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Nutriceuticals: Questions to Ask Print

Nutraceuticals are dietary supplements which make health claims. They are also sold as "alternative" or "complementary" therapies. Complementary and alternative therapies are not intrinsically better or worse than conventional treatments, they’re just different. As a thoughtful, informed consumer, one of your challenges is finding and interpreting information that will you to decide the proper role for these popular, sometimes heavily advertised and lucrative, products. This article is abstracted from the OSU School of Veterinary Medicine's Nutrition Web Site.

This is an abstract from the Ohio State University School of Veterinary Medicine's Nutritional Web Site

    Medical treatments for chronic disease problems often include advice concerning diet. Additionally, many dietary supplements are available for sale, some of which make health claims. These compounds may be sold as "nutraceuticals" or as "alternative" or "complementary" therapies. Complementary and alternative therapies are not intrinsically better or worse than conventional treatments, they’re just different. Use of such therapies does not absolve one of the responsibility to be a thoughtful, informed consumer. One of the many challenges facing caregivers today is finding and interpreting information that will permit them to decide the proper role for these popular, sometimes heavily advertised and lucrative, products.

The Dietary Supplement Health and Education Act of 1994 established a framework for labeling and providing information about nutrition-related products, herbs and other botanicals. The act permits labels to contain a statement describing how the product affects structure and function or general well-being in humans, but not to make specific health claims. The label also must carry the disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.".

Consistency can be a significant problem with natural product-based products. Companies may not have rigid quality control standards to ensure the purity and reliability of the product. This may result in accidental contaminants, allergens, pollens, molds and spores (as can occur in more "conventional" products).

Contradictory pharmacological effects have been reported for herbal preparations containing different subspecies of the intended plant, and the active principle may not be present at all stages of the plant’s lifecycle; some herbs that are edible when immature are poisonous when mature.

Clients expect foods to have important healing properties for a variety of reasons. Foods have indispensable life giving properties, and many well-recognized deficiency diseases exist. In addition to their physiological role as containers of nutrients, foods have important effects on psychological well being. They provide comfort during stressful times, enhance the pleasure of social gatherings, holidays and meetings, and serve powerful religious and cultural functions.

Alternative and complementary therapies also excite interest. Some interest is based on results of clinical trials, as well as the desire for novel or exotic-sounding interventions. Some interest also may result from the anxiety that results from feelings of helplessness in the presence of a complex disease problem, frustration with the many limits of medical knowledge, and occasionally from superstitions and belief in miracles.

Unfortunately, unexamined beliefs in the power of unorthodox treatments leave some people susceptible to quackery. Quackery is defined as "Promotion, for profit, of devices, services, plans or products (including, but not limited to, diets and nutritional supplements) that do not work, or which are untested. (for more information see http://www.quackwatch.com/). In addition to violating the Golden Rule, quackery can delay a person from seeking care for their pet’s problem, be dangerous itself, and delay legitimate research to find an effective cure.

How can we avoid nutritional quackery? By being wary of "experts" who say that:

  1. Malnutrition is common. (only if one includes obesity)

  2. Pet foods contain "poisons". (the increasing longevity of pets suggests otherwise)

  3. Natural vitamins and minerals are better than synthetic ones. (without justification)

  4. Diet causes disease. (although all patients were eating when the fell ill)

  5. They or their products can produce miracles. (which by definition depend on belief)

  6. They are victims of a conspiracy. (only the one to require evidence of safety and efficacy)

  7. They offer only testimonials to support their claims. (and only positive ones)

  8. They have something to sell you. (usually at a handsome profit)

The response to the problems caused by quackery lies in recognition that nutrition and medicine are sciences rather than religions, in that ideas can be experimentally tested to evaluate their validity. The US food and Drug Administration provides us with the appropriate standard; safety and efficacy.

Safety means provision of evidence that the treatment does no harm, that the benefits outweigh the risks. A safe therapy is one that does no unacceptable harm. Efficacy means that the treatment does what it claims to do, the likelihood of benefit from the therapy when applied by a competent practitioner to a comparable patient. Safety and efficacy are assessed based on objective, published evidence. This evidence can be evaluated for both relevance and strength. The following criteria below are helpful when evaluating the relevance of an article about a therapy (http://hiru.mcmaster.ca/:)

1.Can the results be applied to my patients? (consider species, breed, age, sex, specific disease problem)

2.Were all of the clinically relevant outcomes considered? A treatment that changes a physiologic measurement (e.g., BUN in dogs with kidney disease) without influencing an important outcome (survival time, quality of life, cost of care, etc.) is of little value, whereas an important outcome improvement is interesting regardless of effects on physiological measurements.

3.Are the likely benefits worth the potential risks and costs? If the answer to any of these questions was "no", find an article to read that is worthy of your time. If all were answered "yes", proceed on.

4.Are the results of the study valid? Was the assignment of patients to treatments randomized? Were all patients who entered the trial properly accounted for and attributed at its conclusion? Was follow-up complete? Were patients analyzed in the groups to which they were randomized? Were patients, health workers and study personnel "blind" to treatment? Were the groups similar at the start of the trial? Aside from the experimental intervention, were the groups treated similarly?

5.What were the results? How large was the treatment effect? How precise was the estimate of the treatment effect? The strength of evidence from articles, books, websites, etc. can be rated according to the following scale (from the Agency for Health Care Policy and Research - http://www.ahcpr.gov/), a more comprehensive discussion is available from the Centre for Evidence-Based Medicine at Oxford (Levels of Evidence and Grades of Recommendations)

Rating

Evidence obtained from:
A Meta-analysis of randomized controlled trials A- At least one randomized controlled trial
B Well-designed controlled study without randomization B- Other type of well-designed study
C Non-experimental study such as comparative, correlational or case studies C Opinion of experienced expert
D Unbiased testimonial
E. Manufacturer-provided testimonials, "back-of-the- magazine" ads and TV infomercials


.Information about safety and effectiveness of alternative and complementary therapies may be less readily available than information about conventional medical treatments. Research on these therapies is ongoing, and continues to grow. A compendium of monographs describing the safety and efficacy of many common herbal treatments compiled by the German Federal Health Agency’s "Commission E" recently has become available. http://www.herbalgram.org/commission_e/index.html

Credible information also may be found in scientific research literature obtained through public libraries, university libraries, medical libraries, online computer services, and the U.S. National Library of Medicine (NLM) at the National Institutes of Health (NIH) and their Office of Alternative Medicines http://altmed.od.nih.gov/oam/what-is- cam/consider.shtml

For information about researching alternative medical therapies using the NLM, please contact the Office of Alternative Medicine (OAM) Clearinghouse and request the fact sheet, "Alternative Medicine Research Using MEDLINE."

Information to gather for evaluation includes relevant research, advantages and disadvantages compared to other treatments, risks, side effects, expected results, and the expected length of treatment. Speak with people who have undergone the treatment, preferably both those who were treated recently and those treated in the past. Talking with people with pets suffering the same health condition will provide the most relevant information. Testimonials used alone do not adequately assess the safety and effectiveness of an alternative therapy, however, and should never be the exclusive criterion for selecting a therapy. Controlled scientific trials usually provide the best information about a therapy’s effectiveness and should be sought whenever possible.

Problems still arise, however, due the difficulties associated with experimentation, such as biological variability, small sample size, researcher bias, careless interpretation, and use of anecdotal evidence. To guard against these risks, I recommend assessing the following criteria before agreeing with any scientific conclusion:

1.The strength and the he consistency of the association
2.The specificity of the association
3.The temporality of the association (which came first?)
4.The dose-response relationship of the effect
5.The biological plausibility of the effect

Because of the importance of the placebo effect and compassionate belief in the value of the therapy on the outcome of the treatment, the preferred method of testing a treatment is the prospective, blinded, placebo-controlled trial. Even when this method is used, however, the results must be evaluated with care. One must remember that only half the information in science is correct; unfortunately, no one knows which half.

Once evidence concerning the treatment is obtained, one also should take a close look into the background, qualifications, and competence of treatment provider, whether a veterinarian or a practitioner of alternative and complementary health care. First, contact a state or local regulatory agency with authority over practitioners who practice the therapy or treatment you seek. The practice of complementary and alternative medicine usually is not as regulated as the practice of conventional medicine. Licensing, accreditation, and regulatory laws, however, are increasingly being implemented. Local and state medical boards, other health regulatory boards or agencies, and consumer affairs departments provide information about a specific practitioner’s license, education, and accreditation, and whether there are any complaints lodged against the practitioner. Check to see if the practitioner is licensed to deliver the services the practitioner says he or she delivers.

Appropriate state licensing of education and practice is the only way to ensure that the practitioner is competent and provides quality services. Most types of complementary and alternative practices have national organizations of practitioners that are familiar with legislation, state licensing, certification, or registration laws.

Some organizations will direct medical consumers to the appropriate regulatory agencies in their state. These organizations also may provide referrals and information about specific practitioners. The organizations usually do not function as regulatory authorities, but promote the services of their members.

Second, talk with those who have had experience with this practitioner, both health practitioners and other patients. Find out about the confidence and competence of the practitioner in question, and whether there have ever been any complaints from patients.

Third, talk with the practitioner in person. Ask about the practitioner’s education, additional training, licenses, and certifications, both unconventional and conventional. Ask about the practitioner’s approach to treatment and patients. Find out how open the practitioner is to communicating with patients about technical aspects of methods, possible side effects, and potential problems. When selecting a health care practitioner, many medical consumers seek someone knowledgeable in a wide variety of disciplines. Look for a practitioner who is easy to talk to, so you will feel comfortable asking questions. After you select a practitioner, the education process and dialogue between you and your practitioner should become an ongoing aspect of complementary health care.

The quality of the service delivery, or how the treatment or therapy is given and under what conditions, is also an important issue. However, quality of service is not necessarily related to the effectiveness or safety of a treatment or practice. Visit the practitioner’s office, clinic, or hospital. Ask the practitioner how many patients he or she typically sees in a day or week, and how much time the practitioner spends with the patient. Look at the conditions of the office or clinic. Many issues surround quality of service delivery, and each one individually does not provide conclusive and complete information. For example, are the costs of the service excessive for what is delivered? Can the service be obtained only in one place, requiring travel to that place? These issues may serve as warning signs of poor service.

The primary issue to consider is whether the service delivery adheres to regulated standards for medical safety and care. Contact regulatory boards or agencies described in the previous section to obtain objective information. You also may gather information by talking with people who have used the service, and through health care consumer organizations.

Clients also should recognize that costs are an important factor to consider. Many complementary and alternative treatments are as or more expensive than conventional ones. Most importantly, one should discuss all issues concerning treatments and therapies with your health care provider, whether a physician or practitioner of complementary and alternative medicine. Competent health care management requires knowledge of both conventional and alternative therapies for the practitioner to have a complete picture of your treatment plan.

adapted from http://altmed.od.nih.gov/oam/what-is- cam/consider.shtml


 
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