Randomized controlled trials remain fundamental to clinical decision making in Type II diabetes mellitus: A comment to the debate on randomized controlled trials

Diabetologia

Volumn 43, Issue 2, 2000, Pages 254-258

  Richter, B ^a   Berger, M ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; CHLORPROPAMIDE; GLIBENCLAMIDE; SULFONYLUREA DERIVATIVE; TOLBUTAMIDE;

CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DRUG EFFICACY; DRUG SAFETY; HUMAN; HYPOTHESIS; INSULIN DEPENDENT DIABETES MELLITUS; MEDICAL DECISION MAKING; META ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; TREATMENT OUTCOME; TREATMENT PLANNING;

EID: 0033994539     PISSN: 0012186X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s001250050039     Document Type: Review

References (48)

1. 1. Bull JP (1959) The historical development of clinical therapeutic trials. J Chron Dis 10: 218-248
2. 2. Bradford Hill A (1952) The clinical trial. New Engl J Med 247: 113-119
3. 3. Cochrane Database of systematic reviews. Http://www.update-software.com/ccweb/cochrane/cdsr.htm
4. 4. Fullerton-Smith I (1995) How members of the Cochrane Collaboration prepare and maintain systematic reviews of the effects of health care. Evidence-Based medicine 1: 7-8
5. 5. Sackett DL, Richardson WS, Rosenberg W, Haynes RB (1997) Evidence-based Medicine. How to practice and teach EBM. Churchill Livingston Inc., New York, NY, USA
6. 6. Škrabanek P, McCormick J (1992) Follies and Fallacies in Medicine, 2nd edn. Tarragon Press, Glasgow
7. 7. Committee of Principal Investigators (1984) WHO cooperative trial on primary prevention of ischaemic heart disease with clofibrate to lower serum cholesterol: final mortality follow-up. Lancet II: 600-604
8. 8. Riggs BL, Hidgson SF, O'Fallon WM et al. (1990) Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis. New Engl J Med 322: 802-809
9. 9. Onmen GS (1998) Chemoprevention of lung cancer: the rise and demise of beta-carotene. Ann Rev Public Health 19: 73-99
10. 10. Epstein AE, Hallstrom AP, Rogers WJ (1993) Mortality following ventricular arrhythmia suppression with encainide, flecainide, and moricizine after myocardial infarction. The original design concept of the cardiac arrhythmia suppression trial. JAMA 270: 2451-2455
11. 11. Kunz R, Oxman AD (1998) The unpredictability paradox: review of empirical comparisons of randomized and non-randomized clinical trials. BMJ 317: 1185-1190
12. 12. Berger M (1996) To bridge science and patient care in diabetes. Diabetologia 39: 749-757
13. 13. The University Group Diabetes Program (1982) Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes, VIII. Diabetes 31 [Suppl 5]: S1-S81
14. 14. UK Prospective Diabetes Study (UKPDS) Group (1998) Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type 2 diabetes (UKPDS 33). Lancet 352: 837-853
15. 15. Pirart J (1977) Diabetes mellitus and its degenerative complications: a prospective study of 4400 patients observed between 1947 and 1973. Diabetes Care 1: 168-188, 252-261
16. 16. The Diabetes Control and Complications Trial (1993) The effects of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New Engl J Med 329: 977-986
17. 17. Colwell JA, Clark CM (1996) Unanswered research questions about metabolic control in non-insulin-dependent diabetes mellitus. Ann Int Med 124: 178-179
18. 18. UK Prospective Diabetes Study (UKPDS) Group (1998) Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 317: 703-713
19. 19. University Group Diabetes Program (1970) A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes mellitus, II. Mortality results. Diabetes 10 [Suppl 2]: S785-S830
20. 20. American Diabetes Association (1998) Standards of medical care for patients with diabetes mellitus. Diabetes Care 21 [Suppl 1] S23-S31
21. 21. Bretzel RG, Voigt Kh, Schatz H (1998) The United Kingdom Prospective Diabetes Study (UKPDS). Implications for the pharmacotherapy of Type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes 106: 369-372
22. 22. Home PD, Alberti KGMM for the European NIDDM Policy Group (1999) A desktop guide to Type 2 non-insulin-dependent) diabetes mellitus. Diabet Med 16: 716-750
23. 23. Furberg CD, Herrington DM, Psaty BM (1999) Are drugs within a class interchangeable? Lancet 354: 1202-1204
24. 24. UK Prospective Diabetes Study (UKPDS) Group (1991) Study design, progress and performance (UKPDS VIII). Diabetologia 34: 877-890
25. 25. Leibowitz G, Cerasi E (1996) Sulfonylurea treatment of NIDDM patients with cardiovascular disease: a mixed blessing. Diabetologia 39: 503-514
26. + channel blocker. Circulation 90: 700-705
27. 27. Klepzig H, Kobert G, Matter C, Luus H et al. (1999) Sulfonylureas and ischaemic preconditioning. Eur Heart J 20: 839-846
28. 28. Malmberg K for the DIGAMI Study Group (1997) Prospective randomized study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. BMJ 314: 1512-1515
29. 29. Ewart RM (1999) The UKPDS: what was the question? Lancet 353: 1882
30. 30. Cornu C, Cano A, Pornel B Mellis GB, Boissel JP on behalf of the EUTERP Pilot Study Group (1999) Could institutional clinical trials exist in Europe? Lancet 353: 63-64
31. 31. Hulley S, Grady D, Bush T et al. (1998) Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 280: 605-613
32. 32. Vijan S, Kent DM, Hayward RA (1999) Are randomized controlled trials sufficient evidence to guide clinical practice in Type II diabetes mellitus? Diabetologia (in press)
33. 33. Pahor M, Psaty BM, Furberg CD (1998) Treatment of hypertensive patients with diabetes. Lancet 351: 689-690
34. 34. Sawicki PT, Berger M (1999) Prognosis and treatment of cardiovascular disease in diabetes mellitus. J Clin Basic Cardiol 2: 22-33
35. 35. WHO/IDF Europe (1990) Diabetes care and research in Europe: The St. Vincent Declaration. Diabet Med 7: 360
36. 36. Allison J, Kiefe CJ, Weissmann NW (1999) Can data-driven benchmarks be used to set the goals of healthy people 2010? Am J Publ Health 89: 61-65
37. 37. Müller UA, Femerling M, Reinauer KM et al. for the ASD Working Group (1999) Intensified treatment and education of type 1 diabetes as clinical routine. A nationwide quality circle experience in Germany. Diabetes Care 22 [Suppl 2]: 829-834
38. 38. Vijan S, Hofer TP, Hayward RA (1997) Estimated benefits of glycemic control in microvascular complications in Type 2 diabetes. Ann Intern Med 127: 788-795
39. 39. Eastman RC, Javitt JC, Herman WH et al. (1997) Model of complications of NIDDM. II. Analysis of health benefits and cost-effectiveness of treating NIDDM with the goal of normoglycemia. Diabetes Care 20: 735-744
40. 40. American Diabetes Association (1998) Implications of the United Kingdom Prospective Diabetes Study. Position Statement. Diabetes Care 21: 2180-2184
41. 41. The Diabetes Control and Complications Trial Research Group (1995) The relationship of glycemic exposure (HbAIc) to the risk of development and progression of retinopathy in the Diabetes Control and Complications Trial. Diabetes 44: 968-983
42. 42. Bernard C (1984) Introduction a l'étude de la médicine expérimentale. Flammarion, Paris
43. 43. Berger M, Mühlhauser I (1999) Diabetes care and patient-oriented outcomes. JAMA 281: 1676-1678
44. 44. Hayward RA, Manning WG, Kaplan SH et al. (1997) Starting insulin therapy in patients with type 2 diabetes: effectiveness, complications, and resource utilization. J Am Med Ass 278: 1663-1669
45. 45. Berger M, Jörgens V, Mühlhauser I (1999) Rationale for the use of insulin therapy alone as the pharmacological treatment of Type 2 diabetes. Diabetes Care 22 [Suppl 3]: C71-75
46. 46. Müller UA, Müller R, Hunger-Dathe W et al. (1998) Should insulin therapy be started on an out-or inpatient basis? Diabet Metab 24: 251-255
47. 47. Sniderman AD (1999) Clinical trials, consensus conferences, and clinical practice. Lancet 354: 327-330
48. 48. Psaty BM, Weiss NS, Furberg CD et al. (1999) Surrogate end points, health outcomes, and the drug approval process for the treatment of risk factors for cardio-vascular disease. JAMA 282: 786-790