Evaluating treatments for Ménière's disease: controversies surrounding placebo control.

Although double-blind experimental designs are considered the gold standard for documenting treatment effectiveness, many treatments for Ménière's disease have not been evaluated using this methodology. Particularly with a disease characterized by exacerbation and remission, carefully controlled, long-term studies are required. The nature of the placebo effect is described in this article, and the concept of debonafide effect introduced. Ideally, patients should be given treatments supported by evidence-based medicine that have the lowest possible risk of side effects. However, risk minimization may dictate using treatments that have not been proven effective and may evoke debonafide effects.