Journal of Neurosciences in Rural Practice
 


 
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EDITORIAL
Year : 2018  |  Volume : 9  |  Issue : 1  |  Page : 3-4  

Botulinum toxin for refractory trigeminal neuralgia: A trial sequential analysis of randomized clinical trials


1 Department of Pharmacology and Therapeutics, College of Medicine and Medical Sciences, Arabian Gulf University, Manama, Bahrain
2 Department of Prosthodontics, School of Oral Health, College of Medicine, Nursing and Health Sciences, National University, Suva, Fiji

Date of Web Publication19-Jan-2018

Correspondence Address:
Kannan Sridharan
Associate Professor, Department of Pharmacology and Therapeutics, College of Medicine and Medical Sciences, Arabian Gulf University, Manama
Bahrain
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jnrp.jnrp_447_17

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How to cite this article:
Sridharan K, Sivaramakrishnan G. Botulinum toxin for refractory trigeminal neuralgia: A trial sequential analysis of randomized clinical trials. J Neurosci Rural Pract 2018;9:3-4

How to cite this URL:
Sridharan K, Sivaramakrishnan G. Botulinum toxin for refractory trigeminal neuralgia: A trial sequential analysis of randomized clinical trials. J Neurosci Rural Pract [serial online] 2018 [cited 2018 Dec 16];9:3-4. Available from: http://www.ruralneuropractice.com/text.asp?2018/9/1/3/223521

In this issue, Caldera et al.[1] published a study where the authors observed a significant reduction in the symptoms of trigeminal neuralgia (TN) following injection of botulinum toxin at the trigger point in a cohort of South Asian patients. In our earlier network meta-analysis of interventions for refractory TN, we also observed that botulinum toxin injection was associated with significant benefits compared to placebo.[2] A previous systematic review assessing the prospective studies on botulinum toxin in TN observed therapeutic response ranging between 70% and 100% without any significant major adverse events.[3] Although botulinum toxin is approved only for treating chronic migraine, the analgesic effects of botulinum toxin in TN have already been reported first in 1998. Since then, numerous nonrandomized and observational studies and four randomized controlled clinical trials [4],[5],[6],[7] have been conducted with botulinum toxin in refractory TN. We carried out a trial sequential analysis [8] assessing the efficacy of botulinum toxin from the estimates of three randomized clinical trials [4],[5],[6] with the methodology described similarly elsewhere.[7] Relative risk (95% confidence intervals) of patients with pain relief was the outcome variable, and one study [7] did not report this outcome. We observed statistically significant pooled estimates (2.86 [1.82, 4.48]) favoring botulinum toxin [Figure 1], and the trial sequential analysis confirmed the existence of adequate evidence for therapeutic utility of botulinum toxin. Although there is no expert consensus on using botulinum toxin in refractory TN due to lack of robust and long-term follow-up studies and cost-effectiveness data, the agent looks promising to use based on trial sequential analysis principles.
Figure 1: Trial sequential analysis of botulinum toxin compared to placebo for number of patients with pain relief. Blue line indicates the trend in the pooled estimates with addition of results from each trial, and the final pooled estimates were observed to favor botulinum toxin

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   References Top

1.
Caldera MC, Senanayake SJ, Perera SP, Perera NN, Gamage A, Gooneratne IK. Efficacy of botulinum toxin type A in trigeminal neuralgia in a South Asian Cohort. J Neurosci Rural Pract 2018;9:100-5.  Back to cited text no. 1
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2.
Sridharan K, Sivaramakrishnan G. Interventions for refractory trigeminal neuralgia: A bayesian mixed treatment comparison network meta-analysis of randomized controlled clinical trials. Clin Drug Investig. 2017. doi:10.1007/s40261-017-0553-9.  Back to cited text no. 2
    
3.
Hu Y, Guan X, Fan L, Li M, Liao Y, Nie Z, et al. Therapeutic efficacy and safety of botulinum toxin type A in trigeminal neuralgia: A systematic review. J Headache Pain 2013;14:72.  Back to cited text no. 3
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4.
Wu CJ, Lian YJ, Zheng YK, Zhang HF, Chen Y, Xie NC, et al. Botulinum toxin type A for the treatment of trigeminal neuralgia: Results from a randomized, double-blind, placebo-controlled trial. Cephalalgia 2012;32:443-50.  Back to cited text no. 4
[PUBMED]    
5.
Zhang H, Lian Y, Ma Y, Chen Y, He C, Xie N, et al. Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: Observation of therapeutic effect from a randomized, double-blind, placebo-controlled trial. J Headache Pain 2014;15:65.  Back to cited text no. 5
[PUBMED]    
6.
Zúñiga C, Piedimonte F, Díaz S, Micheli F. Acute treatment of trigeminal neuralgia with onabotulinum toxin A. Clin Neuropharmacol 2013;36:146-50.  Back to cited text no. 6
    
7.
Shehata HS, El-Tamawy MS, Shalaby NM, Ramzy G. Botulinum toxin-type A: Could it be an effective treatment option in intractable trigeminal neuralgia? J Headache Pain 2013;14:92.  Back to cited text no. 7
[PUBMED]    
8.
Sridharan K, Sivaramakrishnan G. Vasoactive agents for hepatorenal syndrome: A mixed treatment comparison network meta-analysis and trial sequential analysis of randomized clinical trials. J Gen Intern Med. 2017. doi:10.1007/s11606-017-4178-8.  Back to cited text no. 8
    


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