Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomised trial

M F Vaezi,^a J E Richter,^a C M Wilcox,^c P L Schroeder,^c S Birgisson,^a R L Slaughter,^c R E Koehler,^d M E Baker^b

^a Department of Gastroenterology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA, ^b Division of Radiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA, ^c Division of Gastroenterology, University of Alabama at Birmingham, Birmingham, Alabama, USA, ^d Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama, USA

Correspondence to: Dr J E Richter, Chairman, Department of Gastroenterology, The Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195, USA.

Accepted for publication 19 August 1998

BackgroundIntrasphincteric injection of botulinum toxin is a new treatment option for achalasia.
AimsTo compare the immediate and long term efficacy of botulinum toxin with that of pneumatic dilatation.
MethodsSymptomatic patients with achalasia were randomised to botulinum toxin (22 patients, median age 57 years) or pneumatic dilatation (20 patients, median age 56 years). Symptom scores were assessed initially, and at one, three, six, nine, and 12 months after treatment. Objective assessment included oesophageal manometry initially and at one month, and barium oesophagram initially and at one, six, and 12 months post-treatment.
ResultsPneumatic dilatation resulted in a significantly (p=0.02) higher cumulative remission rate. At 12 months, 14/20 (70%) pneumatic dilatation and 7/22 (32%) botulinum toxin treated patients were in symptomatic remission (p=0.017). Failure rates were similar initially, but failure over time was significantly (p=0.01) higher after botulinum toxin (50%) than pneumatic dilatation (7%). Pneumatic dilatation resulted in significant (p<0.001) reduction in symptom scores, and lower oesophageal sphincter pressure, oesophageal barium column height, and oesophageal diameter. Botulinum toxin produced significant reduction in symptom scores (p<0.001), but no reduction in objective parameters.
ConclusionsAt one year pneumatic dilatation is more effective than botulinum toxin. Symptom improvement parallels objective oesophageal measurements after pneumatic dilatation but not after botulinum toxin treatment for achalasia.
(GUT 1999;44:231-239)

Keywords: achalasia;  pneumatic dilatation;  botulinum toxin;  barium oesophagram