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

In brief

Saffron spray lowers oral mucositis pain to 3.6, matching Mucosamin

In a randomized trial of 68 head-and-neck cancer patients receiving radiotherapy, twice-daily saffron spray reduced average pain scores from 6.3 to 3.6, while Mucosamin fell from 6.7 to 4.0; the difference between groups was not statistically significant. Thus saffron appears as effective as the standard spray, though larger studies are needed to confirm safety and long-term benefit.

Journal
Avicenna journal of phytomedicine (Q1)
Published
1 January 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Fatemeh Zahra Shafiee, Elham Keykha, Hoda Abolhasani, Samira Hajisadeghi
PMID
42769787
DOI
10.22038/ajp.2026.27350

Why clinicians should know about it

Abstract

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.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.