title: Comparison of two different formulations of botulinum toxin A for the treatment of oesophageal achalasia. The Gismad Achalasia Study Group.
abstract: BACKGROUND
  Intrasphincteric injection of botulinum toxin has been reported as a safe and effective alternative treatment in oesophageal achalasia, especially in high-risk and elderly patients.
  
  
  OBJECTIVE
  : To compare two formulations of botulinum toxin in the management of achalasia.
  
  
  METHODS
  We randomly compared the efficacy and safety of 100 U of Botox (Allergan, Irvine, USA) and 250 U of Dysport (Ipsen, Milan, Italy), injected through a sclerotherapy needle at the level of the lower oesophageal sphincter, in 78 consecutive patients with achalasia. Symptom score, oesophageal manometry and 24 h pH-metry were recorded (before and 1 month after therapy). Symptom score was also obtained 6 months after treatment.
  
  
  RESULTS
  One month after treatment, the effects of the toxin on symptoms and oesophageal tests were similar for both formulations. Lower oesophageal sphincter pressure decreased from 31 +/- 12 to 18 +/- 5 mmHg after Botox, and from 35 +/- 9 to 18 +/- 10 after Dysport. At the end of the follow-up period (6 months), symptom score decreased from 5 +/- 1.2 to 1.2 +/- 0.8 after Botox and from 5.2 +/- 1.5 to 1.5 +/- 1 after Dysport. Moreover, the percentages of patients who failed to respond to treatment (10% and 17.5%) and who relapsed during follow-up (12% and 24%) did not differ significantly. No patient complained of reflux symptoms after treatment, although abnormal acid exposure was documented in two subjects.
  
  
  CONCLUSIONS
  Both formulations of botulinum toxin have comparable efficacy in the treatment of oesophageal achalasia, for up to 6 months of follow-up.
authors.affiliation: Divisione di Gastroenterologia, Ospedale 'C.S.S.'-IRCSS, San Giovanni Rotondo, Italy. annesev@tin.it
authors.forename: V
authors.initials: V
authors.lastname: Annese
authors.forename: G
authors.initials: G
authors.lastname: Bassotti
authors.forename: G
authors.initials: G
authors.lastname: Coccia
authors.forename: V
authors.initials: V
authors.lastname: D'onofrio
authors.forename: G
authors.initials: G
authors.lastname: Gatto
authors.forename: A
authors.initials: A
authors.lastname: Repici
authors.forename: A
authors.initials: A
authors.lastname: Andriulli
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D002626:Chemistry, Pharmaceutical; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004931:Esophageal Achalasia / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005764:Gastroesophageal Reflux / Q000209:etiology; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A