Paul S. Heckerling, MD
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Heckerling P.; Treating Controls in Unblinded Trials. Ann Intern Med. 2005;142:309. doi: 10.7326/0003-4819-142-4-200502150-00021
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Published: Ann Intern Med. 2005;142(4):309.
TO THE EDITOR:
In the study by Yardley and colleagues (1) on vestibular rehabilitation for patients with chronic dizziness, it is not clear what scientific information was gained by crossing controls over to vestibular training at 3 months. Efficacy could not be measured, since the intervention group was not crossed over to the control condition (nor could it be, given an inability to wash out the initial vestibular training). Maintenance of effect at 3 months was already measurable in the intervention group, so a similar 3-month period for controls would not add new information. And since vestibular training was not the standard of care, a “staggered-start” trial to measure adverse effects during a 3-month control window was not ethically mandated.
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