Inflammatory bowel diseases (IBDs) often take a chronic debilitating course. Given the chronicity of IBD, the limitations of the available medications, their potential side effects, and the impact of the disease on patients' quality of life, it is not surprising IBD patients are ranked among the highest users of complementary and alternative medicine (CAM). Since CAM has become very popular in real-life practice of Western Communities, caregivers must gain more knowledge about these therapies, their mechanism of action, benefits, and risks. This article reviews and discusses up-to-date scientific and clinical data regarding the most prevalent herbal CAM therapies.
Background The herbal extracts Curcumin and QingDai (QD, Indigo) were previously shown to be effective in mild-moderate and in moderate-severe ulcerative colitis (UC), respectively. We evaluated the efficacy and safety of a combination of curcumin-QingDai (CurQD) in patients with active UC. Methods This was a two parts trial. Part 1 was an open label study of 4 weeks CurQD in patients with active UC, defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≥5 and a modified Mayo endoscopic sub-score≥2. Part 2 was a placebo-controlled trial conducted in two centers in Israel and Greece, that randomized active UC patients at a 2:1 ratio to either enteric-coated CurQD 3gr/day or an identical placebo for eight weeks. The co-primary outcome at week 8 was clinical response (reduction in SCCAI of ≥3 points) and an objective evidence of response (Mayo endoscopic subscore improvement of ≥1 or 50% calprotectin reduction from baseline). Responding patients continued either curcumin or placebo alone for additional 8 weeks as maintenance treatment. Expression of Cyp1A1 in rectal mucosa was assessed as a measure of aryl-hydrocarbon receptor (AhR) pathway activation. Curcumin purity, and indigo and indirubin content in CurQD were confirmed by LC-MS/MS. Results There were 59 patients enrolled in the two study parts. In efficacy analysis of part 1, 7/10 responded including 3/10 who achieved clinical remission. For part 2, 95 patients were screened and 42 were included and randomized (48.8% biologics and/or immuno-modulators experienced, 36.6% biologics-experienced). The co-primary 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), 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. The overall rate of adverse events was comparable between the groups. Among week-8 responders to CurQD, additional 8 weeks of treatment with curcumin alone resulted in 93%, 80% and 40% with maintained clinical response, clinical remission and clinical-biomarker response, respectively, at week 16. CurQD treatment uniquely resulted in activation of the AhR pathway, as gauged by a signficantly up-regulated expression of CYP1A1 in the rectal mucosa, which was not observed among patients receiving placebo, 5ASA or biologic drugs. Conclusion In this randomized controlled trial, combination CurQD was found to be effective for inducing remission in active UC patients. Induction of AhR may merit further study as a potential treatment target in active UC
Curcumin was shown in placebo-controlled trials to induce remission in mild-moderate ulcerative colitis (UC). QingDai (QD, Indigo), another herbal extract, showed efficacy in two UC trials from Japan, but evidence in the Western population is scant. We report on the use of curcumin-QingDai combination (CurQD) for the treatment of moderate-severe UC. Patient 1 was a 24-year-old male with severe UC refractory to cyclosporine and corticosteroids. He partially responded to infliximab but later lost response to an optimized dose of infliximab in combination with 6-mercaptopurine, presenting with worsening symptoms and severe Mayo 3 mucosal inflammation. Initiation of CurQD 2.5 g/day resulted in rapid cessation of blood per rectum. Complete clinical remission ensued within few weeks. Follow-up endoscopies performed 12 weeks later showed only minimal residual inflammation. Infliximab was later stopped due to reimbursement issues, and the patient was successfully maintained on lower doses of CurQD and 6-mercaptopurine for 31 months. Two flares have responded to a temporary increase in QD component dose. Patient 2 was a 59-year-old female with extensive UC not responding to maximal oral + topical 5-ASA and corticosteroids. Despite severe mucosal ulceration (Mayo 3) found on endoscopy, she refused the recommendation for biologics and opted for a short-term limited trial of CurQD. This was initiated at 2,000 mg/day and induced rapid clinical remission. Lower endoscopies performed after 2 and 5 months on CurQD showed complete mucosal healing, and the patient maintained her clinical remission on low-dose CurQD for 49 months. No adverse events were noted in the 2 patients.
Summary Background Curcumin and QingDai (QD, Indigo) have been shown to be effective for treating active ulcerative colitis (UC). Aim To evaluate the real‐world experience with the Curcumin–QingDai (CurQD) herbal combination to induce remission in active UC. Methods A retrospec‑tive multicentre adult cohort study from five tertiary academic centres (2018–2022). Active UC was defined as a Simple Clinical Colitis Activity Index (SCCAI) ≥ 3. Patients were induced by CurQD. The primary outcome was clinical remission at weeks 8–12, defined as SCCAI ≤2 and a decrease ≥3 points from baseline. Secondary outcomes were clinical response (SCCAI decrease ≥3 points), corticosteroid‐free remission, faecal calprotectin (FC) response (reduction ≥50%), FC normalisation (FC ≤100 μg/g for patients with FC ≥300 μg/g at baseline), and safety. All outcomes were analysed for patients who were maintaining stable treatment. Results Eighty‐eight patients were included; 50% were biologics/small molecules experienced, and 36.5% received ≥2 biologics/small molecules. Clinical remission was achieved in 41 (46.5%), and clinical response in 53 (60.2%). Median SCCAI decreased from 7 (IQR:5–9) to 2 (IQR:1–3); p < 0.0001. Of the 26 patients on corticosteroids at baseline, seven achieved corticosteroid‐free remission. Among 43 biologics/small molecules experienced patients, clinical remission was achieved in 39.5% and clinical response in 58.1%. FC normalisation and response were achieved in 17/29 and 27/33, respectively. Median FC decreased from 1000 μg/g (IQR:392–2772) at baseline to 75 μg/g (IQR:12–136) at the end of inductions (n = 30 patients with paired samples); p < 0.0001. No overt safety signals emerged. Conclusion In this real‐world cohort, CurQD effectively induced clinical and biomarker remission in patients with active UC, including patients who were biologics/small molecules experienced.
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