Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double‐blind placebo‐controlled trial. (8th June 2021)

• Record Type: Journal Article
• Authors: Ewies, AAA; Ahmed, I; Al‐Azzawi, F; Pitkin, J; Gupta, P; Persic, M; Sahu, B; Elgobashy, A; Barraclough, L; Woodman, J; Babrah, J; Bowden, S; Stocken, D; Billingham, L; Sundar, S; Rea, D
• Is Part Of: BJOG. Volume 128:Number 12(2021)
• Page Start: 2024
• Page End: 2033
• Publication Date: 2021-06-08
• Subjects: Folic acid -- hot flushes; Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1111/1471-0528.16739
• Languages: English
• ISSNs: 1470-0328

Abstract

Abstract : Objective: To assess whether folic acid supplementation ameliorates hot flushes. Design: Double‐blind, placebo‐controlled randomised trial. Setting: Nine hospitals in England. Population: Postmenopausal women experiencing ≥50 hot flushes weekly. Methods: Women ( n = 164) were randomly assigned in a 1:1 ratio to receive folic acid 5 mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in a Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4‐week intervals. Main outcome measures: The change in daily Hot Flush Score at week 12 from randomisation based on Sloan Diary Composite Score B calculation. Results: Data of 143 (87%) women were available for the primary outcome. The mean change (SD) in Hot Flush Score at week 12 was −6.98 (10.30) and −4.57 (9.46) for folic acid and placebo group, respectively. The difference between groups in the mean change was −2.41 (95% CI −5.68 to 0.87) ( P = 0.149) and in the adjusted mean change −2.61 (95% CI −5.72 to 0.49) ( P = 0.098). Analysis of secondary outcomes indicated an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week 8 when compared with placebo. The difference in the mean change from baseline was 5.22 (95% CI 1.16–9.28) and 1.88 (95% CI 0.23–3.52) for total and emotional score, respectively. Conclusions: The study was not able to demonstrate that folic acid had a statistically significant greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo. Tweetable abstract: Folic acid may ameliorate hot flushes in postmenopausal women but confirmation is required from a larger study. Tweetable abstract: Folic acid may ameliorate hot flushes in postmenopausal women but confirmation is required from a larger study.