Objective  To systematically review the efficacy and safety of pregabalin in the treatment of sciatica.

Methods  PubMed, Embase, Cochrane Library, Web of Science, Medline, CNKI, VIP, WanFang Data and SinoMed databases were electronically searched to collect randomized controlled trials (RCTs) on the treatment of sciatica with pregabalin from inception to April 1, 2025. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software.

Results  A total of 9 RCTs were included, involving 989 patients. The Meta-analysis results showed that there was a statistically significant difference in pain scores between the pregabalin group and the control group [SMD=-0.44, 95%CI (-0.88, -0.01), P=0.05]. Subgroup analysis revealed a significantly lower visual analogue score (VAS) score in the pregabalin group [SMD=-0.73, 95%CI (-1.04, -0.42), P<0.05]. In contrast, no statistically significant differences were observed in numerical rating scale (NRS) scores between the two groups [SMD=0.25, 95%CI (-0.02, 0.52), P=0.08]. The analgesic effect of pregabalin was comparable to that of placebo [SMD=0.25, 95%CI (-0.02, 0.52), P=0.08], but exhibited superior pain relief compared to carbamazepine [SMD=-0.85, 95%CI (-1.07, -0.62), P<0.05]. Subgroup analysis stratified by starting dose and sample size showed no statistically significant differences in pain scores between the two groups after treatment (P>0.05). The total effective rate of the pregabalin group was significantly higher than that of the control group [OR=3.86, 95%CI (1.47, 10.11), P<0.05]. There were no significant differences between the pregabalin group and the control group in terms of improvement in Oswestry Disability Index (ODI) scores, significant improvement rate on the Patient Global Impression of Change (PGIC) scale, and risk of adverse drug events (P>0.05). However, compared with the control group, the incidence of dizziness [RR=2.59, 95%CI (1.65, 4.07), P<0.05], headache, nausea, and vomiting [RR=1.99, 95%CI (1.08, 3.65), P=0.03] were significantly increased in the pregabalin group. Descriptive analysis results indicated that there were no statistically significant differences in quality of life improvement between the pregabalin group and the placebo or limaprost group (P>0.05).

Conclusion  Current evidence indicates that for patients with sciatica, pregabalin lacks sufficient effectiveness in reducing pain intensity and ODI scores, as well as in improving PGIC scores and quality of life, and is associated with a significant risk of nervous system and gastrointestinal adverse drug events. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.

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