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Device-guided breathing as treatment for hypertension in type 2 diabetes mellitus: a randomized, double-blind,
Gijs W D Landman1, Iefke Drion, Kornelis J J van Hateren
1Diabetes Centre, Isala Clinics, the Netherlands University Medical Center, Zwolle, the Netherlands. g.w.d.landman@isala.nl
Importance:
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.
Design:
Single-center, double-blind, sham-controlled trial.
Setting:
A large nonacademic teaching hospital in the Netherlands.
Participants:
Patients with type 2 diabetes mellitus and hypertension.
Intervention:
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.
Main Outcomes And Measures:
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 And Relevance:
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.
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