Abstract：
BACKGROUND: Despite multiple therapy regimens, the decline in the Helicobacter pylori eradication rate poses a significant challenge to the medical community. Adding Lactobacillus reuteri probiotic as an adjunct treatment has shown some promising results. This study aims to investigate the efficacy of Lactobacillus reuteri DSM 17648 in H. pylori eradication and its effect in ameliorating gastrointestinal symptoms and adverse treatment effects.
METHODS: This randomized, double-blinded, placebo-controlled trial involved treatment-naïve H. pylori-positive patients. Ninety patients received standard triple therapy for 2 weeks before receiving either a probiotic or placebo for 4 weeks. The posttreatment eradication rate was assessed via a 14 C urea breath test in Week 8. The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire and an interview on treatment adverse effects were conducted during this study.
RESULTS: The eradication rate was higher in the probiotic group than in the placebo group, with a 22.2% difference in the intention-to-treat analysis (91.1% vs. 68.9%; p = 0.007) and 24.3% difference in the per-protocol analysis (93.2% vs. 68.9%; p = 0.007). The probiotic group showed significant pre- to post-treatment reductions in indigestion, constipation, abdominal pain, and total GSRS scores. The probiotic group showed significantly greater reductions in GSRS scores than the placebo group: indigestion (4.34 ± 5.00 vs. 1.78 ± 5.64; p = 0.026), abdominal pain (2.64 ± 2.88 vs. 0.89 ± 3.11; p = 0.007), constipation (2.34 ± 3.91 vs. 0.64 ± 2.92; p = 0.023), and total score (12.41 ± 12.19 vs. 4.24 ± 13.72; p = 0.004). The probiotic group reported significantly fewer adverse headache (0% vs. 15.6%; p = 0.012) and abdominal pain (0% vs. 13.3%; p = 0.026) effects.
CONCLUSIONS: There was a significant increase in H. pylori eradication rate and attenuation of symptoms and adverse treatment effects when L. reuteri was given as an adjunct treatment.
METHODS: This randomized, double-blinded, placebo-controlled trial involved treatment-naïve H. pylori-positive patients. Ninety patients received standard triple therapy for 2 weeks before receiving either a probiotic or placebo for 4 weeks. The posttreatment eradication rate was assessed via a 14 C urea breath test in Week 8. The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire and an interview on treatment adverse effects were conducted during this study.
RESULTS: The eradication rate was higher in the probiotic group than in the placebo group, with a 22.2% difference in the intention-to-treat analysis (91.1% vs. 68.9%; p = 0.007) and 24.3% difference in the per-protocol analysis (93.2% vs. 68.9%; p = 0.007). The probiotic group showed significant pre- to post-treatment reductions in indigestion, constipation, abdominal pain, and total GSRS scores. The probiotic group showed significantly greater reductions in GSRS scores than the placebo group: indigestion (4.34 ± 5.00 vs. 1.78 ± 5.64; p = 0.026), abdominal pain (2.64 ± 2.88 vs. 0.89 ± 3.11; p = 0.007), constipation (2.34 ± 3.91 vs. 0.64 ± 2.92; p = 0.023), and total score (12.41 ± 12.19 vs. 4.24 ± 13.72; p = 0.004). The probiotic group reported significantly fewer adverse headache (0% vs. 15.6%; p = 0.012) and abdominal pain (0% vs. 13.3%; p = 0.026) effects.
CONCLUSIONS: There was a significant increase in H. pylori eradication rate and attenuation of symptoms and adverse treatment effects when L. reuteri was given as an adjunct treatment.
摘要：
背景：尽管有多种治疗方案，幽门螺杆菌根除率的下降对医学界提出了重大挑战。添加罗伊氏乳杆菌益生菌作为辅助治疗已显示出一些有希望的结果。本研究旨在探讨罗伊氏乳杆菌DSM17648根除幽门螺杆菌的疗效及其在改善胃肠道症状和不良反应中的作用。
方法：这是随机的，双盲,安慰剂对照试验涉及初治幽门螺杆菌阳性患者。90名患者接受标准三联疗法2周，然后接受益生菌或安慰剂4周。在第8周通过14C尿素呼气试验评估治疗后根除率。在这项研究中，进行了胃肠道症状评定量表（GSRS）问卷和对治疗不良反应的访谈。
结果：益生菌组的根除率高于安慰剂组，在意向治疗分析中差异为22.2%(91.1%与68.9%；p=0.007）和24.3%的差异在符合方案分析中（93.2%与68.9%；p=0.007）。益生菌组显示出治疗前后消化不良的显着减少，便秘,腹痛,和GSRS总分。与安慰剂组相比，益生菌组的GSRS评分降低幅度更大：消化不良（4.34±5.00vs.1.78±5.64；p=0.026），腹痛（2.64±2.88vs.0.89±3.11；p=0.007），便秘（2.34±3.91vs.0.64±2.92；p=0.023），和总分（12.41±12.19vs.4.24±13.72；p=0.004）。益生菌组报告的不良头痛明显减少（0％vs.15.6%；p=0.012）和腹痛（0%vs.13.3%；p=0.026）效应。
结论：当罗伊氏乳杆菌作为辅助治疗时，幽门螺杆菌的根除率和症状的减轻以及不良治疗效果显著增加。
方法：这是随机的，双盲,安慰剂对照试验涉及初治幽门螺杆菌阳性患者。90名患者接受标准三联疗法2周，然后接受益生菌或安慰剂4周。在第8周通过14C尿素呼气试验评估治疗后根除率。在这项研究中，进行了胃肠道症状评定量表（GSRS）问卷和对治疗不良反应的访谈。
结果：益生菌组的根除率高于安慰剂组，在意向治疗分析中差异为22.2%(91.1%与68.9%；p=0.007）和24.3%的差异在符合方案分析中（93.2%与68.9%；p=0.007）。益生菌组显示出治疗前后消化不良的显着减少，便秘,腹痛,和GSRS总分。与安慰剂组相比，益生菌组的GSRS评分降低幅度更大：消化不良（4.34±5.00vs.1.78±5.64；p=0.026），腹痛（2.64±2.88vs.0.89±3.11；p=0.007），便秘（2.34±3.91vs.0.64±2.92；p=0.023），和总分（12.41±12.19vs.4.24±13.72；p=0.004）。益生菌组报告的不良头痛明显减少（0％vs.15.6%；p=0.012）和腹痛（0%vs.13.3%；p=0.026）效应。
结论：当罗伊氏乳杆菌作为辅助治疗时，幽门螺杆菌的根除率和症状的减轻以及不良治疗效果显著增加。
