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http://dx.doi.org/10.15204/jkobgy.2010.23.1.042

Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women  

Kim, Kun-Hyung (Acupuncture, Moxibustion and Meridian Research Center, Division of Standard Research, Korea Institute of Oriental Medicine)
Kim, Dong-Il (Dept. of Ob&Gy, Dongguk Univ-Seoul, Graduate School of Oriental Medicine)
Hwang, Deok-Sang (Dept. of Oriental Gynecology, Kyung Hee University)
Lee, Jin-Moo (Dept. of Oriental Gynecology, Kyung Hee University)
Kim, Hyung-Jun (Dept. of Oriental Gynecology, Semyung University)
Yoon, Hyun-Min (Dept. of Acupuncture & Moxibustion, College of Oriental Medicine, Dong-Eui Univ.)
Jung, Hee-Jung (Acupuncture, Moxibustion and Meridian Research Center, Division of Standard Research, Korea Institute of Oriental Medicine)
Kang, Kyung-Won (Acupuncture, Moxibustion and Meridian Research Center, Division of Standard Research, Korea Institute of Oriental Medicine)
Lee, Myeong-Soo (Acupuncture, Moxibustion and Meridian Research Center, Division of Standard Research, Korea Institute of Oriental Medicine)
Choi, Sun-Mi (Acupuncture, Moxibustion and Meridian Research Center, Division of Standard Research, Korea Institute of Oriental Medicine)
Publication Information
The Journal of Korean Obstetrics and Gynecology / v.23, no.1, 2010 , pp. 42-52 More about this Journal
Abstract
Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.
Keywords
Acupuncture; Hot flashes; Multicenter clinical trial; Menopausal symptom; Vasomotor symptom; Pragmatic trial;
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Times Cited By KSCI : 2  (Citation Analysis)
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1 Ratcliffe J et al. A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis. BMJ. 2006;333:626.   DOI   ScienceOn
2 Haines C et al. Prevalence of menopausal symptoms in different ethnic groups of Asian women and responsiveness to therapy with three doses of conjugated estrogens/medroxyprogesterone acetate: The Pan-Asia menopause(PAM) study. Maturitas. 2005;52:264-76.   DOI   ScienceOn
3 Lund I, Lundeberg T. Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls? Acupunct Med. 2006;24:13-5.   DOI   ScienceOn
4 Carpenter JS et al. Is sternal skin conductance monitoring a valid measure of hot flash intensity or distress? Menopause. 2005;12:512-9.   DOI   ScienceOn
5 Wyon Y et al. Postmenopausal women with vasomotor symptoms have increased urinary excretion of calcitonin gene-related peptide. Maturitas. 1998;30:289-94.   DOI   ScienceOn
6 Alraek T, Malterud K. Acupuncture for menopausal hot flashes: a qualitative study about patient experiences. J Altern Complement Med. 2009;15:153-8.   DOI   ScienceOn
7 Thomas KJ et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ. 2006;333:623.   DOI   ScienceOn
8 Nuesch E et al. The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study. BMJ. 2009;339:b3244.   DOI   ScienceOn
9 Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002;359:614-8.   DOI   ScienceOn
10 Conboy L et al. A Qualitative analysis of adolescents' experiences of active and sham japanese-style acupuncture protocols administered in a clinical trial. J Altern Complement Med. 2008;14:699-705.   DOI   ScienceOn
11 Nelson H et al. Management of Menopause-Related Symptoms. Evidence Report/Technology Assessment No. 120. (Prepared by the Oregon Evidence-based Practice Center, under Contract No. 290-02-0024. )AHRQ Publication No. 05-E016-2. Rockville, MD: Agency for Healthcare Research and Quality. 2005.
12 Park JE et al. Moxibustion for treating menopausal hot flashes: a randomized clinical trial. Menopause. 2009;16:660-65.   DOI   ScienceOn
13 Schroer S, MacPherson H, Adamson J. Designing an RCT of acupuncture for depression-identifying appropriate patient groups: a qualitative study. Fam Pract. 2009;26:188-95.   DOI   ScienceOn
14 Lundeberg T et al. Is placebo acupuncture what it is intended to be? Evid Based Complement Alternat Med. 2009;doi:10. 1093/ecam/nep1049.
15 Kim DI et al. A clinical trial to assess the efficacy of acupuncture on hot flashes in postmenopausal women. Korean Journal of Oriental Medicine. 2007;28:74-85.   과학기술학회마을
16 Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496.   DOI   ScienceOn
17 Kaptchuk TJ et al. Components of placeboeffect:randomisedcontrolled trial in patients with irritable bowel syndrome. BMJ. 2008;336:999-1003.   DOI   ScienceOn
18 Guangyi X et al. Application of Delphi technique in identification of appropriate screening questions for chronic low back pain from traditional Chinese medicine experts' opinions. J Altern Complement Med. 2009;15:47-52.   DOI   ScienceOn
19 Kaufert P et al. Menopause research: the korpilampi workshop. Soc Sci Med. 1986;22:1285-9.   DOI   ScienceOn
20 Kim KH et al. Effects of acupuncture on hot flashes in perimenopausal and postmenopausal women-a multicenter randomized clinical trial. Menopause. 2009[Epub ahead of print].
21 Gallicchio L et al. Type of menopause, patterns of hormone therapy use, and hot flashes. Fertility and Sterility. 2006;85:1432-40.   DOI   ScienceOn
22 Wyon Y et al. Effects of acupuncture on climacteric vasomotor symptoms, quality of life, and urinary excretion of neuropeptides among postmenopausal women. Menopause. 1995;2:3-12.
23 Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2003;362:419-27.   DOI   ScienceOn
24 Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009;10:37.   DOI   ScienceOn
25 Kim KH et al. Study protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women - a multicenter randomized clinical trial. Trials. 2008;9:70.   DOI   ScienceOn
26 Low DA et al. Cutaneous and hemodynamic responses during hot flashes in symptomatic postmenopausal women. Menopause. 2008;15:290-5.   DOI   ScienceOn
27 Sloan J et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001;19:4280-90.   DOI
28 Borud E et al. The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial. Menopause. 2009;16:484-93.   DOI   ScienceOn
29 Paterson C, Dieppe P. Characteristic and incidental(placebo) effects in complex interventions such as acupuncture. BMJ. 2005;330:1202-5.   DOI   ScienceOn
30 McNagny S. Prescribing hormone replacement therapy for menopausal symptoms. Ann Intern Med. 1999;131:605-16.   DOI   ScienceOn
31 Lekander I et al. Cost-effectiveness of hormone replacement therapy for menopausal symptoms in the UK. Menopause Int. 2009;15:19-25.   DOI   ScienceOn
32 노진주, 김동일. 갱년기 안면홍조에 대한 침 임상시험 방법론. 대한한방부인과학회지. 2008;21(4):193-206.   과학기술학회마을
33 Million Women Study Collaborators. Endometrial cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2005;365:1543-51.   DOI   ScienceOn
34 Lee MS, Shin BC, Ernst E. Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric. 2009;12:16-25.   DOI   ScienceOn
35 Kim KH, Lee MS, Choi SM. Can we analyze the data more clearly by employing a different approach to estimate hotflushes? Climacteric. 2008;11:39-40.
36 Nelson H. Menopause. Lancet. 2008;371:760-70.   DOI   ScienceOn
37 The North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society. Menopause. 2004;11:11-33.   DOI   ScienceOn
38 Sturdee D. The hot flush: the enigma of the climacteric. Climacteric. 2001;4:1-3.   DOI
39 Cummings M. Why recommend acupuncture for low back pain but not for osteoarthritis? a commentary on recent NICE guidelines. Acupunct Med. 2009;27:128-9.   DOI   ScienceOn