title: Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study.
abstract: OBJECTIVE
  To examine the efficacy of a new device, which slows and regularises breathing, as a non-pharmacological treatment of hypertension and thus to evaluate the contribution of breathing modulation in the blood pressure (BP) reduction.
  
  
  METHODS
  Randomised, double-blind controlled study, carried out in three urban family practice clinics in Israel.
  
  
  METHODS
  Sixty-five male and female hypertensives, either receiving antihypertensive drug therapy or unmedicated. Four patients dropped out at the beginning of the study.
  
  
  METHODS
  Self treatment at home, 10 minutes daily for 8 consecutive weeks, using either the device (n = 32), which guides the user towards slow and regular breathing using musical sound patterns, or a Walkman, with which patients listened to quiet music (n = 29). Medication was unchanged 2 months prior to and during the study period.
  
  
  METHODS
  Systolic BP, diastolic BP and mean arterial pressure (MAP) changes from baseline.
  
  
  RESULTS
  BP reduction in the device group was significantly greater than a predetermined 'clinically meaningful threshold' of 10.0, 5.0 and 6.7 mm Hg for the systolic BP, diastolic BP and MAP respectively (P = 0.035, P = 0.0002 and P = 0.001). Treatment with the device reduced systolic BP, diastolic BP and MAP by 15.2, 10.0 and 11.7 mm Hg respectively, as compared to 11.3, 5.6 and 7.5 mm Hg (P = 0.14, P = 0.008, P = 0.03) with the Walkman. Six months after treatment had stopped, diastolic BP reduction in the device group remained greater than the 'threshold' (P < 0.02) and also greater than in the walkman group (P = 0.001).
  
  
  CONCLUSIONS
  The device was found to be efficacious in reducing high BP during 2 months of self-treatment by patients at home. Breathing pattern modification appears to be an important component in this reduction.
authors.affiliation: Family Medicine Unit, Hadassah University Hospital, Israel. beny@intercure.co.il
authors.forename: M H
authors.initials: MH
authors.lastname: Schein
authors.forename: B
authors.initials: B
authors.lastname: Gavish
authors.forename: M
authors.initials: M
authors.lastname: Herz
authors.forename: D
authors.initials: D
authors.lastname: Rosner-Kahana
authors.forename: P
authors.initials: P
authors.lastname: Naveh
authors.forename: B
authors.initials: B
authors.lastname: Knishkowy
authors.forename: E
authors.initials: E
authors.lastname: Zlotnikov
authors.forename: N
authors.initials: N
authors.lastname: Ben-Zvi
authors.forename: R N
authors.initials: RN
authors.lastname: Melmed
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology*; D001795:Blood Pressure Determination; D001945:Breathing Exercises; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000503:physiopathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009147:Music Therapy / Q000295:instrumentation* / Q000379:methods*