Effect of probiotics combined with metformin on improvement of menstrual and metabolic patterns in women with polycystic ovary syndrome: a randomized clinical trial

Abstract

Objectives: The aim of this study was to access the efficacy of probiotics combined with metformin on improvement of menstrual and metabolic patterns in women with polycystic ovary syndrome (PCOS). Methods: In this single-centre, controlled, randomized clinical trial (NCT03336840), 60 non-obese women with PCOS were randomly assigned (1:1:1) to receive probiotics (4 g daily), metformin (1.5 g daily) or their combination for 12 weeks. The primary outcome was the improvement of menstrual patterns. The secondary outcomes included changes in anthropometric, metabolic profiles and hormonal levels. Results: After 12-week treatment, the recovery rate of menstrual cycle was 40% in probiotics group, 55% in metformin group and 80% in combination group (p = 0.035). Meanwhile, the ovulation rate was 30% in probiotics group, 55% in metformin group and 75% in combination group (p = 0.017). Serum anti-Müllerian hormone, testosterone, free androgen index, BMI, fasting blood glucose, HOMA-IR, lipid profiles were decreased after probiotics or metformin treatment in non-obese women with PCOS. Conclusion: In the present trial, probiotics combined with metformin was superior to probiotics or metformin alone to improve menstrual patterns in women with PCOS. Metabolic and hormonal profiles were also improved after probiotics or metformin treatment.

摘要

目的

本研究的目的是了解益生菌联合二甲双胍对改善多囊卵巢综合征（PCOS）女性的月经和代谢模式的效果。

方法

在这项单中心、对照、随机的临床试验（NCT03336840）中, 60名患有PCOS的非肥胖女性被随机分配（1:1:1）接受益生菌（每天4克）、二甲双胍（每天1.5克）或益生菌+二甲双胍, 治疗12个周。主要结果是月经模式的改善。次要结果包括人体测量、代谢概况和激素水平的变化。

结果

经过12周的治疗, 益生菌组的月经周期恢复率为40%, 二甲双胍组为55%, 联合治疗组为80%（P=0.035）。同时, 益生菌组的排卵率为30%, 二甲双胍组为55%, 联合组为75%（P=0.017）。患有PCOS的非肥胖女性在接受益生菌或二甲双胍治疗后, 血清抗缪勒激素、雄激素、游离睾酮、BMI、空腹血糖、HOMA-IR、血脂水平均有所下降。

结论

在本研究中, 益生菌联合二甲双胍在改善PCOS妇女的月经模式方面优于单用益生菌或单用二甲双胍。在益生菌联合二甲双胍治疗后, 代谢和激素水平也得到改善。

Keywords:

• Probiotics
• metformin
• clinic trial
• polycystic ovary syndrome

关键词:

• 益生菌
• 代谢
• 临床试验
• 多囊卵巢综合征

Acknowledgements

We thank all the participants enrolled in the study for their time and effort.

Disclosure statement

No potential conflict of interest was reported by the authors.

Ethics approval

The study protocol was approved by the Ethics Committee of Nanjing Drum Tower Hospital and was registered at clinicaltrials.gov (NCT03336840). All participants signed informed consent prior to study inclusion.

Additional information

Funding

This study was supported by grants from the National Natural Science Foundation of China Grant Award (81770819, 82030026, 81570736).