A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation.
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.
Oberbaum
M
M
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
Yaniv
I
I
Ben-Gal
Y
Y
Stein
J
J
Ben-Zvi
N
N
Freedman
L S
LS
Branski
D
D
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
D000893:Anti-Inflammatory Agents; D008903:Minerals; D010936:Plant Extracts; C433370:Traumeel S