Journal of Clinical Epidemiology
Volume 59, Issue 9 , Pages 876-880 , September 2006

Placebo surgery research: A blinding imperative

  • Paul S. Heckerling

      Affiliations

    • Dr. Heckerling is Chair of the Biomedical-Behavioral Institutional Review Board, University of Illinois at Chicago. The views expressed herein represent those of the author and do not reflect the views of the University of Illinois at Chicago Office for Protection of Research Subjects.
    • Corresponding Author InformationCorresponding author. Tel.: 312-413-3886; fax: 312-413-8283.

,Accepted 25 March 2006.

References 

  1. Freeman TB, Vawter DE, Leaverton PE, Godbold JH, Hauser RA, Goetz CG, et al. Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson's disease. N Engl J Med. 1999;341:988–992
  2. Freed CR, Greene PE, Breeze RE, Tsai W-Y, DuMouchel W, Kao R, et al. Transplantation of embryonic dopamine neurons for severe Parkinson's disease. N Engl J Med. 2001;344:710–719
  3. Olanow CW, Goetz CG, Kordower JH, Stoessl AJ, Sossi V, Brin MF, et al. A double-blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease. Ann Neurol. 2003;54:403–414
  4. Moseley JB, O'Malley K, Peterson NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled trial of arthroscopy for osteoarthritis of the knee. N Engl J Med. 2002;347:81–88
  5. Connolly SJ, Sheldon R, Thrope KE, Robers RS, Ellenbogen KA, Wilkoff BL, et al. Pacemaker therapy for prevention of syncope in patients with recurrent severe vasovagal syncope. Second Vasovagal Packemaker Study (VPS II): a randomized trial. JAMA. 2003;289:2224–2229
  6. Gragoudas ES, Adamis AP, Cunningham ET, Feinsod M, Guyer DR for the VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004;351:2805–2816
  7. Horng S, Miller FG. Is placebo surgery unethical?. N Engl J Med. 2002;347:137–139
  8. Gillett GR. Unnecessary holes in the head. IRB: Ethics Hum Res. 2001;23:1–6
  9. Albin RL. Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for the use of sham surgery controls. J Med Ethics. 2002;28:322–325
  10. Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med. 1999;141:992–996
  11. Clark PA. Placebo surgery for Parkinson's disease: do the benefits outweigh the risks. J Law Med Ethics. 2002;30:58–68
  12. Miller FG. Sham surgery: an ethical analysis. Am J Bioeth. 2003;3:41–48
  13. Weijer C. I need a placebo like I need a hole in the head. J Law Med Ethics. 2002;30:69–72
  14. London AJ, Kadane JB. Sham surgery and genuine standards of care: can the two be reconciled?. Am J Bioeth. 2003;3:61–64
  15. Dick J, Jampol LM, Haller JA. Macular edema. In:  Ryan S,  Schachat AP editor. Retina. 3rd edition. St. Louis, MO: CV Mosby; 2001;p. 967–979
  16. Jager RD, Aiello LP, Patel S, Cunningham E. Risks of intravitreous injection: a comprehensive review. Retina. 2004;24:676–698
  17. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. 45 C.F.R. § 46.111 (a)(1),(2).
  18. Schulz KF, Grimes DA. Blinding in randomized trials: hiding who got what. Lancet. 2002;359:696–700
  19. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?. JAMA. 2000;283:2701–2711
  20. 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
  21. McRae C, Cherin E, Yamazaki G, Diem G, Vo AH, Russell D, et al. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004;61:412–420
  22. Heckerling PS. The ethics of single-blind trials. IRB: Ethics Hum Res. 2005;27:12–16
  23. Noseworthy JH, Ebers GC, Vandevoort MK, Farquhar RE, Yetisir E, Roberts R. The impact of blinding on a randomized, placebo-controlled multiple sclerosis trial. Neurology. 1994;44:16–20
  24. Schulz KF, Chalmers IA, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodologic quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–412
  25. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo to no treatment. N Engl J Med. 2001;344:1594–1602
  26. Gerritsen AAM, de Vet HCW, Scholten RJPM, Bertelsmann FW, de Krom MCTFM, Bouter LM. Splinting versus surgery in the treatment of carpal tunnel syndrome. JAMA. 2002;288:1245–1251
  27. Piantadosi S. Clinical trials: a methodologic perspective. New York: John Wiley & Sons, Inc.; 1997;120
  28. 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
  29. McPherson K, Britton AR, Wennbur JE. Are randomized controlled trials controlled? Patient preferences and unblind trials. J R Soc Med. 1997;90:652–656
  30. Silverman WA, Altman DG. Patients' preferences and randomised trials. Lancet. 1996;347:171–174
  31. Halpern SD. Evaluating preference effects in partially unblinded randomized trials. J Clin Epidemiol. 2003;56:109–115

PII: S0895-4356(06)00114-4

doi: 10.1016/j.jclinepi.2006.03.001

Journal of Clinical Epidemiology
Volume 59, Issue 9 , Pages 876-880 , September 2006

Article Tools