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Editor's Correspondence
November 13, 2000

Placebo-Controlled Trials Are Unethical in Clinical Hypertension Research—Reply

Arch Intern Med. 2000;160(20):3168-3169. doi:

In reply

We thank Scott D. Halpern, BS, and Jason H. T. Karlawish, MD, for their interest in our article. Their first comment, however, seems to be based on a misunderstanding of the original study1 designed in 1984 and published in 1993 for the purpose of examining the efficacy of representatives of 6 antihypertensive drug classes and placebo in prospectively defined age-by-race groups. Elaborate safety rules were designed and monitored so that patients whose blood pressure was too high—whether while taking active drug or placebo—were removed from the trial by 2 independent sets of blood pressure criteria:

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