A Randomized, Controlled Clinical Trial of theHomeopathic Medication TRAUMEEL S
in theTreatment of Chemotherapy-Induced Stomatitis inChildren Undergoing Stem Cell Transplantation
Laurence S. Freedman,
The Institute of Research on ComplementaryMedicine, The Center of Integrated ComplementaryMedicine, Shaare Zedek Medical Center, Jerusa-lem, Israel.
Bone Marrow Transplantation Unit, The Schnei-der Children’s Medical Center of Israel, Rabin Med-ical Center, Petach Tikva, Sackler School of Med-icine, Tel-Aviv University, Israel.
Department of Mathematics, Statistics, andComputer Sciences, Bar-Ilan University. Ramat-Gan, Israel.
Department of Pediatrics, Shaare Zedek MedicalCenter, Hebrew University Medical School, Jerusa-lem, Israel.Supported by a grant from the International Societyof Homotoxicology, Baden-Baden, Germany.The authors are grateful to Dr. Yoram Neumannfrom the Department of Pediatric Hematology On-cology at The Chaim Sheba Medical Center (Tel- Aviv, Israel) for his help in the planning and designof the ﬁrst version of the study protocol. They alsothank Nitzan Teva, R.N., for her initiative andenthusiastic work at the beginning of the study.Finally, the authors thank the nurses of the BoneMarrow Transplantation Unit at The SchneiderChildren’s Medical Center of Israel for their supportand patience during this study. Address for reprints: Menachem Oberbaum, M.D.,The Institute of Research on Complementary Med-icine, The Center of Integrated ComplementaryMedicine, Shaare Zedek Medical Center, P.O. Box3235, Jerusalem 91031, Israel; Fax:
972-2-6666975; E-mail: firstname.lastname@example.orgReceived December 21, 2000; revision receivedMarch 27, 2001; accepted April 9, 2001.
Stomatitis is a common consequence of chemotherapy and a con-dition 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 andis 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.
A randomized, placebo-controlled, double-blind clinical trial was con-ducted 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 mouthrinse, administered ﬁve times daily from 2 days after transplantation for a mini-mum 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 Organizationgrading system for mucositis.
A total of ﬁve patients (33%) in the TRAUMEEL S treatment group did notdevelop stomatitis compared with only one patient (7%) in the placebo group.Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S treatment groupcompared with 14 patients (93%) in the placebo group. The mean area under thecurve stomatitis scores were 10.4 in the TRAUMEEL S treatment group and 24.3 inthe placebo group. This difference was statistically signiﬁcant (P
This study indicates that TRAUMEEL S may reduce signiﬁcantly theseverity and duration of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation.
© 2001 American Cancer Society.
KEYWORDS: TRAUMEEL S
, stomatitis, mucositis, autologous, allogeneic, stem celltransplantation, bone marrow transplantation, randomized, placebo-controlled, ho-meopathy, complementary medicine.
tomatitis occurs commonly as part of general inﬂammatory dam-age to the mucous membranes in patients receiving chemother-apy or radiation therapy to the oropharyngeal region. The overallincidence of reactive stomatitis is about 40%.
However, it is partic-ularly common in patients receiving 5-ﬂuorouracil (5-FU) treat-ment
and is even more common in those undergoing radiationtherapy for malignancies of the head and neck, in which approxi-mately 80% of patients are affected.
In patients undergoing bonemarrow transplantation (BMT), the incidence of stomatitis reaches95%.
The mechanism of development of stomatitis is primarily cytotoxic,
© 2001 American Cancer Society