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Background and Study Aims: In patients with esophageal achalasia, pneumatic dilation is the treatment of choice, but it bears the risk of perforation in about 4% of cases. A new nonsurgical method, intrasphincteric injection of botulinum toxin A, has shown promising initial results, and we thus undertook this study to compare the long-term outcome of these two methods., Patients and Methods: In a prospective randomized study, 24 patients with definitive esophageal achalasia were divided into two equal groups and underwent either balloon dilation or injection of botulinum toxin (20 U injected into each of the four quadrants in the lower esophageal sphincter). The outcome was assessed on the basis of a symptom score documented before treatment and at regular intervals for two and a half years thereafter. Complications associated with the two techniques were also documented., Results: No relevant complication occurred in either of the treatment groups. Initially, dilation was successful in 10 of 12 patients (83%), and botulinum toxin injection in 9 of 12 patients (75%). The symptom scores showed no significant differences between the two groups before and one month after treatment. Over the two and a half year follow-up, however, all nine successfully treated patients in the botulinum toxin group experienced recurrence of symptoms, but only four of the ten patients (40%) in the dilation group., Conclusions: The two treatment methods initially had equal success rates, but in the long term the effect of the botulinum toxin injection was statistically significantly shorter than that of balloon dilation. As fewer risks are associated with the injection treatment, studies should be undertaken either to identify patient subgroups in whom botulinum toxin can be effective long-term or to test substances with longer-lasting effects.

Background: Pneumatic dilation is the most effective nonsurgical method for treatment of achalasia. The most serious complication of this procedure is esophageal perforation, which occurs in about 5% of cases. We completed a randomized prospective comparative trial with a high-compliance latex balloon (HCB) mounted on an endoscope (40 mm maximum distension diameter, 6 psi inflation pressure) and a low-compliance balloon (LCB) (35 mm, 20 psi) with respect to efficacy and side effects., Methods: Twenty-five patients (13 treated with HCB, 12 treated with LCB) were included. The symptom score was assessed both before and after dilation, biannually, for up to 2 years, and complications were graded for severity. All dilations lasted for 3 minutes and were performed under direct endoscopic control. Patients were randomly assigned to the two different balloon types., Results: One perforation was observed in the LCB group (not significant between HCB and LCB). Superficial mucosal tears appeared in 40% of all dilations. Initial dilation treatment was successful in 20 of 25 (80%) patients (10 of 13 HCB, 10 of 12 LCB). There were no significant differences in the median pretreatment and post-treatment symptom scores. Three patients required repeated dilations during the observation period. They were treated with the competing balloon system and showed no difference compared with the initial posttreatment symptom score., Conclusions: No significant difference could be demonstrated between the HCB and LCB system as far as the complication rate and the clinical outcome are concerned. In consequence, both systems appear equally effective, although the endoscope-mounted system (HCB) can be handled more easily.