Device-Guided Breathing to Lower Blood Pressure: Case Report and Clinical Overview

William J. Elliott, MD, PhD; Joseph L. Izzo, Jr, MD

Disclosures
In This Article

Clinical Studies

Seven separate studies[11,12,13,14,15,16,17] have examined the changes in office BP for subjects who used this device for 15 minutes/day for 8 weeks, compared with "control" interventions (listening to relaxing music,[12] home BP monitoring,[13,16] or both).[14] Four studies were double-blinded and randomized,[12,13,14] one was controlled and randomized,[16] and 2 were open-label experiences.[11,16]

A total of 286 individuals participated in these studies: 55% were men; with an average age of 57 ±11 years; body-mass index of 28 ± 4 kg/m2; and initial office BP of 150 ±13/90 ± 9 mm Hg (9% prehypertensive; 25% Stage 2). Antihypertensive drugs were taken by 78% of the subjects. Figure 4 shows a "box and whiskers plot" of the changes in office systolic BP observed in each of the 7 independent studies of patients who used the device appropriately (as assessed either by achieving ≥ 50% of the recommended 45 minutes of slow breathing per week,[13] or by an independent "help desk" in all other studies).[11,12,14,15,16] This figure shows that, despite some variability (note that only 14 of 18 [78%] of the subjects in the study of Grossman and colleagues[14] had a change in office systolic BP < 0 mm Hg), the mean change from baseline across all the studies was 14 mm Hg, and was fairly homogeneous across studies (P = .61 by analysis of variance).

"Box and whiskers plot" of the age-adjusted changes in office systolic blood pressures seen in each of the 7 trials of the device to guide slow breathing (presented from top to bottom in chronological order of publication). The dashed vertical line represents the overall mean change in systolic blood pressure. The vertical line within each box represents the median value, while the ends of the boxes represent the 25% and 75% values for the population in each trial. The "whiskers" correspond to the extremes of the range. There was no significant heterogeneity across studies (P = .61 by analysis of variance). The first 2 studies were pooled when originally reported.[12]

Figure 4.

Overall, the average decrease in office BP after 8 weeks of device-guided breathing among those with uncontrolled hypertension at baseline was 14/8 mm Hg, compared with control treatment of 9/4 mm Hg (P = .008 and P = .002, respectively for systolic and diastolic BPs). The difference was independent of gender and medication status. Control of BP (< 140/90 mm Hg) was seen more commonly in the group that used the device: 26% vs 4% of those with initial Stage 2 hypertension (≥ 160/100 mm Hg, P < .005); and 48% vs 34% for those with initial Stage 1 hypertension (140-159/90-99 mm Hg, P < .05). The drop in office BP was directly related to the duration of slow breathing during the 8 weeks of treatment. Those who used the device and achieved slow breathing more than 15 minutes/day had the greatest lowering of office BPs. The patient's response was almost exactly what would have been expected, based on her age, initial office BP, and weekly time of slow breathing. As with this patient, 3 to 5 weeks' use of the device was typically necessary for patients in these trials to achieve a sustained reduction in home BP.

Larger decreases in office BPs were seen in older individuals and those with higher baseline BPs, whether taking antihypertensive medications or not. BP lowering has also been seen using home BP measurements (for up to 6 months of use in one study)[16] and ambulatory BP monitoring.[15]

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