Comparative efficacy of benzydamine and alternative mouthwashes in the management of oral mucositis: A systematic review of randomized control trials.

Abstract

e24124 Background: Oral mucositis (OM) is a common complication in patients undergoing chemotherapy (CT) and radiotherapy (RT). This condition impairs nutrition, compromises treatment adherence, and often necessitates dose reductions or delays. The Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology Guidelines (MASCC/ISOO) recommend using benzydamine mouthwash to prevent and manage OM in patients receiving RT and CT. In our systematic review, we compared the efficacy of benzydamine mouthwash with other therapeutic mouthwashes in preventing, reducing the severity, and managing chemotherapy and radiotherapy-induced oral mucositis in patients with head and neck cancers. Methods: Using PRISMA guidelines, a systematic literature search using PubMed, Embase, Cochrane Library, and Scopus using a combination of MeSH terms, including publications up to January 2025. Two reviewers independently extracted data and assessed study quality using the Cochrane RoB 2 tool, with discrepancies resolved by consensus or a third reviewer. Results: Nine randomized controlled trials (RCTs) (n = 665) were included in this review. The studies evaluated the effectiveness of various mouthwashes across different treatment phases, inluding pre-treatment, concurrent, and post-radiotherapy and chemotherapy periods. Among these trials, three RCTs reported that benzydamine significantly reduced the severity of oral mucositis during the later stages of radiotherapy (weeks 4–7) compared to placebo (p < 0.05). Across different trials, when compared to the control groups of povidone-iodine, chlorhexidine, and sodium bicarbonate, benzydamine delayed progression and reduced the degree of mucositis and intensity of pain in patients undergoing RT or chemoradiation therapy. Additionally, benzydamine demonstrated effective prophylactic properties, even at high radiation doses (> 5000 Gy). Amitriptyline mouthwash provided more pain relief than benzydamine in one trial. Natural formulations such as sumac rose water mouthwash, when used prophylactically, led to decreased pain, improved quality of life, and reduced severity of RT-induced oral mucositis compared to benzydamine. Further, studies suggest that aloe vera mouthwash may be as effective as benzydamine in alleviating the severity of RT-induced mucositis. This review highlights conflicting evidence, suggesting that control solutions may exhibit efficacy comparable to benzydamine. Conclusions: Benzydamine mouthwash significantly reduced the severity and incidence of oral mucositis, especially during later treatment phases. It remained effective even under high radiation doses. However, conflicting evidence with alternative mouthwashes suggests the need for further research to establish definitive management strategies for this common and debilitating condition.