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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.
BMC Complement Altern Med. 2007 Feb 26; 7:6.BC

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 > 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.

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.

Authors+Show Affiliations

National Research Center in Complementary and Alternative Medicine, University of Tromsoe, N-9037 Tromsoe, Norway. einar.borud@fagmed.uit.noNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Controlled Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17324253

Citation

Borud, Einar K., et al. "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." BMC Complementary and Alternative Medicine, vol. 7, 2007, p. 6.
Borud EK, Alraek T, White A, et al. 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. BMC Complement Altern Med. 2007;7:6.
Borud, E. K., Alraek, T., White, A., Fonnebo, V., & Grimsgaard, S. (2007). 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. BMC Complementary and Alternative Medicine, 7, 6.
Borud EK, et al. 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. BMC Complement Altern Med. 2007 Feb 26;7:6. PubMed PMID: 17324253.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Borud,Einar K, AU - Alraek,Terje, AU - White,Adrian, AU - Fonnebo,Vinjar, AU - Grimsgaard,Sameline, Y1 - 2007/02/26/ PY - 2006/11/21/received PY - 2007/02/26/accepted PY - 2007/2/28/pubmed PY - 2007/3/21/medline PY - 2007/2/28/entrez SP - 6 EP - 6 JF - BMC complementary and alternative medicine JO - BMC Complement Altern Med VL - 7 N2 - 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 > 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. 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. SN - 1472-6882 UR - https://www.unboundmedicine.com/medline/citation/17324253/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_ L2 - https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/1472-6882-7-6 DB - PRIME DP - Unbound Medicine ER -