Steinmann, D., Eilers, V., Beynenson, D., Buhck, H., & Fink, M. (2012). Effect of Traumeel S on pain and discomfort in radiation-induced oral mucositis: a preliminary observational study. Alternative Therapies in Health and Medicine, 18(4), 12-18.

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.