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Brisinda G, Maria G, Bentivoglio AR, et al. A comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure. N Engl J Med. 1999 Jul 8;341:65-9.
Question
In patients with chronic anal fissure, are botulinum toxin injections more ef-fective than nitroglycerin ointment (glyceryl trinitrate [GTN]) for increasing the healing rate?
Design
Randomised (concealed), blinded (outcome assessor), controlled trial with 1- and 2-month follow-up.
Setting
Clinical centres in Rome.
Patients
50 adults (mean age 42 y, 50% women) with symptomatic chronic anal fissure, which was defined as evidence of posterior circumscribed ulcer with a large sentinel tag of skin, induration at edges, and exposure of horizontal fibres of the internal anal sphincter; and symptoms of post-defecatory or nocturnal pain, bleeding, or both for 2 months. Exclusion criteria were acute fissure, fissure associated with other conditions, or previous surgery in the anal canal. Follow-up was complete.
Intervention
Patients were allocated to 2 injections of botulinum toxin A, 20 U in 0.4 mL of solution (n = 25), or 0.2% GTN (10 g of 2% nitroglycerin diluted to 100 g with soft paraffin) …