Roopashri, G., Jayanthi, K., & Guruprasad, R. (2011). Efficacy of benzydamine hydrochloride, chlorhexidine, and povidone iodine in the treatment of oral mucositis among patients undergoing radiotherapy in head and neck malignancies: A drug trail. Contemporary Clinical Dentistry, 2, 8–12.

DOI Link

Study Purpose

To manage oral mucositis induced by radiotherapy and to reduce pain by using benzydamine hydrochloride, chlorhexidine, and povidone iodine

Intervention Characteristics/Basic Study Process

Selected patients were divided into study and control groups. The study groups were further subdivided into group 1, group 2, and group 3. Each study group consisted of 25 patients, and the control group also consisted of 25 patients; the three study groups and the control group were given benzydamine hydrochloride, chlorhexidine, povidone iodine, and distilled water, respectively. These rinses were given after two weeks of radiation therapy (RT) at the onset of oral mucositis.

Patients in the study groups as well as the control group were instructed to rinse the oral cavity with 15 ml of their respective rinses for at least 30 seconds, 4 times a day at six-hour intervals. The mouth-rinsing regimen was performed under professional supervision. The samples of mouth rinses were given to the patients without dilution for one week use, one at a time, for convenience. Patients also were given measuring cups to measure the quantity of oral rinses. All patients were examined at the end of every week during the RT for about a six-week period.

Sample Characteristics

  • Patients' age ranged from 30–70 years old.
  • Patients all had head and neck malignancies (no explanation offered).

Setting

The study was conducted at the Radiotherapy Department of Kidwai Memorial Institute of Oncology in Bangalore, Karanataka, India.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study did not involve blinding.

Measurement Instruments/Methods

  • The World Health Organization Grading scale for mucositis was used.
  • The Lindquist/Hickey scale was used to evaluate pain.

Conclusions

This study was oorly designed, and the report was confusing and difficult to understand.

Limitations

  • No explanation was given as to how the groups were divided into study and control.
  • The authors were unclear as to whether the groups were all given the same mouth rinses or different ones.
  • No blinding was involved.
  • This was a single institution study.
  • No randomization was noted in the report.
  • No mention was made of how compliance was tracked during the study.
  • No age breakdown was given.
  • The authors did not identify who conducted the oral assessments and what training they received to ensure consistency.
  • No mention was made of whether opioids were permitted during treatment for pain control.

Nursing Implications

Several studies have pointed in the direction that benzydamine hydrochloride is effective in the management of oral mucositis. Further well-designed, randomized placebo controlled studies are needed for verification.