[Benzydamine for prophylaxis of radiation-induced oral mucositis in head and neck cancers; a double-blind clinical trial]

ABSTRACT

This study has been conducted to determine the effect of using oral rinse benzydamine in prevention of radiation induced mucositis. Patients with head and neck cancers, who referred to Cancer Institute between 2004 and 2005, were enrolled in a double blind clinical trail. They had to receive 15 cc of oral rinse benzydamine or placebo, four times a day, from the first day of radiotherapy up to the end of the course. The incidence of mucositis grade 3 or more was evaluated. From 100 patients who were randomized in this trail, 19patients were excluded of the analysis due to minor side-effects of drug, or stopping the radiotherapy. The incidence of mucositis grade 3 or more was 43.6% among 39 cases in treated group, whereas among 42 cases in placebo group this rate was 78.6%. The difference was, therefore, significant [P<0.005]. Mucositis grade 3 or more was 1.8 times more frequent in placebo group [Relative Risk=1.8]. Also, if the patients did not receive benzydamine the attributive risk of mucositis was 35%. After the third week of treatment, the mean grade of mucositis was more than 2 in the placebo group; but in the benzydamine group it was less than 2 up to the end of radiotherapy [P<0.001]. According to these results it seems that oral rinse benzydamine is effective, safe, and well-tolerated for prophylactic treatment of radiation-induced oral mucositis in head and neck tumors. There is a need to evaluate the efficacy of benzydamine in another large study in Iran