The effectiveness of Zataria extract mouthwash for the management of radiation-induced oral mucositis in patients: a randomized placebo-controlled double-blind study.

OBJECTIVES: Oral mucositis (OM) is a common debilitating complication of chemoradiotherapy treatment of head and neck cancers. This randomized placebo-controlled double-blind clinical trial study was performed to evaluate the effectiveness of Zataria multiflora (ZM) extract mouthwash in the prevention and reduction of OM related to local radiotherapy in the treatment of head and neck cancer patients. METHODS: Sixty-three patients with head and neck cancers, who underwent a conventional fractionated radiotherapy regimen, were entered into the study. Patients gargled the ZM mouthwash or a placebo before the beginning of the treatment three times daily and before each radiotherapy session. The assessment of OM was conducted according to WHO and Oral Mucositis Assessment Scale. RESULTS: The OM intensity trends in the ZM group during these weeks of treatment were detected 3.152 times less frequently than in the placebo group. A twofold decrease in the incidence of grades 3-4 OM was observed in the ZM group compared to the placebo. The use of the ZM mouthwash affected the incidence of grades 3-4 OM to a relative risk ratio of 0.432. The pain score was significantly decreased in the ZM group compared to the placebo group. CONCLUSION: The present study revealed that ZM mouthwash effectively decreases the severity of OM and mouth pain in patients with head and neck cancer treated with radiotherapy. CLINICAL RELEVANCE: The use of ZM mouthwash effectively decreases the severity of oral complications induced by ionizing radiation in patients during radiotherapy and resulted in high oral quality care. Graphical abstract ᅟ.