Rastegarpanah Mansoor, Malekzadeh Reza, Vahedi Homayoun, Mohammadi Maryam, Elahi Elham, Chaharmahali Meghedi, Safarnavadeh Tahereh, Abdollahi Mohammad
Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Chin J Integr Med. 2015 Dec;21(12):902-6. doi: 10.1007/s11655-012-1026-x. Epub 2012 Apr 11.
To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients.
A randomized double blinded placebo-controlled clinical trial was conducted in 80 UC patients whose disease had been documented and were in remission state between September 2009 and October 2010. Patients were assigned to silymarin group (42 cases) and placebo group (38 cases) using a random number table. Either silymarin (140 mg) or placebo (lactose mono-hydrate, corn starch magnesium stearate) tablets were given once daily for 6 months along with their standard therapy. The efficacies were assessed by disease activity index (DAI), frequency difference of the disease flare-up, and paraclinical data.
Ten patients (4 in the silymarin group due to nausea and 6 in the placebo group due to disease flare-up and abdominal pain) discontinued the study. An improvement in hemoglobin level (11.8±1.6 g/dL vs. 13.4±1.2 g/dL,P<0.05) and erythrocyte sedimentation rate (23.7±11.5 mm/h vs.10.8±3.2 mm/h,P<0.05) was observed in the silymarin group but not in the placebo group. DAI significantly decreased in the silymarin group and reached from 11.3±3.5 to 10.7±2.8 (P<0.05). Thirty-five out of 38 patients in the silymarin group were in complete remission with no flare-up after 6 months as compared to 21 out of 32 patients in the placebo group (P=0.5000).
Silymarin as a natural supplement may be used in UC patients to maintain remission.
评估水飞蓟素对溃疡性结肠炎（UC）患者的临床疗效。
2009年9月至2010年10月，对80例已确诊且处于缓解期的UC患者进行了一项随机双盲安慰剂对照临床试验。使用随机数字表将患者分为水飞蓟素组（42例）和安慰剂组（38例）。水飞蓟素组服用水飞蓟素（140毫克）片剂，安慰剂组服用安慰剂（一水乳糖、玉米淀粉、硬脂酸镁）片剂，两组均每日服用一次，共6个月，同时接受标准治疗。通过疾病活动指数（DAI）、疾病复发频率差异和辅助临床数据评估疗效。
10例患者（水飞蓟素组4例因恶心，安慰剂组6例因疾病复发和腹痛）退出研究。水飞蓟素组血红蛋白水平（11.8±1.6克/分升对13.4±1.2克/分升，P<0.05）和红细胞沉降率（23.7±11.5毫米/小时对10.8±3.2毫米/小时，P<0.05）有所改善，而安慰剂组未出现此情况。水飞蓟素组DAI显著降低，从11.3±3.5降至10.7±2.8（P<0.05）。6个月后，水飞蓟素组38例患者中有35例完全缓解且未复发，安慰剂组32例患者中有21例完全缓解（P=0.5000）。
水飞蓟素作为一种天然补充剂可用于UC患者维持缓解状态。
