Intra-sphincteric botulinum toxin in the management of functional biliary pain

Abstract

<jats:title>Abstract</jats:title><jats:p> Background and study aims The management of functional biliary-type pain remains a clinical challenge. Intra sphincteric botulinum toxin putatively exerts an anti-spasmodic and anti-nociceptive effect. The objective of this study was to examine the clinical response to intra sphincteric botulinum toxin in patients with functional biliary-type pain.</jats:p><jats:p> Patients and methods This was a cross-sectional (hypothesis-generating) study of prospectively collected data from patients referred to a tertiary center from 2014 to 2019. The efficacy of ampullary botulinum toxin injection for relief of pain was recorded at post-procedure outpatient review. Opioid analgesia, neuromodulatory medication, and frequency of hospital admissions were recorded.</jats:p><jats:p> Results A total of 119 consecutive patients (109 women, 10 men, mean age 45 years; range 17–77) underwent 411 intra-sphincteric botulinum toxin injection procedures (mean 2 procedures; range 1–15). A total of 103 patients (87?%) had a significant improvement in pain on post-procedure review and 77?% and 76?% of patients were opioid and admission free, respectively. Of the patients, 59?% were prescribed tricyclic antidepressants (amitriptyline), 18?% duloxetine, 13?% pregabalin, and 3?% mirtazapine. Loss of response with the initial dose of botulinum toxin occurred in 56?% of patients. Pain control was reestablished in 80?% of patients in this cohort following botulinum toxin injection at a higher dose.</jats:p><jats:p> Conclusions These data suggest that botulinum toxin may improve outcomes in patients with functional biliary pain. Further controlled studies are needed to clarify the role of Botox and neuromodulatory agents.</jats:p>