Jeong, J. S., Ryu, B. H., Kim, J. S., Park, J. W., Choi, W. C., & Yoon, S. W. (2010). Bojungikki-tang for cancer-related fatigue: a pilot randomized clinical trial. Integrative Cancer Therapies, 9, 331–338.

DOI Link

Study Purpose

To evaluate whether Bojungikki-tang has beneficial effects on fatigue and overall quality of life in patients with cancer.

Intervention Characteristics/Basic Study Process

Patients were randomized to the experimental group or the wait-list control group. The experimental group received Bojungikki-tang for two weeks. Bojungikki-tang was administered as granules containing a mixture of 10 medicinal plants given three times daily. Patients were randomized through computer generation. Patients were recruited through newspaper and hospital advertisements.

Sample Characteristics

  • The final sample included 36 patients (37.5% male).
  • Mean age was 52.6 years. 
  • Diagnoses included breast cancer (27.5%), stomach cancer (12.5%), lung cancer (12.5%), colon cancer (12.5%), and other (35%).

Setting

Unknown

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Evaluation forms included the Visual Analogue Scale of Global Fatigue, which was used as the primary outcome variable.
  • The secondary outcome was measured using the Functional Assessment of Cancer Therapy–General (FACT-G), the FACT-Fatigue (FACT-F), and the Trial Outcome Index–Fatigue (TOI-F).

Results

The experimental group had statistically significant improvements in VAS-F scores, as well as FACT-G, FACT-F, and TOI-F (p < 0.05) at week 2.

Conclusions

The study had a possible effect from the study drug, although p-values were on the edge of significance. The benefit shown suggests additional study is required in a larger, placebo-controlled trial.

Limitations

  • The study had no placebo in place, and the treatment time was short.
  • The plant mixture was not controlled for variability.
  • One patient experienced an increase in BUN and creatinine above the reference ranges, and other adverse effects were reported (flatulence and dyspepsia); therefore, the potential for harm needs to be considered and the risks weighed versus potential benefits if additional study is to be performed with a larger population.
  • Exclusion criteria for patients needs to be more rigorous and include consideration of antihypertensive medication and other drug interactions and baseline renal function.

Nursing Implications

Patients pursuing this treatment should be educated on the current need for additional research.