Randomized clinical trial comparing botulinum toxin injections with 0.2 per cent nitroglycerin ointment for chronic anal fissure.
BACKGROUND
In recent years treatment of chronic anal fissure has shifted from surgical to medical. This study compared the ability of two non-surgical treatments-botulinum toxin injections and nitroglycerin ointment-to induce healing in patients with idiopathic anal fissure.


METHODS
One hundred adults were assigned randomly to receive treatment with either type A botulinum toxin (30 units Botox or 90 units Dysport) injected into the internal anal sphincter or 0.2 per cent nitroglycerin ointment applied three times daily for 8 weeks.


RESULTS
After 2 months, the fissures were healed in 46 (92 per cent) of 50 patients in the botulinum toxin group and in 35 (70 per cent) of 50 in the nitroglycerin group (P=0.009). Three patients in the botulinum toxin group and 17 in the nitroglycerin group reported adverse effects (P<0.001). Those treated with botulinum toxin had mild incontinence to flatus that lasted 3 weeks after treatment but disappeared spontaneously, whereas nitroglycerin treatment was associated with transient, moderate-to-severe headaches. Nineteen patients who did not have a response to the assigned treatment crossed over to the other therapy.


CONCLUSIONS
Although treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery for patients with chronic anal fissure, botulinum toxin is the more effective option.
Brisinda
G
G
Department of Surgery, Catholic University Hospital Agostino Gemelli, Istituto di Clinica Chirurgica Generale, Policlinico Universitario Agostino Gemelli, Largo Agostino Gemelli 8, 00168 Rome, Italy. gbrisin@tin.it
Cadeddu
F
F
Brandara
F
F
Marniga
G
G
Maria
G
G
D000287:Administration, Topical; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; 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*; D005996:Nitroglycerin / Q000008:administration & dosage* / Q000009:adverse effects; D009824:Ointments; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014945:Wound Healing / Q000187:drug effects
D009465:Neuromuscular Agents; D009824:Ointments; D014665:Vasodilator Agents; D019274:Botulinum Toxins, Type A; D005996:Nitroglycerin