Efficacy and safety of botulinum toxin a injection compared with topical nitroglycerin ointment for the treatment of chronic anal fissure: a prospective randomized study.
OBJECTIVE
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.
Fruehauf
Heiko
H
Gastroenterology and Hepatology, Department of Internal Medicine, University Hospital Zurich, Raemistrasse, Zurich, Switzerland.
Fried
Michael
M
Wegmueller
Barbara
B
Bauerfeind
Peter
P
Thumshirn
Miriam
M
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000627:therapeutic use; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005260:Female; D005401:Fissure in Ano / Q000188:drug therapy*; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D005996:Nitroglycerin / Q000008:administration & dosage* / Q000627:therapeutic use; D009824:Ointments; D011446:Prospective Studies; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D014945:Wound Healing
D009465:Neuromuscular Agents; D009824:Ointments; D014665:Vasodilator Agents; D019274:Botulinum Toxins, Type A; D005996:Nitroglycerin