Intrarectal Botox Injections Promising for Treatment of Faecal Incontinence
A recent randomized, double-blind, placebo-controlled study has revealed compelling evidence supporting the efficacy of intrarectal injections of botulinum toxin type A (BoNTA) in treating urge faecal incontinence. This five-year study, conducted by a team from eight specialized French hospitals, aimed to evaluate the effectiveness of BoNTA injections compared to a placebo in adult patients experiencing at least one weekly episode of urgency or faecal incontinence for a minimum of three months, despite prior conservative or surgical treatments. The study was published in the Lancet Gastroenterology and Hepatology journal.
Between November 2015 and November 2020, 200 patients were randomly assigned to receive either BoNTA (n=100) or a placebo (n=100). Following withdrawals before injections, 96 patients received BoNTA, and 95 patients received the placebo. The primary endpoint was the number of faecal incontinence and urgency episodes per day, assessed using 21-day patient bowel diaries three months after treatment.
The findings revealed a significant decrease in the mean number of episodes in the BoNTA group from 1.9 at baseline to 0.8 at 3 months post-injections, compared to a decrease from 1.4 to 1.0 in the placebo group. The adjusted mean group difference at 3 months was estimated at -0.51 (95% CI -0.80 to -0.21, p=0.0008), highlighting the remarkable effectiveness of BoNTA injections.
The study demonstrated no serious treatment-related adverse events. Constipation was the most frequently reported non-serious adverse event, observed in 40% of patients receiving both BoNTA and placebo injections.
Lead researcher Anne-Marie Leroi, PhD, highlighted the significance of BoNTA injections as an efficacious treatment for urge faecal incontinence. Despite these promising results, further research is warranted to optimize selection criteria, dosage, injection site, frequency of re-injection, and long-term outcomes.
These findings mark a significant advancement in the treatment landscape for faecal incontinence, offering hope to individuals who have faced challenges with existing treatment options. The study's success in significantly reducing episodes of faecal incontinence and urgency with minimal adverse effects positions BoNTA injections as a potential breakthrough therapy in this field.
The study's results could pave the way for further research aiming to refine treatment protocols and assess the sustained effectiveness of BoNTA injections in managing urge faecal incontinence, ultimately improving the quality of life for affected individuals.
Reference:
Leroi, A.-M., Queralto, M., Zerbib, F., Siproudhis, L., Vitton, V., Amarenco, G., Etienney, I., Mion, F., Bridoux, V., Philip, J., Brochard, C., Damon, H., Lacroix, E., Gillibert, A., & Gourcerol, G. 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. The Lancet. Gastroenterology & Hepatology,2023. https://doi.org/10.1016/s2468-1253(23)00332-1
