The objective of the meta-analysis was to evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) in the treatment of Crohn's disease (CD). Pubmed, Embase, Medline, Web of Science, China National Knowledge Infrastructure, Chinese Biomedical Literature, Wanfang Database, and Cochrane Central Register of Controlled Trials were searched (through October 2018). The quality of randomized clinical trials meeting the inclusion criteria was assessed and the data were extracted according to the Cochrane Review Handbook v5.0 by two evaluators. A meta-analysis was performed using the software Stata 12.0. Twelve randomized controlled trials (RCTs) were selected. The studies were of low methodological quality. The meta-analysis indicated that treatment with TCM and Western Medicine (WM) was significantly superior compared to treatment with WM alone with regard to total effective rate, remission maintenance rate, reduction of C-reactive protein (CRP), reduction of erythrocyte sedimentation rate (ESR), clinical score reduction, and reduction of adverse events. Mucosal healing was improved in both the TCM-WM and WM groups; however, there were no significant differences between the two groups. There was a certain publication bias in the studies with regard to efficiency, adverse reactions, mucosal healing, and recurrence rate; however, there was no obvious publication bias with regard to other indicators. TCM, as an adjuvant therapy with WM, shows advantages in inducing remission in CD. The current evidence suggests that TCM-WM treatment might be more efficient in terms of total effective rate, remission maintenance rate, CRP reduction, ESR reduction, clinical score reduction, and reduction of adverse events than treatment with WM alone. Because of the low quality of the included RCTs, high quality confirmatory evidence is needed to assess the clinical value of TCM in the treatment of CD.
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