Abstract
Digital therapeutics (DTx) intervention is an emerging therapy for the treatment and long-term management of hypertension. We aim to systematically evaluate the overall effect of DTx intervention on improving hypertension management. The systematic review and meta-analysis of RCTs was conducted and the PubMed, EMBASE, Web of Science, and Cochrane Library were searched to identify eligible RCTs published between Jan 1, 1982 and Sep 10, 2023. Random-effect models were utilized to pool estimates of net changes in systolic blood pressure (BP), diastolic BP, BP control rate, body mass index, weight, waist circumference, and physical activity between the DTx group and control group. 15 RCTs were included with a total of 3789 participants. Compared with the control group, DTx intervention was associated with significant changes in systolic BP, diastolic BP, and BP control rate of -3.75 mmHg(95% CI -5.74 to 1.77), -1.79 mmHg (95% CI -2.81 to -0.77) and 1.47% (95% CI 1.10 to 1.95), respectively. In addition, DTx intervention was statistically significant for improving other risk factors such as lower BMI (-0.5 kg/m2, 95% CI -0.86 to -0.15), increased physical activity (66.73 min/week, 95%CI 49.64 to 83.81), and reduced waist circumference (-2.91 cm, 95% CI -5.15 to -0.66). No difference between groups was demonstrated in weight (P = 0.30). Subgroup analyses revealed consistent effects of the change in SBP and DBP across study duration, age, sample size, patient baseline status, and intervention scenario settings(P > 0.05). DTx intervention may be useful for lowering BP and long-term management of hypertension. More large-size trials providing evidence on the same product are needed.