title: Device-guided breathing as treatment for hypertension in type 2 diabetes mellitus: a randomized, double-blind, sham-controlled trial.
abstract: OBJECTIVE
  Biofeedback with device-guided lowering of breathing frequency could be an alternate nonpharmacologic treatment option for hypertension. Evidence from trials with high methodologic quality is lacking.
  
  
  OBJECTIVE
  To evaluate the effects of device-guided lowering of breathing frequency on blood pressure in patients with type 2 diabetes mellitus and hypertension.
  
  
  METHODS
  Single-center, double-blind, sham-controlled trial.
  
  
  METHODS
  A large nonacademic teaching hospital in the Netherlands.
  
  
  METHODS
  Patients with type 2 diabetes mellitus and hypertension.
  
  
  METHODS
  Fifteen-minute sessions with either the device that guides breathing through musical tones to a lower breathing frequency (aiming at <10 breaths/min) or a sham device (music without aiming at lowering of breathing frequency) for an 8-week study period.
  
  
  METHODS
  Systolic and diastolic blood pressure measured in the physician's office.
  
  
  RESULTS
  Forty-eight patients were randomized; 21 patients (88%) in the intervention group and 24 patients (100%) in the control group completed the study. There were no significant changes in systolic and diastolic blood pressure, with a difference in systolic blood pressure of 2.35 mm Hg (95% CI, -6.50 to 11.20) in favor of the control group and a difference in diastolic blood pressure of 2.25 mm Hg (95% CI, -2.16 to 6.67) in favor of the intervention group. Three patients in the intervention group experienced adverse events.
  
  
  CONCLUSIONS
  This high methodologic quality study shows no significant effect of device-guided lowering of breathing frequency on office-measured blood pressure in patients with type 2 diabetes. On the basis of this study, together with results from all but one previous trial, device-guided lowering of breathing frequency does not appear to be a viable nonpharmacologic option for hypertension treatment.
authors.affiliation: Diabetes Centre, Isala Clinics, the Netherlands University Medical Center, Zwolle, the Netherlands. g.w.d.landman@isala.nl
authors.forename: Gijs W D
authors.initials: GW
authors.lastname: Landman
authors.forename: Iefke
authors.initials: I
authors.lastname: Drion
authors.forename: Kornelis J J
authors.initials: KJ
authors.lastname: van Hateren
authors.forename: Peter R
authors.initials: PR
authors.lastname: van Dijk
authors.forename: Susan J J
authors.initials: SJ
authors.lastname: Logtenberg
authors.forename: Jan
authors.initials: J
authors.lastname: Lambert
authors.forename: Klaas H
authors.initials: KH
authors.lastname: Groenier
authors.forename: Henk J G
authors.initials: HJ
authors.lastname: Bilo
authors.forename: Nanne
authors.initials: N
authors.lastname: Kleefstra
mesh_terms: D000368:Aged; D001676:Biofeedback, Psychology; D001945:Breathing Exercises; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009147:Music Therapy / Q000295:instrumentation*; D056152:Respiratory Rate