Perianal Application of Glyceryl Trinitrate Ointment Versus Tocopherol Acetate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial

Abstract

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The study aimed to compare the efficacy of tocopherol acetate ointment with glyceryl trinitrate ointment in treating chronic anal fissures, focusing on pain relief and epithelialization. Conducted as a randomized controlled trial at the Garcilaso Clinic in Madrid, Spain, 160 patients were assigned to either treatment group. The primary endpoint was the reduction in anal pain measured on a Visual Analogue Scale after 8 weeks. Secondary endpoints included healing and recurrence rates. Results showed that the mean anal pain score decreased by 56.2 mm in the glyceryl trinitrate group compared to 67.1 mm in the tocopherol acetate group after 8 weeks, indicating greater pain reduction with tocopherol acetate (mean difference, 10.9 mm; p = 0.018). Furthermore, the recurrence rate 16 weeks post-treatment was significantly lower in the tocopherol acetate group (2.9%) compared to the glyceryl trinitrate group (13.2%) (p = 0.031). Limitations included the absence of pre- and post-treatment manometric measurements and the use of glyceryl trinitrate as an active comparator instead of calcium channel blockers, the current standard treatment. In conclusion, tocopherol acetate ointment demonstrated superior pain relief, healing rates, and lower recurrence rates compared to glyceryl trinitrate ointment in chronic anal fissures. This suggests tocopherol acetate as a promising alternative treatment option for chronic anal fissures.