Evelyn R Hermes DeSantis1, Sheilyn Huang. 1. Drug Information Service, Robert Wood Johnson University Hospital (RWJUH), New Brunswick, NJ, USA. ehermesd@rci.rutgers.edu
Abstract
PURPOSE: The clinical efficacy and adverse reactions of botulinum toxin type A for refractory gastroparesis are discussed. SUMMARY: Botulinum toxin type A does not have an FDA-labeled indication for the treatment of gastroparesis, but it has been evaluated for this indication in several small case studies and open-label trials. The dose of botulinum toxin type A ranged from 80 to 200 units, injected directly into the pylorus in patients refractory to standard management. One study found both clinical and scintigraphic improvements in patients with diabetic gastroparesis that were maintained for at least six weeks. In another study in patients with diabetic gastroparesis, the agent decreased gastric emptying time and improved nausea, vomiting, and abdominal pain but did not significantly improve patients' overall quality of life. In a study consisting of a chart review, 27 (43%) of 63 patients responded to botulinum toxin type A and 36 patients (57%) did not. Responders had a mean duration of response of 5.1 months. A study in patients with idiopathic gastroparesis found improved gastric emptying and improved symptom scores in most cases. Botulinum toxin type A is contraindicated in patients with infection at the injection site or hypersensitivity to any of the ingredients. There have been rare reports of serious hypersensitivity reactions. Dysphagia is common. CONCLUSION: Botulinum toxin type A may be effective in the management of refractory gastroparesis; however, large, double-blind, placebo-controlled trials are needed to confirm this.
PURPOSE: The clinical efficacy and adverse reactions of botulinum toxin type A for refractory gastroparesis are discussed. SUMMARY: Botulinum toxin type A does not have an FDA-labeled indication for the treatment of gastroparesis, but it has been evaluated for this indication in several small case studies and open-label trials. The dose of botulinum toxin type A ranged from 80 to 200 units, injected directly into the pylorus in patients refractory to standard management. One study found both clinical and scintigraphic improvements in patients with diabetic gastroparesis that were maintained for at least six weeks. In another study in patients with diabetic gastroparesis, the agent decreased gastric emptying time and improved nausea, vomiting, and abdominal pain but did not significantly improve patients' overall quality of life. In a study consisting of a chart review, 27 (43%) of 63 patients responded to botulinum toxin type A and 36 patients (57%) did not. Responders had a mean duration of response of 5.1 months. A study in patients with idiopathic gastroparesis found improved gastric emptying and improved symptom scores in most cases. Botulinum toxin type A is contraindicated in patients with infection at the injection site or hypersensitivity to any of the ingredients. There have been rare reports of serious hypersensitivity reactions. Dysphagia is common. CONCLUSION: Botulinum toxin type A may be effective in the management of refractory gastroparesis; however, large, double-blind, placebo-controlled trials are needed to confirm this.