Wang, C., Wang, P., Ouyang, H., Wang, J., Sun, L., Li, Y., . . . Pan, Z. (2017). Efficacy of traditional Chinese medicine in treatment and prophylaxis of radiation-induced oral mucositis in patients receiving radiotherapy: A randomized controlled trial. Integrative Cancer Therapies, 17, 444–450.

DOI Link

Study Purpose

To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer.

Intervention Characteristics/Basic Study Process

70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio in the period between May 2014 to December 2015. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of the irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events, version 4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy.

Sample Characteristics

  • N = 70   
  • AGE: 17-76
  • MALES: 76%  
  • FEMALES: 24%
  • CURRENT TREATMENT: Radiation
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: No history of oral ulcer and salivary gland diseases, No history of anti-tumor therapies.

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Prospective control randomized trial

Measurement Instruments/Methods

  • The National Cancer Institute Common Toxicity Criteria Oral Mucositis Scale.
  • Oral pain and xerostomia were assessed by the patients with the visual analysis scale (VAS).
  • Body mass index (BMI) was used to assess the nutritional status of patients before and after treatment.

Results

  • Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group (p < 0.01).
  • Xerostomia was decreased notably in treatment group compared with control group (p < 0.01).
  • The degrees of OM in the treatment group were 1.57 (SD = 0.51) versus 2.49 (SD = 0.7) in the control group (p < 0.01).

Conclusions

CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)