Comparing the effects of saffron and Mucosamin® spray on oral mucositis induced by radiotherapy: A randomized controlled clinical trial.

OBJECTIVE: Mucositis is a common oral complication of the non-surgical therapy of cancer. Numerous studies have explored the pharmacological effects of saffron (Crocus sativus) in medicine. This study aimed to compare the effectiveness of saffron extract to Mucosamin® on relieving radiotherapy-induced oral mucositis. MATERIALS AND METHODS: This randomized controlled clinical trial was conducted on head and neck cancer patients who received radiotherapy treatment at the oncology clinic of Shahid Beheshti Hospital in Qom. A total of 68 patients were divided into two groups of 34. In addition to standard treatment, the first group received six puffs of brewed saffron spray (100 mg) daily, and the second group received six puffs of Mucosamin® for 4 weeks. Repeated measures ANOVA, T-test, and Chi-square test were utilized to analyze pain intensity and mucositis grading. All data were analyzed using SPSS version 22. RESULTS: The average pain intensity and mucositis grade decreased in both groups (a total of 61 patients). At baseline, the average pain intensity for the saffron and Mucosamin® groups was 6.29 ± 1.61 and 6.70 ± 1.93. By the end of the study, these figures dropped to 3.61 ± 1.35 and 4.00 ± 1.23. Likewise, the average mucositis grade in the two groups was 2.87 ± 0.34 and 2.56 ± 0.50 at the baseline, decreasing to 2.70 ± 0.46 and 2.40 ± 0.49 at the end of the study, respectively. There was no significant difference in the reduction of mucositis grade (p = 0.246) or pain intensity (p = 0.38) between the two groups. CONCLUSION: The brewed saffron spray showed effectiveness comparable to Mucosamin® spray in reducing pain intensity and grading oral mucositis.