Study protocol

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

Einar K Borud¹ , Terje Alraek¹ , Adrian White³ , Vinjar Fonnebo¹ and Sameline Grimsgaard²

¹  National Research Center in Complementary and Alternative Medicine, University of Tromsoe, N-9037 Tromsoe, Norway

²  Clinical Research Centre, University Hospital of North-Norway, N-9038 Tromsoe, Norway

³  Department of General Practice and Primary Care, Peninsula Medical School, Plymouth, PL6 8BU, UK

author email corresponding author email

BMC Complementary and Alternative Medicine 2007, 7:6doi:10.1186/1472-6882-7-6

Published:	26 February 2007

Abstract

Background

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.

Methods/Design

The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥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.

Discussion

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 Women's 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.