January 20, 2023
3 min read
Ben-Horin S, et al. Poster P032. Presented at: Crohn’s and Colitis Congress; Jan. 19-21, 2023; Denver.
Kopylov U, et al. Poster P045. Presented at: Crohn’s and Colitis Congress; Jan. 19-21, 2023; Denver.
Ben-Horin reports financial relationships with Abbvie, Celltrion, Eli Lilly, Galmed, Gilead, GSK, Ferring, Janssen, Medical Earlysign, NeoPharn, Novartis, Pfizer, Predicta Med, Roche, Takeda and Salomon reports financial relationships with Bara Herbs, ITS Medical and Takeda. Additionally, the Sheba Medical Center has filed intellectual property on the combination of curcumin and QD. EviNature is a spin-off company of Sheba Medical Center. Shomron Ben-Horin & Nir Salomon receive consulting fees and hold equity in EviNature.
DENVER — The combination of herbal extracts curcumin and QingDai induced clinical response and remission in patients with active ulcerative colitis, according to data presented at the Crohn’s and Colitis Congress.
“Even our most modern biologics and small molecules drugs are still unable to bring all our patients to complete remission, and prolonged preauthorization and costs sometimes limit patients’ access to needed medications,” Nir Salomon, CHb, founder and director of the Integrative Medicine Clinic at the gastroenterology department of Sheba Medical Center in Israel, told Healio. “It is also obvious that many [inflammatory bowel disease] patients with active disease are looking for alternative, nonimmune-suppressing solutions, whether dietary or other.”
Given previous reports that demonstrated the efficacy of curcumin and QingDai in patients with mild to moderate and moderate to severe UC, respectively, Salomon and Shomron Ben-Horin, MD, professor and chief of the department of gastroenterology at Sheba Medical Center and Tel-Aviv University, worked with colleagues to determine the efficacy and safety of a combination of curcumin-QingDai (CurQD).
Establishing efficacy, safety of CurQD
Researchers conducted a two-part trial in 59 patients with active UC, the first of which was an open-label study of 4 weeks of CurQD. The second was a placebo-controlled trial conducted at two centers in Israel and Greece, in which 42 patients were randomly assigned 2:1 to receive enteric-coated CurQD (3 g/day) or placebo for 8 weeks. Patients who responded continued curcumin or placebo alone for an additional 8 weeks as maintenance.
Researchers defined clinical response as reduction in Simple Clinical Colitis Activity Index score of at least three points and Mayo endoscopic subscore improvement of at least one point or 50% reduction in calprotectin from baseline. They also evaluated expression of Cyp1A1 in the rectal mucosa as a measure of aryl-hydrocarbon receptor pathway activation.
According to Salomon, the primary outcome of clinical and endoscopic or biomarker response was met during the induction phase, achieved in 43% patients vs. only 8% with placebo. Additionally, endoscopic improvement (75%) and clinical remission (50%) rates were statistically significantly better with CurQD compared with placebo.
“These rates are notable for being achieved in a difficult-to-treat population, as half of the patients were biologic or immunomodulators failures, and CurQD was overall well-tolerated,” Salomon said.
Although researchers tapered the amount of QingDai in the combination during the maintenance phase, 90% of patients who responded to CurQD maintained their response with gut-directed curcumin alone.
“We also assessed the activation of the aryl-hydrocarbon receptor pathway and found that CurQD uniquely upregulated this pathway in the colonic mucosa, which was not seen among patients receiving placebo, or among patients who responded — outside the trial — to biologics or to 5-aminosalicylic acid medications,” Ben-Horin told Healio.
“These findings are exciting in suggesting that the mechanism of action of a plant-based compound (CurQD) may directly trigger this mucosal receptor and activate a unique non-immune suppressive natural inflammation-control switch within our gut.”
Support from real-world data
Also being presented during the meeting, Nir reported on real-world experience from five academic centers in Israel that implemented the CurQD protocol in their clinical practice for the past 6 years. Although a non-controlled, retrospective design, evidence demonstrated a 51% remission rate by CurQD in referral IBD centers, with 48% of the population being biologic-experienced.
“Taken together with the placebo-controlled trial results, this definitely paves the way toward incorporation of this botanical approach as an add-on strategy in patients with active UC,” he said.
Ben-Horin echoed this sentiment, noting that GI departments should consider incorporating integrative medicine practitioners within the IBD units along with medical psychologists and dietitians.
“The example we have set in Sheba Medical center can teach us the way for such successful integration for better daily care of all patients’ needs, and for innovative research initiatives that are difficult to conceive and perform without such interdisciplinary close working relationships,” Ben-Horin said.