title: A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation.
abstract: BACKGROUND
  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 homeopathic remedy, TRAUMEEL S(R), in the management of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.
  
  
  METHODS
  A randomized, placebo-controlled, double-blind clinical trial was conducted in 32 patients ages 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 were assigned TRAUMEEL S both as a mouth rinse, administered five times daily from 2 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 World Health Organization grading system for mucositis.
  
  
  RESULTS
  A total of five patients (33%) in the TRAUMEEL S treatment group did not develop stomatitis compared with only one patient (7%) in the placebo group. Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S treatment 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 treatment group and 24.3 in the placebo group. This difference was statistically significant (P < 0.01).
  
  
  CONCLUSIONS
  This study indicates that TRAUMEEL S may reduce significantly the severity and duration of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.
authors.affiliation: The Institute of Research on Complementary Medicine, The Center of Integrated Complementary Medicine, Shaare Zedek Medical Center, P.O. Box 3235, Jerusalem 91031, Israel. oberbaum@netvision.net.il
authors.forename: M
authors.initials: M
authors.lastname: Oberbaum
authors.forename: I
authors.initials: I
authors.lastname: Yaniv
authors.forename: Y
authors.initials: Y
authors.lastname: Ben-Gal
authors.forename: J
authors.initials: J
authors.lastname: Stein
authors.forename: N
authors.initials: N
authors.lastname: Ben-Zvi
authors.forename: L S
authors.initials: LS
authors.lastname: Freedman
authors.forename: D
authors.initials: D
authors.lastname: Branski
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004361:Drug Tolerance; D064420:Drug-Related Side Effects and Adverse Reactions; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006705:Homeopathy; D006801:Humans; D008903:Minerals / Q000627:therapeutic use*; D010936:Plant Extracts / Q000627:therapeutic use*; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D008903:Minerals; D010936:Plant Extracts; C433370:Traumeel S