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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| University of Tromso | OTHER |
In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.
The study objective is to determine whether Traditional Chinese Medicine (TCM) acupuncture-care together with self-care is more effective than self-care alone, to relieve climacteric complaints among women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only.
The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle advice | Active Comparator |
| |
| Lifestyle advice and acupuncture therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional chinese medicine type acupuncture | Procedure | 10 acupuncture sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hot flushes | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (Women's Health Questionnaire) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameline Grimsgaard, MD, MPH, PhD | University Hospital of North Norway. No-9038 Tromsø, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, University Hospital of North Norway | Tromsø | No-9038 | Norway |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012648 | Self Care |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Self Care | Behavioral | Lifestyle advice on diet, physical activity |
|