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.

Luo, Y., Feng, M., Fan, Z., Zhu, X., Jin, F., Li, R., . . . Lang, J. (2016). Effect of Kangfuxin solution on chemo/radiotherapy-induced mucositis in nasopharyngeal carcinoma patients: A multicenter, prospective randomized phase III clinical study. Evidence-Based Complementary and Alternative Medicine, 2016, 8692343. 

doi: 10.1155/2016/8692343
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Study Purpose:

To evaluate the efficacy and safety of Kangfuxin solution, a pure Chinese herbal medicine, on mucositis induced by chemo/radiotherapy in patients with nasopharyngeal carcinoma

Intervention Characteristics/Basic Study Process:

The treatment patients gargled three times a day after each meal. Patients were monitored from the first day of chemotherapy or radiotherapy until the emergence of grade 3 oral mucositis or when the patients finished the entire course of radiotherapy using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Oral mucositis and pain were measured according to guidelines.

Sample Characteristics:

  • N = 215   
  • AGE = 46.3 years (SD = 11)  
  • MALES: 62 (28.8%), FEMALES: 153 (71.2%) 
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma

Setting:

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: China

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design:

Randomized, parallel-group clinical trial

Measurement Instruments/Methods:

  • CTCAE, version 3.0 
  • Verbal rating scale (VRS) 
  • Karnofsky Performance Scale

Results:

The incidence and severity of oral mucositis in the test group significantly reduced (p = 0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in the test group (p < 0.01). Comparing the grades of oral mucositis, the test drug also was shown to reduce the severity of oral mucositis (p = 0.0098), and the accumulated radiation dose was also higher in the test group compared to the control group (p < 0.05). The test group showed a lower incidence of oral pain and gastrointestinal mucositis than the control group (p < 0.01). No significant adverse events were observed.

Conclusions:

Kangfuxin solution reduced the incidence of all levels of mucositis, especially high-grade mucositis, to improve patients' tolerance to radiation, ensuring the continuity of radiotherapy. So, it demonstrated its superiority to compound borax gargle on mucositis induced by chemo/radiotherapy.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Control intervention not standard

Nursing Implications:

Kangfuxin solution effectively prevented chemo/radiotherapy-induced oral mucositis, reduced the incidence of upper gastrointestinal inflammation, and decreased the severity of oral pain compared with compound borax gargle. It improves the quality of life in patients. Additional research to confirm the effects is warranted.

Mutluay Yayla, E., Izgu, N., Ozdemir, L., Aslan Erdem, S., & Kartal, M. (2016). Sage tea-thyme-peppermint hydrosol oral rinse reduces chemotherapy-induced oral mucositis: A randomized controlled pilot study. Complementary Therapies in Medicine, 27, 58–64. 

doi: 10.1016/j.ctim.2016.05.010
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Study Purpose:

To see the preventive effect of a sage tea–thyme–peppermint hydrosol oral rinse used in combination with oral care

Intervention Characteristics/Basic Study Process:

This study aimed at discovering the preventive effect of sage tea–thyme–peppermint hydrosol oral rinse four times a day in addition to oral care (saline rinse and teeth brushing) in patients receiving chemotherapy regimens using 5-fluorouracil (5-FU). The study collected data through a patient questionnaire, the World Health Organization (WHO) Oral Toxicity Scale, oral cavity photos, and compliance checklists. The study completed assessments at 5 and 14 days after the completion of chemotherapy.

Sample Characteristics:

  • N = 60, 30 in control group and 30 in intervention   
  • MEAN AGE = intervention group: 52.6 years (SD = 8.2 years), control group: 48.7 years (SD = 10 years)
  • MALES: 40%, FEMALES: 60%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Colon cancer (majority), solid tumor 
  • OTHER KEY SAMPLE CHARACTERISTICS: Denture use varied in the control and intervention groups.

Setting:

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Ankara, Turkey

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

Patients receiving bolus or infusion of 5-FU chemotherapy were randomly assigned to the intervention or control group.

Measurement Instruments/Methods:

Measurement tools used included a patient questionnaire, the WHO Oral Toxicity Scale, oral cavity photos, and compliance checklists (self-reported by the patients).

Results:

Using kappa analysis, the kappa coefficient on day 5 was 0.98 and on day 14 was 0.85 in the intervention group. Oral mucositis in the invention group occurred in 30% of patients compared to 60% of patients in the intervention group. Grade 1 mucositis was statistically lower in the intervention group (10%) versus the control group (53.3%) on day 5 (p < 0.001). Grade 2 mucositis occurred more in the intervention group (20%) versus the control group (6.7%); on day 5, there was no statistical significance. On day 14, 93% of patients in the intervention group did not have mucositis and 96% in the control group did not have mucositis. No grade 3 or 4 mucositis occurred during this study.

Conclusions:

Oral mucositis occurred in only 30% of the intervention group compared to 60% of the control group. The sage tea–thyme–peppermint hydrosol rinses are cost-effective, well tolerated, safe, and noninvasive. This intervention may be effective, but more randomized, controlled clinical trials of different types of treatment, as well as larger sample sizes, are needed.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Lack of follow-up
  • Some patient-reported data

Nursing Implications:

This intervention is a low-cost, effective, and well tolerated intervention. One downside is that this hydrosol needs refrigerated, and the solution needs to be analyzed in the pharmacy for consistency. Nurses need to educate patients and reinforce the importance of oral hygiene and adherence to the schedule of oral rinsing with this solution four times a day. This intervention may be effective but needs more research and data to show its effectiveness.

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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