Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial

Heat-sensitive moxibustion is considered to be effective for primary hypertension in hospital setting. This study aims to investigate whether heat-sensitive moxibustion self-administration is effective for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting using a multicenter, prospective, non-randomized study design

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Hypertension
• Intervention / Treatment: Other: Heat-sensitive moxibustion plus antihypertensive drugs; Drug: Antihypertensive drugs

Detailed Description

Primary hypertension is a global health issue with high incidence; it affected approximately 1.13 billion people worldwide and directly or indirectly causing an 10.4 million of death yearly. The routine drugs for primary hypertension are limited by adverse effects and expensive costs. Therefore, complementary and alternative medicine with good efficacy and safety and low expenditure is still needed for primary hypertension, especially in poverty-stricken areas.

Heat-sensitive moxibustion is an innovative therapy developed on the basis of traditional moxibustion. Compared with traditional moxibustion, heat-sensitive moxibustion advocates finding heat-sensitive acupoints where patients have special reactions to moxibustion heat, including diathermy, heat transfer, soreness, etc. The application of moxibustion on heat-sensitive acupoints (i.e., heat-sensitive moxibustion) has been shown to be more effective to traditional moxibustion for many diseases, including primary hypertension. Moreover, compared with acupuncture, heat-sensitive moxibustion has a main advantage that moxibustion does not require professional qualifications and patients can self-administer moxibustion after professional training. However, the current evidence is generated only from hospital settings. Therefore, this study is specifically designed to investigate whether heat-sensitive moxibustion self-administration is an effective intervention for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting.

• Study Type: Interventional
• Enrollment (Actual): 767
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330004
      • Jiangxi University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Meet the diagnostic criteria of primary hypertension
2. 18 to 70 years old
3. Sign the informed consent

Exclusion Criteria:

1. Secondary hypertension caused by kidney disease, macrovascular disease, pregnancy, endocrine disease, brain disease, drug-induced factors, etc.
2. Allergic to moxibustion equipment, moxa smoke or moxa
3. Pregnancy or lactation
4. A history of serious cardiovascular and cerebrovascular events such as cerebrovascular accidents and myocardial infarction
5. Complicated by liver and kidney dysfunction indicated by total bilirubin, alanine aminotransferase, aspartate aminotransferase, or blood creatinine are more than 2 times upper limit of normal value
6. Complicated by malignant tumors
7. Complicated by major mental disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat-sensitive moxibustion plus antihypertensive drugs	Other: Heat-sensitive moxibustion plus antihypertensive drugs; In this arm, patients will administer heat-sensitive moxibustion by themselves or by the help of their family after professional training. Patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.
Active Comparator: Antihypertensive drugs	Drug: Antihypertensive drugs; In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in systolic blood pressure (mmHg)		Baseline, 6 months, and 12 months
Changes in diastolic blood pressure (mmHg)		Baseline, 6 months, and 12 months
Changes in dose of antihypertensive drugs	Measured by percentage changes	Baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of quality of life assessed by a validated patient-reported outcome scale	Including 27 items and assessing impacts of hypertension on on the three dimensions, physical (18 items), psychological (4 items) and family-social (5 items). Each item is classified as five grades (0-4 points). The total score ranges from 0 to 108 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Physical score of quality of life assessed by a validated patient-reported outcome scale	Including 18 items. Each item is classified as five grades (0-4 points). The total score ranges from 0 to 72 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Psychological score of quality of life assessed by a validated patient-reported outcome scale	Including 4 items. Each item is classified as five grades (0-4 points). The total score ranges from 0 to 16 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Family-social score of quality of life assessed by a validated patient-reported outcome scale	Including 5 items. Each item is classified as five grades (0-4 points). The total score ranges from 0 to 20 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Changes in fasting blood glucose (mg/dl)		Baseline, 6 months, and 12 months
Changes in glycated hemoglobin (%)		Baseline, 6 months, and 12 months
Changes in total cholesterol (mg/dl)		Baseline, 6 months, and 12 months
Changes in triglycerides (mg/dl)		Baseline, 6 months, and 12 months
Changes in low density lipoprotein cholesterol (mg/dl)		Baseline, 6 months, and 12 months
Changes in high density lipoprotein cholesterol (mg/dl)		Baseline, 6 months, and 12 months
Changes in urinary albumin (g/l)		Baseline, 6 months, and 12 months
Changes in serum creatinine (μmol/l)		Baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Jiangxi University of Traditional Chinese Medicine
• Collaborators: Nangang community healthcare center (Nanchang city, Jiangxi province, China); Honggutan community healthcare center (Nanchang city, Jiangxi province, China); Shengmi community healthcare center (Nanchang city, Jiangxi province, China); Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China)

Publications and helpful links

General Publications

• Zhou X, Wu Q, Zhang G, Wang Y, Li S, Wang B, Chen Z, Zhu W, Wang F, Gan C. Heat-sensitive moxibustion self-administration in patients in the community with primary hypertension: A protocol for a multi-center, pragmatic, non-randomized trial. Medicine (Baltimore). 2020 Sep 18;99(38):e22230. doi: 10.1097/MD.0000000000022230.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

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-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The individual participant data (IPD) of this study will be available from the principal investigator on reasonable request.
• IPD Sharing Time Frame: After all results are published.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

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