Patients in this study showed remarkable improvement when 1.5% lidocaine and 0.3% nifedipine were applied twice daily for 6 weeks. This extremely safe, well tolerated, and effective treatment should provide family physicians with a reliable nonsurgical method for treating chronic anal fissures.
- BACKGROUND: Acute anal fissures generally heal spontaneously with minimal or no intervention. Conversely, chronic anal fissures are traditionally treated with surgery. Therapies such as botulinum toxin, isosorbide dinitrate, and glyceryl tinitrate have shown some benefit, but their side-effect profiles are substantial. With the knowledge that topical nifedipine has been shown to relax smooth muscle, lower anal resting pressure, relieve pain, and heal acute anal fissures, these authors studied its effect on chronic anal fissures.
- POPULATION STUDIED: Patients were recruited from the emergency surgery and gastroenterology center in Italy that conducted the study. Inclusion criteria were chronic anal fissure and age older than 18 years. Chronic anal fissure was assessed by clinical examination and a history of anal pain on defecation for longer than 2 months that did not resolve with stool softeners and simple anesthetic agents. Exclusion criteria were pregnancy, allergy to nifedipine or lidocaine, and complications warranting surgery.
- STUDY DESIGN AND VALIDITY: This was a prospective, randomized, double-blind study. The control group received 1.5% lidocaine and 1% hydrocortisone acetate, and the treatment group received 1.5% lidocaine and 0.3% nifedipine. The ointments were applied every 12 hours for 6 weeks. The ointments were indistinguishable, and all parties were blinded with proper allocation concealment. Data analysis was by intention-to-treat. The groups were randomly assigned and had similar baseline characteristics.
- OUTCOMES MEASURED: Healing of the chronic anal fissure was the primary outcome and was defined by anoscopy when epithelialization or formation of a scar was achieved at 42 days. Patients also subjectively rated pain as absent, modest, or persistent at day 21. Manometric studies were used as a secondary measure of clinical improvement and were measured at baseline and 21 days.
- RESULTS: Of the 55 patients in the nifedipine group, 94.5% healed clinically at 42 days and 87.3% reported no pain at 21 days. Conversely, of the 55 patients in the control group evaluated at the same intervals, 16.4% healed and 10.9% reported no pain (P<.001; number needed to treat=1.3).