Maddern G J, Kiroff G K, Leppard P I, Jamieson G G
J Clin Gastroenterol. 1986 Apr;8(2):135-40.
A double-blind crossover study was conducted of two gastric prokinetic drugs in 23 patients with gastroesophageal reflux. Patients were divided into two groups on the basis of a dual-isotope mixed-meal study of their gastric emptying (GE). Group I had normal GE and group II delayed GE. Nine gastrointestinal symptoms were assessed for frequency and severity before treatment. The trial had three 1-month treatment periods using metoclopramide 10 mg q.i.d., domperidone 20 mg q.i.d., or placebo on a random basis. Symptoms were reassessed at the end of each month. Taken as a whole, the group showed a significant symptomatic response in all three treatment periods (p less than 0.0001), but patients with delayed or normal GE did not differ significantly in their symptomatic response. Eleven patients complained of side effects with metoclopramide and three stopped therapy before the 1-month course was completed. Two patients described side effects with domperidone, including one woman with galactorrhea after 36 h of treatment. Three patients on placebo also complained of important side effects. We conclude that a significant placebo effect is present in the treatment of gastroesophageal reflux. No significant difference was demonstrated in symptomatic improvement between placebo, domperidone, and metoclopramide in this study.
对23例胃食管反流患者进行了两种胃动力药物的双盲交叉研究。根据双同位素混合餐胃排空(GE)研究将患者分为两组。第一组胃排空正常,第二组胃排空延迟。治疗前评估了9种胃肠道症状的频率和严重程度。试验包括三个1个月的治疗期,随机使用甲氧氯普胺10毫克每日4次、多潘立酮20毫克每日4次或安慰剂。每个月末重新评估症状。总体而言,该组在所有三个治疗期均显示出显著的症状改善(p<0.0001),但胃排空延迟或正常的患者在症状反应上无显著差异。11例患者抱怨甲氧氯普胺有副作用,3例在1个月疗程结束前停止治疗。2例患者描述了多潘立酮的副作用,其中1名女性在治疗36小时后出现溢乳。3例服用安慰剂的患者也抱怨有重要副作用。我们得出结论,胃食管反流治疗中存在显著的安慰剂效应。本研究中,安慰剂、多潘立酮和甲氧氯普胺在症状改善方面未显示出显著差异。