益生菌/元和合生制剂的安全性,或需重新反思(综述)
  • 纳入384项评估单独或联合使用益生菌/元或合生制剂干预的安全或有效性的随机对照试验(RCT),分析这些RCT对危害性的报道;
  • 28%的RCT未报告危害相关数据,37%未报告安全性结果,80%未给出严重不良事件(SAE)的数字;
  • 在提及危害相关结果的242项RCT中,37%仅使用一般性语言描述不良事件(AE),16%存在度量不充分;
  • 98%的RCT未给出AE和SAE的定义及相关准确数据;
  • 益生菌/元、合生制剂RCT中,对危害性的报道普遍不足,其安全性难下定论。
主编推荐语
mildbreeze
人们通常认为益生菌、益生元和合生制剂是安全的,但Annals of Internal Medicine近期发表一项系统综述,对384项益生菌/元及合生制剂干预的RCT临床试验进行分析,发现这些RCT普遍缺乏准确、充足的不良危害数据报告,仅2%的研究给出了充分的安全性信息,因而难以对这些菌群干预方法的安全性下定论。这项研究为相关专业人士敲响警钟,若想全面评估益生菌/元等干预方法的收益与风险,RCT中关于安全性的数据不能忽视。
关键字
延伸阅读本研究的原文信息和链接出处,以及相关解读和评论文章。欢迎读者朋友们推荐!

Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota: A Systematic Review

以改造菌群为目进行干预的临床对照试验中的危害报道:系统综述

10.7326/M18-0343

2018-07-17, Article

Abstract & Authors:展开

Abstract:收起
Background: Probiotics, prebiotics, and synbiotics are used increasingly, although the safety and potential harms of these interventions are poorly understood.
Purpose: To examine how harms-related information is reported in publications of randomized controlled trials (RCTs) of probiotics, prebiotics, and synbiotics.
Data Sources: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Web of Science (without language restrictions) from 1 January 2015 to 20 March 2018.
Study Selection: RCTs assessing the safety or efficacy of at least 1 intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition.
Data Extraction: 4 reviewers independently assessed study characteristics, the reporting of harms, and the presentation of safety results.
Data Synthesis: Of 384 trials conducted in healthy volunteers (n = 136) or patients with any of several medical conditions (n = 248), 339 (88%) were published in specialty journals. Trials most often evaluated probiotics (n = 265 [69%]). Studies in persons with medical conditions enrolled outpatients (n = 195) and high-risk patients (n = 53). No harms-related data were reported for 106 trials (28%), safety results were not reported for 142 (37%), and the number of serious adverse events (SAEs) per study group was not given for 309 (80%). Of 242 studies mentioning harms-related results, 37% (n = 89) used only generic statements to describe AEs and 16% (n = 38) used inadequate metrics. Overall, 375 trials (98%) did not give a definition for AEs or SAEs, the number of participant withdrawals due to harms, or the number of AEs and SAEs per study group with denominators.
Limitation: Journal publication processes may have affected the completeness of reporting; only English-language publications were examined.
Conclusion: Harms reporting in published reports of RCTs assessing probiotics, prebiotics, and synbiotics often is lacking or inadequate. We cannot broadly conclude that these interventions are safe without reporting safety data.

First Authors:
Aïda Bafeta

Correspondence Authors:
Aïda Bafeta

All Authors:
Aïda Bafeta,Mitsuki Koh,Carolina Riveros,Philippe Ravaud

评论