Vedolizumab plus curcumin improves remission in moderate-to-severe ulcerative colitis versus vedolizumab alone.
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Key Takeaway
Consider vedolizumab plus curcumin for UC; improves remission vs monotherapy, but safety details are limited.
This multicenter, double-blind randomized controlled trial evaluated the efficacy and safety of adding curcumin to vedolizumab therapy. The study population consisted of 159 patients diagnosed with moderate-to-severe ulcerative colitis. Participants were randomized to receive either vedolizumab combined with curcumin or vedolizumab monotherapy. The primary outcome was the clinical remission rate assessed at 26 weeks, with secondary outcomes including remission at 14 weeks, disease activity index (DAI), inflammatory markers, and safety profiles.
At 14 and 26 weeks, the combination group demonstrated significantly higher clinical remission rates compared to the monotherapy group (P < 0.05 for both time points). Additionally, the combination therapy resulted in a greater reduction in the Disease Activity Index at both 14 and 26 weeks. Inflammatory and immune markers, including CRP, Th17/Treg ratio, and fecal calprotectin, were lower in the combination group at 26 weeks. Conversely, IL-10 levels were higher in the combination group at 14 weeks.
Regarding safety, no statistically significant difference was observed in the incidence of adverse reactions between the two groups (P > 0.05). Specific details regarding adverse events, serious adverse events, discontinuations, and detailed tolerability data were not reported in the study. The study phase was not reported, and absolute numbers or specific effect sizes for the outcomes were not provided.
This evidence provides new data supporting combination treatment strategies for ulcerative colitis. However, the lack of reported absolute numbers, effect sizes, and detailed safety data limits the precision of clinical interpretation. The absence of reported study phase further restricts the ability to contextualize these findings within the broader development of the intervention.
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View Original Abstract ↓
ObjectiveTo investigate the clinical efficacy and immunomodulatory effects of curcumin (Cur) combined with vedolizumab (VDZ) in patients with moderate-to-severe ulcerative colitis (UC).MethodsA 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.ResultsThe 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.ConclusionCurcumin 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.
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