Randomized, prospective trial comparing 0.25 percent glycerin trinitrate ointment and anal cryothermal dilators only with 0.25 percent glycerin trinitrate ointment and only with anal cryothermal dilators in the treatment of chronic anal fissure: a two-year follow-up.

PURPOSE: The objective of this study was to compare the efficacy of 0.25 percent glycerin trinitrate ointment in association with cryothermal anal dilators with 0.25 percent glycerin trinitrate ointment only and cryothermal anal dilators only.

METHODS

A total of 48 patients suffering from chronic anal fissure were enrolled in this prospective, randomized study between January 2002 and December 2003: Group A, 16 patients were treated with 0.25 percent glycerin trinitrate ointment and also used cryothermal anal dilators; Group B, 16 patients were treated with 0.25 percent glycerin trinitrate ointment only; Group C, 16 patients were treated with cryothermal anal dilator use only. All patients in each group followed the specified treatment protocol for six weeks.

RESULTS

After seven weeks of treatment, the symptoms complained of were resolved in 15 patients (93.7 percent) in Group A, 12 patients (75 percent) in Group B, and 12 patients (78 percent) in Group C. After two years of follow-up, 14 patients (87.5 percent) in Group A, 9 patients (56.2 percent) in Group B, and 10 patients (62.5 percent) in Group C presented no recurrence of symptoms. No patient in any group reported serious side effects of the treatment proposed, and treatment did not have to be withdrawn in any of the randomized patients. No episodes of anal incontinence of gas or feces were recorded in the patients who had used the anal dilators.

CONCLUSIONS

The combined treatment for chronic anal fissure proved to be efficacious, safe, and with statistically significant better results than the other treatments analyzed.