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.

AIM:

: To compare two formulations of botulinum toxin in the management of achalasia.

PATIENTS AND 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: V Annese, G Bassotti, G Coccia, V D'onofrio, G Gatto, A Repici, A Andriulli
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 13 Issue 10 Pg. 1347-50 (Oct 1999) ISSN: 0269-2813 [Print] England
• PMID: 10540051 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Adult
• Aged
• Botulinum Toxins, Type A (administration & dosage, adverse effects)
• Chemistry, Pharmaceutical
• Dose-Response Relationship, Drug
• Double-Blind Method
• Esophageal Achalasia (complications, drug therapy)
• Female
• Gastroesophageal Reflux (etiology)
• Humans
• Hydrogen-Ion Concentration
• Male
• Middle Aged
• Neuromuscular Agents (administration & dosage, adverse effects)