Hatakeyama, H., Takahashi, H., Oridate, N., Kuramoto, R., Fujiwara, K., Homma, A., . . . Fukuda, S. (2015). Hangeshashinto improves the completion rate of chemoradiotherapy and the nutritional status in patients with head and neck cancer. ORL: Journal for Oto-Rhino-Laryngology and Its Related Specialties, 77, 100–108. 

To investigate the effect of hangeshashinto to relieve chemotherapy-induced oral mucositis

Patients were to gargle three times daily with 2.5 g hangeshashinto (TJ-14) in 50 ml of water and rinse the oral cavity for about five seconds. Patients were instructed not to swallow it and not eat or drink anything for 30 minutes. Patients who received the intervention were compared to patients who did not. Measurements were done at baseline and at eight weeks.

• N = 57, only 12 received the intervention  
• MEAN AGE = 59.5 years
• AGE RANGE = 40–75 years
• MALES: 93%, FEMALES: 7%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Oropharyngeal and hypopharyngeal cancers; total radiation dose of 70 Gy and cisplatin
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of patients had stage IV disease.

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

• PHASE OF CARE: Active antitumor treatment

• Nonrandomized two-group prospective study

• Common Terminology Criteria for Adverse Events (CTCAE)
• Bioimpedance for body composition
• Measurement of food intake

No significant differences in maximum grade of mucositis or daily morphine dose existed. Oral intake and body weight were improved in those who took the hangeshashinto, but no comparative information on this measure from the control group was provided. The radiation completion rate was higher in the treated group (p = 0.045). Twenty-five percent of patients would not continue to use the gargle because of the bitter taste, nausea, vomiting, and refusal to wait 30 minutes before eating.

The findings do not show a benefit of hangeshashinto gargle on mucositis severity or associated pain.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Subject withdrawals ≥ 10%  
• Very few patients actually received the intervention. Little comparative information is provided. The timing of measurement was not clearly reported.

This study did not show the effectiveness of hangeshashinto to prevent or reduce the severity of oral mucositis in patients with head and neck cancer receiving combined radiation and chemotherapy. Multiple report limitations are noted.