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: M Oberbaum, I Yaniv, Y Ben-Gal, J Stein, N Ben-Zvi, L S Freedman, D Branski
• Journal: Cancer (Cancer) Vol. 92 Issue 3 Pg. 684-90 (Aug 01 2001) ISSN: 0008-543X [Print] United States
• PMID: 11505416 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2001 American Cancer Society.

Chemical References

• Anti-Inflammatory Agents
• Minerals
• Plant Extracts
• Traumeel S

Topics

• Adolescent
• Adult
• Age Distribution
• Anti-Inflammatory Agents (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Double-Blind Method
• Drug Tolerance
• Drug-Related Side Effects and Adverse Reactions
• Hematopoietic Stem Cell Transplantation (adverse effects)
• Homeopathy
• Humans
• Minerals (therapeutic use)
• Plant Extracts (therapeutic use)
• Stomatitis (chemically induced, drug therapy)
• Treatment Outcome