title: Paced respiration for vasomotor and other menopausal symptoms: a randomized, controlled trial.
abstract: BACKGROUND
  Paced respiration has been internationally recommended for vasomotor symptom management, despite limited empirical evidence.
  
  
  OBJECTIVE
  To evaluate efficacy of a paced respiration intervention against breathing control and usual care control for vasomotor and other menopausal symptoms.
  
  
  METHODS
  A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), in a Midwestern city and surrounding area.
  
  
  METHODS
  Two hundred and eighteen randomized women (96 breast cancer survivors, 122 menopausal women without cancer), recruited through community mailings and registries (29 % minority).
  
  
  METHODS
  Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment.
  
  
  METHODS
  Hot flash frequency, severity, and bother (primary); hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.
  
  
  RESULTS
  There were no significant group differences for primary outcomes at 8-weeks or 16-weeks post-randomization. Most intervention participants did not achieve 50 % reduction in vasomotor symptoms, despite demonstrated ability to correctly do paced respiration and daily practice. Statistically significant differences in secondary outcomes at 8 and 16 weeks were small, not likely to be clinically relevant, and as likely to favor intervention as breathing control.
  
  
  CONCLUSIONS
  Paced respiration is unlikely to provide clinical benefit for vasomotor or other menopausal symptoms in breast cancer survivors or menopausal women without cancer.
authors.affiliation: Indiana University, Indianapolis, IN, USA. carpentj@iupui.edu
authors.forename: Janet S
authors.initials: JS
authors.lastname: Carpenter
authors.forename: Debra S
authors.initials: DS
authors.lastname: Burns
authors.forename: Jingwei
authors.initials: J
authors.lastname: Wu
authors.forename: Julie L
authors.initials: JL
authors.lastname: Otte
authors.forename: Bryan
authors.initials: B
authors.lastname: Schneider
authors.forename: Kristin
authors.initials: K
authors.lastname: Ryker
authors.forename: Eileen
authors.initials: E
authors.lastname: Tallman
authors.forename: Menggang
authors.initials: M
authors.lastname: Yu
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000628:therapy; D001945:Breathing Exercises; D005260:Female; D019584:Hot Flashes / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008593:Menopause / Q000502:physiology*; D008875:Middle Aged; D010349:Patient Compliance; D012720:Severity of Illness Index; D016037:Single-Blind Method; D012893:Sleep Wake Disorders / Q000628:therapy; D017741:Survivors; D016896:Treatment Outcome; D014666:Vasomotor System / Q000503:physiopathology*