Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up.

BACKGROUND: The aim of this study was to compare the efficacy of the local application of 0.5% nifedipine ointment vs. lateral internal sphincterotomy in the healing of chronic anal fissure. PATIENTS AND METHODS: Sixty-four patients with symptomatic chronic anal fissures were randomly assigned to 0.5% nifedipine ointment (n=32) every 8 h for 8 weeks or lateral internal sphincterotomy (n=32). Both groups received stool softeners and fiber supplements and were assessed at 2, 4, 6, and 8 weeks. Long-term outcomes were determined after a median follow-up of 19 months (nifedipine group) and 20.5 months (lateral internal sphincterotomy group).
RESULTS: Complete healing at 8 weeks was achieved in 30 out of 31 patients (96.7%) in the nifedipine group and 32 out of 32 patients (100%) in the lateral internal sphincterotomy group (p=0.49). The overall healing rates at the end of follow-up were 28 out of 30 (93%) vs. 32 out of 32 (100%) in the nifedipine and sphincterotomy groups respectively (p=0.48). Two of the 30 patients in the nifedipine group relapsed whereas none in the sphincterotomy group did. Sixteen patients (50%) developed side effects in the nifedipine group, compared with six patients (18.7%) in the sphincterotomy group.
CONCLUSIONS: Topical application of 0.5% nifedipine ointment represents a new, promising, easily handled, effective alternative to lateral internal sphincterotomy.

RCT Entities:   Population Interventions Outcomes