A Modified Method of Botulinum Toxin Injection in Patients with Achalasia: a Pilot Trial

Background and aims: Injection of botulinum toxin (BT) from direct vision into the lower esophageal sphincter (LES) lowers its basal tone and improves symptomatology in most of the patients with achalasia. We hypothesized that the effect could be improved by better degree of LES infiltration by toxin administered from both prograde and retrograde views. The aim of the study was to investigate the feasibility, safety and efficacy of this modified method of intrasphincteric BT injection in patients with achalasia.
Patients and method: Sixteen patients with achalasia were treated with BT injection. Hundred units of BT (Botox®) were diluted with 4 ml of normal saline. Aliquots of 0.5 ml were injected into four quadrants of the LES from retrovision and then into each quadrant from direct vision. The patients were followed up for a median of 25.5 months (range 19 - 31).
Results: No serious adverse events were noted. All patients responded well to the injection within one week and 3 patients (18.7 %) experienced an early relapse. The remaining 13 patients were classified as responders. After a single BT injection, 11 responders reported a relapse and 2 patients remained asymptomatic. The median symptom-free interval was 17 months (8 - 28). Five patients with a relapse underwent BT reinjection. Three of them remained asymptomatic and two experienced the second relapse. After BT reinjection, the median symptom-free interval was 16 months (10 - 19). All other patients with a relapse and without BT reinjection were treated with either balloon dilatation or surgery and are currently asymptomatic
Conclusion: Combining injection of BT into the LES from both direct vision and retrovision was feasible, safe and produced a rapid response which was sustained for more than 1 year in the majority of patients. This method of BT administration might be superior to the traditional injection from direct view only, and a randomized and prospective study comparing those techniques of administration should be performed.

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