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November 7, 2001

A Meta-analysis of Hormone Replacement Therapy for Fracture Prevention—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(17):2096-2097. doi:10.1001/jama.286.17.2091

In Reply: Dr Altman is correct about the differences between allocation concealment and double-blinding, which we, unfortunately, did not clearly differentiate. However, 18 of the 20 studies were placebo-controlled. In placebo-controlled trials it is unlikely that allocation is unconcealed. Only 1 of the remaining studies described the randomization process, which used sealed envelopes.1 Envelopes are often judged an "adequate" method of concealed allocation.2 However, envelopes can be tampered with, as demonstrated in a surgical trial in which 44% of patients allocated using envelopes had suspected spoiled randomization envelopes.3 Importantly, the RRs between placebo and nonplacebo trials were not materially different.

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