A Randomized, Controlled, Crossover Study of Sacral Nerve Stimulation for Irritable Bowel Syndrome
A Randomized, Controlled, Crossover Study of Sacral Nerve Stimulation for Irritable Bowel Syndrome
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DOI：
10.1097/sla.0000000000000559
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发表时间：
2014-07-01
影响因子：
9
通讯作者：
Krogh, Klaus
中科院分区：
文献类型：
--
作者：
Fassov, Janne L.;Lundby, Lilli;Krogh, Klaus
目的：通过一项随机、对照、交叉研究，探讨骶神经刺激是否可以减轻肠易激综合征 (IBS) 特异性症状。背景：IBS 影响全球 3% 至 22% 的人口，但大多数患者尽管接受治疗，但仍出现症状。方法：来自我们三级中心的患者患有腹泻为主或混合型 IBS，最低基线 IBS 症状评分（胃肠道综合征评定量表 -IBS 问卷）为永久植入前经皮神经评估时，40分至少减少30%。患者被随机分配 (1:1)，让刺激器打开或关闭 1 个月，然后再打开或关闭一个月。研究人员和患者并未获悉具体情况。通过肠道日记和经过验证的问卷来评估 IBS 特定症状和生活质量。主要终点是 IBS 特异性症状评分。结果：21 名患者被随机分组。每组有十人符合分析条件。 IBS 特异性症状评分在刺激期间显着降低：ON-OFF 组的中位差异为 12（范围，-22 至 44），OFF-ON 组的中位差异为 17.5（范围，-48 至 -1）（P = 0.0009）。 IBS 特定的生活质量评分在刺激期间显着改善：ON-OFF 组的中位差异为 16（范围，-24 至 69），OFF-ON 组的中位差异为 -42.5（范围，-77 至 0）（P = 0.0003）。 1 年随访时，IBS 特异性症状评分中位数（25；范围，13-65）显着低于基线（62；范围，45-80）（P = 0.0001）。 结论：骶神经刺激可显着减轻精选 IBS 患者的症状并提高生活质量。
Objective: To investigate whether sacral nerve stimulation reduces irritable bowel syndrome (IBS)-specific symptoms by a randomized, controlled, crossover study.Background: IBS affects 3% to 22% of the population worldwide, but most patients continue to have symptoms despite treatment.Methods: Patients included from our tertiary center had diarrhea-predominant or mixed IBS, with a minimum baseline IBS symptom score (Gastrointestinal Syndrome Rating Scale-IBS questionnaire) of 40 points reduced by a minimum of 30% during the percutaneous nerve evaluation before permanent implantation. Patients were randomized (1:1) to have the stimulator ON or OFF for 1 month and then the opposite for another month. Investigators and patients were not informed of the setting. IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires. Primary endpoint was the IBS-specific symptom score.Results: Twenty-one patients were randomized. Ten were eligible for analysis in each group. IBS-specific symptom scores were significantly reduced during stimulation: the median difference in the ON-OFF group was 12 (range, -22 to 44) and in the OFF-ON group-17.5 (range, -48 to -1) (P = 0.0009). IBS-specific quality-of-life scores improved significantly during stimulation: the median difference in the ON-OFF group was 16 (range, -24 to 69) and in the OFF-ON group -42.5 (range, -77 to 0) (P = 0.0003). At 1-year follow-up, the median IBS-specific symptom score (25; range, 13-65) was significantly lower than that at baseline (62; range, 45-80) (P = 0.0001).Conclusions: Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS.