Document Detail

Botulinum neurotoxin to treat chronic anal fissure: results of a randomized "Botox vs. Dysport" controlled trial.
MedLine Citation:
PMID:  15023172     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Botulinum neurotoxin induces healing in patients with idiopathic fissure. The optimal dosage is not well established. AIM: To compare the efficacy and tolerability of two different formulations of type A botulinum neurotoxin, and to provide more evidence with regard to the choice of dosage regimens. METHODS: Symptomatic adults with chronic anal fissure were enrolled in a randomized study. The outcome of each group was evaluated clinically, and by comparing the pressure of the anal sphincters before and after treatment. RESULTS: Fifty patients received injections of 50 units of Botox formulation (group I), and 50 patients received injections of 150 units of Dysport toxin (group II). One month after injection, 11 patients in group I and eight in group II had mild incontinence of flatus. At the 2-month evaluation point, 46 patients in group I and 47 patients in group II had a healing scar. In group I patients, the mean resting anal pressure was 41.8% lower, and the maximum voluntary squeeze pressure was 20.2% lower, than the baseline value. In group II patients, the resting anal pressure and maximum voluntary squeeze pressure were 60.0 +/- 12.0 mmHg and 71.0 +/- 30.0 mmHg, respectively. There were no relapses during an average of about 21 months of follow-up. CONCLUSIONS: Botulinum neurotoxin may be considered an effective treatment in patients with chronic anal fissure. The efficacy and tolerability of the two different formulations of botulinum neurotoxin were indistinguishable.
G Brisinda; A Albanese; F Cadeddu; A R Bentivoglio; A Mabisombi; G Marniga; G Maria
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  19     ISSN:  0269-2813     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2004 Mar 
Date Detail:
Created Date:  2004-03-16     Completed Date:  2004-08-13     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  695-701     Citation Subset:  IM    
Department of Surgery, Catholic School of Medicine, University Hospital Agostino Gemelli, Rome, Italy.
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MeSH Terms
Botulinum Toxin Type A / therapeutic use*
Chronic Disease
Fissure in Ano / drug therapy*
Neuromuscular Agents / therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/Botulinum Toxin Type A; 0/Neuromuscular Agents
Comment In:
Aliment Pharmacol Ther. 2004 Jul 1;20(1):125; author reply 125-7   [PMID:  15225181 ]

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