REVIEW article
Front. Pharmacol.
Sec. Translational Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1659531
Efficacy and safety of pregabalin in the management of low back pain: a comprehensive meta-analysis
Provisionally accepted- 1Hospital Juan Ramón Jiménez, Huelva, Spain
- 2Hospital Universitari Vall d'Hebron, Barcelona, Spain
- 3Hospital Clinic de Barcelona, Barcelona, Spain
- 4Consorci Hospital General Universitari de Valencia, Valencia, Spain
- 5Instituto de Investigacion Sanitaria Aragon, Zaragoza, Spain
- 6Hospiten Rambla, Santa Cruz de Tenerife, Spain
- 7Viatris, Madrid, Spain
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Introduction: Low back pain (LBP) is one of the most prevalent chronic pain conditions that affects nearly 50% of the population. Its complex pathophysiology may involve both nociceptive and neuropathic mechanisms and is often resistant to standard treatment. Pregabalin has emerged as a potential alternative owing to its mechanism of action, the inhibition of excitatory neurotransmitter release. This meta-analysis aimed to evaluate the efficacy and safety of pregabalin in managing LBP. Methods: A systematic review of three major databases was conducted following the PRISMA guidelines. Studies were included if they were comparative studies of pregabalin with placebo or other pain medications, focusing on adult patients with LBP. Data were extracted on efficacy outcomes including pain reduction, anxiety, depression, quality of life, quality of sleep, disability, and adverse events. Statistical analysis was performed using Review Manager 5.4.1. Results: A total of 18 studies (n = 5000) were included. Pregabalin demonstrated significant pain reduction at 4 weeks (Standardized Mean Difference (SMD) = -0.64, 95% Confidence Interval (CI) = -1.09 to -0.20), 6 weeks (SMD = -0.72, 95% CI = -1.15 to -0.29), and 8 weeks (SMD = -0.50 , 95% CI = -0.71 to -0.29) compared to control group. Pregabalin also showed a significant greater improvement in anxiety (Mean Difference (MD) = -1.38, 95% CI = -1.74 to -1.02, p < 0.00001), depression (MD = -1.40 , 95% CI = -1.71 to -1.08, p < 0.00001), quality of life (SMD = 0.22 , 95% CI = 0.07 to 0.37, p = 0.003) and sleep quality (SMD = -0.61 , 95% CI = -0.87 to -0.36, p < 0.00001). There were no significant differences regarding disability and adverse events. Conclusions: Pregabalin in the treatment of neuropathic LBP demonstrated significant improvements in pain relief, associated symptoms of anxiety and depression, and enhancements in quality of life and sleep quality. In addition, it exhibits a favorable safety profile. Nevertheless, these findings should be interpreted with caution due to the limited quality of the evidence and the inadequate reporting of pain etiology in several included studies.
Keywords: Low Back Pain, Radiculopathy, Sciatica, neuropathic pain, Meta-analysis
Received: 04 Jul 2025; Accepted: 15 Aug 2025.
Copyright: © 2025 Cordero, Sanchez-Raya, Rodriguez, Lopez Alarcon, Trillo, Jeronimo and Perez-Paramo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Carlos Cordero, Hospital Juan Ramón Jiménez, Huelva, Spain
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