Botulinum toxin reduces Dysphagia in patients with nonachalasia primary esophageal motility disorders.

Abstract

BACKGROUND & AIMS:

Endoscopic injection of botulinum toxin (BTX) has shown benefits for patients with diffuse esophageal spasm (DES) and nutcracker esophagus (NE) in small uncontrolled trials. We investigated the effect of BTX on symptoms of patients with DES or NE and assessed manometry findings in a prospective, double-blind, randomized, controlled study.

METHODS:

We assessed 22 patients with dysphagia-predominant, manometry-confirmed DES or NE (6 men; age, 63 ± 2 y) at a tertiary care medical center. Patients were given injections of BTX (8 × 12.5 U) or saline (8 × 0.5 mL) in 4 quadrants, at 2 and 7 cm above the esophagogastric junction. After 1 month, patients crossed over between groups and received endoscopic injections of BTX or saline. When the study began and 4 weeks after each injection, the patients were assessed by esophageal manometry and completed a symptom questionnaire (to determine solid and liquid dysphagia, chest pain, and regurgitation and heartburn; all scored 0-4). Responders were defined based on modified Vantrappen criteria for achalasia.

RESULTS:

After BTX injections, patients had significant decreases in total symptom scores (sum of solid and liquid dysphagia and chest pain; from 7.6 ± 0.7 to 4.8 ± 0.8; P = .01); this decrease was not observed in patients who received saline injections. Moreover, BTX injection stabilized unintentional weight loss (weight gain of 0.3 ± 0.3 after BTX injection vs further weight loss of 1.6 ± 0.5 kg after saline injection; P = .01). Fifty percent of patients had a response 1 month after BTX injection, compared with 10% after saline injection (P = .04); 30% still had a response 1 year after BTX injection. BTX injection also caused a significant decrease in the mean esophagogastric junction pressure, compared with baseline (15.8 ± 1.7 vs 24.0 ± 2.8 mm Hg; P = .02).

CONCLUSIONS:

In a prospective controlled study of patients with DES and NE, injections of BTX reduced symptoms and stabilized unintentional weight loss.

TRIAL REGISTRY:

http://www.targid.eu, ML2669, ML6294.

• Authors: Tim Vanuytsel, Raf Bisschops, Ricard Farré, Ans Pauwels, Lieselot Holvoet, Joris Arts, Philip Caenepeel, Dominiek De Wulf, Kostas Mimidis, Nathalie Rommel, Jan Tack
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 11 Issue 9 Pg. 1115-1121.e2 (Sep 2013) ISSN: 1542-7714 [Electronic] United States
• PMID: 23591282 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Botulinum Toxins

Topics

• Adult
• Aged
• Botulinum Toxins (therapeutic use)
• Deglutition Disorders (drug therapy)
• Double-Blind Method
• Endoscopy (methods)
• Esophageal Motility Disorders (complications)
• Esophageal Spasm, Diffuse (complications)
• Female
• Humans
• Male
• Manometry
• Middle Aged
• Prospective Studies
• Surveys and Questionnaires
• Treatment Outcome