The Ethics of Placebo-Controlled Trials

Streiner, David L.

doi:10.1177/070674379504000401

Cited by 9 publications

(2 citation statements)

References 7 publications

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“…The role of placebo controls in research studies has been widely debated. 3,34,35 On one hand, the United States Food and Drug Administration, the World Health Organization, and other regulatory groups support the use of placebos in clinical trials. On the other hand, it has been argued that placebo-controlled trials for wellcharacterized disorders violate the Declaration of Helsinki on the use of human subjects, which states that all patients, including controls, should receive established treatment.…”

Section: Discussionmentioning

confidence: 99%

Tubefeeding and Mortality in Children With Severe Disabilities and Mental Retardation

et al. 1997

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We hypothesize that the increased mortality associated with tubefeeding may be attributable to a differential increase in pulmonary disease secondary to overly vigorous nutritional maintenance and subsequent aspiration after tube placement. For children with tracheostomy this risk may be reduced. If tracheostomy proves to be associated with a relatively more favorable outcome for tubefeeding, we hypothesize that it would reflect the benefits of tracheostomy in allowing access to the airway for suctioning and ventilation. Given the observed higher mortality rates among the less severely disabled children who are tubefed and the substantial costs associated with tubefeeding, a prospective, controlled study may be clinically indicated, ethically justifiable, and economically warranted.

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Section: Discussionmentioning

confidence: 99%

Tubefeeding and Mortality in Children With Severe Disabilities and Mental Retardation

et al. 1997

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“…D 'Agostino et al, 2003 ;Fleischhacker et al, 2003 ;Garattini & Bertele, 2009 ;Hasnain et al, 2018 ;Ovosi et al, 2017 ;Splawinski & Kuzniar, 2004 ;Streiner, 1995 ;Vieta & Cruz, 2012 ;Walsh et al, 2002 4. The growing placebo-effect does not negate the need for placebo-controlled trials (vs. only using active-controlled trials).…”

Section: Non-inferiority Trialsmentioning

confidence: 99%