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


CONCLUSIONS
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.
Borud
Einar K
EK
National Research Center in Complementary and Alternative Medicine, University of Tromsoe, N-9037 Tromsoe, Norway. einar.borud@fagmed.uit.no
Alraek
Terje
T
White
Adrian
A
Fonnebo
Vinjar
V
Grimsgaard
Sameline
S
D015670:Acupuncture Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D019584:Hot Flashes / Q000628:therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D009664:Norway; D017060:Patient Satisfaction; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016387:Women's Health