Zhang Min-Min, Qian Wei, Qin Ying-Yi, He Jia, Zhou Yu-Hao
Min-Min Zhang, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China.
World J Gastroenterol. 2015 Apr 14;21(14):4345-57. doi: 10.3748/wjg.v21.i14.4345.
To summarize the evidence from randomized controlled trials (RCTs) regarding the effect of probiotics by using a meta-analytic approach.
In July 2013, we searched PubMed, EMBASE, Ovid, the Cochrane Library, and three Chinese databases (Chinese Biomedical Literature Database, Chinese Medical Current Content, and Chinese Scientific Journals database) to identify relevant RCTs. We included RCTs investigating the effect of a combination of probiotics and standard therapy (probiotics group) with standard therapy alone (control group). Risk ratios (RRs) were used to measure the effect of probiotics plus standard therapy on Helicobacter pylori (H. pylori) eradication rates, adverse events, and patient compliance using a random-effect model.
We included data on 6997 participants from 45 RCTs, the overall eradication rates of the probiotic group and the control group were 82.31% and 72.08%, respectively. We noted that the use of probiotics plus standard therapy was associated with an increased eradication rate by per-protocol set analysis (RR = 1.11; 95%CI: 1.08-1.15; P < 0.001) or intention-to-treat analysis (RR = 1.13; 95%CI: 1.10-1.16; P < 0.001). Furthermore, the incidence of adverse events was 21.44% in the probiotics group and 36.27% in the control group, and it was found that the probiotics plus standard therapy significantly reduced the risk of adverse events (RR = 0.59; 95%CI: 0.48-0.71; P < 0.001), which demonstrated a favorable effect of probiotics in reducing adverse events associated with H. pylori eradication therapy. The specific reduction in adverse events ranged from 30% to 59%, and this reduction was statistically significant. Finally, probiotics plus standard therapy had little or no effect on patient compliance (RR = 0.98; 95%CI: 0.68-1.39; P = 0.889).
The use of probiotics plus standard therapy was associated with an increase in the H. pylori eradication rate, and a reduction in adverse events resulting from treatment in the general population. However, this therapy did not improve patient compliance.
采用荟萃分析方法总结随机对照试验(RCT)中关于益生菌作用的证据。
2013年7月,我们检索了PubMed、EMBASE、Ovid、Cochrane图书馆以及三个中文数据库(中国生物医学文献数据库、中国医学现刊和中国科学期刊数据库)以识别相关的随机对照试验。我们纳入了研究益生菌与标准疗法联合使用(益生菌组)及单独使用标准疗法(对照组)效果的随机对照试验。风险比(RRs)用于采用随机效应模型衡量益生菌加标准疗法对幽门螺杆菌(H. pylori)根除率、不良事件及患者依从性的影响。
我们纳入了来自45项随机对照试验的6997名参与者的数据,益生菌组和对照组的总体根除率分别为82.31%和72.08%。我们注意到,根据符合方案集分析(RR = 1.11;95%CI:1.08 - 1.15;P < 0.001)或意向性分析(RR = 1.13;95%CI:1.10 - 1.16;P < 0.001),使用益生菌加标准疗法与根除率提高相关。此外,益生菌组不良事件发生率为21.44%,对照组为36.27%,并且发现益生菌加标准疗法显著降低了不良事件风险(RR = 0.59;95%CI:0.48 - 0.71;P < 0.001),这表明益生菌在降低与幽门螺杆菌根除治疗相关的不良事件方面具有有益作用。不良事件的具体降低幅度在30%至59%之间,且这种降低具有统计学意义。最后,益生菌加标准疗法对患者依从性几乎没有影响(RR = 0.98;95%CI:0.68 - 1.39;P = 0.889)。
使用益生菌加标准疗法与幽门螺杆菌根除率提高以及普通人群治疗引起的不良事件减少相关。然而,这种疗法并未改善患者依从性。