Efficacy of <i>Lactobacillus</i> spp. Supplementation in <i>Helicobacter pylori</i> Eradication: A Systematic Meta‐Analysis of Randomized Controlled Trials With Trial Sequential Analysis
Vivek Mishra, Debabrata Dash, Aditya K. Panda, Sushil Kumar Pathak
Abstract
BACKGROUND: Helicobacter pylori infection is a major global health concern and has been associated with a number of gastrointestinal disorders. Probiotics, especially Lactobacillus spp., have been suggested to have beneficial effect in managing H. pylori infection. This meta-analysis of randomized control trials (RCTs) aimed to evaluate the effect of Lactobacillus spp. supplementation on H. pylori eradication rates and associated side effects when combined with standard therapy. MATERIALS AND METHODS: Relevant studies were retrieved from PubMed, Scopus, Google Scholar and the Cochrane Library. Comprehensive Meta-Analysis (CMA) Software 4.0 was used for all the statistical analyses. TSA 0.9.5.10 Beta software was used for the trial sequential analysis (TSA). GRADEpro GDT was used to assess the certainty of evidence. RESULTS: An analysis of 26 selected studies showed that supplementing with Lactobacillus spp. significantly increased the rates of H. pylori eradication in per-protocol (PP) analysis (Overall risk ratio [RR] = 1.063, p = 0.000, 95% CI of -0.21 to 2.11; adults: RR = 1.050, p = 0.005, 95% CI = -0.55 to 2.03, children: RR = 1.223, p = 0.001, 95% CI = -13.35 to 4.55). In comparison to quadruple therapy, Lactobacillus spp. supplementation to triple therapy showed significant benefit (RR: 1.124; p = 0.000, 95% CI of -0.48 to 2.61). L. reuteri supplementation indicated better efficacy (RR: 1.049; p = 0.055, 95% CI of -0.56 to 3.26) than Lactobacillus GG (RR: 0.980; p = 0.595, 95% CI of -0.69 to 1.21). The 28-30 day (RR: 1.103; p = 0.003, 95% CI of -2.14 to 4.19) and 14-day supplementation periods (RR: 1.102; p = 0.003, 95% CI of -1.69 to 3.51) showed the most improvement. The analysis also revealed that Lactobacillus spp. significantly reduced gastrointestinal side effects: nausea/vomiting (RR: 0.566; p = 0.037, -3.11 to 1.45), diarrhea (RR: 0.324; p = 0.000, -5.46 to 0.48), and abdominal pain (RR: 0.438; p = 0.007, -5.65 to 4.22). The effect on bloating was non-significant (RR: 0.820; p = 0.498, -4.01 to 0.96). TSA graphs validated sufficient evidence for the conclusions. CONCLUSION: Lactobacillus spp. significantly enhances H. pylori eradication rates and may reduce gastrointestinal side effects when used alongside standard therapy, offering a promising adjunctive treatment option. The evidence was supported by TSA and assessed using GRADEpro, indicating a high certainty of the findings.