Niacin – also known as vitamin B3 or nicotinic acid - is a natural compound (formula C
2 ) and an essential nutrient for humans. It is water-soluble, which means it is not stored in the body. Excess amounts of the vitamin leave the body through the urine. That means we need a continuous supply of niacin in your diet.
Niacin is found in variety of foods, including liver, chicken, beef, fish, cereal, peanuts and legumes. It can also be synthesized from tryptophan, an essential amino acid found in protein. Niacin has long been an accepted treatment for high cholesterol. It is well-documented to increase the levels of high-density cholesterol (HDL or “good cholesterol”) and to decrease the levels of low-density cholesterol (LDL or “bad cholesterol”).
But what do these effects really mean? Do they translate into true health benefits? A brand-new study casts doubt on the value of niacin therapy:
After a pre-randomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants’ ability to take extended-release niacin without clinically significant adverse effects, the researchers randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The primary outcome was the first major vascular event (non-fatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).
During a median follow-up period of 3.9 years, participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was 10 mg per deciliter (0.25 mmol/l) lower and an HDL cholesterol level that was 6 mg per deciliter (0.16 mmol/l) higher than the levels in those assigned to placebo. Thus the lipid-effects of previous studies were confirmed.
However, assignment to niacin-laropiprant, as compared with assignment to placebo, had no significant effect on the incidence of major vascular events Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious and with an increased incidence of diabetes diagnoses as well as increases in serious adverse events associated with the gastrointestinal system, the musculoskeletal system, the skin and infections and bleeding.
Based of these data, the authors arrived at the following conclusion: among participants with atherosclerotic vascular disease, the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.
This extremely well-done trial is a poignant reminder of the fact that, in health care, we must never take our assumptions for granted. Here the underlying assumption was that the Niacin-induced lipid changes lead to a reduction of cardiovascular risks. Not only it proved to be erroneous but, through serious adverse effects, Niacin actually decreased patients’ health status.
The lessons from all this are straight forward, I think:
- ‘Natural’ does not necessarily mean safe.
- Long-established does not necessarily mean efficacious.
- Assumptions are merely assumptions, nothing more; if we want to make sure that they hold, we need to test them.
- When we finally do test assumptions, we better do it rigorously.
Dr. Oz, famous through his TV show promoting all types of quackery, recently testified before a US Senate subcommittee hearing on protecting consumers from false and deceptive advertising of weight loss products. This event turned out to be less than flattering for Dr Oz. One journalist commented that he “might as well be a cowardly lion — sent home with his tail between his legs after being accused at a congressional hearing of lying on his show about weight-loss claims.”
“I don’t get why you need to say this stuff, because you know it’s not true,” said Senator Claire McCaskill, who led the commerce subcommittee hearing. “The scientific community is almost monolithically against you in terms of the efficacy of the products you called ‘miracles,’ ” the Democratic senator from Missouri told Oz. “It’s a major problem when people are spending more and more money and they’re gaining more and more weight,” said Senator Amy Klobuchar.“Either you don’t talk about these things at all, or you’re going to have to be more specific because right now . . . this is not working.”
A source close to Dr Oz said he was perplexed: “We were invited down to Washington to testify at a hearing about scams and instead it became all about how much we hate your show.” Oz himself testified that he “heard the message…I do personally believe in the items that I talk about.”
“I intensively study them. I have given my family these products. . . . If you can lose a pound a week more than you would have lost by using them, it jump-starts you and gets you going. I think it makes sense.” “I’m surprised you’re defending this,” McCaskill replied. “It’s something that gives people false hope. I don’t see why you need to go there.”
Another journalist commented that the Senators repeatedly placed him on the defense over his weight loss products: “I know you know how much power you have. I know you know that. You are very powerful and [with] power comes a great deal of responsibility,” Senator Claire McCaskill , who led the Senate’s consumer protection hearing titled “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products…You are being made an example of today because of the power you have in this space…We didn’t call this hearing to beat up on you but we did call this hearing to talk about a real crisis in consumer protection. You can either be part of the police here or you can be part of the problem.”
Oz insisted he was no huckster but admitted the products promoted on his show don’t always have “the scientific muster” to present their benefits as “fact…I actually do personally believe in the items that I talk about in the show. I passionately studied them. I recognize that oftentimes they don’t have the scientific muster to present as fact but nevertheless I would give my audience the advice I give my family all the time. And I have given my family these products,” he said.
Dr Oz also said that some alternative treatments, such as prayer, cannot be tested scientifically. “I don’t think this ought to be a referendum on the use of alternative medical therapies. Because if that’s the case, listen, I’ve been criticized for having folks coming on my show talking about the power of prayer,” he said. “I can’t prove that prayer helps people survive an illness.”
No, Dr Oz! I know you are mistaken! I have done the research – both on alternative slimming aids and on spiritual healing. The results quite clearly show that these methods are not more effective than a placebo.
Guest post by Michelle Dunbar
According to the CDC, more than 30,000 people died as a result of a drug overdose in 2010. Of those deaths none were attributed to marijuana. Instead the vast majority were linked to drugs that are legally prescribed such as opiates, anti-depressants, anti-psychotics, tranquilizers and benzodiazepines. As misuse and abuse of prescription medications continues to rise, the marijuana legalization debate is also heating up.
Nearly 100 years of propaganda, fear mongering and blatant misinformation regarding marijuana has taken its toll on our society. As the veil of lies surrounding marijuana is being lifted, more and more people are pushing for legalization. Marijuana is now legal for both medicinal and recreational use in two states and other states are introducing legislation of their own. Marijuana is approved for medicinal use with a prescription in 21 states and also Washington, D.C. with most other states expected to introduce legislation to approve use for medicinal purposes in the next few years.
Last year Dr. Sanjay Gupta, the medical correspondent for CNN, aired a controversial documentary, “Weed”, where he showed various promising medicinal uses for marijuana. He admits that he was wrong for many years about marijuana legalization, and after doing his own extensive research he is encouraged by the many real life cases he has seen where people with chronic, serious medical issues have been and continue to be helped by marijuana. He noted that marijuana does not have the dangerous side effects that many prescription medications do and that it is actually safer than many drugs being prescribed today. Dr. Gupta said in the program that there is not one documented case where death was due to marijuana overdose and he is right.
But as with any systematic paradigm shift, there will always be those whose minds are closed to change. So as the march toward legalization continues, there is new anti-legalization propaganda being written and spread through mainstream and social media. There have been multiple reports out of Colorado that there are now deaths attributed to marijuana overdose. Some say children were involved which automatically evokes feelings of fear in parents across the country. But when I tried to find more reliable sources to verify these articles, none existed. The AP reported on April 2 that a Wyoming college student jumped to his death in Colorado after eating a marijuana cookie while on Spring Break in Colorado. The autopsy listed marijuana intoxication as a “significant contributing factor” in the teen’s death. (Gurman)
Like alcohol, Colorado bans the sale of marijuana and marijuana edibles to people under the age of 21. But much like alcohol, teens that want to get it will always find a way. This young man was just 19, and his death has been ruled accidental. While it is true his death is tragic, is it a reason to reverse the course with marijuana? If you believe this is the case then you must consider the real dangers posed by alcohol. Many people who would like to see marijuana legalized say that it is much safer than the legal drug alcohol. Based solely on the numbers of hospitalizations and deaths, especially with young people, they would be right.
According to an article posted on Forbes.com in March of this year, “1,825 college students between the ages of 18 and 24 die each school year from alcohol-related unintentional injuries.” The author, Dr. Robert Glatter, MD attributes these deaths to one of the leading health risks facing our young people, and that is binge drinking. This number is quite small in comparison to emergency room visits and hospitalizations of young people that are a direct result of alcohol use.
Taking the most heat are the marijuana edibles that are now for sale in states where marijuana has become legal. The concern is that children are eating marijuana laced candy and baked goods and becoming ill. This would seem to be confirmed by an article in USA Today that reported that calls to the Rocky Mountain Poison Control is Colorado regarding marijuana ingestion in children had risen to 70 cases last year. While they admitted that this number was low, it was the rapid rise from years previous that caused concern. To put this in perspective, there are approximately 1.4 million pediatric poisonings each year involving prescription medications not including marijuana. (Henry, et.al) That is an average of approximately 28,000 calls per state. Tragically several hundreds of these cases result in deaths of these children, with the highest rates of death involving narcotics, sedatives and anti-depressants. (Henry, et.al.)
Of those 70 cases reported in Colorado involving marijuana, none resulted in death. The results are quite clear marijuana is as safe as prescription drugs are dangerous. For those who want to weigh in on the marijuana legalization debate, it is important to do your research, look at the big picture and put everything in perspective. Alcohol is legal and heavily regulated, yet its use is linked to thousands of deaths each year. Prescription drugs are legal and heavily regulated, yet they too are linked to thousands of deaths each year. Marijuana, on the other hand, is not legal and not available in much of the country, and thus far has not caused one death from overdose ever.
Additionally, research is showing marijuana has promise in treating many diseases more effectively and safely than dangerous prescription medications being used today. From cancer to epilepsy to depression and anxiety, to chronic autoimmune diseases, scientists are just scratching the surface when it comes to the potential life-changing and perhaps even, life-saving uses for marijuana.
Drug Overdose in the United States: Fact Sheet. (2014, February 10). Centers for Disease Control and Prevention. Retrieved May 4, 2014, from http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html
Glatter, R. (2014, March 11). Spring Break’s Greatest Danger. Forbes. Retrieved May 5, 2014, from http://www.forbes.com/sites/robertglatter/2014/03/11/spring-breaks-greatest-danger/
Gurman, S. (2014, April 2). Young man leaps to death after eating pot-laced cookie. USA Today. Retrieved May 5, 2014, from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edible-death-colorado-denver/7220685/
Henry, K., & Harris, C. R. (2006). Deadly Ingestions. Pediatric Clinics of North America, 53(2), 293-315.
Hughes, T. (2014, April 2). Colo. Kids getting into parents’ pot-laced goodies. USA Today. Retrieved May 5, 2014 from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edibles-colorado/7154651/
Cancer patients are bombarded with information about supplements which allegedly are effective for their condition. I estimate that 99.99% of this information is unreliable and much of it is outright dangerous. So, there is an urgent need for trustworthy, objective information. But which source can we trust?
The authors of a recent article in ‘INTEGRATIVE CANCER THARAPIES’ (the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments) review the issue of dietary supplements in the treatment of cancer patients. They claim that the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. This sounds promising, and we might thus trust them to deliver something reliable.
In order to enable doctors and other health care professionals to have such discussion, the authors then report on the work of the ‘Clinical Practice Committee’ of ‘The Society of Integrative Oncology’. This panel undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of supplements that have the best suggestions of benefit was constructed by “leading researchers and clinicians“ who have experience in using these supplements:
- vitamin D,
- maitake mushrooms,
- fish oil,
- green tea,
- milk thistle,
The authors claim that their review includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would be aware of the supplements and be able to discuss realistic expectations and potential benefits and risks (my emphasis).
At first glance, this task looks ambitious but laudable; however, after studying the paper in some detail, I must admit that I have considerable problems taking it seriously – and here is why.
The first question I ask myself when reading the abstract is: Who are these “leading researchers and clinicians”? Surely such a consensus exercise crucially depends on who is being consulted. The article itself does not reveal who these experts are, merely that they are all members of the ‘Society of Integrative Oncology’. A little research reveals this organisation to be devoted to integrating all sorts of alternative therapies into cancer care. If we assume that the experts are identical with the authors of the review; one should point out that most of them are proponents of alternative medicine. This lack of critical input seems more than a little disconcerting.
My next questions are: How did they identify the 10 supplements and how did they evaluate the evidence for or against them? The article informs us that a 5-step procedure was employed:
1. Each clinician in this project was requested to construct a list of supplements that they tend to use frequently in their practice.
2. An initial list of close to 25 supplements was constructed. This list included supplements that have suggestions of some possible benefit and likely to carry minimal risk in cancer care.
3. From that long list, the group agreed on the 10 leading supplements that have the best suggestions of benefit.
4. Each participant selected 1 to 2 supplements that they have interest and experience in their use and wrote a manuscript related to the selected supplement in a uniformed and agreed format. The agreed format was constructed to provide a base of knowledge, so physicians and other health care providers would be able to discuss realistic expectations and potential benefits and risks with patients and families that seek that kind of information.
5. The revised document was circulated among participants for revisions and comments.
This method might look fine to proponents of alternative medicine, but from a scientific point of view, it is seriously wanting. Essentially, they asked those experts who are in favour of a given supplement to write a report to justify his/her preference. This method is not just open bias, it formally invites bias.
Predictably then, the reviews of the 10 chosen supplements are woefully inadequate. These is no evidence of a systematic approach; the cited evidence is demonstrably cherry-picked; there is a complete lack of critical analysis; for several supplements, clinical data are virtually absent without the authors finding this embarrassing void a reason for concern; dosage recommendations are often vague and naïve, to say the least (for instance, for milk thistle: 200 to 400 mg per day – without indication of what the named weight range refers to, the fresh plant, dried powder, extract…?); safety data are incomplete and nobody seems to mind that supplements are not subject to systematic post-marketing surveillance; the text is full of naïve thinking and contradictions (e.g.”There are no reported side effects of the mushroom extracts or the Maitake D-fraction. As Maitake may lower blood sugar, it should be used with caution in patients with diabetes“); evidence suggesting that a given supplement might reduce the risk of cancer is presented as though this means it is an effective treatment for an existing cancer; cancer is usually treated as though it is one disease entity without any differentiation of different cancer types.
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. But I do wonder, isn’t being in favour of integrating half-baked nonsense into cancer care and being selected for one’s favourable attitude towards certain supplements already a conflict of interest?
In any case, the review is in my view not of sufficient rigor to form the basis for well-informed discussions with patients. The authors of the review cite a guideline by the ‘Society of Integrative Oncology’ for the use of supplements in cancer care which states: For cancer patients who wish to use nutritional supplements, including botanicals for purported antitumor effects, it is recommended that they consult a trained professional. During the consultation, the professional should provide support, discuss realistic expectations, and explore potential benefits and risks. It is recommended that use of those agents occur only in the context of clinical trials, recognized nutritional guidelines, clinical evaluation of the risk/benefit ratio based on available evidence, and close monitoring of adverse effects. It seems to me that, with this review, the authors have not adhered to their own guideline.
Criticising the work of others is perhaps not very difficult, however, doing a better job usually is. So, can I offer anything that is better than the above criticised review? The answer is YES. Our initiative ‘CAM cancer’ provides up-to-date, concise and evidence-based systematic reviews of many supplements and other alternative treatments that cancer patients are likely to hear about. Their conclusions are not nearly as uncritically positive as those of the article in ‘INTEGRATIVE CANCER THERAPIES’.
I happen to believe that it is important for cancer patients to have access to reliable information and that it is unethical to mislead them with biased accounts about the value of any treatment.
I am sure, we have all heard it hundreds of times: THERE ARE IMPORTANT LINKS BETWEEN OUR DIET AND CERTAIN CANCERS. The evidence for this statement seems fairly compelling. Yet it also is complex and often confusing.
A recent review, for instance, suggested that fruits (particularly citrus) and vegetable consumption may be beneficial in the primary prevention of pancreatic cancer, the consumption of whole grains has been shown to reduce the risk and fortification of whole grains with folate may confer further protection. Red meat, cooked at high temperatures, should be avoided, and replaced with poultry or fish. Total fat should be reduced. The use of curcumin and other flavonoids should be encouraged in the diet. Another equally recent review, however, indicated that there is no conclusive evidence as an independent risk factor for isolated nutrients versus adoption of dietary patterns for cancer risk. Cancer colon risk derived from meat intake is influenced by both total intake and its frequency. The interaction of phenolic compounds on metabolic and signalling pathways seems to exert an inhibitory effect on cell proliferation and tumor metastasis and induces apoptosis in various types of cancer cells, including colon, lung, prostate, hepatocellular or breast cancer. A third recent review concluded that cruciferous vegetable intake protects against cancer of the colon, while a forth review suggested that the Mediterranean dietary pattern and diets composed largely of vegetables, fruit, fish, and soy are associated with a decreased risk of breast cancer. There was no evidence of an association between traditional dietary patterns and risk of breast cancer.
Not least based on these mixed messages from the scientific literature, an entire industry has developed selling uncounted alternative cancer-diets and dietary supplements to desperate patients and consumers. They promise much more than just cancer prevention, in fact, leave little doubt about the notion that cancer might be curable by diet. Here are just a few quotes from the thousands of websites promoting alternative cancer diets:
- The Ketogenic Diet is believed capable of starving cancer cells to death, and thus capable of restricting tumour development.
- a more alkaline body makes it difficult for tumors to grow.
- Budwig diet: This diet was developed by Dr. Johanna Budwig who was nominated for the noble Prize sixth times. The diet is intended as a preventative as well as an alternative cancer treatment.
- the Gerson Therapy naturally reactivates your body’s magnificent ability to heal itself – with no damaging side effects. This a powerful, natural treatment boosts the body’s own immune system to heal cancer, arthritis, heart disease, allergies, and many other degenerative diseases. Dr. Max Gerson developed the Gerson Therapy in the 1930s, initially as a treatment for his own debilitating migraines, and eventually as a treatment for degenerative diseases such as skin tuberculosis, diabetes and, most famously, cancer.
- the concept of macrobiotics is much more than an alternative diet for cancer, or any other illness, but rather the ancient Chinese belief that all life, indeed the whole universe, is a balance of two opposing forces Yin and Yang.
Confused? Yes, I do worry how many cancer patients listen to these claims and pin their hopes on one of these diets. But what exactly does the evidence tell us about them?
A German team of researchers evaluated the following alternative cancer-diets: raw vegetables and fruits, alkaline diet, macrobiotics, Gerson’s regime, Budwig’s and low carbohydrate or ketogenic diet. Their extensive searches of the published literature failed to find clinical evidence supporting any of the diets. Furthermore, case reports and pre-clinical data pointed to the potential harm of some of these diets. The authors concluded that considering the lack of evidence of benefits from cancer diets and potential harm by malnutrition, oncologists should engage more in counselling cancer patients on such diets.
In other words, alternative cancer diets – and I mean not just the ones mentioned above, but all of them – are not supported by good evidence for efficacy as a treatment or prevention of any type of cancer. In addition, they might also cause harm.
What follows is obvious: cancer patients should take sound nutritional advice and adopt a healthy general life-style. But they should run a mile as soon as anyone suggests an alternative dietary cure for their disease.
I am constantly on the look-out for good studies of alternative medicine, particularly those that yield positive findings. The trouble is that there aren’t many of those; studies tend to be either good or positive. Could this one be an exception?
The aim of this brand-new trial was to determine, if dietary supplements of glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain in patients with knee osteoarthritis. It was designed as a double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45–75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both of these dietary supplements (n=151) or placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0–10) was self-reported in a participant diary for 7 days every 2 months over 1 year.
The results indicate that, after adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden’s nodes), allocation to the dietary supplement combination (glucosamine–chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm 0.20 mm); no significant structural effect for the single treatment allocations was detected. All 4 groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period.
The authors drew the following conclusions: allocation to the glucosamine–chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo.
This study has many strengths: it addresses a relevant research question, has a sufficiently large sample size, includes a long follow-up, and is well reported. So, it is a good study of an alternative therapy that is used by many patients. But did it really produce a positive result, i.e. findings which suggest that the tested treatments are effective? The answer seems ‘yes and no’. The combined, regular intake of both supplements caused less joint space narrowing which is a good objective sign of reduced disease activity. However, this was not paralleled by a reduction in pain that was better than that on placebo.
So, if you are a fan of glucosamine/chondroitin supplements, you will be pleased with this study, but if you are not in favour of such medications or do not have the spare cash to afford the considerable costs, you might say: I told you, they are pretty useless!
Many dietary supplements are heavily promoted for the prevention of chronic diseases, including cardiovascular disease (CVD) and cancer. But do they actually work or are they just raising false hopes? The evidence on this subject is confusing and proponents of both camps produce data which seemingly support their claims. In this situation, we need an independent analysis of the totality of the evidence to guide us. And one such review has just become available
The purpose of this article was to systematically review evidence for the use of multivitamins or single nutrients and functionally related nutrient pairs for the primary prevention of CVD and cancer in the general population.
The authors searched 5 databases to identify literature that was published between 2005 and January 29, 2013. They also examined the references from the previous reviews and other relevant articles to identify additional studies. In addition, they searched Web sites of government agencies and other organizations for grey literature. Two investigators independently reviewed identified abstracts and full-text articles against a set of a priori inclusion and quality criteria. One investigator abstracted data into an evidence table and a second investigator checked these data. The researchers then qualitatively and quantitatively synthesized the results for 4 key questions and grouped the included studies by study supplement. Finally, they conducted meta-analyses using Mantel-Haenzel fixed effects models for overall cancer incidence, CVD incidence, and all-cause mortality.
103 articles representing 26 unique studies met the inclusion criteria. Very few studies examined the use of multivitamin supplements. Two trials showed a protective effect against cancer in men; only one of these trials included women and found no effect. No effects of treatment were seen on CVD or all-cause mortality.
Beta-carotene showed a negative effect on lung cancer incidence and mortality among individuals at high risk for lung cancer at baseline (i.e., smokers and asbestos-exposed workers); this effect was persistent even when combined with vitamin A or E. Trials of vitamin E supplementation showed mixed results and altogether had no overall effect on cancer, CVD, or all-cause mortality. Only one of two studies included selenium trials showed a beneficial effect for colorectal and prostate cancer; however, this trial had a small sample size. The few studies addressing folic acid, vitamin C, and vitamin A showed no effect on CVD, cancer, and mortality. Vitamin D and/or calcium supplementation also showed no overall effect on CVD, cancer, and mortality. Harms were infrequently reported and aside from limited paradoxical effects for some supplements, were not considered serious.
The authors’ conclusion are less than encouraging: there are a limited number of trials examining the effects of dietary supplements on the primary prevention of CVD and cancer; the majority showed no effect in healthy populations. Clinical heterogeneity of included studies limits generalizability of results to the general primary care population. Results from trials in at-risk populations discourage additional studies for particular supplements (e.g., beta-carotene); however, future research in general primary care populations and on other supplements is required to address research gaps.
A brand-new RCT provides further information, specifically on the question whether oral multivitamins are effective for the secondary prevention of cardiovascular events. In total, 1708 patients aged 50 years or older who had myocardial infarction (MI) at least 6 weeks earlier with elevated serum creatinine levels were randomly assigned to an oral, 28-component, high-dose multivitamin and multi-mineral mixture or placebo. The primary end point was time to death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. Median follow-up was 55 months. Patients received treatments for a median of 31 months in the vitamin group and 35 months in the placebo group. 76% and 76% patients in the vitamin and placebo groups completed at least 1 year of oral therapy, and 47% and 50% patients completed at least 3 years. Totals of 46% and 46% patients in both groups discontinued the vitamin regimen, and 17% of patients withdrew from the study.
The primary end point occurred in 27% patients in the vitamin group and 30% in the placebo group. No evidence suggested harm from vitamin therapy in any category of adverse events. The authors of this RCT concluded that high-dose oral multivitamins and multiminerals did not statistically significantly reduce cardiovascular events in patients after MI who received standard medications. However, this conclusion is tempered by the nonadherence rate.
These findings are sobering and in stark contrast to what the multi-billion dollar supplement industry promotes. The misinformation in this area is monumental. Here is what one site advertises for heart disease:
Vitamin C could be helpful, limit dosage to 100 to 500 mg a day.
Vitamin E works better with CoQ10 to reduce inflammation in heart disease. Limit vitamin E to maximum 30 to 200 units a few times a week. Use a natural vitamin E complex rather than synthetic products.
CoQ10 may be helpful in heart disease, especially in combination with vitamin E. I would recommend limiting the dosage of Coenzyme Q10 to 30 mg daily or 50 mg three or four times a week.
Curcumin protects rat heart tissue against damage from low oxygen supply, and the protective effect could be attributed to its antioxidant properties. Curcumin is derived from turmeric, which is often used in curries.
Garlic could be an effective treatment for lowering cholesterol and triglyceride levels for patients with a history or risk of cardiovascular disease, especially as a long term strategy.
Terminalia arjuna, an Indian medicinal plant, has been reported to have beneficial effects in patients with ischemic heart disease in a number of small studies. Arjuna has been tested in angina and could help reduce chest pain.
Magnesium is a mineral that could help some individuals. It is reasonable to encourage diets high in magnesium as a potential means to lower the risk of coronary heart disease.
Danshen used in China for heart conditions.
And in the area of cancer, the choice is even more wide and audacious as this web-site for example demonstrates.
So, the picture that emerges from all this seems fairly clear. Despite thousands of claims to the contrary, dietary supplements are useless in preventing cardiovascular diseases or cancer. All they do produce, I am afraid, is rather expensive urine.
Web-sites have become a leading source of information on health matters. This is particularly true in the realm of alternative medicine. Conventional health care professionals often know too little about this subject to advise their patients, and alternative practitioners are usually too biased to be trusted. So many consumers turn to the Internet and hope that it offers information which is reliable. But is it?
American pharmacists published a study evaluating the quality of on-line information on herbal supplements. They conducted a search of 13 common herbals – including black cohosh, echinacea, garlic, ginkgo, ginseng, green tea, kava, saw palmetto, and St John’s wort - and reviewed the top 50 Web sites for each using a Google search. Subsequently, they analysed clinical claims, warnings, and other safety information.
A total of 1179 Web sites were examined in this way. Less than 8% of retail sites provided information regarding potential adverse effects, drug interactions, and other safety information; only 10.5% recommended consultation with a healthcare professional. Less than 3% cited scientific literature to support their claims.
The authors’ conclusions were worrying: Key safety information is still lacking from many online sources of herbal information. Certain nonretail site types may be more reliable, but physicians and other healthcare professionals should be aware of the variable quality of these sites to help patients make more informed decisions.
Having conducted my fair share of similar research (e.g. here or here or here or here), I can only concur with these conclusions. When it comes to health care, the Internet is a scary place! In the realm of alternative medicine, it is dominated by people who seem not to care much about anything other than their profits.
But what can be done to change this situation? How can we protect the public from Internet-charlatans? How can one control the Internet? I wish I knew! But there are nevertheless means of directing consumers to those sites which do offer reliable information. Kite-marking high quality sites might be one way of achieving this. This task would, of course, be huge and difficult, but in the interest of public safety, governments and other official institutions should consider tackling it.
Hypercholesterolemia is an important, independent risk factor for cardiovascular disease, according to a generally accepted wisdom. Measures to normalise elevated blood lipids include diet, exercise and drugs, of which statins are the most widely prescribed. But many people have become somewhat sceptical about the wide-spread use of statins: Traditionally, doctors have viewed statin drugs as the most effective way to lower high LDL cholesterol. But today researchers are starting to believe that statins may not be the magic bullet they’ve always been made out to be. Statins can cause severe adverse effects and some experts have questioned whether they generate more benefit than harm and suggested that ‘BIG PHARMA’ are pushing statins not for the benefit of public health but for maximising profit.
This begs the question: is there an alternative?
This RCT tested the efficacy of a dietary supplement providing 1.8 g/day esterified plant sterols and stanols to improve the fasting lipid profile of men and women with primary hypercholesterolemia. Repeated measures analysis of covariance was used to compare outcomes for sterol/stanol and placebo treatment conditions using the baseline value as a covariate. Thirty subjects were randomized and all of them completed the trial.
Baseline (mean±standard error of the mean) plasma lipid concentrations were: total cholesterol 236.6±4.2 mg/dL (6.11±0.11 mmol/L), high-density lipoprotein (HDL) cholesterol 56.8±3.0 mg/dL (1.47±0.08 mmol/L), LDL cholesterol 151.6±3.3 mg/dL (3.92±0.09 mmol/L), non-HDL cholesterol 179.7±4.6 mg/dL (4.64±0.12 mmol/L), and triglycerides 144.5±14.3 mg/dL (1.63±0.16 mmol/L). Mean placebo-adjusted reductions in plasma lipid levels were significant (P<0.01) for LDL cholesterol (-4.3%), non-HDL cholesterol (-4.1%), and total cholesterol (-3.5%), but not for triglycerides or HDL cholesterol.
The authors conclude that these results support the efficacy of 1.8 g/day esterified plant sterols/stanols in softgel capsules, administered as an adjunct to the National Cholesterol Education Program Therapeutic Lifestyle Changes diet, to augment reductions in atherogenic lipid levels in individuals with hypercholesterolemia.
These findings are encouraging but certainly not rock solid. The study was too small, and the effect sizes were less than impressive. A brand-new systematic review, however, provides much more convincing data.
Its aim was to quantify the LDL-cholesterol-lowering effect of plant sterols/stanols as supplements. Eight eligible clinical trials were identified. Among the trials with a duration between 4 and 6 weeks, plant sterol/stanol dose ranged from 1.0 to 3.0 g/day administrated mainly with the main meals (2 or 3 times/day). Intake of plant sterol/stanol supplements decreased LDL-cholesterol concentrations by 12 mg/dL (0.31 mmol/L) compared with placebo. Further analysis showed no significant difference between the LDL-cholesterol-lowering action of plant sterols/stanols supplements vs foods enriched with plant sterols/stanols. The authors concluded that plant sterol/stanol supplements as part of a healthy diet represent an effective means of delivering LDL-cholesterol-lowering similar to plant sterols/stanols delivered in various food formats.
Crucially, this positive verdict does not stand alone. Another recent review included 5 trials and concluded that a dose-effect relationship of plant stanols in higher doses than currently recommended has been demonstrated by recent clinical studies and a meta-analysis.
Plant sterols seem to be not just effective but also safe: none of the trials published to date reported significant adverse effects. The only concern is the potential decrease in the concentrations of lipid-soluble antioxidants and vitamins, including β-carotene, α-tocopherol, lutein, and α-carotene. It is currently not clear whether these effects are clinically relevant.
The relative merits of phytosterols versus statins are not easy to evaluate. We have hundreds of studies of statins but just a few of sterols. This means our knowledge in this area is incomplete. Statins can cause serious adverse effects but their effects on blood lipids is about one order of magnitude larger that those of sterols. There is plenty of evidence to show that statins lower the risk of cardiovascular disease, while such data are missing for phytosterols.
The choice between statins and plant sterols is thus not easy, particularly considering the often emotional arguments and hype used in the ‘cholesterol-debate’. Phytosterols offer one more alternative therapy for lowering LDL-cholesterol levels. They seem safe and have the added attraction of being ‘natural’ – but the lipid-effects are relatively small, the impact on cardiovascular morbidity and mortality is uncertain, and fairly high doses are required to see any lipid-lowering at all.
For those who know about the subject, this is an old hat, of course. But for many readers of this blog, it might be news: ‘Traditional’ Chinese Medicine (TCM) is not nearly as traditional as it pretends to be. In fact, it is an artefact of recent creation. The man who has been saying that for years is Professor Paul Unschuld, one of the leading sinologist worldwide and an expert who has written many books and journal articles on the subject.
During an interview given in 2004, he defined TCM as “an artificial system of health care ideas and practices generated between 1950 and 1973 by committees in the People’s Republic of China, with the aim of restructuring the vast and heterogenous heritage of Chinese traditional medicine in such a way that it fitted the principles–Marxist Maoist type democracy and modern science and technology on which the future of the PRC was to be built…[the Daoist underpinning for TCM] is incorrect for two reasons. First . . . TCM is a product of Communist China. Second, even if we were to apply the term TCM to pre-revolutionary Chinese medicine, the Daoist impact should be considered minimal.”
In a much more recent interview entitled INVENTION FROM THE FAR EAST which he gave to DER SPIEGEL (in German), he explained this in a little more detail (I have tried to translate his words as literally as possible):
What is being offered in our country to patients as TCM is a construct that was created in China on an office desk which has been altered further on its way to the West.
Already at the beginning of the 20th century, reformers and revolutionaries urged that the traditional medicine in China should be abolished and that the western form of medicine should be introduced instead. Traditional thinking was seen as backwards and it was held responsible for the oppressing superiority of the West. The introduction of Western natural sciences, medicine and technology was also thought later, after the foundation of the People’s Republic, to be essential for rendering the country competitive again. Since the traditional Chinese medicine could not be totally abolished then because it offered a living to many citizens, it was reduced to a kernel, which could be brought just about in line with the scientific orientation of the future communist society. In the 1950s and 60s, an especially appointed commission had been working on this task. The filtrate which they created from the original medical tradition was hence forward to be called TCM vis a vis foreigners.
There is little more to add, I think - perhaps just two brief after-thoughts. TCM is a most lucrative export article for China. So don’t expect Chinese officials to rid TCM of the highly marketable ‘TRADITIONAL’ label. And remember: the ‘appeal to tradition’ argument is a fallacy anyway.