Efficacy and safety of pregabalin in the management of low back pain: a comprehensive meta-analysis

Other authors

Institut Català de la Salut

[Cordero-García C] Department of Physical Medicine and Rehabilitation, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain. [Sánchez-Raya J] Servei de Medicina Física i Rehabilitació, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Rodríguez-Araya TL] Rheumatology Service, Hospital Clinic, Barcelona, Spain. [López-Alarcón MD] Pain Unit, General University Hospital of Valencia, Valencia, Spain. [Trillo-Calvo E] Primary Care, Aragon Institute for Health Research (IIS Aragón), Primary Care Center Campo de Belchite, Zaragoza, Spain. [Balsalobre-Aznar J] Rheumatology Service, Hospiten, Santa Cruz de Tenerife, Spain

Vall d'Hebron Barcelona Hospital Campus

Publication date

2025-12-19T09:14:13Z

2025-12-19T09:14:13Z

2025-09-08



Abstract

Low back pain; Neuropathic pain; Radiculopathy


Dolor lumbar; Dolor neuropàtic; Radiculopatia


Dolor lumbar; Dolor neuropático; Radiculopatía


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 = 5,000) 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. Conclusion: 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.


This study was financially supported by Viatris, which funded the statistical analysis and the medical writing services.

Document Type

Article


Published version

Language

English

Publisher

Frontiers Media

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https://doi.org/10.3389/fphar.2025.1659531

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Rights

Attribution 4.0 International

http://creativecommons.org/licenses/by/4.0/

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