fish oil
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.
The US Food and Drug Administration (FDA) state that dietary supplements can help people improve or maintain their overall health. But they may also come with health risks. Whether you’re a consumer of dietary supplements or it’s your job to inform and educate, it’s important to know the facts before deciding to take any dietary supplement.
Therefore, they launched the initiative, “Supplement Your Knowledge”. It aims to help inform health care professionals, consumers, and educators about dietary supplements.
“Dietary supplements can be valuable to your health but taking some supplements can also involve health risks,” Douglas Stearn, JD, deputy director for regulatory affairs in the FDA’s Center for Food Safety and Applied Nutrition, said in a statement. “These Supplement Your Knowledge resources will help provide consumers and health care professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements.”
In collaboration with the American Medical Association, publisher of JAMA, the FDA has developed a free continuing medical education program for physicians and other health care professionals about the regulation of dietary supplements, informing patients about their use, and reporting adverse events to the agency. The program includes 3 videos and accompanying educational materials. It is available on the FDA website and the AMA Ed Hub.
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The objectives of the program are:
1. Define dietary supplements
2. Describe how dietary supplements are regulated
3. Describe how dietary supplements are labelled and the types of claims permitted
4. Review potential interactions of dietary supplements with other supplements, medications, and laboratory tests
5. Identify adverse events and how to report them to FDA
Even though some parts of the program are quite specific to the US, I think that the initiative is most laudable and an excellent resource for physicians, SCAM practitioners, consumers, and decision-makers to learn more about this important subject.
Fish and omega-3 polyunsaturated fatty acids (PUFA) have been suggested to play a role in improving cancer prognosis. However, results from epidemiological studies remain inconsistent. A new systematic review was aimed at creating clarity by assessing the association between dietary fish and/or omega-3 PUFAs intake and cancer prognosis. For this purpose, the authors conducted a meta-analysis of observational studies.
A systematic search of related publications was performed using PubMed and Web of Science databases. Hazard ratios (HR) and 95% confidence intervals (CI) were extracted and then pooled using a random-effect model. Potential linear and non-linear dose-response relationships were explored using generalized least squares estimation and restricted cubic splines.
As a result, 21 cohort studies were included in the analysis. Compared to the lowest category, the highest category of fish intake was associated with a significant lower mortality in patients with ovarian cancer (n = 1, HR = 0.74, 95% CI: 0.57-0.95) and overall cancer (n = 12, HR = 0.87, 95% CI: 0.81-0.94). Marine omega-3 PUFAs intake rather than total omega-3 PUFAs intake showed significant protective effects on survival of overall cancer (n = 8, HR = 0.81, 95% CI: 0.71-0.94), in particular prostate cancer (n = 2, HR = 0.62, 95% CI: 0.46-0.82).
Yes, correlation is not causation, I know. This is all the more important, as the mechanism of action of PUFAs in relation to cancer seems speculative at present. On the other hand, causality is rendered more likely by a dose-response meta-analysis. It indicated a nonlinear and a linear relationship between fish intake, as well as marine omega-3 PUFAs intake, and overall cancer survival, respectively.
Thus I feel that the conclusion drawn by the authors is reasonable: our analysis demonstrated a protective effect of dietary fish and marine omega-3 PUFAs consumption on cancer survival.
Alzheimer is a devastating condition. Despite much research, we are still far from being able to effectively prevent or treat it. Some claim that relatively simple dietary interventions might work. What does the evidence tell us?
The aim of this systematic review was to evaluate the effect of dietary interventions on the cognitive performance of individuals with Alzheimer’s disease (AD). Thirty-two RCT could be included.
The findings show that a wide range of supplements have been submitted to testing in RCTs. Most of the supplements seem to be less than useful. However, some seem to show some promise:
- Omega-3 fatty acid has positive effects at different doses.
- ‘Fortasyn Connect’ (a multi-nutrient mixture) seems to be effective in the early stages of the disease.
- Probiotic, Ginseng, Inositol and specialized nutritional formulas seem to have a positive effect on cognition.
Most of the primary studies had poor methodological quality, included patients with mild AD, small samples, and did not obtain significative results for all the cognitive outcomes.
The authors concluded that the effect of most dietary interventions on cognition in AD patients remains inconclusive, however, several nutrients, isolated or not, show potential to improve cognitive function in AD, especially in its early stages.
I am relieved that the authors of this thoroughly-researched review phrased their conclusions as cautiously as they did. The thing is, most of the primary trials are truly not worth writing home about. Some are just 4 weeks long, others include merely 30 odd patients. Many look more like marketing excercises than science.
The authors also stated that better quality studies are urgently needed to confirm the therapeutic potential of the diet so that a dietary recommendation in AD that contributes to the quality of life of patients and relatives can be established. This has become almost a standard sentence for ending a scientific paper. In this instance, however, it seems very true.
Vitamin D and Omega-3 supplements help the elderly avoid Covid-19 infection by boosting their immune systems, study claims. Yes, that was the headline in the DAILY MAIL on 11/11/2020. Naturally, I found this interesting. So, I looked up the original paper. Here is its abstract:
Importance: The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear.
Objective: To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults.
Design, setting, and participants: Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017.
Interventions: Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270).
Main outcomes and measures: The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance.
Results: Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups.
Conclusions and relevance: Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes.
Speachless?
Me too!
The study has noting to do with COVID-19 and very little with infections. The bit about infections shows almost the opposite of what the MAIL claims. So, where does the notion stipulated in the headline come from?
The MAIL article gives the answer: Professor Heike Bischoff-Ferrari from Zurich University in Switzerland, who led the latest study, said: ‘Our findings suggest supplementation of vitamin D and omega-3s in adults aged 70 or older who lead an active lifestyle and have no pre-existing conditions does not provide any benefits when it comes to bone health, memory and muscle function. ‘However, we believe there is an effect on infections – such as Covid-19.’
I would not be surprised, if the last sentence in the quote was taken out of context.
I would not be surprised, if this is the worst health related article in the DAIL MAIL this year.
And, by Jove, there are plenty to choose from.
And why do I report all this?
As I have pointed out before, I believe that journalists have a lot to answer for when it comes to misleading the public about so-called alternative medicine (SCAM):
- “Scientists have shown how homeopathy works” – journalists’ obsession with ‘balance’
- ACUPUNCTURE: journalists, be aware of your responsibility not to mislead the public
- Drowning in a sea of misinformation. Part 10: Journalists
My hope is that, by reminding them of their ‘errors’ every now and then, I might contribute to some progress.
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Yes, I know, I am an incurable optimist!
