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

Jiangxi University of Traditional Chinese Medicine

Status: Completed

Conditions: Primary Hypertension

Treatments: Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm); Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm); Drug: Original antihypertensive treatment (compulsively randomized arm); Drug: Original antihypertensive treatment (voluntarily randomized arm); Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm); Drug: Original antihypertensive treatment (preference selection arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT04788563

JXUTCM-Mox-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 6 patient groups

Heat-sensitive moxibustion group A

Experimental group

Description:

In this group, patients are compulsively randomized to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Treatment:

Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)

Control group A

Active Comparator group

Description:

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).

Treatment:

Drug: Original antihypertensive treatment (compulsively randomized arm)

Heat-sensitive moxibustion group B

Experimental group

Description:

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).

Treatment:

Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)

Control group B

Active Comparator group

Description:

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).

Treatment:

Drug: Original antihypertensive treatment (voluntarily randomized arm)

Heat-sensitive moxibustion group C

Experimental group

Description:

Patients who voluntarily choose to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Treatment:

Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)

Control group C

Active Comparator group

Description:

Patients who voluntarily choose to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Treatment:

Drug: Original antihypertensive treatment (preference selection arm)