BACKGROUND Managing chronic constipation is challenging as patients frequently remain dissatisfied with laxative treatments. Novel studies using transabdominal electrical interferential therapy in children have shown benefit but there are inadequate adult studies. AIM To examine the effects of transabdominal interferential stimulation on bowel symptoms and quality of life in women with refractory constipation. METHODS In a single-blind, randomised, sham-controlled pilot study, women aged ≥18 years with refractory constipation were randomised to receive interferential stimulation (with crossing of electric currents) or a novel sham stimulation (with no crossing of currents) for 1 hour a day for 6 weeks. Primary outcome was the number of patients with ≥3 spontaneous bowel movements/week. Secondary endpoints included change in PAC-SYM (Patient Assessment of Constipation-SYMptoms), PAC-QOL (Patient Assessment of Constipation-Quality of Life) and an overall symptom severity score (measured at baseline, mid time point of stimulation, end of treatment and 3 months after cessation of treatment). RESULTS Interferential therapy (n = 17) met the primary outcome in 9(53%) compared with 2(12%) with sham therapy (n = 16) (P = 0.02). Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05). Laxative use more than halved in 66% with interferential therapy compared with 14% with sham therapy (P = 0.01). Significant improvements in symptom outcomes were maintained at 3 months. There were no treatment-related adverse effects. CONCLUSION Transabdominal interferential electrical stimulation is effective in reducing constipation in adult women. Three months after therapy, response is maintained and quality of life improved. Not allowing currents to cross intra-abdominally was an effective placebo. (Australianclinicaltrials.gov.au ACTRN12614000736640).

中文翻译：

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随机临床试验：功能性便秘妇女经腹干扰电刺激与假刺激。

背景技术由于患者经常对泻药治疗不满意，因此应对慢性便秘具有挑战性。在儿童中使用经腹电干扰疗法进行的新研究显示出了益处，但成人研究不足。目的探讨经腹干扰刺激对难治性便秘妇女肠道症状和生活质量的影响。方法在一项单盲，随机，假手术对照的先导研究中，将≥18岁难治性便秘的妇女随机接受干扰刺激（电流交叉）或新型假手术（电流不交叉）1次。每天一小时，持续6周。主要结局是每周自发排便次数≥3的患者人数。次要终点包括PAC-SYM（便秘患者症状评估），PAC-QOL（便秘患者生活质量评估）和总体症状严重程度评分（在基线，刺激中点，治疗结束时测量）的变化和停止治疗后3个月）。结果干预治疗（n = 17）达到主要结局的9例（53％），而假手术（n = 16）的2例（12％）达到了主要结果（P = 0.02）。干扰治疗导致PAC-SYM（P = 0.03）和总体症状评分（P = 0.05）降低。干扰疗法的轻泻剂使用率为66％，而假手术为14％（P = 0.01）。症状预后显着改善维持3个月。没有治疗相关的不良反应。结论经腹干扰性电刺激可有效减少成年女性的便秘。治疗后三个月，反应得以维持，生活质量得到改善。有效的安慰剂是不允许电流流过腹部。（Australianclinicaltrials.gov.au ACTRN12614000736640）。