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Device-guided slow-paced respiration for menopausal hot flushes: a randomized controlled trial |
Huang AJ, Phillips S, Schembri M, Vittinghoff E, Grady D |
Obstetrics and Gynecology 2015 May;125(5):1130-1138 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate the efficacy of device-guided slow-paced respiration for reducing the frequency and severity of menopausal hot flushes. METHODS: Perimenopausal or postmenopausal women reporting four or more hot flushes per day were recruited into a parallel-group, randomized trial of slow-paced respiration using a portable guided-breathing device. Women were randomly assigned to use a standard device to practice slowing their resting breathing rate to less than 10 breaths per minute for at least 15 minutes everyday or use an identical-appearing control device programmed to play relaxing nonrhythmic music while monitoring spontaneous breathing. The primary outcome, change in hot flush frequency over 12 weeks, was assessed using data from validated 7-day diaries abstracted by blinded analysts. RESULTS: Among the 123 participants, mean age was 53.4 (+/- 3.4) years. Women reported an average of 8.5 (+/- 3.5) hot flushes per day at baseline. After 12 weeks, women randomized to paced respiration (n = 61) reported an average reduction of 1.8 (95% confidence interval (CI) 0.9 to 2.6) hot flushes per day (-21%) compared with 3.0 (95% CI 2.1 to 3.8) hot flushes per day (-35%) in the music-listening group (n = 62) (p = 0.048). Paced respiration was associated with a 19% decrease in frequency of moderate-to-severe hot flushes compared with a 44% decrease with music listening (p = 0.02). CONCLUSION: In this randomized trial, women assigned to device-guided slow-paced respiration reported modest improvements in the frequency and severity of their hot flushes, but the paced respiration intervention was significantly less effective than a music-listening intervention in decreasing the frequency and severity of these symptoms. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT01466998. LEVEL OF EVIDENCE: I.
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