Integrity of Active Components of Botanical Products Used in Complementary and Alternative Medicine

Abstract

TotheEditors:TheEditorialbyDrChan, whichaccompanied the randomized trial of use of Hypericum perforatum (St John’s wort)forattention-deficit/hyperactivitydisorderinchildrenand adolescentsbyDrWeberandcolleagues, summarizedtheneed for rigorous researchoncomplementaryandalternativemedicine(CAM)interventions. Itprovidedinsights intosomeof the challenges in performing high-quality CAM research. An additional challenge in studies of herbal remedies, which was well documented in the study by Weber et al but not emphasized in the Editorial, is the importance of the integrity and stability of biologically active components of herbal products. The study by Weber et al documented only at the end of the trial the oxidative degradation of the investigational product over time, such that the dose delivered during some portion of the study was less than half of the target dose. The article also acknowledged the challenge, encountered in studies of many herbal remedies, of identifying the optimal components for standardizing the preparation. Such issues raise concern about the generalizability of the results. The National Institutes of Health (NIH) National Center for Complementary and Alternative Medicine (NCCAM) has established a policy regarding biologically active agents used in all studies that it funds. Although the study by Weber et al preceded the establishment of this policy, its results highlight the need for investigators to document product stability over the course of the study. The center now requires that detailed information regarding the composition and integrity of botanical products, as well as plans to assess stability, be provided for evaluation and approval by a group of independent technical experts prior to funding. The NIH Office of Dietary Supplements (ODS) endorses this approach to the characterization and integrity of products used in research. The ODS has developed its own program to enhance the availability of tools such as methods and reference materials to support this work.