Department of Internal Medicine, Infectious Disease Section, Florida Hospital Orlando, Orlando, FL, United States of America.
Department of Medicinal Chemistry, School of Pharmacy, University of Washington Medical Center, Seattle, Washington United States of America.
PLoS One. 2018 Dec 26;13(12):e0209205. doi: 10.1371/journal.pone.0209205. eCollection 2018.
Clinicians and patients face a daunting task when choosing the most appropriate probiotic for their specific needs. Available preparations encompass a diverse and continuously expanding product base, with most available products lacking evidence-based trials that support their use. Even when evidence exists, not all probiotic products are equally effective for all disease prevention or treatment indications. At this point in time, drug regulatory agencies offer limited assistance with regard to guidance and oversight in most countries, including the U.S.
We reviewed the current medical literature and sources on the internet to survey the types of available probiotic products and to determine which probiotics had evidence-based efficacy data. Standard medical databases from inception to June 2018 were searched and discussions with experts in the field were conducted. We graded the strength of the evidence for probiotics having multiple, randomized controlled trials and developed a guide for the practical selection of current probiotic products for specific uses.
We found the efficacy of probiotic products is both strain-specific and disease-specific. Important factors involved in choosing the appropriate probiotic include matching the strain(s) with the targeted disease or condition, type of formulation, dose used and the source (manufacturing quality control and shelf-life). While we found many probiotic products lacked confirmatory trials, we found sufficient evidence for 22 different types of probiotics from 249 trials to be included. For example, several types of probiotics had strong evidence for the prevention of antibiotic-associated diarrhea [Saccharomyces boulardii I-745, a three-strain mixture (Lactobacillus acidophilus CL1285, L. casei Lbc80r, L. rhamnosus CLR2) and L. casei DN114001]. Strong evidence was also found for four types of probiotics for the prevention of a variety of other diseases/conditions (enteral-feed associated diarrhea, travellers' diarrhea, necrotizing enterocolits and side-effects associated with H. pylori treatments. The evidence was most robust for the treatment of pediatric acute diarrhea based on 59 trials (7 types of probiotics have strong efficacy), while an eight-strain multi-strain mixture showed strong efficacy for inflammatory bowel disease and two types of probiotics had strong efficacy for irritable bowel disease. Of the 22 types of probiotics reviewed, 15 (68%) had strong-moderate evidence for efficacy for at least one type of disease.
The choice of an appropriate probiotic is multi-factored, based on the mode and type of disease indication and the specific efficacy of probiotic strain(s), as well as product quality and formulation.
This review was registered with PROSPERO: CRD42018103979.
当临床医生和患者需要根据特定需求选择最合适的益生菌时，他们面临着艰巨的任务。现有的制剂涵盖了多样化且不断扩大的产品基础，大多数可用产品缺乏支持其使用的基于证据的试验。即使存在证据，也不是所有的益生菌产品对所有疾病预防或治疗适应症都同样有效。在这个时候，药物监管机构在大多数国家（包括美国）提供的指导和监督方面提供的帮助有限。
我们回顾了当前的医学文献和互联网上的资料，以调查可用益生菌产品的类型，并确定哪些益生菌具有基于证据的疗效数据。从最初到 2018 年 6 月，我们搜索了标准医学数据库，并与该领域的专家进行了讨论。我们对具有多项随机对照试验的益生菌的证据强度进行了分级，并为特定用途的当前益生菌产品的实用选择制定了指南。
我们发现益生菌产品的疗效具有菌株特异性和疾病特异性。选择合适的益生菌的重要因素包括将菌株与目标疾病或病症相匹配、制剂类型、使用剂量以及来源（制造质量控制和保质期）。虽然我们发现许多益生菌产品缺乏确证试验，但我们发现有足够的证据支持从 249 项试验中纳入 22 种不同类型的益生菌。例如，几种类型的益生菌对预防抗生素相关性腹泻（Saccharomyces boulardii I-745，三菌株混合物（Lactobacillus acidophilus CL1285、L. casei Lbc80r、L. rhamnosus CLR2）和 L. casei DN114001）具有强有力的证据。对于预防各种其他疾病/病症（肠内喂养相关腹泻、旅行者腹泻、坏死性小肠结肠炎和与 H. pylori 治疗相关的副作用）的四种益生菌也有强有力的证据。基于 59 项试验（7 种益生菌具有强大的疗效），对于儿科急性腹泻的治疗证据最为可靠，而一种八菌株多菌株混合物对炎症性肠病具有强大的疗效，两种益生菌对肠易激综合征具有强大的疗效。在审查的 22 种益生菌中，有 15 种（68%）对至少一种疾病的疗效有强有力的证据。
选择合适的益生菌是多方面的，基于疾病的模式和类型以及益生菌菌株的具体疗效，以及产品质量和制剂。
本综述已在 PROSPERO 注册：CRD42018103979。
