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

Ayman A A Ewies; Ikhlaaq Ahmed; Farook Al-Azzawi; Joan Pitkin; Pratima Gupta; Mojca Persic; Banchhita Sahu; Alaa El-Ghobashy; Lisa Barraclough; Jacqueline Woodman; Jaspreet Babrah; Sarah Bowden; Deborah Stocken; Lucinda Billingham; Sudha Sundar; Daniel Rea

doi:10.1111/1471-0528.16739

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

Ayman A A Ewies, Ikhlaaq Ahmed, Farook Al-Azzawi, Joan Pitkin, Pratima Gupta, Mojca Persic, Banchhita Sahu, Alaa El-Ghobashy, Lisa Barraclough, Jacqueline Woodman, Jaspreet Babrah, Sarah Bowden, Deborah Stocken, Lucinda Billingham, Sudha Sundar, Daniel Rea

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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.

Original language	English
Pages (from-to)	2024-2033
Journal	BJOG: An International Journal of Obstetrics & Gynaecology
Volume	128
Issue number	12
Early online date	13 May 2021
DOIs	https://doi.org/10.1111/1471-0528.16739
Publication status	E-pub ahead of print - 13 May 2021

Bibliographical note

Funding Information:
SB has reported grants from National Institute of Health Research (NIHR) Research for Patient Benefit during the conduct of the study. DR has reported personal fees from Pfizer, personal fees from Novartis, personal fees from Roche, personal fees from Daiiachi‐Sankyo, personal fees from Lily, grants from Roche, grants from Biotheranostics and grants from RNA diagnostics. All of these are outside the submitted work. No potential conflicts of interest were reported by the other authors. The trial was funded by a grant from ‘Research for Patient Benefit’, Ref: PB‐PG‐1111‐26094. The funder and the manufacturers had no role in the design of the study, in the collection, analysis or interpretation of the data, or in the writing of the report.

Publisher Copyright:
© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Keywords

Folic acid
hot flushes

ASJC Scopus subject areas

Obstetrics and Gynaecology

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10.1111/1471-0528.16739Licence: Creative Commons: Attribution (CC BY)

1471-0528.16739Final published version, 1.37 MBLicence: Creative Commons: Attribution (CC BY)

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Ewies, A. A. A., Ahmed, I., Al-Azzawi, F., Pitkin, J., Gupta, P., Persic, M., Sahu, B., El-Ghobashy, A., Barraclough, L., Woodman, J., Babrah, J., Bowden, S., Stocken, D., Billingham, L., Sundar, S., & Rea, D. (2021). Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 128(12), 2024-2033. Advance online publication. https://doi.org/10.1111/1471-0528.16739

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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.",

keywords = "Folic acid, hot flushes",

author = "Ewies, {Ayman A A} and Ikhlaaq Ahmed and Farook Al-Azzawi and Joan Pitkin and Pratima Gupta and Mojca Persic and Banchhita Sahu and Alaa El-Ghobashy and Lisa Barraclough and Jacqueline Woodman and Jaspreet Babrah and Sarah Bowden and Deborah Stocken and Lucinda Billingham and Sudha Sundar and Daniel Rea",

note = "Funding Information: SB has reported grants from National Institute of Health Research (NIHR) Research for Patient Benefit during the conduct of the study. DR has reported personal fees from Pfizer, personal fees from Novartis, personal fees from Roche, personal fees from Daiiachi‐Sankyo, personal fees from Lily, grants from Roche, grants from Biotheranostics and grants from RNA diagnostics. All of these are outside the submitted work. No potential conflicts of interest were reported by the other authors. The trial was funded by a grant from {\textquoteleft}Research for Patient Benefit{\textquoteright}, Ref: PB‐PG‐1111‐26094. The funder and the manufacturers had no role in the design of the study, in the collection, analysis or interpretation of the data, or in the writing of the report. Publisher Copyright: {\textcopyright} 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.",

year = "2021",

month = may,

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doi = "10.1111/1471-0528.16739",

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Ewies, AAA, Ahmed, I, Al-Azzawi, F, Pitkin, J, Gupta, P, Persic, M, Sahu, B, El-Ghobashy, A, Barraclough, L, Woodman, J, Babrah, J, Bowden, S, Stocken, D, Billingham, L , Sundar, S & Rea, D 2021, 'Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial', BJOG: An International Journal of Obstetrics & Gynaecology, vol. 128, no. 12, pp. 2024-2033. https://doi.org/10.1111/1471-0528.16739

TY - JOUR

T1 - Folic acid supplementation in postmenopausal women with hot flushes

T2 - phase III randomised double-blind placebo-controlled trial

AU - Ewies, Ayman A A

AU - Ahmed, Ikhlaaq

AU - Al-Azzawi, Farook

AU - Pitkin, Joan

AU - Gupta, Pratima

AU - Persic, Mojca

AU - Sahu, Banchhita

AU - El-Ghobashy, Alaa

AU - Barraclough, Lisa

AU - Woodman, Jacqueline

AU - Babrah, Jaspreet

AU - Bowden, Sarah

AU - Stocken, Deborah

AU - Billingham, Lucinda

AU - Sundar, Sudha

AU - Rea, Daniel

N1 - Funding Information: SB has reported grants from National Institute of Health Research (NIHR) Research for Patient Benefit during the conduct of the study. DR has reported personal fees from Pfizer, personal fees from Novartis, personal fees from Roche, personal fees from Daiiachi‐Sankyo, personal fees from Lily, grants from Roche, grants from Biotheranostics and grants from RNA diagnostics. All of these are outside the submitted work. No potential conflicts of interest were reported by the other authors. The trial was funded by a grant from ‘Research for Patient Benefit’, Ref: PB‐PG‐1111‐26094. The funder and the manufacturers had no role in the design of the study, in the collection, analysis or interpretation of the data, or in the writing of the report. Publisher Copyright: © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

PY - 2021/5/13

Y1 - 2021/5/13

N2 - 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.

AB - 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.

KW - Folic acid

KW - hot flushes

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U2 - 10.1111/1471-0528.16739

DO - 10.1111/1471-0528.16739

M3 - Article

C2 - 33982872

SN - 1470-0328

VL - 128

SP - 2024

EP - 2033

JO - BJOG: An International Journal of Obstetrics & Gynaecology

JF - BJOG: An International Journal of Obstetrics & Gynaecology

IS - 12

ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this