Acupuncture in Menopause (AIM)

• ClinicalTrials.gov Identifier: NCT01276028
• Recruitment Status: Completed
• First Posted: January 13, 2011
• Last Update Posted: August 9, 2018
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Vasomotor Symptoms	Procedure: Acupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 209 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acupuncture for Vasomotor Symptoms
• Study Start Date: April 2011
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Subjective Hot Flashes [ Time Frame: Up to 14 months ]
   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.

Secondary Outcome Measures :

1. Objective Hot Flashes [ Time Frame: 3 days ]
   Objective hot flashes measured by skin conductance
2. Other Symptoms [ Time Frame: Up to 14 months ]
3. Quality of Life [ Time Frame: Up to 58 weeks ]
   Measures your quality of life over the last week

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Chapel Hill Doctors

Chapel Hill, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Nancy Avis, PhD; Wake Forest University Health Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01276028
• Other Study ID Numbers: IRB00014892
• First Posted: January 13, 2011
• Last Update Posted: August 9, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

Acupuncture; Hot Flashes; Menopause; Vasomotor Symptoms