Colon to Rectum
Clin Gastroenterol Hepatol. 2024;22(2):347–56.e6
Curcumin-QingDai combination for patients with active ulcerative colitis: A randomized, double-blinded, placebo-controlled trial
Background and aims: The authors evaluated the efficacy of herbal combination of curcumin-QingDai (CurQD) in active ulcerative colitis (UC).
Methods: Part I was an open-label trial of CurQD in patients with active UC, defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≥ 5 and a Mayo endoscopic subscore (MES) ≥ 2. Part II was a placebo-controlled trial conducted in Israel and Greece, randomizing active UC patients at a 2:1 ratio to enteric-coated CurQD 3 g/day or placebo for 8 weeks. The coprimary outcome was clinical response (reduction in the SCCAI of ≥ 3 points) and an objective response (MES improvement of ≥ 1 or a 50% fecal calprotectin reduction). Responding patients continued either maintenance curcumin or placebo alone for an additional 8 weeks. Aryl-hydrocarbon receptor activation was assessed by cytochrome P450 1A1 (CYP1A1) mucosal expression.
Results: In part I, 7 of 10 patients responded and 3 of 10 achieved clinical remission. Of 42 patients in part II, the week-8 coprimary outcome was achieved in 43% and 8% of CurQD and placebo patients, respectively (p = 0.033). Clinical response was observed in 85.7% versus 30.7% (p < 0.001), clinical remission in 14 of 28 (50%) versus 1 of 13 (8%; p = 0.01), a 50% calprotectin reduction in 46.4% versus 15.4% (p = 0.08), and endoscopic improvement in 75% versus 20% (p = 0.036) in the CurQD and placebo groups, respectively. Adverse events were comparable between groups. By week 16, curcumin-maintained clinical response, clinical remission, and clinical biomarker response rates were 93%, 80%, and 40%, respectively. CurQD uniquely up-regulated mucosal CYP1A1 expression, which was not observed among patients receiving placebo, mesalamine, or biologics.
Conclusions: In this placebo-controlled trial, curcumin-QingDai was effective for inducing response and remission in active ulcerative colitis (UC) patients. The aryl-hydrocarbon receptor pathway may merit further study as a potential UC treatment target.