Lim Na Rae, Choi Soo Yeon, Chung Woo Chul
Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
Korean J Helicobacter Up Gastrointest Res. 2023 Mar;23(1):34-41. doi: 10.7704/kjhugr.2022.0051. Epub 2023 Feb 27.
BACKGROUND/AIMS: The effects of probiotic supplementation on eradication therapy are not completely understood. In this study, we investigated the effects of continuous probiotic administration on eradication rates, recrudescence, and symptom response following completion of a course of therapy.
This prospective, randomized, double-blind placebo-controlled trial was performed between June 2018 and 2020. Twohundred seventy patients who received a standard triple regimen for eradication, were included in the study. Participants were randomized to receive a probiotic as adjunctive therapy ( 4.5×10 and Bacillus subtilis 5.0×10; Medilac-S, Hanmi Pharmaceuticals, Seoul, Korea) or a placebo (one tablet thrice daily) for 28 days, following eradication. Participants who showed successful eradication underwent a repeat C-urea breath test after 6 months.
Eradication rates in the probiotic and placebo groups were 77.1% and 72.4%, respectively (=0.48) using per-protocol analysis. Using intention-to-treat analysis, eradication rates were 67.4% and 65.9%, respectively (=0.43). Of 149 patients who were followed-up after 6 months, four patients had recrudescence (2.7%). Recrudescence rates did not differ between the probiotic and placebo groups. Of the 76 patients who had non-ulcer dyspepsia, 60 (78.9%) showed symptom resolution after 6 months. This beneficial effect was most pronounced in patients with postprandial distress syndrome (=0.02).
Consecutive probiotic supplementation following eradication therapy did not increase eradication rates or decrease recrudescence rates.
背景/目的：益生菌补充剂对根除治疗的影响尚未完全明确。在本研究中，我们调查了连续服用益生菌对根除率、复发率以及完成一个疗程治疗后的症状反应的影响。
本前瞻性、随机、双盲、安慰剂对照试验于2018年6月至2020年期间进行。270例接受标准三联根除方案的患者纳入研究。根除治疗后，参与者被随机分配接受益生菌作为辅助治疗（4.5×10和枯草芽孢杆菌5.0×10；美常安，韩国首尔韩美制药）或安慰剂（每日三次，每次一片），持续28天。根除成功的参与者在6个月后接受重复C-尿素呼气试验。
采用符合方案分析，益生菌组和安慰剂组的根除率分别为77.1%和72.4%（P=0.48）。采用意向性分析，根除率分别为67.4%和65.9%（P=0.43）。在6个月后接受随访的149例患者中，有4例复发（2.7%）。益生菌组和安慰剂组的复发率无差异。在76例非溃疡性消化不良患者中，60例（78.9%）在6个月后症状缓解。这种有益效果在餐后不适综合征患者中最为明显（P=0.02）。
根除治疗后连续补充益生菌并未提高根除率或降低复发率。
