Efficacy of Curcumin and Spirulina in the Management of Oral Submucous Fibrosis: A Randomised Clinical Trial

Introduction: Oral Submucous Fibrosis (OSMF) is a chronic, potentially malignant oral disorder that is progressive in nature. Steroids are the mainstay in the treatment of OSMF; however, considering their side effects and contraindications, natural agents such as curcumin and spirulina are used as alternative therapies for OSMF. Aim: To assess and compare the efficacy of curcumin and spirulina in the management of OSMF. Materials and Methods: This randomised clinical trial was conducted in the Department of Oral Medicine and Radiology at Sinhgad Dental College and Hospital, Pune, Maharashtra, India from November 2023 to July 2024. The trial included 52 subjects clinically diagnosed with OSMF (Stage I and Stage II), who were equally divided into two groups: Group I (curcumin capsules 300 mg twice a day) and Group II (spirulina capsules 500 mg twice a day) for three months. Clinical parameters such as burning sensation, mouth opening, and tongue protrusion were evaluated at baseline and upto three months. The data were analysed using frequency and mean values. The paired t-test was used to compare study characteristics, and the unpaired t-test was used to compare the differences between the two groups. Results: The mean age of the study participants was 35.94 +/- 12.12 years (male: 35.58 +/- 12.19; female: 40.25 +/- 11.79). The burning sensation in Group I was 5.92 +/- 2.56 and in Group II was 6.42 +/- 1.793 at baseline, which reduced to 1.04 +/- 1.18 and 1.15 +/- 1.255, respectively, at the end of three months. The mouth opening in Group I was 33.46 +/- 8.38 and in Group II was 35.38 +/- 8.110 at baseline, which increased to 34.15 +/- 8.16 and 36.12 +/- 7.881, respectively, at the end of three months. The tongue protrusion in Group I was 42.81 +/- 8.40 and in Group II was 45.85 +/- 8.418 at baseline, which increased to 43.12 +/- 8.32 and 46.15 +/- 8.394, respectively, at the end of three months. There was improvement in all three parameters at subsequent visits, which was highly statistically significant in both groups when compared from baseline to three months (p-value <0.001). The comparison between Group I and Group II at three months revealed a non statistically significant difference in burning sensation (p-value=0.734), mouth opening (p-value=0.382), and tongue protrusion (p-value=0.196). Conclusion: The results suggest that both drugs are equally effective in reducing burning sensation and improving mouth opening and tongue protrusion. Therefore, natural agents, including spirulina and curcumin, can be effectively used in the management of OSMF.