Sheibani, K.M., Mafi, A.R., Moghaddam, S., Taslimi, F., Amiran, A., & Ameri, A. (2015). Efficacy of benzydamine oral rinse in prevention and management of radiation-induced oral mucositis: A double-blind placebo-controlled randomized clinical trial. Asia-Pacific Journal of Clinical Oncology, 11, 22–27.

To assess the efficacy of prophylactic benzydamine in an oral solution for reducing the signs and symptoms of oral mucositis in patients receiving radiation therapy (RT) with or without chemotherapy for head and neck cancers

A 0.15% benzydamine or placebo oral rinse of 15 ml was used for two minutes four to eight times daily starting the day before RT and continuing till two weeks RT completion.

• N = 51  
• MEAN AGE = 52.65 years
• MALES: 60.8%, FEMALES: 39.2%
• KEY DISEASE CHARACTERISTICS: Head and neck cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Adults receiving at least 5,000 cGy RT via megavoltage treatment with either cobalt 60 or a linear accelerator to at least two oral mucosal sites with a Karnofsky Performance Status (KPS) > 60

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Jorjani Cancer Center at the Shahid Beheshti University of Medical Sciences in Tehran, Iran (2009–2012)

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded, placebo-controlled trial stratified according to KPS and treatment schedule (once- or twice-daily fraction) and then randomized

• The oral cavity was divided into 14 anatomical sites.  
• A complete oral examination was done weekly after the initiation of treatment, and a four-point scale was used to score each oral site.  
• At each weekly visit, an overall mean score was calculated based on at-risk areas.

No difference in the severity of mucositis was found during weeks 1–3. By week 4, the placebo arm had significantly more mucositis than the treatment arm (p = 0.01), and this trend continued until the end of treatment. The difference in the mean score at one and two weeks after treatment continued to show lower scores in the treatment group, but this was nonsignificant.

An oral rinse of benzydamine 0.15% was safe and well-tolerated with no noticeable side effects reported by patients. It reduced the incidence and severity of radiation-induced oral mucositis.

• Small sample (< 100)
• Risk of bias(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Single site; unable to analyze data regarding analgesic consumption because of noncompliance; unclear who did the oral examination and training to ensure interrater reliability

Benzydamine was well-tolerated, easy to administer, and may be an appropriate prophylactic treatment for oral mucositis in patients receiving RT for head and neck cancer.