Sencer, S. F., Zhou, T., Freedman, L. S., Ives, J. A., Chen, Z., Wall, D., et al. (2012). Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group. Bone Marrow Transplantation, 47(11), 1409-1414.

To assess the use of Traumeel S for the prevention and  treatment of mucositis. To replicate a previous study that showed benefit in using Traumeel S.

Patients were entered into COG Cancer Registry and identified by number. Study medications were identified by number only. Traumeel S and a placebo identical in appearance and taste were provided by Heel (company that makes Traumeel S). Patients were assigned by block randomization to receive Traumeel S or placebo (1:1). Participants were stratified by TBI (yes/no), allogeneic versus autologous transplant, and by COG institution versus Israeli institution. A pharmacist drew up the solution into an oral syringe, and patients were instructed to rinse the mouth vigorously, maintain it in their mouth, and then swallow. The medication was administered five times per day. Patients were instructed to be NPO for 30 minutes after the medication. Any type of analgesia was allowed, and the doses were normalized to morphine equivalents. Treatment began on the day before transplant and ended when patients met the completion criteria and no later that the 20th day post-transplant.

The study was comprised of 195 patients, age 3 to 25 years.

MALES (%) 62.6 (56 in Traumeel S group, 70 in placebo group), FEMALES (%) 37.4 (44 in Traumeel S group, 30 in placebo group).  

KEY DISEASE CHARACTERISTICS: ALL (55 patients), AML (36 patients), CNS tumor (11 patients), lymphoma (26 patients), solid tumor (37 patients), hemoglobinopathy (13 patients), other (8 patients), and missing (4 patients)

OTHER KEY SAMPLE CHARACTERISTICS: Median age in Traumeel S group = 12 years (range 3 to 24). Median age in placebo group = 11 years (age range 3 to 25)

SITE: Mutli-site

SETTING TYPE: Inpatient setting

PHASE OF CARE: Active treatment

CLINICAL APPLICATIONS: Pediatrics (and to age 25), palliative care

International, multi-center, double-blind, placebo-controlled, randomized clinical trial.

• Three-grade modified Walsh Scale for mucositis    
• Five-grade World Health Organization oral toxicity scale
• Amount of narcotic equivalents per day
• Number of days of parenteral nutrition
• Number of days of nasogastric feeding
• National Cancer Institute Common Terminology of Adverse Events v. 3.0

No statistical significance between the placebo group and the Traumeel S group on chemotherapy-induced mucositis. Also, no statistically significant difference in narcotic use or days of total parenteral nutrition or nasogastric feeding.

Traumeel S is not a useful complementary medication for the prevention and treatment of oral mucositis.

Multiple centers with variable data collectors and a high non-compliance rate may have impacted this study.

Complimentary and alternative medicine (CAM) is an important topic for our patients, and it is important to study these therapies. There was no mention of adverse outcomes from using Traumeel S, but there was also not a benefit in this study. It is important to help our patients use their financial resources wisely and to invest their energies into treatments that are beneficial.