Comparison of Pneumatic Dilation with Pneumatic Dilation Plus Botulinum Toxin for Treatment of Achalasia

Among the therapeutic options for achalasia are pneumatic dilatation (PD)، an appropriate long-term therapy، and botulinum toxin injection (BT) that is a relatively short-term therapy. This study aimed to compare therapeutic effect of repetitive pneumatic dilation with a combined method (botulinum toxin injection and pneumatic dilation) in a group of achalasia patients who are low responder to two initial pneumatic dilations. Thirty- four patients with documented primary achalasia that had low response to two times PD (<50% decrease in symptom score and barium height at 5 minute in timed esophagogram after 3month of late PD) were randomized to receive pneumatic dilation (n=18) or botulinum toxin injection and pneumatic dilation by four weeks interval (n=16)، PD and BT+PD groups respectively. Symptom scores were evaluated before and at 1، 6 and 12 months after treatment. Clinical remission was defined as a decrease in symptom score ≥ 50% of baseline. There were no significant differences between the two groups in gender، age and achalasia type. Remission rate of patients in BT-PD group in comparison with PD group were 87. 5% vs. 67. 1% (P = 0. 7)، 87. 5% vs. 61. 1% (P = 0. 59) and 87. 5% vs. 55. 5% (P = 0. 53) at 1، 6 and 12 months respectively. There were no major complications in either group. The mean symptom score decreased by 62. 71% in the BT-PD group (P < 0. 002) and 50. 77% in the PD group (P < 0. 01) at the end of the first year. Despite a better response rate in BT+PD group، a difference was not statistically significant. A difference may be meaningful if a large numbers of patients are included in the study.