Acupuncture in Menopause (AIM)

Wake Forest University (WFU)

Status: Completed

Conditions: Vasomotor Symptoms

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01276028

IRB00014892

Details and patient eligibility

About

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.

Enrollment: 209 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Acupuncture

Waitlist

Other group

Description:

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

Treatment:

Procedure: Acupuncture