NORTRIPTYLINE-FLUPHENAZINE VS CARBAMAZEPINE IN THE SYMPTOMATIC TREATMENT OF DIABETIC NEUROPATHY

We compared the efficacy and tolerance of the combination of nortripty line-fluphenazine (NF) vs. carbamazepine (CMZ) in the symptomatic ther apy of patients with severe, distal, symmetrical, predominantly sensit ive diabetic polyneuropathy (DPN). We followed a double blind, crossov er, randomized and double placebo design. Sixteen patients with severe DPN participated in the study. Patients received either NF (1 tablet three times a day(tid)), for 2 weeks and 2 tablets tid for the next 2 weeks or CMZ 1/2 tablet tid for 2 weeks and 1 tablet tid for the next 2 weeks. After this, patients received placebos of both drugs (wash-ou t period), until symptoms returned to baseline levels (100%), then the y were crossed over to receive the other comparing drug schedule. A vi sual analogue scale was used to evaluate the percent changes in pain a nd paresthesia. HbA1, fasting serum glucose, and safety tests were per formed at 2- and 4-week intervals, respectively. Both therapies produc ed significant improvement of both pain and paresthesia. No statistica lly significant differences were observed between both therapies for e ither pain or paresthesia. No significant biochemical changes were obs erved with any of the two therapies. Side effects were mild and more f requent in the NF period. In this study no superiority of either drug schedule was demonstrated; therefore, the decision to use any of them should be made according to the associated pathology and potential sid e effects of each drug.