Product Quality for Dietary Supplement Research: Resources for Authors
The Office of Dietary Supplements has compiled this list of valuable resources for authors and editors working in the area of natural products research.
Suggested Guidelines for Articles about Botanical Dietary Supplements
This commentary authored by ODS's Christine Swanson, Ph.D., in The American Journal for Clinical Nutrition asserts that the standards for research evaluation for botanicals and other dietary supplements should be held to the same rigorous standards as other test materials. Dr. Swanson addresses the need for establishing criteria for the identification and characterization of botanical preparations used in nutrition research.
Swanson CA. Suggested guidelines for articles about botanical dietary supplements. Am J Clin Nutr. 2002 Jan;75(1):8-10.
NIH Guidelines for Studies of Bioactives & Natural Products
The National Center for Complementary and Alternative Medicine (NCCAM) at the NIH has developed guidelines for the design and conduct of experiments that use bioactive constituents or natural products for all investigators seeking funding from the Center. An extensive array of information is provided on the NCCAM web site.
Presentation Tips for Natural Products Investigations (PDF)
The Journal of Natural Products in conjunction with the American Chemical Society periodically publishes "Preparation and Submission of Manuscripts" for investigators working in the field of natural products. This publication provides useful information on how to present the specific details about instruments used, sources of specialized chemicals and natural products and related experimental details that should be incorporated into a manuscript.
American Chemical Society. Preparation and Submission of Manuscripts. J Nat Prod. 2006 Jul;69(1):10A-15A.
Herbal Medicine Trial Checklist
CONSORT (Consolidated Standards of Reporting Trials) has been extended to trials with herbal interventions. To improve the reporting of randomized controlled trials using herbal medicine interventions, members of the CONSORT Group elaborated on the original 22-item CONSORT checklist with nine additional items specifically for randomized controlled trials of herbal medicines. This consensus statement published in the Annals of Internal Medicine is an informative reference for authors and journal editors.
Gagnier JJ, Boon H, et al. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann Intern Med. 2006 Mar 7;144(5):364-7.
Quality Control Issues for Herbal Supplement Trials
This review in The American Journal of Medicine provides information on quality-control issues that warrant attention prior to conducting clinical trials in herbal supplements. In an effort to examine the extent of inadequate characterization of popular herbal products that have been used in clinical studies, investigators at Kaiser Permanente, Tufts University School of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School identified 81 randomized controlled trials using herbals products and evaluated the level of documented product characterization.
Wolsko PM, Solondz DK, et al. Lack of herbal supplement characterization in published randomized controlled trials. Am J Med. 2005 Oct;118(10):1087-93.
This document provides guidance for collecting, handling, and storing voucher plant specimens. Voucher specimens are botanical reference materials that are associated with specific batches of plant material and serve to document the authenticity of the bulk materials. Proper documentation of the original botanical source is a critical part of developing any standardized dietary supplement or herbal medicine used in research or commercially.
Hildreth J, Hrabeta-Robinson E, Applequist W, et al. Standard operating procedure for the collection and preparation of voucher plant specimens for use in the nutraceutical industry. Anal Bioanal Chem. 2007 Sep;389(1):13-7.
Establishing botanical identity is a key step in the scientific study of medicinal plants. This paper examines common taxonomic problems relevant to medicinal plant research and provides a basic guide to plant taxonomy for medicinal plant researchers. In addition to discussing voucher specimens, plant identification, and botanical nomenclature, it cites references and other resources that may be useful to researchers.
Bennett, BC, Balick MJ. Phytomedicine 101: Plant taxonomy for preclinical and clinical medicinal plant researchers. Journal of the Society for Integrative Oncology 2008 Fall;6(4):150-157.