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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Hypertension
• Intervention / Treatment: 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)

Detailed Description

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
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330004
      • Erliuling
    • Nanchang, Jiangxi, China, 330004
      • Hongmiao
    • Nanchang, Jiangxi, China, 330004
      • Jinghexinggong community
    • Nanchang, Jiangxi, China, 330004
      • Jinsheng community
    • Nanchang, Jiangxi, China, 330004
      • Nangang community
    • Nanchang, Jiangxi, China, 330004
      • Shajing
    • Nanchang, Jiangxi, China, 330004
      • Wuliangdian community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months.
2. Ages: 18-80 years;
3. The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers.
4. Did not receive acupoint stimulation therapies for hypertension in the last month.
5. 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.
6. Consent to sign an informed consent form

Exclusion Criteria:

1. Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs;
2. Secondary hypertension.
3. Pregnancy and lactation;
4. Allergic to moxibustion devices, moxa smoke or Artemisia argyi.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat-sensitive moxibustion group A; 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); 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.
Active Comparator: Control group A; 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); In this group, patients will maintain their original antihypertensive treatment.
Experimental: Heat-sensitive moxibustion group B; 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); 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.
Active Comparator: Control group B; 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); In this group, patients will maintain their original antihypertensive treatment.
Experimental: Heat-sensitive moxibustion group C; 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); 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.
Active Comparator: Control group C; 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); In this group, patients will maintain their original antihypertensive treatment.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangxi University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Xu Zhou, M.D., Jiangxi University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Zhou X, Li S, Li L, Deng G, Dai L, Chai L, Wu Q, Yao Z, Deng M, Zhu W, Fu Y, Sun X. Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms. Trials. 2022 Feb 16;23(1):154. doi: 10.1186/s13063-022-06092-4.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Antihypertensive Agents
• Other Study ID Numbers: JXUTCM-Mox-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No