Powerful placebo: the dark side of the randomised controlled trial.

hypnosis, where the power of the imagination was accepted. 7 If there was a " medical " value for a placebo it was as an occasional diagnostic tool to separate imaginary " psychological " symptoms from real problems. 8 In 1945, an influential article stated that the placebo was a valuable device " to smooth [the patient's] path " , which " cannot harm and may comfort " patients, especially the " ignorant. .. disappointed and displeased. .. hopeless, [and] incurable case[s] ". 9 A 1954 Lancet article, entitled " The Humble Humbug " , depicted the swan song on this old-fashioned understanding of the placebo; " a means of reinforcing a patient's confidence in his recovery, when the diagnosis is undoubted and no more effective treatment is possible; that for some unintelligent or inadequate patients life is made easier by a bottle of medicine to comfort their ego; that to refuse a placebo to a dying incurable patient may be simply cruel; and that to decline to humour an elderly 'chronic' brought up on the bottle is hardly within the bounds of possibility ". In 1955, the modern biomedical concept of the placebo makes its first definitive appearance with the publication of Henry Beecher's (1904–1976), " The Powerful Placebo " in the Journal of the American Medical Association (JAMA) 11 Beecher, a distinguished medical researcher at The placebo went through a dramatic metamorphosis in the years after World War II as the double-blinded randomised controlled trial (RCT) developed. Until 1945 the placebo was a " morally " useful but innocuous management tool without curative or symptomatic consequences. By the time the double-blind randomised controlled trial took form and began to establish itself, around 1955, the placebo was imbued with powerful therapeutic effects and its ethical clinical use was more generally being questioned. In 10 years, the placebo changed from what was called the " humble humbug " to an entity with occult-like powers that could mimic potent drugs. It may be that efforts to bring the precision of science into the evaluation of efficacy with the RCT has its own form of confusion and darkness. When pre-World War II paternalistic ethics prevailed, informed consent was not a standard of care. 1 Physicians were generally comfortable with benevolent deception and a " polychromatic assortment of sugar pills " was routinely swallowed by patients. described the placebo's persuasiveness. He was " …