利福昔明和乳果糖氢呼气试验在海湾战争退役军人中治疗肠易激综合征的双盲安慰剂对照研究。
Double-Blind Placebo-Controlled Study of Rifaximin and Lactulose Hydrogen Breath Test in Gulf War Veterans with Irritable Bowel Syndrome.
机构信息
George E. Whalen Veterans Affairs Medical Center, Salt Lake City, UT, USA.
Division of Gastroenterology, Department of Medicine, School of Medicine, University of Utah, 30 N 1900 E, 4R118 SOM, Salt Lake City, UT, 84132, USA.
出版信息
Dig Dis Sci. 2019 Mar;64(3):838-845. doi: 10.1007/s10620-018-5344-5. Epub 2018 Oct 28.
BACKGROUND
Irritable bowel syndrome (IBS) occurs in up to 33% of Gulf War (GW) Veterans. Alterations in gut microflora including small intestinal bacterial overgrowth (SIBO) during deployment may play a role in development of IBS. Rifaximin is a minimally absorbed antibiotic speculated to improve IBS symptoms, in part, by restoring normal gut microflora. The aim of this study was to compare rifaximin to placebo on IBS symptoms and quality of life (QOL) in GW Veterans with IBS without constipation.
METHODS
A double-blind, placebo-controlled study was performed. One hundred and twenty-two GW Veterans with IBS (Rome III) from our database and referral to gastroenterology and internal medicine clinics were screened. After a 2-week run-in period, 50 patients were randomized (1:1) to receive either rifaximin 550 gm or placebo twice daily for 2 weeks in a double-blind study. Patients were advised not to change their diet or medications during the study. The symptoms assessed were: (1) stool frequency, (2) stool consistency (Bristol stool scale, 1-7, very hard to watery), (3) urgency (1 = yes/0 = no daily for 7 days), (4) severity of abdominal pain (0-4, none to severe), (5) severity of bloating (1-4, none to severe), and (6) global improvement scale (1-7, substantially worse to substantially improved). These were recorded for 7 consecutive days and then averaged across the 7 days, to generate a continuous variable. The symptom data were compared after 2 weeks of treatment. QOL was assessed using IBS-QOL. The lactulose hydrogen breath test (LHBT) was performed at baseline and after 2 weeks of treatment.
RESULTS
Fifty Veterans were randomized to receive treatment; 3 withdrew and 3 were lost to follow-up. Data were analyzed from 44 patients (38 men, 6 women, median age 52, range 33-77 years). Rifaximin was not associated with significant improvement in global symptoms, abdominal pain, bloating, stool urgency, frequency, or consistency (all P ≥ 0.25) or QOL (all P ≥ 0.26). Normalization of SIBO by LHBT was not different between rifaximin- and placebo-treated Veterans (7 vs. 22%, P = 0. 54).
CONCLUSION
Rifaximin was not effective in improving IBS symptoms and QOL in GW Veterans with non-constipated IBS.
背景
肠易激综合征（IBS）在海湾战争（GW）退伍军人中发生率高达 33%。部署期间肠道微生物群的改变，包括小肠细菌过度生长（SIBO），可能在 IBS 的发展中起作用。利福昔明是一种吸收较少的抗生素，据推测可以通过恢复正常的肠道微生物群来改善 IBS 症状。本研究旨在比较利福昔明与安慰剂对 GW 退伍军人中无便秘的 IBS 患者的 IBS 症状和生活质量（QOL）的影响。
方法
进行了一项双盲、安慰剂对照研究。从我们的数据库和胃肠病学和内科诊所的转诊中筛选了 122 名 GW 退伍军人，他们患有 IBS（罗马 III 期）。在 2 周的导入期后，50 名患者被随机（1:1）接受利福昔明 550mg 或安慰剂，每天两次，持续 2 周，进行双盲研究。研究期间，患者被建议不要改变饮食或药物。评估的症状包括：（1）粪便频率，（2）粪便稠度（Bristol 粪便量表，1-7，非常硬至水样），（3）急迫性（每天 1=是/0=否 7 天），（4）腹痛严重程度（0-4，无至严重），（5）腹胀严重程度（1-4，无至严重），和（6）整体改善量表（1-7，明显恶化至明显改善）。这在连续 7 天内记录，并在 7 天内平均生成连续变量。治疗 2 周后比较症状数据。使用 IBS-QOL 评估 QOL。在基线和治疗 2 周后进行乳果糖氢呼气试验（LHBT）。
结果
50 名退伍军人被随机分配接受治疗；3 人退出，3 人失访。对 44 名患者（38 名男性，6 名女性，中位年龄 52 岁，范围 33-77 岁）的数据进行了分析。利福昔明治疗与全球症状、腹痛、腹胀、排便急迫性、频率或稠度（均 P≥0.25）或生活质量（均 P≥0.26）无显著改善相关。LHBT 正常化 SIBO 在利福昔明和安慰剂治疗的退伍军人之间无差异（7%对 22%，P=0.54）。
结论
利福昔明对 GW 退伍军人中非便秘性 IBS 患者的 IBS 症状和生活质量没有改善作用。
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