Traumeel S

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.

Evaluate the efficacy of Traumeel S in management of oral mucositis in patients receiving radiation for head and neck cancer.

Patient were matched and assigned to either mouth rinses with sage tea or with Traumeel S solution in alcohol. Participants were to rinse with the solution for 30 seconds before swallowing. Analgesics were prescribed according to stated individual patient requirements. Patients were assessed weekly.

The study was comprised of 20 patients, with a mean age of 58.8 years.
MALES 75%, FEMALES 25%
KEY DISEASE CHARACTERISTICS: All had head and neck cancer and were receiving 60-70 Gy median radiation dosage. 12 patient were also receiving Cisplatin. 75% had tumors of the oropharynx.

SITE: Single site

SETTING TYPE: Outpatient

LOCATION: Germany

PHASE OF CARE: Active antitumor treatment

Matched pairs design – non random

• CTC for adverse events v 3.0
• EORT-QOL–C30 questionnaire
• Head and neck, 35 questionnaire
• Patient diary of symptoms

No significant differences between groups in oral pain or occurrence of mucositis. Oral pain, pain on swallowing, and taste disturbances were lower in the Traumeel S group; however, this difference was not statistically significant, and patients on Traumeel S also received more frequent analgesics.

The study shows no effect of Traumeel S on mucositis or oral pain.

Small sample (<30)

Risk of bias (no blinding) 

Risk of bias (no random assignment)

Unintended interventions or applicable interventions not described that would influence results

Key sample group differences that could influence results

Measurement/methods not well described

Other limitations/*explanation:  Diary measurement of symptoms was not described. There was no control or description of other analgesics used. Frequency of mouthrinses was not stated, and there is no information about patient adherence to rinses. Samples differed in tumor location and radiation delivery site somewhat. More patients in the experimental group were receiving analgesics prior to beginning radiation.

Findings of this small study do not show that Traumeel S is effective in the prevention or management of oral mucositis in patients receiving radiation for head and neck cancers.