Lee Sang-Hoon, Cho Doo-Yeoun, Lee Seok-Hoon, Han Kyung-Sun, Yang Sung-Won, Kim Jin-Ho, Lee Su-Hyun, Kim Soo-Min, Kim Kyu-Nam
Department of Family Practice and Community Health, Ajou University School of Medicine, Suwon, Korea.
Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea.
Korean J Fam Med. 2019 Jan;40(1):2-8. doi: 10.4082/kjfm.17.0064. Epub 2018 Oct 26.
This double-blind, randomized controlled design study aimed to assess the dose-dependent effects of synbiotics on gastrointestinal symptoms of and fatigue in irritable bowel syndrome (IBS).
Thirty subjects with IBS were randomly assigned into the following three groups and received 2 capsules a day for 8 weeks: (1) high-dose (2 capsules of synbiotics); (2) low-dose (1 capsule of synbiotics and 1 capsule of placebo); and (3) placebo (2 capsules of placebo). At baseline and 8 weeks, they completed the study questionnaires.
Two subjects in the high-dose group were lost to follow-up, leaving a total of 28 patients for the analysis. After 8 weeks, abdominal discomfort, abdominal bloating, frequency of formed stool, fatigue Visual Analog Scale (VAS), and Multidimensional Fatigue Inventory were significantly different among the groups (P=0.002, 0.006, 0.007, 0.028, and 0.041, respectively, by Kruskal-Wallis test). However, only abdominal discomfort, abdominal bloating, frequency of formed stool, and fatigue VAS were significantly improved in the high-dose group compared with those in the placebo group (P=0.002, 0.003, 0.002, and 0.013, respectively) by Mann-Whitney test with Bonferroni correction. No adverse drug reactions were reported.
High-dose synbiotics were superior to placebo in improving bowel symptoms and fatigue of IBS patients, suggesting that synbiotic dosage plays an important role in the treatment of IBS.
本双盲、随机对照设计研究旨在评估合生元对肠易激综合征（IBS）胃肠道症状及疲劳的剂量依赖性影响。
30例IBS患者被随机分为以下三组，每天服用2粒胶囊，共8周：（1）高剂量组（2粒合生元胶囊）；（2）低剂量组（1粒合生元胶囊和1粒安慰剂胶囊）；（3）安慰剂组（2粒安慰剂胶囊）。在基线和8周时，他们完成了研究问卷。
高剂量组有2名受试者失访，共28例患者纳入分析。8周后，各组间腹部不适、腹胀、成形粪便频率、疲劳视觉模拟量表（VAS）及多维疲劳量表存在显著差异（Kruskal-Wallis检验，P值分别为0.002、0.006、0.007、0.028和0.041）。然而，经Bonferroni校正的Mann-Whitney检验显示，与安慰剂组相比，高剂量组仅腹部不适、腹胀、成形粪便频率及疲劳VAS有显著改善（P值分别为0.002、0.003、0.002和0.013）。未报告药物不良反应。
高剂量合生元在改善IBS患者肠道症状及疲劳方面优于安慰剂，提示合生元剂量在IBS治疗中起重要作用。
