Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial

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.