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A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation.
Cancer 2001; 92(3):684-90C

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+Show Affiliations

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.ilNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11505416

Citation

Oberbaum, M, et al. "A Randomized, Controlled Clinical Trial of the Homeopathic Medication TRAUMEEL S in the Treatment of Chemotherapy-induced Stomatitis in Children Undergoing Stem Cell Transplantation." Cancer, vol. 92, no. 3, 2001, pp. 684-90.
Oberbaum M, Yaniv I, Ben-Gal Y, et al. A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer. 2001;92(3):684-90.
Oberbaum, M., Yaniv, I., Ben-Gal, Y., Stein, J., Ben-Zvi, N., Freedman, L. S., & Branski, D. (2001). A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer, 92(3), pp. 684-90.
Oberbaum M, et al. A Randomized, Controlled Clinical Trial of the Homeopathic Medication TRAUMEEL S in the Treatment of Chemotherapy-induced Stomatitis in Children Undergoing Stem Cell Transplantation. Cancer. 2001 Aug 1;92(3):684-90. PubMed PMID: 11505416.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. AU - Oberbaum,M, AU - Yaniv,I, AU - Ben-Gal,Y, AU - Stein,J, AU - Ben-Zvi,N, AU - Freedman,L S, AU - Branski,D, PY - 2001/8/16/pubmed PY - 2001/8/31/medline PY - 2001/8/16/entrez SP - 684 EP - 90 JF - Cancer JO - Cancer VL - 92 IS - 3 N2 - 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. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/11505416/A_randomized_controlled_clinical_trial_of_the_homeopathic_medication_TRAUMEEL_S_in_the_treatment_of_chemotherapy_induced_stomatitis_in_children_undergoing_stem_cell_transplantation_ L2 - http://www.diseaseinfosearch.org/result/7171 DB - PRIME DP - Unbound Medicine ER -