Longstreth G F, Fox D D, Youkeles L, Forsythe A B, Wolochow D A
Ann Intern Med. 1981 Jul;95(1):53-6. doi: 10.7326/0003-4819-95-1-53.
A randomized, double-blind trial of a psyllium preparation was initiated in 77 patients with painful irritable bowel syndrome. Sixty-patients finished and submitted symptom data for 8 weeks while taking placebo (n = 34) or psyllium (n = 26). Increase in normal stools and decrease in pain severity (p less than 0.05) occurred equally in both groups. Subjective improvement was reported by 24 of 34 patients on placebo and 20 or 26 on psyllium (p greater than 0.05). Five symptom variables were significantly correlated (p less than 0.05) with patient's subjective global assessment (R = 0.64). Discriminant analysis of Minnesota Multiphasic Personality Inventory variables yielded overall rates of correct prediction of 66.1% for whether patients got "much better" and 77.9% for whether they voluntarily dropped from the study. A major placebo effect occurs in patients with painful irritable bowel syndrome and is probably responsible for the efficacy of psyllium. Personality factors influence the magnitude of therapeutic response and whether patients discontinue treatment within 8 weeks.
一项关于车前子制剂的随机双盲试验在77例伴有疼痛的肠易激综合征患者中展开。60例患者完成了试验，并在服用安慰剂（n = 34）或车前子（n = 26）的8周内提交了症状数据。两组患者正常大便次数增加和疼痛严重程度降低（p < 0.05）的情况相同。服用安慰剂的34例患者中有24例报告主观症状改善，服用车前子的26例患者中有20例报告主观症状改善（p > 0.05）。五个症状变量与患者的主观整体评估显著相关（p < 0.05）（R = 0.64）。对明尼苏达多相人格调查表变量进行判别分析得出，对于患者是否“明显好转”的正确预测总体率为66.1%，对于患者是否自愿退出研究的正确预测总体率为77.9%。在伴有疼痛的肠易激综合征患者中存在显著的安慰剂效应，这可能是车前子发挥疗效的原因。人格因素影响治疗反应的程度以及患者是否在8周内停止治疗。
