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The case against aggressive treatment of type 2 diabetes: critique of the UK prospective diabetes study

R M Ewart (rewart@siumed.edu), associate professor

Department of Family and Community Medicine, Southern Illinois University School of Medicine, Springfield, Illinois, USA
^a Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford OX2 6HE
^b Oxford Centre for Diabetes, Endocrinology and Metabolism
^c St Bartholomew's and Royal London School of Medicine, London EC1M 6BQ

Correspondence to: Southern Illinois University Center for Family Medicine, 520 North 4th Street, Springfield, IL 62702-5238, USA

Accepted 12 March 2001

Summary points

During the course of the UK prospective diabetes study the length of follow up was changed, and changes seem to have been made to the end points and the groups under analysis

These changes are not in keeping with accepted scientific principles and make the results of the trial suspect

An independent review of the trial's design and analysis is needed

The results of the study do not justify aggressive treatment of type 2 diabetes

Methods

I searched Medline (Ovid's CD version) from 1976 to March 2000, using various combinations of the keywords “UKPDS” and “prospective diabetes study” and the names of the principal authors of the study's reports. I reviewed the resulting articles for any description of the design of the UKPDS. I reviewed reference lists for other references.

Changes in the end points

The authors have presented various end points over the life of the study (box). The UKPDS grew originally out of the authors' interest in the use of basal rather than postprandial glucose in monitoring diabetes. They concluded, “A prospective controlled trial of different ways of obtaining basal normoglycaemia is needed to determine whether the improved control of mild diabetes is beneficial.”3 In the first report of the study, published in 1983, the authors set out their rationale: “If, after dietary therapy, the fasting plasma glucose continues to be raised, there is little information available to determine whether one should continue with diet alone, or add a sulphonylurea, biguanide or insulin.”4 Specific end points were not laid out in this original description but were set out the following year in a letter discussing the paper. 4 5 The authors later argued (1999) that this “brief letter” had only “minor differences in wording.”6 It seems, however, that the letter was written specifically to clarify the vagueness and ambiguities of the …

Correspondence to: R Holman