Pharmaceutical Research Institute at Albany College of Pharmacy and Health Sciences, Rensselaer, NY 42101, USA.
J Altern Complement Med. 2012 Feb;18(2):112-9. doi: 10.1089/acm.2011.0015.
Multiple clinical trials within the past decade have aimed to study the safety and efficacy of various probiotic strains in treating patients with irritable bowel syndrome (IBS). However, there exists much heterogenicity in study design among these trials, namely, in bacterial strain, dose, dosage form, sample size, study duration, and population demographics.
The aim of this study was to identify the shortcomings of clinical trials using probiotic treatments in subjects with IBS, so that researchers may realize where limitations exist, allowing them to curtail these limitations in future trials.
An extensive PubMed search was conducted using the following keywords: probiotics in irritable bowel syndrome, probiotic pharmacokinetics, Lactobacillus, Bifidobacterium, Alosetron, Tegaserod, Alosetron, and Tegaserod safety profile. A total of 62 articles were used in constructing this review, with 20 original articles.
Stark differences in study design existed among the 20 original articles analyzed, as well as an outstandingly high "placebo effect," making the ability to compare these articles as a means for evidence-based treatment therapy in IBS very difficult.
Future large, randomized, double-blind, placebo-controlled clinical trials must be conducted, embodying minimal variability in study designs, to appropriately assess the efficacy of specific probiotic strains over placebo.
在过去十年中，多项临床试验旨在研究各种益生菌菌株治疗肠易激综合征（IBS）患者的安全性和疗效。然而，这些试验在研究设计上存在很大的异质性，即细菌株、剂量、剂型、样本量、研究持续时间和人群特征。
本研究旨在确定使用益生菌治疗 IBS 患者的临床试验的不足之处，以便研究人员能够认识到存在哪些局限性，从而在未来的试验中减少这些局限性。
使用以下关键字在 PubMed 上进行了广泛的搜索：益生菌在肠易激综合征中的应用、益生菌药代动力学、乳杆菌、双歧杆菌、阿洛司琼、替加色罗、阿洛司琼、替加色罗安全性概况。总共使用了 62 篇文章来构建这篇综述，其中包括 20 篇原始文章。
分析的 20 篇原始文章在研究设计上存在明显差异，并且“安慰剂效应”非常高，这使得很难将这些文章作为 IBS 循证治疗的手段进行比较。
必须进行未来的大型、随机、双盲、安慰剂对照临床试验，体现出研究设计中最小的变异性，以适当评估特定益生菌菌株相对于安慰剂的疗效。
