A Randomized, Controlled Exploratory Study of Clonidine in Diarrhea-Predominant Irritable Bowel Syndrome
A Randomized, Controlled Exploratory Study of Clonidine in Diarrhea-Predominant Irritable Bowel Syndrome
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DOI：
10.1053/cgh.2003.50019
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发表时间：
2003-03-01
影响因子：
12.6
通讯作者：
Zinsmeister, Alan R.
中科院分区：
文献类型：
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作者：
Camilleri, Michael;Kim, Doe-Young;Zinsmeister, Alan R.
背景和目标：本研究的目的是在一项双盲、随机、平行组、安慰剂对照试验中评价α-2肾上腺素受体激动剂可乐定治疗以结肠炎为主的肠易激综合征（D-IBS）患者的疗效和耐受性。方法：2周的导入期评估基线症状。患者接受0.05、0.1或0.2 mg可乐定或安慰剂，每天两次，持续4周。我们通过每周一次的问题和每日日记的粪便参数来评估IBS的满意缓解。满意的缓解和整体肠功能是主要终点。次要终点是大便频率、粘稠度和排便难易程度;肠道转运;空腹和餐后胃容量。分析遵循意向治疗原则。结果：44例D-IBS患者参与;有4例治疗相关的脱落：0.2 mg可乐定组2/2例，0.05 mg可乐定组2/12例。安慰剂组、可乐定0.05 mg组和可乐定0.1 mg组IBS满意缓解的比例分别为0.46、0.42和0.67。可乐定0.1 mg，每日2次治疗后，缓解持续4周，肠功能障碍（大便变硬，大便更容易通过[P < 0.05]）减轻。可乐定并没有显著改变胃肠道传输或胃容量。嗜睡、头晕和口干是0.1 mg剂量最常见的不良事件;不良反应的严重程度在治疗第一周后消退。一项试验复制20%或更多的反应与可乐定将需要95例每treatment arm. Conclusions：可乐定，0.1毫克，每天两次，4周，缓解肠功能障碍，并出现有希望的缓解D-IBS，这些影响是不相关的运输显着改变。
Background & Aims: The aim of this study was to evaluate the efficacy and tolerability of the alpha-2 adreno-receptor agonist, clonidine, in patients with diarrhea-predominant irritable bowel syndrome (D-IBS) in a double-blind, randomized, parallel-group, placebo-controlled trial. Methods: A 2-week run-in evaluated baseline symptoms. Patients received 0.05, 0.1, or 0.2 mg clonidine or placebo twice a day for 4 weeks. We evaluated satisfactory relief of IBS by weekly question and stool parameters with a daily diary. Satisfactory relief and overall bowel function were primary end points. Secondary end points were stool frequency, consistency, and ease of passage; gut transit; and fasting and post-prandial gastric volumes. Analysis followed intention-to-treat principles. Results: Forty-four D-IBS patients participated; there were 4 treatment-related dropouts: 2/2 in the 0.2-mg and 2/12 in the 0.05-mg clonidine groups. Proportion with satisfactory relief of IBS was 0.46, 0.42, and 0.67 with placebo, 0.05 mg, and 0.1 mg clonidine, respectively. Relief was sustained through 4 weeks of treatment, and bowel dysfunction (firmer stools and easier stool passage [P < 0.05]) was reduced with clonidine, 0.1 mg twice a day. Clonidine did not significantly alter gastrointestinal transit or gastric volumes. Drowsiness, dizziness, and dry mouth were the most common adverse events with the 0.1-mg dose; severity of adverse effects subsided after the first week of treatment. A trial to replicate 20% or more responders with clonidine will require 95 patients per treatment arm. Conclusions: Clonidine, 0.1 mg twice a day for 4 weeks, relieves bowel dysfunction and appears promising for relief of D-IBS; these effects are unassociated with significant alterations in transit.