Ye, X., Lu, D., Chen, X., Li, S., Chen, Y., & Deng, L. (2016). A multicenter, randomized, double-blind, placebo-controlled trial of Shuangbai San for treating primary liver cancer patients with cancer pain. Journal of Pain and Symptom Management, 51, 979–986. 

To evaluate the effect of Shuangbai San on pain relief among patients with liver cancer

Shuangbai San is a traditional Chinese medicine that includes five major herbal components that was prepared for external application. Patients with low level pain (3 or less on an 11-point scale) were randomly assigned to the study intervention or placebo. Two hundred grams of the preparation or placebo was mixed with water and honey to make a paste that was heated in a microwave for three minutes. The mixture was spread on a transparent film, then applied and kept in place around the liver or upper abdomen for six hours for seven days of treatment. Pain scores were measured after one, three, and six hours daily. Quality of life (QOL) was measured pre- and post-treatment.

• N = 133   
• MEAN AGE = 57
• MALES: 86.5%, FEMALES: 13.5%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: All had primary liver cancer.

• SITE: Multi-site   
• SETTING TYPE: Home    
• LOCATION: China

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

• Double-blind, placebo-controlled randomized trial

• Numeric pain rating scale
• EORTC Cancer Care Quality of Life (EORTC-QLQ-C30) questionnaire

The pain rating scores were significantly lower in the study treatment group at all time points (p < 0.001). Pain scores declined in all. On the EORTC, the intervention group had significant improvement is subscale scores for physical, emotional, fatigue, pain, insomnia, appetite, and global health compared to controls (p < 0.001). These aspects of QOL improved in all study patients. No adverse effects were seen. Only one patient used any analgesic.

Topical application of Shuangbai San was shown to reduce cancer pain and improve aspects of QOL among patients with low-level pain associated with liver cancer.

• Limited availability of the mixture was used.

The traditional Chinese medicine compound Shuangbai San was associated with reduced pain and enhanced QOL among patients with low-level pain from liver cancer. This may hold promise for relief of mild pain. Further testing and application in other types of pain that may be responsive to topical treatment is needed.