Heat-sensitive moxibustion, an important mean of external therapy of traditional Chinese medicine, has unique advantages in treating various chronic diseases than common moxibustion. This study aims to evaluate the efficacy, safety, and cost-effectiveness of heat-sensitive moxibustion for primary hypertension under community self-management setting using a multicenter, pragmatic, randomized controlled trial design with patient-preference arms.
Primary hypertension is a common chronic disease that threatens the life and health of human beings. The conventional western drug therapy often has side effects and many patients are unable to achieve ideal blood pressure control with drugs alone. Therefore, the treatment of primary hypertension still requires active exploration of complementary and alternative therapies with clear clinical efficacy. Heat-sensitive moxibustion is an innovative moxibustion therapy. By stimulating the patient's special moxibustion sensation, heat-sensitive moxibustion can achieve better results than traditional moxibustion for many diseases, including primary hypertension. Heat-sensitive moxibustion is an easy, inexpensive and safe treatment method. The practitioner does not need to be professionally qualified to perform moxibustion, making it a suitable technique for patients to self-medicate on a daily basis. Traditional moxibustion has been shown to lower blood pressure in patients with primary hypertension. Theoretically, heat-sensitive moxibustion could achieve better blood pressure lowering effects, but its effects in lowering blood pressure in the setting of self-management in community patients is unclear. To verify the efficacy and safety of heat-sensitive moxibustion community self-management for hypertension, we plan to perform a randomized controlled trial. In this trial, we designed the trial grouping scheme as a randomized controlled trial with patient preference arms in order to improve patient adherence and reduce the impact of patient preference effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
In this group, patients will maintain their original antihypertensive treatment.
Erliuling
Nanchang, Jiangxi, China
Hongmiao
Nanchang, Jiangxi, China
Jinghexinggong community
Nanchang, Jiangxi, China
Jinsheng community
Nanchang, Jiangxi, China
Systolic blood pressure
Changes from baseline in systolic blood pressure
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Diastolic blood pressure
Changes from baseline in diastolic blood pressure
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Response to treatment
Definition: (i) a decrease in systolic blood pressure ≥ 20 mmHg or diastolic blood pressure ≥ 10 mmHg; or (ii) blood pressure control of \< 140 mmHg systolic and \< 90 mmHg diastolic in patients aged ≥ 65 years; blood pressure control of \< 130 mmHg systolic and \< 80 mmHg diastolic in patients aged \< 65 years.
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Dose of antihypertensive drugs
Changes from baseline in dose of antihypertensive drugs
Time frame: Measure at baseline screening, monthly for 6 months
Score of EQ-5D-5L
Quality of life will be measured using Euro-Qol-5 Dimensions-5 Levels questionnaire (EQ-5D-5L)
Time frame: Baseline and months 3 and 6
Symptom score
Symptoms will be scored using the scale in "Guiding Principles of Clinical Research on New Drugs of Chinese Medicines"
Time frame: Baseline and months 3 and 6
Cost-effectiveness ratio
Outpatient and inpatient costs for each group will be recorded and used to calculate the cost-effectiveness ratio
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
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Enrollment
400
In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
In this group, patients will maintain their original antihypertensive treatment.
In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
In this group, patients will maintain their original antihypertensive treatment.
Nangang community
Nanchang, Jiangxi, China
Shajing
Nanchang, Jiangxi, China
Wuliangdian community
Nanchang, Jiangxi, China
Patients' compliance to heat-sensitive moxibustion
Patients' compliance will be assessed by recording the frequency and duration of heat-sensitive moxibustion.
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Incidence of cardiovascular events
Newly developed cardiovascular events
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Any adverse events
Adverse event data will be derived from patient self-reports and physician reviews.
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Heat-sensitive moxibustion-related adverse events
Heat-sensitive moxibustion-related adverse event data will be derived from patient self-reports and physician reviews.
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6