Acupuncture in Menopause

Wake Forest University Health Sciences209 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

209

Conditions

Vasomotor Symptoms

Interventions

AcupuncturePROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Chapel Hill Doctors

Chapel Hill, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 14 months

Secondary Outcomes

Objective Hot Flashes

Objective hot flashes measured by skin conductance

Time frame: 3 days

Other Symptoms

Time frame: Up to 14 months

Quality of Life

Measures your quality of life over the last week

Time frame: Up to 58 weeks

Data from ClinicalTrials.gov

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