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 of the characteristics of a good study include the following:
• It is “randomized, double-blind, and placebo-controlled”
• It includes a large number of patients
• It has well-defined events or endpoints
• It has been evaluated mathematically by appropriate statistical analysis
What do all of these terms mean? The following is an explanation of important terms related to clinical studies.
Randomization : This method assigns an individual or patient to a particular study group or intervention based on chance. This decreases the possibility of some sort of “bias” or result that favors a particular treatment.
Double blind : This means that the medication, supplement, or intervention being used in the study is hidden from both the patient and the researcher. In other words, neither the patient nor the researcher knows what the patient is taking no one knows whether the patient is taking the medication, or supplement, or a “dummy pill”) and both the researcher and the patient are “blind” to what is being used. The purpose of double-blind” design is to decrease the possibility of “bias,” since knowing what treatment is being used may influence either party.
Placebo : This is an inactive or “dummy pill” or treatment that looks and tastes and smells like the real product. The purpose of a placebo group is to compare the effectiveness of the active treatment or real medication, supplement, or herb against something that has no treatment value (the placebo).
Endpoint: An endpoint is an event that has been pre-defined and is being measured in the clinical study. For instance, examples of an “endpoint” would be a change in A1C (to see whether or not there is diabetes improvement), a change in pain scores (to determine improvement in pain due to neuropathy), or a change in laboratory values such as LDL cholesterol the “bad” type of cholesterol).
An excellent “endpoint” is one that measures an effect on mortality (death) or on morbidity (a disease outcome such as heart attack or stroke; or on adverse occurrence such as blindness, nerve damage or amputations, or kidney failure). A good study that shows decreases in mortality and morbidity has usually been conducted for a long period of time (for years) and has sufficiently large number of patients to demonstrate a benefit.
Open-label: In an open-label study, both the researcher and the patient know what is being taken. This type of study design introduces “bias,” possibly because of the power of suggestion. Hence, an “open-label” study is not optimal.
Run-in: A run-in is a phase or period where no treatment is being given, often at the beginning of a study. This is sometimes done to provide some sort of baseline observation or to try to eliminate persons who may not cooperate. For instance, a participant does not show up for important pre-study meetings or treatments, they probably will not comply with the treatments being studied (such as sticking to a diet).
Washout: This is the period of time needed for a drug or herb or other treatment to be eliminated from the body. Some times a “run-in” may be called a “washout” to allow enough time for the drug or herb to be cleared out from the body. An adequate “washout” becomes important when a participant is being changed to a different treatment during the study.
Cross-over: In a cross-over study, patients are given a certain medication, supplement, or herb for a period of time, and then the researchers might change them (“cross-over”)