IN BRIEF

Botox Appears Safe for Treatment of Defecation Disorders

February 6, 2020
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Complications reported are rare and temporary.

Anal botulinum toxin injections (Botox) have increasingly been used in children with functional anorectal and colonic disorders during the past 15 years. A study at Nationwide Children’s Hospital, combined with a review of published literature, shows this off-label use of Botox is safe and complications are rare.

Complications occurred in less than 0.7% of 1332 Botox injections used to treat children with severe functional constipation or those who were still symptomatic children after surgery for Hirschsprung disease. The complications included urinary incontinence, pelvic muscle paresis, perianal abscess, pruritis ani and rectal prolapse. None were severe or permanent.

“If one does see a complication, which is incredibly rare, one can counsel family’s that ‘as much as this is frustrating, it is self-limiting and will go away,’” says Richard Wood, MBChB, FCPS(SA), chief of the Department of Pediatric Colorectal and Pelvic Reconstructive Surgery at Nationwide Children’s and senior author of the study. “They go away because the effect of botulinum toxin goes away.”

The research is published in Journal of Pediatric Surgery.

The investigators reviewed the charts of 332 patients who had received one or more anal botulinum toxin injections at Nationwide Children’s from 2014 to 2018, and studies of a total of 549 patients treated at other institutions. All together, the studies report nine complications.

“Even though our perception was that it was safe and effective, we wanted to make sure that was the case,” says Carlo Di Lorenzo, MD, division chief of Pediatric Gastroenterology, Hepatology and Nutrition at Nationwide Children’s and study co-author. “Our own cases and the literature suggest that yes, it is safe at the doses we use and the way we do it. Clinicians should feel comfortable using it in the right type of patient.”

In these patients, the injections are supposed to relax the sphincter muscles slightly, making it easier for them to pass stools. But not all children appear to benefit.

Drs. Wood and Di Lorenzo and colleagues are continuing their study, to show that the injections are effective and determine which patients benefit most.

“Even if it is safe, we don’t want to use Botox unnecessarily,” says Dr. Wood, who is also an assistant professor of Pediatric Surgery at The Ohio State University College of Medicine. “We want to be able to direct therapy in a more refined way.”

The investigators will also study dosage size and frequency, and where, precisely, is the best location to inject Botox for the condition being treated.

The researchers hope their findings will add to the body of literature that may persuade more insurance companies to cover costs of the off-label use, and in the future, gain approval from the U.S. Food and Drug Administration.

 

Reference

Halleran DR, Lu PL, Ahmad H, Paradiso MM, Lehmkuhl H, Akders A, Hallagan A, Bali N, Vaz K, Yacob D, Di Lorenzo C, Wood RJ. Anal sphincter botulinum toxin injection in children with functional anorectal and colonic disorders: A large institutional study and review of the literature focusing on complications. Journal of Pediatric Surgery. 2019 Nov;54(11):2305-2310.

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