The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH)

Tittel
The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH) Study: A study protocol of an ongoing multi-centre randomised controlled clinical trial.

Forfatter(e)
Borud EK, Alraek T, White A, Fønnebø V, Grimsgaard S.

Tidsskrift/bok
BMC Complementary and Alternative Medicine 2007, 7:6, doi:10.1186/1472-6882-7-6, eller gå direkte hit.

Årstall
2007

Abstract
After menopause, 10-20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints.

The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document more than 7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate. The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments.

The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. 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, assessed by the Womens Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.