Effect of Traumeel S on Pain and Discomfort in Radiation-induced Oral Mucositis: A Preliminary Observational Study

Context . Painful oral mucositis is an almost inevitable side effect of radiotherapy of head and neck tumors that simultaneous chemotherapy intensifies and that is notoriously difficult to treat. In a previous study, chemotherapy-induced stomatitis in children undergoing bone marrow transplantation responded well to the homeopathic complex remedy Traumeel S. Objective . To evaluate the efficacy of Traumeel S in the management of radiation-induced oral mucositis in patients with head and neck tumors. Design . The research team designed a nonrandomized, prospective, observational study with matched pairs. Setting . The research team performed the study in a tertiary cancer-care center at the Institute of Radiotherapy and Special Oncology, Medical School Hanover, Germany. Participants . The participants were 20 patients who were receiving radiotherapy or radiochemotherapy for head and neck tumors. Intervention . Five times per day during the observational period, participants self-administered daily mouth rinses with either sage tea (Salvia officinalis, control group) or Traumeel S solution (intervention group). Outcome Measures . Two independent physicians determined the grade of oral mucositis at least once per week, and the research team derived the degree of oral pain from diaries that participants kept. Results . Both groups were comparable in terms of tumor and treatment characteristics. The research team could not confirm any appreciable specific effect of Traumeel S on the primary endpoints; the limited reduction in pain for the intervention group compared to the control group was not significant, and the more frequent analgesia in the Traumeel S group most likely explained that reduction. Among the secondary endpoints, loss of taste and swallowing difficulty responded to Traumeel S to some extent. Conclusions . Traumeel S may have some potential in the treatment of radiation-induced oral mucositis, but its possible effects need confirmation by further studies. This article discusses some methodological requirements.