Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of sulphasalazine in preventing acute gastrointestinal complications due to radiotherapy

Background and purpose: Acute radiation-induced diarrhea occurs in approxim ately 80% of the patients receiving pelvic radiotherapy. It is caused by ga strointestinal irritation and inflammation. Eicosanoids are thought to be o ne of the mechanisms of this. Sulphasalazine is an inhibitor of their synth esis in the mucosa. This randomized clinical trial was undertaken to evalua te its effect in preventing acute radiation enteritis (ARE). Materials and methods: Prospectively, 87 patients receiving pelvic radiothe rapy were randomized, in a double-blind fashion. Two tablets twice daily of sulphasalazine (500 mg) or placebo were administered orally. Patients were evaluated weekly according to diarrhea grading for the primary study endpo int and according to late effect of normal tissue-subjective objective mana gement analytic (LENT-SOMA) criteria for the secondary endpoint during irra diation. Results: Groups did not differ for age, gender, tumour site or irradiation procedure. Diarrhea occurred in 55 and 86% of the sulphasalazine and placeb o groups, respectively (P = 0.001). Gastrointestinal toxicity was seen in 8 0 and 93% of the sulphasalazine and placebo groups according to the maximum LENT-SOMA score (P = 0.07). According to the maximum LENT-SOMA score betwe en the two groups, significant differences in favor of sulphasalazine were found for each week. Conclusion: Sulphasalazine (2 g/day) was found to be effective in decreasin g the symptoms of ARE. (C) 2000 Elsevier Science Ireland Ltd. All rights re served.