BLINDING, UNBLINDING, AND THE PLACEBO-EFFECT - AN ANALYSIS OF PATIENTS GUESSES OF TREATMENT ASSIGNMENT IN A DOUBLE-BLIND CLINICAL-TRIAL
BLINDING, UNBLINDING, AND THE PLACEBO-EFFECT - AN ANALYSIS OF PATIENTS GUESSES OF TREATMENT ASSIGNMENT IN A DOUBLE-BLIND CLINICAL-TRIAL
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DOI：
10.1038/clpt.1987.26
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发表时间：
1987-03-01
影响因子：
6.7
通讯作者：
COX, C
中科院分区：
文献类型：
--
作者：
MOSCUCCI, M;BYRNE, L;COX, C
在渗透释放口服系统苯丙醇胺 (PPA) 与安慰剂治疗轻度肥胖症的双盲临床试验结束时，我们进行了一份调查问卷，以评估患者失明的维持情况。 74% 的安慰剂参与者和 43% 的 PPA 参与者正确猜测了他们的治疗方法。食欲控制是猜测 PPA 最常见的依据，即使是安慰剂参与者也是如此。缺乏药物不良反应是猜测安慰剂最常见的依据，即使是 PPA 参与者也是如此。与接受 PPA 或安慰剂并猜测安慰剂的参与者相比，接受 PPA 或安慰剂并猜测 PPA 的参与者体重减轻更多，饮食困难更少，并且药物不良反应更多。虽然 PPA 组可能保持失明，但安慰剂组似乎至少在研究结束时是未失明的。这些结果表明，在双盲研究中，药物不良反应的结果或发生率的差异可能充当非盲因素。
We administered a questionnaire to assess maintenance of patients'' blindness at the end of a double-blind clinical trial of Osmotic Release Oral System phenylpropanolamine (PPA) vs. placebo in mild obesity. Seventy-four percent of placebo participants and 43% of PPA participants guessed their treatment correctly. Appetite control was the most frequently reported basis for guessing PPA, even by placebo participants. Lack of adverse drug reactions was the most frequently reported basis for guessing placebo, even by PPA participants. Participants receiving either PPA or placebo and guessing PPA lost more weight, had less diet difficulty, and had more adverse drug reactions than had participants receiving either PPA or placebo and guessing placebo. Although blindness was probably maintained in the PPA group, the placebo group seems to have been, at least at the study''s end, unblinded. These results suggest that in double-blind studies, differences in outcome or incidence of adverse drug reactions may act as unblinding factors.