Nifedipine for local use in conservative treatment of anal fissures: preliminary results of a multicenter study

PURPOSE: This study was performed according to a prospective, randomized, double-blind, multicenter design. The aim was to test the efficacy of local application of nifedipine gela in healing acute anal fissure by relaxing the internal anal sphincter. METHODS: Two hundred eighty-three patients who gave informed consent were recruited; they received a clinical examination. A questionnaire to evaluate the symptoms and the pain was administered, and a proctoscopy and anorectal manometry were performed. Patients treated with nifedipine (n=141) used topical 0.2 percent nifedipine gel every 12 hours for three weeks. The control group, consisting of 142 patients, received topical 1 percent lidocaine and 1 percent hydrocortisone acetate gel during therapy. Manometry was performed before and on Days 14 and 21. Anal pressures were measured by recording resting and squeeze pressures. RESULTS: Results obtained were as follows: total remission from acute anal fissure was achieved after 21 days of therapy in 95 percent of the nifedipine-treated patients (P