Ethics, methodology and the use of placebo controls in surgical trials

Brain Research Bulletin

Volumn 67, Issue 4, 2005, Pages 290-297

  Polgar, Stephen ^a   Ng, Joanna ^a  

^a LA TROBE UNIVERSITY   (Australia)

Author keywords

Best practice; Ethics; Evidence based medicine; Methodology; Placebo effects; Sham surgery

Indexed keywords

PLACEBO;

ARTHROSCOPIC SURGERY; CLINICAL TRIAL; DECISION MAKING; ETHICS; EVIDENCE BASED MEDICINE; HUMAN; MEDICAL RESEARCH; METHODOLOGY; NERVE GRAFT; OSTEOARTHRITIS; PARKINSON DISEASE; PRIORITY JOURNAL; RANDOMIZATION; REVIEW; SAFETY; SURGICAL TECHNIQUE;

EID: 25144482475     PISSN: 03619230     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.brainresbull.2005.06.028     Document Type: Article

References (32)

1. R. Albin Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for use of sham surgery controls J. Med. Ethics 28 2002 322 325
2. G. Boer, and H. Widner Clinical neurotransplantation: core assessment protocol rather than sham surgery as control Brain Res. Bull. 58 6 2002 547 553
3. P. Brundin, O. Pogarell, and P. Hagell Bilateral caudate and putamen grafts of embryonic mesencephalic tissue treated with lazaroids in Parkinson's disease Brain 123 2000 1380 1390
4. J. Cohen Statistical Power Analysis for the Behavioural Sciences second ed. 1988 Lawrence Erlbaum Associates Inc. New York
5. R. de la Fuente-Fernandez, and A. Stoessel The placebo effect in Parkinson's disease Trends Neurosci. 25 2001 302 306
6. W. Dekkers, and G. Boer Sham surgery in patients with Parkinson's disease: is it morally acceptable? J. Med. Ethics 27 2001 151 156
7. J. Fletcher Sham neurosurgery in Parkinson's disease: ethical at the time Am. J. Bioethics 3 4 2003 54 56
8. C. Freed, P. Greene, and R. Breeze Transplantation of embryonic dopamine neurons for severe Parkinson's disease New Engl. J. Med. 344 10 2001 710 719
9. T. Freeman, D. Vawter, and P. Leaverton Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson's disease New Engl. J. Med. 341 1999 988 991
10. T. Freeman, R. Watts, and R. Hauser A prospective, randomized, double-blind, surgical placebo-controlled trial of intrastriatal transplantation of fetal porcine ventral mesencephalic tissue (neurocell-PD) in subjects with Parkinson's disease Exp. Neurol. 175 2002 426
11. T. Freeman, C. Goetz, and J. Kordower Double blind controlled trial of bilateral fetal nigral transplantation in Parkinson's disease Exp. Neurol. 181 2003 84 112
12. T. Freeman, and D. Vawter From the laboratory to the clinic: unique issues in the clinical evaluation of neural reconstructive therapies Exp. Neurol. 187 1 2004 203
13. R. Hauser, T. Freeman, and B. Snow Long-term evaluation of bilateral fetal nigral transplantation in Parkinson's disease Arch. Neurol. 56 1999 179 187
14. A. Hrobjartsson, and P.C. Goetzsche Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment New Engl. J. Med. 344 2001 1594 1602
15. A. Hrobjartsson, P.C. Goetzsche, Placebo Treatment Versus No Treatment (Cochrane Review), The Cochrane Library Issue 2, 2004, http://www.cochrane.org/ cochrane/revabstr/AB003974.htm.
16. S. Kim The sham surgery debate and the moral complexity of risk-benefit analysis Am. J. Bioethics 3 4 2003 68 70
17. H. Leeds Social aspects of sham surgeries Am. J. Bioethics 3 4 2003 70 71
18. A. London, and J. Kadane Placebo that harm: sham surgery controls in clinical trials Stat. Methods Med. Res. 11 2002 413 427
19. A. London, and J. Kadane Sham surgery and genuine standards of care: can the two be reconciled? Am. J. Bioethics 3 4 2003 61 64
20. R. Macklin The ethical problems with sham surgery in clinical research New Engl. J. Med. 341 1999 992 996
21. F. Miller Sham-surgery: an ethical analysis Am. J. Bioethics 3 4 2003 41 48
22. J. Moseley, K. O'Malley, and N. Petersen A controlled trial of arthroscopic surgery for osteoarthritis of the knee New Engl. J. Med. 347 2002 81 88
23. J. Obeso Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease New Engl. J. Med. 345 2001 956 963
24. C. Olanow, C. Goetz, and J. Kordower A double-blind controlled trial of bilateral nigral transplantation in Parkinson's disease Ann. Neurol. 54 2003 403 414
25. S. Polgar Cells to best-practice: the structure of the research program for neural reconstruction Exp. Neurol. 187 2004 216 217
26. S. Polgar, and S. Thomas Introduction to Research in the Health Sciences fourth ed. 2000 Churchill Livingstone Australia
27. S. Polgar, M. Morris, and S. Reilly Reconstructive neurosurgery for Parkinson's disease: a systematic review and preliminary meta-analysis Brain Res. Bull. 60 2003 1 24
28. D. Sackett, S. Straus, W. Richardson, W. Rosenberg, and R. Haynes Evidence-based Medicine: How to Practice and Teach EBM second ed. 2000 Churchill Livingstone Edinburgh
29. J. Schumacher, S. Ellias, E. Palmer, and H. Kott Transplantation of embryonic porcine mesencephalic tissue in patients with PD Neurology 54 2000 1042 1050
30. M. Schwartz, and S. Polgar Statistics for Evidence-Based Health Care 2003 Australia Tertiary Press
31. D. Vawter, K. Gervais, and T. Freeman Does placebo surgery-controlled research call for new provisions to protect human research participants? Am. J. Bioethics 3 4 2003 50 53
32. D. Vawter, K. Gervais, and A. Prehn Placebo controlled surgical trials; perspectives of Parkinson's disease (PD) researchers Exp. Neurol. 187 1 2004 221 222