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| Name | Class |
|---|---|
| Nangang community healthcare center (Nanchang city, Jiangxi province, China) | UNKNOWN |
| Honggutan community healthcare center (Nanchang city, Jiangxi province, China) | UNKNOWN |
| Shengmi community healthcare center (Nanchang city, Jiangxi province, China) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat-sensitive moxibustion plus antihypertensive drugs | Experimental |
| |
| Antihypertensive drugs | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat-sensitive moxibustion plus antihypertensive drugs | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi University of Traditional Chinese Medicine | Nanchang | Jiangxi | 330004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32957364 | Derived | 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. |
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The individual participant data (IPD) of this study will be available from the principal investigator on reasonable request.
After all results are published.
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| Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China) | UNKNOWN |
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|
| Antihypertensive drugs | Drug | In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year. |
|
| 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 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000959 | Antihypertensive Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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