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A noninferiority design clinical trial is a type of randomized controlled clinical trials that examines whether the treatment of the experimental group is not inferior to the treatment of the control group. This paper introduces the basic concept, design points, comparison with equivalence and superiority trials, and case analysis to help readers fully understand, implement and evaluate noninferiority design clinical trials. [ABSTRACT FROM AUTHOR]

Objective·To examine, using a systematic review and meta-analysis, the effectiveness of vitamin E on treating oral mucositis caused by radiotherapy and chemotherapy. Methods·A systematic literature search was performed by using PubMed, Embase, Cochrane Library, Web of Science, CINAHL, OpenGrey, Chinese biomedical literature database (CBM), Chinese national knowledge infrastructure (CNKI), Wanfang Data, and China Science and Technology Journal Database (VIP). The retrieval time was up to March 2022. The risk of bias was assessed by using the Cochrane Risk-of-Bias tool, version 2.0. RevMan 5.4 was used for meta-analysis. Results·A total of 563 literatures were retrieved. A total of 7 randomized controlled trials were included. The results of meta-analysis revealed that vitamin E supplementation did not significantly affect oral mucositis caused by chemoradiotherapy (RR=0.44, 95%CI 0.15 - 1.25, Z=1.54, P=0.120). However, vitamin E may have some effect on severe oral mucositis (RR=0.22, 95%CI 0.11-0.43, Z=4.33, P=0.000). Conclusion·It cannot be explained that vitamin E can effectively treat oral mucositis caused by radiotherapy and chemotherapy, but vitamin E may be effective for severe oral mucositis. [ABSTRACT FROM AUTHOR]

Objective • To systematically review the efficacy of cryotherapy in head and neck cancer patients with radiation-induced oral stomatitis. Methods • >ubMed, EMbase, Cochrane Library, Web of Science, CNKI, WanFang, VIP and CBM databases were searched to collect randomized controlled trials (RCTs) of cryotherapy in head and neck cancer patients with ration-induced stomatitis from inception to January 31th, 2022. Literature screening, data extraction, and quality evaluation were performed independently by two researchers. Meta-analysis was then performed by using RevMan 5.4 and Stata 16.0 software. Results • A total of 36 RCTs were included. The results of meta-analysis showed that compared to control group, cryotherapy group had a lower total incidence of radiation-induced stomatitis [adds ratio (OR)=0.30, 95% confidence interval (CI) 0.23-0.39, P=0.000] and a lower incidence of severe radiation-induced stomatitis (OR=0.17, 95%CI 0.14-0.21, P=0.000). Conclusion • Cryotherapy may contribute to reducing the incidence of radiation-induced stomatitis and the incidence of severe radiation-induced stomatitis. [ABSTRACT FROM AUTHOR]