Clinical study on combined therapy of botulinum toxin injection and small balloon dilation in patients with esophageal achalasia.

BACKGROUND AND STUDY AIMS: To compare the efficiency of pneumatic balloon dilation, botulinum toxin (BT) injection, and the combination of the two modalities in the management of esophageal achalasia. PATIENTS AND METHODS: Ninety patients with esophageal achalasia were randomly divided into three groups according to different interventions, i.e. patients in group A received 100 U BT injection; patients in group B were given balloon dilation, and patients in group C were subjected to balloon dilation plus 100 U BT injection 15 days after the dilation. Clinical assessment and esophageal manometry were performed by experienced gastroenterologists. All patients were followed-up for more than 2 years.
RESULTS: At any time after the treatment, the lower esophageal sphincter pressure and symptom score in group C were lower compared with those in group A or group B (p < 0.05). At 2 years after treatment, the response rate in group C remained 56.67%, still higher than those in the other groups (p < 0.05); the response rate in group B was only 35.71% (10/28); the response rate in group A was 13.79%, the lowest among the three groups.
CONCLUSIONS: The efficiency of the combination of 100 U BT administration and small balloon dilation is superior to the single modality approach. Copyright (c) 2010 S. Karger AG, Basel.

RCT Entities:   Population Interventions Outcomes