Department of Gastroenterology and Medicine, Dayanand Medical College and Hospital, Ludhiana, India.
Clin Gastroenterol Hepatol. 2009 Nov;7(11):1202-9, 1209.e1. doi: 10.1016/j.cgh.2009.07.016. Epub 2009 Jul 22.
BACKGROUND & AIMS: Probiotics can maintain ulcerative colitis (UC) in remission effectively, but little is known of their ability to induce remission. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of a high-potency probiotic, VSL#3, for the treatment of mild-to-moderately active UC.
Adult patients with mild-to-moderate UC were assigned randomly to groups that were given 3.6 x 10(12) CFU VSL#3 (n = 77) or placebo (n = 70), twice daily for 12 weeks. The primary end point was a 50% decrease in the Ulcerative Colitis Disease Activity Index (UCDAI) at 6 weeks. The secondary end points included remission by 12 weeks and reduction in total individual UCDAI parameters from baseline at 12 weeks. Intention-to-treat analysis was performed.
At week 6, the percentage of patients with an improvement in UCDAI score that was greater than 50% was significantly higher in the group given VSL#3 (25; 32.5%) than the group given placebo (7; 10%) (P = .001). At week 12, there were 33 patients given VSL#3 (42.9%) who achieved remission, compared with 11 patients given placebo (15.7%) (P < .001). Furthermore, significantly more patients given VSL#3 (40; 51.9%) achieved a decrease in their UCDAI that was greater than 3 points, compared with those given placebo (13; 18.6%) (P < .001). The VSL#3 group had significantly greater decreases in UCDAI scores and individual symptoms at weeks 6 and 12, compared with the placebo group.
VSL#3 is safe and effective in achieving clinical responses and remissions in patients with mild-to-moderately active UC.
益生菌可有效维持溃疡性结肠炎（UC）缓解，但对其诱导缓解的能力知之甚少。我们进行了一项多中心、随机、双盲、安慰剂对照试验，研究了一种高活性益生菌 VSL#3 治疗轻中度活动期 UC 的疗效。
将轻度至中度 UC 成年患者随机分为两组，分别给予 3.6 x 10(12) CFU VSL#3（n = 77）或安慰剂（n = 70），每日两次，持续 12 周。主要终点为 6 周时溃疡性结肠炎疾病活动指数（UCDAI）下降 50%。次要终点包括 12 周时缓解和 12 周时总个体 UCDAI 参数从基线降低。采用意向治疗分析。
第 6 周时，VSL#3 组 UCDAI 评分改善大于 50%的患者比例明显高于安慰剂组（25 例，32.5%比 7 例，10%；P =.001）。第 12 周时，VSL#3 组 33 例（42.9%）患者缓解，安慰剂组 11 例（15.7%）（P <.001）。此外，VSL#3 组 UCDAI 评分下降大于 3 分的患者比例明显高于安慰剂组（40 例，51.9%比 13 例，18.6%；P <.001）。与安慰剂组相比，VSL#3 组在第 6 周和第 12 周时 UCDAI 评分和个体症状均有显著降低。
VSL#3 安全有效，可使轻中度活动期 UC 患者获得临床缓解和缓解。
