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Comparing hormone therapy effects in two RCTs and two large observational studies that used similar methods for comprehensive data collection and outcome assessment
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Other responses

  • Published on:
    Differences between RCTs and observational studies of hormone therapy effects have not been definitely reconciled

    Rossouw et al. addressed only the comparisons of results from randomized controlled trials (RCTs) and observational studies (OSs). They did not consider analyses that compared outcomes of participants who had the same treatment but were in different studies. These analyses found that adjusting for the WHI risk factors was not sufficient to account for unmeasured risk differences between subjects in different studies. T...

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    Conflict of Interest:
    None declared.
  • Published on:
    Reconciling hormone therapy effects in RCTs and observational studies
    • Jacques E Rossouw, Medical Officer
    • Other Contributors:
      • Ross L Prentice, Garnet L Anderson, Andrea Z LaCroix, JoAnn E Manson

    Hartz et al1 analyzed the Women's Health Initiative (WHI) public use dataset in an attempt to reconcile certain divergent findings from clinical trials (CTs) of hormone therapy (HT) and observational studies (OS) primarily by extensive adjustment for confounders. Their conclusion that the WHI (and other observational studies) did not collect sufficient information to give reliable information about treatment effects appe...

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    Conflict of Interest:
    None declared.