Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer -: a prospective, randomized, placebo-controlled, double-blind study

Objective: To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucose during irradiation. Design: Prospective, randomized, placebo-controlled, double-blind trial, Setting: University hospital, Germany. Patients: 48 patients who had radiotherapy to the head and neck, Main outcome measures: Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score), Results: 23 patients (11 experimental, 12 placebo) completed the study. The global efficacy measure combining scintigraphy and RTOG score favoured the experimental arm (P=0.07), The RTOG score showed significantly fewer acute side-effects of radiation in the experimental arm (P<0.05), Conclusion: The results suggest that coumarin/troxerutine have a favourable effect in the treatment of radiogenic sialadenitis and mucositis. (C) 2001 The British Association of Oral and Maxillofacial Surgeons.