Efficacy of benzydamine oral rinse in prevention and management of radiation-induced oral mucositis: A double-blind placebo-controlled randomized clinical trial.

AIM

Several studies have demonstrated positive effects of benzydamine oral rinse in prevention of radiation-induced oral mucositis. The aim of this study was to assess the efficacy of this medication in reducing the signs and symptoms of oral mucositis in patients receiving radiotherapy for head and neck cancer.

METHODS

Fifty-one patients with head and neck carcinoma 2012 received external beam radiotherapy for 5 days/week to total planned cumulative radiotherapy doses of at least 5000 cGy. Patients were randomized to treatment with either benzydamine oral rinse or placebo, initiated the day before radiotherapy and continued for 2 weeks after the end of treatment. Oral cavity was divided into 14 anatomical sites and relevant sites were examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and then a "mean mucositis score" was calculated.

RESULTS

Up to the end of third week, two groups did not show any difference in the severity of mucositis. However, by the end of week 4, the mean score of placebo group was more than that of treatment group (1.81 vs 1.27, P=0.001). This trend continued to end of week 7 (1.98 vs 1.43, P=0.001).

CONCLUSION

Benzydamine oral rinse can be considered as an effective, safe and well-tolerated medication for prevention of radiation-induced oral mucositis and alleviating its symptoms.