fish oil
For several decades, eggs were commonly portrayed as a major cause of raised cholesterol and cardiovascular disease. That position has been substantially revised: current evidence suggests that dietary cholesterol has a relatively modest effect on blood cholesterol in most people, whereas saturated and trans fats are more important determinants of LDL cholesterol and cardiovascular risk.
The physiology is more nuanced than the older “cholesterol-in, cholesterol-out” model implied. The liver does synthesise cholesterol endogenously, and many people compensate for increased dietary cholesterol by reducing hepatic production, but the degree of compensation varies considerably between individuals. For that reason, eggs are not best understood as “heart-healthy” in all circumstances, but rather as a food whose impact depends on the wider dietary pattern and the individual’s metabolic risk profile.
There is stronger support for improving lipid profiles by changing the quality of dietary fat and increasing fibre intake. Replacing saturated fats with unsaturated fats, particularly polyunsaturated fats, is associated with lower LDL cholesterol and a reduced risk of cardiovascular events, while soluble fibre helps lower LDL cholesterol by interrupting enterohepatic bile acid recycling. In practical terms, this means that foods such as olive oil, nuts, seeds, legumes, oats, vegetables, and oily fish are more consistently supported than a narrow focus on single items such as eggs.
Low-carbohydrate and ketogenic diets are more complex. Many people lose weight on them, which may improve some cardiometabolic markers, but a subset of lean individuals show pronounced rises in LDL cholesterol and related atherogenic markers during carbohydrate restriction. Emerging evidence also indicates that gut microbial changes may contribute to altered lipid metabolism, although this area is still developing and should not be overstated.
Highly restrictive “detox” or “alternative” dietary programs are unsupported by clinical evidence and may be nutritionally unbalanced and thus harmful. They might be claimed to “purify” the body or reset metabolism, but heart health is better served by sustainable patterns that improve LDL cholesterol, support fibre intake, and minimise excess saturated fat.
What does all that mean in practice? Here are a few simple rules that follow from the new insights:
- Do not over-emphasize dietary cholesterol (e.g., eggs) as a primary driver of cardiovascular risk.
- Focus instead on reducing saturated and trans fat intake.
- Replace saturated fats with unsaturated fats, especially polyunsaturated fats (e.g., use olive oil, eat nuts and seeds).
- Increase intake of soluble fibre (e.g., oats, legumes, vegetables) to help lower LDL cholesterol.
- Consider overall dietary patterns rather than judging single foods in isolation.
- Recognize that individual responses to dietary cholesterol vary; tailor intake accordingly if lipid levels are a concern.
- Include foods with consistent cardiovascular benefit, such as oily fish, plant-based foods, and whole grains.
- Be cautious with low-carbohydrate or ketogenic diets, particularly if lean, and monitor lipid profiles if following such diets.
- Prioritize sustainable, balanced eating patterns over restrictive or extreme diets.
- Avoid “detox” or alternative dietary regimens lacking clinical evidence, as they are ineffective or harmful.
Key references
- Carson JAS, Lichtenstein AH, Anderson CAM, et al. Dietary cholesterol and cardiovascular risk: a science advisory from the American Heart Association. Circulation. 2020;141:e39–e53.
- Estruch R, Ros E, Salas-Salvadó J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368:1279–1290.
- Hooper L, Martin N, Jimoh OF, et al. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020;(5):CD011730.
- British Heart Foundation. Healthy eating – reduce your risk of developing heart disease. 2023. – Search
- NHS. Facts about fat. 2022. – Search
- Ketogenic Diet reduces friendly gut bacteria and raises cholesterol levels
- Gut bacteria can break down cholesterol | Nature Reviews Cardiology
- Healthy eating: applying All Our Health – GOV.UK
The US Health Secretary Robert F Kennedy (JFKJr) famously claimed that vitamin A could work “as a prophylaxis” of measles infection. That claim is not just wrong, it also is dangerous. Overuse of vitamin A can have serious health consequences. As a result of JFKJr yet again promoting dangerous nonsense, doctors treating patients during the measles outbreak in Texas and New Mexico are now facing the problem of vitamin A toxicity.
At Covenant Children’s Hospital in Lubbock, near the outbreak’s epicenter, several patients have been found to have abnormal liver function on routine lab tests, a probable sign that they’ve taken too much of the vitamin, according to Dr. Lara Johnson, pediatric hospitalist and chief medical officer for Covenant Health-Lubbock Service Area.
Vitamin A is fat-soluble. It therefore accumulate in organs like the liver when over-doesed. Excess vitamin A can cause dry skin and eyes, blurry vision, bone thinning, skin irritation, liver damage and other serious issues. In pregnant women, it can even lead to birth defects. Recovery for patients with acute toxicity is normally rapid, if the vitamin is discontinued. But the more serious problems with vitamin A toxicity are not always reversible.
The Council for Responsible Nutrition, a trade association for dietary supplement and functional food manufacturers, issued a statement warning parents against using high doses of vitamin A to try to keep their children from getting measles. “While vitamin A plays an important role in supporting overall immune function, research hasn’t established its effectiveness in preventing measles infection. CRN is concerned about reports of high-dose vitamin A being used inappropriately, especially in children,” the statement says.
JFKJr made his remarks in an interview with Fox News medical correspondent Dr. Marc Siegel. Snippets of the interview were featured in four Fox News or Fox Business segments airing on March 4. “They have treated most of the patients, actually, over 108 patients in the last 48 hours. And they’re getting very, very good results, they report from budesonide, which is a steroid, it’s a 30-year-old steroid,” Kennedy said in the longest of the segments. “And clarithromycin [an antibiotic] and also cod liver oil, which has high concentrations of vitamin A and vitamin D. We need to look at those therapies and other therapies,” he said in another segment. “We need to really do a good job of talking to the front-line doctors and see what is working on the ground, because those therapeutics have really been ignored by the agency for a long, long time.”
Local doctors are increasingly concerned about the growing popularity of unproven remedies for preventing and treating measles. They fear that they are causing people to delay critical medical treatment and to reject vaccination, the only proven way to prevent a measles infection.
The measles outbreak has now affected at least 379 people across Texas, New Mexico and Oklahoma. Kansas has reported 23 measles cases, and officials said that they may also be linked to the outbreak. The best measure to get to grips with the outbreak, I think, would be to make JFKJr shut up and let those who understans the issues get on with it.
Measles had been declared eliminated from the US in 2000. Now the disease is back with a vengeance. In February, an unvaccinated Texan child became the first person in a decade to die from measles in the US. Another death occurred in New Mexico.
The reason for the outbreak is simple: the uptake of the measles vaccine dropped below the 95% rate that is necessary for herd immunity. In the region where the current outbreak began, only 82% of the kids were vaccinated. This triggered the outbreak and, in turn, might mean that the US will lose its ‘measles elimination status’.
Only days after his appointment, Trump pledged to withdraw the United States from the World Health Organization and to drastically cut the US Agency for International Development. Both moves are likely to cause more cases of measles and similarly vaccine-preventable diseases in the US and around the world. To make matters worse, Trump administration has fired hundreds of workers from the US Centers for Disease Control and Prevention (CDC).
And to make matters even worse, Trump appointed Robert F. Kennedy Jr., one of the US most deluded antivaxer. Since being appointed, Kennedy has downplayed the importance of the current measles outbreak, postponed a meeting of the CDC vaccine advisers, made statements like “vaccinations are over-rated” and claimed that good nutrition and treatment with vitamin A as ways to reduce measles severity. He even praised the benefits of cod liver oil as a measure against measles. “There are adverse events from the vaccine,” Kennedy said in a March 11 interview. “It does cause deaths every year. It causes all the illnesses that measles itself causes, encephalitis and blindness, et cetera. And so people ought to be able to make that choice for themselves.” Further confirming his cluelessness Kennedy also stated: “When you and I were kids, everybody got measles, and measles gave you … lifetime protection against measles infection. The vaccine doesn’t do that… The vaccine wanes 4.5% per year.”
But Kennedy does not just propagate BS in interviews, he also plans to investigate whether vaccines cause autism — an assumption that has been discredited ad nauseam. A spokesperson for the US Department of Health and Human Services (DHHS) said: “The rate of autism in American children has skyrocketed. CDC will leave no stone unturned in its mission to figure out what exactly is happening.”
Meanwhile in Texas, some parents, who evidently believe Kennedy’s deluded nonsense, are giving unvaccinated children vitamin A, which, of course, is toxic at high doses.
As we all know, the FDA cannot require that dietary supplements be proven effective before they are sold. Yet, Robert F. Kennedy Jr. once said the FDA is exhibiting an “aggressive suppression” of vitamins, dietary supplements, and other substances and that he will end the federal agency’s “war on public health”.
With Kennedy now in the driver’s seat, the supplement industry expects to make bolder health claims for its products and to get the government, private insurers, and flexible spending accounts to pay for supplements, essentially putting them on an equal footing with FDA-approved pharmaceuticals.
The day Kennedy was sworn in as secretary of Health and Human Services, Trump issued a “Make America Healthy Again” agenda instructing health regulatory agencies to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits that support beneficial lifestyle changes and disease prevention.” Kennedy added that dietary supplements are one key to good health. Supplement makers now want programs like health savings accounts, Medicare, and even benefits from the Supplemental Nutrition Assistance Program, or SNAP, to pay for vitamins, fish oil, protein powders, herbal remedies and probiotics.
In speeches and in a pamphlet called “The MAHA Mandate,” Emord and alliance founder Robert Verkerk said Kennedy would free companies to make greater claims for their products’ alleged benefits. Emord said his group was preparing to sue the FDA to prevent it from restricting non-pharmaceutical products.
With their ‘Mandate’ Emord and Verkerk want “to shift the healthcare paradigm towards one that restores the health of the American people through a holistic and individual-centered approach that works with, rather than against, nature”.
But do they ever question whether:
- vitamins do anything at all to people who eat a normal diet?
- fish oil is effective and safe for which conditions?
- protein powders have any effects beyond eating a steak?
- herbal remedies generate more good than harm?
- probiotics work for which conditions?
The short answer is no. To me, it seems that the MAHA are as uninterested in the evidence regarding efficacy and safety (quite possible they know how flimsy it is) as they are keen on the promotion of quackery.
This study evaluated efficacy of krill oil supplementation, compared with placebo, on knee pain in people with knee osteoarthritis who have significant knee pain and effusion-synovitis. It was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial that took place in 5 Australian cities. Participants with clinical knee osteoarthritis, significant knee pain, and effusion-synovitis on magnetic resonance imaging were enrolled from December 2016 to June 2019; final follow-up occurred on February 7, 2020.
The patients received
- 2 g/d of krill oil (n = 130)
- or matching placebo (n = 132) for 24 weeks.
The primary outcome was change in knee pain as assessed by visual analog scale (range, 0-100; 0 indicating least pain; minimum clinically important improvement = 15) over 24 weeks.
Of 262 participants randomized (mean age, 61.6 [SD, 9.6] years; 53% women), 222 (85%) completed the trial. Krill oil did not improve knee pain compared with placebo (mean change in VAS score, -19.9 [krill oil] vs -20.2 [placebo]; between-group mean difference, -0.3; 95% CI, -6.9 to 6.4) over 24 weeks. One or more adverse events was reported by 51% in the krill oil group (67/130) and by 54% in the placebo group (71/132). The most common adverse events were musculoskeletal and connective tissue disorders, which occurred 32 times in the krill oil group and 42 times in the placebo group, including knee pain (n = 10 with krill oil; n = 9 with placebo), lower extremity pain (n = 1 with krill oil; n = 5 with placebo), and hip pain (n = 3 with krill oil; n = 2 with placebo).
The authors concluded that, among people with knee osteoarthritis who have significant knee pain and effusion-synovitis on magnetic resonance imaging, 2 g/d of daily krill oil supplementation did not improve knee pain over 24 weeks compared with placebo. These findings do not support krill oil for treating knee pain in this population.
This is a rigorous and well-presented study. Apart from the ineffectiveness of krill, it confirms two issues very clearly:
- Placebo effects plus regression to the mean can lead to symptomatic improvements.
- Adverse effects occur even with placebo therapy.
Krill is a small crustacean consumed by whales, penguins and other sea creatures. It is a source of omega 3 fatty acids. The alleged benefits of krill supplements include anti-inflammatory effects. So, it could theoretically help reducing the inflammation that is part of knee osteoarthritis.
A review including five trials with 700 patients using krill oil for knee pain was recently published. Results showed no significant difference between krill oil and placebo for knee pain, knee stiffness, and lipid profiles. However, krill oil demonstrated a significant small effect in improving knee physical function. Trial sequential analysis provided certainty that krill oil enhances knee physical function compared to placebo and indicated no improvement in knee pain, but the findings for knee stiffness need to be confirmed by further research. The authors concluded that krill oil supplementation did not significantly improve knee pain, stiffness, or lipid profile, although it may help knee physical function. Based on these findings, krill oil supplementation is not yet justified for knee pain.
The two papers should settle the issue: KRILL IS NOT EFFECTIVE FOR KNEE OSTEOARTHRITIS. Will this stop the many manufacturers of krill supplements selling their products to gullible consumers? I would not hold my breath.
This prospective cohort study examined the effects of fish oil supplements on the clinical course of cardiovascular disease, from a healthy state to atrial fibrillation, major adverse cardiovascular events, and subsequently death.
The analysis is based on the UK Biobank study (1 January 2006 to 31 December 2010, with follow-up to 31 March 2021 (median follow-up 11.9 years)) including 415 737 participants, aged 40-69 years. Incident cases of atrial fibrillation, major adverse cardiovascular events, and death, identified by linkage to hospital inpatient records and death registries. Role of fish oil supplements in different progressive stages of cardiovascular diseases, from healthy status (primary stage), to atrial fibrillation (secondary stage), major adverse cardiovascular events (tertiary stage), and death (end stage).
Among 415 737 participants free of cardiovascular diseases, 18 367 patients with incident atrial fibrillation, 22 636 with major adverse cardiovascular events, and 22 140 deaths during follow-up were identified. Regular use of fish oil supplements had different roles in the transitions from healthy status to atrial fibrillation, to major adverse cardiovascular events, and then to death:
- For people without cardiovascular disease, hazard ratios were 1.13 (95% confidence interval 1.10 to 1.17) for the transition from healthy status to atrial fibrillation and 1.05 (1.00 to 1.11) from healthy status to stroke.
- For participants with a diagnosis of a known cardiovascular disease, regular use of fish oil supplements was beneficial for transitions from atrial fibrillation to major adverse cardiovascular events (hazard ratio 0.92, 0.87 to 0.98), atrial fibrillation to myocardial infarction (0.85, 0.76 to 0.96), and heart failure to death (0.91, 0.84 to 0.99).
The authors concluded that regular use of fish oil supplements might be a risk factor for atrial fibrillation and stroke among the general population but could be beneficial for progression of cardiovascular disease from atrial fibrillation to major adverse cardiovascular events, and from atrial fibrillation to death. Further studies are needed to determine the precise mechanisms for the development and prognosis of cardiovascular disease events with regular use of fish oil supplements.
I must admit that I am slightly puzzled by this study and its findings. The authors clearly speak of the ‘role’ regular use of fish oil supplements has. This language implies a casual impact. Yet, what we have here are associations, and every 1st year medical student knows that
correlation is not causation.
Other things to note are that:
- the associations are only very weak;
- they go in opposite directions depending on the subpopulation that is examined,
- there is no plausible mechanism of action to explain all this.
Collectively, these facts suggest to me that we are indeed more likely dealing here with a non-causal association and not a causal link. All the more surprising then that the (UK) press took up this paper in a major and occasionally alarmist fashion (the headline in THE TELEGRAPH was Revealed: How cod liver oil could be bad for your health). I learned of it by listening to the BBC headline news.
Omega-3 fatty acids (fish oil) supplementation reduces the occurrence of cardiovascular disease (CVD) and CVD-related mortality in patients at high-risk of CVD and in patients with elevated plasma triglyceride level. Yet, some studies have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results.
This review evaluated the effect of omega-3 fatty acids on the risk of AF. The results suggest that omega-3 fatty acids supplementation is associated with increased AF risk, particularly in trials that used high doses. Therefore, several factors should be considered before prescribing omega-3 fatty acids, including their dose, type, and formulation (fish, dietary fish oil supplements, and purified fatty acids), as well as patient-related factors and atrial mechanical milieu. Because the benefits of omega-3 fatty acids are dose-dependent, the associated AF risk should be balanced against the benefit for CVD. Patients who take omega-3 fatty acids, particularly at high doses, should be informed of the risk of AF and followed up for the possible development of this common and potentially hazardous arrhythmia.
Another recent review included 54,799 participants from 17 cohorts. A total of 7,720 incident cases of AF were ascertained after a median 13.3 years of follow-up. In multivariable analysis, EPA levels were not associated with incident AF, HR per interquintile range (ie, the difference between the 90th and 10th percentiles) was 1.00 (95% CI: 0.95-1.05). HRs for higher levels of DPA, DHA, and EPA+DHA, were 0.89 (95% CI: 0.83-0.95), 0.90 (95% CI: 0.85-0.96), and 0.93 (95% CI: 0.87-0.99), respectively.
The authors concluded that in vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF. Our data suggest the safety of habitual dietary intakes of omega-3 fatty acids with respect to AF risk. Coupled with the known benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption can be maintained.
Faced with contradictory results based on non-RCT evidence, we clearly need an RCT. Luckily such a trial has recently been published. It was an ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.
Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). The primary outcome was incident AF confirmed by medical record review.
Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).
The authors concluded that among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.
So, does the regular supplementation with omega-3 fatty acids increase the risk of atrial fibrillation? The evidence is not entirely clear but, on balance, I conclude that the risk is low or even non-existent.
Chronic kidney disease is common, often progressive, and difficult to treat or prevent. Effective interventions would therefore be more than welcome. This paper explored the relation of habitual fish oil use with the risk of chronic kidney diseases (CKD).
A total of 408,023 participants (54.2% female) without prior CKD and with completed information regarding their consumption of major food groups and fish oil in the UK Biobank were enrolled. Fish oil use and dietary intakes were assessed by touch screen questionnaire and food frequency questionnaire, respectively. Incident CKD was recorded from hospital inpatient records.
At baseline, 128,843 (31.6%) participants reported taking fish oil supplements. During a median follow-up period of 12.0 years, a total of 10,782 (2.6%) participants developed CKD. With adjustments for important confounders, habitual fish oil use was associated with a significantly lower hazard of incident CKD (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.87-0.95), compared with non-use. Consistently, participants reporting ≥2 servings/week of oily fish (HR, 0.86; 95% CI, 0.79-0.94) and nonoily fish (HR, 0.86; 95% CI, 0.77-0.97) consumption had a lower hazard of incident CKD compared to those reporting no consumption ever. Additionally, among the 97,914 participants with data on plasma fatty acid, there were significant inverse relationships of plasma omega-3 polyunsaturated fatty acid (PUFA) (per SD increment, HR, 0.89, 95% CI, 0.84-0.94) and eicosatetraenoic acid (per SD increment, HR, 0.91, 95% CI, 0.87-0.96) with incident CKD.
The authors concluded that habitual fish oil use was associated with a lower hazard of CKD, which was further confirmed by the consistent inverse relations between fish consumption and circulating omega-3 PUFA concentration with incident CKD.
I like this paper! It shows in an exemplary fashion how to interpret an association between two variables: fish oil consumption does not necessarily CAUSE the lower risk, it is merely associated with it and there might be a number of non-causal explanations for the link. Whether there is a true cause-effect relationship needs to be investigated in further, differently designed studies. The present paper does not overstate its conclusions but it is nevertheless important, as it hopefully will prompt others to clarify the crucial issue of causality.
Wouldn’t it be nice, if researchers of so-called alternative medicine (SCAM) finally learned this simple lesson?
The American Heart Association has issued a statement outlining research on so-called alternative medicine (SCAM) for heart failure. They found some SCAMs that work, some that don’t work, and some that are harmful.
Alternative therapies that may benefit people with heart failure include:
- Omega-3 polyunsaturated fatty acids (PUFA, fish oil) have the strongest evidence among complementary and alternative agents for clinical benefit in people with heart failure and may be used safely, in moderation, in consultation with their health care team. Omega-3 PUFA is associated with a lower risk of developing heart failure and, for those who already have heart failure, improvements in the heart’s pumping ability. There appears to be a dose-related increase in atrial fibrillation (an irregular heart rhythm), so doses of 4 grams or more should be avoided.
- Yoga and Tai Chi, in addition to standard treatment, may help improve exercise tolerance and quality of life and decrease blood pressure.
Meanwhile, some therapies were found to have harmful effects, such as interactions with common heart failure medications and changes in heart contraction, blood pressure, electrolytes and fluid levels:
- While low blood levels of vitamin D are associated with worse heart failure outcomes, supplementation hasn’t shown benefit and may be harmful when taken with heart failure medications such as digoxin, calcium channel blockers and diuretics.
- The herbal supplement blue cohosh, from the root of a flowering plant found in hardwood forests, might cause a fast heart rate called tachycardia, high blood pressure, chest pain and may increase blood glucose. It may also decrease the effect of medications taken to treat high blood pressure and Type 2 diabetes.
- Lily of the valley, the root, stems and flower of which are used in supplements, has long been used in mild heart failure because it contains active chemicals similar to, but less potent than, the heart failure medicine digoxin. It may be harmful when taken with digoxin by causing very low potassium levels, a condition known as hypokalemia. Lily of the valley also may cause irregular heartbeat, confusion and tiredness.
Other therapies have been shown as ineffective based on current data, or have mixed findings, highlighting the importance of patients having a discussion with a health care professional about any non-prescribed treatments:
- Routine thiamine supplementation isn’t shown to be effective for heart failure treatment unless someone has this specific nutrient deficiency.
- Research on alcohol varies, with some data showing that drinking low-to-moderate amounts (1 to 2 drinks per day) is associated with preventing heart failure, while habitual drinking or intake of higher amounts is toxic to the heart muscle and known to contribute to heart failure.
- There are mixed findings about vitamin E. It may have some benefit in reducing the risk of heart failure with preserved ejection fraction, a type of heart failure in which the left ventricle is unable to properly fill with blood between heartbeats. However, it has also been associated with an increased risk of hospitalization in people with heart failure.
- Co-Q10, or coenzyme Q10, is an antioxidant found in small amounts in organ meats, oily fish and soybean oil, and commonly taken as a dietary supplement. Small studies show it may help improve heart failure class, symptoms and quality of life, however, it may interact with blood pressure lowering and anti-clotting medicines. Larger trials are needed to better understand its effects.
- Hawthorn, a flowering shrub, has been shown in some studies to increase exercise tolerance and improve heart failure symptoms such as fatigue. Yet it also has the potential to worsen heart failure, and there is conflicting research about whether it interacts with digoxin.
“Overall, more quality research and well-powered randomized controlled trials are needed to better understand the risks and benefits of complementary and alternative medicine therapies for people with heart failure,” said Chow. “This scientific statement provides critical information to health care professionals who treat people with heart failure and may be used as a resource for consumers about the potential benefit and harm associated with complementary and alternative medicine products.”
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No doubt, this assessment is a laudable attempt to inform patients responsibly. Personally, I am always a bit skeptical about such broad statements. SCAM encompasses some 400 different therapies, and I doubt that these can all be assessed in one single overview.
It is not difficult to find SCAMs that seem to have not been considered. Take this systematic review, for instance. It included 24 RCTs (n = 1314 participants) of 9 different mind-body interventions (MBI) types: Tai Chi (n = 7), yoga (n = 4), relaxation (n = 4), meditation (n = 2), acupuncture (n = 2), biofeedback (n = 2), stress management (n = 1), Pilates (n = 1), and reflexology (n = 1). Most (n = 22, 95.8%) reported small-to-moderate improvements in quality of life (14/14 studies), exercise capacity (8/9 studies), depression (5/5 studies), anxiety and fatigue (4/4 studies), blood pressure (3/5 studies), heart rate (5/6 studies), heart rate variability (7/9 studies), and B-type natriuretic peptide (3/4 studies). Studies ranged from 4 minutes to 26 weeks and group sizes ranged from 8 to 65 patients per study arm.
The authors concluded that, although wide variability exists in the types and delivery, RCTs of MBIs have demonstrated small-to-moderate positive effects on HF patients’ objective and subjective outcomes. Future research should examine the mechanisms by which different MBIs exert their effects.
Or take this systematic review of 38 RCTs of oral TCM remedies. The majority of the included trials were assessed to be of high clinical heterogeneity and poor methodological quality. The main results of the meta-analysis showed improvement in total MLHFQ score when oral Chinese herbal medicine plus conventional medical treatment (CMT) compared with CMT with or without placebo [MD = -5.71 (-7.07, -4.36), p < 0.01].
The authors concluded that there is some encouraging evidence of oral Chinese herbal medicine combined with CMT for the improvement of QoL in CHF patients. However, the evidence remains weak due to the small sample size, high clinical heterogeneity, and poor methodological quality of the included trials. Further, large sample size and well-designed trials are needed.
Don’t get me wrong: I am not saying that TCM remedies are a viable option – in fact, I very much doubt it – but I am saying that attempts to provide comprehensive overviews of all SCAMs are problematic, and that incomplete overviews are just that: incomplete.
The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
The warning letters were issued to:
- Essential Elements (Scale Media Inc.);
- Calroy Health Sciences LLC;
- Iwi;
- BergaMet North America LLC;
- Healthy Trends Worldwide LLC (Golden After 50);
- Chambers’ Apothecary;
- Anabolic Laboratories, LLC.
“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
