Int J Colorectal Dis. 2006 Mar;21(2):179-83. Epub 2005 Aug 10.
Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up.
Department of Endoscopy and Motility Unit, Central Hospital, Ethnikis Aminis 41, 54635 Thessaloniki, Greece. firstname.lastname@example.org
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).
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.
Topical application of 0.5% nifedipine ointment represents a new, promising, easily handled, effective alternative to lateral internal sphincterotomy.
Acta Medica Iranica, Vol. 48, No. 5 (2010)
The Effect of Topical Nifedipine in Treatment of Chronic Anal Fissure
Farzaneh Golfam, Parisa Golfam, Alireza Khalaj, and Sayed Saaid Sayed Mortaz
Depatment of Surgery, Mostafa Khomeini Hospital, Shahed University of Medical Sciences, Tehran, Iran
Depatment of Anesthesiology, Kermanshah University of Medical Sciences, Kermanshah, Iran
Abstract- Chronic anal fissure is the most common cause of anal pain associated with internal anal sphincter hypertonia. Reduction of hypertonocity is a special treatment for fissure healing. For this purpose chronic anal fissures were conventionally treated by anal dilatation or by lateral sphincterotomy. However, both of these methods may cause a degree of incontinence in some patients. The uptake of medical therapies that create a reversible chemical sphincterotomy has recently become widespread. The aim of this prospective
clinical trial study was to assess the effectiveness of nifedipine in healing anal fissure, a calcium channel blocker that reduces sphincter pressure. A single-blind randomized comparative trial was setup to compare traditional treatment with stool softeners and 2% lidocaine cream against 0.5% nifedipine cream for 4 weeks. 110 patients were included in this study, 60 patients in the nifedipine group and 50 patients in the control groupand the therapeutic outcome and side effects were recorded. Healing had occurred in 70% of patients in
the nifedipine group and in 12% of patients in the control group after 4 weeks treatment (P < 0.005). Recurrence of symptoms occurred in four of healed patients in the nifedipine group and three patients in the
control group in two months. The final result of nifedipine application after 12 months follow up was recurrence in 11 patients (26.19%). Mild headache occurred in four patients (6.6%) of the nifedipine group. Patients in the nifedipine group showed significant healing and relief from pain compared with patients in the control group. Recurrence rate with nifedipine use in spite of control of predisposing factors such as constipation was significant. Another finding was low complication rate with this treatment.