Baroni Irene, Fabrizi Diletta, Luciani Michela, Magon Arianna, Conte Gianluca, De Angeli Giada, Paglione Giulia, Ausili Davide, Caruso Rosario
Clinical Research Service, IRCCS Policlinico San Donato, 20097 San Donato Milanese, Italy.
Department of Medicine and Surgery, University of Milan-Bicocca, 20900 Monza, Italy.
Clin Nutr. 2024 Apr;43(4):1041-1061. doi: 10.1016/j.clnu.2024.03.006. Epub 2024 Mar 20.
BACKGROUND & AIMS: The escalating prevalence of diabetes mellitus may benefit from add-on therapeutic approaches. Given the recognized need for an updated synthesis of the literature, this systematic review and meta-analysis aimed to synthesize and critically assess the available randomized controlled trials (RCTs) that investigate the efficacy of probiotics and synbiotics on glycemic control in patients with Type 1 (T1DM) and Type 2 (T2DM) diabetes mellitus.
Comprehensive searches were conducted on PubMed, Embase, CINAHL, Scopus, and Web of Science, focusing on adults with T1DM or T2DM. All comparators were deemed eligible. Primary outcomes included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and insulin levels. Only RCTs were included, and the Cochrane RoB2 tool assessed the risk of bias. Random-effect models facilitated data analysis, supplemented by sensitivity, subgroup analyses, and meta-regressions.
A total of 537 records were screened, resulting in 41 RCTs for analysis, which comprises 2991 (54% females) patients with diabetes. The meta-analysis revealed statistically significant improvements in HbA1c (standardized mean difference (SMD) = -0.282, 95% CI: [-0.37, -0.19], p < 0.001), FPG (SMD = -0.175, 95% CI: [-0.26, -0.09], p < 0.001), and insulin levels (SMD = -0.273, 95% CI: [-0.35, -0.20], p < 0.001). A medium degree of heterogeneity between studies was found in HbA1c (I = 62.5%), FPG (I = 71.5%), and insulin levels (I = 66.4%) analyses. Subgroup analyses indicated that the efficacy varied based on the type of strains used and the country. Multispecies strains were particularly effective in improving HbA1c levels.
The study findings suggest that probiotics and synbiotics may be effective as complementary therapies for managing diabetes. Additionally, the study underscores the need for further tailored research that considers variables such as strain types and geographical factors to deepen the understanding of the role of these interventions in diabetes care.
PROSPERO (CRD42023396348).
糖尿病患病率不断上升，补充治疗方法可能会带来益处。鉴于公认需要对文献进行更新的综合分析，本系统评价和荟萃分析旨在综合并批判性评估现有的随机对照试验（RCT），这些试验研究了益生菌和合生元对1型糖尿病（T1DM）和2型糖尿病（T2DM）患者血糖控制的疗效。
在PubMed、Embase、CINAHL、Scopus和Web of Science上进行了全面检索，重点关注患有T1DM或T2DM的成年人。所有对照均被视为合格。主要结局包括糖化血红蛋白（HbA1c）、空腹血糖（FPG）和胰岛素水平的变化。仅纳入RCT，并用Cochrane RoB2工具评估偏倚风险。随机效应模型便于进行数据分析，并辅以敏感性分析、亚组分析和Meta回归分析。
共筛选出537条记录，最终纳入41项RCT进行分析，其中包括2991例糖尿病患者（54%为女性）。荟萃分析显示，HbA1c（标准化均数差（SMD）=-0.282，95%置信区间：[-0.37，-0.19]，p<0.001）、FPG（SMD=-0.175，95%置信区间：[-0.26，-0.09]，p<0.001）和胰岛素水平（SMD=-0.273，95%置信区间：[-0.35，-0.20]，p<0.001）均有统计学意义的改善。在HbA1c（I²=62.5%）、FPG（I²=71.5%）和胰岛素水平（I²=66.4%）分析中发现研究间存在中等程度的异质性。亚组分析表明，疗效因所用菌株类型和国家而异。多菌种菌株在改善HbA1c水平方面特别有效。
研究结果表明，益生菌和合生元可能作为糖尿病管理的辅助疗法有效。此外，该研究强调需要进一步开展针对性研究，考虑菌株类型和地理因素等变量，以加深对这些干预措施在糖尿病护理中作用的理解。
PROSPERO（CRD42023396348）。
