Rasmussen M H, Andersen T, Breum L, Gøtzsche P C, Hilsted J
Department of Endocrinology, Hvidovre University Hospital, Denmark.
BMJ. 1993 Apr 24;306(6885):1093-6. doi: 10.1136/bmj.306.6885.1093.
To study the effect of cimetidine suspension compared with placebo suspension on weight loss in moderately obese patients taking a 5 MJ/day diet supplemented with dietary fibre. To determine the relation between the effectiveness of the blinding and weight loss.
Randomised double blind study with an eight week parallel group phase and a subsequent eight week crossover or continuation phase.
Outpatient clinic.
60 patients (51 women) aged 18-60.
Weight loss.
After eight weeks of treatment the mean weight loss in the cimetidine group (5.7 kg) was similar to that of the placebo group (5.9 kg; p = 0.78, 95% confidence interval -2.0 to 1.5 kg). Body mass index, waist and hip measurements, waist-hip ratio, and systolic and diastolic blood pressures decreased similarly in the two groups. No association was found between weight loss and the patients' ability to guess if they were being given drug or placebo. Correct guesses of current drug were more prevalent than expected by chance (25/37 correct, p = 0.05 for the parallel group phase; 26/30, p = 0.0001 for the crossover phase).
Cimetidine had no effect on weight loss in moderately obese patients. The study underlines the potential problem that blinding of patients to treatment can be compromised.
研究西咪替丁混悬液与安慰剂混悬液对摄入含膳食纤维的5兆焦耳/天饮食的中度肥胖患者体重减轻的影响。确定盲法效果与体重减轻之间的关系。
随机双盲研究,包括为期8周的平行组阶段以及随后为期8周的交叉或延续阶段。
门诊诊所。
60名年龄在18至60岁之间的患者(51名女性)。
体重减轻。
治疗8周后,西咪替丁组的平均体重减轻(5.7千克)与安慰剂组(5.9千克;p = 0.78,95%置信区间为-2.0至1.5千克)相似。两组的体重指数、腰围和臀围测量值、腰臀比以及收缩压和舒张压下降情况相似。未发现体重减轻与患者猜测自己服用的是药物还是安慰剂的能力之间存在关联。正确猜出当前服用药物的情况比随机预期更为普遍(平行组阶段为25/37正确,p = 0.05;交叉阶段为26/30,p = 0.0001)。
西咪替丁对中度肥胖患者的体重减轻没有影响。该研究强调了患者对治疗的盲法可能受到损害这一潜在问题。