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Journal of Integrative Medicine ›› 2015, Vol. 13 ›› Issue (3): 136-139.doi: 10.1016/S2095-4964(15)60172-8

• Commentary • Previous Articles     Next Articles

The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions

Arthur Yin Fan   

  1. McLean Center for Complementary and Alternative Medicine, PLC., Vienna, VA 22182, USA
  • Received:2015-02-20 Accepted:2015-03-05 Online:2015-05-10 Published:2015-05-15


Key words: Acupuncture, Chronic knee pain, Hinman, Zelen design, Clinical trial, Statistics, Flaws

[1] Hinman RS, McCrory P, Pirotta M, Relf I, Forbes A, Crossley KM, Williamson E, Kyriakides M, Novy K, Metcalf BR, Harris A, Reddy P, Conaghan PG, Bennell KL . Acupuncture for chronic knee pain: a randomized clinical trial. JAMA, 2014,312(13):1313-1322
doi: 10.1136/acupmed-2014-010727
[2] Fan AY . The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. J Integr Med, 2015,13(2):65-68
doi: 10.1016/S2095-4964(15)60170-4
[3] Campbell JP, Maxey VA, Watson WA . Hawthorne effect: implications for prehospital research. Ann Emerg Med, 1995,26(5):590-594
doi: 10.1016/S0196-0644(95)70009-9 pmid: 7486367
[4] Adamson J, Cockayne S, Puffer S, Torgerson DJ . Review of randomised trials using the post-randomised consent(Zelen’s) design. Contemp Clin Trials, 2006,27(4):305-319
doi: 10.1016/j.cct.2005.11.003 pmid: 16455306
[5] Ding Y. Zelen design (Randomized consent design/Prerandomization design). In: The new advance on randomized control trial. Page 23-35. [2015-02-22]. . Chinese.
[6] Homer CS . Using the Zelen design in randomized controlled trials: debates and controversies. J Adv Nurs, 2002,38(2):200-207
doi: 10.1046/j.1365-2648.2002.02164.x pmid: 11940133
[7] Common-used statistical methods in evidence-based medicine. [ 2015-02-22]. .
[8] National Institutes of Health. Quality assessment of controlled intervention studies. Systematic evidence reviews & clinical practice guidelines.[ 2015-03-04]. .
[9] Vickers AJ, Linde K . Acupuncture for chronic pain. JAMA, 2014,311(9):955-956
doi: 10.1001/jama.2013.285478
[10] Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC . Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med, 2004,141(12):901-910
doi: 10.7326/0003-4819-141-12-200412210-00006
[11] White A, Cummings M . Acupuncture for knee osteoarthritis: study by Hinman et al represents missed opportunities. Acupunct Med, 2015,33(1):84-86
doi: 10.1136/acupmed-2014-010719
[12] Hinman RS, McCrory P, Pirotta M, Relf I, Crossley KM, Reddy P, Forbes A, Harris A, Metcalf BR, Kyriakides M, Novy K, Bennell KL . Efficacy of acupuncture for chronic knee pain: protocol for a randomized controlled trial using a Zelen design. BMC Complement Altern Med, 2012,12:161
doi: 10.1186/1472-6882-12-S1-P161
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