Background:This study was performed to systematically review the efficacy of Salvia miltiorrhiza injection combined with steroids in the treatment of oral submucous fibrosis.Methods:We searched 9 databases: Web of Science, PubMed, Medline, EBSCO, Embase, The Cochrane Library, WanFang Data, the China National Knowledge Infrastructure (CNKI), and Chinese Scientific Journals Full-text Database (VIP). Randomized controlled trials were collected to study the treatment of oral submucous fibrosis by S miltiorrhiza injection combined with steroids. Each database was searched from inception to November 2018. RevMan 5.3 software was used for the meta-analysis.Results:In total, 13 randomized controlled trials involving 1190 patients were included. The results of the meta-analysis showed that compared with conventional treatment, S miltiorrhiza injection combined with steroids could significantly increase the maximal mouth opening [mean difference (MD), 0.23; 95% confidence interval (CI), 0.16–0.30; P <.0001], decrease the oral mucosal lesion area (MD, −1.35; 95% CI, −2.46 to −0.25; P = .02), improve the subjective symptom burning sensation (MD, −0.77; 95% CI, −1.38 to −0.16; P = .01), and reduce adverse drug reactions (risk ratio, 0.27; 95% CI, 0.14–0.49; P <.0001).Conclusions:The results of this meta-analysis from current evidence showed that compared with conventional treatment, S miltiorrhiza injection combined with steroid could significantly improve the maximal mouth opening and the subjective symptom burning sensation as well as decrease the oral mucosal lesion area without increasing adverse effects.