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

Menachem Oberbaum, Isaac Yaniv, Yael Ben-Gal, Jerry Stein, Nurit Ben-Zvi, Laurence S. Freedman, David Branski

Research output: Contribution to journalArticlepeer-review

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®, 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.

Original languageEnglish
Pages (from-to)684-690
Number of pages7
JournalCancer
Volume92
Issue number3
DOIs
StatePublished - 1 Aug 2001

Keywords

  • Allogeneic
  • Autologous
  • Bone marrow transplantation
  • Complementary medicine
  • Homeopathy
  • Mucositis
  • Placebo-controlled
  • Randomized
  • Stem cell transplantation
  • Stomatitis
  • TRAUMEEL S®

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