Bethanechol

Bethanechol

PEP Topic 
Mucositis
Description 

Bethanechol is a cholinergic agent that stimulates the parasympathetic nervous system. It is most often used related to its effect on improvement of bladder emptying and improvement in esophageal gastric sphincter pressure for reflux control. It is also a salivary stimulant. Bethanechol mouth rinse has been evaluated in patients with cancer in the prevention and management of mucositis.

Effectiveness Not Established

Research Evidence Summaries

Jham, B.C., Chen, H., Carvalho, A.L., & Freire, A.R. (2009). A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy: A secondary analysis. Journal of Oral Science, 51, 565–572.

doi: 10.2334/josnusd.51.565
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Study Purpose:

To determine the impact of bethanechol administration concomitant to radiotherapy on oral mucositis, candidiasis, and taste loss

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of two treatment groups. Group 1 received 25 mg oral bethanechol, 3 times a day; group 2 received artificial saliva (OralBalance). Patients who experienced severe mucositis were subject to daily laser applications until remission of the lesions.

Sample Characteristics:

  • The mean age of participants in the bethanechol group was 59 years and in the artificial saliva group was 55 years.
  • The sample was 25% female and 75% male in both groups.
  • Patients had been diagnosed with malignant neoplasms of the head and neck region and were receiving external beam radiotherapy (RT) encompassing one or more major salivary glands for a minimum of 45 Gy.

Setting:

This was an outpatient radiation study conducted in Brazil.

Study Design:

Secondary analysis, stratified, open-label, random allocation to one of two groups.

Measurement Instruments/Methods:

  • Mucositis was scored weekly using the World Health Organization (WHO) grading scale.
  • Patients were examined weekly for Candida.
  • Taste loss was defined as the patient’s subjective report of absence of taste.
  • Fisher exact tests were used for categorical variables.
  • t-tests were used for continuous variables.
  • The Kaplan-Meier method was used.
  • Log-rank tests were performed.

Results:

No significant differences in frequency and severity of mucositis, candidiasis, or taste loss were found.

Conclusions:

Bethanechol did not appear to reduce the incidence of mucositis, candidiasis, or taste loss when administered during RT.

Limitations:

  • The sample size was small
  • Differences in the anticancer treatment regimen existed between the two groups.
  • A wide variety of treatment protocols were used (bethanechol, sucralfate, and laser therapy).
  • No delineation was provided as to the type of chemotherapy that patients received. Possible implications exist (e.g., perhaps taste was a factor of chemotherapy).

Nursing Implications:

Larger, randomized, double-blind, placebo-controlled studies are needed possibly to further test the hypothesis that bethanechol could minimize RT-induced mucositis incidence or severity.

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