Efficacy of Methylene Blue and Benzydamine Oral Rinse in Managing Oral Mucositis Pain in Head and Neck Cancer Patients: a Prospective Randomized Study
摘要
Oral mucositis (OM) is a common and distressing complication of radiotherapy (RT) and chemoradiotherapy (CRT) in head and neck cancer (HNC) patients, often necessitating opioid use and compromising nutritional intake and treatment adherence. This study aimed to evaluate the effectiveness and safety of methylene blue oral rinse (MBOR) as a topical analgesic for OM-related pain, in comparison with benzydamine mouthwash, a commonly used anti-inflammatory agent. A randomized, prospective study was conducted at our institute, including 60 adult patients undergoing adjuvant RT or CRT for HNC, with participants being enrolled over a period of 3 months. Patients were randomly assigned to receive either MBOR (n = 30) or benzydamine (n = 30), alongside standard systemic analgesics. The Visual Analog Scale (VAS) was employed to assess pain, and the severity of mucositis was evaluated according to WHO criteria. Assessments were performed at baseline (day 7 of treatment), immediately after the first rinse, and at regular intervals. Furthermore, pain diaries and opioid consumption records were also maintained. The median age of the patients was 49 (27–81) years with male predominance. In majority, the primary site was buccal mucosa (56.9%) followed by tongue (29.31%) and upper alveolus (6.91%). 35 patients had stage 4 tumor and 47 have undergone CRT. 2 patients succumbed to disease and in the rest, MBOR provided faster pain relief, longer duration of analgesia, reduced opioid use, and less Ryle’s tube dependency compared to benzydamine. By day 90, 96% of MBOR patients had complete mucosal healing with minimal adverse events. MBOR is a promising, well-tolerated, and effective adjunct for OM-related pain in HNC patients, providing benefits that surpass those of benzydamine.