Comparison of triamcinolone acetonide mucoadhesive film with licorice mucoadhesive film on radiotherapy-induced oral mucositis: A randomized double-blinded clinical trial.

AIM: Mucositis is a major complication of irradiation in head and neck tumors, the addition of chemotherapy to irradiation may enhance this dose-limiting problem. Licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of this study was to compare the therapeutic safety and efficacy of triamcinolone acetonide (T) and licorice (L) mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment.

METHODS

The study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis that occurred during head and neck cancer radiotherapy. Oral mucositis was assessed using a quantitative scale (World Health Organization scales) and symptoms were assessed using visual analog scale. Sixty patients were enrolled in the study: 30 patients in the triamcinolone and 30 in the licorice group.

RESULTS

With respect to visual analog scores, repeated observations in consecutive weeks showed a meaningful difference (P-value < 0.05), suggesting the efficacy of both T and L in reducing pain during radiotherapy. Comparison of the pain scores between two groups by independent sample t-test, however, demonstrated no meaningful difference in any consecutive week.

CONCLUSIONS

We concluded that both triamcinolone and licorice mucoadhesive films are effective in the management of oral mucositis during radiotherapy. Furthermore, comparison of the pain scores between two groups demonstrated no meaningful difference, although an overall trend to reduced oral discomfort was seen in the licorice group.