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Efficacy and Safety of Pregabalin and Duloxetine in Painful Diabetic Neuropathy: A Systematic Review and Meta-Analysis.

Ahmed Mansour,Ahmed Mostafa Amin,Ahmed Farid Gadelmawla,Ahmed Elbataa,Anas Mansour,M. Elnady,Muhammad Ashraf Husain,O. A. Saad,Amr Elshahat,Abdallah Abbas,Ahmed Elshahat,Y. Mahmoud,Sohaila Mansour Abdelsatar,Mohamed Yasser Elnaggar,Ayman E Fayk,Abdullah Farahat Elbanna,A. Abd-Elsayed

Published 2025 in Pain medicine (Malden, Mass.)

ABSTRACT

BACKGROUND AND OBJECTIVE Pregabalin (PGB) and duloxetine (DLX) are commonly used first-line medications in the clinical management of painful diabetic neuropathy (PDN), yet high-quality comparative evidence is limited. This meta-analysis evaluates the comparative efficacy and safety of PGB versus DLX, focusing on efficacy outcomes such as pain reduction and mental health, and safety outcomes including adverse events in PDN patients. METHOD We searched electronic databases for relevant studies assessing the efficacy and safety of PGB and DLX in PDN. The primary outcomes were the mean change of the visual analog scale (VAS) and the improvement ratio for patients achieving ≥ 50% pain reduction. Secondary outcomes, including the numeric rating scale (NRS) for pain, the short form 12 health survey (SF-12), and related adverse events. A random-effects meta-analysis was performed to evaluate these outcomes. RESULTS We analyzed 19 studies involving 4,483 patients. PGB significantly reduced VAS scores at 24 weeks (MD = -0.38; 95% CI [-0.45, -0.31], P < 0.0001) and decreased the mental component of SF-12 compared to DLX (MD = -3.36; 95% CI [-6.64, -0.07], P = 0.05) and lower rates of achieving >50% pain reduction (RR = 0.88; 95% CI [0.79, 0.98], P = 0.03). Regarding safety, PGB showed a lower incidence of several adverse events, including anorexia, decreased appetite, diarrhea, nausea, and vomiting. However, no significant differences in VAS scores were observed between PGB and DLX at 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks, with similar results observed in NRS. CONCLUSION We found that PGB and DLX showed similar efficacy in relieving PDN. Ultimately, the two drugs' similar effectiveness and different safety profiles highlight the importance of considering patient-specific factors when choosing the appropriate treatment.

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