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Open-label placebos for menopausal hot flushes: a randomized controlled trial
Yiqi Pan1,2, Ramona Meister3, Bernd Löwe4
1Department of Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces, Hamburg, Germany. y.pan@uke.de.
Scientific Reports
|November 19, 2020
Summary
Open-label placebos (OLP) significantly reduced hot flush severity and frequency in menopausal women compared to no treatment. These benefits were maintained for up to eight weeks, suggesting OLP is a safe and effective alternative.
Area of Science:
- Gynecology
- Menopause Research
- Psychosomatic Medicine
Background:
- Menopausal hot flushes significantly impact quality of life.
- Conventional treatments may have limitations or side effects.
- Exploring novel therapeutic strategies is crucial for managing menopausal symptoms.
Purpose of the Study:
- To evaluate the efficacy of open-label placebos (OLP) in reducing the frequency and intensity of menopausal hot flushes.
- To assess the impact of OLP on menopause-related quality of life.
- To determine the duration of OLP treatment needed to maintain benefits.
Main Methods:
- A randomized controlled trial comparing OLP (twice daily for 4 weeks) with a no-treatment group.
- Participants (n=100) had at least five moderate to severe hot flushes daily.
- Intention-to-treat analysis was used; benefits maintenance was assessed up to 8 weeks.
Main Results:
- OLP significantly reduced the composite hot flush score (frequency × intensity) compared to no-treatment (p < 0.001).
- Hot flush frequency (p = 0.02) and menopause-related quality of life (p = 0.02) also improved with OLP.
- Benefits were maintained at 8 weeks, with no significant difference between 4 or 8 weeks of OLP treatment.
Conclusions:
- Open-label placebos represent a safe and effective alternative for managing menopausal hot flushes.
- OLP demonstrated significant reductions in hot flush burden and improvements in quality of life.
- The therapeutic effects of OLP were sustained for at least eight weeks.
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