A Randomized Patient Preference Trial on Heat-sensitive Moxibustion for Primary Hypertension in Community

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms

Conditions
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Primary Hypertension

Intervention / Treatment
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* Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)
* Drug: Original antihypertensive treatment (compulsively randomized arm)
* Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)
* Drug: Original antihypertensive treatment (voluntarily randomized arm)
* Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)
* Drug: Original antihypertensive treatment (preference selection arm)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months. Ages: 18-80 years; The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers. Did not receive acupoint stimulation therapies for hypertension in the last month. Patients in the heat-sensitive moxibustion groups need to develop at least one type of moxibustion sensation around the following acupoints: Yongquan, Baihui, Shenque, Quchi, Zusanli, Hegu, Taichong and Dazhui. Consent to sign an informed consent form Exclusion Criteria: Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs; Secondary hypertension. Pregnancy and lactation; Allergic to moxibustion devices, moxa smoke or Artemisia argyi. Complicated with severe diseases that are not recommended for heat-sensitive moxibustion, such as acute cerebral hemorrhage, hypertensive crisis, sensory disturbances, serious mental diseases, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with patient preference arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heat-sensitive moxibustion group A<br>In this group, patients are compulsively randomized to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). | Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)<br>* 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.<br>|
| Active Comparator: Control group A<br>In this group, patients are compulsively randomized to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). | Drug: Original antihypertensive treatment (compulsively randomized arm)<br>* In this group, patients will maintain their original antihypertensive treatment.<br>|
| Experimental: Heat-sensitive moxibustion group B<br>Patients who voluntarily choose to receive randomization and are randomly assigned to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). | Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)<br>* 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.<br>|
| Active Comparator: Control group B<br>Patients who voluntarily choose to receive randomization and are randomly assigned to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). | Drug: Original antihypertensive treatment (voluntarily randomized arm)<br>* In this group, patients will maintain their original antihypertensive treatment.<br>|
| Experimental: Heat-sensitive moxibustion group C<br>Patients who voluntarily choose to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). | Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)<br>* 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.<br>|
| Active Comparator: Control group C<br>Patients who voluntarily choose to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). | Drug: Original antihypertensive treatment (preference selection arm)<br>* In this group, patients will maintain their original antihypertensive treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Changes from baseline in systolic blood pressure | Baseline and months 1, 2, 3, 4, 5, and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic blood pressure | Changes from baseline in diastolic blood pressure | 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. | Baseline and months 1, 2, 3, 4, 5, and 6 | 
| Dose of antihypertensive drugs | Changes from baseline in dose of antihypertensive drugs | 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) | 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 | 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 | Baseline and months 1, 2, 3, 4, 5, and 6 | 
| Patients' compliance to heat-sensitive moxibustion | Patients' compliance will be assessed by recording the frequency and duration of heat-sensitive moxibustion. | Baseline and months 1, 2, 3, 4, 5, and 6 | 
| Incidence of cardiovascular events | Newly developed cardiovascular events | 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. | 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. | Baseline and months 1, 2, 3, 4, 5, and 6 |