Abstract
BackgroundLow- and middle-income countries have a high prevalence of primary hypertension, but its treatment and control are often low. Heat-sensitive moxibustion (HSM), an innovative acupoint stimulation technique, may be effective for treating hypertension and thus used appropriately in primary healthcare. The objective of this study is to investigate whether HSM is effective and safe for the treatment of primary hypertension in the community.MethodsThis study is a multicenter, pragmatic, randomized controlled trial (RCT) with patient-preference arms. Four hundred patients with primary hypertension from seven communities will be enrolled. Initially, the communities will be randomly assigned into two study clusters, one using compulsory randomization and the other allowing treatment selection by patient preferences. Then, patients in the compulsory randomization cluster will be randomized to receive HSM plus their original antihypertensive regimen (HSM group) or only their original antihypertensive regimen (control group) for 6 months. Patients in the patient preference cluster may choose to receive HSM or control if they have a preference; otherwise, patients will be randomly assigned. The primary outcome is the change in systolic blood pressure from baseline; secondary outcomes include change in diastolic blood pressure, dosage of antihypertensive drugs, quality of life (QoL), severity of hypertensive symptoms, and incidence of cardiovascular events. Patient compliance with the HSM regimen, the cost-effectiveness ratio, and safety outcomes will also be evaluated. Outcome data will be collected at 6 monthly visits.DiscussionThis trial will provide important evidence regarding HSM as a technique for primary hypertension in primary healthcare settings. Given the randomization with patient preferences considered, the trial will also allow analyzing patient-preference effects and the comparison of randomized and nonrandomized samples, to improve the robustness and extrapolation of study conclusions.Trial registrationClinicalTrials.govNCT04788563. Registered on March 9, 2021.
Highlights
Low- and middle-income countries have a high prevalence of primary hypertension, but its treatment and control are often low
In China, for example, one episode of intensive blood pressure control costs up to $766, which in 2015 was equivalent to 22.7% of the average citizen’s annual disposable income [3], while the rate of optimally controlled hypertension has remained low in the past dozen years [4]
Developing appropriate treatment regimens for hypertension that are effective, safe, and inexpensive and can be widely popularized in the community is warranted to compensate for the inadequacy of the hospital management model [8]
Summary
Low- and middle-income countries have a high prevalence of primary hypertension, but its treatment and control are often low. The objective of this study is to investigate whether HSM is effective and safe for the treatment of primary hypertension in the community. A key reason for the imbalance in cost-effectiveness in low- and middle-income countries may be that primary healthcare interventions for hypertension are not yet well developed [5, 6]. Despite consensus on the effects of reducing blood pressure and cardiovascular disease risk with long-term adherence to antihypertensive drugs, under a single hospital management model, a large proportion of patients cannot maintain their blood pressure at the ideal level [7]. Developing appropriate treatment regimens for hypertension that are effective, safe, and inexpensive and can be widely popularized in the community is warranted to compensate for the inadequacy of the hospital management model [8]
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