All About Supplements: the FAQ from the New York Buyers’ Club

This FAQ is now posted on the New York Buyers’ Club website in an easy-to-navigate format:

FAQ ON NUTRITIONAL SUPPLEMENTS

Topics covered include supplements used to improve gut function, manage cholesterol/triglycerides, address liver disease, help with mood/memory, maintain lean muscle mass and optimal weight, and address conditions like nausea, diarrhea and neuropathy.

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Niatab 500mg from Douglas Labs – sustained release Niacin for use in managing cholesterol

The New York Buyers’ Club now stocks Niatab 500 from Douglas Labs. This timed-release product is better tolerated than regular Niacin formulas (that is, minimizes flushing, which can be bothersome to some), and may be especially helpful to those who are using Niacin on a regular basis in managing their cholesterol.

With federally-funded research now pointing to Niacin + a statin drug as the new standard of preventive care for cardiovascular disease, this is a very welcome addition to the Douglas Labs line. For background on the recent revival of interest in Niacin, see “An Old Cholesterol Remedy is New Again,” by Michael Mason in The New York Times, Jan. 23, 2007.


PRODUCT DESCRIPTION
Niatab™ 500 tablets, provided by Douglas Laboratories®, slowly release 500 mg of pure niacin. Sustained release niacin is better tolerated than regular crystalline high-potency niacin supplements. Niatab 500 is a scored uncoated tablet which can be broken in half when lower dosage is desired.
REFERENCES
Alderman JD et al. Effect of a modified, well-tolerated niacin regimen on serum total cholesterol, high density lipoprotein cholesterol and the cholesterol to high density lipoprotein ratio. Am J Cardiol 1989;64:725-729.
Canner PL et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol 1986;8:1245-1255.
Colletti RB et al. Niacin treatment of hypercholesterolemia in children. Pediatrics 1993;92:78-82.
Keenan JM et al. Niacin revisited: a randomized, controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia. Arch Intern Med 1991;151:1424-1432.
Lavie CJ et al. Marked benefit with sustained-release niacin therapy in patients with ‘isolated’ very low levels of high-density lipoprotein cholesterol and coronary artery disease. Am J Cardiol 1992;69:1083-1085.
Probstfield JL. Nicotinic acid as a lipoprotein-altering agent: therapy directed by the primary physician. Arch Int Med 1994;154:1557-1559.


Product Description and References from: Douglas Labs Product Info Sheet

Cholesterol and cardiovascular health: the debate in the New York Times letters to the editor page continues

A recent letter to the editor of the NYT from a nutritionist expresses some of the same concerns about cholesterol control and cardiovascular health that we’ve been raising recently.

See also today’s NYT editorial on the FDA, which has lately been beset, bothered and besieged by questions about its ability to manage the drug approval process.


To the Editor:

Yet again, we miss the point about cholesterol. To read Gary Taubes’s article, one might think that cholesterol is a toxic substance.

In truth, cholesterol is a naturally occurring lipid produced by the liver. It is the biochemical precursor to vitamin D and to the sex hormones. It is an integral part of every cell membrane. So this war against cholesterol is a war against ourselves.

Perhaps a better question to ask would be, Under what conditions does cholesterol become part of the plaque that contributes to heart disease? And guess what? We’ve had some of the answers for years.

When free radicals attack or oxidize the LDLs, cholesterol may enter the plaque. This problem can be addressed by including more antioxidants in the diet or with vitamin supplementation.

Another factor is uncontrolled high blood glucose, which can damage blood vessels, increasing the potential for plaques to form. Here also, diet, exercise and antidiabetic drugs can help.

Moreover, there is a huge and valuable literature connecting heart disease to stress and emotional wounds. All the statin drugs in the world won’t scratch that itch.

Bottom line: When the questions we ask about health are defined by the pharmaceutical companies, the answers we get will be better for Big Pharma’s profits than for our health and healing.

Rona S. Weiss
Teaneck, N.J., Jan. 28, 2008

The writer is a nutritionist and health consultant.

EPA (fish oil): from the Physician’s Desk Reference Health site

Thought we’d draw attention to a great online resource for getting the basics on a supplement, and for checking on potential interactions among supplements, drugs, food, alcohol:  Physicians’ Desk Reference (PDR) Health.
Below is an excerpt from the entry for EPA (fish oil), which includes the usual warning about interaction with blood-thinnning medications like Coumadin.

See also the entry on fish oil on the NYBC website.

EPA

What is it?
EPA is an oil that comes from fish. It is used to treat asthma, cancer, arthritis, Lupus, blood clotting, gingivitis (gum disease), high cholesterol, hypertension (high blood pressure), colitis (inflammatory bowel disease), Crohn’s disease, and psoriasis. EPA is also used as an antiinflammatory (help with pain and swelling), to stimulate the immune system, and for cardiovascular health, to help prevent heart disease and stroke. It may also be used to prevent Alzheimer’s disease.

Other names for EPA include: Eicosapentaenoic Acid, Fish Oil, Omega-3 Fatty Acid, Essential Fatty Acid. 

Drug and Food Interactions:
Do not take omega-3 fish oils such as EPA without talking to your doctor first if you are taking:

Blood thinning medicines (examples: warfarin (Coumadin(R); dicumarol (Dicumarol(R))

Whatever happened to policosanols?

Several years ago, there was growing interest in policosanols, a newly identified supplement, as a cholesterol-lowering agent. Major international scientific journals published promising studies of this substance derived from sugar cane wax, and it was already being marketed in a number of countries by the Cuban manufacturer, which had also conducted all the major studies (hmmm…). As of 2005, the accumulation of evidence was so impressive that even the NIH decided to fund an investigation of policosanols to lower lipid levels in people with HIV on HAART.

So what happened to this once-promising supplement? The tale is told in a piece of investigative reporting that NYBC published in early 2007. Author: Sean-Michael Fleming, with additional contributions from George Carter and Jared Becker.

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While updating the NYBC website [in 2006], I encountered disturbing reports of new, damning studies of policosanols, once the cholesterol-lowering darling of the supplement world. After some investigation, I realized I had started down a trail of…international intrigue.



Policosanols (chemically speaking, a mix of different kinds of long-chain fatty acids) became the golden child of supplements in recent years, with dazzling promise of being able to lower LDL (“bad”) cholesterol up to 30% with negligible side effects – and at far less cost than prescription statins. They seemed a godsend for those on HAART (highly active antiretroviral therapy), who often struggle with cholesterol control. Described in many respected scientific journals worldwide, they had been tested successfully on thousands of people!

Studies of sugarcane-derived policosanols first emerged from Cuba in the mid-1990s. Interest grew as human trials confirmed the supplement’s effectiveness in treating dyslipidemia. (Dyslipidemia refers to abnormal blood fat levels: elevated “bad” cholesterol and triglycerides, and low HDL or “good” cholesterol; it is frequently the precursor of cardiovascular disease.)


The Cuban studies received a major seal of approval from German scientists reviewing them in the American Heart Journal in 2002. Surveying over 20 published studies, the scientists declared the supplement to be “a fascinating new agent for the prevention and treatment of atherosclerotic disease.”
Meanwhile the sale of Cuban sugarcane policosanols – now patented – expanded to more than 40 countries, mainly in South America and the Caribbean. The Cuban version couldn’t be sold in the US due to the trade embargo, but a multitude of policosanol products appeared here as well. At NYBC we were enthusiastic about policosanol’s potential, and added it to our catalog in 2005.But doubts were surfacing. Studies of policosanols extracted from wheat germ and from rice failed to find an effect, though some claimed these forms did not contain the right balance of aliphatic alcohols (=policosanols).


In 2006 the German scientists who had given the Cuban studies high marks returned with results of their own rigorous trial of Cuban sugarcane policosanols, which found them no more effective than a dummy pill. Later in the year, Canadian researcher Dr. Peter Jones also reported a study using Cuban sugarcane policosanols that showed the supplement had no value in lowering cholesterol. (However, he used a 10 mg dose that may have been too low; others suggest the study was too short, being only 28 days long.)


Perhaps there was cause for skepticism from the start. Almost all the Cuban studies came from Dalmer Labs, which was connected to the nation’s Center for Scientific Research and then became the marketer of Cuba’s patented policosanols. No independent scientific verification took place outside of Cuba for years. And was it coincidence that the policosanol studies came out just when Cuba’s sugar industry was staggering under the loss of Soviet subsidies and a string ofbad harvests? Boosting sales of sugarcane derivatives became an acknowledged national goal, and would certainly be a good way to restore profitability to the island’s major cash crop.


We don’t yet know the full back-story to this “policontroversy.” At NYBC we are considering discontinuing policosanols, and would like to hear reactions from any member who has used them. In the meantime, we urge anyone interested in using them to do so at the beginning of bloodwork on a stable regimen. Then see if they work for you—or not. And please share your experiences with us.


With the promise of policosanols tarnished, what lipid-lowering alternatives to prescription drugs do people have? Fish oils continue to gain respect in scientific/medical communities in Europe and the US (see info about them on our new Supplement Fact Sheets – see “Resource Relaunch Revealed” in this issue). Dr. Jones sees a potentially bright future for plant sterols, which may significantly improve lipid profiles—we look forward to more study of these substances. Then there’s niacin, which despite the problem of “flushing/itching,” works very well for some people as a cholesterol-lowering agent (see detailed suggestions on our website).


Of course, nutritionists have long known about the moderate cholesterol-lowering effect of high-fiber foods like oatmeal. If you are trying to control your cholesterol, you should also understand that sugar intake, not just fat intake, influences your cholesterol level. And when monitoring cholesterol and cardiovascular risk, remember that the more recent focus has been not just on lowering “bad” cholesterol, but raising “good” cholesterol (which niacin does very well). And of course, making dietary changes and getting routine exercise are the first basis with which to start.


Thoughts? Comments? Any further information to offer us as we prepare to close the books on this once-promising supplement?

Fish oil, inflammation and metabolic complications in HIV: a clinical trial and related research

We noticed with interest that Dr. Todd T Brown, a Johns Hopkins researcher who has studied body fat changes in people with HIV, has recently started a wide-ranging investigation of fish oil / omega-3 fatty acid supplementation as a way of preventing/treating metabolic complications associated with highly active antiretroviral therapy (HAART). Metabolic complications, including fat wasting, central body fat build-up, insulin resistance, high cholesterol and triglycerides, and bone loss, have been some of the major side effects experienced by people with HIV on medication, so it’s quite interesting to see research that may “connect the dots” and find links between these various problems. 

Furthermore, this is a study that focuses on fish oil / omega-3 fatty acids, which have quite recently gained more respect in US medical circles, especially as a means of preventing/treating cardiovascular disease, but also for a surprising effect on depression. (You can read more about this aspect of fish oil supplementation in the “depression” category on this blog.)

 Here’s the description of Dr. Brown’s research, as provided on the website of NCCAM/NIH, one of the major sponsors of the study:

Abstract: DESCRIPTION (provided by applicant): The overall goal of this proposal is to understand the role of inflammatory cytokines in the metabolic and skeletal abnormalities in HIV disease and to determine whether omega-3 fatty acid supplementation, in the form of fish oil, will alter the pathophysiology of these clinical disorders. Complementary and alternative medicines (CAM) are used widely among HIV-infected patients, often with the hope of preventing or treating complications associated with highly active antiretroviral therapy (HAART). Metabolic abnormalities, including peripheral fat wasting, central adiposity, insulin resistance, and dyslipidemia, and skeletal abnormalities (reduced bone mineral density and high bone turnover), are common in HIV-infected patients on HAART, yet their relationship is unclear. We hypothesize that these metabolic and skeletal abnormalities are related by abnormal inflammatory cytokine expression and that these conditions can be improved with fish oil, a widely-used CAM agent with anti-inflammatory properties. We have the following specific aims: 1) To understand the association between the metabolic and skeletal abnormalities in HIV-infected subjects and their relationship to inflammation, 2) To determine whether treatment with omega-3 fatty acids will have hypotriglyeridemic, anti-inflammatory, and anti-bone resorptive effects in a randomized trial of HIV-infected patients, and 3) To clarify the mechanisms of action of omega-3 fatty acids, namely the effect on lipolysis and bone turnover using stable isotope infusion techniques. To accomplish our specific aims, I intend to do a secondary analysis of data from two cohorts of HIV-infected subjects, and to then perform a randomized trial using a standardized fish oil product. These results will help to define the pathophysiology of the metabolic and skeletal abnormalities in HIV and evaluate the efficacy and potential mechanisms of action of an important complementary treatment […]

(According to the published information, the clinical trial of fish oil is scheduled to run from 2006-2010.)

Note: An interview with Dr. Brown on body fat changes in people with HIV can be found on the website of our friends at www.thebody.com.

Statins and people with HIV: overview of special concerns

This information from  www.aidsmap.com provides a good overview of the special concerns involved in the prescription of cholesterol-lowering statins for people with HIV. (Note: references to the scientific literature in this piece may be retrieved by going back to the aidsmap website.)

You may want to read this information together with our posts on Niacin +statins, an emerging standard of care for cholesterol control (see under Niacin on this Blog). 

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Atorvastatin (Lipitor) is a statin that can reduce the levels of low-density lipoprotein (LDL or ‘bad’) cholesterol in the blood. This can reduce the risk of cardiovascular disease, including heart attacks and strokes. Statins work by inhibiting the enzyme 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, which is responsible for the production of cholesterol.

Patients with liver disease or who are pregnant should not take statins. However, they are safe drugs in most patients. The main side-effects are muscle pain, as well as headache, altered liver function, tingling sensations, abdominal pain, flatulence, constipation, diarrhoea, nausea and vomiting.

Statins, including atorvastatin, are effective in the treatment of the alterations of blood fat levels due to treatment with anti-HIV drugs, particularly protease inhibitors. However, atorvastatin is broken down by the cytochrome P450 3A4 enzyme, and interacts with all available protease inhibitors and non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Protease inhibitors cause an increase in atorvastatin levels, increasing the risk of side-effects such as muscle pain and damage to the muscle fibres. Consequently, patients taking protease inhibitors should use another statin such as pravastatin sodium (Lipostat) or fluvastatin (Lescol) in place of atorvastatin, or they should use the lowest possible dose of atorvastatin with caution.

In contrast, NNRTIs reduce the levels of atorvastatin, putting patients at risk of poor anti-cholesterol effects. Patients taking an NNRTI and atorvastatin should have their dose of atorvastatin adjusted as required to keep cholesterol levels low.

Some experts believe that statins may have anti-HIV properties in their own right. However, a recent study found that atorvastatin failed to prevent CD4 cell count declines in patients interrupting anti-HIV treatment.