The aim of this study is To analyze the efficacy and safety of duloxetine and gabapentin in painful diabetic neuropathy (PDN).

A randomized, open-label, active control, 12-week trial was conducted. A total of 86 participants were randomized in 1:1 ratio into gabapentin 300 mg and duloxetine 60 mg groups. The primary efficacy objective was comparison of mean change in Visual Analogue Scale (VAS) (0-100 points) scores between duloxetine and gabapentin. The symptom scores and adverse events were assessed as secondary outcomes. Statistically significant (P value<.001) improvement was observed in VAS scores in both duloxetine group and gabapentin group at 12 weeks as compared to baseline. However, no significant difference in VAS scores between duloxetine and gabapentin. Similar improvement in diabetic neuropathy symptoms (DNS), diabetic neuropathy examination (DNE), and neuropathic disability score (NDS) was observed in either group over 12 weeks. There were no significant differences in DNS (P = 0.578), DNE (P = 0.410), and NDS (P = 0.071) scores between the two treatment groups. The overall safety evaluation of both duloxetine and gabapentin were similar.

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