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Meta-Analysis
. 2019 Oct;9(10):e01409.
doi: 10.1002/brb3.1409. Epub 2019 Sep 21.

The efficacy and safety of botulinum toxin type A in treatment of trigeminal neuralgia and peripheral neuropathic pain: A meta-analysis of randomized controlled trials

Jiangshan Wei  1 , Xiangyu Zhu  2 , Guang Yang  3 , Jun Shen  3 , Peng Xie  4 , Xiaohua Zuo  5 , Lei Xia  6 , Qiu Han  6 , Ying Zhao  3
Affiliations
Meta-Analysis

The efficacy and safety of botulinum toxin type A in treatment of trigeminal neuralgia and peripheral neuropathic pain: A meta-analysis of randomized controlled trials

Jiangshan Wei et al. Brain Behav. 2019 Oct.

Abstract

Background: Although recent studies have shown that botulinum toxin-A (BTX-A) has a good analgesic effect on trigeminal neuralgia (TN) and peripheral neuropathic pain (PNP), the quality of evidence is low due to limited data. This meta-analysis is used to synthesize existing evidence for the treatment of these conditions with BTX-A.

Methods: Relevant trials were accessed by using an electronic search in databases (Web of Science, PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov). Data from included randomized controlled trials (RCTs) on the efficacy and safety of BTX-A in treating TN and PNP were extracted for meta-analysis.

Results: Finally, 10 RCTs (n = 391) were included in this meta-analysis. The pooled effect of BTX-A was superior to placebo based on pain intensity (SMD = -0.48, 95% CI [-0.74, 0.23] at 1 month, SMD = -0.58, 95% CI [-0.91, -0.24] at 2 months, and SMD = -0.55, 95% CI [-0.87, -0.22] at 3 months). Number needed to treat (NNT) for 50% pain intensity reduction showed better effect of BTX-A on TN and postherpetic neuralgia (PN). Adverse events associated with BTX-A were similar to placebo (OR = 1.58, 95% CI [0.51, 4.87], p = .424).

Conclusion: Pooled data from our meta-analysis suggest that BTX-A is efficacious and safe in treating TN and PNP. However, due to the limited sample size and heterogeneity, further larger and well-designed RCTs are imperative to validate these findings.

Keywords: botulinum toxin-A; meta-analysis; peripheral neuropathic pain; randomized controlled trials; trigeminal neuralgia.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
PRISMA flow diagram
Figure 2
Figure 2
Cochrane bias assessment for individual trial
Figure 3
Figure 3
Graph of risk of bias for eligible RCTs
Figure 4
Figure 4
Bias assessment plot for the effect of BTX‐A on pain score by funnel blot
Figure 5
Figure 5
Forest plots of standard mean difference in pain score for BTX‐A versus placebo at 1 month (a), 2 months (b), and 3 months (c)
Figure 6
Figure 6
Forest plots of standard mean difference in pain score for BTX‐A versus placebo at 3 months, and subgroup analyses for different types of NP
Figure 7
Figure 7
Forest plots of standard mean difference in pain score for BTX‐A versus placebo at 1 month (a), 2 months (b), and 3 months (c), excluding the single‐blind study (Shehata et al., 2013)
Figure 8
Figure 8
Forest plot of odds ratio (OR) in adverse events comparing BTX‐A with placebo
See this image and copyright information in PMC

References

    1. Allam, N. , Brasil‐Neto, J. P. , Brown, G. , & Tomaz, C. (2005). Injections of botulinum toxin type A produce pain alleviation in intractable trigeminal neuralgia. The Clinical Journal of Pain, 21(2), 182–184. 10.1097/00002508-200503000-00010 - DOI - PubMed
    1. Aoki, K. R. (2008). Future aspects of botulinum neurotoxins. Journal of Neural Transmission, 115(4), 567–573. 10.1007/s00702-007-0758-9 - DOI - PubMed
    1. Apalla, Z. , Sotiriou, E. , Lallas, A. , Lazaridou, E. , & Ioannides, D. (2013). Botulinum toxin A in postherpetic neuralgia: A parallel, randomized, double‐blind, single‐dose, placebo‐controlled trial. The Clinical Journal of Pain, 29(10), 857–864. 10.1097/AJP.0b013e31827a72d2 - DOI - PubMed
    1. Attal, N. , de Andrade, D. C. , Adam, F. , Ranoux, D. , Teixeira, M. J. , Galhardoni, R. , … Bouhassira, D. (2016). Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): A randomised, double‐blind, placebo‐controlled trial. The Lancet Neurology, 15(6), 555–565. 10.1016/s1474-4422(16)00017-x - DOI - PubMed
    1. Attal, N. , Lanteri‐Minet, M. , Laurent, B. , Fermanian, J. , & Bouhassira, D. (2011). The specific disease burden of neuropathic pain: Results of a French nationwide survey. Pain, 152(12), 2836–2843. 10.1016/j.pain.2011.09.014 - DOI - PubMed

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