DIABETIC POLYNEUROPATHY IN CONTROLLED CLINICAL-TRIALS - CONSENSUS REPORT OF THE PERIPHERAL-NERVE SOCIETY

For prospective, double-blind, controlled clinical trials comparing a test versus a placebo medication, there is a need to establish a meani ngful level of prevention, stabilization, or improvement of diabetic p olyneuropathy that indicates efficacy [1, 2]. The difference between t est and placebo effects must be statistically significant and of suffi cient magnitude to be considered clinically useful. Neuropathic sympto ms and deficits and abnormalities of nerve conduction (NC), quantitati ve sensory testing (QST), and quantitative autonomic examination (QAE) are useful in characterizing and quantitating diabetic polyneuropathy . Results of one evaluation tend to be significantly associated wish t he results of another evaluation [3, 4]. Consensus panels recommended that standard evaluation of symptoms, neurological examination, NC, QS T, and QAE be used to characterize and quantitate diabetic neuropathy [5, 6]. Morphometric assessment of the number and size of nerve fibers , frequency of pathological abnormalities of teased fibers, and freque ncy of regenerating sprouts assessed in sural nerve from one side befo re the trial and from the sural nerve of the other side after the tria l have also been used [7, 8]. Other approaches that could be considere d ate the kind and severity of complications or outcomes attributable to polyneuropathy [9].