Background: Several different interventions have been examined to alleviate pain and reduce frequency of trigeminal neuralgia (TN) paroxysms. However, some patients continue to have persistent or recurrent painful attacks. Using a systematic review and meta-analysis approach, we aimed to synthesize evidence from published randomized controlled trials (RCTs) regarding safety and efficacy of botulinum toxin type A (BTX-A) as a possible emerging choice of treatment for TN.
Methods: We conducted an electronic search in 10 databases/electronic search engines to access relevant publications. All articles in all languages reporting RCTs on the efficacy and safety of BTX-A in the treatment of TN were included for systematic review and meta-analysis.
Results: A total of four RCTs (n = 178) were identified for final meta-analysis. The overall effect favored BTX-A versus placebo in terms of proportion of responders (risk ratio RR = 2.87, 95 % confidence interval CI [1.76, 4.69], p <0.0001) with no significant detected heterogeneity (p = 0.31; I(2) = 4 %). Paroxysms frequency per day was significantly lower for BTX-A group (mean difference MD = -29.79, 95 % CI [-38.50,-21.08], p <0.00001) with no significant heterogeneity (p = 0.21; I(2) = 36 %).
Conclusion: Despite limited data, our results suggest that BTX-A may be an effective and safe treatment option for patients with TN. Further larger and well-designed RCTs are encouraged to translate these findings into better clinical outcome and better quality of life for TN patients.
Keywords: BTX-A; Botulinum; Clinical trials; Meta-analysis; Systematic review; Trigeminal neuralgia.