A Cochrane review [Abstract] 1 included 12 studies with a total of 2146 subjects comparing 5-ASA to placebo.
There was no statistically significant difference in relapse rates at 12 months. 53% (526/998) of 5-ASA patients (dose 1.6 g to 4 g/day) relapsed at 12 months compared to 54% (544/1016) of placebo patients (RR 0.98, 95% CI 0.91 to 1.07; 11 studies; 2014 patients). One study found no difference in relapse rates at 24 months. 54% (31/57) of 5-ASA patients (dose 2 g/day) relapsed at 24 months compared to 58% (36/62) of placebo patients (RR 0.94, 95% CI 0.68 to 1.29, 119 patients). One paediatric study found no statistically significant difference in relapse rates at 12 months. 62% (29/47) of paediatric 5-ASA patients (dose 50 mg/kg/day) relapsed at 12 months compared to 64% (35/55) of paediatric placebo patients (RR 0.97, 95% CI 0.72 to 1.31; 102 patients). There was no statistically significant difference in the proportion of patients who experienced an adverse event, withdrawal due to adverse events or serious adverse events. Common adverse events reported in the studies included diarrhoea, nausea and vomiting, abdominal pain, headache and skin rash.
Primary/Secondary Keywords