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低剂量口服姜黄素对轻至中度溃疡性结肠炎的缓解诱导无效:一项随机双盲安慰剂对照试验的结果。

Low dose oral curcumin is not effective in induction of remission in mild to moderate ulcerative colitis: Results from a randomized double blind placebo controlled trial.

作者信息

Kedia Saurabh, Bhatia Vikram, Thareja Sandeep, Garg Sushil, Mouli Venigalla Pratap, Bopanna Sawan, Tiwari Veena, Makharia Govind, Ahuja Vineet

机构信息

Saurabh Kedia, Sushil Garg, Venigalla Pratap Mouli, Sawan Bopanna, Veena Tiwari, Govind Makharia, Vineet Ahuja, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi 110029, India.

出版信息

World J Gastrointest Pharmacol Ther. 2017 May 6;8(2):147-154. doi: 10.4292/wjgpt.v8.i2.147.

Abstract

AIM

To evaluate the role of oral curcumin in inducing clinical remission in patients with mild to moderate ulcerative colitis (UC).

METHODS

A prospective randomized double-blind placebo-controlled trial comparing the remission inducing effect of oral curcumin and mesalamine 2.4 g with placebo and mesalamine 2.4 g in patients of ulcerative colitis with mild to moderate severity was conducted from January 2003 to March 2005. The included patients received 1 capsule thrice a day of placebo or curcumin (150 mg) for 8 wk. Patients were evaluated clinically and endoscopically at 0, 4 and 8 wk. The primary outcome was clinical remission at 8 wk and secondary outcomes were clinical response, mucosal healing and treatment failure at 8 wk. The primary analysis was intention to treat worst case scenario (ITT-WCS).

RESULTS

Of 300 patients with UC, 62 patients (curcumin: 29, placebo: 33) fulfilled the inclusion criteria and were randomized at baseline. Of these, 21 patients did not complete the trial, 41 patients (curcumin: 16, placebo: 25) finally completed 8 wk. There was no significant difference in rates of clinical remission (31.3% 27.3%, = 0.75), clinical response (20.7% 36.4%, = 0.18), mucosal healing (34.5% 30.3%, = 0.72), and treatment failure (25% 18.5%, = 0.59) between curcumin and placebo at 8 wk.

CONCLUSION

Low dose oral curcumin at a dose of 450 mg/d was ineffective in inducing remission in mild to moderate cases of UC.

摘要

目的

评估口服姜黄素在诱导轻至中度溃疡性结肠炎(UC)患者临床缓解中的作用。

方法

2003年1月至2005年3月进行了一项前瞻性随机双盲安慰剂对照试验,比较口服姜黄素和2.4 g美沙拉嗪与安慰剂和2.4 g美沙拉嗪对轻至中度溃疡性结肠炎患者的缓解诱导效果。纳入的患者每天服用3次1粒安慰剂或姜黄素(150 mg),持续8周。在0、4和8周时对患者进行临床和内镜评估。主要结局是8周时的临床缓解,次要结局是8周时的临床反应、黏膜愈合和治疗失败。主要分析采用意向性治疗最差情况分析(ITT-WCS)。

结果

在300例UC患者中,62例患者(姜黄素组:29例,安慰剂组:33例)符合纳入标准并在基线时随机分组。其中,21例患者未完成试验,41例患者(姜黄素组:16例,安慰剂组:25例)最终完成了8周的治疗。在8周时,姜黄素组和安慰剂组在临床缓解率(31.3%对27.3%,P = 0.75)、临床反应率(20.7%对36.4%,P = 0.18)、黏膜愈合率(34.5%对30.3%,P = 0.72)和治疗失败率(25%对18.5%,P = 0.59)方面均无显著差异。

结论

每天450 mg的低剂量口服姜黄素对轻至中度UC患者诱导缓解无效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22f2/5421114/829ba6c42e5d/WJGPT-8-147-g001.jpg

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