The effectiveness of Zataria extract mouthwash for the management of radiation-induced oral mucositis in patients: a randomized placebo-controlled double-blind study
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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.
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.
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.
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.
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.
KeywordsOral mucositis Radiotherapy Zataria Head and neck Cancer
Head and neck cancers
Food and Drug Administration
Karnofsky Performance Status
World Health Organization
Oral Mucositis Assessment Scale
Visual analog scale
High-performance liquid chromatography
Analysis of variance
Statistical Package for the Social Sciences
1. The conception and design of the study, or acquisition of data, or analysis and interpretation of data: Seyed Jalal Hosseinimehr, Azar Aghamohammadi, Daryush Moslemi, Jafar Akbari, Mohammad Azadbakht, Arash Ghesmi, and Askari Asgharpour.
2. Drafting the article or revising it critically for important intellectual content: Seyed Jalal Hosseinimehr, Azar Aghamohammadi, and Daryush Moslemi.
3. Final approval of the version to be submitted: all authors.
This study was supported by a grant from Mazandaran University of Medical Science, Sari, Iran.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of research committee of Mazandaran University of Medical Sciences and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. This protocol was approved by the Ethical and Research Committee of Mazandaran University of Medical Sciences (code 92-48). This study was registered in the Iranian Registry of Clinical Trials with the IRCT number IRCT201305285830N3.
Informed consent was obtained from all individual participants included in the study.
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