Samital® Mouth Rinse

Samital® Mouth Rinse

PEP Topic 
Mucositis
Description 

Samital® is a combination of botanical extracts from bilberry, macleaya cordata fruits, and Echinaceas angustifolia roots. These extracts have antifungal, antiviral, analgesic, and antinflammatory properties, as well as activity to protect mucosa and improve fibroblast proliferation. This solution was examined for its effect in prevention and management of oral mucositis.

Effectiveness Not Established

Research Evidence Summaries

Bertoglio, J.C., Calderon, S., Lesina, B., Pilleux, L., Morazzoni, P., Riva, A., . . . Petrangolini, G. (2013). Effect of SAMITAL® in the treatment of chemotherapy-induced mucositis in adult oncohematological patients. Future Oncology, 9, 1727–1732. 

doi: 10.2217/fon.13.164
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Study Purpose:

To evaluate the efficacy and safety of SAMITAL in reducing mucositis in patients undergoing treatment for hematologic malignancies

Intervention Characteristics/Basic Study Process:

Patients used SAMITAL mouth rinse three to four times daily and held it in the mouth for one minute.

Sample Characteristics:

  • N = 25  
  • AGE: 18–84 years (Note: in the abstract, age was 18–74 years)
  • MALES: 19 (76%), FEMALES: 6 (24%)
  • KEY DISEASE CHARACTERISTICS: Adult patients with cancer undergoing treatment for hematologic malignancies

Setting:

  • SITE: Single site  
  • SETTING TYPE: Inpatient   
  • LOCATION: Hospital Clinico Regional de Valdivia, Valdivia, Chile

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care

Study Design:

  • Observational, uncontrolled study

Measurement Instruments/Methods:

  • World Health Organization (WHO) mucositis grading scale (variables: stomatitis, dysphagia, gastritis, enteritis, pain, and feeding) performance status of less than 2

Results:

The grade of mucositis was reduced from grade 2 to 0–1 in seven patients (25%). It is stated that pain, mucosal erosions, bleeding, and dysphagia were reduced; however, it is unclear how these were measured.

Conclusions:

SAMITAL may have some benefit in the prevention and management of oral mucositis.

Limitations:

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)  
  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)
  • Selective outcomes reporting
  • Findings not generalizable
  • Other limitations/explanation: Due to the small sample, the researchers performed only descriptive statistics.

 

Nursing Implications:

The authors suggested performing randomized, placebo-controlled clinical trials to confirm the suitability of SAMITAL for the treatment and prophylaxis of mucositis.

Pawar, D., Neve, R. S., Kalgane, S., Riva, A., Bombardelli, E., Ronchi, M., et al. (2012). SAMITAL((R)) improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study. Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer.

10.1007/s00520-012-1586-5
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Study Purpose:

Investigate the safety and efficacy of SAMITAL in the treatment of oral mucoitis with chemo-radiation therapy.

Intervention Characteristics/Basic Study Process:

Patients received either Samital or a matching placebo mouth rinse. Patients were blinded to which treatment they had. Random assignment was not described.  Samital is a combination of three botanical drug extracts: vaccinium myrtillus, macleaya cordad, and Echinacea angustifolial root. The formulation is standardized, and forms a gel-like substance when re-constituted. Patients were to use the rinse 4 times daily for a total of 7 weeks. Each rinse was done using 4 aliquots over 30 minutes.

Sample Characteristics:

The study was comprised of 17 patients, with a mean age of 52.4 years.

MALES 89%, FEMALES 11%

KEY DISEASE CHARACTERISTICS: All had head and neck cancer and were receiving chemo-radiation. All had oral mucositis ≥ grade 3 on study entry, and 30% had cancer of the tongue.
 

Setting:

SITE: Single site

SETTING TYPE: Outpatient

LOCATION: India

 

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

Single, blind, placebo controlled phase II

Measurement Instruments/Methods:

  • Investigator modified WHO mucositis scale
  • Daily oral mucositis questionnaire
  • VAS for oral pain
     

Results:

None of the control group patients completed the study; most only completed seven days. Patients on SAMITAL showed significant improvement from baseline in mucositis grade from 2.94 ± 0.43 to 2.0 ± 0.35, drinking, eating, sleeping, and speaking (p < 0.05) after day 31. Those in the placebo group did not show significant changes from baseline.

Conclusions:

Findings suggest that SAMITAL might have some benefit in management of oral mucositis; however, this study has substantial limitations and does not provide strong evidence.

Limitations:

  • Small sample (<30)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results*
  • Measurement/methods were not well described.  
  • Measurement validity/reliability questionable*
  • Subject withdrawals ≥10%
  • Other limitations/*explanation: There was no discussion of analgesics used in the analysis. Very high number of dropouts, and patients lost to followup. The lack of most control patients beyond week 2 makes any differences seen between the controls and experimental group highly suspect. Revised WHO scale has unknown reliability etc. It is not stated that group assignment was actually random, and though patients were blinded to the treatment, evaluators were not.

Nursing Implications:

This study examined use of SAMITAL, a botantical preparation, for its efficacy in management of oral mucositis. Some positive effects are described; however, this study does not provide strong evidence. Further well-designed research in this area may be warranted.


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