L'altrastatistica S.r.l., for GB Pharma Services & Consulting S.r.l, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2020 Jan;24(2):963-973. doi: 10.26355/eurrev_202001_20082.
A high-concentration of a multi-strain probiotic mixture, VSL#3® is widely used 'whenever it is useful to promote the balance of intestinal flora'. As a food supplement, VSL#3® has been so far scarcely investigated on the aspect of safety. To fill this gap, in this paper, we analyzed the adverse events (AEs) recorded during the conduct of three (3) double-blind, randomized, placebo-controlled trials carried out to explore the efficacy of VSL#3® in various clinical settings. Data from a large open-label observational trial were also considered.
All trials included in the analysis were carried out according to good clinical practice (GCP) rules. AEs were classified by System Organ Class (SOC), Preferred Term (PT) and frequency. Differences vs. placebo control were considered as statistically significant if the p-value was < 0.05.
A total of 120 patients were analyzed, 70 patients being included in the randomized controlled trials. In this population, 45 patients had at least one AE, 20 (64.5%) in the placebo group and 25 (64.1%) in the VSL#3® group. 29 patients had at least one related AE, 14 (45.2%) and 15 (38.5%) in the two treatment groups, respectively. Only one AE was assessed as serious, i.e., Foetal malformation, which occurred in the placebo group and was considered unrelated. No significant difference was found between VSL#3® and placebo for any of the SOC considered, with the exception of Injury, poisoning and procedural complications, which was in favor of VSL#3®.
Based on GCP-quality data from clinical trials, we conclude that VSL#3® is a safe and well-tolerated agent.
高浓度多菌株益生菌混合物 VSL#3® 被广泛应用于“凡是有助于促进肠道菌群平衡的情况”。作为一种食品补充剂，VSL#3® 在安全性方面迄今为止几乎没有被研究过。为了填补这一空白，在本文中，我们分析了在三项（3 项）双盲、随机、安慰剂对照临床试验中记录的不良反应 (AE)，这些试验旨在探索 VSL#3® 在各种临床环境中的疗效。还考虑了一项大型开放标签观察性试验的数据。
分析中纳入的所有试验均按照良好临床实践 (GCP) 规则进行。根据系统器官类别 (SOC)、首选术语 (PT) 和频率对 AE 进行分类。如果 p 值 < 0.05，则认为与安慰剂对照的差异具有统计学意义。
共分析了 120 名患者，其中 70 名患者纳入随机对照试验。在该人群中，有 45 名患者至少有 1 种 AE，安慰剂组有 20 名（64.5%），VSL#3®组有 25 名（64.1%）。有 29 名患者至少有 1 种相关 AE，安慰剂组有 14 名（45.2%），VSL#3®组有 15 名（38.5%）。只有 1 种 AE 被评估为严重，即胎儿畸形，发生在安慰剂组，被认为与治疗无关。除损伤、中毒和程序并发症外，VSL#3® 对任何考虑的 SOC 均未显示出与安慰剂的显著差异，后者有利于 VSL#3®。
基于临床试验的 GCP 质量数据，我们得出结论，VSL#3® 是一种安全且耐受良好的药物。
