Schindel L
Eur J Clin Pharmacol. 1978 May 31;13(3):231-5. doi: 10.1007/BF00609988.
Placebos have been used since about 1950 in evaluation and interpretation of drug efficacy, especially of new drugs, and in comparison with existing compounds to establish their clinical therapeutic value. There are a number of problems connected with use of an "inert nothing" the informed consent, which is required in a human experiment, the doctor's consciousness of deceitful behaviour, the potential risk for the patient and the doctor, the high effect rate of placebos (+/- 35%), unexpected side-effects, dependency of patients on placebos, discovery by the patient of the placebo treatment, factors independent of the medication, such as the doctor's bias, the nurses influence, the significance of colour, the inconsistency of placebo-reactor or non-reactor types and the genetic state of the patient, as well as the problems associated with a double blind test, which can hardly be used when a patient has previously received a medicine, such as morphine, with its euphoric effect, and the colour change produced in urine by drugs like rifampicin or riboflavin. Only a well-trained and experienced clinical observer should employ a placebo in establishing the therapeutic value of drugs whilst avoiding undesirable pitfalls.
自1950年左右以来,安慰剂就被用于药物疗效的评估和解释,尤其是新药的疗效评估,并与现有药物进行比较以确定其临床治疗价值。使用“无活性物质”存在诸多问题,如人体实验所需的知情同意、医生对欺骗行为的认知、对患者和医生的潜在风险、安慰剂的高有效率(±35%)、意外副作用、患者对安慰剂的依赖、患者发现接受了安慰剂治疗、与药物无关的因素(如医生的偏见、护士的影响、颜色的意义、安慰剂反应者或无反应者类型的不一致以及患者的基因状态),以及双盲试验相关的问题(当患者先前接受过如吗啡这种有欣快作用的药物,或利福平或核黄素等药物导致尿液颜色改变时,双盲试验很难实施)。只有训练有素且经验丰富的临床观察者在确定药物治疗价值时才可使用安慰剂,同时避免不良陷阱。