Open-label placebos for menopausal hot flushes: a randomized controlled trial

Yiqi Pan, Ramona Meister, Bernd Löwe, Ted J Kaptchuk, Kai J Buhling, Yvonne Nestoriuc, Yiqi Pan, Ramona Meister, Bernd Löwe, Ted J Kaptchuk, Kai J Buhling, Yvonne Nestoriuc

Abstract

This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p < 0.001, Cohen's d = 0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p = 0.02, Cohen's d = 0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p = 0.02, Cohen's d = 0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: - 0.04 [- 0.06; 0.14], p = 0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [- 0.17; 0.25], p = 0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Flow of participants. IC informed consent, OLP open-label placebo, wk week, AE adverse event.
Figure 2
Figure 2
Changes in hot flushes and overall improvement (observed values). Changes in (a) hot flush score, and (b) hot flush frequency over time. (c) Proportion of patients who indicated improvement, and (d) proportion of patients with clinically meaningful improvements. Error bars indicate standard deviations. OLP Open-label placebo.
Figure 3
Figure 3
Individual trajectories of hot flush score from baseline, week 4, to week 8 (observed values). Each line represents one case. OLP 4wk OLP intake from baseline to week 4, OLP 8wk OLP intake from baseline to week 8.

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