Department of Pediatrics, Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Section of Pediatric Emergency Medicine, Department of Pediatrics, Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
JAMA Netw Open. 2021 Oct 1;4(10):e2125236. doi: 10.1001/jamanetworkopen.2021.25236.
The published evidence in support of probiotic use is conflicting, which may be a result of selective publication of probiotic trials.
To compare the proportion of registered trials that evaluate pediatric probiotics vs those that evaluate antibiotics that are published and to identify study-related factors associated with publication status.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study evaluated eligible trials registered in ClinicalTrials.gov, an online clinical trials registry, from July 1, 2005, to June 30, 2016. Eligible studies included participants younger than 18 years, evaluated a probiotic or 1 of the 5 most commonly prescribed antibiotics in children and adolescents, and randomized study participants. All searches were updated and finalized as of September 9, 2020.
Probiotic or antibiotic.
The primary outcome was study publication status. In addition, exposure status (probiotic vs antibiotic), trial result, and funding source were assessed for independent association with publication status. Whether study design elements, publication journal impact factor, and the interval from study completion to publication differed by exposure status were also evaluated.
A total of 401 unique trials (265 probiotic and 136 antibiotic) met eligibility criteria. A greater proportion of antibiotic compared with probiotic studies were published (83 [61.0%] vs 119 [44.9%]; difference, 16.1% [95% CI, 5.8%-25.9%]). After adjustment for funding source, blinding, and purpose, studies evaluating an antibiotic were more likely to be published (odds ratio, 2.1 [95% CI, 1.3-3.4]). No other covariates included in the model were independently associated with publication status. Antibiotic trials, compared with probiotic trials, were more likely to have a therapeutic purpose (114 [83.8%] vs 117 [44.2%]; difference, 39.6% [95% CI, 31.1%-48.3%]) and to be multicenter (46 [33.8%] vs 46 [17.4%]; difference, 16.5% [95% CI, 7.5%-25.7%]). The median impact factor of the journals in which the studies were published was higher for the antibiotic trials (7.2 [IQR, 2.8-20.5] vs 3.0 [IQR, 2.3-4.2]; P < .001). The median number of days to publication did not differ between the probiotic and antibiotic trials (683 [IQR, 441-1036] vs 801 [IQR, 550-1183]; P = .24).
The findings of this cross-sectional study suggest that probiotic studies are less likely to be published than antibiotic trials. No other study characteristics were associated with publication status. This finding raises concerns regarding the results of meta-analyses of probiotic trials.
支持益生菌使用的已发表证据相互矛盾，这可能是由于益生菌试验的选择性发表。
比较评估儿科益生菌的注册试验与评估抗生素的已发表试验的比例，并确定与发表状态相关的研究相关因素。
设计、设置和参与者：本横断面研究评估了 2005 年 7 月 1 日至 2016 年 6 月 30 日期间 ClinicalTrials.gov 在线临床试验注册库中符合条件的试验。符合条件的研究包括年龄小于 18 岁的参与者，评估益生菌或儿童和青少年中最常开的 5 种抗生素之一，并对研究参与者进行随机分组。截至 2020 年 9 月 9 日，所有搜索均已更新并最终确定。
益生菌或抗生素。
主要结局是研究发表状态。此外，还评估了暴露状态（益生菌与抗生素）、试验结果和资金来源与发表状态的独立关联。还评估了研究设计要素、出版期刊影响因子以及从研究完成到出版的间隔是否因暴露状态而异。
共有 401 项独特的试验（265 项益生菌和 136 项抗生素）符合入选标准。与益生菌研究相比，抗生素研究更有可能发表（83 [61.0%] vs 119 [44.9%]；差异为 16.1% [95%CI，5.8%-25.9%]）。在调整资金来源、盲法和目的后，评估抗生素的研究更有可能发表（优势比，2.1 [95%CI，1.3-3.4]）。模型中包含的其他协变量与发表状态均无独立关联。与益生菌试验相比，抗生素试验更有可能具有治疗目的（114 [83.8%] vs 117 [44.2%]；差异为 39.6% [95%CI，31.1%-48.3%]）和多中心研究（46 [33.8%] vs 46 [17.4%]；差异为 16.5% [95%CI，7.5%-25.7%]）。发表研究的期刊的中位影响因子更高抗生素试验（7.2 [IQR，2.8-20.5] vs 3.0 [IQR，2.3-4.2]；P<0.001）。益生菌和抗生素试验的中位出版天数无差异（683 [IQR，441-1036] vs 801 [IQR，550-1183]；P=0.24）。
本横断面研究的结果表明，益生菌研究发表的可能性低于抗生素试验。其他研究特征与发表状态均无关联。这一发现引发了对益生菌试验荟萃分析结果的担忧。
