Botulinum neurotoxin type A for the treatment of pain: not just in migraine and trigeminal neuralgia

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Abstract

Background

Despite their huge epidemiological impact, primary headaches, trigeminal neuralgia and other chronic pain conditions still receive suboptimal medical approach, even in developed countries. The limited efficacy of current pain-killers and prophylactic treatments stands among the main reasons for this phenomenon. Botulinum neurotoxin (BoNT) represents a well-established and licensed treatment for chronic migraine, but also an emerging treatment for other types of primary headache, trigeminal neuralgia, neuropathic pain, and an increasing number of pain conditions.

Methods

We searched and critically reviewed evidence for the efficacy of BoNT for the treatment of chronic pain.

Results

Meta-analyses and randomized controlled trials (RCTs) suggest that BoNT potentially represents a multi-purpose drug for the treatment of pain in several disorders due to a favorable safety profile and a long-lasting relief after a single injection.

Conclusions

BoNT is an emerging treatment in different pain conditions. Future RCTs should explore the use of BoNT injection therapy combined with systemic drugs and/or physical therapies as new pain treatment strategies.

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Most cited references 38

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Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact.

Kim J. Reid, Julie Harker, Malgorzata Bala … (2011)

Estimates on the epidemiology of chronic non-cancer pain vary widely throughout Europe. It is unclear whether this variation reflects true population differences or methodological factors. Such epidemiological information supports European decision makers in allocating healthcare resources. Pan-Europe epidemiological data about chronic non-cancer pain was obtained using systematic review principles in searching and summarising results. Multiple databases (MEDLINE, EMBASE, Cochrane Library, CRD Databases, and GIN) were systematically searched for primary studies containing epidemiological data on chronic non-cancer pain in Europe excluding studies that solely concerned migraines, headaches and pain associated with specific disease conditions. The studies were prioritised according to quality, recency and validity. Eighteen research questions concerning aspects of chronic pain included: prevalence; incidence; pain treatments, control and compliance; treatment satisfaction; and quality of life and economic impacts. The search yielded 16 619 references and 45 were relevant to Europe. Studies for each question were selected that provided the most recent, representative and valid data. There was a clear lack of studies concerning chronic non-cancer pain in Europe as a whole. The 1-month prevalence of moderate-to-severe non-cancer chronic pain was 19%. Chronic pain significantly impacted on patient-perceived health status, affected everyday activities including economic pursuits and personal relationships, and was significantly associated with depressive symptoms. The majority relied on drugs for pain control and NSAIDs were the most frequent drug choice. Despite pain medications, a large proportion had inadequate pain control. To the authors' knowledge this is the most comprehensive literature review on epidemiological data in this field. It is clear that chronic pain has a dramatic impact on European society. Since chronic non-cancer pain is treated differently from cancer-related pain, the lack of data in this area clearly underlines the need for decision makers in healthcare to gather further epidemiological data.

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A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience

Andrea Negro, Martina Curto, Luana Lionetto … (2016)

Background The efficacy and safety of OnabotulinumtoxinA (BOTOX®) in adults with chronic migraine (CM) were demonstrated in the PREEMPT program. However, the dosage used in this study was flexible from 155 U to 195 U at the physician’s discretion. Therefore, the objective of this prospective study was to compare the efficacy and safety of OnabotulinumtoxinA 195 U vs. 155 U for the treatment of CM and medication overuse headache (MOH) during a 2-year period. Methods We prospectively evaluated the mean reduction in headache days, migraine days, acute pain medication intake days and Headache Impact Test (HIT)-6 score in 172 patients injected with OnabotulinumtoxinA 195 U. Successively, we compared the efficacy measures with data of 155 patients injected with OnabotulinumtoxinA 155 U and followed up for 2 years. All patients were affected by CM and MOH, and failed one or more previous detoxification and preventative therapies. Results Both OnabotulinumtoxinA 195 U and 155 U reduced significantly the number of headache and migraine days, acute pain medication intake days and HIT-6 score, when compared with the baseline measures. Nevertheless, OnabotulinumtoxinA 195 U proved to be superior of 155 U in all efficacy measures since the first injection and for all the 2 years of treatment, with the exception of the reduction in pain medication intake days that resulted significantly larger with 195 U only after the 4th injection. The safety and tolerability of the two doses were similar and treatment related adverse events were transient and mild-moderate. Conclusions This study represents the largest and longest post-marketing studies of doses comparison with OnabotulinumtoxinA in a real-life clinical setting. Here, we demonstrate the superior efficacy of OnabotulinumtoxinA 195 U compared to 155 U in CM patients with MOH during a 2-year treatment period with similar safety and tolerability profile. Electronic supplementary material The online version of this article (doi:10.1186/s10194-016-0591-3) contains supplementary material, which is available to authorized users.

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Pharmacologic interventions for treating phantom limb pain.

Maria Jenelyn M Alviar, Tom Hale, Monalisa Lim‐Dungca (2016)

This is an updated version of the original Cochrane review published in Issue 12, 2011. Phantom limb pain (PLP) is pain that arises in the missing limb after amputation and can be severe, intractable, and disabling. Various medications have been studied in the treatment of phantom pain. There is currently uncertainty in the optimal pharmacologic management of PLP.

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Author and article information

Contributors

Giorgio Sandrini: giorgio.sandrini@unipv.it

Roberto De Icco: rob.deicco@gmail.com

Cristina Tassorelli: cristina.tassorelli@mondino.it

Nicola Smania: nicola.smania@univr.it

Stefano Tamburin:

ORCID: http://orcid.org/0000-0002-1561-2187

+39-045-812-4285 , stefano.tamburin@univr.it

Journal

Journal ID (nlm-ta): J Headache Pain

Journal ID (iso-abbrev): J Headache Pain

Title: The Journal of Headache and Pain

Publisher: Springer Milan (Milan )

ISSN (Print): 1129-2369

ISSN (Electronic): 1129-2377

Publication date (Electronic): 21 March 2017

Publication date PMC-release: 21 March 2017

Publication date Collection: 2017

Volume: 18

Issue: 1

Electronic Location Identifier: 38

Affiliations

[1 ]C. Mondino National Institute of Neurology Foundation, IRCCS, Pavia, Italy

[2 ]ISNI 0000 0004 1762 5736, GRID grid.8982.b, Department of Brain and Behavioural Sciences, , University of Pavia, ; Pavia, Italy

[3 ]ISNI 0000 0004 1763 1124, GRID grid.5611.3, Department of Neurosciences, Biomedicine and Movement Sciences, , University of Verona, ; Piazzale Scuro 10, I-37134 Verona, Italy

[4 ]ISNI 0000 0004 1763 1124, GRID grid.5611.3, Neuromotor and Cognitive Rehabilitation Research Centre, , University of Verona, ; Verona, Italy

Author information

Stefano Tamburin http://orcid.org/0000-0002-1561-2187

Article

Publisher ID: 744

DOI: 10.1186/s10194-017-0744-z

PMC ID: 5360746

PubMed ID: 28324318

SO-VID: d5b674c2-3b99-48a1-b362-086343f65b6a

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

History

Date received : 17 January 2017

Date accepted : 10 March 2017

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ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: botulinum neurotoxin,primary headaches,migraine,neuropathic pain,pain,trigeminal neuralgia,treatment

Data availability:

ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: botulinum neurotoxin, primary headaches, migraine, neuropathic pain, pain, trigeminal neuralgia, treatment

Botulinum neurotoxin type A for the treatment of pain: not just in migraine and trigeminal neuralgia

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Most cited references 38

Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact.

A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience

Pharmacologic interventions for treating phantom limb pain.

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