Toward Establishing Guidelines for Evaluating Cognitive Enhancement With Complementary and Alterative Medicines

Abstract

The growing use of complementary and alternative medications (CAM) for cognitive enhancement in both healthy elderly and patients with Alzheimer’s disease (AD) and other dementing disorders has led to rapidly growing literature with conflicting results. There are studies that suggest benefit from CAM in both the healthy elderly and dementing patients as well as studies that suggest no benefit for either group. Because of the lack of regulatory oversight (e.g., Food and Drug Administration [FDA], European Medicines Agency [EMeA]), there are currently no generally accepted guidelines to standardize the types of studies that are conducted. Due to the absence of guidelines that set standards for study design, outcomes, and analysis, it is difficult to compare studies with conflicting results. For example, Ginkgo biloba has been shown both to provide benefit and no benefit on cognition in both healthy elderly and patients with AD. Reconciling these divergent studies has been challenging because both sides often use divergent methodologies and designs and widely varying cognitive measures that may or may not be validated in the populations being studied. In this article, the authors suggest a roadmap for establishing guidelines for the evaluation of CAM in cognition. They then apply these guidelines to the conflicting literature on Ginkgo to determine whether they might help resolve the conflicting results.