Abstract
We conducted a verification clinical study on the safety and efficacy of the local application of calcium channel blocker ointment (nifedipine ointment) in patients with chronic anal fissures who had failed to respond to conservative treatment.
A group of 40 patients with chronic anal fissures were treated with nifedipine ointment, and pain (Face Scale (FS)) and anorectal mean resting pressure (MRP) were measured. Assessment was possible in 32 cases. After application, FS pain decreased significantly both during defecation and at rest compared to that before treatment.
Those who progressed to surgery were considered the unresponsive group. If the remaining patients are considered the effective group, the efficacy rate was 87.5%. MRP in the unresponsive group was significantly higher than that in the effective group, and no signs of a significant decrease in MRP were noted after treatment, compared to baseline. The only adverse drug reaction reported was headache in 1 patient.
Nifedipine ointment acts by relaxing the smooth muscles of the anus, thus decreasing MRP, and it is thought to promote wound healing. However, although significant improvements in pain relief were observed during this study, the MRP failed to decrease, suggesting that factors other than MRP may be associated with pain relief.
