title: Randomized controlled trial comparing botulinum toxin injection to pneumatic dilatation for the treatment of achalasia.
abstract: BACKGROUND
  Therapeutic options for achalasia include pharmacological therapy, surgical myotomy, pneumatic dilatation and intrasphincteric botulinum toxin injection.
  
  
  OBJECTIVE
  To compare botulinum toxin injection with pneumatic dilatation in a randomized trial.
  
  
  METHODS
  Forty adults with newly diagnosed achalasia were randomized to receive botulinum toxin (n=20) or pneumatic dilatation (n=20). Symptom scores were evaluated at 1, 6 and 12 months. Clinical relapse was defined as a symptom score greater than 50% of baseline. Relapsers received a second botulinum toxin injection or pneumatic dilatation.
  
  
  RESULTS
  The cumulative 12-month remission rate was significantly higher after a single pneumatic dilatation (53%) compared to a single botulinum toxin injection (15%)(P < 0.01). The 12-month estimated adjusted hazard for relapse and need for retreatment for the botulinum toxin group was 2.69 times that of the pneumatic dilatation group (95% confidence interval; 1.18-6.14). When a second treatment was administered to the relapsers in each group, the cumulative remission rate 1 year after initial treatment was significantly higher in the pneumatic dilatation group (100%) compared to the botulinum toxin group (60%) (P < 0.01). There were no major complications in either group.
  
  
  CONCLUSIONS
  Pneumatic dilatation is more efficacious than botulinum toxin in providing sustained symptomatic relief in patients with achalasia. The efficacy of a single pneumatic dilatation is similar to that of two botulinum toxin injections.
authors.affiliation: Digestive Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: J
authors.initials: J
authors.lastname: Mikaeli
authors.forename: A
authors.initials: A
authors.lastname: Fazel
authors.forename: G
authors.initials: G
authors.lastname: Montazeri
authors.forename: M
authors.initials: M
authors.lastname: Yaghoobi
authors.forename: R
authors.initials: R
authors.lastname: Malekzadeh
mesh_terms: D001905:Botulinum Toxins / Q000627:therapeutic use*; D002404:Catheterization / Q000379:methods*; D004931:Esophageal Achalasia / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D001905:Botulinum Toxins