• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
Grand Rounds

FOAM RCT Results: Does Supplemental Folic Acid Reduce Hot Flushes?

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Folic acid reduces noradrenaline secretion and increases serotonin activity
  • Ewies et al. (BJOG, 2021) assessed whether folic acid supplementation ameliorated hot flushes

METHODS:

  • Phase III double-blind, placebo-controlled randomized trial
    • FOlic Acid supplementation in the management of Menopausal symptoms (FOAM Trial)
  • Participants
    • 40 to 70 years
    • Postmenopausal
    • Normal baseline serum folate level (3.1-20.0µg/L)
    • ≥50 hot flushes weekly
  • Interventions
    • Folic acid 5 mg daily for 12 weeks
    • Placebo
  • Study design
    • Frequency and severity of hot flushes: Recorded daily by participants (Sloan Diary)
    • Quality of life: Greene Climacteric and Utian Quality of Life (UQoL) Scales
    • All outcomes measured at 4, 8 and 12 weeks
  • Sample size
    • Target: Detect 3.4 point mean difference in the change in Hot Flush Score with folic acid vs placebo
    • 80% power | Two-sided type 1 error alpha=0.05
    • 70 patients required per arm | Plan for 162 women to account for a 15% rate loss to follow-up rate
  • Primary outcome
    • Change in daily Hot Flush Score at week 12, based on Sloan Diary Composite Score
  • Secondary outcomes
    • Hot flush frequency and severity as calculated
    • Reduction in Hot Flush Score
    • Other menopausal symptoms
    • Longitudinal QoL data as measured by the Utian QoL Scale

RESULTS:

  • 143 women
  • Mean (SD) change in Hot Flush Score at week 12
    • Folic acid group: -6.98 (10.30)
    • Placebo: -4.57 (9.46)
  • No significant difference in mean change in Hot Flush Score between the two groups
    • Mean change: -2.41 (95% CI, -5.68 to 0.87); P=0.149
    • Adjusted mean change: -2.61 (95% CI, -5.72 to 0.49); P=0.098
  • Only benefit in secondary outcomes for folic acid group was seen in changes in total and emotional UQoL scores at week 8
    • Mean change for total score: 5.22 (95% CI, 1.16 to 9.28)
    • Mean change for emotional score: 1.88 (95% CI, 0.23 to 3.52)
    • Difference was not present at 12 weeks

CONCLUSION:

  • Compared to placebo, folic acid did not have a significant benefit in reducing hot flush scores over 12 weeks in postmenopausal women
  • The authors note that the lack of difference between the two groups

…may be due to higher than expected response to placebo

Definitive evidence of benefit would however require a larger study

Learn More – Primary Sources:

Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial

Want to stay on top of key guidelines and research papers?

ObGFirst® – Try It Free! »

image_pdfFavoriteLoadingFavorite
< Previous
All Grand Rounds Posts
Next >

Related ObG Topics:

Can Resistance Training Exercise Reduce Menopausal Hot Flushes?
Are Menopausal Hot Flushes Really Triggered by Core Temperature?
Can Mindfulness Alleviate Menopausal Hot Flashes?

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

Are you an
ObG Insider?

Get specially curated clinical summaries delivered to your inbox every week for free

  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Download Your ObG App
HERE!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site