Trials / Completed
CompletedNCT00284492
Acupuncture for Hot Flushes in Menopause
Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 286 (actual)
- Sponsor
- University Hospital of North Norway · Academic / Other
- Sex
- Female
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.
Detailed description
The study objective is to determine whether Traditional Chinese Medicine (TCM) acupuncture-care together with self-care is more effective than self-care alone, to relieve climacteric complaints among women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only. The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Traditional chinese medicine type acupuncture | 10 acupuncture sessions |
| BEHAVIORAL | Self Care | Lifestyle advice on diet, physical activity |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2007-05-01
- Completion
- 2008-05-01
- First posted
- 2006-01-31
- Last updated
- 2012-05-14
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT00284492. Inclusion in this directory is not an endorsement.