Randomized controlled trial comparing botulinum toxin injection to pneumatic dilatation for the treatment of achalasia.
BACKGROUND
Therapeutic options for achalasia include pharmacological therapy, surgical myotomy, pneumatic dilatation and intrasphincteric botulinum toxin injection.


OBJECTIVE
To compare botulinum toxin injection with pneumatic dilatation in a randomized trial.


METHODS
Forty adults with newly diagnosed achalasia were randomized to receive botulinum toxin (n=20) or pneumatic dilatation (n=20). Symptom scores were evaluated at 1, 6 and 12 months. Clinical relapse was defined as a symptom score greater than 50% of baseline. Relapsers received a second botulinum toxin injection or pneumatic dilatation.


RESULTS
The cumulative 12-month remission rate was significantly higher after a single pneumatic dilatation (53%) compared to a single botulinum toxin injection (15%)(P < 0.01). The 12-month estimated adjusted hazard for relapse and need for retreatment for the botulinum toxin group was 2.69 times that of the pneumatic dilatation group (95% confidence interval; 1.18-6.14). When a second treatment was administered to the relapsers in each group, the cumulative remission rate 1 year after initial treatment was significantly higher in the pneumatic dilatation group (100%) compared to the botulinum toxin group (60%) (P < 0.01). There were no major complications in either group.


CONCLUSIONS
Pneumatic dilatation is more efficacious than botulinum toxin in providing sustained symptomatic relief in patients with achalasia. The efficacy of a single pneumatic dilatation is similar to that of two botulinum toxin injections.
Mikaeli
J
J
Digestive Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Fazel
A
A
Montazeri
G
G
Yaghoobi
M
M
Malekzadeh
R
R
D001905:Botulinum Toxins / Q000627:therapeutic use*; D002404:Catheterization / Q000379:methods*; D004931:Esophageal Achalasia / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D016896:Treatment Outcome
D001905:Botulinum Toxins