Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind
Aaa Ewies1,2, I Ahmed3, F Al-Azzawi4
1Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
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.
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