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

갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈

  • 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)
  • 김건형 (한국한의학연구원 침구경락연구센터) ;
  • 김동일 (동국대학교 대학원 한의학과 부인과학 교실) ;
  • 황덕상 (경희대학교 한의과대학 한방부인과) ;
  • 이진무 (경희대학교 한의과대학 한방부인과) ;
  • 김형준 (세명대학교 제천한방병원 한방부인과) ;
  • 윤현민 (동의대학교 부속한방병원 침구과) ;
  • 정희정 (한국한의학연구원 침구경락연구센터) ;
  • 강경원 (한국한의학연구원 침구경락연구센터) ;
  • 이명수 (한국한의학연구원 침구경락연구센터) ;
  • 최선미 (한국한의학연구원 침구경락연구센터)
  • Received : 2009.11.04
  • Accepted : 2010.02.10
  • Published : 2010.02.28

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

References

  1. Sturdee D. The hot flush: the enigma of the climacteric. Climacteric. 2001;4:1-3. https://doi.org/10.1080/cmt.4.1.1.3
  2. The North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society. Menopause. 2004;11:11-33. https://doi.org/10.1097/01.GME.0000108177.85442.71
  3. 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. https://doi.org/10.1016/j.maturitas.2005.03.012
  4. Nelson H. Menopause. Lancet. 2008;371:760-70. https://doi.org/10.1016/S0140-6736(08)60346-3
  5. McNagny S. Prescribing hormone replacement therapy for menopausal symptoms. Ann Intern Med. 1999;131:605-16. https://doi.org/10.7326/0003-4819-131-8-199910190-00010
  6. Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2003;362:419-27. https://doi.org/10.1016/S0140-6736(03)14065-2
  7. Million Women Study Collaborators. Endometrial cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2005;365:1543-51. https://doi.org/10.1016/S0140-6736(05)66455-0
  8. Lee MS, Shin BC, Ernst E. Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric. 2009;12:16-25. https://doi.org/10.1080/13697130802566980
  9. Lund I, Lundeberg T. Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls? Acupunct Med. 2006;24:13-5. https://doi.org/10.1136/aim.24.1.13
  10. Sloan J et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001;19:4280-90. https://doi.org/10.1200/JCO.2001.19.23.4280
  11. Paterson C, Dieppe P. Characteristic and incidental(placebo) effects in complex interventions such as acupuncture. BMJ. 2005;330:1202-5. https://doi.org/10.1136/bmj.330.7501.1202
  12. 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. https://doi.org/10.1186/1745-6215-9-70
  13. 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].
  14. Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009;10:37. https://doi.org/10.1186/1745-6215-10-37
  15. Kaptchuk TJ et al. Components of placeboeffect:randomisedcontrolled trial in patients with irritable bowel syndrome. BMJ. 2008;336:999-1003. https://doi.org/10.1136/bmj.39524.439618.25
  16. 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. https://doi.org/10.1089/acm.2008.0230
  17. Lundeberg T et al. Is placebo acupuncture what it is intended to be? Evid Based Complement Alternat Med. 2009;doi:10. 1093/ecam/nep1049.
  18. 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.
  19. Park JE et al. Moxibustion for treating menopausal hot flashes: a randomized clinical trial. Menopause. 2009;16:660-65. https://doi.org/10.1097/gme.0b013e318198cdf7
  20. Nuesch E et al. The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study. BMJ. 2009;339:b3244. https://doi.org/10.1136/bmj.b3244
  21. Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002;359:614-8. https://doi.org/10.1016/S0140-6736(02)07750-4
  22. 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.
  23. Borud E et al. The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial. Menopause. 2009;16:484-93. https://doi.org/10.1097/gme.0b013e31818c02ad
  24. 노진주, 김동일. 갱년기 안면홍조에 대한 침 임상시험 방법론. 대한한방부인과학회지. 2008;21(4):193-206.
  25. Low DA et al. Cutaneous and hemodynamic responses during hot flashes in symptomatic postmenopausal women. Menopause. 2008;15:290-5. https://doi.org/10.1097/gme.0b013e3180ca7cfa
  26. Carpenter JS et al. Is sternal skin conductance monitoring a valid measure of hot flash intensity or distress? Menopause. 2005;12:512-9. https://doi.org/10.1097/01.gme.0000170957.31542.1c
  27. Wyon Y et al. Postmenopausal women with vasomotor symptoms have increased urinary excretion of calcitonin gene-related peptide. Maturitas. 1998;30:289-94. https://doi.org/10.1016/S0378-5122(98)00047-4
  28. 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.
  29. Gallicchio L et al. Type of menopause, patterns of hormone therapy use, and hot flashes. Fertility and Sterility. 2006;85:1432-40. https://doi.org/10.1016/j.fertnstert.2005.10.033
  30. Kaufert P et al. Menopause research: the korpilampi workshop. Soc Sci Med. 1986;22:1285-9. https://doi.org/10.1016/0277-9536(86)90196-6
  31. 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.
  32. Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496. https://doi.org/10.1136/bmj.b3496
  33. 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. https://doi.org/10.1093/fampra/cmp021
  34. 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. https://doi.org/10.1089/acm.2007.0718
  35. Alraek T, Malterud K. Acupuncture for menopausal hot flashes: a qualitative study about patient experiences. J Altern Complement Med. 2009;15:153-8. https://doi.org/10.1089/acm.2008.0310
  36. 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. https://doi.org/10.1136/bmj.38878.907361.7C
  37. Ratcliffe J et al. A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis. BMJ. 2006;333:626. https://doi.org/10.1136/bmj.38932.806134.7C
  38. 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. https://doi.org/10.1136/aim.2009.001214
  39. Lekander I et al. Cost-effectiveness of hormone replacement therapy for menopausal symptoms in the UK. Menopause Int. 2009;15:19-25. https://doi.org/10.1258/mi.2009.009004

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