Efficacy of latiglutenase in treating celiac disease: a systematic review and meta-analysis of randomized controlled trials

BACKGROUND: Celiac Disease (CeD) is a chronic immunological illness. So far, the only known treatment for CeD is a lifelong gluten-free diet. However, enzyme therapy was proposed as an alternative. This study aimed to assess the impact of Latiglutenase, an example of enzyme therapy, on CeD patients compared to a placebo through a comprehensive assessment of existing literature. METHODS: We searched the following databases: Scopus, Web of Science, Cochrane Central Library, and PubMed from their respective inception date to February 18, 2024. We included randomized controlled trials comparing Latiglutenase with a placebo, with accessible full text in English. Outcomes included symptoms and histological findings improvement. We used the Revman 5.4 software to conduct the statistical analysis. For assessing the risk of bias, we utilized the Cochrane Collaboration tool ROB 2. RESULTS: Data from five randomized controlled trials was collected, with 1003 participants meeting the inclusion criteria. We found no significant differences between the Latiglutenase group and placebo group regarding adverse events like bloating (P = 0.55), nausea (P = 0.43), vomiting (P = 0.39), diarrhea (P = 0.83), tiredness (P = 0.83), headache (P = 0.08), and flatulence (P = 0.64); and histological findings like villous height to crypt depth ratio (Vh:Cd ratio), and intraepithelial lymphocytes (IELs) (mean difference (MD) = 0.19, 95 % confidence interval (CI) = [-0.24,0.62]; P = 0.39 and MD = -10.78, 95 % CI = [-26.97, 5.40]; P = 0.19, respectively). CONCLUSION: Latiglutenase did not significantly improve adverse events or histological findings in CeD patients. However, there is still a need for further RCTs to evaluate its effectiveness more precisely.