Acupuncture in Menopause (AIM)

Acupuncture for Vasomotor Symptoms

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 Overview

• Status: Completed
• Conditions: Vasomotor Symptoms
• Intervention / Treatment: Procedure: Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • Chapel Hill Doctors
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
OTHER: Waitlist; This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Nancy Avis, PhD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Avis NE, Coeytaux RR, Isom S, Prevette K, Morgan T. Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial. Menopause. 2016 Jun;23(6):626-37. doi: 10.1097/GME.0000000000000597.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (ESTIMATE): January 13, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Acupuncture; Menopause; Vasomotor Symptoms; Hot Flashes
• Other Study ID Numbers: IRB00014892

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No