Effect of sulpiride on menopausal hot flashes: a randomized, double-blind, placebo-controlled clinical trial

Abstract

Low doses of sulpiride have been used off-label to treat menopausal hot slashes in Southern Brazil despite limited scientific evidence. This randomized controlled trial aimed at assessing the effects of sulpiride as compared to placebo on the frequency and severity of hot flashes. Postmenopausal women, aged 47–62, were recruited from the Menopause Clinic at Hospital de Clínicas de Porto Alegre, Rio Grande do Sul, Brazil, between March 2016 and January 2017. After a baseline assessment of 4 weeks, women were included if they had at least a mean of five moderate to severe hot flashes per day and then randomized to receive for 8 weeks either placebo (n= 14) or sulpiride 50 mg/d (n= 14). The number and severity of hot flashes were evaluated after the 8-week intervention. A generalized estimating equations (GEE) model with Bonferroni correction was used to simultaneously assess the frequency and severity of hot flashes. Baseline frequency and severity of hot flashes/day were similar in both groups. Sulpiride significantly reduced the total weekly mean of hot flash frequency (GEE, p_interaction=.019) and the total weekly mean of severity scores (GEE, p_interaction=.09, p_group=.006, p_time≤.0001) after 4 and 8 weeks of treatment. Treatment with sulpiride 50 mg/d significantly reduced the frequency and severity of hot flashes. Further studies are needed to confirm its benefits and related mechanisms of action.

摘要

虽然科学证据有限, 但在巴西南部, 低剂量的舒必利已被超说明书用于治疗绝经潮热。这项随机对照试验旨在评估舒必利与安慰剂相比对潮热的频率和严重程度的影响。在2016年3月至2017年1月之间, 从巴西南里奥格兰德州阿雷格里港医院的绝经门诊招募了47至62岁的绝经后妇女。经过4周的基线评估, 如果她们每天平均至少5次中度至重度潮热则随机分组接受8周的安慰剂（n = 14）或舒必利50mg / d（n = 14）。在8周的干预后, 评估潮热的频率和严重程度。Bonferroni校正的广义估计方程（GEE）模型用于同时评估潮热的频率和严重程度。两组受试者每天潮热的基线频率和的严重程度相似。在治疗4周和8周后, 舒必利显著降低了受试者每周平均潮热频率（GEE, p_interaction = .019）和严重程度评分的每周总平均值（GEE, p_interaction = .09, p_group = .006, p_time≤.0001）。舒必利50mg / d治疗显著降低潮热的频率和严重程度。需要进一步研究以确认其益处和相关的作用机制。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Hot flashes
• menopause
• sulpiride
• vasomotor symptoms
• Brazilian women

Acknowledgments

The authors would like to thank all the researchers from the Menopause Research Group and also express our deepest gratitude to the participants for their time and patience throughout this study.

Disclosure statement

All authors state having no competing financial interests. C.F.F. receives a postdoctoral fellowship (National Program of Postdoctoral – PNPD) from the Coordination for the Improvement of Higher Educational Personnel (CAPES, Brazil) and also states having no competing financial interests.

Author contribution

All authors contributing to the protocol/project development, data collection/analysis and interpretation and manuscript writing/editing.

Additional information

Funding

This study was supported with grants from the Coordination for the Improvement of Higher Education Personnel (CAPES, Brazil) and the Research and Events Incentive Fund (FIPE/HCPA, Brazil).