Effect of curcumin combined with vedolizumab on disease activity in patients with moderate to severe ulcerative colitis and its correlation with inflammatory and immune factors

Objective To investigate the clinical efficacy and immunomodulatory effects of curcumin (Cur) combined with vedolizumab (VDZ) in patients with moderate-to-severe ulcerative colitis (UC). Methods A prospective, multicenter, randomized controlled double-blind study was conducted. Patients with moderate-to-severe UC admitted between March 2021 and March 2024 were enrolled and randomly assigned to either the VDZ monotherapy group (76 cases) or the VDZ combined with Cur combination group (83 cases). The treatment period was 26 weeks. The primary outcome was the clinical remission rate at 26 weeks. Secondary outcomes included the remission rate at 14 weeks, the disease activity index (DAI), inflammatory and immune markers, and safety. Results The combination group showed significantly higher clinical remission rates at both 26 and 14 weeks compared to the VDZ group ( P < 0.05). DAI scores decreased significantly over time in both groups ( P < 0.05), with a greater reduction observed in the combination group at both 14 and 26 weeks ( P < 0.05). The combination group demonstrated more significant improvements in inflammatory and immune markers: at 26 weeks, CRP, Th17/Treg ratio, and fecal calprotectin levels were lower than those in the VDZ group ( P < 0.05), while IL-10 levels were higher at 14 weeks ( P < 0.05). No statistically significant difference in the incidence of adverse reactions was observed between the two groups ( P > 0.05), indicating comparable safety profiles. In the combination group, DAI exhibited a stronger positive correlation with Th17/Treg ratio, CRP, and fecal calprotectin, and a more pronounced negative correlation with IL-10 ( P < 0.05). Subgroup analysis showed that both the VDZ group and the combination group had higher benefits in moderate UC compared to severe UC. Conclusion Curcumin as an combination group to VDZ significantly improves clinical remission rates, alleviates inflammatory and immune imbalances in patients with moderate-to-severe UC, without increasing safety risks, highlighting its important clinical translational value. This study provides new evidence for combination treatment strategies in UC.