Trial reportEuropean heart journal2021
Efficacy of a digital therapeutics system in the management of essential hypertension: the HERB-DH1 pivotal trial.
Trial report in European heart journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07397260 (Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care), which is not on this map. Cited by 121 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care
Who cites it
121 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Smartphone application-based interventions for cardiometabolic risk factor management: A systematic review and meta-analysis.Hypertension research : official journal of the Japanese Society of Hypertension · 2026Pooled it
- A systematic review and meta-analysis of digital interventions targeting lifestyle factors in patients with hypertension.Journal of human hypertension · 2025Pooled it
- The effect of digital therapeutics intervention on improving hypertension management in adults: a meta-analysis of randomized controlled trial.Hypertension research : official journal of the Japanese Society of Hypertension · 2025Pooled it
- Smartphone application-based intervention to lower blood pressure: a systematic review and meta-analysis.Hypertension research : official journal of the Japanese Society of Hypertension · 2025Pooled it
- Effectiveness of digital health interventions for telemedicine/telehealth for managing blood pressure in adults: a systematic review and meta-analysis.Hypertension research : official journal of the Japanese Society of Hypertension · 2025Pooled it
- Nurse-Led Digital Intervention for Sodium Restriction in Chronic Kidney Disease: Mixed Methods Implementation Study.JMIR nursing · 2026Trial
- Mobile Application as a Digital Therapeutic for Chronic Tinnitus: A Randomized Clinical Trial.JAMA otolaryngology-- head & neck surgery · 2026Trial
- Trial
- Effects of a Hypertension Management Mobile App on Urinary Sodium Excretion in Patients With Chronic Kidney Disease: Randomized Controlled Trial.JMIR mHealth and uHealth · 2026Trial
- Effects of Artificial Intelligence Recognition-Based Telerehabilitation on Exercise Capacity in Patients With Hypertension: Randomized Controlled Trial.Journal of medical Internet research · 2026Trial
- Effect of a Mobile Health Intervention in the Management of Hypertension: Open-Label Cluster-Randomized Trial.JMIR mHealth and uHealth · 2025Trial
- Evaluating the Efficacy of a Digital Therapeutic Intervention for Temporomandibular Disorders: Multicenter, Randomized, Sham-Controlled Trial.Journal of medical Internet research · 2025Trial
- Efficacy of Telemedical Interventional Management in Patients with Coronary Heart Disease Undergoing Percutaneous Coronary Intervention: Randomized Controlled Trial.Journal of medical Internet research · 2025Trial
- The effects of a digital lifestyle intervention in patients with hypertension: Results of a pilot randomized controlled trial.Journal of clinical hypertension (Greenwich, Conn.) · 2024Trial
- Smart Start - Designing Powerful Clinical Trials Using Pilot Study Data.NEJM evidence · 2024Trial
- Daily self-reported behavioural efficacy records on hypertension digital therapeutics as digital metrics associated with the reduction in morning home blood pressure: post-hoc analysis of HERB-DH1 trial.Hypertension research : official journal of the Japanese Society of Hypertension · 2024Trial
- Efficacy of a WeChat-Based Multimodal Digital Transformation Management Model in New-Onset Mild to Moderate Hypertension: Randomized Clinical Trial.Journal of medical Internet research · 2023Trial
- Home blood pressure-lowering effect of digital therapeutics in hypertension: impact of body weight and salt intake.Hypertension research : official journal of the Japanese Society of Hypertension · 2023Trial
- Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial.JAMA internal medicine · 2022Trial
- Effects on Adherence to a Mobile App-Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial.JMIR mHealth and uHealth · 2022Trial
61 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsDigital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication. METHODS AND
resultsThis prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension [office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg] were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population. Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group (n = 199) or control (n = 191) group. Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were -2.4 (95% confidence interval -4.5 to -0.3), -4.3 (-6.7 to -1.9), and -3.6 (-6.2 to -1.0) mmHg, respectively. No major programme-related safety events occurred up to 24 weeks.
conclusionThe HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.
Indexed as
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.