：我们于2014年2月至2015年3月随访了100名于清迈Maharaj Nakorn医院更年期门诊就诊的饱受失眠问题困扰的泰国女性, 并将其随机分为两组。两组人员均接受1mg戊酸雌二醇（补佳乐）治疗。第一组加用10mg地屈孕酮（达芙通）, 第二组加用100mg微粒化黄体酮（安琪坦）治疗。连续治疗三个月并记录其临床症状和匹兹堡睡眠质量指数（PSQI）。本研究已在clinicaltrial.gov注册（代号NCT02086032）。

结果：两组围绝经期女性的睡眠质量均有所改善（地屈孕酮组10.52 ± 4.27〜4.91 ± 3.15, 黄体酮组10.16 ± 3.60〜6.27 ± 3.04, p = 0.08）。黄体酮组的女性的药物副反应少于地屈孕酮组。

结论：围绝经期失眠女性的睡眠质量经激素治疗一个月后得到显著改善。然而, 地屈孕酮和黄体酮改善睡眠质量的疗效差异尚需更多的试验证明。

关键词: 睡眠, 绝经, 地屈孕酮, 黄体酮, 更年期

Keywords:

• Sleep
• menopause
• dydrogesterone
• progesterone
• climacteric

View correction statement:

Correction to: Leeaunkulsathean et al., The effect of different progestogens on sleep in postmenopausal women: a randomized trial

Acknowledgements

The authors would like to acknowledge the nurses, residents and staff at the Menopause Clinic, Chiang Mai University for their invaluable help in recruiting the patients. Thanks also go to all of the participants. This study was funded by the Faculty of Medicine, Chiang Mai University.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This study was funded by the Faculty of Medicine, Chiang Mai University.