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Clinical Oral Investigations

, Volume 22, Issue 6, pp 2263–2272 | Cite as

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

  • Azar Aghamohammadi
  • Daryush Moslemi
  • Jafar Akbari
  • Arash Ghasemi
  • Mohammad Azadbakht
  • Askari Asgharpour
  • Seyed Jalal Hosseinimehr
Original Article

Abstract

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

Keywords

Oral mucositis Radiotherapy Zataria Head and neck Cancer 

Abbreviations

OM

Oral mucositis

ZM

Zataria multiflora

HNC

Head and neck cancers

FDA

Food and Drug Administration

KPS

Karnofsky Performance Status

SSD

Source-to-surface distance

WHO

World Health Organization

OMAS

Oral Mucositis Assessment Scale

VAS

Visual analog scale

HPLC

High-performance liquid chromatography

ANOVA

Analysis of variance

SPSS

Statistical Package for the Social Sciences

Notes

Author contributions

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.

Funding information

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.

Ethical approval

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

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Traditional and Complementary Medicine Research CenterMazandaran University of Medical SciencesSariIran
  2. 2.Department of Radiopharmacy, Faculty of PharmacyMazandaran University of Medical SciencesSariIran
  3. 3.Health Reproductive Research Center, Sari BranchIslamic Azad UniversitySariIran
  4. 4.Department of Radiation Oncology, Faculty of MedicineBabol University of Medical SciencesBabolsarIran
  5. 5.Department of Pharmaceutics, Faculty of PharmacyMazandaran University of Medical SciencesSariIran
  6. 6.Department of Radiology and Radiation Oncology, Faculty of MedicineMazandaran University of Medical SciencesSariIran
  7. 7.Department of Pharmacognosy, Faculty of PharmacyMazandaran University of Medical SciencesSariIran
  8. 8.Babolsar Shahid Rajaee HospitalBabol University of Medical SciencesBabolIran

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