Folic acid supplementation in postmenopausal women with hot flushes: Phase III randomised double-blind placebo-controlled trial
Authors
Ewies, A. A. A.Ahmed, I.
Al-Azzawi, F.
Pitkin, J.
Gupta, P.
Persic, M.
Sahu, B.
El-Ghobashy, A.
Barraclough, Lisa H
Woodman, J.
Babrah, J.
Bowden, S.
Stocken, D.
Billingham, L.
Sundar, S
Rea, D.
Affiliation
Sandwell and West, Birmingham Hospitals NHS Trust, Birmingham, UK.Issue Date
2021
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, et al. Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial. BJOG: Int J Obstet Gy. 2021 Jun 8.Journal
BJOG-an International Journal of Obstetrics and GynaecologyDOI
10.1111/1471-0528.16739PubMed ID
33982872Additional Links
https://dx.doi.org/10.1111/1471-0528.16739Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1111/1471-0528.16739
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