安慰剂进入现代医学视野通常认为最初始于美国的H. K. Beecher医生。Beecher是一个二战战场麻醉师。在攻占意大利南部海滩战斗中，镇痛剂很快用完。当伤兵嚎叫着要镇痛剂时，万般无奈的护士告诉他现在给他注射的是强力镇痛剂，但实际注射的是盐水。让Beecher震惊的是，注射盐水后，伤兵居然真的停止了哀嚎，疼痛止住了。对这一情形印象深刻的Beecher战后回到美国哈佛，开始了一系列新的测试药物疗效的实验。1955年，他在《美国医学会杂志》（JAMA）上发表了著名的论文“The Powerful Placebo”（强力的安慰剂）,描述了数十个常规药物的效果其实来自安慰剂效应。他第一次指出吃药这个动作本身就有一定的治疗作用，只有强于安慰剂的药物作用才能认定为有效药物。此后，临床试验中，与安慰剂组对照成为开发新的药物或者疗法的不二规则。
但也有人认为安慰剂效应被夸大了。1997年，Kienle和Kiene分析了大量安慰剂的研究后，认为安慰剂组病人出现的症状缓解不是来自安慰剂效应，而是因为病程的自然缓解，症状的波动，附加的别的治疗，报告的偏差，病人为了取悦医生的礼貌汇报，诱导性的调查，或者仅仅是心理现象。2007年，Bausell发表论文说，病人的自然病程，以及在接受治疗期间病人会不自觉地改变生活行为方式，或者因为想要取悦医生而社交性地回答医生所期待的答案，都可能导致观察到的安慰剂效应被夸大。2001年，一项大型的大批量研究分析指出，与未治疗组比较，无论主观或者客观指标，安慰剂组并没有出现显著的不同。出现疗效的安慰剂研究一旦加大样本数量，效果就会减低，提示观察到的效果可能只是观察偏差。典型的案例是外科医生J. Bruce Moseley做的一个有名的安慰剂试验。他给10个膝关节炎病人的其中8个做了假手术，切开皮肤后就缝上，但告诉病人做的是正常手术。结果所有假手术患者6个月后都出现了缓解。因此Moseley认为安慰剂手术有效。但实际上，这些患者可能根本不需要手术也会自行缓解。
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