Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study
M H Schein1, B Gavish2,a, M Herz3, D Rosner-Kahana3, P Naveh1, B Knishkowy1, E Zlotnikov3, N Ben-Zvi3 and R N Melmed4
1Family Medicine Unit, Hadassah University Hospital, Israel
2InterCure, Neve Ilan, Israel
3Department of Family Medicine, Tel Aviv University and Kupat Holim Clalit, Israel
4Unit of Behavioural Medicine in Internal Medicine, Department of Medicine, Hadassah University Hospital, Israel
Correspondence to: Dr Moshe Schein, Family Medicine Unit, Hadassah University Hospital, PO Box 12000, Jerusalem 91120, Israel. E-mail:email@example.com (via Dr B Gavish)
aRequest for reprints: Dr Benjamin Gavish, InterCure, Communication Park, Neve Ilan, 90850, Israel
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.
Design and setting: Randomised, double-blind controlled study, carried out in three urban family practice clinics in Israel.
Patients: Sixty-five male and female hypertensives, either receiving antihypertensive drug therapy or unmedicated. Four patients dropped out at the beginning of the study.
Intervention: 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.
Main outcome measures: 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.