Entry Level Clinical Nutrition™- Redefining What We Do in a New Age of Increased Sickness & Increased Scarcity – Part II

Does Published Research Support My Contention That We Need A New Approach?

In part I of this series I closed with a promise to explore the chronic phase response in more detail with emphasis on research that focuses on underlying physiology and biochemistry.  However, given that the first newsletter was largely theory and personal observations, upon further introspection I felt I had an obligation to you to follow up in part II with at least basic review of the published literature so as to provide you with some evidence that what I presented was more than just a personal agenda.  In turn, what follows is an overview of research and published information that I feel documents my claim that the models we have traditionally used to determine optimal nutritional supplementation are not serving our needs in terms of providing a high degree of cost and time effective clinical efficacy from the patient’s point of view when dealing with chronic illness.  Before continuing, though, one other “big picture” thought.  Another major reason I am presenting this information is because, for me, it strengthens my resolve to try to remedy these deficiencies in our traditional models by seriously examining critical care nutrition and the large amount of published research it has generated as an underlying conceptual basis for the creation of Entry Level Clinical Nutrition™.

To begin this discussion I would like to present a quote from a fascinating article from the November 23, 2009 edition of Business Week entitled “10 ways to cut health-care costs right now: Employers and hospitals don’t have to wait for Congress to address inefficiencies and waste” by Catherine Arnst.  This quote relates to the idea of improved decision-making by both patients and health care professionals as a way of reducing health care costs:

“When Floyd ‘Jack’ Fowler Jr. holds focus groups of heart patients, he’s amazed at their misplaced faith in the benefits of medical procedures.  ‘They all think they’ll die if they don’t have bypass surgery or angioplasty,’ says Fowler – even though studies show that both procedures extend lives or prevent heart attacks in only a tiny minority of especially sick patients.”

Of course, we have heard and read much lately that excessive use of ineffective products and procedures in the allopathic medical community has been a significant reason for the high cost of health care.  While I realize that the amount of money spent on supplements pales in comparison, should we still be concerned about whether money spent on supplements delivers a great enough return to justify the cost?  Given that, according to the article “As economy is down, vitamin sales are up” by Alex Williams” (The New York Times, April 5, 2009), total domestic sales of supplements has been as much as $23 billion annually over the last few years, I feel strongly that, during these difficult financial times when cost containment and cost justification is a major health care concern, we, as providers of supplements, should also be very concerned that the money spent on supplements is well spent.

Interestingly, the sales figures mentioned above do not tell the whole story.  During the economic downturn, have consumer attitudes towards supplements changed?  According to an October 23, 2009 press release from the Council for Responsible Nutrition (CRN), confidence is up:

“In the last several years, confidence levels in dietary supplements have been on a gradual rise, with 80 percent of American adults indicating a favorable level of confidence in dietary supplements in 2007, and 79 percent of American adults responding similarly in 2006.”

Furthermore:

“According to the results from the 2009 CRN Consumer Survey on Dietary Supplements, confidence in dietary supplements isn’t the only thing on the rise-the on-line survey also showed a slightly higher percentage of adults who label themselves as supplement users, with 65 percent classifying themselves as such.  In 2008, 64 percent of American adults identified themselves as supplement users.  These numbers are also consistent with previous years’ findings, as 68 percent and 66 percent of Americans identified themselves as supplement users in 2007 and 2006, respectively.”

Of course, these numbers are impressive.  Unfortunately, they fail to address the key question I am posing:

Is this confidence justified?

Very simply, based on a significant body of research I am about to present, the answer is “No”.  Why?  To fully appreciate my reply to this equally important question, I would like to divide my discussion into the two main reasons Americans tend to purchase supplements:

  1. To prevent future occurrence of chronic diseases such as cardiovascular disease and cancer.
  2. To reduce current disease severity or eliminate it completely.

Of course, there are other reasons such as optimizing health in totally healthy individuals, anti-aging, and improvement of athletic and intellectual performance.  However, in my experience, the first two reasons are encountered most frequently.  Therefore, my review and commentary will focus only on those two.

PREVENTION OF FUTURE OCCURRENCE OF CHRONIC DISEASES SUCH AS CARDIOVASCULAR DISEASE (CVD) AND CANCER USING MICRONUTRIENT SUPPLEMENTATION – DOES IT WORK?

Can ingestion of nutrients lead to reduced incidence of the major chronic illnesses in our society?  Certainly, a very large body of research, which has been highly publicized, makes it very clear that ingestion of foods high in certain nutrients is linked with reduced incidence of CVD and cancer.  Furthermore, heightened concerns about colds and flu have led to a great deal of publicity about micronutrients in food and their role in optimization of immune function as exemplified by the following headline in the November 24, 2009 edition of The Wall Street Journal:

“The Flu Fighters – in Your Food: New Research Points to Ways to Boost Immunity by Making Sure Your diet Has the Right Nutrients”

With all of this interest on the relationship between nutrients in food and health status, it should come as no surprise that an assumption was made that those who ingest diets that have suboptimal levels of these nutrients can ingest these nutrients in supplemental form as an “insurance policy” to prevent disease.  Or, more to the point, it was assumed that the American public could ingest supplemental nutrients along with their fast food meal and expect a highly reliable outcome in terms of disease prevention.  This assumption was reinforced by research, which I will present, that made it very clear that nutrient supplementation could optimize markers of chronic illness such as serum homocysteine.  Unfortunately, primarily due to the complexities of composition of whole foods, the epidemiologic data and suggestive findings in relation to laboratory markers did not lead to the ultimate endpoint most desired by the public of highly reliable and consistent chronic disease prevention in large groups of people no matter what their unique genetic considerations or personal variations in lifestyle.  As an example of this poor performance, consider the following statements from just a small selection of studies that have reported negative outcomes.

In one of the most recently published reviews of the literature, “Is there are role for supplemented antioxidants in the prevention of atherosclerosis?” by Katsiki and Manes (1), the authors state:

“As the majority of studies included in this review do not support a possible role of antioxidant supplementation in reducing the risks of cardiovascular disease, no definite conclusion can be drawn to justify the use of antioxidant vitamin supplements for the prevention of atherosclerotic diseases.”

Again, I want to emphasize that most of the studies considering the value of supplements in preventing chronic illness do not employ elaborate dietary controls.  Therefore, it can be assumed with reasonable certainly that, in many if not most of the studies that led to the above conclusion, the participants were, quite often, ingesting the supplements along with their standard American dietary fare.  This assumption is backed by the findings of a recently published study by King et al (2) that stated:

“Generally, adherence to a healthy lifestyle pattern has decreased during the last 18 years, with decreases documented in 3 of 5 healthy lifestyle habits.”

Another recently published paper by Neuhouser et al examined multivitamin use in relation to the risk of cancer and CVD in a very large group of postmenopausal women (161,808 participants) (3).  In this paper the authors begin by acknowledging that the public is highly motivated by product health claims and consumer testimonials to believe that multivitamin use will be effective in preventing chronic diseases such as cancer and CVD.  Nevertheless, despite these beliefs, the authors reported the following:

“After a median follow-up of 8.0 and 7.9 years in the clinical trial and observational study cohorts, respectively, the Women’s Health Initiative study provided convincing evidence that multivitamin use has little or no influence on the risk of common cancers, CVD, or total mortality in postmenopausal women.”

Still another large scale study (77,719 participants) by Pocobelli et al (4) noted the following:

“Multivitamin use was not related to total mortality.  However, vitamin C and vitamin E use were associated with small decreases in risk.”

Then, a review of the literature published in 2007 by Prentice (5) concluded the following:

“The data are not compelling concerning a role for multivitamin-multimineral supplements in preventing cancer or cardiovascular disease morbidity or mortality, although some interesting leads merit further evaluation.”

Finally, a fascinating paper by Lichtenstein and Russell entitled “Essential nutrients: Food or supplements?: Where should the emphasis be? (6) addressed the popular assumption mentioned above that supplementation can be used as an “insurance policy” to compensate for a nutrient depleted diet.  In their conclusion, the authors state:

“There are insufficient data to justify an alteration in public health policy from one that emphasizes a food-based diet to fulfill nutrient requirements and promote optimal health outcomes to one that emphasizes dietary supplementation.  Our conclusion is based on the lack of a complete understanding of nutrient requirements and interactions, disappointing results of intervention studies with single nutrients or nutrient cocktails, and limited understanding of how the message would be interpreted with respect to dietary and lifestyle behaviors.”

While I would very much like to tell you that the above mentioned papers are the only ones I could find that suggest poor efficacy of large scale micronutrient supplementation in terms of chronic disease prevention, unfortunately, they are just a sampling.  Others include the following:

  • Sesso et al found that supplementation of vitamins C and E in male physicians did not prevent cardiovascular disease (7)
  • Marmsjo et al reported that multivitamin supplements did not reduce risk of allergic disease in 8 year old children (8)

Before closing this section, I again want to emphasize that none of these studies, as far as I could tell, employed any major dietary and lifestyle controls.  Therefore, as I suggested, I feel it is safe to assume that many if not most participants in these studies were ingesting supplemental nutrients in a broader context of dietary and lifestyle considerations that are less than optimal.

What about the studies that demonstrate optimization of laboratory markers related to chronic illness?

Many in the nutritional community have countered the above findings by maintaining that, because nutritional supplementation can optimize markers of chronic disease such as serum homocysteine, for example, these supplements will, by extension, be helpful in preventing the chronic diseases related to these markers.  While this point of view seems logical, several studies on homocysteine and B vitamin supplementation clearly point out that disease prevention does not inherently follow when laboratory markers are optimized using nutritional supplementation without dietary controls.  For example, two major studies that were highly publicized demonstrated that B vitamin supplementation, despite being very successful in lowering serum homocysteine, was clearly not successful in preventing future cardiovascular events in patients with pre-existing cardiovascular disease or diabetes.  The first, authored by The Heart Outcomes Prevention Evaluation 2 Investigators (9) noted the following after supplementation of folic acid, vitamin B6, and vitamin B12 or placebo for five years:

“Mean plasma homocysteine levels decreased by 2.4 µmol per liter (0.3 mg per liter) in the active-treatment group and increased by 0.8 µmol per liter (0.1 mg per liter) in the placebo group.”

Nevertheless, the following was concluded about prevention of future cardiovascular disease:

“Supplements combining folic acid and vitamins B6, and B12 did not reduce the risk of major cardiovascular events in patients with vascular disease.”

Similar findings were noted in the Bonaa et al (10) study that was published in the same issue of The New England Journal of Medicine.  Even though folic acid and vitamin B12 supplementation lowered serum homocysteine levels by 27 percent in 3749 men and women who had experienced a recent acute myocardial infarction, the following was noted by the authors:

“Treatment with B vitamins did not lower the risk of recurrent cardiovascular disease after acute myocardial infarction.”

Another major study by Ebbing et al (11) demonstrated similar findings.  In addition, lowering homocysteine with B vitamins such as folic acid and vitamin B12 was not effective in reducing risk of cardiocerebrovascular diseases such as stroke (12, 13).  What about type 2 diabetes?  Song et al (14) reported the following after supplementing 4,252 women aged 40 years or more with a history of cardiovascular disease but no history of type 2 diabetes with folic acid and vitamins B6 and B12:

“Lowering homocysteine levels by daily supplementation with folic acid and vitamins B6 and B12 did not reduce the risk of developing type 2 diabetes among women at high risk for CVD.”

Thus, with these papers in mind, it is not surprising that a major meta-analysis of the published literature on the subject (15) concluded the following about homocysteine-lowering with B vitamins and clinical outcomes related to CVD:

“In this review we included eight randomized controlled trials equivalent to 24,210 participants.  We found no evidence that homocysteine-lowering interventions, in the form of supplements of vitamins B6, B9, or B12 given alone or in combination, at any dosage compared with placebo or standard care, prevents myocardial infarction, stroke, or reduces total mortality in participants at risk or with established cardiovascular disease.”

In closing this discussion on the value of optimization of laboratory values with nutrient supplementation and incidence of chronic illness, I want to emphasize two points.  First, I want to make it absolutely clear that there is no evidence in any of these papers that any dietary or lifestyle controls were utilized in addition to the supplementation.  Second, I also want to make it absolutely clear that I am not suggesting that efforts to optimize laboratory values are worthless from a clinical outcome standpoint.  Rather, what I am suggesting, as I will discuss in more detail shortly, is that the problem is not with diagnostic and treatment modalities which I feel are high quality but with the fact that they were used in ways for which they were never designed.  In turn, I am certainly a strong advocate of measuring serum homocysteine and making efforts to reduce elevated levels with B vitamins.  However, if that is all you are doing to aid your patient at risk for CVD, there is no evidence that what you are doing has any long term clinical value.  In turn, are these modalities worthless?  Of course not!!  They were just misused.  As an analogy, consider a priceless Strativarius violin.  No matter what it is worth, it is still does a lousy job of hitting tennis balls.  However, the fact that a Strativarius violin does a poor job of hitting tennis balls in no way decreases its value.

USING NUTRIENT SUPPLEMENTATION TO REDUCE CHRONIC DISEASE SEVERITY OR ELIMINATE IT COMPLETELY – DOES THIS WORK?

Given the increased prevalence of supplements on the Internet and in retail establishments, the public is now consulting nutritional practitioners about purely preventive issues less frequently than in the past.  In turn, as I have been suggesting in this series, feedback from you suggests that your patient population is primarily composed of individuals who are already ailing, sometimes for years, and are seeking relief from their ailments using nutrient and lifestyle based approaches.  Therefore, the discussion in this section is probably more applicable to most of you as opposed to the previous section on prevention.

Can supplementation of nutrients without use of any other modalities such as dietary and lifestyle interventions be used to reliably reduce or eliminate chronic symptoms and/or chronic disease states?  As I suggested in part I of this series, it is my opinion, based on current methods of utilization, the answer is no.  While anecdotal reports from many of you certainly support this stance, I would like to strengthen this position by reviewing several papers that address the question of whether nutrient supplementation has curative properties on a large scale perspective for chronic disease states.  Before continuing, please note again my use of the phrase “…on a large scale perspective…”  Certainly all of us have witnessed situations where certain patients responded favorably to isolated nutrient supplementation.  However, do these positive occurrences represent a one out of 100 scenario or a 99 out of 100 scenario?  With the assumption that you are like me in taking satisfaction knowing that one patient responded well to a supplemental regimen, but feeling anxiety that the next 99% or 50% or 40% or even 30% may not, this is an important question to address accurately.  Of course, as many of you know, the lecture circuit has no shortage of very charismatic speakers who maintain that the supplemental protocols they advocate work every time without any significant dietary or lifestyle interventions.  Does research suggest that these claims are valid or somewhat of an exaggeration?  To help answer this question, consider the studies that follow.

The first paper I would like to discuss is one of which many of you who have attended my seminars are probably aware since I have discussed it in some form in virtually every presentation I have given over the last 4-5 years.  Interestingly, though, I have only discussed it briefly in one edition of the Moss Nutrition Report.  Therefore, I am pleased to be writing about it even now after discussing it so frequently in seminars because, in my experience, it still provides the best detailed answer to the key clinical question that we must now answer to maintain successful nutritionally based practices:

What gives the best time and cost efficient results in relation to chief complaints based on the opinion of the patients?     

Of course, as you know, there is no shortage of studies that examine the impact of supplementation of a nutrient or a set of nutrients on a specific chronic symptom or disease entity.  In contrast, I have found very few studies that examine in detail the key factor in the above question; how well these nutrients work when compared to other alternative and/or allopathic modalities.  Furthermore, even fewer have compared different alternative and allopathic modalities in terms of frequency of adverse reactions based on the patients’ point of view.  Therefore, I have found the study I am about to discuss a continuous source of information and inspiration in terms of my long standing quest to find out precisely what will work best to time and cost effectively reduce chief complaints and improve quality of life in chronically ill patients.

In “Perceived treatment efficacy for conventional and alternative therapies reported by persons with multiple chemical sensitivity” by Gibson et al (16) the first aspect I found to be especially valuable was the information on the study participants.  As you will see in the quote that follows, participants, from a demographic standpoint, tended to be those who comprise the bulk of the patient population in many practices, chronically ill, middle-aged, Caucasian females:

“Respondents were 82% women and 95% Caucasian.  Participants ages ranged from 20 to 82 years, with a mean age of 53 years.”

Furthermore:

“When asked to identify the severity of their condition, 7% identified their multiple chemical sensitivity (MCS) as mild, 32% as moderate, 45% as severe, and 13% as totally disabling.”

Given that many if not most studies employing supplementation examine impact on healthy populations, the fact that this study, as suggested in the above quote, is one of the few that considers states of ill health very similar to those presented by many of our patients, makes it especially valuable.

Another great value of this study is that, unlike many studies evaluating efficacy of nutritional supplementation in chronically ill patients that consider only a few dozen participants, the Gibson et al (16) paper considered 917 participants.

Still another somewhat unique aspect of this paper, as suggested above, is that it methodically considered relative rates of adverse events as well as rates of benefit:

“For each treatment, participants were asked whether they had tried it and, if so, for how long.  Those who had used a treatment were then asked to rate the efficacy of the treatment as ‘very harmful,’ ‘somewhat harmful,’ ‘no noticeable effect,’ ‘somewhat helpful,’ or ‘very helpful.'”

In addition, the treatment modalities were rated in terms of the ratio between how many participants felt they were helped and how many felt they were harmed.  This ratio was called the “help:harm ratio.”

What were the most relevant findings in relation to this discussion?  First, it should be noted that not every one of the 917 participants reported usage of every treatment.  For example, 175 participants reported results of using intravenous magnesium and 325 participants reported results of using grapefruit seed extract.  Second, another important finding relates to the popular belief that nutritional supplements and other alternative modalities, because they are “natural,” present no risk of adverse effects.  In fact, for every treatment modality at least one participant reported a “very harmful” or “somewhat harmful” experience.  Similarly, for every treatment modality at least one participant reported “somewhat helpful” or “very helpful.”  With this reality in mind, I feel, in turn, it is important that we, as I suggested, view with a certain degree of healthy skepticism those lecturers and writers in the nutritional community who suggest that one or two case report presentations where supplementation without lifestyle modifications led to “miraculous” results can reliably be extrapolated to high levels of positive results in large patient populations.  For, as you will see from the data to be presented, positive responses from a few patients in no way guarantees that the majority of your patients will respond in a similar fashion.

What modalities were reported to be the most helpful and demonstrated the best help:harm ratio?  As you might expect given that the population being studied was patients with multiple chemical sensitivity, avoidance efforts such as “creating a chemical-free living space” and “chemical avoidance” demonstrated the best results. However, beyond these two, the best rated modality might surprise you.  No, it had nothing to do with micronutrient supplementation.  In fact, it was a modality that is more directly related to optimization of stress physiology.  What was it?  “Prayer.”  The authors state:

“The three most highly rated treatments were creating a chemical-free living space, chemical avoidance, and prayer.  Both creating a chemical-free living space and chemical avoidance were rated by 95% of people as helpful.  The chemical free living space was 155 times more likely to be rated as helpful than as harmful, and chemical avoidance was 119 times more likely to be rated as helpful than harmful.  Prayer was 48 times more likely to be rated as helpful than harmful, with 94% of people rating it as helpful.”

Of the other treatment modalities that were highly rated, two related to diet or supplementation and none related to supplementation of micronutrients:

“Other therapies rated as highly effective and with help:harm ratios above 10 included rotation diet, air filters to prevent exposures, personal oxygen to cope with exposures, acidophilus, acupuncture, touch for health reflexology, moving to a safer location, and meditation.”

Before continuing, I would like to comment on some of the key aspects of this quote.  First, please note the presence of meditation.  Similar to prayer, this modality, as we know, relates to optimization of stress physiology.  Therefore, it should be no surprise that it rated so highly in terms of clinical effectiveness with chronically ill patients.  Second,  in terms of the multiphasic approach I have advocated with Entry Level Clinical Nutrition™, the two modalities mentioned in the above quote that do relate to diet or supplementation are particularly notable.  Why?  First, a large body of clinical and research data suggests that a rotation diet, which is an excellent way to reduce intake of foods that may be inducing sensitivity reactions, can, as a result, reduce overall inflammation, a major component of both the chronic and acute phase responses that I maintain are creating much of the symptomatology that brings patients to your practices.  Second, acidophilus supplementation has a long history in both the research and clinical environments of improving GI function, another major component of both the acute and chronic phase responses.

Specifically, what were the numbers of these highly rated modalities I have just emphasized?  Prayer, based on 609 responses, helped 64.2 % of the respondents and harmed 1.4%, yielding a help:harm ratio of 48.3.  To give some perspective, prayer rated third, with chemical-free living space rating first (820 responses with 94.8% being helped and 0.6% being harmed, yielding a help:harm ratio of 155.2) and chemical avoidance rating second (875 responses with 94.5% being helped and 0.8% being harmed, yielding a help:harm ratio of 118.6).  In terms of help:harm ranking, meditation ranked fourth (423 responses with 53.8% being helped and 2.8% being harmed, yielding a help:harm ratio of 19.2).  Rotation diet ranked eighth (560 responses with 72.2% being helped and 5.7% being harmed, yielding a help:harm ratio of 12.7).  Finally, acidophilus ranked ninth (661 responses with 52% being helped and 4.1% being harmed, yielding the same help:harm ratio as the rotation diet of 12.7).

Were any micronutrient supplements on the highest rated list in terms of help:harm ratio?  Yes.  Which ones?  It should be no surprise to many of you that magnesium supplements ranked highest of all micronutrient supplements coming in at 16th overall (644 respondents with 52.4% being helped and 6.1% being harmed yielding an 8.6 help:harm ratio).  A category titled “Other mineral supplements,” which includes any minerals besides calcium, magnesium, and chromium, ranked 23rd overall (666 respondents with 48.9% being helped and 7.7% being harmed, yielding a 6.4 help:harm ratio).  A category titled “Other vitamin C,” which included all vitamin C forms except buffered vitamin C powder, ranked 29th overall (683 respondents with 51.7% being helped and 9.5% being harmed, yielding a 5.5 help:harm ratio).  Vitamin E supplements ranked 30th overall (709 respondents with 39.6% being helped and 7.2% being harmed, yielding a 5.4 help:harm ratio).  Finally, for the sake of completeness, I should mention that intravenous magnesium ranked 26th overall (175 respondents with 63.5% being helped and 11% being harmed, yielding a 5.8 help:harm ratio).

Beyond, those noted above, were any other micronutrient supplements considered in the study?  Yes:

Calcium – 663 respondents with 35.6% being helped and 7.8% being harmed, yielding a 4.6 help:harm ratio.

Chromium – 399 respondents with 34% being helped and 8.3% being harmed, yielding a 4.1 help:harm ratio.

In closing my discussion on this fascinating, unique, and very important study, I would like to share some “big picture” thoughts.  First, it provides a rare opportunity to see how more mainstream nutritional/alternative therapies compare in terms of efficacy based on patient feedback to some truly esoteric, rarely researched modalities such as Bach flower remedies, juicing, coffee enemas, colonics, liver and gall bladder flushes, aromatherapy, and many others.  Second, while, as stated above, many micronutrient supplements performed well compared to both many other alternative therapies and pharmaceuticals, they were far from the “helps everyone/hurts no one” panaceas that has been suggested by many in the nutritional community.  Does this mean they are worthless modalities as suggested by others?  Of course not; no more than water should be considered worthless because it does not cure all diseases and has been responsible for the deaths of millions over recorded history.  Rather, to me, it suggests the analogy I mentioned above of violins and tennis balls.  Valuable tools that are being used incorrectly.  But what if they had been used correctly?  What if, after careful evaluation to determine need, meditation, a rotation diet, magnesium supplements and acidophilus supplements were used in a carefully orchestrated manner as I am suggesting with Entry Level Clinical Nutrition™?  Instead of the mediocre success rates seen in this study that are certainly consistent with similar research environments where micronutrient supplementation is used in isolation with no other lifestyle modifications, might we see rates of positive outcomes that are 70-80% or more, which is what we need to see to maintain successful practices today?  I will explore this key question shortly.

Before closing I would like to address one other key point about this study that might have occurred to you.  Of all the modalities considered, which performed the worst?  Or, more precisely, which caused identical or higher levels of harm as opposed to help in the eyes of the respondents, yielding a help:harm ratio of 1 or below?  As you might expect, virtually all on this list were pharmaceuticals such as antidepressants and antiseizure medications, all having a help:harm ratio of less than 1.  However, there was one very popular nutritional supplement on this list, which, even though I will not mention it here, was mentioned by brand name in the study.  Would you like a hint?  It has to do with the fact that, as you may have noticed and contrary to what you may have expected, nothing relating to detoxification procedures ranked anywhere near the top in terms of help:harm ratio.  In fact, it was one of the most popular detoxification powder products in the professional marketplace today.  What were the numbers?  There were 232 respondents with 34% being helped and 35.7% being harmed, yielding a 1.0 help:harm ratio.  Pretty sobering numbers; certainly not what we would expect based on the massive marketing promises made by detox program promoters that we have all experienced over the years.  However, does this suggest, as I posed with micronutrient supplements, that powdered detoxification products are, in reality, worthless in terms of improving quality of life in chronically ill patients?  In the strongest possible terms I must answer No!!  Rather, in the strongest possible way, it suggests violins and tennis balls; excellent products that are probably being grossly misused.

Based on the Entry Level Clinical Nutrition™ model I am proposing, what is the proper way to use detoxification powders and other detoxification modalities with chronically ill patients?  My answer to this question is to follow the successful paradigm long established by critical care nutritionists where the first order of priority is to stabilize the patient by addressing key aspects of the acute phase response such as fluid/electrolyte imbalances, inflammation, and protein loss from hypermetabolism, insulin resistance, etc.  Then, after stabilization, address repair and healing of the burns, trauma, or whatever else brought the patient to the critical care environment in the first place.  As noted in much of the critical care literature, to immediately start focusing solely on the burns, for example, without addressing the acute phase response could rapidly lead to death due to what is known as “multiple organ failure syndrome” (MOFS).  What is MOFS?  Very basically, it is a situation where all major organs such as the kidneys and lungs cease functioning due to factors such as massive inflammation and infection from enteric organisms that entered the systemic circulation due to acute phase response-induced gut lining atrophy and resultant “leaky gut.”

Similarly, as suggested by the results of the Gibson et al (16) study, to immediately start detoxifying a chronically ill patient without first stabilizing the patient by addressing the chronic phase response can be an invitation to disaster that we know as “detox reactions,” which, from a metabolic standpoint, is basically a micro-version of the MOFS situation mentioned above.  Therefore, what I am suggesting with Entry Level Clinical Nutrition™ is that we, similar to the burn patient in critical care, begin by stabilizing the chronic phase response by addressing fluid/electrolyte imbalances, inflammation, protein loss from hypermetabolism, insulin resistance, etc. and then begin detoxification and other functional medicine procedures as needed.

Can I present research that supports this type of approach to the care of chronically ill patients?  As you will see, there is a massive body of research which I will be presenting in future installments of this series.

Beyond the Gibson et al study (16), does any other research exist that examines efficacy of micronutrient supplementation in terms of addressing pre-existing chronic illness with emphasis on comparisons with other therapeutic modalities?

Unfortunately, I could find only one other study that compared the efficacy of micronutrient therapy with other modalities in terms of resolving symptoms in chronically ill patients.  In “Complementary and Alternative medicine use for vasomotor symptoms among women who have discontinued hormone therapy” by Kupferer et al (17), 563 menopausal women who had discontinued hormonal therapy were surveyed about their experiences with complementary and alternative medicine.  Of the therapies considered, antidepressants, based on 80 users, were most useful with approximately 55% giving positive feedback.  Then, in descending order based on efficacy, the following modalities were noted:

  • Homeopathy (31 users)
  • Meditation and relaxation (65 users)
  • Evening primrose oil (43 users)
  • Antihypertensives (34 users)
  • Black cohosh (116 users)
  • Soy (106 users)

Only after soy did micronutrient supplementation appear.  148 women reported multivitamin use with 25% noting positive experiences.  Other therapeutic modalities were reported by the respondents.  However, usage rates were too low to provide any meaningful data about efficacy.

Before continuing, I would like to offer some comments on these findings.  First, it is interesting to note that, as with the Gibson et al study (16), therapies relating to stress physiology and the hypothalamic-pituitary-adrenal axis performed very well, certainly better than micronutrient therapy.  To me, these findings lend more credence to one of the foundational concepts of Entry Level Clinical Nutrition™ that suggests symptoms in chronically ill patients are actually manifestations of the body’s response to environmental, psychological and physiological stresses.  Second, while nutritional supplementation was helpful, as with the Gibson et al (16) study, the results were mediocre, in contrast to what has been suggested by many in the industry and mass media.  Finally, as with the Gibson et al (16) study, it appears that these modalities were used in isolation with no concurrent lifestyle and dietary controls, as is seen with most of the other studies discussed where nutritional supplementation has demonstrated mediocre results in terms of efficacy.

Since these two studies suggest that therapeutic use of micronutrient supplementation without other concurrent use of other alternative/lifestyle modalities provides, based on patient feedback, positive results approximately 50% of the time at the most, do other studies suggest similar results?

I feel it is extremely important to address this question because it exposes a major difference between the goals of researchers and the goals of clinicians who are basing therapeutic decisions on papers written by these researchers.  For the most part, researchers performing controlled and blinded research are comparing the efficacy of nutrient supplementation to that of a placebo.  In turn, as long as performance of the supplemented nutrient is statistically better than that of the placebo, the study is considered to be both successful and publishable no matter how many subjects responded positively from a strict numerical standpoint.  Therefore, for example, if 10 out of 100 responded positively to the placebo and 30 out of 100 responded positively to the supplemented nutrient, the study is considered successful and publishable because three times as many subjects responded to the supplemented nutrient compared to placebo.  Furthermore, what the public hears is glowing reports claiming how well the supplemented nutrient performed “compared to placebo.”  However, what do these numbers mean to us clinically?  What it means is that using the supplemented nutrient clinically in the way it was used in the study will yield a situation where 70% of your patients do not have a positive response.  Can your practice tolerate a situation where 70% of your patients, or even ½ or 1/3, after spending their hard-earned money on a supplement, encounter no positive results?  Not in my world.  Therefore, while studies that use the phrase “compared to placebo” can be helpful, I feel, in terms of maximizing chances of successful practices and happy patients, we need to know the actual percentage of patients who responded positively.  As you have seen in the papers reviewed so far, isolated supplementation of micronutrients virtually never yields positive results in more than 50% of the patients.  To determine if this is a trend or an exception, I decided to examine, at random, one of the best compendiums of nutritional and alternative approaches to illness, Textbook of Natural Medicine, Third Edition (18).

In the chapter on migraine headache (19), riboflavin is discussed as a potential therapeutic modality based on several studies, one of which being “Effectiveness of high-dose riboflavin in migraine prophylaxis.  A randomized controlled trial” by Schoenen et al (20)  As you might expect, because this study was referenced in the above mentioned text, riboflavin supplementation performed well compared to placebo:

“We now compared riboflavin (400 mg) and placebo in 55 patients with migraine in a randomized trial of 3 months duration.  Using an intention to treat analysis, riboflavin was superior to placebo in reducing attack frequency (p=0.005) and headache days (p=0.012).”

However, in terms of actual patient numbers, was the percent of positive responders in the 70th to 80th percentile that we need to assure successful practices?  Or, were the numbers in the range I have discussed thus far?  The authors state:

“…the proportion of patients who improved by at least 50%, i.e. ‘responders,’ was 15% for placebo and 59% for riboflavin (p=0.002)…”

While the results are impressive from a statistical standpoint, can you afford to have 40% of your patients who purchase supplements from you report no positive results?  I know I can’t.

Of course, as indicated in the Gibson et al (16) study, magnesium seems to perform best clinically of all isolated supplemental micronutrients.  However, in contrast to the findings of Gibson et al (16), did supplemental magnesium perform better than 50% in terms of patient response with migraine headaches?  In the above mentioned chapter on migraine headache, the authors state:

“Two recent double-blind studies have provided conflicting results in the prevention of migraine in people prone to recurrent migraine headaches.  In the first study, 250 mg of magnesium or placebo was given twice daily to 69 patients (35 received magnesium, 34 the placebo) for 12 weeks.  The number of responders was 10 in each group (28.6% with magnesium and 29.4% with placebo).  There was no benefit from magnesium compared with placebo, with respect to migraine frequency or intensity.  In the other double-blind study, 81 patients experiencing recurrent migraines were given either 600 mg or oral magnesium daily for 12 weeks or placebo.  By the ninth week, the attack frequency was reduced by 41.6% in the magnesium group compared with only 15.8% in the placebo group.”

As you can see, even the positive findings, while impressive compared to placebo, are far less than what most of us need to have successful practices and large amounts of happy patients.

The second condition I considered at random from The Textbook of Natural Medicine, Third Edition in terms of efficacy of micronutrient supplementation was osteoarthritis.  In the chapter on osteoarthritis by Murray and Bongiorno (21) a positive study by Jonas et al (22) in relation to niacinamide supplementation was discussed.  The protocol was 3000 mg daily in six divided dosages or placebo for 12 weeks.  What were the results?  Again, compared to placebo, they were impressive.  But what about the actual numbers?  In the abstract of the study the following is noted:

“Global arthritis impact improved by 29%…in subjects on niacinamide and worsened by 10% in placebo subjects (p=0.04).  Pain levels did not change but those on niacinamide reduced their anti-inflammatory medications by 13%…”

So now that I have, hopefully, strongly suggested that there is often a large difference between “hype,” sales pitches from supplement company reps and speakers, and reality, where does this leave us?  Should we all just abandon clinical nutrition and chalk it up to therapies that, over the centuries, never seemed to live up to their theoretical potential?  I would guess that many of you would respond to this suggestion and my whole treatise outlined so far in this newsletter with a forceful and somewhat indignant “WAIT A MINUTE!!  NO MATTER WHAT YOU SAY AND RESEARCH YOU PRESENT, I DISAGREE!!  FOR, I GET GREAT RESULTS WITH MY PATIENTS USING MICRONUTRIENT SUPPLEMENTATION!!

What would be my reply to your forceful and vehement disagreement?  I would say, with equal force and vehemence, “I HAVE NO DOUBT THAT YOU DO!!”  Why?  Because I have still not told the whole story about the efficacy of micronutrient supplementation.  In fact, so far I have only told the side of the story that addresses the way most of the public and many nutritionists use micronutrient supplementation; as single entities assumed to have such panacea-like qualities that they can be used in isolation without any other supplementation or lifestyle modifications.  Again, as I hope I have demonstrated, this approach to micronutrient supplementation shown in the research environment has consistently failed to demonstrate efficacy in more than a small percentage of patients.  But, as many of you suggest with your successful clinical results, the rest of the story does not lead to a conclusion of complete worthlessness – just as violins and tennis balls are high quality modalities, yet, because they are being used incorrectly, they appear to be worthless.

PUBLISHED RESEARCH INDEED SUGGESTS THAT RECOMMENDATIONS OF MICRONUTRIENT SUPPLEMENTATION BY KNOWLEDGEABLE NUTRITIONAL PRACTITIONERS CERTAINLY DOES MAKE A DIFFERENCE IN TERMS OF PATIENT EFFICACY.

Why are your results so different from what is being seen in so many studies?  While there are many reasons, I would suggest one of the most important is that you take the time to thoroughly evaluate your patient so as to determine which supplemental micronutrients would uniquely fit individual patient needs.  When talented clinicians take the time to determine individual patient need, does the picture presented in published research concerning efficacy of supplemental micronutrients take on a different appearance?  As suggested by a commentary on B vitamins, homocysteine, and CVD seen below, it most certainly does.  Furthermore, several studies that I am about to present make it clear that, when specific patients needs are considered in terms of supplemental micronutrient combinations or use of micronutrient supplementation along with other lifestyle modifications, rates of efficacy, as you have suggested, increase dramatically.  As I mentioned, this was suggested by an interesting commentary that accompanied the Bonaa et al (10) and HOPE2 (9) studies on homocysteine, CVD, and B vitamin supplementation discussed above.  Of course, very often editorials that accompany negative studies on supplements that appear in major medical journals often take on a “Ha ha I told you so” tone.  In contrast, the editorial by Loscalzo entitled “Homocysteine trials -Clear outcomes for complex reasons” (23) takes on a very different tone that affirms the existence of the issues you evaluate in your patients every day before initiating nutritional therapies:

“The straightforward but incorrect view that folic acid can decrease homocysteine levels and, thus, reduce the risk of atherosclerosis effectively may be an unintended consequence of oversimplifying a complicated metabolic network.”

As this quote suggests, just because folic acid supplementation cannot, alone, reduce atherosclerosis risk does not make it worthless.  Atherosclerosis, in fact, is “complicated,” involving homocysteine imbalances and a whole lot more.  Therefore, folic acid has value, not as a heart disease cure-all as claimed by many, but as a vital component in patient care when employed by those who understand the “…complicated metabolic network.”

Do other papers exist on the homocysteine/CVD connection that suggests, when considered by knowledgeable clinicians who understand unique patient needs, valid correlations can be found?  In “Impact of homocysteine-lowering vitamin therapy on long-term outcome of patients with coronary artery disease” by Mager et al (24) 492 patients with early-onset coronary artery disease were treated with at least 400 mcg of folic acid per day with or without additional B vitamins at the discretion of the attending physicians.  Furthermore, the data was subdivided based on levels of serum homocysteine.  With this type of supplemental customization and analysis of severity of homocysteine elevations, was a different outcome noted compared to the large population, one-size-fits-all approach to supplementation in relation to homocysteine and CVD that was used in the studies discussed earlier in this monograph?  The authors state:

“Treatment was associated with significantly lower all-cause mortality in patients with homocysteine levels >15 micromol/L…but not in patients with lower levels…”

In addition, a study by Siragusa et al (25)on 216 cardiovascular patients found some interesting correlations in relation to how fast B vitamin supplementation lowers homocysteine levels.  The supplemental protocol consisted of the following:

“All of them received folate (5 mg twice a week) and B vitamins (Vitamin B1 250 mg, Vitamin B6 250 mg and Vitamin B12 500 mg twice a week) for 3 months.”

The patients were then followed for five years concerning any reports of cardiovascular events.  During this time the authors noted three different types of impact of the supplemental program on plasma homocysteine levels:

“…i) those in whom plasma homocysteine levels decreased within ❤ months of therapy (Group I); ii) those in whom plasma homocysteine levels decreased after 3 months of therapy (Group 2), and iii) those in whom homocysteinemia never decreased.”

There were 145 patients in Group I, 53 patients in Group II, and 18 patients in Group III.  What were the findings in relation to occurrence of cardiovascular events?  As expected, based on the above mentioned studies, many patients demonstrated no observable impact of the B vitamin regimen on occurrence of cardiovascular events.  However, others did note a reduction.  In relation to homocysteine, was there anything unique about those who noted a reduction and those who did not?  Siragusa et al (25) point out the following:

“Timing and entity of homocysteinemia reduction clearly influenced the risk of cardiovascular recurrent events: it was significantly low only when vitamin therapy acted rapidly (Group 1).”

With this data in mind, the authors concluded:

“In conclusion, these data show that vitamin therapy is efficacious for reducing the risk of recurrent cardiovascular events only when it rapidly decreases homocysteinemia levels.  In all the other cases (lack or delayed reduction of homocysteinemia levels) the risk for recurrent events remains consistently high.”

Thus, the reality of reducing homocysteine levels with B vitamin supplements and its relationship to CVD incidence is that the studies that reported no positive impact were, in reality only reporting what happens due to poor matching of the right treatment regimen with the group of patients who could most benefit because homocysteine levels were not evaluated intelligently.  In contrast, other, less publicized, research makes it clear that, in the hands of clinicians like you who are adept at both interpretation of diagnostic tests and the creation of optimal, patient specific treatment programs, the B vitamin/homocysteine paradigm appears to have great value for certain selected patients.  As I mentioned, truly amazing things can occur when discerning people decide not to try to hit tennis balls with a violin and, instead, play music with it.

With this theme in mind that, quite possibly, when recommended by knowledgeable practitioners who understand that violins have value even though they cannot be used to hit tennis balls because they are, in fact, valuable for the important role of making music, should we take another look at the study discussed previously on antioxidants and atherosclerosis by Katsiki and Manes (1)?  As you may recall, the authors concluded that antioxidant supplementation had no value in relation to the prevention of atherosclerosis.  However, in a letter to the editor by Levy (26) that addressed this study, the following, in agreement with my premise concerning recommendations by knowledgeable practitioners, was stated by the author:

“In conclusion, we absolutely agree with the reviewers that there has been no consistent protective effect of any single antioxidant or combination against cardiovascular morbidity and mortality.  However, one reason why antioxidant trials may have failed to show clinical benefit in these studies may be related to inappropriate patient selection.  Groups with evidence of a significant pro-oxidative and pro-inflammatory milieu may benefit from antioxidants.  Thus, better identification of such sub-groups, which will respond favourably to treatment with antioxidants is worthy of investigation.”

With this theme in mind, I would also like to go back to the study by Marmsjo et al (8) that concluded use of multivitamin supplements by children over five years of age had no positive impact on incidence of allergic disease.  Does this mean we totally dismiss the idea that multivitamin supplements might have value in relation to allergic disease in children?  Not if we take the time and have the knowledge to further investigate the situation to see if there might be certain subgroups of patients that might receive benefit.  In agreement, Marmsjo et al (8) state the following in their study:

“…children who reported that they started taking multivitamins before or at age 4 y had a decreased risk of sensitization to food allergens…and tendencies toward inverse associations with allergic rhinitis.”

Next, in support of my hypotheses that recommendations made by knowledgeable nutritional practitioners can play a major role in determining efficacy of supplemented micronutrients in chronically ill patients, consider the use of vitamin B6 with patients with premenstrual syndrome (PMS) as reported by Hudson (27).  According to the author, research has shown that vitamin B6 supplementation with PMS patients certainly is an exception to the trend I have been suggesting of low efficacy percentages:

“…in one double-blind crossover trial, 84% of the subjects had a lower symptomatology score during the B6treatment period.”

However, Hudson goes on to note that not all studies on vitamin B6 supplementation and PMS have shown a positive effect.  Does this mean that the value of vitamin B6 supplementation should now be questioned for all PMS patients?  According to Hudson (27), the answer is no.  In contrast, negative results could mean that the patient has unique needs in addition to vitamin B6 supplementation that knowledgeable practitioners should both identify and treat:

“The negative results in some trials may have been caused by many factors, such as the inability of some women to convert B6 to its active form owing to a deficiency in another nutrient (e.g., vitamin B2 or magnesium) that was not supplemented.  These results suggest that supplementing pyridoxine by itself may have adequate clinical results for all women suffering from this disorder and that some women may have difficulty converting vitamin B6 into its active form, pyridoxal-5-phosphate.  To overcome this conversion difficulty, it may be necessary to use a broader-spectrum nutritional supplement or to use injectable pyridoxal-5-phosphate.”

Still another example in support of my hypotheses also supports my contention that, for most patients, supplementation of both potassium and magnesium as determined by a knowledgeable nutritional practitioner is the place to begin with Entry Level Clinical Nutrition™.  In the discussion of chronic fatigue syndrome by Murray and Bongiorno (28), the following is stated about potassium and magnesium supplementation in combination:

“These studies used oral magnesium and potassium aspartate (1 g each) rather than injectable magnesium.  Between 75% and 91% of the nearly 3000 patients studied experienced relief of fatigue during treatment with the magnesium and potassium aspartate.  In contrast, the number of patients responding to a placebo was between 9% and 26%.  The beneficial effect was usually noted after only 4 to 5 days, but sometimes 10 days were required.  Patients usually continued treatment for 4 to 6 weeks; afterward, fatigue frequently did not return.”

Why do practitioner recommendations make such a difference in terms of efficacy of supplemented micronutrients?

While I will admit that the answer to this question is probably multifactorial and somewhat self obvious based on the research presented above, I would like to present one answer that is so simple and common sense-based that it is frequently overlooked by many.  Contrary to the assertions by many in the mass media and in the supplement industry, micronutrient supplements, being natural, do not have magical, mythical curative properties.  In fact, an important reason they work so well is that they are very effective in addressing symptoms related to micronutrient deficiency.  In turn, which micronutrient supplements will perform the best in terms of efficacy with any particular patient?  The all too simple but, most likely, the most accurate answer to the question is:

The ones for which the patient demonstrates deficiency!!

In agreement, Mark Kantor, an associate of nutrition and food science at the University of Maryland’s College of Agriculture & Natural Resources, discusses which nutrients patients should ingest to reduce the risk of flu in an article by Jennifer Larue Huget that appeared in the September 29, 2009 edition of our local newspaper, The Daily Hampshire
Gazette.  
How does Kantor answer this issue?

“Kantor suggests that we look instead at ‘which key nutrient you’re not getting enough of in the first place.'”

Does published research support my contention that the place to begin with micronutrient supplementation in terms of maximizing efficacy is with deficiency?  One interesting study by Wu et al (29) addressed this question in relation to the controversial relationship between folic acid supplements and risk of recurrent colorectal adenoma.  As you might expect, based on the research I have discussed in this monograph in relation to the efficacy of approaches where large populations are supplemented with single nutrients with no consideration of other risk factors, overall results concerning prevention were not favorable:

“Our results do not support an overall protective effect of folic acid supplementation on adenoma recurrence.”

However, how well did folic acid supplementation perform with patients who were deficient in folate?  The authors state:

“Among participants with low plasma folate concentrations at baseline (≤7.5 ng/mL), those randomly assigned to receive folic acid experienced a significant decrease in adenoma recurrence.”

Interestingly, many may counter the above statement by pointing out the popular belief that micronutrient deficiency is fairly rare in our society.  Therefore, dietary optimization is all that is necessary to assure sufficient micronutrient intake.  Unfortunately, as many of you know, there is a major flaw in this logic.  Virtually all the published information that suggests optimal diet can assure optimal micronutrient intake points out that this is true for healthy individuals.  However, how many people in this country are truly healthy?  I would suggest that research pointing out explosive levels of increases in obesity, diabetes, and demand in health care services make it fairly clear that truly healthy individuals are not as commonplace as some of the “all you need is a good diet if you are healthy” proponents would like to believe.  In turn, as I will demonstrate, several documented aspects of the acute and chronic phase responses such as gut dysfunction, hypermetabolism, inflammation, and metabolic acidosis increase micronutrient requirements to amounts that greatly exceed RDA levels, making supplementation an absolute necessity in chronically ill individuals, even when optimal diets have been instituted.

Of course, with the assumption that micronutrient deficiency is more common than is generally believed due to increased levels of chronic illness and poor diets, and with the assumption that micronutrient supplementation is most efficacious when deficiency exists, it should come as no surprise that virtually all large scale, one-size-fits-all approaches to micronutrient supplementation will yield fair to poor results in most instances.  Does this mean we should condemn micronutrient supplementation as suggested by many?  Not any more than we should condemn violins because they are poor tennis rackets.  In contrast, we need to fully accept the fact that, if micronutrient supplementation is truly going to lead to happy patients and successful practices, our involvement as knowledgeable practitioners with patients must be an integral part of the process if accurate determination of the nutritional needs that often accompany ever growing levels of chronic illness is to occur.

As an affirmation of the above, consider this statement that appeared in the December 7, 2009 edition of The Daily Hampshire Gazette in relationship to how women should react to the new recommendations on mammography.  An editorial using the somewhat worn out, often used, but appropriate phrase “Talk to your doctor” as a title, stated the following:

“…it doesn’t appear that cutting costs was the motivation behind the task force’s recommendations.  This was essentially an effort to move in the direction of what’s called evidenced-based medicine, which means taking a hard look at what the evidence actually shows about detection and treatment of disease.

And that, as we’ve just seen, isn’t a neat and tidy process.  Studies are complicated and sometimes flawed.  Scientific findings are full of nuance and qualifications.  That means that as patients we have to take responsibility for asking questions of our health care providers.  It means understanding that medical best practices aren’t set in stone and actually should be subject to scrutiny.  It’s frustrating, and no one says it’s easy-but it’s also necessary.”

SOME PARTING, “BIG PICTURE” THOUGHTS

As I hope I have demonstrated in this monograph, there is certainly a large body of research and clinical data to support my hypothesis expressed in part I of this series that we need a new approach to clinical nutrition so as to optimally and time and cost effectively address the needs of chronically ill patients with clinical nutrition.  Why?  Certainly most of the reasons relate to the more direct issues I have been emphasizing concerning better patient outcomes that lead to happy patients and successful practices, which generally leads to something equally important, happy practitioners.  However, there is another, larger-perspective reason that I highlighted at the beginning of this newsletter.  As we all know, containment of health care expenditures on a nationwide basis is major concern.  While, as I mentioned, the total amount spent on supplements pales in comparison to the amounts spent on other forms of health care, the fact that we in clinical nutrition are responsible for less spending does not exempt us from an obligation to do everything we can to reduce costs while maintaining efficacy.

As I hope I have also demonstrated, it is quite apparent that vast sums of money are being spent on micronutrient supplements without yielding any tangible benefit.  With this reality in mind, I feel that the defense presented by many in the nutritional community that we are better and wiser because we are responsible for lower costs than what is seen in allopathic medicine is really no defense at all.  For, in my opinion, if a supplement demonstrates no tangible benefit to the user, one penny is an excessive expenditure.

With these proximate and large perspective issues in mind, I hope I have convinced you that a new approach to making micronutrient supplementation more efficacious and more cost effective must involve, as part of the process, you and me, knowledgeable nutritional practitioners.  For, broad-based, panacea-type approaches to clinical nutrition that do not involve knowledgeable practitioners as an integral part of the process are simply not even coming close to attaining the levels of efficacy we need today from both preventive and treatment standpoints.  Fortunately, in terms of optimal efficacy, I feel that our involvement though the use of functional medicine and other diagnostic and treatment modalities that many of you routinely use is leading to fulfillment of this goal.  In contrast, as I mentioned in part I, I continue to feel strongly that functional medicine and many of the other diagnostic and treatment modalities we are currently using have not, up to this point, optimally addressed the issue of cost and time effectiveness, particularly for patients in middle to lower income categories.  Furthermore, if practitioner involvement is the key to optimizing efficacy with clinical nutrition, functional medicine and many other diagnostic and treatment modalities currently available to nutritional practitioners have also not optimally addressed the issue of cost and time effectiveness for practitioners in today’s challenging health care provider environment.  Therefore, I am suggesting that we institute an additional set of chronic illness diagnostic and treatment criteria that can provide a predictable level of efficacy on a cost and time efficient basis for both patients and practitioners before functional medicine and other diagnostic and treatment modalities are, when necessary, implemented.  These criteria consist of the foundational metabolic stabilization procedures outlined in part I of this series that form the essence of Entry Level Clinical Nutrition™, which is basically a set of cost and time effective diagnostic and treatment modalities that are built upon biochemical and physiological principles and practices derived from probably the most intensively researched area of clinical nutrition in terms of patient outcome, critical care nutrition.

In part III of this series, I truly will begin my explanation of the approaches used in critical care nutrition, emphasizing the focus of critical care nutritionists on the acute phase response which, in my opinion, more than anything else explains why these nutritionists get such good results using relatively straight forward and simple diagnostic and treatment modalities.

Moss Nutrition Report #230 – 12/01/2009 – PDF Version

REFERENCES

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