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December 27, 2000

What Is the Best Evidence for Making Clinical Decisions?—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Executive Deputy EditorIndividualAuthor

JAMA. 2000;284(24):3127-3128. doi:10.1001/jama.284.24.3123

In Reply: Dr Shah suggests that systematic reviews of observational studies provide better evidence than single randomized trials. We disagree strongly. Shah's proposal would, for instance, rank a meta-analyses of observational studies of hormone replacement therapy1 (which suggested a 50% reduction in relative risk of coronary events) higher than the Heart and Estrogen/progestin Replacement Study (HERS) RCT,2 which found no effect of hormone replacement therapy for secondary prevention of coronary events. We would rank the HERS RCT higher and, pending further RCT evidence, would not recommend hormone replacement therapy to women to decrease their risk of cardiovascular events. When consistent biases exist in observational studies (such as the tendency for women with lower cardiovascular risk to receive hormone replacement therapy), a meta-analysis offers no protection.

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