Is chemodenervation with incobotulinumtoxinA an alternative to invasive chronic anal fissure treatments?

Botulinum toxin type A is currently strongly recommended for the treatment of anal fissures (AFs). However, there is still no consensus on dosage or injection technique. This study provides further efficacy and safety evidence in a 2-year follow-up. Prospective, open-label, single-arm, single-center...

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Bibliographic Details
Published in:BMC gastroenterology 2024-09, Vol.24 (1), p.334-8, Article 334
Main Authors: Calderón, T, Arriero, L, Cruz, P, Gómez, L, Asanza, J, Santiago, J C, Garrido, R, Bustamante, C, Balsa, T
Format: Article
Language:English
Subjects:
Adult
Aged
Anal Canal
Anal fissure
Anus
Botulinum toxin
Botulinum toxin type A
Botulinum Toxins, Type A - administration & dosage
Botulinum Toxins, Type A - adverse effects
Botulinum Toxins, Type A - therapeutic use
Care and treatment
Chronic anal fissure
Chronic Disease
Constipation
Defecation
Denervation
Dosage and administration
Efficacy
Fecal Incontinence
Female
Fissure in Ano - drug therapy
Humans
Male
Medical research
Medicine, Experimental
Methods
Middle Aged
Neuromuscular Agents - administration & dosage
Neuromuscular Agents - adverse effects
Neuromuscular Agents - therapeutic use
Nitrates
Pain
Pain perception
Patients
Prospective Studies
Recurrence
Safety
Sphincter
Treatment Outcome
Visual perception
Wound Healing - drug effects
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Description
Summary:Botulinum toxin type A is currently strongly recommended for the treatment of anal fissures (AFs). However, there is still no consensus on dosage or injection technique. This study provides further efficacy and safety evidence in a 2-year follow-up. Prospective, open-label, single-arm, single-center study carried out in adult patients with AFs non-responsive to previous treatments. Patients were treated with incobotulinumtoxinA (incoBoNT/A) injected in both laterals and posterior intersphincteric groove. Healing rate at 2 years was the primary endpoint. Secondary endpoints included internal anal sphincter pressures, incontinence, and safety. A total of 49 patients were treated with a mean incoBoNT/A dose of 40.5 U (spread across three locations). Healing rate at 2 years was 83.9% with a 24.5% of recurrence throughout the study. Only 7 patients (14.3%) reported adverse events (AEs) that were mild and temporary. Mean reduction in anal resting pressure was -9.1 mmHg at 3 months (p = 0.001). Mean reduction in voluntary squeeze pressure was -27.5 mmHg at 3 months (p 
ISSN:1471-230X
1471-230X
DOI:10.1186/s12876-024-03428-z