Limitations of the Double-Blind Pharmaceutical Study:

This paper examines the limitations of the double-blind pharmaceutical study in medical research. These areas are often neglected. First, common difficulties are discussed. These include lack of appropriate demographic controls including cigarettes, alcohol, caffeine and drug interactions. Additionally, not eliciting side-effects and therapeutic effects may occur because the measuring instruments are insufficient. Additionally, insufficient duration of the study may lead to inappropriate interpretations of efficacy or lack of efficacy, insufficient subject size may produce insufficient power, recruitment difficulties may produce distorted populations, crossover studies may result in lingering effects and withdrawal confounding factors, and statistical aberrations may lead to the wrong conclusions but particularly certain drugs are not necessarily suitable for such methodologies because of their special variable dose requirements. All these may lead to Type 1 and 2 errors in analysis. The subtle difficulties of blind studies are then examined: The experimenter effect; the triple-blind study; intelligent prescription; the distortions of published versus non-published studies; and adjunctive medication. These factors all exemplify the challenge of appropriate methodology that can be more adequately interpreted.