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.