Vasomotor Symptoms
Conditions
Keywords
Acupuncture, Hot Flashes, Menopause, Vasomotor Symptoms
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.
Interventions
PROCEDUREAcupuncture
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.
Sponsors
National Institutes of Health (NIH)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Hot Flashes | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Hot Flashes | 3 days | Objective hot flashes measured by skin conductance |
| Other Symptoms | Up to 14 months | — |
| Quality of Life | Up to 58 weeks | Measures your quality of life over the last week |
Countries
United States
Outcome results
None listed