Babaee, N., Moslemi, D., Khalilpour, M., Vejdani, F., Moghadamnia, Y., Bijani, A., … Moghadamnia, A. (2013). Antioxidant capacity of calendula officinalis flowers extract and prevention of radiation induced oropharyngeal mucositis in patients with head and neck cancers: A randomized controlled clinical study. Daru: Journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 21(1), 18.doi: 10.1186/2008-2231-21-18
To determine the effect of Calendula officinalis flowers extract mouthwash as an oral gel on radiation-induced oropharyngeal mucositis (OM) in patients with head and neck cancer and to determine possible mechanism of action; total antioxidant, polyphenol, and flavonoid content; and quercetin concentration of mouthwash
Patients were randomly assigned to either the calendula mouthwash group or a placebo group. Both solutions were in a gel formation. Patients were to use 5 ML solution twice per day (every 12 hours) and hold the solution in the oral cavity for at least one minute.
Assays were done to assess antioxidant activity, phenol content of the mouthwash, and flavonoid content. Two physicians performed mucositis grading and grading of oral ulcers.
The study was conducted at a single outpatient site in Babolsar, Iran.
Patients were undergoing the active antitumor treatment phase of care.
This was a double-blind, placebo-controlled, randomized trial.
The Oral Mucositis Assessment Scale (OMAS) was used.
No patients in the treatment group required medication for OM, and radiation was not stopped for mucositis. Three patients in the treatment group did not develop OM during the whole treatment period. Overall OMAS scores were significantly lower in the treatment group at weeks 2, 3, and 6 of the study (p < 0.001).
Calendula-containing oral mouthwashes may be effective in decreasing OM intensity in this patient population.
The authors make reference to some participants withdrawing, but numbers of participants do not seem to reflect this. The number of patients analyzed and the number of patients reported as leaving the study do not add up correctly. Reasons for study withdrawal are not fully described. Very little data are presented in the article.
Oral use of a calendula-containing agent might be an effective and simple intervention. The agent was prepared specifically for this study; therefore, availability of the agent is not clear. No conclusions can be drawn from this study alone, but, given the promising results and lack of known effective preventive agents, further research in this area would be helpful.