KEY TAKEAWAYS
- The phase 3 trial aimed to assess rebamipide gargle’s effectiveness vs. benzydamine in patients with HNC undergoing radiotherapy.
- The results revealed both rebamipide and benzydamine mouthwashes reduced severe oral mucositis, with rebamipide gargles showing superior efficacy.
Basma Elsaadany and the team aimed to compare the preventive and therapeutic effects of rebamipide gargle to benzydamine in patients with head and neck cancer (HNC) undergoing radiotherapy, with or without chemotherapy.
A Phase III randomized clinical trial was conducted from January 2021 to August 2022 on 100 patients with HNC undergoing high doses of radiotherapy. Patients were equally assigned to either the rebamipide group or the benzydamine group.
The study measured outcomes such as the incidence of oral mucositis ≥ grade 1, according to the WHO mucositis scale, along with the duration and onset of oral mucositis.
The results revealed no statistically significant difference between the two groups regarding the incidence of severe-grade oral mucositis (WHO grade 3) and the onset and duration of oral mucositis. Both gargles effectively prevented the development of WHO grade 4 oral mucositis. Reported side effects included primarily a burning sensation in the benzydamine group and nausea in the rebamipide group.
The study concluded that rebamipide mouthwash was equally effective as benzydamine mouthwash in reducing severe oral mucositis induced by HNC treatment. However, rebamipide gargle demonstrated superiority over benzydamine in reducing the severity of radiation-induced oral mucositis.
The Science, Technology & Innovation Funding Authority (STDF), in partnership with The Egyptian Knowledge Bank (EKB), provided open-access funding.
Source: https://pubmed.ncbi.nlm.nih.gov/38824583/
Clinical Trial: https://clinicaltrials.gov/study/NCT04685395
Elsaadany B, Anayb SM, Mashhour K, et al. (2024). “Rebamipide gargle and benzydamine gargle in prevention and management of chemo-radiotherapy and radiotherapy-induced oral mucositis in head and neck cancer patients (randomized clinical trial).” BMC Oral Health. 2024 Jun 1;24(1):645. doi: 10.1186/s12903-024-04379-3. PMID: 38824583; PMCID: PMC11143556.
