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
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
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.
In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.
Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China
Changes in systolic blood pressure (mmHg)
Time frame: Baseline, 6 months, and 12 months
Changes in diastolic blood pressure (mmHg)
Time frame: Baseline, 6 months, and 12 months
Changes in dose of antihypertensive drugs
Measured by percentage changes
Time frame: Baseline, 6 months, and 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Baseline, 6 months, and 12 months
Changes in fasting blood glucose (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in glycated hemoglobin (%)
Time frame: Baseline, 6 months, and 12 months
Changes in total cholesterol (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in triglycerides (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in low density lipoprotein cholesterol (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in high density lipoprotein cholesterol (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in urinary albumin (g/l)
Time frame: Baseline, 6 months, and 12 months
Changes in serum creatinine (μmol/l)
Time frame: Baseline, 6 months, and 12 months