Randomisierte, kontrollierte klinische studie zum nachweis der wirksamkeit von Traumeel S® bei der behandlung von chemotherapieinduzierter stomatitis bei Kindern nach stammzelltransplantation

Stomatitis is a common consequence of chemotherapy and a condition for which there is little effective treatment. Although the management of patients with other chemotherapy-related toxicities has improved in recent years, the incidence of stomatitis is increasing because of more intensive treatment, and is often a dose-limiting factor in chemotherapy. The authors assessed the efficacy of a homoeopathic remedy, Traumeel S®, in the management of chemotherapy-induced stomatitis in children and young adults undergoing bone-marrow transplantation. Methods: A randomized, placebo-controlled double-blind clinical trial was conducted in 32 patients aged 3-25 years who had undergone allogeneic (16 patients) or autologous (16 patients) stem cell transplantation. Of the 30 evaluable patients, 15 were assigned placebo and 15 Traumeel S, both as a mouth rinse, administered 5 times daily from two days after transplantation for a minimum of 14 days or until at least 2 days after all signs of stomatitis were absent. Stomatitis scores were evaluated according to the WHO grading system for mucositis. Results: A total of five patients (33%) in the Traumeel S treatment group did not develop stomatitis compared to only one patient (7%) in the placebo group. Stomatitis worsened in only 7 patients (47%) in the Traumeel S treatment group compared with 14 (93%) in the placebo group. The mean area under the curve stomatitis scores were 10.4 in the Traumeel S treatment group and 24.3 in the placebo group. This difference was statistically significant (p < 0.01). Conclusion: This study indicates that Traumeel S may significantly reduce the severity and duration of chemotherapy-induced stomatitis in children undergoing bone-marrow transplantation.