Well, not everywhere actually; if you go on Medline, for instance, and search for ‘detox’, you hardly find anything at all on detox as used in alternative medicine. This is because there is no science behind it (for the purpose of this post, ‘detox’ means the alternative detox that is supposed to rid us from environmental poisons and, more relevant to the Christmas season, of the effects of over-indulgence). Notwithstanding this lack of science and evidence, detox is currently being heavily promoted in magazines, newspapers and, of course, via the Internet.
Take the heir to our thrown, Prince Charles, for instance; he famously marketed his Duchy Originals ‘DETOX TINCTURE’. And he has competition from thousands who also exploit the gullible with similar placebos. One website even claimed that “2014 was the year of the cleanse diet. Celebrities swear by them and more and more people have been getting in on the action, whether it’s to detox diet, brighten skin, lose weight, or get a fresh start. And nowhere is that more evident than in Yahoo’s Year in Review, where different health cleanses consistently topped the site’s most popular stories lists. Here, the year’s top 10 most popular cleanses.”
The author then continues by promoting 10 different forms of detox:
1. A Colon Cleanse.
2. A Liver Cleanse.
3. The Master Cleanse.
4. The 10-Day Green Smoothie Cleanse.
5. A Juice Cleanse.
6. Detox Cleanse.
7. Slendera Garcinia and Natural Cleanse.
8. Dherbs Full Body Cleanse.
9. Blueprint Cleanse.
10. Isagenix Cleanse for Life.
These treatments seem diverse but they all have one thing in common: they do not work; they do not eliminate poisons from the body, they merely eliminate cash from your wallet.
But being so very negative is not the way forward, some might argue. Why does he not tell us which forms of detox do actually work?
Because it is Christmas, I will do just that and provide my readers with a full list of detox treatments that are effective. If you are looking for a specific type of detox and it is not on the list, it means you should spend your money on something else, stop over-indulging yourself and adopt a sensibly health lifestyle.
HERE WE GO – THIS IS MY COMPLETE LIST OF EFFECTIVE FORMS OF DETOX:
MERRY CHRISTMAS EVERYONE
The regular consumption of fish-oil has a potentially favourable role in inflammation, carcinogenesis inhibition and cancer outcomes. An analysis of the literature aimed to review the evidence for the roles of dietary-fish and fish-oil intake in prostate-cancer (PC) risk, aggressiveness and mortality.
A systematic-review, following PRISMA guidelines was conducted. PubMed, MEDLINE and Embase were searched to explore PC-risk, aggressiveness and mortality associated with dietary-fish and fish-oil intake. 37 studies were selected.
A total of 37-studies with 495,321 participants were analysed. They revealed various relationships regarding PC-risk (n = 31), aggressiveness (n = 8) and mortality (n = 3). Overall, 10 studies considering PC-risk found significant inverse trends with fish and fish-oil intake. One found a dose–response relationship whereas greater intake of long-chain-polyunsaturated fatty acids increased risk of PC when considering crude odds-ratios [OR: 1.36 (95% CI: 0.99–1.86); p = 0.014]. Three studies addressing aggressiveness identified significant positive relationships with reduced risk of aggressive cancer when considering the greatest intake of total fish [OR 0.56 (95% CI 0.37–0.86)], dark fish and shellfish-meat (p < 0.0001), EPA (p = 0.03) and DHA (p = 0.04). Three studies investigating fish consumption and PC-mortality identified a significantly reduced risk. Multivariate-OR (95% CI) were 0.9 (0.6–1.7), 0.12 (0.05–0.32) and 0.52 (0.30–0.91) at highest fish intakes.
The authors concluded that fish and fish-oil do not show consistent roles in reducing PC incidence, aggressiveness and mortality. Results suggest that the specific fish type and the fish-oil ratio must be considered. Findings suggest the need for large intervention randomised placebo-controlled trials.
Several other recent reviews have also generated encouraging evidence, e.g.:
…omega-3 fatty acids may exert their anticancer actions by influencing multiple targets implicated in various stages of cancer development, including cell proliferation, cell survival, angiogenesis, inflammation, metastasis and epigenetic abnormalities that are crucial to the onset and progression of cancer.
If I was aiming for a career as a cancer quack, I would now use this evidence to promote my very own cancer prevention and treatment diet. As I have no such ambitions, I should tell you that regular fish oil consumption is no way to treat cancer. It also is no way to prevent cancer. If anything, it might turn out to be a way of slightly reducing the risk of certain cancers. To be sure, we need a lot more research, and once we have it, fish oil will be entirely mainstream. Raising false hopes regarding ‘alternative cancer cures’ based on fairly preliminary evidence is counter-productive, unethical and irresponsible.
As I have said on several occasions before: I am constantly on the lookout for new rigorous science that supports the claims of alternative medicine. Thus I was delighted to find a recent and potentially important article with some positive evidence.
Fish oil has been studied extensively in terms of its effects on health. We know that it has powerful anti-inflammatory properties and might thus benefit a wide range of conditions. However, the effects of FO in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA.
A new study has tried to fill this gap by examining the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).
Patients with RA <12 months’ duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.
In the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti–cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.
The authors concluded that FO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.
So here we have a dietary supplement that actually might generate more good than harm! There is a mountain of data of good research on the subject. We understand the mechanism of action and we have encouraging clinical evidence. Some people might still say that we do not need to take supplements in order to benefit from the health effects of FO, consuming fatty fish regularly might have the same effects. This is true, of course, but the amount of fish that one would need to eat every day would probably be too large for most people’s taste.
The drawback (from the perspective of alternative medicine) in all this is, of course, that some experts might deny that FO has much to do with alternative medicine. Again: what do we call alternative medicine that works? We call it MEDICINE! And perhaps FO is an excellent example of exactly that.
Dietary supplements (DS) are heavily promoted usually with the claim that they have stood the test of time and that they are natural and hence harmless. Unsurprisingly, their use has become very wide-spread. A new study determined the use of DSs, factors associated with DS use, and reasons for use among U.S. college students.
College students (N = 1248) at 5 U.S. universities were surveyed. Survey questions included descriptive demographics, types and frequency of DS used, reasons for use and money spent on supplements. Supplements were classified using standard criteria. Logistic regression analyses examined relationships between demographic and lifestyle factors and DS use.
Sixty-six percent of college students surveyed used DS at least once a week, and 12% consumed 5 or more supplements a week. Forty-two percent used multivitamins/multiminerals, 18% vitamin C, 17% protein/amino acids and 13% calcium at least once a week. Factors associated with supplement use included dietary patterns, exercise, and tobacco use. Students used supplements to promote general health (73%), provide more energy (29%), increase muscle strength (20%), and enhance performance (19%).
The authors of this survey concluded that college students appear more likely to use DS than the general population and many use multiple types of supplements weekly. Habits established at a young age persist throughout life. Therefore, longitudinal research should be conducted to determine whether patterns of DS use established early in adulthood are maintained throughout life. Adequate scientific justification for widespread use of DS in healthy, young populations is lacking.
Another new study investigated the use of DSs in 334 dancers from 53 countries, who completed a digitally based 35-question survey detailing demographic information and the use of DSs. Supplement use was prevalent amongst this international cohort, with 48% reporting regular DSs use. Major motives for supplement use were to improve health, boost immunity, and reduce fatigue. Forty-five percent believed that dancing increased the need for supplementation, whilst 30% recognized that there were risks associated with DSs.
The most frequently consumed DSs were vitamin C (60%), multivitamins (67%), and caffeine (72%). A smaller group of participants declared the use of whey protein (21%) or creatine (14%). Supplements were mainly obtained from pharmacies, supermarkets, and health-food stores. Dancers recognized their lack of knowledge in DSs use and relied on peer recommendations instead of sound evidence-based advice from acknowledged nutrition or health care professionals.
The authors concluded that this study demonstrates that DSs use is internationally prevalent amongst dancers. Continued efforts are warranted with regard to information dissemination.
Finally, a third study investigated use of DSs in patients in Japan. This survey was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about DSs. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using DSs, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses.
The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used DSs to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using DSs concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention DSs use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with DSs.
The authors concluded that communication between patients and physicians is important to avoid health problems associated with the use of DSs.
There is little doubt, DSs are popular with all sorts of populations and have grown into a multi billion dollar industry. There is also no doubt that the use of only very few DSs are evidence-based (and if so, in only relatively rare situations). And there can be no doubt that many DSs can do harm. What follows is simple: for the vast majority of DSs the benefits do not demonstrably out-weigh the risks.
If that is true, we have to ask ourselves: Why are they so popular?
The answer, I think, is because of the very phenomenon I am constantly trying to fight on this blog – IRRESPONSIBLE CHARLATANS PULLING WOOL OVER CONSUMERS EYES.
While the previous post was about seeing a traditional herbalist (who prescribe their own herbal mixtures, tailor-made for each individual patient), this post provides essential information for those consumers who are tempted to take a commercially available herbal remedy available in pharmacies, health food shops, over the Internet etc. These remedies are usually bought by consumers and then be self-administered, or (less frequently) they might be prescribed/recommended/sold by a clinician such as a doctor, naturopath, chiropractor etc. Typically, they contain just one (or relatively few) herbal extracts and are used under similar assumptions as conventional medicines: one (hopefully well-tested) remedy is employed for treating a defined condition, diagnosed according to validated and generally accepted criteria (for instance, St John’s Wort for depression or Devil’s claw for back pain). This approach is sometimes referred to as ‘rational phytotherapy’ – it is certainly more rational than the traditional herbalism referred to in my previous post. The manufacture, promotion and sale of commercial herbal remedies (in many countries marketed as ‘dietary supplements’) has grown into a multi-billion dollar industry.
Here are a few essentials you ought to know before you decide to take such an herbal remedy:
- Many people claim that herbal medicine is effective because many of our modern drugs are based on plants. The latter part of this claim is true, of course, but this does not necessarily mean that herbal remedies are effective. The drugs derived from plants contain one single, well-defined, extensively researched molecule (by definition, this makes them conventional drugs and not herbal remedies), while herbal remedies are based on entire (parts of) plants; thus they contain many pharmacologically active molecules. This often means that it is difficult or impossible to tell what dose of which ingredient is being administered and what pharmacological actions can be expected.
- Even though national regulations differ greatly, herbal remedies generally do not have to be supported by evidence for efficacy in order to be legally available. This means that a given remedy might or might not have been tested in clinical trials to determine whether it works for the condition advertised. In fact, only very few (less than 30, I estimate) herbal remedies are supported by sound evidence for efficacy; thousands do not meet this criterion.
- The extremely wide-spread notion that herbal remedies are by definition natural and therefore safe is nothing but a promotional myth. Plants contain many chemicals which can have pharmacological activity. This means they might be therapeutic, but it also means that they might be toxic (traditionally the most powerful poisons originated from the plant kingdom). If anyone uses the ‘natural = safe fallacy’ remind him/her of hemlock, poison ivy etc.
- In addition to potential toxicity of an herbal ingredient, there are other important safety issues to be considered. Most importantly, herbal remedies can interact with prescribed medicines. For instance, St John’s Wort (one of the best-studied herbal remedies in this respect) powerfully interacts with about 50% of all prescription drugs – in fact, it lowers their level in the blood which means that a patient on anti-coagulants would lose her anti-coagulant protection and might suffer from a (potentially fatal) blood clot.
- In many countries, including the US, the regulation of herbal remedies is so lax, that there is no guarantee that an herbal remedy which is being legally sold is safe. The regulators are only allowed to intervene once there are reports of adverse effects. This means that the burden of proof of safety is effectively reversed which obviously exposes consumers to incalculable risks.
- The quality of the herbal product is equally poorly regulated in most countries. A plethora of investigations in the US, for instance, has shown that the dose of the herbal ingredient printed on the label of a commercial product can range virtually from 0 – 100%. Similarly there is little safe-guard that the ingredients listed on the label correspond to the ones in the preparation. This means that it is worth purchasing not just well-researched herbal remedies but also those marketed by high quality manufacturers via respectable outlets.
- Any regulation of herbal remedies, even the European one that is often praised as protecting consumers adequately, is null and void once consumers go on the Internet and purchase their herbal remedies from one of the many dubious sources found there in truly alarming profusion. Bogus claims, inferior quality and even outright dangerous products abound, and it is often impossible to tell the acceptable from the fraudulent product.
For this blog, I am constantly on the lookout for ‘positive news’ about alternative medicine. Admittedly, I rarely find any.
All the more delighted I was when I found this new study aimed to analyse the association between dietary long-chain n-3 polyunsaturated fatty acids (PUFAs) and incidence of rheumatoid arthritis (RA) in middle-aged and older women.
Data on diet were collected in 1987 and 1997 via a self-administered food-frequency questionnaire (FFQ). The risk of RA associated with dietary long-chain n-3 PUFAs and fish intake was estimated using Cox proportional hazard regression models, adjusted for age, cigarette smoking, alcohol intake, use of aspirin and energy intake.
The results show that, among 32 232 women born 1914–1948, 205 RA cases were identified during a mean follow-up of 7.5 years. An intake of dietary long-chain n-3 PUFAs (FFQ1997) of more than 0.21 g/day (lowest quintile) was associated with a 35% decreased risk of developing RA compared with a lower intake. Long-term intake consistently higher than 0.21 g/day (according to both FFQ1987 and FFQ1997) was associated with a 52% decreased risk. Consistent long-term consumption (FFQ1987 and FFQ1997) of fish ≥1 serving per week compared with<1 was associated with a 29% decrease in risk.
The authors concluded that this prospective study of women supports the hypothesis that dietary intake of long-chain n-3 PUFAs may play a role in aetiology of RA.
These are interesting findings which originate from a good investigation and which are interpreted with the necessary caution. As all epidemiological data, this study is open to a number of confounding factors, and it is therefore impossible to make firm causal inferences. The results thus do not led themselves to clinical recommendation, but they are an indication that more definitive research is warranted, all the more so since we have plausible mechanisms to explain the observed findings.
A most encouraging development for alternative medicine, one could conclude. But is this really true? Most experts would be surprised, I think, to find that PUFA-consumption should fall under the umbrella of alternative medicine. Remember: What do we call alternative medicine that works? It is called MEDICINE!
Many experts have warned us that, when we opt for dietary supplements, we might get more than we bargained for. A recent article reminded us that the increased availability and use of botanical dietary supplements and herbal remedies among consumers has been accompanied by an increased frequency of adulteration of these products with synthetic pharmaceuticals. Unscrupulous producers may add drugs and analogues of various classes, such as phosphodiesterase type 5 (PDE-5) inhibitors, weight loss, hypoglycemic, antihypertensive and anti-inflammatory agents, or anabolic steroids, to develop or intensify biological effects of dietary supplements or herbal remedies. The presence of such adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers.
Other authors recently warned that these products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans’ use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.
A new study has shown that these problems are not just theoretical but are real and common.
Twenty-four products suspected of containing anabolic steroids and sold in fitness equipment shops in the UK were analyzed for their qualitative and semi-quantitative content using full scan gas chromatography-mass spectrometry (GC-MS), accurate mass liquid chromatography-mass spectrometry (LC-MS), high pressure liquid chromatography with diode array detection (HPLC-DAD), UV-Vis, and nuclear magnetic resonance (NMR) spectroscopy. In addition, X-ray crystallography enabled the identification of one of the compounds, where reference standard was not available.
Of the 24 products tested, 23 contained steroids including known anabolic agents; 16 of these contained steroids that were different to those indicated on the packaging and one product contained no steroid at all. Overall, 13 different steroids were identified; 12 of these are controlled in the UK under the Misuse of Drugs Act 1971. Several of the products contained steroids that may be considered to have considerable pharmacological activity, based on their chemical structures and the amounts present.
The authors concluded that such adulteration could unwittingly expose users to a significant risk to their health, which is of particular concern for naïve users.
The Internet offers thousands of supplements for sale; specifically for bodybuilders there are hundreds of supplements all claiming things that are untrue or untested. The lax regulations that exist in this area seem to be often ignored completely. I think it is important to inform customers that most supplements are a waste of money and some even a waste of health.
Many experts are critical about the current craze for dietary supplements. Now a publication suggests that it is something that can save millions.
This article examines evidence suggesting that the use of selected dietary supplements can reduce overall disease treatment-related hospital utilization costs associated with coronary heart disease (CHD) in the United States among those at a high risk of experiencing a costly, disease-related event.
Results show that:
- the potential avoided hospital utilization costs related to the use of omega-3 supplements at preventive intake levels among the target population can be as much as $2.06 billion on average per year from 2013 to 2020. The potential net savings in avoided CHD-related hospital utilization costs after accounting for the cost of omega-3 dietary supplements at preventive daily intake levels would be more than $3.88 billion in cumulative health care cost savings from 2013 to 2020.
- the use of folic acid, B6, and B12 among the target population at preventive intake levels could yield avoided CHD-related hospital utilization costs savings of an average savings of $1.52 billion per year from 2013 to 2020. The potential net savings in avoided CHD-related health care costs after accounting for the cost of folic acid, B6, and B12 utilization at preventive daily intake levels would be more than $5.23 billion in cumulative health care cost net savings during the same period.
The authors conclude that targeted dietary supplement regimens are recommended as a means to help control rising societal health care costs, and as a means for high-risk individuals to minimize the chance of having to deal with potentially costly events and to invest in increased quality of life.
These conclusions read like a ‘carte blanche’ for marketing all sorts of useless supplements to gullible consumers. I think we should take them with more than a pinch of salt.
To generate results of this nature, it is necessary to make a number of assumptions. If the assumptions are wrong, so will be the results. Furthermore, we should consider that the choice of supplements included was extremely limited and highly selected. Finally, we need to stress that the analysis related to a very specific patient group and not to the population at large. In view of these facts, caution might be advised in taking this analysis as being generalizable.
Because of these caveats, my conclusion would have been quite different: provided that the assumptions underlying these analyses are correct, the use of a small selection of dietary supplements by patients at risk of CHD might reduce health care cost.
Linus Carl Pauling (1901 – 1994), the American scientist, peace activist, author, and educator who won two Nobel prizes, was one of the most influential chemists in history and ranks among the most important scientists of the 20th century. Linus Pauling’s work on vitamin C, however, generated considerable controversy. Pauling wrote many papers and a popular book, Cancer and Vitamin C. Vitamin C, we know today, protects cells from oxidative DNA damage and might thereby block carcinogenesis. Pauling popularised the regular intake of vitamin C; eventually he published two studies of end-stage cancer patients; their results apparently showed that vitamin C quadrupled survival times. A re-evaluation, however, found that the vitamin C groups were less sick on entry to the study. Later clinical trials concluded that there was no benefit to high-dose vitamin C. Since then, the established opinion is that the best evidence does not support a role for high dose vitamin C in the treatment of cancer. Despite all this, high dose IV vitamin C is in unexpectedly wide use by CAM practitioners.
Yesterday, new evidence has been published in the highly respected journal ‘Nature'; does it vindicate Pauling and his followers?
Chinese oncologists conducted a meta-analysis to assess the association between vitamin C intake and the risk to acquire lung cancer. Pertinent studies were identified by a searches of several electronic databases through December of 2013. Random-effect model was used to combine the data for analysis. Publication bias was estimated using Begg’s funnel plot and Egger’s regression asymmetry test.
Eighteen articles reporting 21 studies involving 8938 lung cancer cases were included in this meta-analysis. Pooled results suggested that highest vitamin C intake level versus lowest level was significantly associated with the risk of lung cancer. The effect was largest in investigations from the United States and in prospective studies. A linear dose-response relationship was found, with the risk of lung cancer decreasing by 7% for every 100 mg/day increase in the intake of vitamin C . No publication bias was found.
The authors conclude that their analysis suggested that the higher intake of vitamin C might have a protective effect against lung cancer, especially in the United States, although this conclusion needs to be confirmed.
Does this finding vindicate Pauling’s theory? Not really.
Even though the above-quoted conclusions seem to suggest a causal link, we are, in fact, far from having established one. The meta-analysis pooled mainly epidemiological data from various studies. Such investigations are doubtlessly valuable but they are fraught with uncertainties and cannot prove causality. For instance, there could be dozens of factors that have confounded these data in such a way that they produce a misleading result. The simplest explanation of the meta-analytic results might be that people who have a very high vitamin C intake tend to have generally healthier life-styles than those who take less vitamin C. When conducting a meta-analysis, one does, of course, try to account for such factors; but in many cases the necessary information to do that is not available, and therefore uncertainty persists.
In other words, the authors were certainly correct when stating that their findings needed to be confirmed. Pauling’s theory cannot be vindicated by such reports – in fact, the authors do not even mention Pauling with one word.
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.