Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.
SUNY Upstate Medical University in Syracuse, Syracuse, NY.
J Clin Gastroenterol. 2021 Sep 1;55(8):702-708. doi: 10.1097/MCG.0000000000001416.
The aim of this study was to assess the efficacy and safety of a novel, hydrophilic, bioenhanced curcumin (BEC) as add-on therapy in inducing clinical and endoscopic remission in mild to moderately active ulcerative colitis (UC).
Mild to moderately active UC patients (partial Mayo score 2 to 6 with endoscopic Mayo score >1) on standard dose of mesalamine were randomized to either 50 mg twice daily BEC or an identical placebo. Clinical response (≥2 reduction of partial Mayo score), clinical remission (partial Mayo score ≤1), and endoscopic remission (endoscopic Mayo score of ≤1) were evaluated at 6 weeks and 3 months. Responders were followed-up at 6 and 12 months for assessing maintenance of remission.
Sixty-nine patients were randomly assigned to BEC (n=34) and placebo (n=35). At 6 weeks, clinical and endoscopic remission occurred in 44.1% (15/34) and 35.3% (14/34) patients, respectively, compared with none in the placebo group (P<0.01). Clinical response was also significantly higher in the BEC group (18/34, 52.9%) compared with placebo (5/35, 14.3%) (P=0.001). The clinical remission, clinical response, and endoscopic remission rates at 3 months were 55.9% (19/34), 58.8% (20/34), 44% (16/34) and 5.7% (2/35), 28.6% (10/35), 5.7% (2/35) in BEC and placebo groups, respectively. At 6 and 12 months, 95% (18/19) and 84% (16/19) of the responders to BEC maintained clinical remission. None of the responders to placebo maintained clinical remission at 6 months. BEC appeared safe with no significant side effects.
A low-dose BEC as add-on therapy was superior to placebo in inducing sustained clinical and endoscopic remission in patients with mild-to-moderately active UC on maximal dose of mesalamine (ClinicalTrials.gov: NCT02683733).
本研究旨在评估新型亲水性生物增强型姜黄素（BEC）作为辅助治疗药物在诱导轻中度活动性溃疡性结肠炎（UC）患者达到临床和内镜缓解方面的疗效和安全性。
正在接受标准剂量美沙拉嗪治疗的轻中度活动性 UC 患者（部分 Mayo 评分 2-6 分，内镜 Mayo 评分>1 分）随机分为每日 2 次，每次 50mg BEC 或相同安慰剂。在 6 周和 3 个月时评估临床缓解（部分 Mayo 评分降低≥2 分）、临床缓解（部分 Mayo 评分≤1 分）和内镜缓解（内镜 Mayo 评分≤1 分）。应答者在 6 个月和 12 个月时进行随访以评估缓解的维持情况。
69 例患者被随机分配至 BEC（n=34）和安慰剂（n=35）组。在 6 周时，分别有 44.1%（15/34）和 35.3%（14/34）的患者达到临床和内镜缓解，而安慰剂组均无缓解（P<0.01）。BEC 组的临床应答率也显著高于安慰剂组（18/34，52.9%）对比 5/35，14.3%）（P=0.001）。3 个月时的临床缓解率、临床应答率和内镜缓解率分别为 55.9%（19/34）、58.8%（20/34）、44%（16/34）和 5.7%（2/35）、28.6%（10/35）、5.7%（2/35），在 BEC 和安慰剂组中。在 6 个月和 12 个月时，BEC 应答者中有 95%（18/19）和 84%（16/19）维持临床缓解。安慰剂组的应答者无一在 6 个月时维持临床缓解。BEC 显示出良好的安全性，无明显不良反应。
与安慰剂相比，在接受最大剂量美沙拉嗪治疗的轻中度活动性 UC 患者中，低剂量 BEC 作为辅助治疗药物在诱导持续的临床和内镜缓解方面优于安慰剂（ClinicalTrials.gov：NCT02683733）。
