Comparative Study of the Effect of Licorice Muco-adhesive Film on Radiotherapy Induced Oral Mucositis, A Randomized Controlled Clinical Trial.

Abstract

Background: Oral mucositis is a common complication induced by radiation in head and neck cancer patients. OM can cause pain, dysphagia, dehydration and impaired quality of life. The main objective of this study was to assess the effectiveness of licorice mucoadhesive film on symptoms of head and neck radiotherapy-induced mucositis.

Methods: sixty head and neck cancer patients who have been scheduled to undergo radiotherapy were randomly assigned to receive radiotherapy plus licorice mucoadhesive film (30) or radiotherapy plus placebo mucoadhesive film. In this double blinded randomized clinical trial, oral mucositis was estimated by world health organization scales, a quantitative scale, and symptoms were evaluated by visual analog scale.

Results: The results showed a meaningful difference in pain score between two groups in third and fourth weeks (P-value <0.05). Also, there was a significant difference in scale of mucositis between the two groups in weeks 3 and 4 (P-value <0.05). However, there were no meaningful differences with regard to pain and scale of mucositis in weeks 0, 1, 2. (P-value>0.05).

Conclusion: This study showed that licorice mucoadhesive film can be effective in decreasing pain and level of radiation-induced mucositis and it could be administered as an alternative agent in OM management. Key words: Oral mucositis, Radiotherapy, Licorice, Mucoadhesive film, Placebo.