OBJECTIVE: To assess the efficacy of isosorbide dinitrate in healing anal fissures. DESIGN: Randomised, prospective, double blind, placebo controlled trial. SETTING: Teaching hospital, The Netherlands. SUBJECTS:37 consecutive subjects with anal fissure diagnosed in the surgical outpatient department. INTERVENTIONS: After randomisation, 20 patients were givenisosorbide dinitrate, and 17 patients placebo. MAIN OUTCOME MEASURES: Healing of anal fissure, recurrence, and tolerance. RESULTS: Both groups were treated for a median (range) of 5 weeks (range 1-10). After this period, 17 in the isosorbide group had healed compared with 6 controls (p < 0.003). The fissure recurred in 2 patients who had had an initial good response to isosorbide, and in 2 in the control group. Side effects (particularly headache) were more common after isosorbide dinitrate, but not significantly so (9/20 compared with 3/17). CONCLUSIONS:Isosorbide dinitrate is an effective treatment for anal fissure, and is significantly better than placebo.
RCT Entities:
OBJECTIVE: To assess the efficacy of isosorbide dinitrate in healing anal fissures. DESIGN: Randomised, prospective, double blind, placebo controlled trial. SETTING: Teaching hospital, The Netherlands. SUBJECTS: 37 consecutive subjects with anal fissure diagnosed in the surgical outpatient department. INTERVENTIONS: After randomisation, 20 patients were given isosorbide dinitrate, and 17 patients placebo. MAIN OUTCOME MEASURES: Healing of anal fissure, recurrence, and tolerance. RESULTS: Both groups were treated for a median (range) of 5 weeks (range 1-10). After this period, 17 in the isosorbide group had healed compared with 6 controls (p < 0.003). The fissure recurred in 2 patients who had had an initial good response to isosorbide, and in 2 in the control group. Side effects (particularly headache) were more common after isosorbide dinitrate, but not significantly so (9/20 compared with 3/17). CONCLUSIONS:Isosorbide dinitrate is an effective treatment for anal fissure, and is significantly better than placebo.
Authors: R L Nelson; D Manuel; C Gumienny; B Spencer; K Patel; K Schmitt; D Castillo; A Bravo; A Yeboah-Sampong Journal: Tech Coloproctol Date: 2017-08-09 Impact factor: 3.781
Authors: Kemal Arslan; Bülent Erenoğlu; Osman Doğru; Ersin Turan; Mehmet Ali Eryilmaz; Arif Atay; Said Kökçam Journal: Surg Today Date: 2012-09-09 Impact factor: 2.549