CONTROLLED TRIAL OF BOTULINUM TOXIN INJECTION VERSUS PLACEBO AND PNEUMATIC DILATION IN ACHALASIA

Background & Aims: Intrasphincteric injection of botulinum toxin has b een suggested as an alternative treatment modality in esophageal achal asia. A controlled trial comparing botulinum toxin, placebo, and pneum atic dilation is reported. Methods: Sixteen patients received random i ntrasphincteric injections of either botulinum toxin or saline. The ef ficacy of treatment was assessed by symptom score, esophageal manometr y, and scintigraphy. In case of failure, pneumatic dilation was perfor med. Results: One month after injection, symptoms had improved in all patients treated with botulinum toxin (symptom score, 0.9 +/- 0.6 vs. 5.5 +/- 1.4; P < 0.02). In the placebo group, symptoms were unchanged in all patients, who were all dilated, Lower esophageal sphincter pres sure decreased by 49% after treatment with botulinum toxin (P < 0.03) and by 72% after dilation (P < 0.01). Similarly, esophageal retention decreased by 47% after treatment with botulinum toxin (P < 0.02) and b y 59% after dilation (P < 0.02). No significant difference in symptom score and esophageal function test results was found between patients treated with botulinum toxin injections and those undergoing dilation. However, 7 of the 8 patients in the botulinum toxin group required a- second injection because of recurrent dysphagia. Conclusions: Treatmen t of achalasia with botulinum toxin was as effective as pneumatic dila tion in relieving symptoms and improving: esophageal function. The eff ect of the first injection was temporary, but the effect of the second injection lasted longer.