Clinical Question: Is a topical gel containing nifedipine and lidocaine effective in the treatment of chronic anal fissures?

Setting: Outpatient (specialty)

Study Design: Randomized controlled trial (double-blinded)

Synopsis: Treatment of chronic anal fissures includes stool softeners, topical anesthetics, and nitroglycerin ointment. Many patients are unable to tolerate the adverse affects (e.g., headaches) of nitroglycerin ointment. This study involved 110 consecutive patients with chronic anal fissures. Inclusion criteria were defined by clinical examination and a history of anal pain on defecation for at least two months despite treatment with stool softeners and topical anesthetic agents.

Patients were randomly assigned in a double-blind fashion with properly concealed allocation to either topical nifedipine (0.3 percent) and lidocaine ointment (1.5 percent) every 12 hours for six weeks, or topical lido-caine (1.5 percent) and hydrocortisone acetate ointment (1 percent) on the same schedule.

Investigators who were blinded to the treatment group assignments assessed study outcomes using intention-to-treat analysis. At the end of six weeks, healing of anal fissures occurred in 94.5 percent of patients treated with nifedipine/lidocaine gel compared with 16.4 percent of patients receiving lidocaine/hydrocortisone gel (P < 0.001; number needed to treat: 1.3). After 18 months of follow-up, anal fissures recurred in three of the 52 patients in the nifedipine/lidocaine group. Two of the three patients responded to a second course of nifedipine/lidocaine gel. No significant side effects were reported in the patients who were treated with nifedipine/lidocaine. No patients dropped out of the study or were lost to follow-up.

Bottom Line: Topical nifedipine plus lido-caine gel is effective and well tolerated in the treatment of chronic anal fissures. (Level of Evidence: 1b)