Evidence-based Medicine Research Center, Jiangxi University of Chinese Medicine, Nanchang City, Jiangxi, China.
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Guo Xue Xiang No.37, Chengdu City, 610041, Sichuan, China.
Trials. 2022 Feb 16;23(1):154. doi: 10.1186/s13063-022-06092-4.
Low- 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.
This 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.
This 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.
ClinicalTrials.gov NCT04788563 . Registered on March 9, 2021.
中低收入国家原发性高血压的患病率较高，但治疗和控制率往往较低。热敏灸（HSM）是一种创新的穴位刺激技术，可能对治疗高血压有效，因此可在初级卫生保健中适当使用。本研究旨在探讨 HSM 是否对社区原发性高血压的治疗有效且安全。
本研究为多中心、实用、随机对照试验（RCT），并采用患者偏好分组。将从 7 个社区招募 400 名原发性高血压患者。首先，将社区随机分为两个研究组，一组采用强制随机分组，另一组允许患者根据自身偏好选择治疗方法。然后，强制随机分组组中的患者将被随机分为接受 HSM 加其原有的降压方案（HSM 组）或仅接受其原有的降压方案（对照组）治疗 6 个月。偏好组中的患者如果有偏好，可以选择接受 HSM 或对照组；否则，患者将被随机分配。主要结局是从基线开始收缩压的变化；次要结局包括舒张压的变化、降压药物的剂量、生活质量（QoL）、高血压症状的严重程度以及心血管事件的发生率。还将评估患者对 HSM 方案的依从性、成本效益比以及安全性结局。在 6 个月的就诊时收集结局数据。
本试验将为 HSM 作为初级卫生保健中原发性高血压治疗技术提供重要证据。鉴于考虑了患者偏好的随机分组，该试验还将允许分析患者偏好效应以及随机和非随机样本的比较，以提高研究结论的稳健性和外推性。
ClinicalTrials.gov NCT04788563。于 2021 年 3 月 9 日注册。
