A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S (R) in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation

BACKGROUND. Stomatitis is a common consequence of chemotherapy and a condit ion for which there is little effective treatment. Although the management of patients with other chemo therapy-related toxicities has improved in rec ent years, the incidence of stomatitis is increasing because of more intens ive treatment and is often a dose limiting factor in chemotherapy. The auth ors assessed the efficacy of a homeopathic remedy, TRAUMEEL S(R), in the ma nagement of chemotherapy-induced stomatitis in children undergoing bone mar row transplantation. METHODS. A randomized, placebo-controlled, double-blind clinical trial was conducted in 32 patients ages 3-25 years who had undergone allogeneic (16 p atients) or autologous (16 patients) stem cell transplantation. Of the 30 e valuable patients, 15 were assigned placebo, and 15 were assigned TRAUMEEL S both as a mouth rinse, administered five times daily from 2 days after tr ansplantation 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 World Health Organization grading system for mucositis. RESULTS. A total of five patients (33%) in the TRAUMEEL S treatment group d id not develop stomatitis compared with only one patient (7%) in the placeb o group. Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S tre atment group compared with 14 patients (93%) in the placebo group. The mean area under the curve stomatitis scores were 10.4 in the TRAUMEEL S treatme nt group and 24.3 in the placebo group, This difference was statistically s ignificant (P < 0.01). CONCLUSIONS. This study indicates that TRAUMEEL S may reduce significantly the severity and duration of ch emo therapy-induced stomatitis in children undergoing bone marrow transplantation. Cancer 2001;92:684-90. (C) 2001 Ame rican Cancer Society.