1 Max Rubner-Institut, Federal Research Institute of Nutrition and Food, Department of Microbiology and Biotechnology; Hermann-Weigmann-Straβe 1, 24117 Kiel, Germany.
2 Clinical Research Center, Schauenburgerstraβe 116, 24118 Kiel, Germany.
Benef Microbes. 2019 May 28;10(5):483-496. doi: 10.3920/BM2018.0129. Epub 2019 Apr 23.
We aimed at assessing the evidence for an effect on vaginal dysbiosis by oral administration of a mixture of strains isolated from vaginal microbiota. For this purpose, we systematically reviewed the literature for randomised clinical trials (RCTs) in which the effect of oral administration of a mixture of four strains ( LbV 88 (DSM 22566), LbV 150N (DSM 22583), LbV 116 (DSM 22567) and LbV96 (DSM 22560)) on vaginal dysbiosis was examined based on Nugent score. Four RCTs were identified: a double-blind (DB)-RCT in 60 male-to-female transsexual women with neovagina; an open label RCT in 60 pregnant women with herpes virus infection; a DB-RCT in 36 women with bacterial vaginosis; a DB-RCT in 22 postmenopausal breast cancer patients receiving chemotherapy. Only in the three DB-RCTs Nugent score was assessed. The meta-analysis of these trials showed a significant reduction of Nugent score by probiotics compared to placebo in the fixed (standardised mean differences (SMD) -0.561; confidence interval (CI) -0.935 to -0.186; =0.004 and random effect models (SMD -0.561; CI -0.935 to -0.186; =0.004). The odds ratio (OR) of the cases presenting with improved Nugent score after probiotics compared to placebo treatment showed a significant effect in the fixed (OR=3.936; CI 1.702 to 9.100; =0.001) and random effect model (OR=3.902; CI 1.681 to 9.059; =0.001) Cochran's Q and I statistics showed no heterogeneity. This meta-analysis indicates that the oral intake of the pertinent strains improves the microbial pattern in vaginal dysbiosis.
我们旨在评估口服混合阴道微生物分离株对阴道菌群失调的影响。为此，我们系统地综述了随机临床试验（RCT）的文献，这些试验基于 Nugent 评分，评估了口服四种混合菌株（LbV88（DSM22566）、LbV150N（DSM22583）、LbV116（DSM22567）和 LbV96（DSM22560））对阴道菌群失调的影响。共确定了 4 项 RCT：一项 60 例有新阴道的男-女易性癖患者的双盲（DB）-RCT；一项 60 例疱疹病毒感染孕妇的开放性 RCT；一项 36 例细菌性阴道病患者的 DB-RCT；一项 22 例接受化疗的绝经后乳腺癌患者的 DB-RCT。只有在这三项 DB-RCT 中评估了 Nugent 评分。这些试验的荟萃分析显示，与安慰剂相比，益生菌可显著降低 Nugent 评分（固定效应模型：标准化均数差（SMD）-0.561；置信区间（CI）-0.935 至-0.186；=0.004；随机效应模型：SMD-0.561；CI-0.935 至-0.186；=0.004）。与安慰剂治疗相比，益生菌治疗后 Nugent 评分改善的病例的比值比（OR）在固定效应模型（OR=3.936；CI 1.702 至 9.100；=0.001）和随机效应模型（OR=3.902；CI 1.681 至 9.059；=0.001）中均显示出显著效果。Cochran's Q 和 I 统计量显示无异质性。这项荟萃分析表明，口服特定菌株可改善阴道菌群失调的微生物模式。
