The placebo mystique: Implications for clinical trial methodology

Journal of Paediatrics and Child Health

Volumn 47, Issue 6, 2011, Pages 361-366

  Clifford, Vanessa ^a  

^a MURDOCH CHILDREN'S RESEARCH INSTITUTE   (Australia)

Author keywords

Clinical trial; Placebo; Placebo effect; Randomised controlled trial

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONTROL GROUP; HUMAN; METHODOLOGY; PLACEBO EFFECT; PRIORITY JOURNAL; QUESTIONNAIRE; TERTIARY HEALTH CARE; THERAPEUTIC MISCONCEPTION;

ATTITUDE OF HEALTH PERSONNEL; HEALTH CARE SURVEYS; HUMANS; MEDICAL STAFF, HOSPITAL; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; VICTORIA;

EID: 79959834190     PISSN: 10344810     EISSN: 14401754     Source Type: Journal    
DOI: 10.1111/j.1440-1754.2010.01983.x     Document Type: Article

References (35)

1. Weijer C. I need a placebo like I need a hole in the head. J. Law Med. Ethics 2002; 30: 69-72. (Pubitemid 39277859)
2. Angell M. Investigators' responsibilities for human subjects in developing countries. N. Engl. J. Med. 2000; 342: 967-9. (Pubitemid 30177058)
3. Ashcroft R. The declaration of Helsinki. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press, 2008.
4. Michels KB, Rothman KJ. Update on unethical use of placebos in randomised trials. Bioethics 2003; 17: 188-204. (Pubitemid 36416574)
5. Vickers AJ, De Craen AJ. Why use placebos in clinical trials? A narrative review of the methodological literature. J Clin. Epidemiol. 2000; 53: 157-61. (Pubitemid 30151220)
6. Shapiro AK, Shapiro E. The Powerful Placebo: From Ancient Priest to Modern Physician. Baltimore, MD: The John Hopkins University Press, 1997.
7. Wolff H. Conferences on therapy: the use of placebos in therapy. N. Y. State Med. J. 1946; 17: 722-27.
8. Micks RH. The Essentials of Materia Medica, Pharmacology and Therapeutics. London: J&A Churchill Ltd, 1954.
9. Beecher HK. The powerful placebo. JAMA 1955; 159: 1602.
10. Anon. Editorial. The humble humbug. Lancet 1954; 264: 321.
11. Kaptchuk T. Powerful placebo: the dark side of the randomised controlled trial. Lancet 1998; 351: 1722-5. (Pubitemid 28254542)
12. Kienle GS, Kiene H. the placebo effect: fact or fiction. J. Clin. Epidemiol. 1997; 50: 1311-18. (Pubitemid 28034984)
13. Hrobjartsson A, Gotzche PC. Is the placebo powerless. N. Engl. J. Med. 2001; 344: 1594-602.
14. Moore DS, McCabe G. Introduction to the Practice of Statistics, 2nd edn. New York, NY: W.H. Freeman and Company, 1993.
15. Utts JM. Seeing Through Statistics. Belmont, CA: Duxbury Press, 1996.
16. Royal Children's Hospital. Annual Report 2004-2005. Melbourne: Royal Children's Hospital, 2005.
17. Higby GJ, Stroud EC. The Inside Story of Medicines: A Symposium. Madison: American Institute for the History of Pharmacy, 1997.
18. Kaptchuk T. Intentional ignorance: a history of blind assessment and placebo controls in medicine. Bull. Hist. Med. 1998; 72: 389-433. (Pubitemid 128461770)
19. Tramer MR, Reynolds DJM, Moore RA, McQuay HJ. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ 1998; 317: 875-80. (Pubitemid 28434561)
20. Collier J. Confusion over use of placebos in clinical trials. BMJ 1995; 311: 821-2.
21. Lucero MG, Nohynek H, Williams G et al. Efficacy of an 11-valent pneumococcal conjugate vaccine against radiologically confirmed pneumonia among children less than 2 years of age in the Philippines: a randomized, double-blind, placebo-controlled trial. Pediatr. Infect. Dis. J. 2009; 28: 455-62.
22. Madhi SA, Kuwanda L, Cutland C, Klugman KP. The impact of a 9-valent pneumococcal conjugate vaccine on the public health burden of pneumonia in HIV-infected and -uninfected children. Clin. Infect. Dis. 2005; 40: 1511-18. (Pubitemid 40628641)
23. Linhares AC, Velazquez FR, Perez-Schael I et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet 2008; 371: 1181-9. (Pubitemid 351458523)
24. Ragi-Eis S, Zerbini CA, Provenza JR et al. Is it ethical to use placebos in osteoporosis trials. J. Clin. Densitom. 2006; 9: 274-80. (Pubitemid 44247796)
25. Watts NB. Is it ethical to use placebos in osteoporosis clinical trials. Curr. Osteoporos. Rep. 2004; 2: 31-6.
26. Crawford F, Harris R, Williams HC. Are placebo-controlled trials of creams for athlete's foot still justified. Br. J. Dermatol. 2008; 159: 773-9.
27. Halpern SD, Doyle R, Kawut SM. The ethics of randomized clinical trials in pulmonary arterial hypertension. Proc. Am. Thorac. Soc. 2008; 5: 631-5. (Pubitemid 352031536)
28. Moseley JB, O'Malley K, Petersen NK. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N. Engl. J. Med. 2002; 347: 81-8. (Pubitemid 34753477)
29. Horng S, Miller FG. Is placebo surgery unethical. N. Engl. J. Med. 2002; 347: 137-9.
30. Clark PA. Placebo surgery for Parkinson's disease: do the benefits outweigh the risks. J. Law Med. Ethics 2002; 30: 58-69.
31. Shaddy RE, Denne SC. Clinical report - guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 2010; 125: 850-60.
32. Food and Drug Administration. The Use of Placebos in Clinical Trials and the Ethics of the Use of Placebos. Rockville, MD: US Department of Health and Human Services, 1999.
33. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N. Engl. J. Med. 1994; 331: 394-8. (Pubitemid 24233862)
34. Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. Lancet 2009; 373: 13-14.
35. Goodyear MD, Lemmens T, Sprumont D, Tangwa G. Does the FDA have the authority to trump the declaration of Helsinki. BMJ 2009; 338: b1559.