Document Detail

Efficacy and safety of botulinum toxin a injection compared with topical nitroglycerin ointment for the treatment of chronic anal fissure: a prospective randomized study.
MedLine Citation:
PMID:  16848808     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To evaluate the efficacy and safety of botulinum toxin A injection compared with topical nitroglycerin ointment for the treatment of chronic anal fissure (CAF). METHODS: Fifty outpatients with CAF were randomized to receive either a single botulinum toxin injection (30 IU Botox) or topical nitroglycerin ointment 0.2% b.i.d. for 2 wk. If the initial therapy failed, patients were assigned to the other treatment group for a further 2 wk. If CAF still showed no healing at wk 4, patients received combination therapy of botulinum toxin and nitroglycerin for 4 additional wk. Persisting CAF at wk 8 was treated according to the investigator's decision. Healing rates, symptoms, and side effects of the therapy were recorded at wk 2, 4, 8, 12, and 24 after randomization. RESULTS: The group initially treated with nitroglycerin showed a higher healing rate of CAF (13 of 25, 52%) as compared with the botulinum toxin group (6 of 25, 24%) after the first 2 wk of therapy (p < 0.05). At the end of wk 4, CAF healed in three additional patients, all receiving nitroglycerin after initial botulinum toxin injection. Mild side effects occurred in 13 of 50 (26%) patients, all except one were on nitroglycerin. CONCLUSIONS: Nitroglycerin ointment was superior to the more expensive and invasive botulinum toxin injection for initial healing of CAF, but was associated with more but mild side effects.
Heiko Fruehauf; Michael Fried; Barbara Wegmueller; Peter Bauerfeind; Miriam Thumshirn
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-07-18
Journal Detail:
Title:  The American journal of gastroenterology     Volume:  101     ISSN:  0002-9270     ISO Abbreviation:  Am. J. Gastroenterol.     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-09-13     Completed Date:  2006-10-19     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0421030     Medline TA:  Am J Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2107-12     Citation Subset:  IM    
Gastroenterology and Hepatology, Department of Internal Medicine, University Hospital Zurich, Raemistrasse, Zurich, Switzerland.
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MeSH Terms
Administration, Topical
Botulinum Toxin Type A / administration & dosage*,  therapeutic use
Chronic Disease
Drug Therapy, Combination
Fissure in Ano / drug therapy*
Follow-Up Studies
Injections, Intralesional
Middle Aged
Neuromuscular Agents / administration & dosage*,  therapeutic use
Nitroglycerin / administration & dosage*,  therapeutic use
Prospective Studies
Treatment Outcome
Vasodilator Agents / administration & dosage*,  therapeutic use
Wound Healing
Reg. No./Substance:
0/Botulinum Toxin Type A; 0/Neuromuscular Agents; 0/Ointments; 0/Vasodilator Agents; 55-63-0/Nitroglycerin

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