Does an Administration Technique of Botulinum Toxin (BT) Injection Matter? Final Results of a Randomized, Double-Blind Study in Patients with Non-advanced Achalasia

Abstract

BACKGROUND&AIM: BT injection is an alternative treatment for achalasia. We have suggested in a pilot study that standard BT injection from the antegrade view may not result in adequate lower esophageal sphincter (LES) infiltration and that combining BT injection from both antegrade and retroflexed views might be better. The aim of the study was to compare the standard and the modified administration techniques. The primary endpoint was the proportion of asymptomatic subject one year after the single injection. METHODS: A total of 35 patients with non-advanced achalasia were included into the study. In 18 patients, BT was administered from the antegrade view (group A). In 17 patients, BT was administered from both antegrade and retroflexed views (group B). In both groups, a total of 250 IU of Dysport (Beaufor Ipsen, France) was used. RESULTS: The mean age was 51.9 years (range 24-78) and there were 19 women and 16 men. The patients were followed up for a median of 24 months (13-30). There were two non-responders (one in each group). All remaining patients had rapid symptomatic improvement. In group A, 14 (82.4%) patients experienced a relapse during a median of 11 (6-15) months after the first injection. Three patients (17.6%) remained asymptomatic during a median of 29 (23-30) months. In group B, 10 patients (62.5%) reported a relapse over a median of 10.5 (5-16) months after the first injection. Six patients (37.5%) remained asymptomatic during a median of 20 (13-24) months (p=0.08 vs. group A). One year after the single BT injection, there were 7 asymptomatic patients in group A and 8 asymptomatic patients in group B (NS). Six relapsers (three in each group) were treated by the second and two of them (group B) by the third BT injection. Four of these patients remained asymptomatic. Remaining relapsers were treated by balloon dilatation (13 patients), surgery (3 patients) or calcium antagonists (2 patients). CONCLUSION: The modified BT administration technique combining BT injection from both antegrade and retroflexed views is at least as effective as the standard BT injection from the antegrade view. It can be used in patients where it is technically difficult to inject the BT from the antegrade view due to e.g. spastic sphincter or food residues.