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, ran domized, placebo-controlled, double-blind trial, Setting: University hospit al, Germany. Patients: 48 patients who had radiotherapy to the head and nec k, Main outcome measures: Salivary gland scintigraphy and acute side-effect s 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 experim ental arm (P=0.07), The RTOG score showed significantly fewer acute side-ef fects of radiation in the experimental arm (P<0.05), Conclusion: The result s suggest that coumarin/troxerutine have a favourable effect in the treatme nt of radiogenic sialadenitis and mucositis. (C) 2001 The British Associati on of Oral and Maxillofacial Surgeons.