title: Controlled trial of botulinum toxin injection versus placebo and pneumatic dilation in achalasia.
abstract: OBJECTIVE
  Intrasphincteric injection of botulinum toxin has been suggested as an alternative treatment modality in esophageal achalasia. A controlled trial comparing botulinum toxin, placebo, and pneumatic dilation is reported.
  
  
  METHODS
  Sixteen patients received random intrasphincteric injections of either botulinum toxin or saline. The efficacy of treatment was assessed by symptom score, esophageal manometry, and scintigraphy. In case of failure, pneumatic dilation was performed.
  
  
  RESULTS
  One month after injection, symptoms had improved in all patients treated with botulinum toxin (symptom score, 0.9 +/- 0.6 vs. 5.5 +/- 1.4; P < 0.02). In the placebo group, symptoms were unchanged in all patients, who were all dilated. Lower esophageal sphincter pressure decreased by 49% after treatment with botulinum toxin (P < 0.03) and by 72% after dilation (P < 0.01). Similarly, esophageal retention decreased by 47% after treatment with botulinum toxin (P < 0.02) and by 59% after dilation (P < 0.02). No significant difference in symptom score and esophageal function test results was found between patients treated with botulinum toxin injections and those undergoing dilation. However, 7 of the 8 patients in the botulinum toxin group required a second injection because of recurrent dysphagia.
  
  
  CONCLUSIONS
  Treatment of achalasia with botulinum toxin was as effective as pneumatic dilation in relieving symptoms and improving esophageal function. The effect of the first injection was temporary, but the effect of the second injection lasted longer.
authors.affiliation: Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, Istituto di Ricovero e Cura a Carattere Scientifico, San Giovanni Rotondo, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Annese
authors.forename: M
authors.initials: M
authors.lastname: Basciani
authors.forename: F
authors.initials: F
authors.lastname: Perri
authors.forename: G
authors.initials: G
authors.lastname: Lombardi
authors.forename: V
authors.initials: V
authors.lastname: Frusciante
authors.forename: P
authors.initials: P
authors.lastname: Simone
authors.forename: A
authors.initials: A
authors.lastname: Andriulli
authors.forename: G
authors.initials: G
authors.lastname: Vantrappen
mesh_terms: D000328:Adult; D000368:Aged; D001905:Botulinum Toxins / Q000008:administration & dosage*; D002404:Catheterization; D004311:Double-Blind Method; D004931:Esophageal Achalasia / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged
chemical_list: D001905:Botulinum Toxins