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Is a double-blind clinical trial really double-blind?

A report of doctors' medication guesses

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Summary

In a double-blind trial of meprobamate and placebo, carried out with 138 anxious neurotic outpatients, psychiatrists performed medication guesses after 2, 4, and 6 weeks of therapy. At the same time, physician and patient independently completed several improvement measures and the physician recorded the presence or absence of side reactions as spontaneously reported by the patient.

The results may be summarized as follows: a) Clinical improvement and side effects often enable the physician to make reliable medication guesses and thus break the double-blind design in drug trials. b) Clinical improvement seems to exert the most important influence in determining physician medication guesses, at least with anti-anxiety drugs in studies of only 4 to 6 weeks duration. c) The correlation between side effects and medication guesses increases with the duration of therapy.

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This research was supported by USPHS Grants MH-04731 and MH-04732. It was conducted at the Departments of Psychiatry of the Johns Hopkins University, the University of Pennsylvania and the Philadelphia General Hospital and the Psychopharmacology Research Branch of the National Institute of Mental Health.

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Rickels, K., Lipman, R.S., Fisher, S. et al. Is a double-blind clinical trial really double-blind?. Psychopharmacologia 16, 329–336 (1970). https://doi.org/10.1007/BF00404739

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  • DOI: https://doi.org/10.1007/BF00404739

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