Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Sep 1;23(9):3125-3132.
doi: 10.31557/APJCP.2022.23.9.3125.

Efficacy of Curcumin in Combination with Intralesional Dexamethasone with Hyaluronidase in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial

Sagar Adhikari  1 , Jyotsna Rimal  1 , Iccha Kumar Maharjan  1 , Ashish Shrestha  2
Affiliations
Randomized Controlled Trial

Efficacy of Curcumin in Combination with Intralesional Dexamethasone with Hyaluronidase in the Treatment of Oral Submucous Fibrosis: A Randomized Controlled Trial

Sagar Adhikari et al. Asian Pac J Cancer Prev. .

Abstract

Objective: The objective of this study was to determine the efficacy of curcumin in combination with intralesional dexamethasone with hyaluronidase in the treatment of oral submucous fibrosis (OSF).

Methods: This randomized, double blind, parallel design, clinical trial was conducted at B.P. Koirala Institute of Health Sciences, Nepal. Thirty-four patients with clinically diagnosed OSF were randomized into two groups (17 participants in each) with baseline treatment of intralesional dexamethasone with hyaluronidase for 6 weeks for the both. Curcumin (2gm/day) was provided to Group A (Test) and Group B (Control) received placebo. Interincisal mouth opening, tongue protrusion, cheek flexibility and visual analogue scale (VAS) scoring of burning sensation of oral mucosa was recorded at baseline, 6, 8 and 12 weeks follow-up and independent t-test was used to compare the improvements in two groups.

Results: On comparing the 6 weeks and baseline values, in Group A and B the mean difference in mouth opening was 8.82±1.33 mm and 5.53±1.17 mm respectively (p<0.001), in cheek flexibility was 2.94±1.02 mm and 1.94±1.24 mm respectively (p=0.02) and in tongue protrusion was 6.23±1.48 and 3.65±1.37 mm respectively (p<0.001). The findings were consistent in the 8 weeks follow-up. In 12 weeks follow-up, on comparing with the baseline values, in Group A and B, the mean difference in mouth opening was 8.71±1.16 mm and 5.35±1.22 mm respectively (<0.001), ), in cheek flexibility was 2.81±1.01 mm and 1.76±1.35 mm respectively (p=0.02) and in tongue protrusion was 6.06±1.48 and 3.35±1.50 mm respectively (p<0.001). Both the arms showed 100% improvement in burning sensation in 6, 8 and 12 weeks follow-up.

Conclusion: Curcumin in combination with intralesional dexamethasone with hyaluronidase is efficacious in the treatment of OSF.

Keywords: Efficacy; Oral submucous fibrosis (OSF); curcumin; randomized controlled trial; treatment.

PubMed Disclaimer

Conflict of interest statement

The authors declare no potential conflict of interest.

Figures

Figure 1
Figure 1
CONSORT Participant Flow Diagram
See this image and copyright information in PMC

References

    1. Agrawal A, Kaushal Y, Vaidya S, Shrivastava K. Medical management of oral submucous fibrosis. Int J Otorhinolaryngol Head Neck Surg. 2017;3:628–31.
    1. Alok A, Singh ID, Singh S, Kishore M, Jha PC. Curcumin – Pharmacological actions and its role in oral submucous fibrosis: A review. J Clin Diagnostic Res. 2015;9:ZE01–3. - PMC - PubMed
    1. Angadi PV, Rao SS. Areca nut in pathogenesis of oral submucous fibrosis: Revisited. Oral Maxillofac Surg. 2011;15:1–9. - PubMed
    1. Arakeri G, Brennan PA. Oral submucous fibrosis: An overview of the aetiology, pathogenesis, classification, and principles of management. Br J Oral Maxillofac Surg. 2013;51:587–93. - PubMed
    1. Asifali S, Khan M, Khan S, Mehdi H, Sawani A. Frequency and clinical presentation of oral submucous fibrosis. Pak J Med Dent. 2014;3:48–53.

Publication types