WHI clinical trial revisit: imprecise scientific methodology disqualifies the study's outcomes

Am J Obstet Gynecol. 2005 Nov;193(5):1599-604; discussion 1605-6. doi: 10.1016/j.ajog.2005.07.085.

Abstract

We analyzed The Women's Health Initiative (WHI) Study because it had a significant impact on clinical practice, both nationally and internationally. However, despite the widespread public and professional awareness of the results, an independent, nonbiased analysis of the quality of the methodology of the study has not been available. We find the study design and its execution question the validity of the results, making it difficult to apply the WHI results to healthy postmenopausal women, different ethnic groups, or as general postmenopausal prevention.

MeSH terms

  • Aged
  • Drug Combinations
  • Estrogen Replacement Therapy*
  • Estrogens, Conjugated (USP) / therapeutic use
  • Female
  • Humans
  • Medroxyprogesterone Acetate / therapeutic use
  • Middle Aged
  • Postmenopause
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards*
  • Research Design / standards*

Substances

  • Drug Combinations
  • Estrogens, Conjugated (USP)
  • Prempro
  • Medroxyprogesterone Acetate