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Cautions of using "nutraceuticals" or "diet supplements" or "any non-prescribed nutritional, diet or other supplements"

Vernon M Neppe MD, PhD

Definitions:
Many different terms are used for the numerous over the counter medications or supplements that are commonly used.
Terms such as diet supplements are common when dieting is involved, but also when some attempt to improve their health.
Additionally, such terms as nutritional supplements or nutraceuticals or herbal medications are at times used.
To simplify, in this document, I use the term Alternative Medications.

Disclaimer:
While you may find it useful to  read the documents below on Alternative Medications (such as herbs, non-prescription chemicals and other diet supplements) and specific compounds, please understand that the ultimate choice as to whether to take them is yours alone, and you, not your physician, assume full responsibility for any choice (taking or not taking) and any consequences that result, now and in the future. This is so, even in the context of your medical doctor assisting you or guiding you in making that choice, as there is a great deal that is unknown or contradictory and uncertain, in this area, and your physician —who is usually not specifically trained in Alternative Medications —may not necessarily know about the side effects and interactions and the preparations —even the well-documented ones —of the specific Alternative Medications you are taking, considering or may have taken. You may wish to independently review the literature on the specific compounds you want to take, but in doing so, please bear in mind that it may be difficult , if not impossible to obtain all the pertinent information , with all the pros and cons, and such interpretations of the literature may be best suited to experts in the area. You should nevertheless endeavor to keep your physician current as to any medications and Alternative Medications you are taking.

Introduction:
A major consideration of consulting your physician is to optimize the assessment of your difficulties and manage your condition appropriately. Usually this involves prescription of medications in the correct dosage and combinations. Today, it is common for patients to be taking "Alternative Medications" or "Nutraceuticals" such as herbs, mineral, vitamin, diet and synthetic chemical supplements with prescribed medications. We recognize that these Alternative Medications may be valuable drugs, but they also have their dangers, including when they are taken with prescription medications. These are outlined below, as the choice of whether to take these Alternative Medications rests ultimately with the patient, not the physician. Physicians are not specialists in Alternative Medications.

Alternative medicines using herbs like St. John’s wort, Echinaceae, Grape-seed extract, Melatonin and Gingko biloba, and chemicals such as SAMe and glucosamine, have become a significant practical option amongst patients.  The growing use of special "diet" drugs with numerous different compositions complicates such aspects further.

Similarly, weight loss has become extremely important amongst many who are over-weight. Many different herbal and over the counter formulas and nutritional solutions are suggested. The lay public is bombarded with "information" which may be disinformation.

Consequently, this section clarifies briefly, and incompletely, the difficulties of taking such "Nutraceuticals". The term Nutraceutical is used synonymously here with "Nutritional supplement" and this includes "Diet supplement" and is therefore a group of  Alternative medications

A significant proportion of patients consulting physicians may inquire about or take Alternative Medicines, either alone or in addition to their current medication. Sometimes these have therapeutic value, and at other times they don't have therapeutic effects, but this does not mean to say they will not work for other indications. The whole area needs scientific control and scrutiny as well as empathic understanding. Studies on herbal products are not done using the stringent criteria that regulatory bodies such as the American Food and Drug Administration require prescription drugs to go through, nor do they go through the same approval process. Many prescription medications derive originally from plants, though today synthetic preparations are easier and often better.

The problems with Alternative Medications
Because something is supposedly a "natural" substance, like a natural herb, doesn't mean to say that it's completely harmless. Snake venom is natural. Herbs have pharmacological activity. Herbal treatments and other alternative medications such as synthetic chemicals may produce problems. This is not to say that there may not be a therapeutic value to any specific Alternative Medication. It is important always to weigh the risks with the benefits. The benefits may relate to the potential value of the compound for any individual. Such benefits may be based on research and clinical knowledge as well as the individual's specific experience with the compound. The risks may similarly be based on accumulated research, clinical and individual data, but can also be delineated below.

Below are several reasons recommending caution when using Alternative Medications. There may be others, but these seem amongst the most cogent. There are many cautions which we are aware of for the use of regular prescribed medications, but these generally are listed in the package insert. There do not appear to be FDA approved, regulated package inserts (equivalent to prescribed drugs) available for Alternative Medications. However, please bear in mind that even though these are general principles, this does not mean that any specific Alternative Medication is necessarily bad. The good may outweigh the bad.

First, herbs and other Alternative Medications are not as well regulated as prescription medications. We often do not know about the purity of the preparation, the consistency of batches of the same preparation, the correct doses or their appropriate indications. These drugs may have potential pharmacological effects, but are frequently inadequately studied. This may mean that they could even be more risky than regular prescribed drugs because of their many unknowns, impurities, degree of stability of batches, and other variabilities.

Second, Alternative Medications, such as herbal remedies are often not single chemical preparations. There usually is an active chemical inside them, but we may not even know what it is. For example, there is still debate what the active ingredient of St. John’s wort is. This creates a situation where different chemicals, some unnecessary, may interact with each other.

Third, with some of these Alternative Medications, we're not even sure whether a placebo —a drug without therapeutic effect such as a sugar —won't not work as well. This is because they have often not appropriately been studied to demonstrate added therapeutic benefit over and above what placebo would show.

Fourth, the Alternative Medication might have side effects due to the active chemical compounds. Common side effects may be irritation of the stomach, sleepiness or anxiety. Not even vitamins are always safe. Some vitamins are toxic in too high a dosage, like the fat-soluble ones, vitamin A and vitamin E. The side effects may not be immediate or short-term: Instead, they may be noted only after many years.

Fifth, side effects may not be due to the active chemical. It may be due to the vehicle —the wrapping around the drug —and not the herb or prescription medication or vitamin itself. For example, even the apparently innocuous drug, L-tryptophan (a component in foods such as milk) produced a potentially fatal reaction probably because the vehicle produced an allergic reaction. The vehicle can vary greatly from one preparation of the same medication to another and might increase or decrease drug absorption. If the compound absorbs too quickly, unpleasant side effects may occur because the blood level increases precipitously. But if it is absorbed too slowly, it could cause nausea or diarrhea, especially if the drug is not absorbed, and then the medication will not work as well. Different parts of the gastrointestinal tract may be involved, a capsule might be absorbed differently from a tablet, and a particular long-acting preparation will vary from the shorter-acting one. We see these problems with prescription medications as well, but the preparation is generally better controlled.

Sixth, because the active ingredients of these herbal remedies are as yet inadequately studied chemicals, we do not know what interactions will occur with other medications. These could relate to absorption from the stomach or other parts of the gastro-intestinal tract, as well as metabolism in the liver, and sometimes even to binding of proteins. Moreover, foods may be involved: For example, St. John’s wort may, theoretically, produce a dangerous food reaction called the "tyramine effect" or another compound, Gingko biloba, may, in practice, interact with anticoagulant medication like Coumadin.

When taking Alternative Medications like herbs, irregularly, not on a daily basis, at a different time from other medications, there may be reduced interactions in absorption at the stomach level but there may still be some inconsistency with absorption of regular prescribed medications. When taking Alternative Medications regularly, at a regular time and under consistent conditions e.g. before meals, any absorption interactions may be more consistent. However, interactions at the liver level may occur in any event, and an increase or decrease or unchanged levels of prescribed medications may result. Conversely, the Alternative Medications may be altered, or there may be changes in absorption or effects. We are unaware of how many vitamin, mineral, herbal products and synthetic chemicals are going to interact with medications. Absorption and metabolism is also sometimes a problem with regular prescribed medications. We are gradually building up a body of knowledge, in this regard, but there are still numerous unknowns.

Seventh, often dosage of these Alternative Medications —non-prescription drugs— is questionable. For example, melatonin was marketed for sleep at much too high a dosage —3 mg or 6 mg a day —when the physiologic dose may be half a mg a day. The problem, however, is different absorptions producing a question as to the correct individual dosage. :Different preparations may vary enormously.

Eighth, it is possible that Alternative Medications may in some way change the way some prescription drugs are working. They may amplify some effects, they may neutralize some effects or they may modify them: This can have adverse consequences, so that specific prescription drugs may not work properly.

Ninth, it is possible that these Alternative Medications could cause problems in pregnancy or during breast-feeding. They have generally not been studied in that regard.

Tenth, different tablets or capsules of the herbal remedy might have different levels of the relevant active chemicals. Even when those differences are subtle, that might make a big difference. This is because there are less stringent requirements than producing a prescription drug.

Finally, eleventh, we do not know whether even Alternative Medications like a herb that has been demonstrated to have a therapeutic effect will maintain that effect over time. We also do not know whether chemical changes in one's body or one's brain may not require habituation to the chemical even after it has lost its effect. Your realistic choices about Alternative Medications: When you take Alternative Medications, you should carefully and sensibly observe the changes that are happening to you, and exhibit as much care and respect towards potential problems as they would while taking a prescription medication. The herbs you taking may ultimately be shown to be food or poison.

The following are general guidelines as to choice of action.
1. A "safe" way to avoid interactions may be to avoid taking new Alternative Medications with your prescription medications. However, this has the limitation of not receiving any therapeutic value these Alternative Medications may have in your particular case.
2. On the other hand, just stopping the Alternative Medication you are taking, may result in withdrawal effects or loss of the therapeutic effects of these drugs. If you choose to withdraw off these Alternative Medications, it sometimes may be necessary to gradually taper over several weeks. However, every chemical is different and such a taper may also run the risk of side effects and drug interactions, and there are times when it may be preferable to go off the non-prescription drug immediately.
3. Your third choice, may be to take the Alternative Medications in conjunction with your current medical prescription drugs. In this instance, you do not to lose the benefits that the non-prescription Alternative Medication drug provides for you. However, this involves risk, including those listed above. You should regard such compounds understanding there may be benefits and risks.

You are free to disregard the advice above. The choice as to whether to take Alternative Medications is yours alone. We, medical practitioners, cannot take responsibility for your taking them. We cannot guarantee the safety of any of these alternative compounds, nor their potential drug interactions. Even when medical doctors assist you or guide you in making that choice, you must understand there is a great deal that is unknown or contradictory and uncertain, in this area, and that your physician —who is not specifically trained in Alternative Medications —may not necessarily know about the side effects and interactions and the specific preparations —even the well-documented ones —of the specific Alternative Medications you are taking, considering or may have taken. You should nevertheless endeavor to keep your physician current as to any medications and Alternative Medications, you are taking.

This document is meant as a guide only .to information and accuracy cannot be guaranteed. The document is not intended to provide medical consultation regarding the diagnosis, management or treatment of any patient.

Taking alternative medications is taking them at your own risk. The choice is yours.

© Pacific Neuropsychiatric Institute (PNI) Pacific Neuropsychiatric Institute and Vernon M Neppe MD, PhD, Seattle, WA. 2003. The public or office of these pages without written permission is not allowed.

This document was developed in consultation with a special committee of the American Society for Clinical Psychopharmacology (ASCP) during 2000. Acknowledgment: A major source for information for this document is the book, Cry the Beloved Mind: A Voyage of Hope, and more specifically Chapters 7 and 8, by Dr Vernon M Neppe (see http://www.brainvoyage.com for more details). This document is not intended as nor must substitute for the professional judgment of a physician or other health care provider. No responsibility, by omission or commission, can be taken for decisions to take or not take any Alternative or other medications, by any of these parties, including the PNI, Dr Neppe, ASCP and theirs committees, and the publishers and authors of the Cry the Beloved Series or any adaptation, literary, theatrical , media or any other way.


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