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Therapeutics
High-dose glyceryl trinitrate was no more effective than usual dose for chronic anal fissure

https://doi.org/10.1136/ebm.4.6.174

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    Carapeti EA, Kamm MA, McDonald PJ, et al. Randomised controlled trial shows that glyceryl trinitrate heals anal fissures, higher doses are not more effective, and there is a high recurrence rate. Gut. 1999 May; 44:727-30.

    Question

    In patients with chronic anal fissure, does a higher dose of glyceryl trinitrate (GTN) prompt a faster or higher healing rate than the usual dose?

    Design

    10-week randomised (concealed), blinded (clinician and patient), placebo-controlled trial.

    Setting

    Surgical outpatient clinics in Harrow, England, UK.

    Patients

    70 patients who had anal fissure for 3 months with clinical features of chronicity (fibrosis of the base of the ulcer or sentinel pile). Exclusion criteria were fissures caused by Crohn disease or HIV, receipt of nitrate treatment for ischaemic heart disease, history of migraine, or pregnancy. 68 patients (97%) (median age 36 y, 51% men) completed the study.

    Intervention

    Patients were allocated to GTN ointment, 0.2% (usual dose) (n = 23); an escalating dose of GTN starting at 0.2% with weekly increments of 0.1% to a maximum of 0.6% (n = 23); or placebo (n = 22). The ointment was applied manually to the skin of the anal verge 3 times daily for 8 weeks.

    Main outcome measures

    Healing rate, pain, headache, and fissure recurrence. …

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