Background: This study has been conducted to determine the effect of using oral rinse benzydamine in prevention of radiation induced mucositis. Materials and Methods: 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 upto the end of the course. The incidence of mucositis grade 3 or more was evaluated. Results: From 100 patients who were randomized in this trail, 19 patients 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 upto the end of radiotherapy (P<0.001). Conclusion: 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.
Kamian Sh, Kazemian A, Aghili M, Amuzegar Hashemi F, Haddad P. Benzydamine for Prophylaxis of Radiation-Induced Oral Mucositis in Head and Neck Cancers A Double-Blind Clinical Trial. pajoohande 2008; 13 (3) :183-191 URL: http://pajoohande.sbmu.ac.ir/article-1-633-en.html