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Previous studies have demonstrated a sustained reduction of high blood pressure (BP) with device guided breathing exercises. We are evaluating compliance & performance of patients using “treat & measure” devices at home and the possible occurrence of placebo effect. Me hods: Patients, were uncontrolled hypertensives, age 30 to 65 either unmedicated or medicated with antihypertensive drugs. The design includes 4 visits (#1 to #4) at the office defining a 2-weeks baseline (#1 to #2) followed by an 8-weeks treatment phase (#2 to #4) with follow up at #3. Self treatment takes place at home 15 minutes every evening using the RESPeRATE device (InterCure Ltd., Israel), which guides the user interactively to slow breathing while storing automatically compliance & performance data. BP & heart rate (HR) are measured at both office & home using a digital BP monitor with automatic data logging (A&D, Japan). Self measurements at home are applied every morning between visits #1 to #4. Outcomes are average BP & HR changes from Baseline (applied over visits #1[0002] for “office” and daily for “home”) to “End” (visit #4 for “office” and last 3 treatment weeks for “home”). Compliance & performance are evaluated using data logged by the devices. Placebo effect during baseline is tested by linear regression of daily averaged BP & HR changes during Baseline. The time course of home BP changes from baseline by nonlinear regression using a logistic function. Results: Interim analysis of the first 17 treated patients with available outcomes shows that patient were compliant in both BP measurements and treatment and were able to achieve slow breathing, as required. Significant systolic & diastolic BP reduction was observed in response to treatment for both “office” (from 141616/8866 to 125611/8169 mmHg with p,0.01) and “home” (from 133 68/8269 to 12568/7768 mmHg with p,0.0001) with no significant HR changes (69 to 67 at “office” and 68 to 70 at “home”). No placebo effect was observed during baseline. The home BP reduction was developed in 2 to 5 treatment weeks and then reached a plateau. Conclusion: Self-treatment of hypertension by device-guided breathing exercises with self-BP monitoring at home is technically feasible and enables objective quantification of the patients compliance and performance as well as time course of the BP response.

Response and compliance of hypertensives to treatment by device-guided breathing exercises: interim results