Comparison of two different formulations of botulinum toxin A for the treatment of oesophageal achalasia. The Gismad Achalasia Study Group.
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.
Annese
V
V
Divisione di Gastroenterologia, Ospedale 'C.S.S.'-IRCSS, San Giovanni Rotondo, Italy. annesev@tin.it
Bassotti
G
G
Coccia
G
G
D'onofrio
V
V
Gatto
G
G
Repici
A
A
Andriulli
A
A
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
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A