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Meta-Analysis
. 2016 Dec;17(1):63.
doi: 10.1186/s10194-016-0651-8. Epub 2016 Jul 5.

Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: a systematic review and meta-analysis of randomized controlled trials

Mostafa Ebraheem Morra  1 , Ahmed Elgebaly  1 , Ahmed Elmaraezy  1 , Adham M Khalil  2 , Ahmed M A Altibi  3 , Tran Le-Huy Vu  4 , Mostafa Reda Mostafa  5 , Nguyen Tien Huy  6   7 , Kenji Hirayama  8
Affiliations
Meta-Analysis

Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: a systematic review and meta-analysis of randomized controlled trials

Mostafa Ebraheem Morra et al. J Headache Pain. 2016 Dec.

Abstract

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.

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Figures

Fig. 1
Fig. 1
PRISMA flow diagram of studies’ screening and selection
Fig. 2
Fig. 2
Cochrane bias assessment of included studies
Fig. 3
Fig. 3
A Forest plots of relative risk (RR) for proportion of respondents comparing BTX A with placebo. M-H: Mantel-Haenzel, CI: confidence interval. B Forest plots of mean difference in VAS score comparing BTX A with placebo at the end of follow up (A), 1 month (B), 2 month (C), and 3 month (D). VAS: Visual analogue scale, MD: Mean difference, M-H: Mantel-Haenzel, CI: confidence interval. C Forest plots of mean difference in number of paroxysm comparing BTX A with placebo. MD: Mean difference, M-H: Mantel-Haenzel, CI: confidence interval
Fig. 4
Fig. 4
Forest plots of Sensitivity analysis (random effects model)
Fig. 5
Fig. 5
Forest plots of Sensitivity analysis (removing one study at a time)
See this image and copyright information in PMC

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