Hopton, A.K., MacPherson, H. Assessing blinding in randomised controlled trials of acupuncture: Challenges and recommendations., Chin. J. Integr. Med. 17, 173–176 (2011). https://doi.org/10.1007/s11655-011-0663-9
Ann K. Hopton, Hugh MacPherson. Assessing blinding in randomised controlled trials of acupuncture: Challenges and recommendations[J]. Chinese Journal of Integrative Medicine, 2011,17(3):173-176.
Hopton, A.K., MacPherson, H. Assessing blinding in randomised controlled trials of acupuncture: Challenges and recommendations., Chin. J. Integr. Med. 17, 173–176 (2011). https://doi.org/10.1007/s11655-011-0663-9DOI:
Ann K. Hopton, Hugh MacPherson. Assessing blinding in randomised controlled trials of acupuncture: Challenges and recommendations[J]. Chinese Journal of Integrative Medicine, 2011,17(3):173-176. DOI: 10.1007/s11655-011-0663-9.
Assessing blinding in randomised controlled trials of acupuncture: Challenges and recommendations
摘要
The revision of CONSORT guidelines for reporting blinding in randomised controlled trials is the subject of controversy and criticism. To determine whether the criticism is justified
in this short communication paper we discuss the problems encountered in the methodology of the assessment of blinding
and the reporting of blinding in randomised controlled trials and the standards of reporting on blinding with reference to their usage in clinical trials of acupuncture for chronic pain. To conclude we recommend two simple guidelines: the development of sound clinical protocols that anticipate potential difficulties and reinforce overall internal validity
and secondly. the accurate reporting of the methodologies used to ensure a clear view of blinding procedures.
Abstract
The revision of CONSORT guidelines for reporting blinding in randomised controlled trials is the subject of controversy and criticism. To determine whether the criticism is justified
in this short communication paper we discuss the problems encountered in the methodology of the assessment of blinding
and the reporting of blinding in randomised controlled trials and the standards of reporting on blinding with reference to their usage in clinical trials of acupuncture for chronic pain. To conclude we recommend two simple guidelines: the development of sound clinical protocols that anticipate potential difficulties and reinforce overall internal validity
and secondly. the accurate reporting of the methodologies used to ensure a clear view of blinding procedures.
关键词
blinding assesmentmethodologyreportingacupuncture
Keywords
blinding assesmentmethodologyreportingacupuncture
references
Moher D. Reports of randomized trials: ensure they are transparent, accurate, and complete. J Chin Integr Med (Chin) 2010;8:601–603.
Manheimer E, White A, Berman B, Forys K, Ernst E. Metaanalysis: acupuncture for low back pain. Ann Intern Med 2005;142:651–663.
Manheimer E, Linde K, Lao L, Bouter LM, Berman BM. Meta-analysis: acupuncture for osteoarthritis of the knee. Ann Intern Med 2007;146:868–877.
White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology (Oxford) 2007;46:384–390.
Fu LM, Li JT, Wu WS. Randomized controlled trials of acupuncture for neck pain: systematic review and metaanalysis. J Altern Complement Med 2009;15:133–145.
Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: A systematic review and meta-analysis of randomised controlled trials. Eur J Pain 2009;13:3–10.
Altman DG, Schulz KF, Moher D. Turning a blind eye: testing the success of blinding and the CONSORT statement. BMJ 2004;328:1135.
Schulz KF ADMD, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Chin Integr Med (Chin) 2010;8:604–612.
Kolahi J, Bang H, Park J, Desbiens N. CONSORT 2010 and controversies regarding assessment of blindness in RCTs. Dent Hypotheses. In press 2010.
Boutron I, Estellat C, Ravaud P. A review of blinding in randomized controlled trials found results inconsistent and questionable. J Clin Epidemiol 2005;58:1220–1226.
Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res Regul Affairs 2010;27:42–51.
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials 2004;25:143–156.
James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation —a VA cooperative study. Stat Med 1996;15:1421–1434.
Scharf H, Mansmann U, Streitberger K, Witte S, Krämer J, Maier C, et al. Acupuncture and Knee Osteoarthritis. Ann Intern Med 2006;145:12–20.
Enblom A, Hammar M, Steineck G, Börjeson S. Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle? Complement Ther Med 2008;16:288–294.
Hrobjartsson A, Forfang E, Haahr MT, ls-Nielsen B, Brorson S. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol 2007;36:654–663.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637–639.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663–694.
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
Sackett DL. Turning a blind eye: why we don’t test for blindness at the end of our trials. BMJ 2004;328:1136.
Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet 2002;359:696–700.
Fergusson D, Glass KC, Waring D, Shapiro S. Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ 2004;328:432.
You XM, Qin X, Dong ZY, Wang GL. Integrated traditional Chinese and Western medicine versus Western medicine in treatment of arteriosclerosis obliterans: a systematic review of randomized controlled trials. J Chin Integr Med (Chin) 2010;8:917–927.
MacPherson H, Altman DG, Hammerschlag R, Li Y, Wu T, White A, et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med 2010;28:83–93.
MacPherson H. Towards better reporting of interventions in clinical trials of acupuncture. J Chin Integr Med (Chin) 2010;8:801–802.
Miller LE, Stewart ME. The blind leading the blind: Use and misuse of blinding in randomized controlled trials. Contemp Clin Trials. In Press, Corrected Proof.
Effects of acupuncture at Baihui (DU20) and Zusanli (ST36) on the expression of heat shock protein 70 and tumor necrosis factor α in the peripheral serum of cerebral ischemia-reperfusion-injured rats
The status of acupuncture and oriental medicine in the United States
Effectiveness of acupuncture for palliative care in cancer patients: A systematic review
Meridian essence: Modern thought
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相关机构
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
The First Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
The Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences