Injection of botulinum toxin before pneumatic dilatation in achalasia treatment: a randomized‐controlled trial

BACKGROUND: Pneumatic dilatation is the first line therapy in achalasia, but half of patients relapse within 5 years of therapy and require further dilatations. AIM: To assess whether botulinum toxin injection before pneumatic dilatation is superior to pneumatic dilatation alone in achalasia patients. METHODS: Newly diagnosed achalasia patients were randomly assigned to receive botulinum toxin 1 month before pneumatic dilatation (botulinum toxin-pneumatic dilatation group: 27 patients with median age of 38) or to undergo pneumatic dilatation alone (pneumatic dilatation group: 27 patients with median age of 30). Response to therapy was assessed by clinical and objective methods at various intervals. RESULTS: One-year remission rate of patients in botulinum toxin-pneumatic dilatation group was 77% compared with 62% in pneumatic dilatation group (P = 0.1). In pneumatic dilatation group, the oesophageal barium volume significantly (P < 0.001) decreased at 1 month, but this reduction did not persist over 1-year follow-up. Botulinum toxin-pneumatic dilatation group showed a significant (P < 0.001) reduction in barium volume at the various times intervals post-treatment. In the botulinum toxin-pneumatic dilatation group, 10/11 (91%) patients over 40 were in remission at 1 year, comparing with only five of nine (55%) cases in pneumatic dilatation group (P = 0.07). CONCLUSION: Injection of botulinum toxin before pneumatic dilatation does not significantly enhance the efficacy of pneumatic dilatation.