Khurmi N S, Bowles M J, Kohli R S, Raftery E B
Am J Cardiol. 1986 Apr 15;57(11):907-11. doi: 10.1016/0002-9149(86)90728-9.
The effects of placebo were studied in 150 patients (135 men, 15 women) aged 42 to 75 years with stable exertional angina pectoris, using multistage graded exercise testing. Treadmill exercise, using on-line computer analysis of the electrocardiogram, was performed after a basal period, during which time the patients had no treatment for 2 weeks, and after 2 weeks of placebo therapy. Mean exercise time during no treatment was 6.0 +/- 0.2 minutes and during placebo was 6.1 +/- 0.2 minutes (difference not significant). Similarly, time to development of 1 mm of ST-segment depression of 4.0 +/- 0.2 minutes without treatment was 4.1 +/- 0.2 minutes after 2 weeks of placebo therapy (difference not significant). Placebo failed to show any effect on rest or maximal heart rate or on maximal ST-segment depression. It also failed to increase exercise tolerance or to improve other objective indexes of effort-induced myocardial ischemia in both single-and double-blind protocols in patients with stable exertional angina pectoris. Therefore, placebo control of antianginal drug trials that use exercise testing for evaluation of effect is unnecessary and can be omitted.
采用多级运动试验，对150例年龄在42至75岁之间、患有稳定型劳力性心绞痛的患者（135名男性，15名女性）进行了安慰剂效应研究。在基础期后，使用在线计算机心电图分析进行跑步机运动，基础期患者2周未接受治疗，安慰剂治疗2周后同样进行运动。未治疗期间平均运动时间为6.0±0.2分钟，安慰剂治疗期间为6.1±0.2分钟（差异不显著）。同样，未治疗时出现1毫米ST段压低的时间为4.0±0.2分钟，安慰剂治疗2周后为4.1±0.2分钟（差异不显著）。安慰剂对静息心率或最大心率以及最大ST段压低均无任何影响。在稳定型劳力性心绞痛患者的单盲和双盲试验方案中，安慰剂也未能提高运动耐量或改善劳力性心肌缺血的其他客观指标。因此，在使用运动试验评估疗效的抗心绞痛药物试验中，无需进行安慰剂对照，可予以省略。
