Université Clermont Auvergne, Inserm, 3iHP, CHU Clermont-Ferrand, Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France; Université Clermont Auvergne, Inserm U1071, M2iSH, USC-INRA 2018, Clermont-Ferrand, France.
Gastroenterology Department, University Hospital, Bordeaux, France.
Clin Gastroenterol Hepatol. 2020 Jun;18(7):1553-1560.e1. doi: 10.1016/j.cgh.2019.08.041. Epub 2019 Aug 27.
Recurrence of Crohn's disease (CD) after surgery is a major concern. Curcumin has anti-inflammatory properties and induces endoscopic remission in patients with ulcerative colitis. We investigated the efficacy of curcumin vs placebo in preventing post-operative recurrence of CD, based on endoscopic and clinical indices, in patients receiving concomitant thiopurine therapy.
We conducted a double-blind randomized controlled trial at 8 referral centers in France, from October 2014 through January 2018, of 62 consecutive patients with CD undergoing bowel resection. Patients received azathioprine (2.5 mg/kg) and were randomly assigned to groups given oral curcumin (3 g/day; n = 31) or an identical placebo (n = 31) for 6 months, and were then evaluated by colonoscopy. We also collected data on CD activity index, results from laboratory tests, and answers to quality of life questionnaires during this 6-month period. The primary endpoint was postoperative recurrence of CD in each group (Rutgeerts' index score ≥i2) at month 6 (determined by central reading). An interim analysis (intent to treat) was scheduled after 50% of the patients were enrolled.
At month 6, postoperative recurrence (Rutgeerts' index score ≥i2) occurred in 18 patients (58%) receiving curcumin and 21 patients (68%) receiving placebo (P = .60). A significantly higher proportion of patients receiving curcumin (55%) had a severe recurrence of CD (Rutgeerts' index score ≥i3) than patients receiving placebo (26%) (P = .034). We observed a clinical recurrence of CD (CD activity index score >150) at month 6 in 45% of patients receiving placebo and 30% of patients receiving curcumin (P = .80). Quality of life scores at month 6 did not differ significantly between groups (P = .80). Severe adverse events developed in 6% of patients receiving placebo and 16% of patients receiving curcumin (P = .42).
In a randomized controlled trial of patients who underwent surgery for CD and received thiopurine treatment, we found that curcumin was no more effective than placebo in preventing CD recurrence. There were no significant differences between groups in quality of life or severe adverse events. The study was discontinued after interim analysis due to futility. ClinicalTrials.gov no: NCT 02255370.
手术后克罗恩病（CD）的复发是一个主要关注点。姜黄素具有抗炎特性，并可诱导溃疡性结肠炎患者内镜下缓解。我们研究了姜黄素与安慰剂在预防接受硫嘌呤治疗的患者手术后 CD 复发方面的疗效，基于内镜和临床指标。
我们在法国的 8 家转诊中心进行了一项双盲、随机对照试验，2014 年 10 月至 2018 年 1 月期间，纳入 62 例接受肠切除术的 CD 患者。患者接受硫唑嘌呤（2.5mg/kg）治疗，并随机分为两组，分别给予口服姜黄素（3g/天；n=31）或相同的安慰剂（n=31），疗程为 6 个月，然后进行结肠镜检查。在此 6 个月期间，我们还收集了 CD 活动指数、实验室检查结果和生活质量问卷的答案。主要终点是两组患者术后 6 个月时的 CD 复发（Rutgeerts 指数评分≥i2）（由中心阅读确定）。在 50%的患者入组后，进行了中期分析（意向治疗）。
在术后 6 个月时，接受姜黄素治疗的 18 例（58%）患者和接受安慰剂治疗的 21 例（68%）患者发生术后复发（Rutgeerts 指数评分≥i2）（P=0.60）。接受姜黄素治疗的患者中，有更高比例的患者（55%）发生严重的 CD 复发（Rutgeerts 指数评分≥i3），而接受安慰剂治疗的患者中，有 26%（P=0.034）。我们观察到，在术后 6 个月时，接受安慰剂治疗的患者中有 45%（n=22）和接受姜黄素治疗的患者中有 30%（n=9）发生 CD 临床复发（CD 活动指数评分>150）（P=0.80）。两组患者在 6 个月时的生活质量评分无显著差异（P=0.80）。接受安慰剂治疗的患者中有 6%（n=2）和接受姜黄素治疗的患者中有 16%（n=5）发生严重不良事件（P=0.42）。
在一项对接受 CD 手术治疗且接受硫嘌呤治疗的患者进行的随机对照试验中，我们发现姜黄素在预防 CD 复发方面并不优于安慰剂。两组患者在生活质量或严重不良事件方面无显著差异。由于无效，该研究在中期分析后停止。临床试验.gov 编号：NCT02255370。
