Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial

Shomron Ben-Horin, Nir Salomon, Georgios Karampekos, Nikos Viazis, Adi Lahat, Bella Ungar, Rami Eliakim, Rafael Kuperstein, Ofra Kriger-Sharabi, Hilla Reiss-Mintz, Henit Yanai, Iris Dotan, Eran Zittan, Nitsan Maharshak, Ayal Hirsch, Michal Weitman, Gerassimos J. Mantzaris, Uri Kopylov

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Background & Aims: We 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 score of 5 or higher and a Mayo endoscopic subscore of 2 or higher. 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/d or placebo for 8 weeks. The co-primary outcome was clinical response (reduction in the Simple Clinical Colitis Activity Index of ≥3 points) and an objective response (Mayo endoscopic subscore 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 co-primary outcome was achieved in 43% and 8% of CurQD and placebo patients, respectively (P =.033). Clinical response was observed in 85.7% vs 30.7% (P <.001), clinical remission in 14 of 28 (50%) vs 1 of 13 (8%; P =.01), a 50% calprotectin reduction in 46.4% vs 15.4% (P =.08), and endoscopic improvement in 75% vs 20% (P =.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, CurQD was effective for inducing response and remission in active UC patients. The aryl-hydrocarbon receptor pathway may merit further study as a potential UC treatment target. ClinicalTrials.gov ID: NCT03720002.

Original languageEnglish
Pages (from-to)347-356.e6
JournalClinical Gastroenterology and Hepatology
Volume22
Issue number2
Early online date9 Jun 2023
DOIs
StatePublished - Feb 2024

Bibliographical note

Publisher Copyright:
© 2024 AGA Institute

Funding

Funding This study was supported by the Alan B. Slifka Foundation and by a generous private donation from the Mousseif family . The funders did not intervene in the design or interpretation of the study.

FundersFunder number
Alan B. Slifka Foundation

    Keywords

    • Complementary Medicine
    • Inflammatory Bowel Disease
    • Treatment
    • Ulcerative Colitis

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