Curcumin maintenance therapy for ulcerative colitis: Randomized, multicenter, double-blind, placebo-controlled trial
Curcumin maintenance therapy for ulcerative colitis: Randomized, multicenter, double-blind, placebo-controlled trial
复制标题
DOI：
10.1016/j.cgh.2006.08.008
复制
发表时间：
2006-12-01
影响因子：
12.6
通讯作者：
Koide, Yukio
中科院分区：
文献类型：
--
作者：
Hanai, Hiroyuki;Iida, Takayuki;Koide, Yukio
背景和目标：姜黄素是存在于姜黄中的生物活性植物化学物质，具有可能有益于溃疡性结肠炎（UC）患者的药理作用。本试验的目的是评估姜黄素作为静止期溃疡性结肠炎（UC）患者维持治疗的疗效。研究方法：招募了89名静止期UC患者参加这项姜黄素预防复发的随机、双盲、多中心试验。45名患者接受姜黄素，早餐后1g和晚餐后1g，加上柳氮磺胺吡啶（SZ）或美沙拉嗪，44名患者接受安慰剂加SZ或美沙拉嗪6个月。在入组时、每2个月（CAI）、6个月试验结束时和6个月随访结束时测定临床活动指数（CAI）和内镜指数（EI）。结果：7例患者违反方案。在接受姜黄素治疗的43名患者中，2名在6个月的治疗期间复发（4.65%），而安慰剂组39名患者中有8名（20.51%）复发（P = .040）。基于意向治疗评估的复发率显示姜黄素和安慰剂之间存在显著差异（P = 0.049）。此外，姜黄素改善CAI（P = .038）和EI（P = .0001），从而抑制与UC相关的发病率。进行了6个月的随访，在此期间，两组患者均使用SZ或美沙拉嗪。姜黄素组的另外8名患者和安慰剂组的6名患者复发。结论：姜黄素似乎是一个有前途的和安全的药物，以维持缓解静止期UC患者。对姜黄素的进一步研究应该会加强我们的发现。
Background & Aims: Curcumin is a biologically active phytochemical substance present in turmeric and has pharmacologic actions that might benefit patients with ulcerative colitis (UC). The aim in this trial was to assess the efficacy of curcumin as maintenance therapy in patients with quiescent ulcerative colitis (UC). Methods: Eighty-nine patients with quiescent UC were recruited for this randomized, double-blind, multicenter trial of curcumin in the prevention of relapse. Forty-five patients received curcumin, 1g after breakfast and 1g after the evening meal, plus sulfasalazine (SZ) or mesalamine, and 44 patients received placebo plus SZ or mesalamine for 6 months. Clinical activity index (CAI) and endoscopic index (EI) were determined at entry, every 2 months (CAI), at the conclusion of 6-month trial, and at the end of 6-month follow-up. Results: Seven patients were protocol violators. Of 43 patients who received curcumin, 2 relapsed during 6 months of therapy (4.65%), whereas 8 of 39 patients (20.51%) in the placebo group relapsed (P = .040). Recurrence rates evaluated on the basis of intention to treat showed significant difference between curcumin and placebo (P = .049). Furthermore, curcumin improved both CAI (P = .038) and EI (P = .0001), thus suppressing the morbidity associated with UC. A 6-month follow-up was done during which patients in both groups were on SZ or mesalamine. Eight additional patients in the curcumin group and 6 patients in the placebo group relapsed. Conclusions: Curcumin seems to be a promising and safe medication for maintaining remission in patients with quiescent UC. Further studies on curcumin should strengthen our findings.