RADIATION-INDUCED PROCTOSIGMOIDITIS - PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND CONTROLLED TRIAL OF ORAL SULFASALAZINE PLUS RECTAL STEROIDS VERSUS RECTAL SUCRALFATE

In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P < 0.01 for group I and P < 0.001 for group II) and endoscopic healing (P < 0.01 for group I and P < 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P < 0.05), although endoscopically the response was not statistically different (P > 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.