Clinical trials: Specific problems associated with the use of a placebo control group

British Journal of Clinical Pharmacology

Volumn 43, Issue 3, 1997, Pages 219-221

  Cleophas, T J M ^a,c   Meulen, J V D ^a   Kalmansohn, R B ^b  

^a Merwede Ziekenhuis   (Netherlands)

^b UCLA MEDICAL CENTER   (United States)

^c NONE   (Netherlands)

Author keywords

clinical trials; control group; placebo

Indexed keywords

CLINICAL TRIAL; DRUG DEVELOPMENT; ETHICS; HUMAN; METHODOLOGY; MORBIDITY; MORTALITY; PRIORITY JOURNAL; SHORT SURVEY;

EID: 0031044759     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2125.1997.00562.x     Document Type: Short Survey

References (34)

1. Turner JA, Deyo RA, Lieser JD, et al. The importance of placebo effects in pain treatment and research. JAMA 1994; 271: 1609-1614.
2. Kleijnen J, de Craen AJM, van Everdingen J, et al. Placebos in medicine. Placebo effect in double-blind clinical trials: a review of interactions with medications. Lancet 1994; 344: 1347-1349.
3. Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ 1995; 311: 551-553.
4. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994; 331: 394-398.
5. The SOLVD investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991; 325: 293-302.
6. The SOLVD investigators. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fraction. N Engl J Med 1992; 327: 685-691.
7. Pfeffer MA, Braunwald E, Moyé L, et al. on behalf of the SAVE investigators. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the Survival and Ventricular Enlargement Trial. N Engl J Med 1992; 327: 669-677.
8. The multicenter Diltiazem Post Infarction Trial Research Group. The effect of diltiazem on mortality and reinfarction after myocardial infarction. N Engl J Med 1988; 319: 385-392.
9. Lau J, Antman EM, Jimenez-Silva J, et al. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med 1992; 327: 248-254.
10. Pfeffer MA. Angiotensin converting enzyme inhibition therapy following myocardial infarction: rationale for clinical trials. Herz 1991; 16: 278-282.
11. ISIS-4 Collaborative Group. Fourth International Study of Infarct Survival: protocol for a large simple study of the effects of oral mononitrate, of oral captopril, and of intravenous magnesium. Am J Cardiol 1991; 68: 87-100.
12. Doolittle RF. Biomedical research - the enormous costs of success. N Engl J Med 1991; 324: 1360-1362.
13. Kant I. Kritik der Urteilskraft. Janecke. Leipzig, 1920.
14. World Medical Association: Declaration of Helsinki 1964, after revision adopted by the 41th World Medical Assembly, Hong Kong 1989.
15. The cardiac Suppression Trial II (CAST II) Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med 1992; 327: 227-233.
16. Echt DS, Liebson PB, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324: 781-788.
17. Greene HL, Roden DM, Katz RJ, et al. The Cardiac Arrhythmia Suppression Trial: first CAST ... then CAST II. J Am Coll Cardiol 1992; 19: 804-898.
18. Yusuf S, Wittes J, Friedman L, et al. Overview of randomized trials in heart disease. Treatments following myocardial infarction. JAMA 1988; 260: 2088-2093.
19. Antman EM, Lau J, Kupelnick B, et al. A comparison of results of meta-analyses of randomized controlled trials and recommendations of clinical experts: treatments for myocardial infarction. JAMA 1992; 268: 240-248.
20. Cohn JN, Archibald DG, Ziesche S, et al. Effect of vasodilator therapy on mortality in chronic congestive heart failure: results of a Veterans/Administration Cooperative Study. N Engl J Med 1986; 314: 547-552.
21. Brewin CR, Bradley C. Patients' preferences and randomised clinical trials. BMJ 1989; 299: 313-315.
22. Silverman WA, Altman DG. Patients' preferences and randomised trials. Lancet 1996; 347: 171-174.
23. Biros MH, Lewis RJ, Olson CM, et al. Informed consent in emergency research. JAMA 1995; 273: 1283-1287.
24. Clayton EW, Steinberg KK, Khoury MJ, et al. Informed consent for genetic research. JAMA 1995; 274: 1786-1792.
25. Silverman A, Altman DG. Patients' preferences and randomised trials. Lancet 1996; 347: 171-174.
26. Yusuf S, Pepine CJ, Garces C, et al. Effect of enalapril on myocardial infarction and unstable angina pectoris in patients with low ejection fractions. Lancet 1992; 340: 1173-1178.
27. Cleophas TJM. The use of a placebo-control group in clinical trials. J Mol Med 1995; 73: 421-424.
28. Cleophas TJM. Clinical trials: design flaws associated with the use of a placebo. Am J Ther 1995; 3: 591-596.
29. Campbell JP, Maxey VA, Watson WA. Hawthorne effect: implications for prehospital research. Ann Emergency Med 1995; 26: 590-594.
30. Adedeji OA. Informed consent in clinical trials. Br Med J 1993; 307: 1494-1497.
31. Waldrom HA, Cookson RF. Avoiding the pitfalls of sponsored multicentre research in general practice. Br Med J 1993; 307: 1331-1334.
32. Ernst E, Cleophas TJM, Turner JA, et al. The importance of placebo effects. JAMA 1995; 273: 283-284.
33. Psaty BM, Heckbert SR, Koepsell TD, et al. The risk of myocardial infarction associated with antihypertensive drug therapies. JAMA 1995; 274: 620-625.
34. Furberg CD, Psaty BM, Meyer JV, et al. Nifedipme. Dose-related increase in mortality in patients with coronary heart disease. Circulation 1995; 92: 1326-1331.