Prophylactic therapy of angina pectoris with organic nitrates : relationship of drug efficacy and clinical experimental design Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/79408116r

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  • The objective of this study was to examine the published clinical literature on the prophylactic therapy of angina pectoris with the organic nitrates in order to determine the relationship between experimental design and the conclusion of efficacy reported by the investigator. A search for articles reporting original clinical investigations on immediate and long term prophylactic therapy of angina pectoris with erythrityl tetranitrate, glyceryl trinitrate, isosorbide dinitrate or pentaerythritol tetranitrate yielded 59 articles that were published in the period of 1952 to 1972. The design elements of an adequate and well controlled clinical trial include a method of minimizing bias on the part of the observer and patient (blinding procedures), appropriate control procedures, statistical analysis and appropriate treatment allocation procedures. The proportion of articles concluding effective therapy with the organic nitrates was significantly greater among the investigations that failed to report any of these generally accepted design elements. Clinical investigations finding the organic nitrates as effective prophylactic agents outnumbered the investigations reporting ineffective therapy by almost three to one. Among the investigations that included the generally accepted design elements of an adequate and well controlled clinical trial, the reports of ineffective prophylactic therapy outnumbered the reports of effective therapy by three to two. Although simply including these design elements will not necessarily validate the conclusions reached by the investigator, their importance is dramatically illustrated in the present study. Because of these demonstrated relationships, any consideration of efficacy of the organic nitrates in the prophylactic therapy of angina pectoris must be weighed against considerations of experimental design in a given clinical trial.
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