Introduction: Our trial (ClinicalTrials.gov Identifier: NCT04246619) evaluates the efficacy of two generic medications, pregabalin and duloxetine, for treating pain in PDPN patients.
Methods: The patients were randomised either into the pregabalin (99) or the duloxetine (102) arm. Pain was evaluated using the DN-4 questionnaire, and visual analogue scales (VASs, 0-100 mm) were used to measure the average pain intensity (API), worst pain intensity (WPI) in the last 24 h and current pain intensity (CPI).
Results: The proportion of patients with a clinically significant improvement in the API at Week 12 was 88.3% [CI 81.7%, 94.8%] in the pregabalin arm and 86.9% [CI 76.7%, 97.1%] in the duloxetine arm. After 12 weeks, the CPI, API, and WPI decreased by -35.3 [-40.5, -30.0], -37.0 [-41.4, -32.6], and -41.6 [-46.6, -36.5] in the pregabalin arm, and by -35.0 [-39.2, -30.7], -36.9 [-41.5, -32.3], and -40.0 [-44.8, -35.2] in the duloxetine arm (all in mm, all p < 0.001).
Conclusion: Our results demonstrate that pregabalin and duloxetine are effective medications for treating pain in PDPN in more than 86% of all randomised patients.
Keywords: diabetic polyneuropathy; duloxetine; neuropathic pain; pregabalin; randomised clinical trial.