Effect of sulpiride on menopausal hot flashes: a randomized, double-blind, placebo-controlled clinical trial.
Clarissa Moreira BorbaCharles Francisco FerreiraFernanda Vargas FerreiraFaustino Ramón Pérez-LópezMaria Celeste Osorio WenderPublished in: Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology (2019)
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, pinteraction=.019) and the total weekly mean of severity scores (GEE, pinteraction=.09, pgroup=.006, ptime≤.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.
Keyphrases
- double blind
- placebo controlled
- clinical trial
- postmenopausal women
- randomized controlled trial
- phase iii
- study protocol
- phase ii
- healthcare
- bone mineral density
- pregnant women
- emergency department
- primary care
- radiation therapy
- squamous cell carcinoma
- adipose tissue
- type diabetes
- systematic review
- smoking cessation
- locally advanced