Acupuncture for Hot Flushes in Menopause

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women

Conditions
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Menopause, Hot Flashes

Intervention / Treatment
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* Procedure: Traditional chinese medicine type acupuncture
* Behavioral: Self Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women (at least one year past the last menstrual period) who are willing to receive acupuncture and who during two weeks of self-completed diaries10 document a mean value of 7 flushes/24 hours or more (or 50 flushes or more over a period of seven consecutive days), will be randomized after a baseline evaluation. Current users prescribed medications that influence hot flush rate (e. g. HRT, SSRI's) can be included after a washout period. The washout-periods are eight weeks for SSRI's and systemic (including transdermal) HRT and four weeks for local estradiol preparations Exclusion Criteria: Surgical menopause History of cancer within the past five years Use of anticoagulant drugs Heart valve disease Poorly controlled hypertension Hypothyroidism Hyperthyroidism or diabetes mellitus Organ transplant Mental disease Overt drug or alcohol dependency Inability to complete study forms

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle advice<br> | Behavioral: Self Care<br>* Lifestyle advice on diet, physical activity<br>|
| Experimental: Lifestyle advice and acupuncture therapy<br> | Procedure: Traditional chinese medicine type acupuncture<br>* 10 acupuncture sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hot flushes |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (Women's Health Questionnaire) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women, Acupuncture, Menopause, Hot flashes, Health related quality of life