United States Pharmacopoeia (www.usp.org). You’ll also want to purchase products from large, nationally known companies. These companies are more likely to incorporate good manufacturing practices and stringent quality assurance.
If you have questions about a product, you may want to contact the manufacturer directly. The manufacturer should be able to answer the following questions:
• Has your product been evaluated in scientific studies that have been published in reputable medical journals? If so, are you willing to share these studies? Or, is most of the product information the result of testimonials by people with diabetes who have used the product?
• Can you explain how the product works? Do you have scientific studies that verify the mechanism of action?
• Does your company conduct a chemical analysis of the active and inactive ingredients to verify that the product contains what it says on the label?
• Does the product break down and dissolve appropriately in the stomach?
• Does your company specify specific storage or stability instructions, such as what temperature to store the product, whether light may affect the product, or whether it should be stored in a dark place? Do you list an expiration date for the shelf life of the product?
• Do you specify any side effects or possible interactions with other supplements or prescription drugs or disease states? Do you specify which patients should not use the product?
Even when armed with these questions and the best intentions, consumers may find it difficult to evaluate the safety and efficacy of products. Unfortunately, many of the scientific studies done on dietary supplements are unreliable. For example, studies may include only small numbers of patients. Some scientists never examine the actual contents of the studied products, so their results could be unintentionally skewed. For these reasons and others, the Natural Standard, an independent group of scientists who evaluate complementary and alternative medicines, has given most dietary supplements for diabetes a grade “B” or lower in terms of efficacy.
In Part II, you’ll find summaries of the best studies done on each individual supplement, as well as tips for evaluating the results. Keep in mind that some supplements have been more rigorously studied than others. It’s always best to talk with you health care provider about questions regarding the efficacy and safety of product, rather than trying to troubleshoot on your own.
HOW MUCH SHOULD YOU TAKE?
The National Academy of Sciences provides information reference daily intake (RDI) for many—but not all—vitamins and minerals. Most other dietary supplements, such as herbs, do not have recommended daily allowances. In fact, the appropriate doses of many dietary supplements are unknown. In Part II, you’ll find the available information on recommended doses for individual supplements.
Some dietary supplements are sold in “packs” to people with diabetes. These packs may contain a handful of supplements marketed for improving diabetes. These products can make it difficult for patients to evaluate their responses to individual supplements. Instead of taking supplements together as they are packaged, take only one supplement at a time to determine your body’s response when beginning new products. However, if you wish to take a “pack,” then make sure you obtain it from a reputable manufacturer and discuss this with your doctor. Then the doctor may assess the impact on the control of your diabetes or other medical conditions.
TIPS FROM THE FDA
Because manufacturers may use deceptive marketing tactics to promote their products, the FDA has put together a number of helpful resources for evaluating products.
“How to Spot Health Fraud”
Web article available at www.fda.gov
This website warns against a single product that the manufacturers claim benefits a variety of unrelated diseases (i.e., difficulties ranging from menstrual problems to asthma to rheumatic complaints). It also suggests buyers be wary of evidence of benefit based on personal testimonials, claims of unusually rapid benefit, or use of meaningless phrases that may sound scientifically impressive to lay consumers but do not actually describe a beneficial medicinal effect.
“Tips for the Savvy Supplement User”
Web article available at www.cfsan.fda.gov
Includes basic points to consider, such as talking with a health care provider before using a supplement and broaching the issue that some supplements may interact with prescription or over-the-counter medicines or have untoward effects during surgery. It also provides information on how to report adverse effects of dietary supplements. Furthermore, it provides tips on searching the Internet for information on supplements, including pointers on how to find out who operates a product website, the purpose of the site, the information sources and references, and whether the information is current.
“Tips for Older Dietary Supplement Users”
Web article available at www.cfsan.fda.gov
Discusses potential risks, such as the danger of substitution of dietary supplements for conventional medications or consuming more than recommended amounts. It also advocates discussion of dietary supplement use with a health care provider. It provides a checklist of important considerations such as issues with side effects, drug interactions, and possible discontinuation before scheduled surgery.
Contacting the FDA to report an issue
The FDA encourages patients and their health care providers to report any adverse effects related to dietary supplements through the FDA’s MedWatch online at www.fda.gov/safety/medwatch/default.htm or by calling 1-800-FDA-1088.
A NOTE ON CLINICAL STUDIES
There is a lot of perplexing information regarding products. When deciding whether or not to use a particular supplement, it is important for you as a consumer to understand information about different clinical studies, especially since the media may not always accurately represent the information from studies. Many times, the reporting on clinical studies leaves out important details or fails to mention how the study was conducted. This means that results from poorly designed studies are sometimes given more credence than they deserve, and results from well-run trials may be cherry-picked for the most sensational tidbits.
In this book, each supplement or herb has information about different studies regarding the type of scientific evaluations that have been published. Thus, to better understand the significance of these studies, knowing some important definitions and terms is essential.
What are the characteristics of a good clinical study?
A clinical study is simply an experiment where a researcher tests whether a specific product (such as a medication, herb, or supplement) or a type of intervention (such as a special diet or a certain type of exercise) will work to achieve a certain endpoint. An “endpoint” is simply an event or outcome that has been defined and that a clinical study will evaluate. For instance, an endpoint may be losing a certain amount of weight, or improving a certain disease, symptom, or a laboratory value such as blood glucose or cholesterol.
Not all studies are equal, however, and it is important to understand the characteristics of a good clinical study. The most important aspect of a clinical study is how it is set up—this is called the “study design.” The study design is critical in determining whether the published results are reliable enough to help you decide whether a product is worth taking. Some
