Menopause Clinical Trial
Official title:
Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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