Abstract

Pain management in patients with TN is challenging, as facial pain often does not respond well to conventional therapies. Botulinum toxin type A (BTX-A) has been suggested as a potential treatment option, but there is limited evidence regarding its long-term efficacy. This review aimed to analyze the current data for the use of in the treatment of trigeminal neuralgia (TN) and highlight the evidence for its efficacy and safety. A comprehensive search was conducted in various databases (PubMed, Scopus, Embase, ClinicalTrials, and Cochrane Library) to identify clinical studies evaluating the use of BTX-A in TN until October 2023. Randomized controlled trials (RCTs), single-arm studies, and stratified studies were included in the analysis. The mean difference (MD), effect size (ES), and 95% confidence interval (CI) were estimated for visual analogue scale (VAS) scores, pain episode frequency, and the proportion of responders. The analysis included 23 studies, including 4 RCTs, 14 single-arm studies, and 5 stratified studies. In the RCTs, BTX-A was found to significantly reduce mean VAS scores compared with baseline (ES: -4.05; 95% CI: -6.13, -1.97; P =0.002). In 19 non-RCTs, the pooled single-arm analysis revealed that BTX-A decreased VAS scores (ES: -5.19, 95% CI: -6.05, -4.33, P <0.001) and pain attack frequency (ES: -17.85, 95% CI: -23.36, -12.34, P <0.001) from baseline to the end of follow-up. The overall proportion of responders to BTX-A treatment was also significant (95% CI: 0.653, 0.761, P =0.003). Current evidence indicates that BTX-A injection is an effective and safe option for patients with refractory TN or not responding to medical or surgical management. However, more high-quality studies are needed to further confirm its efficacy.

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