Acupuncture in Menopause

Study Overview
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Brief Summary
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The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the real world setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.

Official Title
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Acupuncture for Vasomotor Symptoms

Conditions
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Vasomotor Symptoms

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women experiencing on average 4 Hot Flashes a day Women aged 45-60 Peri or Post menopausal Women (No periods for at least 3 months) Exclusion Criteria: Women who have initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks Women who have changed their dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks Women who have initiated antidepressants in the last 3 months Women who have changed their dose of an antidepressant in the last 3 months Women who have had acupuncture in the last 4 weeks Women who have received acupuncture from one of the study acupuncturists in the last 6 months will be excluded from the study Women who describe their health as fair or poor are excluded from the study Women who have a diagnosis of Hemophilia Relatives and Co-Workers of the treating acupuncturists

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Acupuncture<br>This group will start acupuncture treatments within 3 weeks of consent and continue to receive up to 20 treatments over a six month period. The number of treatments will be jointly determined by the participant and the acupuncturist. | Procedure: Acupuncture<br>* For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a Traditional Chinese Medicine (TCM) diagnosis as well as a recommended treatment schedule which they can then negotiate. Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.<br>|
| Other: Waitlist<br>This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture. | Procedure: Acupuncture<br>* For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a Traditional Chinese Medicine (TCM) diagnosis as well as a recommended treatment schedule which they can then negotiate. Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Hot Flashes | Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months (post randomization) of the study and then 1 week per month for the remaining 6 months of the study. | Up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Hot Flashes | Objective hot flashes measured by skin conductance | 3 days | 
| Other Symptoms |  | Up to 14 months | 
| Quality of Life | Measures your quality of life over the last week | Up to 58 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Hot Flashes, Menopause, Vasomotor Symptoms