Randomized controlled trial comparing botulinum toxin injection to pneumatic dilatation for the treatment of achalasia
Open Access
- 27 September 2001
- journal article
- clinical trial
- Published by Wiley in Alimentary Pharmacology & Therapeutics
- Vol. 15 (9), 1389-1396
- https://doi.org/10.1046/j.1365-2036.2001.01065.x
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.Keywords
This publication has 21 references indexed in Scilit:
- Comparison of two different formulations of botulinum toxin A for the treatment of oesophageal achalasiaAlimentary Pharmacology & Therapeutics, 1999
- Esophageal Achalasia: Intrasphincteric Injection of Botulinum Toxin A Versus Balloon DilationEndoscopy, 1999
- Current Therapies for AchalasiaJournal of Clinical Gastroenterology, 1998
- Pneumatic dilation in achalasia with a low-compliance balloon: results of a 5-year prospective evaluationGastrointestinal Endoscopy, 1995
- Endoscopic Intrasphincteric Injection of Botulinurn Toxin for the Treatment of AchalasiaJournal of Clinical Gastroenterology, 1995
- The Cohen test does not predict outcome in achalasia after pneumatic dilationGastrointestinal Endoscopy, 1993
- Achalasia: Prospective Evaluation of Relationship Between Lower Esophageal Sphincter Pressure, Esophageal Transit, and Esophageal Diameter and Symptoms in Response to Pneumatic DilationMayo Clinic Proceedings, 1993
- Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trialsJAMA, 1991
- Forceful balloon dilation: an outpatient procedure for achalasiaGastrointestinal Endoscopy, 1990
- Balloon dilatation in achalasia: a new dilator.Gut, 1986