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Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study.

Lancet Gastroenterol Hepatol

February 2024

Université de Rouen Normandie, Institut National de la Santé et de la Recherche Médicale (INSERM), ADEN UMR1073, Centre Hospitalier Universitaire (CHU) Rouen, Centre d'Investigation Clinique-Centre de Ressources Biologiques (CIC-CRB) 1404, Department of Digestive Physiology, Rouen, France.

Background: Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study.

Methods: In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence.

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Botulinum toxins are neurotoxins produced by . This toxin can be lethal for humans as a cause of botulism; however, in small doses, the same toxin is used to treat different conditions. Even if the therapeutic doses are effective and safe, the adverse reactions could be local and could unmask a subclinical impairment of neuromuscular transmissions.

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Brachial plexus birth palsy (BPBP) is a neurologic injury that can result in mild to full paralysis of the affected upper extremity. In severe cases, nerve surgery is often performed before age 1 year. Several studies report gains in elbow flexion with onabotulinum toxin type A (OBTT-A) injections to the triceps; however, its use in infants is not widely reported.

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Objective: To evaluate the capacity of the Upper Limb Performance Analysis: Comparative Analysis of Performance-Motor (CAP-M) to quantify change in adults with focal spasticity following injection of Botulinum Toxin-A (BTX-A) as a focal treatment for positive Upper Motor Neuron (UMN) features.

Methods: Twenty-three adults with moderate-to-severe spasticity were assessed pre- and post-BTX-A injection using CAP-M. Post-hoc video analysis of three sub-tests from the Action Research Arm Test were analysed against expected movements for each task.

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Introduction: A recent paper in the Journal of Drugs in Dermatology by Koshy and colleagues (2012, 11( 4 ):507-512) report on "Effect of Dietary Zinc and Phytase Supplementation on Botulinum Toxin Treatments" and conclude by claiming the discovery of "a potentially meaningful role for zinc and/or phytase supplementation in increasing the degree and duration of botulinum toxin effect in the treatment of cosmetic facial rhytids, benign essential blepharospasm, and hemifacial spasm". The purpose of this paper is to examine these published claims for possible methodological and design errors and potential sources of bias.

Methods: The authors evaluated the published results in comparison to the published literature on zinc deficiency, the role of phytase, prior reports of an effect of zinc on activity of botulinum toxin, issues of study design and execution and if the reported results of the study supported the study's conclusions.

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