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, d ouble-blind, multicenter design. The aim was to test the efficacy of local application of nifedipine gel(a) 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, a nd a proctoscopy and anorectal manometry were performed. Patients treated w ith nifedipine (n = 141) used topical 0.2 percent nifedipine gel every 12 h ours for three weeks. The control group, consisting of 142 patients, receiv ed topical 1 percent lidocaine and 1 percent hydrocortisone acetate gel dur ing therapy. Manometry was performed before and on Days 14 and 21. Anal pre ssures were measured by recording resting and squeeze pressures. RESULTS: R esults obtained were as follows: total remission from acute anal fissure wa s achieved after 21 days of therapy in 95 percent of the nifedipine-treated patients (P < 0.01), as opposed to 50 percent of the controls (P < 0.01), and previously elevated maximum resting anal pressures decreased from a mea n value +/- standard deviation of 72.5 +/- 10.07 mmHg to 50.5 +/- 10.03 mmH g in the nifedipine group. This represents a mean reduction of 30 percent ( P < 0.01). We also observed a significant decrease in squeeze pressures in nifedipine-treated patients (from a mean +/- standard deviation of 130.5 +/ - 19.25 mmHg to 108.5 +/- 18.55 mmHg, a mean reduction of 16.8 percent; P < 0.01). No changes in anal pressures were observed in the control group. We did not observe any systemic side effect or significant anorectal bleeding in patients treated with nifedipine. CONCLUSIONS: Our study clearly demons trates that the therapeutic use of nifedipine, which at present is used onl y in cardiovascular pathologies, should be extended with local use to the c onservative treatment of anal fissures.