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Randomized controlled trial comparing botulinum toxin injection to pneumatic dilatation for the treatment of achalasia.

Abstract：

BACKGROUND:Therapeutic options for achalasia include pharmacological therapy, surgical myotomy, pneumatic dilatation and intrasphincteric botulinum toxin injection. AIM:To compare botulinum toxin injection with pneumatic dilatation in a randomized trial. PATIENTS/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.

journal_name

Aliment Pharmacol Ther

journal_title

Alimentary pharmacology & therapeutics

authors

Mikaeli J,Fazel A,Montazeri G,Yaghoobi M,Malekzadeh R

doi

10.1046/j.1365-2036.2001.01065.x

subject

Has Abstract

pub_date

2001-09-01 00:00:00

pages

1389-96

issue

9

eissn

0269-2813

issn

1365-2036

pii

apt1065

journal_volume

15

pub_type

临床试验,杂志文章,随机对照试验

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