Effect of Traumeel S on pain and discomfort in radiation-induced oral mucositis: a preliminary observational study.

摘要

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.To evaluate the efficacy of Traumeel S in the management of radiation-induced oral mucositis in patients with head and neck tumors.The research team designed a nonrandomized, prospective, observational study with matched pairs.The research team performed the study in a tertiary cancer-care center at the Institute of Radiotherapy and Special Oncology, Medical School Hanover, Germany.The participants were 20 patients who were receiving radiotherapy or radiochemotherapy for head and neck tumors.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).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.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.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.