Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy. A randomized, double-blind trial.

OBJECTIVE To evaluate the efficacy and safety of carbamazepine, pregabalin, and venlafaxine in patients with painful diabetic neuropathy (PDN). METHODS Our study was performed as a randomized, double-blind, parallel-group clinical trial between December 2012 and December 2013 at Kermanshah University of Medical Sciences, Kermanshah, Iran. Two hundred and fifty-seven patients with clinically definite PDN were randomized to receive, carbamazepine, venlafaxine, or pregabalin. The primary outcome was subjective pain as assessed by the visual analogue scale (VAS). Secondary outcomes consisted of sleep, mood, and work interference assessments, and a percentage of patients achieving at least 50% reduction in pain intensity. RESULTS Means of VAS scores for carbamazepine, pregabalin, and venlafaxine treatment groups at the baseline (74.5, 82.3, and 74.5) and endpoint (39.6, 33.4, and 46.6) revealed significant reduction, although pregabalin was more efficacious than carbamazepine, and venlafaxine. Improvements in means scores of sleep, mood, and work interferences were identified in all treatment groups. CONCLUSION This study showed the efficacy of venlafaxine, pregabalin, and carbamazepine in pain reduction in patients with diabetic neuropathy, although pregabalin was shown to be superior to carbamazepine, and venlafaxine in relieving pain, no significant superiority was shown between carbamazepine, and venlafaxine.