Clinical Trials Directory

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

TypeNameDescription
PROCEDURETraditional chinese medicine type acupuncture10 acupuncture sessions
BEHAVIORALSelf CareLifestyle 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.