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.


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.
Katsinelos
Panagiotis
P
Department of Endoscopy and Motility Unit, Central Hospital, Ethnikis Aminis 41, 54635 Thessaloniki, Greece. papaziog@med.auth.gr
Papaziogas
Basilios
B
Koutelidakis
Ioannis
I
Paroutoglou
George
G
Dimiropoulos
Stavros
S
Souparis
Anastasios
A
Atmatzidis
Konstantinos
K
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000187:drug effects / Q000601:surgery*; D002908:Chronic Disease; D013505:Digestive System Surgical Procedures / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005401:Fissure in Ano / Q000188:drug therapy* / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*
D014665:Vasodilator Agents; D009543:Nifedipine