Herbal Medicine

Herbal Medicine

PEP Topic 
Fatigue
Description 

An herb is a plant or part of a plant that people take for health benefits, such as dietary supplements or medication. Herbal medicine also may be referred to as phytotherapy or use of botanicals. Herbal medicine interventions include a variety of subtances and combinations of substances.

Effectiveness Not Established

Research Evidence Summaries

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: 10.1177/1534735410383170
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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.

Zhao, H., Zhang, Q., Zhao, L., Huang, X., Wang, J., & Kang, X. (2012). Spore powder of Ganoderma lucidum improves cancer-related fatigue in breast cancer patients undergoing endocrine therapy: a pilot clinical trial. Evidence-Based Complementary and Alternative Medicine, 809614.

doi: 10.1155/2012/809614
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Study Purpose:

To evaluate whether spore powder of Ganoderma lucidum (G. lucidum) has beneficial effects on fatigue and overall quality of life in patients with breast cancer undergoing endocrine therapy.

Intervention Characteristics/Basic Study Process:

Patients in the experimental group received spore powder of G. lucidum 1,000 mg three times a day for four weeks (from Beijing Great Wall Pharmaceutical Factory, batch # B20050008). This is a traditional Chinese medicine that contains polysaccharides, alkaloids, enzymes, and proteins. The control group received placebo for four weeks. Outcomes were evaluated at baseline and the end of four weeks. 

Sample Characteristics:

  • The total sample was comprised of 48 women, with 25 patients in the experiemental group and 23 in the control group.  
  • Median age was 51.3 years (standard deviation [SD] = 9.8) in the experiemental group and 53.2 years (SD = 8.7) in the control group (p > 0.1).
  • Patients were stage I to IIIA. 
  • Multimodal treatment included surgery, radiation and/or chemotherapy, and endocrine therapy for all patients. 
  • Duration of endocrine therapy varied from more than six months to up to five years. 
  • No statistically significant differences existed between the groups.
  • Patients received endocrine therapy for breast cancer.
     

Setting:

The study was conducted at the Third Affiliated Hospital of Harbin Medical University in Harbin, China, from June 2009 to September 2010.

Phase of Care and Clinical Applications:

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for patients undergoing endocrine therapy.
     

Study Design:

The study was a randomized, placebo-controlled trial.

Measurement Instruments/Methods:

  • Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
  • Hospital Anxiety and Depression Scale (HADS)
  • European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30)
  • Biological Markers of Fatigue:  tumor necrosis factor (TNF) and interleukin-6 (IL-6)
  • Safety and toxicity tests, such as a renal function test, liver function test, and the Common Toxicity Criteria version 2.0 scale
  • Fatigue was measured with a single-item numeric rating scale with possible values from 0 (a great deal of fatigue) to 10 (no fatigue).
  • Energy was measured with a single item, “How much energy have you had during the past 4 weeks?,” with possible values from 0 (no energy at all) to 10 (a great deal of energy).
     

Results:

No serious adverse effects occurred. No significant changes occurred in the renal and liver function tests. Fatigue scores were improved in the experimental group at four weeks (p < 0.01), but no significant improvement occurred in the control group. At four weeks, anxiety and depression scores had improved significantly from baseline in the experimental group. No significant improvement occurred over time in the control group.

Conclusions:

The pilot suggested that spore powder G. lucidum may have beneficial effects on cancer-related fatigue and quality of life in patients with breast cancer undergoing endocrine therapy with no significant safety concerns.

Limitations:

  • The study had a small sample size, with less than 100 patients.
  • Nonspecific aspects of the intervention (social support) may influence the study. 
  • Patients were healthy (e.g., no other comorbid conditions).
  • No blinding was performed.
     

Nursing Implications:

Additional research should be conducted in a larger randomized, controlled trial.

Systematic Review/Meta-Analysis

Zhang, M., Liu, X., Li, J., He, L., Tripathy, D. (2007) Chinese medicinal herbs to treat the side-effects of chemotherapy in breast cancer patients. Cochrane Database of Systematic Reviews, CD004921. 

doi: 10.1002/14651858.CD004921.pub2
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Purpose:

To review the evidence regarding the effects of Chinese herbal medicine on side effects of chemotherapy in women with breast cancer.

Search Strategy:

Databases searched were Cochrane Library, EMBASE, LILACS, SIGLE, and Chinese Biomedical Disk. Handsearching of key medical journals and references lists of retrieved articles was also performed.

Search keywords were Chinese medicine, plants, drugs, botanical, herbal medicine, and additional search terms related to herbal medicine as well as breast cancer treatments. A full listing of search terms was provided.

Studies were included if they included

  • Women with breast cancer receiving chemotherapy as adjuvant or palliative treatment. 
  • Single and compound herbal treatments. 
  • Randomized clinical trials with chemotherapy-induced side effects.

Patients were excluded if they had other cancers as well as breast cancer (except for skin cancer).

Literature Evaluated:

In total, 88 references were retrieved. The authors allocated trials to quality categories described in the Cochrane Reviewers' Handbook and assessed quality according to criteria from Schultz (1995); studies were categorized as having a low, moderate, or high risk of bias.

Sample Characteristics:

  • The final number of studies included was seven.  
  • The sample range across studies was 48 to 120 patients (N = 541).
  • All patients had breast cancer and were receiving chemotherapy. 
  • All studies were performed on Chinese patients in a mix of settings.

Phase of Care and Clinical Applications:

Patients were undergoing multiple phases of care.

Results:

Trial duration ranged from 14 to 84 days. Treatments were varied with different herbal concoctions; most included radix ginseng along with other substances. The authors did not provide the findings for all outcomes of interest. A few studies measured quality of life, and several attempted to evaluate the effect on thrombocytopenia and white blood cell volumes and types. Some studies used inappropriate statistical methods. The quality of the included trials was poor.

Conclusions:

The nature of the evidence in use of Chinese herbal medicine was not sufficient to draw any conclusions.

Limitations:

The study included a small number of studies with relatively small samples and poor quality.

Nursing Implications:

The evidence reviewed did not provide clear implications for the incorporation of findings into practice. Further well-designed research is needed.


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