QUALITY ASSESSMENT OF RANDOMIZED CLINICAL-TRIALS ON MEDICAL-TREATMENTOF DIABETIC NEUROPATHY

The aim of this study was to critically assess the Literature concerne d with medical treatment for the prevention bf the deterioration of ne rve function in diabetic patients. The analysis of 38 randomised clini cal trials (RCTs) has shown that most of the studies suffer from serio us methodological drawbacks; the methods of randomisation were unspeci fied in 95% of the RCTs, in one-third of the studies more than 15% of the patients were excluded from the analysis; 95% of the studies faile d to provide evidence of having estimated the sample size needed to de tect a pre-specified treatment difference. In addition to presenting a n unsatisfactory picture regarding methodological quality, the results of the examined trials are seriously limited by their dubious clinica l relevance: only 2 trials (5%) observed a clinically relevant outcome . Furthermore, the short length of follow-up does not allow the detect ion of important changes in the main outcomes investigated.