Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group

Abstract

Mucositis can be a serious complication of hematopoietic SCT (HSCT). A previous phase II trial in 32 children undergoing HSCT reported a beneficial effect of the homeopathic remedy Traumeel S. The Children’s Oncology Group sought to replicate the results in a multi-institutional trial. The study was an international multi-center, double-blind, randomized trial comparing Traumeel with placebo in patients aged 3–25 years undergoing myeloablative HSCT. Traumeel/placebo was started on Day −1 as a five-time daily mouth rinse. Efficacy of the treatment was assessed using the modified Walsh scale for mucositis, scored daily from Day −1 to 20 days after HCST. The main outcome was the sum of Walsh scale scores (area-under-the-curve (AUC)) over this period. Other outcomes included narcotic use, days of total parenteral feeding, days of nasogastric feeding and adverse events. In 181 evaluable patients, there was no statistical difference in mucositis (AUC) in the Traumeel group (76.7) compared with placebo (67.3) (P = 0.13). There was a trend towards less narcotic usage in the Traumeel patients. No statistically beneficial effect from Traumeel was demonstrated for mucositis. We could not confirm that Traumeel is an effective treatment for mucositis in children undergoing HSCT.

A perspective on complementary/alternative medicine use among survivors of hematopoietic stem cell transplant: Benefits and uncertainties

“…Table shows other complementary health approaches . A small RCT was performed testing the efficacy of Traumeel S (homeopathy) in reducing the incidence of chemotherapy‐induced stomatitis in pediatric patients undergoing HCT .…”

“…There appeared to be relatively few studies testing natural products and alternative systems of medicine such as homeopathy and there were no published studies on Ayurvedic medicine. Literature exists regarding exaggerated intervention effect sizes in RCTs with a small sample size, resulting in discrepancies with the results of large RCTs, a finding that was observed in studies on Traumeel S in patients undergoing HCT . SAEs were not reported in the majority of studies, which could be due to small sample size or underreporting, among other factors.…”

Integrative approaches in breast cancer patients: A mini-review

“…In cancer care the effect of this compound is Integr Cancer Sci Therap, 2016 doi: 10.15761/ICST.1000188 controversial. One small single-center trial reported a beneficial effect of Traumeel S on chemotherapy-induced mucositis compared with placebo [49] whereas a multi-center, double-blind, placebo-controlled randomized trial did not confirm these positive results [50]. However, a trend towards less narcotic usage in the Traumeel-arm group was still observed.…”

The safety and feasibility of probiotics in children and adolescents undergoing hematopoietic cell transplantation

“…36 Excellent compliance may be related to a once-daily administration, a small amount of liquid and a highly motivated patient population as many patients undergoing HCT self-prescribe probiotic therapy. These results suggest that if probiotics are found to be effective and safe, patients may be largely compliant to probiotic therapy because of the perceived benefits of probiotics and its extensive safety profile.…”