Xu, Y., Chen, Y., Li, P., & Wang, X.S. (2015). Ren Shen Yangrong Tang for fatigue in cancer survivors: A phase I/II open-label study. Journal of Alternative and Complementary Medicine, 21, 281–287. 

DOI Link

Study Purpose

To establish the safety and efficacy of traditional Chinese herbal medicine for the treatment of fatigue in patients with cancer who do not have anemia

Intervention Characteristics/Basic Study Process

Patients were recruited from those who visited a herbal medicine clinic. Patients were given a combination of 12 herbs, which they slowly cooked in 150 ml of water. This decoction was taken twice daily for six weeks. Study measures were obtained at baseline and after six weeks. Patients were evaluated by a traditional Chinese medicine doctor at the beginning and end of the study.

Sample Characteristics

  • N = 33
  • MEDIAN AGE = 60 years (range = 41–81 years)
  • MALES: 42%, FEMALES: 58%
  • KEY DISEASE CHARACTERISTICS: Varied tumor types; off treatment for at least one month
  • OTHER KEY SAMPLE CHARACTERISTICS: All had moderate to severe fatigue defined as a score of at least 4 on a 0–10 point scale; hemoglobin of at least 10 g/dl

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

Open-label phase I–II

Measurement Instruments/Methods

  • Single fatigue item scale from the Chinese version of the MD Anderson Symptom Inventory (MDASI)

Results

Fatigue levels declined during the study (p = 0.024), and 64% of patients said they felt better within two weeks, and 33% felt better after three weeks. No adverse events were reported.

Conclusions

The findings of this study suggest that that a traditional Chinese herbal medicine formulation appears to be safe and may be helpful in the treatment of depression among patients with cancer.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Other limitations/explanation: The approach described for the evaluation of potential side effects was according to traditional Chinese medicine practice, and its general validity is not clear.

Nursing Implications

This study was limited by design and sample size, so no firm conclusions about the safety and efficacy of traditional Chinese herbal medicine can be made.