Acupuncture in Menopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-07-31

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.

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Detailed Description

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Conditions

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Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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.

Waitlist

This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.

Group Type OTHER

Acupuncture

Intervention Type PROCEDURE

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.

Interventions

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Acupuncture

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No