Acupuncture in Menopause

Vasomotor Symptoms Clinical Trial

— AIM  

Official title:

Acupuncture for Vasomotor Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276028
• Other study ID #: IRB00014892
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: July 2014

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Chapel Hill Doctors	Chapel Hill	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Hot Flashes	Objective hot flashes measured by skin conductance	3 days
Secondary	Other Symptoms		Up to 14 months
Secondary	Quality of Life	Measures your quality of life over the last week	Up to 58 weeks