Efficacy of Lycopene in the Treatment of Oral Submucous Fibrosis: A Meta-analysis of Randomized Controlled Trials.

OBJECTIVES

The aim of this meta-analysis was to systematically evaluate the efficacy of lycopene in improving maximum mouth opening and other clinical symptoms in patients with oral submucous fibrosis (OSF).

METHODS

We searched 5 databases: PubMed, Web of Science, Embase, The Cochrane Library, and EBSCO. Randomized controlled trials were collected to evaluate the efficacy of lycopene in the treatment of OSF. Each database was searched from inception to April 30, 2019. The RevMan 5.3 software was used for this meta-analysis.

RESULTS

The included studies were 7 randomized controlled trials involving 758 patients with OSF. The results of this meta-analysis showed that lycopene was significantly more effective in improving maximum mouth opening in OSF patients than placebo treatment (mean difference [MD]: 3.15; 95% confidence interval [CI]: 2.19-4.10, P < .0001, I2 = 0%). Compared with control groups, lycopene could significantly increase the maximum mouth opening in patients with OSF after 1 month of treatment (MD, 2.40; 95% CI, 2.22-2.58; P = .91; I2 = 0%), 2 months of treatment (MD, 3.19; 95% CI, 2.87-3.51; P = .93; I2 = 0%), and 3 months of treatment (MD, 4.89; 95% CI, 4.51-5.28; P = .86; I2 = 0%). However, no significant difference was found in alleviation of burning sensation after 1 month (risk ratio [RR], 1.04; 95% CI, 0.89-1.23; P = .73; I2 = 0%), 2 months (RR, 0.98; 95% CI, 0.73-1.31; P = .69; I2 = 0%), and 3 months of treatment (RR, 0.84; 95% CI, 0.47-1.52; P = .81; I2 = 0%); tongue protrusion (MD, -1.59; 95% CI, -4.15 to 0.97; P = .12; I2 = 58%); and pain associated with the lesion after 1 month (RR, 1.05; 95% CI, 0.92-1.21; P = .77; I2 = 0%), 2 months (RR, 0.95; 95% CI, 0.75-1.19; P = .35; I2 = 0%), and 3 months (RR, 0.95; 95% CI, 0.68-1.33; P = .14; I2 = 51%) in patients with OSF between lycopene and control groups.

CONCLUSIONS

The results of this meta-analysis showed that lycopene is more effective for improving symptoms of maximum mouth opening than placebo groups and control groups, but there were no significant differences in burning sensation, pain associated with lesion, and tongue protrusion in patients with OSF compared with control groups.