Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial.
Author
Ewies, Ayman A. A.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
Publication date
2021-06-08Subject
Gynaecology
Metadata
Show full item recordAbstract
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.Citation
Ewies A, 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. Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial. BJOG. 2021 Nov;128(12):2024-2033. doi: 10.1111/1471-0528.16739. Epub 2021 Jun 8Type
ArticleAdditional Links
http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1471-0528PMID
33982872Publisher
Wiley-Blackwellae974a485f413a2113503eed53cd6c53
10.1111/1471-0528.16739