Trans-atlantic data harmonization in the classification of medicines and dietary supplements: a challenge for epidemiologic study and clinical research.

OBJECTIVES: As international scientific collaboration increases, there is a growing requirement for research data to be comparable among countries. Despite the importance of medication and dietary supplement data in research, there are no international standards for the collection and storage of these data. In the absence of such standards, we needed to adopt a strategy for classification and coding of medications and dietary supplements to meet demands of our multi-national study. METHODS: Given the inter-country variations in nomenclature that characterize prescription, over-the-counter (OTC) medications, traditional herbal medicines, and dietary supplements, we adopted RxNorm as a data standard for medication data, and developed an independent system that extends this standard and allows for flexible and scalable data collection for dietary supplements. RESULTS: RxNorm was implemented in May 2005 and as of July 2006, coverage has been 99%, at the level of active ingredients, of all the medications reported in our study. Development of a dietary supplement database began in August 2005, and has thus far coded some 1200 dietary supplements and 650 infant formula products and forms from the four countries in our study. CONCLUSION: The methods we have used to collect, store, and manage medication and dietary supplement data serve as interim solutions until international standards are developed. It is hoped that such standards will ultimately emerge, and that our strategy and data model will be of value in other research environments in the immediate future.

Medications as adjunct therapy for weight loss: approved and off-label agents in use.

Although a nutritionally balanced, energy-controlled diet and regular exercise form the cornerstone of weight management, supporting therapies may include antiobesity medications when a clinician determines that pharmacologic assistance could contribute to treatment success. The US Food and Drug Administration has approved certain medications for helping achieve weight loss in patients with obesity or overweight who have comorbidities. However, some clinicians prescribe medications not approved for weight loss for this purpose. Evidence from clinical trials indicates that weight loss resulting from the use of many of these off-label pharmaceutical agents is modest, but in a range that correlates with favorable modification of cardiovascular risk factors, and significant when compared with placebo plus diet and lifestyle modification. Clinical trials also demonstrate a slight but significant effect in the weight-maintenance phases following weight loss. Pharmacotherapy alone, without behavior modification, is not effective; patients who respond to medication typically regain weight when the drug is discontinued. The fact that many weight-loss medications are sold over the Internet without a prescription suggests that they are being used without medical supervision. The purpose of this review is to present evidence for and against the obesity medications currently used in clinical practice, and the possible role for these agents in a person's overall weight loss plan.

Green tea polyphenols and cancer chemoprevention: multiple mechanisms and endpoints for phase II trials.

Among the numerous polyphenols isolated from green tea, the catechin EGCG predominates and is the target of anticancer research. But studies suggest that EGCG and other catechins are poorly absorbed and undergo substantial biotransformation to species that include glucuronides, sulfates, and methylated compounds. Numerous studies relate the antioxidant properties of the catechins with anticancer effects, but recent research proposes other mechanisms of action, including those involving methyl transfers that are subject to allelic variability in the enzyme catechol O-methyl transferase. However, preclinical research is promising and EGCG appears to be ready for further study in phase II and III trials.

Use of complementary/integrative nutritional therapies during cancer treatment: implications in clinical practice.

BACKGROUND: The objectives of this study were to determine the prevalence and characterize the use of complementary/integrative nutritional therapies (CINTs) by patients during cancer treatment. METHODS: This retrospective review used data collected as a part of standard clinical care provided by the registered clinical dietitians and included nutritional history, demographic variables, anthropometrics, prevalence of use, and the specific integrative nutritional therapies used by these patients during cancer treatment. RESULTS: Twenty-nine percent of 820 patients reported use of CINTs not prescribed by their physician. Caucasians and patients over age 60 were the principal users of CINTs during treatment. Modular vitamins were the most frequently reported additive (86.9%), followed by botanicals/biologics (43.8%) and mineral supplements (28.6%). CONCLUSIONS: A considerable proportion of cancer patients use unproven CINTs during cancer treatment. The health professional should become more aware of the complementary/integrative therapies that their patients are using during cancer treatment.