Herbal Medicine

Herbal Medicine

PEP Topic 
Mucositis
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

Giacomelli, I., Scartoni, D., Fiammetta, M., Baki, M., Zei, G., Muntoni, C., . . . Livi, L. (2015). Oral lapacho-based medication: An easy, safe, and feasible support to prevent and/or reduce oral mucositis during radiotherapy for head and neck cancer. Nutrition and Cancer, 67, 1249–1254. 

doi: 10.1080/01635581.2015.1082114
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Study Purpose:

To demonstrate the benefits and tolerance of a multicomponent herbal oral agent for mucositis in patients with head and neck cancer receiving radiation or combination therapy

Intervention Characteristics/Basic Study Process:

Orasol plus solution (a mixture of lapacho, hyaluronic acid, green tea, calendula, erisiom, propolis, marigold, plantain, and mauve) was administered to patients from the first day of radiotherapy until the end of therapy. It was given at a dose of 10 ml three times daily. The authors indicated that it can be swallowed, but did not state how patients were instructed to use it.

Sample Characteristics:

  • N = 40
  • AGE = 70% were older than 60 years
  • MALES: 68%, FEMALES: 32%
  • KEY DISEASE CHARACTERISTICS: Patients had head and neck cancer. The primary site of cancer was the oral cavity in 30% of patients and the hypopharynx in 30%. In addition, 72.5% were getting radiation only, and the rest were getting radiation and chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Thirty-five percent were current smokers.

Setting:

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Italy

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

  • Phase II prospective trial

Measurement Instruments/Methods:

  • Common Terminology Criteria for Adverse Effects (CTCAE) version 4

Results:

Of the patients, 47.5% developed grade 1, 27.5% developed grade 2, and 10% developed grade 3 mucositis. Median Gy doses to the oral mucosa were lowest in those with grade 1 mucositis. Six patients did not develop mucositis. None of these patients was receiving radiation and chemotherapy. The prevalence of grade 2 or greater mucositis was higher among smokers (p < 0.02). One patient developed itching and one developed glossitis. Twenty-five percent needed an increase in dosage or additional analgesic therapy.

Conclusions:

The herbal nutritional supplement tested here may have some benefit for the prevention of severe mucositis in patients with head and neck cancer during therapy. Additional research is needed to establish any benefit.

Limitations:

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • No information is given regarding patient adherence to use. The sample was too small for subgroup analysis for those getting combination chemoradiation therapy.

Nursing Implications:

Very few interventions have been shown to be effective for the prevention and treatment of oral mucositis in patients receiving cancer treatment. The substance tested here appeared safe, and findings suggest that it may be beneficial; however, numerous study design limitations exist. Further research with this agent is needed to determine efficacy.

Systematic Review/Meta-Analysis

Meyer-Hamme, G., Beckmann, K., Radtke, J., Efferth, T., Greten, H.J., Rostock, M., & Schroder, S. (2013). A survey of Chinese medicinal herbal treatment for chemotherapy-induced oral mucositis. Evidence-Based Complementary and Alternative Medicine: ECAM, 2013, 284959.

doi: 10.1155/2013/284959
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Purpose:

  • STUDY PURPOSE: To examine the evidence of Chinese herbal treatment in oral mucositis
  • TYPE OF STUDY: Systematic review

Search Strategy:

  • DATABASES USED: PubMed, MEDLINE via OVID, Embase via OVID, Cochrane Database, and CNKI
  • KEYWORDS: Chemotherapy, chemotherapy-induced, oral ulcer, mouth ulcer, oral mucositis, stomatitis, Chinese herbal medicine, medicinal herbs, Chinese herbs, traditional Chinese medicine, antioxidant, anti-inflammatory
  • INCLUSION CRITERIA: All induced oral mucositis treated by Chinese herbal medicine that offered an English or Chinese medicine were included.  
  • EXCLUSION CRITERIA: Articles investigating radiochemotherapy-induced oral mucositis were excluded.

Literature Evaluated:

  • TOTAL REFERENCES RETRIEVED: 686
  • EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Only articles that included oral mucositis treated by Chinese herbal medicine were included. Therefore, 632 articles were excluded, leaving 54 articles of which only 18 met the inclusion criteria.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 18
  • TOTAL PATIENTS INCLUDED IN REVIEW: 1, 476
  • KEY SAMPLE CHARACTERISTICS: Patients with oral mucositis, based on the World Health Organization Oral Toxicity Scale, who were treated with either a single herb or a combination of herbs involving more than one component

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active treatment

Results:

All reviewed studies reported positive effects of Chinese herbal treatment for chemotherapy-induced oral mucositis.

Conclusions:

Additional well-designed RCT studies are needed, especially to look at the mechanism of action for each herbal remedy. Due to poor design in terms of treatment and control groups, it was almost impossible to evaluate which parts of the treatment concepts are responsible for the measured effects in the reviewed trials.

Limitations:

Some studies used more than one herbal treatment with different routes of administration; therefore, it was difficult to determine which agent may have been more effective in treating oral mucositis. In general, most trials had a poor design.

Nursing Implications:

No recommendations for use in clinical practice were made; recommendations were made for further studies. These studies could use placebo capsules or placebo liquids. It also was recommended that future studies decrease the complexity of the treatments in order to determine what treatments were effective.

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