|Year : 2019 | Volume
| Issue : 3 | Page : 145-148
Profile of botulinum toxin injections in a neurology outpatient service Hospital: A preliminary report
Frank Aiwansoba Imarhiagbe
Department of Medicine, Neurology Unit, University of Benin Teaching Hospital, Benin City, Nigeria
|Date of Submission||15-Jan-2018|
|Date of Acceptance||12-May-2018|
|Date of Web Publication||26-Sep-2019|
Dr. Frank Aiwansoba Imarhiagbe
Department of Medicine, Neurology Unit, University of Benin Teaching Hospital, Benin City
Background: The use of botulinum toxin in neurology outpatient service is at its infancy in sub-Saharan Africa owing largely to the prohibitive cost and lack of requisite expertise in the use of the toxin. This leaves a huge gap in the treatment of focal dystonias and dyskinesias. Objective: The objective of this study is to profile the use of botulinum toxin in a neurology outpatient service in Nigeria. Methods: Ten consecutive patients with different neurologic disorders who had the injection of onabotulinum toxin type A (Otesaly ®, Guangzhou Boss Biological Technique Ltd., China) were reviewed for demographics and clinical diagnosis and whether or not they have been exposed to botulinum toxin before, units of botulinum toxin received, and response to the injection. Botulinum toxin was supplied with strict adherence to the cold chain prescription (2°C–8°C) and constituted with normal saline before injection, and all injections were given by a neurologist-trained hands-on in the use of botulinum toxin. Results: The mean age of study participants was 54.77 ± 10.17 years and all of them were males. Blepharospasm alone or as part of Meige syndrome with spasmodic dysphonia was the most frequent clinical diagnosis, which accounted for 7 (70%) of the total; 1 (10%) had cervical dystonia and 2 (20%) had hemifacial dyskinesia. The median dose of botulinum toxin type A injected was 83.33 units (interquartile range [IQR]: 50–100) and the median duration of symptoms was 5 years (IQR: 5–10). Eight (80%) cases had good response with moderate-to-complete resolution of symptoms by Jankovic rating 0–2. Conclusion: The gap in the treatment of craniocervical dystonias and blepharospasm as the dominant presentation is obvious.
Keywords: Africa, botulinum toxin, focal dystonia, profile, Sub-Saharan
|How to cite this article:|
Imarhiagbe FA. Profile of botulinum toxin injections in a neurology outpatient service Hospital: A preliminary report. Sahel Med J 2019;22:145-8
|How to cite this URL:|
Imarhiagbe FA. Profile of botulinum toxin injections in a neurology outpatient service Hospital: A preliminary report. Sahel Med J [serial online] 2019 [cited 2019 Oct 13];22:145-8. Available from: http://www.smjonline.org/text.asp?2019/22/3/145/267893
| Introduction|| |
The regular use of botulinum toxin in neurology service in Nigeria and in parts of Sub-Saharan Africa is rare largely because of the cost of procurement of the toxin and the lack of requisite expertise in its utilization. Viewed against the background of the prevalence of focal dyskinesias and dystonias requiring the use of botulinum toxin, the dearth of the toxin and its use leave a huge treatment gap.
Botulinum toxin is a purified substance produced naturally by the bacterium Clostridium botulinum, a Gram-positive spore-forming rod, and it occurs in eight different forms that are antigenically and serologically different, such as A, B, C1, C2, D, E, F, and G, but only A, B, E, and F can cause the disease botulism in humans and C and D can cause disease only in animals. Botulinum toxin is produced originally as a protein of 150 kDa later separated into two chains of a heavy and a light chain of 100 and 50 kDa, respectively, by a disulfide bond. It causes chemical denervation by irreversibly binding to cholinergic presynaptic vesicles, preventing the release of acetylcholine in neuromuscular junction, autonomic ganglia, postganglionic parasympathetic nerve fibers, and cholinergic sympathetic nerve fibers.
In clinical use, botulinum toxin A is the most potent followed by botulinum toxin B. Forms of botulinum toxin in clinical use are onabotulinum toxin A, abobotulinum toxin A, incobotulinum toxin A, and rimabotulinum toxin B. Only onabotulinum toxin A and incobotulinum toxin A can be exchanged unit for unit in terms of doses, but abobotulinum toxin A and rimabotulinum toxin B have to be calculated differently by manufacturer's specification in terms of unit.,
The clinical use of botulinum toxin was first discovered in the late 1960s and early 1970s by Allan Scott following its use in the treatment of strabismus; this led to the approval by the Food and Drug Administration of the United States of America in the treatment of blepharospasm and hemifacial spasm in 1979, and now, it is used in nearly all subspecialties in medicine. In neurology practice, botulinum toxin is used in the treatment of blepharospasm, hemifacial spasm, Meige syndrome (blepharospasm and oromandibular dystonia), muscle spasticity, headaches, cervical dystonia, and spasmodic dysphonia.,,,,
This preliminary study profiles the use of botulinum toxin in a Nigerian neurology outpatient service following a recent steady supply at a rate relatively cheaper than what is prevalent.
| Methods|| |
Ten consecutive patients with different neurologic disorders who had the injection of open-label, generic onabotulinum toxin type A (Otesaly ®, Guangzhou Boss Biologic Technique Ltd., China), from August 2016 to May 2017 after informed consent, were reviewed for age, sex, educational attainment and clinical diagnosis and whether or not they have been exposed to botulinum toxin before, units of botulinum toxin received, and response to the injection and side effects if any post injection. Botulinum toxin was supplied with strict adherence to the cold chain prescription in ice packs and constituted with normal saline before injection, and all injections were given by a neurologist-trained hands-on and certified in the use of botulinum toxin. The injection of the larynx in the patient who had Meige syndrome with spasmodic dysphonia was done by an otorhinolaryngologist. Severity of the symptoms and response of blepharospasm to the injection of botulinum toxin were assessed using the Jankovic rating scale.
The study was approved by the Ethics Committee of the University of Benin Teaching Hospital (protocol number ADM/E22/A/VOL.VII/14785 dated in May 2016).
| Results|| |
The mean age of study participants was 54.77 ± 10.17 years, and all of them were males. Blepharospasm alone or as part of facial dyskinesia or Meige syndrome was the most frequent clinical diagnosis, which accounted for 7 (70%) of the total; 1 (10%) had cervical dystonia and 2 (20%) had hemifacial dyskinesia [Table 1] and [Figure 1]. The median dose of botulinum toxin type A injected was 83.33 units (interquartile range [IQR]: 50–100) and the median duration of symptoms was 5 years (IQR: 5–10). Only 1 (10%) had previous exposure to botulinum toxin type A outside our facility about a year earlier and 8 (80%) cases had good response with moderate-to-complete resolution of symptoms by Jankovic rating 0–2. Two (20%) had ptosis within a week of the injection for blepharospasm and 1 (10%) had transient dysphagia following injection of the larynx for spasmodic dysphonia.
| Discussion|| |
The mean age of study participants is consistent with a previous work on dystonic movements, though all were outside the clime of this work. Female preponderance is the rule in dystonic movements, and the all males seen in this work may be due to the small number of participants. Blepharospasm is the most frequent of the cranial dystonias as shown in this study. The median dose of botulinum toxin injected was calculated based on the severity of the complaints and the minimum effective dose, mindful of the fact that the higher the dose injected once, the higher the probability of raising higher antibodies to botulinum which engenders secondary nonresponders. The duration of symptoms appears high in our opinion apparently suggestive of the wide treatment gap of dystonia using botulinum toxin in the environment in which the study was carried out. The relative difficulty in the sourcing and the prohibitive cost of botulinum toxin may contribute to this. That only one patient had previous exposure to botulinum toxin again lends credence to the wide treatment gap. The 80% response rate as assessed by Jankovic rating scale is remarkable, and the two patients who had poor response were later observed to have had botulinum toxin with a breach of the cold chain preservation and the possibility of denatured products. They were, however, billed to have repeat injections after at least 4 months by the current protocol for the use of botulinum toxin.,,
Ptosis and dysphagia as observed in this study are common side effects in the use of botulinum toxin in cranial and cervical dystonias. The expertise of an otorhinolaryngologist was required in the treatment of the only patient with Meige syndrome with spasmodic dysphonia, which is consistent with standard practice.
The small sample size of this preliminary study is an obvious limitation. The huge gap in the treatment of craniocervical dystonias and the frequency of blepharospasm as the dominant presentation is obvious in this study. It is hoped that more light will be thrown on the use of botulinum toxin in neurologic practice in the setting of this study and in Sub-Saharan Africans as more patients are studied. There are 2 main limitations of this study: the small sample size and absence of female gender. The final report will take care of these limitations.
The contribution of doctors and support staff of the Neurology unit in the University of Benin Teaching Hospital is acknowledged.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Nigam PK, Nigam A. Botulinum toxin. Indian J Dermatol 2010;55:8-14.
] [Full text]
Truong D. Botulinum toxins in the treatment of primary focal dystonias. J Neurol Sci 2012;316:9-14.
Cardoso F. Botulinum toxin type B in the management of dystonia non-responsive to botulinum toxin type A. Arq Neuropsiquiatr 2003;61:607-10.
Saad J, Gourdeau A. A direct comparison of onabotulinumtoxina (Botox) and incobotulinumtoxinA (Xeomin) in the treatment of benign essential blepharospasm: A split-face technique. J Neuroophthalmol 2014;34:233-6.
Jabbari B. History of botulinum toxin treatment in movement disorders. Tremor Other Hyperkinet Mov (N
Hellman A, Torres-Russotto D. Botulinum toxin in the management of blepharospasm: Current evidence and recent developments. Ther Adv Neurol Disord 2015;8:82-91.
Charles PD. Botulinum neurotoxin serotype A: A clinical update on non-cosmetic uses. Am J Health Syst Pharm 2004;61:S11-23.
Ababneh OH, Cetinkaya A, Kulwin DR. Long-term efficacy and safety of botulinum toxin A injections to treat blepharospasm and hemifacial spasm. Clin Exp Ophthalmol 2014;42:254-61.
Colosimo C, Tiple D, Berardelli A. Efficacy and safety of long-term botulinum toxin treatment in craniocervical dystonia: A systematic review. Neurotox Res 2012;22:265-73.
Walter U, Dressler D. Ultrasound-guided botulinum toxin injections in neurology: Technique, indications and future perspectives. Expert Rev Neurother 2014;14:923-36.
Jankovic J, Orman J. Botulinum A toxin for cranial-cervical dystonia: A double-blind, placebo-controlled study. Neurology 1987;37:616-23.
Asgeirsson H, Jakobsson F, Hjaltason H, Jonsdottir H, Sveinbjornsdottir S. Prevalence study of primary dystonia in Iceland. Mov Disord 2006;21:293-8.
Strader S, Rodnitzky RL, Gonzalez-Alegre P. Secondary dystonia in a botulinum toxin clinic: Clinical characteristics, neuroanatomical substrate and comparison with idiopathic dystonia. Parkinsonism Relat Disord 2011;17:749-52.
Wabbels B, Jost WH, Roggenkämper P. Difficulties with differentiating botulinum toxin treatment effects in essential blepharospasm. J Neural Transm (Vienna) 2011;118:925-43.
Defazio G, Hallett M, Jinnah HA, Stebbins GT, Gigante AF, Ferrazzano G, et al.
Development and validation of a clinical scale for rating the severity of blepharospasm. Mov Disord 2015;30:525-30.
Ramirez-Castaneda J, Jankovic J. Long-term efficacy, safety, and side effect profile of botulinum toxin in dystonia: A 20-year follow-up. Toxicon 2014;90:344-8.