Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Scand J Gastroenterol. 2024 Sep;59(9):1023-1034. doi: 10.1080/00365521.2024.2381694. Epub 2024 Jul 25.
Chronic diarrhea affects approximately 5% of the population. Opioids inhibit gastrointestinal motility, and opium tincture has shown anti-propulsive effects in healthy, but no controlled studies of its clinical efficacy exist. We aimed to investigate the anti-propulsive and central nervous system (CNS) effects of opium tincture in patients with chronic diarrhea.
The study was a randomized, double-blinded, placebo-controlled, cross-over trial in subjects with chronic diarrhea refractory to standard treatment. Participants received opium tincture or placebo during two intervention periods, each lasting seven days. Bowel movements were recorded daily, and gastrointestinal transit time was investigated with the wireless motility capsule system. Gastrointestinal symptoms, health-related quality of life, and CNS effects (pupil size, reaction time, memory, and general cognition) were also investigated, along with signs of addiction.
Eleven subjects (mean age: 45 ± 17 years, 46% males) with a median of 4.7 daily bowel movements were included. The number of daily bowel movements was reduced during opium tincture treatment to 2.3 ( = 0.045), but not placebo (3.0, = 0.09). Opium tincture prolonged the colonic transit time compared to placebo (17 h vs. 12 h, < 0.001). In both treatment arms, there were no changes in self-reported gastrointestinal symptoms, health-related quality of life, or CNS effects, and no indication of addiction was present.
Opium tincture induced anti-propulsive effects in patients with chronic diarrhea refractory to standard treatment. This indicates that opium tincture is a relevant treatment strategy for selected patients with chronic diarrhea. Moreover, no evidence of opioid-induced sedation or addiction was found. NCT05690321 (registered 2023-01-10).
慢性腹泻影响约 5%的人群。阿片类药物抑制胃肠动力，鸦片酊在健康人群中显示出抗推进作用，但尚无其临床疗效的对照研究。我们旨在研究鸦片酊在慢性腹泻患者中的抗推进和中枢神经系统（CNS）作用。
这是一项针对慢性腹泻且对标准治疗无反应的患者进行的随机、双盲、安慰剂对照、交叉试验。参与者在两个干预期内分别接受鸦片酊或安慰剂治疗，每个干预期持续七天。每天记录排便次数，使用无线动力胶囊系统研究胃肠道转运时间。还调查了胃肠道症状、健康相关生活质量以及 CNS 效应（瞳孔大小、反应时间、记忆和总体认知），并观察了成瘾迹象。
11 名患者（平均年龄：45±17 岁，46%为男性），每日排便中位数为 4.7 次。与安慰剂相比，鸦片酊治疗时每日排便次数减少至 2.3 次（=0.045），但安慰剂组为 3.0 次（=0.09）。与安慰剂相比，鸦片酊延长了结肠转运时间（17 小时比 12 小时，<0.001）。在两种治疗臂中，自我报告的胃肠道症状、健康相关生活质量或 CNS 效应均无变化，且无成瘾迹象。
在对标准治疗无反应的慢性腹泻患者中，鸦片酊诱导出抗推进作用。这表明鸦片酊是慢性腹泻患者的一种相关治疗策略。此外，未发现阿片类药物引起的镇静或成瘾的证据。NCT05690321（于 2023-01-10 注册）。
