Herbal Medicine

Herbal Medicine

PEP Topic 
Chemotherapy-Induced Nausea and Vomiting—Adult
Description 

Herbal medicine involves the use of plants or parts of plants for health benefits as dietary supplements or medication. Herbal medicine also may be referred to as phytotherapy or botanicals. Herbal medicine interventions include a variety of substances and combinations of substances. 

Effectiveness Not Established

Systematic Review/Meta-Analysis

Chen, M.H., May, B.H., Zhou, I.W., Zhang, A.L., & Xue, C.C. (2016). Integrative medicine for relief of nausea and vomiting in the treatment of colorectal cancer using oxaliplatin-based chemotherapy: A systematic review and meta-analysis. Phytotherapy Research, 30, 741–753. 

doi: 10.1002/ptr.5586
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Purpose:

STUDY PURPOSE: To assess whether integrative management of colorectal cancer, in which traditional medicines are added to oxaliplatin regimens, reduced the incidence of chemotherapy-induced nausea and vomiting (CINV) and to determine if specific particular traditional medicines provided enough evidence to pursue further research for CINV

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: PubMed, EMBASE, Cochrane CENTRAL, CINAHL, Science Direct, PsycINFO, China Academic Journals, and Chinese Science and Technology Journals
 
INCLUSION CRITERIA: Adults with colorectal cancer at any stage, randomized controlled trials that used an oxaliplatin regimen combined with a traditional medicine in the test group (could be single substance or multi-ingredient formulation). Concurrent use of antiemetics was permitted.
 
EXCLUSION CRITERIA: None listed

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 2,163
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The researchers removed (a) preclinical studies, (b) studies that included traditional medicine plus oxaliplatin versus a oxaliplatin design, and (c) studies that did not report outcomes for nausea and vomiting or did not have data deemed “suitable for pooling.”

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 27 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,843
  • SAMPLE RANGE ACROSS STUDIES: 16–74 patients
  • KEY SAMPLE CHARACTERISTICS: Adult patients from China and Australia with a colorectal diagnosis

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Results:

Across all 27 studies, the test groups showed significantly reduced CINV (RR = 0.65) with an absolute risk reduction of 24% compared to controls. They further divided test groups into an injection group and an oral administration group. Four different injection products were tested in six studies, with an overall RR of 0.73 in the traditional medicine plus oxaliplatin group. In the oral administration, 21 studies were analyzed, which contained 98 different plant-based ingredients with an average of 12 ingredients per traditional medicine intervention. The oral agents demonstrated an overall reduction in CINV with a RR of 0.62. The absolute risk reduction was 25% for the test groups compared to controls. In addition, each plant was analyzed individually as well as in all combinations (2, 3, 4, 5, 6, and 7 plants). The results demonstrated that six plants influenced the relative risk for CINV, including atractylodes, poria, coix, glycyrrhiza, astragalus, and panax ginseng.

Conclusions:

This meta-analysis of 27 studies suggested the potential benefit of adding traditional medicines in the reduction of CINV associated with oxaliplatin-based chemotherapy in adults with colorectal cancer. The lack of blinding in most studies may have led to an overestimation of the effects on CINV. Sensitivity analysis identified six plants that were associated with significant reductions in CINV, which may warrant further clinical research.

Limitations:

  • No quality evaluation
  • Low sample sizes
  • Most studies were not blinded and did not have a placebo for the control groups, which is likely to influence participant-reported CINV. The use of antiemetics also may have affected study results. No dosing information on treatment regimens were used other than the inclusion of oxaliplatin. Most studies were small single institutions studies, and the methodological reporting of the quality of studies and randomization was weak.

Nursing Implications:

In this meta-analysis of traditional medicine interventions in adult patients with colorectal cancer receiving oxaliplatin-based therapies, six plants demonstrated reductions in CINV. Although the studies had limitations related to methodology, no serious adverse events or increase in CINV occurred. These plants warrant further research and consideration in patients whose CINV is not well-controlled by conventional therapies.

Research Evidence Summaries

Mok, T.S., Yeo, W., Johnson, P.J., Hui, P., Ho, W.M., Lam, K.C., … Zee, B. (2007). A double-blind placebo-controlled randomized study of Chinese herbal medicine as complementary therapy for reduction of chemotherapy-induced toxicity. Annals of Oncology, 18, 768-774.

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Study Purpose:

To evaluate the use of Chinese herbal medicine as a complementary therapy for the reducing chemotherapy-induced toxicity

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of three Chinese herbalists who evaluated and prescribed combination, single-item, packaged, herbal extract granules. Herbalists completed university training and were licensed to practice Chinese herbal medicine (CHM) in Hong Kong and China. Patients were randomly assigned to each group and received either CHM or placebo packages with corresponding serial numbers in a 14-day supply at each clinic visit. The placebo package contained nontherapeutic herbs with an artificial smell and taste similar to typical herb tea. Each patient completed the log for each day’s consumption. On days 1 and 14, patients met with the herbalist in the clinic setting for evaluation and the herbalist documented the visit in case report form. A quality-of-life questionnaire was completed at baseline, day 1 of each cycle, and after four months.

Sample Characteristics:

The sample consisted of 120 patients with early-stage breast and colon cancer receiving adjuvant treatment in a university-based cancer center in Hong Kong.

Patients were included in the study if they

  • Were 18 years or older
  • Had an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2
  • Had no prior chemotherapy
  • Had normal hematologic, liver, and renal function.

Patients were excluded from the study if they

  • Required concurrent radiotherapy
  • Were unable to take or follow directions for daily oral medications
  • Had evidence of distant metastasis
  • Had concurrent medical illness
  • Had received prior chemotherapy
  • Were pregnant or breast feeding.

Setting:

The study was conducted at a university-based cancer center in Hong Kong.

Study Design:

This was a double-blind, placebo-controlled, randomized study.

Measurement Instruments/Methods:

The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 were used.

Patients recorded their daily intake of the herbal package contents on patient logs. Herbalists documented patient visits in case report form 

 

Results:

  • CHM was not found to be efficacious for reducing hematologic toxicity associated with adjuvant chemotherapy for breast and colon cancer.
  • CHM did reduce grade 2 nausea in the CHM group compared to the placebo group.
  • Accrual to the study was slow because patients had a preference for receiving the true CHM rather than participating in a controlled, placebo trial. Therefore, a formal interim analysis was conducted with only half of the target accrual. The review committee eventually terminated the study. 

 

Limitations:

  • Patient accrual was difficult because the population believed CHM to be effective.
  • Cost and storage is a barrier with the herbal or natural product granules.
  • More than 225 different types of preparations are available.
  • CHM requires use of trained and certified herbalists.

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