When placebo controlled trials are essential and equivalence trials are inadequate

British Medical Journal

Volumn 317, Issue 7162, 1998, Pages 875-880

  Tramèr, Martin R ^a,c   Reynolds, D John M ^b   Moore, R Andrew ^a   McQuay, Henry J ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b RADCLIFFE INFIRMARY   (United Kingdom)

^c GENEVA UNIVERSITY HOSPITALS   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ALIZAPRIDE; DEXAMETHASONE; DROPERIDOL; GRANISETRON; METOCLOPRAMIDE; ONDANSETRON; PERPHENAZINE; PLACEBO; PROCHLORPERAZINE; PROMETHAZINE; SULPIRIDE; TROPISETRON;

AGITATION; ANXIETY NEUROSIS; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; FLUSHING; HEADACHE; HUMAN; MEDICAL ETHICS; META ANALYSIS; NAUSEA; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RESTLESSNESS; STANDARD; URTICARIA; VOMITING;

EID: 0032569383     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.317.7162.875     Document Type: Article

References (59)

1. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl Med 1994;331:394-8.
2. Gilbert EM, Packer EM. Letter to editor. N Engl J Med 1995;332:61.
3. Collier J. Confusion over use of placebos in clinical trials. BMJ 1995;311:821-2.
4. Citron ML. Placebos and principles: a trial of ondansetron. Ann Intern Med 1993;118:470-1.
5. Markman M. When regulatory requirements conflict with ethical study design: the case of oral ondansetron. Cancer Invest 1994;12:654-6.
6. Aspinall RL, Goodman NW. Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials. BMJ 1995;311:844-6.
7. Stone PG, Blogg CE. National research ethics committee is needed. BMJ 1997;315:60-1.
8. Talbot O, Reynolds DJM. Local research ethics committees. BMJ 1997;315:1464.
9. Tramèr MR, Reynolds DJM, Moore RA, McQuay HJ. Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomised placebo-controlled trials. Anesthesiology 1997;87:1277-89.
10. Tramèr MR, Moore RA, Reynolds DJM, McQuay HJ. A quantitative systematic review of ondansetron in treatment of established postoperative nausea and vomiting. BMJ 1997;314:1088-92.
11. Eriksson H, Korttila K. Recovery profile after desflurane with or without ondansetron compared with propofol in patients undergoing outpatient gynecological laparoscopy. Anesth Analg 1996;82:533-8.
12. Alon E, Himmelseher S. Ondansetron in the treatment of postoperative vomiting: a randomized, double-blind comparison with droperidol and metoclopramide. Anesth Analg 1992;75:561-5.
13. Alon E, Biro P, Lenzlinger PM, Atanassoff PG. Ondansetron als Prophylaxe für postoperative Übelkeit und Erbrechen. Eine prospektive, randomisierte Doppelblind-Vergleichsstudie mit Droperidol. Anaesthesist 1994;43:500-3.
14. Calamandrei M, Andreuccetti T, Crescioli M, Messeri A, Sarti A, Sestini G, et al. Effets de l'ondansétron et du métoclopramide sur les nausées et vomisseements postopératoires après anesthésie péridurale chez l'enfant. Cah Anesth 1994;42:19-23.
15. Cantanna R, Morini M, Lopez T, Mariana A. Efficacia di un 5HT3 antagonista nella prevenzione del vomito postoperatorio. Minerva Anestesiol 1994;60(suppl 1):109-11.
16. Cetica P, Di Filippo A, Rizzo L, Benvenuti S, Novelli GP. Prevenzione della nausea e del vomito postoperatorio nella chirurgia strabologica in etá pediatrica. Minerva Anestesiol 1994;60(suppl 1):41-3.
17. Chen PP, Chui PT, Gin T. Comparison of ondansetron and metoclopramide for the prevention of post-operative nausea and vomiting after major gynaecological surgery. Eur J Anaesth 1996;13:485-91.
18. D'Ari M, Caccia A, Lo Sapio D, Verde A, Badolato A, Chiefari M. Ondansetron vs metoclopramide e placebo nella prevenzione della nausea e del vomito postoperatorio. Minerva Anestesiol 1994;60(suppl 1): 85-7.
19. Davis A, Krige S, Moyes D. A double-blind randomized prospective study comparing ondansetron with droperidol in the prevention of emesis following strabismus surgery. Anaesth Intens Care 1995;23:438-43.
20. Davis PJ, McGowan FX Jr, Landsman I, Maloney K, Hoffmann P. Effect of antiemetic therapy on recovery and hospital discharge time. A double-blind assessment of ondansetron, droperidol, and placebo in pediatric patients undergoing ambulatory surgery. Anesthesiology 1995;83:956-60.
21. Desilva PH, Darvish AH, McDonald SM, Cronin MK, Clark K. The efficacy of prophylactic ondansetron, droperidol, perphenazine, and metoclopramide in the prevention of nausea and vomiting after major gynecologic surgery. Anesth Analg 1995;81:139-43.
22. Furst SR, Rodarte A. Prophylactic antiemetic treatment with ondansetron in children undergoing tonsillectomy. Anesthesiology 1994;81:799-803.
23. Gan TJ, Collis R, Hetreed M. Double-blind comparison of ondansetron, droperidol and saline in the prevention of postoperative nausea and vomiting. Br J Anaesth 1994;72:544-7.
24. Giorgi L, Cavuta M, Novelli GP. Ondansetron nella prevenzione della nausea e vomito postoperatorio nella chirurgia dell'orecchio medio. Minerva Anestesiol 1994;60(suppl 1):73-5.
25. Grond S, Lynch J, Diefenbach C, Altrock K, Lehmann KA. Comparison of ondansetron and droperidol in the prevention of nausea and vomiting after inpatient minor gynecologic surgery. Anesth Analg 1995;81:603-7.
26. Litman RS, Wu CL, Lee A, Griswold JD, Voisine R, Marshall C. Prevention of emesis after strabismus repair in children: a prospective, double-blinded, randomized comparison of droperidol versus ondansetron, J Clin Anesth 1995;7:58-62.
27. Lopez-Olaondo L, Carrascosa F, Pueyo FJ, Monedero P, Busto N, Saez A. Combination of ondansetron and dexamethasone in the prophylaxis of postoperative nausea and vomiting. Br J Anaesth 1996;76:835-40.
28. Malins AF, Field JM, Nesling PM, Cooper GM. Nausea and vomiting after gynaecological laparoscopy: comparison of premedication with oral ondansetron, metoclopramide and placebo. Br J Anaesth 1994;72:231-3.
29. Maltepe F, Günerli A, Sagirogiu E, Kuvaki H, Mavioglu O. Çocuklarda postoperatif emezisin profilaksisinde dehidrobenzperidol metklopramid ve ondansetron'un karsilastirilmasi. Türk Anest Rean Cem 1996;24:180-3.
30. Modesti C, Rodola F, Caricato A. La profilassi dell'emesi post-operatoria in ortopedia e traumatologia: valutazione comparative di ondansetron. metoclopramide e prometazina. Acta Anaesth Ital 1995;46:73-8.
31. Naguib M, El Bakry AK, Khoshim MHB, Channa AB, El Gammal M, El Gammal K, et al. Prophylactic antiemetic therapy with ondansetron, tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: A randomized, double-blind comparison with placebo. Can J Anaesth 1996;43:226-31.
32. Paech MJ, Pavy TJG, Evans SF. Single-dose prophylaxis for postoperative nausea and vomiting after major abdominal surgery: ondansetron versus droperidol. Anaesth Intens Care 1995;23:548-54.
33. Paxton LD, McKay AC, Mirakhur RK. Prevention of nausea and vomiting after day case gynaecological laparoscopy. A comparison of ondansetron, droperidol, metoclopramide and placebo. Anaesthesia 1995;50:403-6.
34. Paxton D, Taylor RH, Gallagher TM, Crean PM. Postoperative emesis following otoplasty in children. Anaesthesia 1995;50:1083-5.
35. Pueyo FJ, Carrascosa F, Lopez L, Iribarren MJ, Garcia Pedrajas F, Saez A. Combination of ondansetron and droperidol in the prophylaxis of postoperative nausea and vomiting. Anesth Analg 1996;83:117-22.
36. Raphael JH, Norton AC. Antiemetic efficacy of prophylactic ondansetron in laparoscopic surgery: randomized, double-blind comparison with metoclopramide. Br J Anaest 1993;71:845-8.
37. Roccalagliata DC, Boutseros A, Fuccaro P, Mazzarello MR, Sburlati E. Ondansetron versus metoclopramide nella prevenzione del vomito post-operatorio nelle IVG. Minerva Anestesiol 1994;60(suppl 1):95-8.
38. Rose JB, Martin TM, Corddry DM, Zagnoev M, Kettrick RG. Ondansetron reduces the incidence and severity of poststrabismus vomiting in children. Anesth Analg 1994;79:486-9.
39. Rossi AK, Lamarca S, Scanni E, Corcione A, Grandis V, Mastronardi P. Valutazione comparative dell'ondansetron come antiemetico nella paziente ostetrica. Minerva Anestesiol 1994;60(suppl 1):99-101.
40. Rowe L, de Boer F, Crocker S. Nausea and vomiting following day case gynaecological surgery: a comparison of ondansetron with droperidol as prophylaxis. J One-Day Surg 1995;winter:9-10.
41. Rust M. Intravenöse Gabe von Ondansetron vs Metoclopramid zur Prophylaxe von postoperativer Übelkein und Erbrechen. Anaesthesist 1995;44:288-90.
42. Splinter WM, Rhine EJ, Roberts DW, Baxter MRN, Gould HM, Hall LE, et al. Ondansetron is a better prophylactic antiemetic than droperidol for tonsillectomy in children. Can J Anaesth 1995;42:848-51.
43. Tang J, Watcha MF, White PF. A comparison of costs and efficacy of ondansetron and droperidol as prophylactic antiemetic therapy for elective outpatient gynecologic procedures. Anesth Analg 1996;83:304-13.
44. Van den Berg AA. Comparison of ondansetron and prochlorperazine for the prevention of nausea and vomiting after adenotonsillectomy. Br J Anaesth 1996;76:449-51.
45. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials; is blinding necessary? Control Clin Trials 1996;17:1-12.
46. Eddy DM. Principles for making difficult decisions in difficult times. JAMA 1994;271:1792-8.
47. McQuay HJ, Tramèr M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain 1996;68:217-27.
48. Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ 1995;311:551-3.
49. Moore RA, Gavaghan D, Tramèr MR, Collins S, McQuay HJ. Size is everything - large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain (in press).
50. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996;313:36-9.
51. Rothman KJ. Placebo mania. BMJ 1996;313:3-4.
52. Lewis MA, Fishman DA. Ondansetron for postoperative nausea and vomiting: decisions in the absence of comparative trials. Am J Hosp Pharm 1994;51:524-5.
53. Tramèr M, Moore A, McQuay H. Meta-analytic comparison of prophylactic antiemetic efficacy for postoperative nausea and vomiting: propofol anaesthesia vs omitting nitrous oxide vs a total i.v. anaesthesia with propofol. Br J Anaesth 1997;78:256-259.
54. Kalso E, Tramèr MR, Carroll D, McQuay HJ, Moore RA. Pain relief from intra-articular morphine after knee surgery: a qualitative systematic review. Pain 1997;71:127-34.
55. McQuay H, Moore A. Placebos are essential when extent and variability of placebo response are unknown. BMJ 1996;313:1008.
56. Taubes G. Use of placebo controls in clinical trials disputed. Science 1995;267:25-6.
57. Savulescu J, Chalmers I, Blunt J. Are research ethics commitees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996;31:1390-3.
58. Korttila K. The study of postoperative nausea and vomiting. Br J Anaesth 1992;69(suppl 1):20-38.
59. Bremner WGM, Kumar CM. Delayed surgical emphysema, pneumomediastimum and bilateral pneumothoraces after postoperative vomiting. Br J Anaest 1993;71:296-7. (Accepted 9 June 1998)