title: Randomized controlled trial of botulinum toxin versus laparoscopic heller myotomy for esophageal achalasia.
abstract: OBJECTIVE
  To compare laparoscopic cardia myotomy and fundoplication with botulinum toxin (BoTx) injection in patients with esophageal achalasia.
  
  
  BACKGROUND
  Although myotomy is thought to offer better results, recent studies have reported 80% success rates after 2 BoTx injections a month apart. No randomized controlled trials comparing the 2 treatments have been published so far.
  
  
  METHODS
  Newly diagnosed achalasia patients were randomly assigned to BoTx injection or laparoscopic myotomy. Symptoms were scored; lower esophageal sphincter resting and nadir pressures were measured by manometry; barium swallow was used to assess esophageal diameter pre- and post-treatment. Eight to one hundred units of BoTx were injected twice, a month apart, at the esophagogastric junction. Myotomy included anterior partial (Dor) or Nissen fundoplication.
  
  
  RESULTS
  Eighty patients were involved in the study: 40 received BoTx and 40 underwent myotomy. Mortality was nil. One surgical patient bled from the trocar site. Median hospital stay was 6 days for surgery; BoTox patients were treated as day-hospital admissions. All patients completed the follow-up. After 6 months, the results in the 2 groups were comparable, although symptom scores improved more in surgical patients (82% confidence interval [CI] 76-89 vs. 66% CI 57-75, P < 0.05). The drop in lower esophageal sphincter pressure was similar in the 2 groups; the reduction in esophageal diameter was greater after surgery (19% CI 13-26 vs. 5% CI 2-11, P < 0.05). Later on, symptoms recurred in 65% of the BoTx-treated patients and the probability of being symptom-free at 2 years was 87.5% after surgery and 34% after BoTx (P < 0.05).
  
  
  CONCLUSIONS
  Laparoscopic myotomy is as safe as BoTx treatment and is a 1-shot treatment that cures achalasia in most patients. BoTx should be reserved for patients who are unfit for surgery or as a bridge to more effective therapies, such as surgery or endoscopic dilation.
authors.affiliation: Department of Medical and Surgical Sciences, Clinica Chirurgica 4, University of Padova, Padova, Italy. giovanni.zaninotto@unipd.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Zaninotto
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.forename: Mario
authors.initials: M
authors.lastname: Costantini
authors.forename: Alberto
authors.initials: A
authors.lastname: Del Genio
authors.forename: Michela
authors.initials: M
authors.lastname: Costantino
authors.forename: Magdalena
authors.initials: M
authors.lastname: Epifani
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gatto
authors.forename: Vittorio
authors.initials: V
authors.lastname: D'onofrio
authors.forename: Luigi
authors.initials: L
authors.lastname: Benini
authors.forename: Sandro
authors.initials: S
authors.lastname: Contini
authors.forename: Daniela
authors.initials: D
authors.lastname: Molena
authors.forename: Giorgio
authors.initials: G
authors.lastname: Battaglia
authors.forename: Berardino
authors.initials: B
authors.lastname: Tardio
authors.forename: Angelo
authors.initials: A
authors.lastname: Andriulli
authors.forename: Ermanno
authors.initials: E
authors.lastname: Ancona
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000627:therapeutic use*; D001905:Botulinum Toxins / Q000627:therapeutic use*; D003679:Deglutition; D013505:Digestive System Surgical Procedures; D004931:Esophageal Achalasia / Q000601:surgery*; D004943:Esophagogastric Junction / Q000502:physiology; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged
chemical_list: D018726:Anti-Dyskinesia Agents; D001905:Botulinum Toxins