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.
RCT Entities:
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.
Authors: R L Nelson; D Manuel; C Gumienny; B Spencer; K Patel; K Schmitt; D Castillo; A Bravo; A Yeboah-Sampong Journal: Tech Coloproctol Date: 2017-08-09 Impact factor: 3.781
Authors: Sabrina Maria Ebinger; Julia Hardt; René Warschkow; Bruno Martin Schmied; Alexander Herold; Stefan Post; Lukas Marti Journal: J Gastroenterol Date: 2017-04-10 Impact factor: 7.527
Authors: Pierpaolo Sileri; Alessandra Mele; Vito M Stolfi; Michele Grande; Giuseppe Sica; Paolo Gentileschi; Sara Di Carlo; Achille L Gaspari Journal: J Gastrointest Surg Date: 2007-08-31 Impact factor: 3.452
Authors: Kemal Arslan; Bülent Erenoğlu; Osman Doğru; Ersin Turan; Mehmet Ali Eryilmaz; Arif Atay; Said Kökçam Journal: Surg Today Date: 2012-09-09 Impact factor: 2.549
Authors: Scott M Berry; Charles F Barish; Raj Bhandari; Gemma Clark; Gregory V Collins; Julian Howell; John E Pappas; Dennis S Riff; Michael Safdi; Ann Yellowlees Journal: BMC Gastroenterol Date: 2013-07-01 Impact factor: 3.067