A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Oberbaum M, Yaniv I, Ben-Gal Y, Stein J, Ben-Zvi N, Freedman LS, Branski D.
The Institute of Research on Complementary Medicine, The Center of Integrated Complementary Medicine, Shaare Zedek Medical Center, P.O. Box 3235, Jerusalem 91031, Israel. [email protected]
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.
Homeopathic medicines for adverse effects of cancer treatments
Sosie Kassab, Mike Cummings, Saul Berkovitz, Robbert van Haselen, Peter Fisher
Royal London Homoeopathic Hospital, London, UK. 2British Medical Acupuncture Society, London, UK. 3INTMEDI, Surrey, UK
Homeopathic
medicines are used by many patients with cancer, usually alongside
conventional treatment. Cancer treatments can cause adverse effects, and
one of the reasons patients use homeopathic medicines is to help with
these symptoms. This review looked at whether these medicines could help
patients with problems caused by cancer treatments. Eight studies with a
total of 664 participants were included in this review. Three studied
adverse effects of radiotherapy, three studied adverse effects of
chemotherapy and two studied menopausal symptoms associated with breast
cancer treatment. Two studies with low risk of bias demonstrated
benefit: one with 254 participants demonstrated benefits from calendula
ointment in the prevention of radiotherapy-induced dermatitis, and
another with 32 participants demonstrated benefits from Traumeel S (a
complex homeopathic medicine) over placebo as a mouthwash for
chemotherapy-induced stomatitis. These trials need replicating. Two
other studies reported positive results, although the risk of bias was
unclear, and four further studies reported negative results. The
homeopathic medicines used in all eight studies did not seem to cause
any serious adverse effects or interact with conventional treatment. No
cancer treatments were modified or stopped because of the homeopathic
interventions.