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首页> 外文期刊>Scandinavian journal of gastroenterology. >Long-term treatment with probiotics in primary care patients with irritable bowel syndrome- A randomised, double-blind, placebo controlled trial
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Long-term treatment with probiotics in primary care patients with irritable bowel syndrome- A randomised, double-blind, placebo controlled trial

机译：肠易激综合征的初级保健患者长期使用益生菌治疗-一项随机，双盲，安慰剂对照试验

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Objective. Meta-analyses have indicated effect of probiotics on irritable bowel syndrome (IBS). However, few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting. We aimed to investigate the effect of probiotics compared with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up. Material and methods. We randomized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12 in an amount of 1.3 × 1010 CFU per capsule. Primary endpoint was proportion of responders defined as patients reporting adequate relief (AR) at least 50% of the time in the 6-month treatment period. Secondary outcomes were proportions of patients reporting AR at different time points, and change in gastrointestinal symptoms and health-related quality of life (HrQOL) from baseline to 6 and 12 months. Results. A total of 131 patients were included in this study. The proportion of responders in the treatment period was 52% (35/67) in the probiotic group versus 41% (26/64) in the placebo group, p = 0.18. Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment. Patients improved in HrQOL, but with no statistically significant difference between the groups. Conclusion. During a 6-month treatment period, we were not able to detect a positive effect of probiotic when compared with placebo.
机译：目的。荟萃分析表明益生菌对肠易激综合症（IBS）有作用。但是，很少进行长期试验，并且在初级保健机构中有效性和长期效果尚不确定。我们旨在研究益生菌与安慰剂相比，在6个月的治疗期间和6个月的随访中，在IBS的初级保健管理中的作用。材料与方法。我们将符合Rome III标准的IBS患者随机分为两组，分别服用安慰剂或益生菌副干酪乳杆菌ssp paracasei F19，嗜酸乳杆菌La5和双歧杆菌Bb12的益生菌混合物，每次两次，每次胶囊1.3×1010 CFU。主要终点是反应者所占的比例，定义为在6个月的治疗期内至少50％的时间报告有充分缓解（AR）的患者。次要结果是在不同时间点报告AR的患者比例，以及从基线到6个月和12个月的胃肠道症状和健康相关生活质量（HrQOL）的变化。结果。本研究共纳入131例患者。益生菌组在治疗期间有反应的比例为52％（35/67），而安慰剂组为41％（26/64），p = 0.18。总体而言，我们发现治疗后两组之间的胃肠道症状变化无差异。患者的HrQOL有所改善，但两组之间无统计学差异。结论。在6个月的治疗期内，与安慰剂相比，我们无法检测到益生菌的积极作用。

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