Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial
Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial
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DOI：
10.1016/j.cgh.2015.06.022
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发表时间：
2015-11-01
影响因子：
12.6
通讯作者：
Boyce, Philip
中科院分区：
文献类型：
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作者：
Bensoussan, Alan;Kellow, John E.;Boyce, Philip
背景与目的：肠易激综合征（IBS）是最常见的慢性功能性肠病，治疗方案很少。肠易激综合征影响10%-20%的人口；多达58%的患者患有便秘为主的IBS （IBS- c）。我们评估了一种标准化的、专门配制的中草药（CHM）制剂治疗IBS-C患者的疗效和安全性。方法：我们对125名IBS-C患者（根据Rome III标准）进行了一项双盲试验，这些患者从2009年7月至2012年2月在澳大利亚的13个医疗中心或诊所招募。患者被随机分为两组，分别给予7种中草药成分的标准化提取物（n = 61）或安慰剂（n = 64），疗程8周（5粒胶囊，每日两次）。然后对受试者进行了16周的随访。完成了该制剂的化学定义、标准化和稳定性试验。受试者在第2周、第4周、第8周和第16周完成了一份自我管理的、有效的总体症状改善二元问卷（主要结局）。次要结果包括自我给予IBS症状严重程度量表和Bristol粪便形式量表（BSFS）的结果，分别在第4周、第8周和第16周完成。结果：与对照组（n = 58）相比，接受8周CHM治疗的受试者（n = 50）有统计学和临床显著的改善（每个方案分析）。接受CHM治疗的受试者中有更大比例的人报告有足够的缓解（P = 0.010）。与对照组相比，CHM组在第8周的排便习惯有所改善，包括IBS症状严重程度量表评分较低（P < 0.001），排便时紧张程度减少（P = 0.002），硬块性便明显减少（P = 0.031）。根据布里斯托尔粪便形态量表（Bristol stool Form Scale，第8周，P < 0.001）， CHM组的粪便稠度也有所增加。第8周腹痛组间差异无统计学意义（P = .692）。CHM耐受性良好。结论：在一项前瞻性对照研究中，与安慰剂相比，CHM减轻了IBS-C的症状，增加了肠道满意度和粪便一致性，减少了拉稀和硬块性大便。
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic functional bowel disorder, with few treatment options. IBS affects 10%-20% of the population; as many as 58% of patients have constipation-predominant IBS (IBS-C). We evaluated efficacy and safety of a standardized, specifically formulated Chinese herbal medicine (CHM) preparation in treatment of patients with IBS-C.METHODS: We performed a double-blind trial of 125 patients with IBS-C (according to Rome III criteria), who were recruited from 13 medical centers or clinics in Australia from July 2009 through February 2012. Patients were randomly assigned to groups given a standardized extract of 7 selected CHM ingredients (n = 61) or placebo (controls, n = 64) for 8 weeks (5 capsules, twice daily). Subjects were then followed for 16 weeks. Chemical definition, standardization, and stability testing of the formulation were completed. Subjects completed a self-administered, validated binary questionnaire of global symptom improvement at weeks 2, 4, 8, and 16 (primary outcome). Secondary outcomes included results from the self-administered IBS Symptom Severity Scale and the Bristol Stool Form Scale (BSFS), which were completed at weeks 4, 8, and 16.RESULTS: There was statistically and clinically significant (per protocol analyses) improvement among subjects who received CHM (n = 50) vs controls (n = 58) for 8 weeks. A greater proportion of subjects receiving CHM reported adequate relief (P = .010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS Symptom Severity Scale scores (P < .001), reduced straining during defecation (P = .002), and a significant decrease in hard lumpy stools (P = .031). The CHM group also had increased stool consistency, which was based on the Bristol Stool Form Scale (week 8, P < .001). There was no statistically significant difference between groups in abdominal pain at week 8 (P = .692). The CHM was well-tolerated.CONCLUSIONS: In a prospective, controlled study, CHM reduced symptoms of IBS-C, increased bowel satisfaction and stool consistency, and reduced straining and hard lumpy stools, compared with placebo.