Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients:A proposed classification scheme of interventions and meta-analysis of randomized controlled trials

Purpose: To identify, classify, and evaluate agents used in the prophylaxis of oral mucositis in if radiated head and neck cancer patients. Methods: Data sources included multiple databases and manual citation revie w of relevant literature. Based on the eligibility criteria, 59 studies wer e independently reviewed by two reviewers. Forty-two studies were included in the classification scheme, of which 15 met the criteria for inclusion in the meta-analysis. Data were extracted by duplicate independent review, wi th disagreement resolved by consensus. Results: Overall, the interventions reduced the odds of developing severe o ral mucositis, when assessed by clinicians, by 36% (OR: 0.64; 95% CI: 0.46, 0.88), Subgroup analysis suggested that only the narrow-spectrum antibacte rial lozenges were effective (OR: 0.45; 95% CI: 0.23, 0.86); however, the p ower of the aggregated data in the other classes may have been insufficient to detect differences. When the outcome was assessed by patients, no signi ficant difference was seen in the outcome between the treatment and the con trol groups (OR: 0.79; 95% CI: 0.56-1.12), Conclusions: Overall, interventions chosen on a sound biologic basis to pre vent severe oral mucositis are effective, In particular, when oral mucositi s is assessed by clinicians, narrow-spectrum antibiotic lozenges appear to be beneficial. Methodologic limitations were evident in many of the studies . Further research using validated measurement tools in larger, methodologi cally sound trials is warranted. (C) 2001 Elsevier Science Inc.