OnabotulinumtoxinA for trigeminal neuralgia: a review of the available data

Kowacs, Pedro A.; Utiumi, Marco A. T.; Nascimento, Fábio A.; Piovesan, Elcio J.; Teive, Helio A. G.

doi:10.1590/0004-282X20150109

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VIEW AND REVIEW • Arq. Neuro-Psiquiatr. 73 (10) • Oct 2015 • https://doi.org/10.1590/0004-282X20150109 copy

OnabotulinumtoxinA for trigeminal neuralgia: a review of the available data

Toxina Onabotulínica-A para neuralgia do trigêmeo: uma revisão dos dados disponíveis

Authorship SCIMAGO INSTITUTIONS RANKINGS

Trigeminal neuralgia (TN) patients may develop side effects from centrally acting drugs, have contraindications for neurosurgical procedures, or experience relapse during conventional therapies. OnabotulinumtoxinA (BoNT/A) has been reported to be effective for TN, although this finding has been challenged. An overview of the available evidence based on a narrative/qualitative analysis of the literature is presented. About 90% of patients who receive BoNT/A show an improvement, a higher figure than that reported for the placebo effect of BoNT/A for other headaches. Tolerability of BoNT/A is good, and its few side-effects are transient. The articles reviewed were mainly case reports, case series and open-label trials; however, randomized controlled trials have endorsed the efficacy of BoNT/A for TN. This evidence, together with a better understanding of the analgesic mechanisms of BoNT/A and its proven efficacy in treating other pain syndromes, supports the use of this toxin as a therapeutic option for TN.

trigeminal neuralgia; botulinum neurotoxin type A; botulinum-A toxin; onabotulinumtoxin A; neuropathic pain

Author, year	Type of Publication	BoNT/A therapy	Number of cases, response	Type of measurement, p
Wang and Jankovic, 1998*⁵	Mention		1/1	Patient report
Micheli et al., 2002.⁶	Case report	2.5 MU in 5 sites (12.5 U) at 12 wk intervals	1/1	Patient report
Borodic and Acquadro, 2002.⁷	Case series	30-50 U	8/11	Patient report
Piovesan et al., 2005.⁴	Open-label trial	6.45-9.11 U per branch (3.3 U/cm²)	13/13	Pain area, p < 0.0001 (at 60 days); VAS, p = NR
Türk et al., 2005.⁹	Open-label trial	50 U in 2 sites (BoNT/A)	8/8	VAS, p = 0.011 and Frequency, p = 0.012 (at 1^stwk, 2^ndmo, 6^thmo)
Allam et al., 2005.⁸	Case report	2 U in 8 points (16 U) (BoNT/A)	1/1	VAS, p = NR
Boscá-Blasco et al., 2006*.¹¹	Case series	17.5 U at 6 mo intervals	4/4	PAS, p = NR
Volcy et al., 2006.¹⁰	Case report	6-7.5 U at 4 mo intervals	1/1	Patient report
Uluduz et al., 2007.¹²	Case report	75 U at 3 mo intervals	1/1	Patient report
Felicio et al., 2007*.¹³	Case report	100 U at 2 mo intervals	1/1	Patient report
Zúñiga et al., 2008.¹⁴	Open-label trial	20-50 U (BoNT/A)	10/12	VAS, p = NR and Frequency, p = NR (during 8 wk)
Ngeow and Nair, 2010.¹⁹	Case report	100 U divided into two sites (BoNT/A)	1/1	Patient report
Yoon et al., 2010.³⁸	Case report	10 U (BoNT/A)	1/1	Patient report and current perception threshold measurements at 2 mo
Bohluli et al., 2011.²⁰	Open-label trial	50-100 U injected at each trigger zone	15/15	VAS, p < 0.001 and Frequency, p < 0.001 (at 1^stwk and 1^stmo); Global assessment, p < 0.001 (at 6 mo)
Wu et al., 2012.²¹	RCT	75 U injected at 15 points (BoNT/A)	15/22 responders	VAS, p < 0.05 (from 2^ndwk to 12^thwk); Responders (≥ 50% reduction), p < 0.01; Frequency, p < 0.05 (from 1^stwk to12^thwk); PGIC, p < 0.01
Shehata et al., 2013.²³	RCT	40-60 U (5 U per point) in a “follow the pain method” (BoNT/A)	Proportion NR	VAS, p < 0.0001 and Frequency, p < 0.0001 (from 2^ndwk to 12^thwk); QoL, p < 0.0001
Zúñiga et al., 2013.¹⁸	RCT	50 U subcutaneously with additional 10 U in the masseter if there is V3 involvement (BoNT/A)	Proportion NR	VAS, p = 0.01 (at 3 mo); Frequency, p = 0.036, 0.01, 0.006 (at 1, 2 and 3 mo respectively); Functional impact (no difference)
Li et al., 2014.²²	Open-label trial	25-170 U (2.5-5 U per point) (BoNT/A)	88/88 (at 2 mo) to 34/88 (at 14 mo)	Responders (≥ 50% reduction), p = NR
Zhang et al., 2014.²⁴	RCT	25 U and 75 U at 20 points intradermally and/or submucosally (BoNT/A)	19/27 (25 U) and 25/29 (75 U) from 1^stwk to 8^thwk	VAS, p < 0.017; Responders (≥ 50% reduction), p < 0.017; PGIC, p < 0.017
Total	1 mention; 7 case reports; 2 case series; 5 open-label trials; 4 RCT	6 U to 170 U	213/237	Patient report: 8 VAS: 9 PAS: 1 Pain area: 1 Frequency: 6

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[1] Correspondence: Pedro André Kowacs; Instituto de Neurologia de Curitiba; Rua Jeremias Maciel Perretto, 300; 81210-310 Curitiba PR, Brasil; E-mail: pkowacs@gmail.com