Herb medicine for relieving radiation induced oral mucositis: A systematic review and meta-analysis protocol

Oral mucositis (OM) is a common and unavoidable side effect in patients suffering from head and neck cancer who are undergoing radiotherapy. It is characterized by unbearable pain, as well as eating and speech disorders. This has serious negative effects on the patients' quality of life and can even reduce radiotherapy tolerance, ultimately resulting in a poor prognosis. At present, many prevention and treatment methods are still in the experimental stage, and the efficacies are controversial.

Four English databases: Medline via pubmed, EMBASE, the Cochrane Library, Web of Science and another 4 Chinese databases: China National Knowledge Infrastructure (CNKI), China Science and Technology Journal database (VIP), Wanfang Database and CBM, will be searched from inception to August 2019. All randomized controlled trials in Chinese and English language will be included. Literature selection, data extraction and quality assessment will be completed by 2 independent authors. The primary outcomes will include the incidence of OM (1-4 grade) and the pain degree. The onset time of OM, the improvement rate for quality of life, and any adverse effects will be evaluated as the secondary outcomes. The data will be synthesized by Review Manager and Stata software.

This study provides a high-quality synthesis from existing evidence for Chinese herbal medicine in radiotherapy induced OM treatment, according to the criteria: incidence of OM, onset time of OM, status changes in quality of life and adverse events.

This study will provide evidence to help determine whether Chinese herbal medicine is effective and safe for use in the prevention and/or treatment of radiotherapy induced OM.

No additional formal ethical recognition or informed consent is required since no primary data collection is involved. The study result will be published in peer-reviewed journals or at related conferences.PROSPERO registration number: PROSPERO CRD42019141900.