Kono, T., Satomi, M., Chisato, N., Ebisawa, Y., Suno, M., Asama, T., . . . Furukawa, H. (2010). Topical application of hangeshashinto (TJ-14) in the treatment of chemotherapy-induced oral mucositis. World Journal of Oncology, 1, 232–235.

To determine if hangeshashinto (TJ-14) is an effective treatment for oral mucositis

Patients with oral lesions 7–10 days after chemotherapy were given a 50 ml oral rinse with 2.5 g of TJ-14 and tap water three times per day for 7 days. Patients held the solution in their mouth for 10 seconds and spit it out. TJ-14 also was applied to the lesions with a cotton pellet as soon as the lesion appeared. Patients could not eat or drink 30 minutes before or after treatment. No other mucosal treatments were used during the study. Two blinded physicians graded mucositis.

• N = 14  
• MEAN AGE: 62 years
• AGE RANGE: 34–80 years
• MALES: 43%, FEMALES: 57%
• KEY DISEASE CHARACTERISTICS: Colorectal cancer

• SITE: Single site   
• SETTING TYPE: Outpatient   
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

• Non-randomized trial

• Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 mucositis scale

In this study, 92.8% of patients had improvements in oral mucositis. There was a significant reduction in CTCAE grades of mucositis for all participants from 2.4 ± 0.8 to 1.1 ± 0.8 (p = 0.0012). No adverse events or side effects from NJ-14 were reported.

NJ-14 was effective at improving oral mucositis and did not have any reported side effects in this small sample. However, caution must be used in interpreting this data due to the limitations of the study.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)

NJ-14 is a promising intervention to treat chemotherapy-induced oral mucositis; however, more research is needed from large RCTs.