coronary heart disease
This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.
Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.
Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.
The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.
Tongxinluo is mixture of various active ingredients, including
- Paeonia lactiflora,
- cicada slough,
- woodlouse bug,
With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.
Tongxinluo is by no means a mixture that has not been studied before.
A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.
A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.
A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.
Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.
So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.
Let’s not forget:
if it sound too good to be true, it probably is!
This systematic review aimed to assess the impact of Tai Chi on individuals with essential hypertension and to compare the effects of Tai Chi with other therapies. The researchers conducted a systematic literature search of the Medline, Scholar, Elsevier, Wiley Online Library, Chinese Academic Journal (CNKI) and Wanfang databases from January 2003 to August 2023. Using the methods of the Cochrane Collaboration Handbook, a meta-analysis was conducted to assess the collective impact of Tai Chi exercise in controlling hypertension. The primary outcomes measured included blood pressure and nitric oxide levels.
A total of 32 RCTs were included. The participants consisted of adults with an average age of 57.1 years who had hypertension (mean ± standard deviation systolic blood pressure at 148.2 ± 12.1 mmHg and diastolic blood pressure at 89.2 ± 8.3 mmHg). Individuals who practiced Tai Chi experienced reductions in systolic blood pressure of 10.6 mmHg, diastolic blood pressure of 4.7 mmHg and an increase in nitric oxide levels.
The authors concluded that Tai Chi can be a viable lifestyle intervention for managing hypertension. Greater promotion of Tai Chi by medical professionals could extend these benefits to a larger patient population.
Tai Chi allegedly incorporates principles rooted in the Yin and Yang theory, Chinese medicine meridians and breathing techniques, and creates a unique form of exercise characterized by its inward focus, continuous flow, the balance of strength and gentleness, and alternation between fast and slow movements. What sets Tai Chi apart from other forms of excercise is the requirement for mindful guidance during practice. This aspect may, according to the authors, be the reason why Tai Chi also outperforms general aerobic exercise in managing hypertension.
I can well imagine that any form of relaxation reduces blood pressure. What I find hard to believe is that Tai Chi is better than any other relaxing SCAMs. The 32 RCTs included in this new review fail to impress me because they are all from China, and – as we have often mentioned before – studies from China are to be taken with a pinch of salt.
Yet, the subject is important enough, in my view, to merit a few rigorous trials conducted by independent researchers. Until such data are available, I think, I prefer to rely on our own systematic review which conculded that the evidence for tai chi in reducing blood pressure … is limited. Whether tai chi has benefits over exercise is still unclear. The number of trials and the total sample size are too small to draw any firm conclusions.
As we have recently discussed diet and its effects on health, it seems reasonable to ask whether there is a diet that is demonstrably healthy. A recent investigation attempted to answer this question.
This study was aimed at developing a healthy diet score that is associated with health outcomes and is globally applicable. It used data from the Prospective Urban Rural Epidemiology (PURE) study and tried to replicate it in five independent studies on a total of 245 000 people from 80 countries.
A healthy diet score was developed on the basis of the data from 147 642 people from the general population, from 21 countries in the PURE study. The consistency of the associations of the score with events was examined in five large independent studies from 70 countries.
The healthy diet score was developed based on six foods each of which has been associated with a significantly lower risk of mortality [i.e. fruit, vegetables, nuts, legumes, fish, and dairy (mainly whole-fat); range of scores, 0–6]. The main outcome measures were all-cause mortality and major cardiovascular events [cardiovascular disease (CVD)].
During a median follow-up of 9.3 years in PURE, compared with a diet score of ≤1 point, a diet score of ≥5 points was associated with a lower risk of:
- mortality [hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.63–0.77)],
- CVD (HR 0.82; 0.75–0.91),
- myocardial infarction (HR 0.86; 0.75–0.99),
- stroke (HR 0.81; 0.71–0.93).
In three independent studies with vascular patients, similar results were found, with a higher diet score being associated with lower mortality (HR 0.73; 0.66–0.81), CVD (HR 0.79; 0.72–0.87), myocardial infarction (HR 0.85; 0.71–0.99), and a non-statistically significant lower risk of stroke (HR 0.87; 0.73–1.03). Additionally, in two case-control studies, a higher diet score was associated with lower first myocardial infarction [odds ratio (OR) 0.72; 0.65–0.80] and stroke (OR 0.57; 0.50–0.65). A higher diet score was associated with a significantly lower risk of death or CVD in regions with lower than with higher gross national incomes (P for heterogeneity <0.0001). The PURE score showed slightly stronger associations with death or CVD than several other common diet scores (P < 0.001 for each comparison).
The authors concluded that consumption of a diet comprised of higher amounts of fruits, vegetables, nuts, legumes, and a moderate amount of fish and whole-fat dairy is associated with a lower risk of CVD and mortality in all world regions, but especially in countries with lower income where consumption of these natural foods is low. Similar associations were found with the inclusion of meat or whole grain consumption in the diet score (in the ranges common in the six studies that we included). Our findings indicate that the risks of deaths and vascular events in adults globally are higher with inadequate intake of protective foods.
The authors rightly stress that their analyses have a number of limitations:
First, diet (as in most large epidemiologic studies) was self-reported and variations in reporting might lead to random errors that could dilute real associations between diet scores and clinical outcomes. Therefore, the beneficial effects of a healthier diet may be larger than estimated.
Second, the researchers did not examine the role of individual types of fruits and vegetables as components in the diet score, since the power to detect associations of the different types of fruits and vegetables vs. CVD or mortality is low (i.e. given that the number of events per type of fruit and vegetable was relatively low). Recent evidence suggests that bioactive compounds and, in particular, polyphenols which are found in certain fruit or vegetables (e.g. berries, spinach, and beans) may be especially protective against CVD.
Third, in observational studies, the possibility of residual confounding from unquantified or imprecise measurement of covariates cannot be ruled out—especially given that the differences in risk of clinical events are modest (∼10%–20% relative differences). Ideally, large randomized trials would be needed to clarify the clinical impact on events of a policy of proposing a dietary pattern in populations.
Fourth, the use of the median intake of each food component as a cut-off in the scoring scheme for each diet may not reflect the full range of consumption or provide a meaningful indicator of consumption associated with the disease. However, the use of quintiles instead of medians within each study or within each region yielded the same results indicating the robustness of our findings.
Fifth, the level of intake to meet the cut-off threshold for each food group in the diet score may differ between countries. However, in sensitivity analyses where region-specific median cut-offs were used to classify participants on each component of the diet score, the results were similar to using the overall cohort median of each food component. Further, with unprocessed red meat and whole grains included or excluded from the diet score in these sensitivity analyses, the results were again similar.
Sixth, misclassification of exposures cannot be ruled out as repeat measures of diet were not available in all studies. However, the ORIGIN study, in which repeat diet assessments at 2 years were conducted, showed similar results based on the first vs. second diet assessments. This indicates that misclassification of dietary intake during follow-up was not undermining the findings.
Seventh, one unique aspect of the study is the focus on only protective foods, i.e. a dietary pattern score that highlights what is missing from the food supply, especially in poorer world regions, but this does not negate the importance of limiting the consumption of harmful foods such as highly processed foods. While the PURE diet score had significantly stronger associations with events than other diet scores, the HRs were only slightly larger for PURE than for most other diet scores. However, the Planetary score was the least predictive of events. The analyses provide empirical evidence that all diet scores (other than the Planetary diet score) are of value to predicting death or CVD globally and in all regions of the world.
So, what should we, according to these findings, be looking for and how much of it should we consume? Here is the table that should answer these questions:
|Fruits and vegetables||4 to 5 servings daily||1 medium apple, banana, pear; 1 cup leafy vegs; 1/2 cup other vegs|
|Legumes||3 to 4 servings weekly||1/2 cup beans or lentils|
|Nuts||7 servings weekly||1 oz., tree nuts or peanuts|
|Fish||2 to 3 servings weekly||3 oz. cooked (pack of cards size)|
|Dairy||14 servings weekly||1 cup milk or yogurt; 1 ½ oz cheese|
|Whole grainsc||Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet||1 slice (40 g) bread; ½ medium (40 g) flatbread; ½ cup (75–120 g) cooked rice, barley, buckwheat, semolina, polenta, bulgur, or quinoa|
|Unprocessed meatsc||Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet||3 oz. cooked red meat or poultry|
The ‘keto diet’ is a currently popular high-fat, low-carbohydrate diet; it limits the intake of glucose which results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. It is said to be an effective treatment for intractable epilepsy. In addition, it is being promoted as a so-called alternative medicine (SCAM) for a wide range of conditions, including:
- weight loss,
- cognitive and memory enhancement,
- type II diabetes,
- neurological and psychiatric disorders.
Now, it has been reported that the ‘keto diet’ may be linked to higher levels of cholesterol and double the risk of cardiovascular events. In the study, researchers defined a low-carb, high-fat (LCHF) diet as 45% of total daily calories coming from fat and 25% coming from carbohydrates. The study, which has so far not been peer-reviewed, was presented Sunday at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.
“Our study rationale came from the fact that we would see patients in our cardiovascular prevention clinic with severe hypercholesterolemia following this diet,” said Dr. Iulia Iatan from the Healthy Heart Program Prevention Clinic, St. Paul’s Hospital, and University of British Columbia’s Centre for Heart Lung Innovation in Vancouver, Canada, during a presentation at the session. “This led us to wonder about the relationship between these low-carb, high-fat diets, lipid levels, and cardiovascular disease. And so, despite this, there’s limited data on this relationship.”
The researchers compared the diets of 305 people eating an LCHF diet with about 1,200 people eating a standard diet, using health information from the United Kingdom database UK Biobank, which followed people for at least a decade. They found that people on the LCHF diet had higher levels of low-density lipoprotein and apolipoprotein B. Apolipoprotein B is a protein that coats LDL cholesterol proteins and can predict heart disease better than elevated levels of LDL cholesterol can. The researchers also noticed that the LCHF diet participants’ total fat intake was higher in saturated fat and had double the consumption of animal sources (33%) compared to those in the control group (16%). “After an average of 11.8 years of follow-up – and after adjustment for other risk factors for heart disease, such as diabetes, high blood pressure, obesity, and smoking – people on an LCHF diet had more than two times higher risk of having several major cardiovascular events, such as blockages in the arteries that needed to be opened with stenting procedures, heart attack, stroke, and peripheral arterial disease.” Their press release also cautioned that their study “can only show an association between the diet and an increased risk for major cardiac events, not a causal relationship,” because it was an observational study, but their findings are worth further investigation, “especially when approximately 1 in 5 Americans report being on a low-carb, keto-like or full keto diet.”
I have to say that I find these findings not in the slightest bit surprising and would fully expect the relationship to be causal. The current craze for this diet is concerning and we need to warn consumers that they might be doing themselves considerable harm.
Other authors have recently pointed out that, within the first 6-12 months of initiating the keto diet, transient decreases in blood pressure, triglycerides, and glycosylated hemoglobin, as well as increases in HDL and weight loss may be observed. However, the aforementioned effects are generally not seen after 12 months of therapy. Despite the diet’s favorable effect on HDL-C, the concomitant increases in LDL-C and very-low-density lipoproteins (VLDL) may lead to increased cardiovascular risks. And another team of researchers has warned that “given often-temporary improvements, unfavorable effects on dietary intake, and inadequate data demonstrating long-term safety, for most individuals, the risks of ketogenic diets may outweigh the benefits.”
The concept of ultra-processed food (UPF) was initially developed and the term coined by the Brazilian nutrition researcher Carlos Monteiro, with his team at the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo, Brazil. They argue that “the issue is not food, nor nutrients, so much as processing,” and “from the point of view of human health, at present, the most salient division of food and drinks is in terms of their type, degree, and purpose of processing.”
Examples of UPF include:
- Carbonated soft drinks,
- Sweet, fatty or salty packaged snacks,
- Candies (confectionery),
- Mass-produced packaged breads and buns,
- Cookies (biscuits),
- Cakes and cake mixes,
- Margarine and other spreads,
- Sweetened breakfast cereals,
- Sweetened fruit yoghurt and energy drinks,
- Powdered and packaged instant soups, noodles, and desserts,
- Pre-prepared meat, cheese, pasta and pizza dishes,
- Poultry and fish nuggets and sticks,
- Sausages, burgers, hot dogs, and other reconstituted meat products,
Ultra-processed food is bad for our health! This message is clear and has been voiced so many times – not least by proponents of so-called alternative medicine (SCAM) – that most people should now understand it.
But how bad?
And what diseases does UPF promote?
How strong is the evidence?
I did a quick Medline search and was overwhelmed by the amount of research on this subject. In 2022 alone, there were more than 2000 publications! Here are the conclusions from just a few recent studies on the subject:
- Higher intake of UPFs was associated with higher incidence of Crohn’s disease, but not ulcerative colitis. In individuals with a pre-existing diagnosis of inflammatory bowel disease, consumption of UPFs was significantly higher compared to controls, and was associated with an increased need for IBD-related surgery. Further studies are needed to address the impact of UPF intake on disease pathogenesis, and outcomes.
- In this prospective cohort study, higher consumption of UPF was associated with higher risk of dementia, while substituting unpr2ocessed or minimally processed foods for UPF was associated lower risk of dementia.
- In almost all countries and age groups, increases in the dietary share of ultraprocessed foods were associated with increases in energy density and free sugars and decreases in fiber, suggesting that ultraprocessed food consumption is a potential determinant of obesity in children and adolescents.
- Higher ultraprocessed foods consumption was independently associated with a higher risk of incident chronic kidney disease in a general population.
- These data suggest that a consistent intake of ultra-processed foods over time is needed to impact nutritional status and body composition of children and adolescents.
- This meta-analysis suggests that high consumption of UPF, sugar-sweetened beverages, artificially sweetened beverages, processed meat, and processed red meat might increase all-cause mortality, while breakfast cereals might decrease it.
- The consumption of ultraprocessed foods represents a significant cause of premature death in Brazil.
- Available evidence suggests that UPFs may increase cancer risk via their obesogenic properties as well as through exposure to potentially carcinogenic compounds such as certain food additives and neoformed processing contaminants.
- The high consumption of UPF, almost more than 10% of the diet proportion, could increase the risk of developing type 2 diabetes in adult individuals.
Don’t get me wrong: this is not a systematic review of the subject. I am merely trying to give a rough impression of the research that is emerging. A few thoughts seem nonetheless appropriate.
- The research on this subject is intense.
- Even though most studies disclose associations and not causal links, there is in my view no question that UPF aggravates many diseases.
- The findings of the current research are highly consistent and point to harm done to most organs.
- Even though this is a subject on which advocates of SCAM are exceedingly keen, none of the research I saw was conducted by SCAM researchers.
- The view of many SCAM proponents that conventional medicine does not care about nutrition is clearly not correct.
- Considering how unhealthy UPF is, there seems to be a lack of effective education and action aimed at preventing the harm UPF does to us.
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;
- 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.
Ischemic heart disease (IHD) related to cardiovascular or cerebrovascular disease is the leading cause of mortality and an important issue of public health worldwide. The cost of long-term healthcare for IHD patients may result in a huge financial burden. This study analyzed the medical expenditure incurred for and survival of IHD patients treated with Chinese herbal medicine (CHM) and Western medicine.
Subjects were randomly selected from the National Health Insurance Research Database in Taiwan. The Cox proportional hazards regression model, Kaplan–Meier estimator, logrank test, chi-square test, and analysis of variance were applied. Landmark analysis was used to assess the cumulative incidence of death in IHD patients.
A total of 11,527 users were identified as CHM combined with Western medicine and 11,527 non-CHM users. CHM users incurred a higher medical expenditure for outpatient care within 1 (24,529 NTD versus 18,464 NTD, value <0.0001) and 5 years (95,345 NTD versus 60,367 NTD, value <0.0001). However, CHM users had shorter hospitalizations and lower inpatient medical expenditure (7 days/43,394 NTD in 1 year; 11 days/83,141 NTD in 5 years) than non-CHM users (11 days/72,939 NTD in 1 year; 14 days/107,436 NTD in 5 years).
The CHM group’s adjusted hazard ratio for mortality was 0.41 lower than that of the non-CHM group by Cox proportional hazard models with time-dependent exposure covariates. Danshen, Huang qi, Niu xi, Da huang, and Fu zi were the most commonly prescribed Chinese single herbs; Zhi-Gan-Cao-Tang, Xue-Fu-Zhu-Yu-Tang, Tian-Wang-Bu-Xin-Dan, Sheng-Mai-San, and Yang-Xin-Tang were the five most frequently prescribed herbal formulas in Taiwan.
The authors concluded that combining Chinese and Western medicine can reduce hospital expenditure and improve survival for IHD patients.
Why, you will ask, do I think that this study deserves to be in the ‘worst paper cometition’?
It is not so bad!
It is an epidemiological case-control study with a large sample size that generates interesting findings.
But, as a case-control study, it cannot establish a causal link between CHM and the outcomes. You might argue that the conclusions avoid doing this – “can … improve survival” is not the same as “does improve survival”. This may be true, yet the title of the article leaves little doubt about the interpretation of the authors:
Chinese Herbal Medicine as an Adjunctive Therapy Improves the Survival Rate of Patients with Ischemic Heart Disease: A Nationwide Population-Based Cohort Study
I find it difficult not to view this as a deliberate attempt of the authors, editors, and reviewers to mislead the public.
Looking at the details of the study, it is easy to see that the two groups were different in a whole range of parameters that were measured. More importantly, they most likely differ in a range of variables that were not measured and had significant influence on IHD survival. It stands to reason, for instance, that patients who elected to use CHM in addition to their standard care were more health conscious. They would thus have followed a healthier diet and lifestyle. It would be foolish to claim that such factors do not influence IHD survival.
The fact that the authors fail even to mention this possibility, interpret an association as a causal link, and thus try to mislead us all makes this paper, in my view, a strong contender for my
WORST PAPER OF 2022 COMPETITION
If you have been following my blog for a while, you probably know the answer to this question. A recent article published in JAMA re-emphasizes it in an exemplary fashion:
According to National Health and Nutrition Examination Survey data, 52% of surveyed US adults reported using at least 1 dietary supplement in the prior 30 days and 31% reported using a multivitamin-mineral supplement. The most commonly cited reason for using supplements is for overall health and wellness and to fill nutrient gaps in the diet. Cardiovascular disease and cancer are the 2 leading causes of death and combined account for approximately half of all deaths in the US annually. Inflammation and oxidative stress have been shown to have a role in both cardiovascular disease and cancer, and dietary supplements may have anti-inflammatory and antioxidative effects.
Objective To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a review of the evidence on the efficacy of supplementation with single nutrients, functionally related nutrient pairs, or multivitamins for reducing the risk of cardiovascular disease, cancer, and mortality in the general adult population, as well as the harms of supplementation.
Population Community-dwelling, nonpregnant adults.
Evidence Assessment The USPSTF concludes with moderate certainty that the harms of beta carotene supplementation outweigh the benefits for the prevention of cardiovascular disease or cancer. The USPSTF also concludes with moderate certainty that there is no net benefit of supplementation with vitamin E for the prevention of cardiovascular disease or cancer. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplementation with multivitamins for the prevention of cardiovascular disease or cancer. Evidence is lacking and the balance of benefits and harms cannot be determined. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplementation with single or paired nutrients (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. Evidence is lacking and the balance of benefits and harms cannot be determined.
Recommendation The USPSTF recommends against the use of beta carotene or vitamin E supplements for the prevention of cardiovascular disease or cancer. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamin supplements for the prevention of cardiovascular disease or cancer. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of single- or paired-nutrient supplements (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. (I statement)
The report also elaborates on potential harms:
For many of the vitamins and nutrients reviewed, there was little evidence of serious harms. However, an important harm of increased lung cancer incidence was reported with the use of beta carotene by persons who smoke tobacco or have occupational exposure to asbestos.
Excessive doses of vitamin supplements can cause several known adverse effects; for example, moderate doses of vitamin A supplements may reduce bone mineral density, and high doses may be hepatotoxic or teratogenic. Vitamin D has potential harms, such as a risk of hypercalcemia and kidney stones, when given at high doses. The potential for harm from other supplements at high doses should be carefully considered.
There is nothing new here, of course. I (and others) have been trying to get these points across for many years. But it is nevertheless most gratifying to see the message repeated by a top journal such as JAMA. I hope JAMA is more successful than I was in changing the behavior of the often all too gullible public!
This story made the social media recently:
I was on a plane to Toronto and had fallen asleep after a good meal and a few glasses of wine when a stewardess woke me saying: “We think you are a doctor!?”
“That’s right, I am a professor of alternative medicine”, I said trying to wake up.
“We have someone on board who seems to be dying. Would you come and have a look? We moved him into 1st class.”
Arrived in 1st class, she showed me the patient and a stethoscope. The patient was unconscious and slightly blue in the face. I opened his shirt and used the stethoscope only to find that this device is utterly useless on a plane; the sound of the engine by far overwhelms anything else. With my free hand, I tried to find a pulse – without success! Meanwhile, I had seen a fresh scar on the patient’s chest with something round implanted underneath. I concluded that the patient had recently had a pacemaker implant. Evidently, the electronic device had malfunctioned.
At this stage, two stewardesses were pressing me: “The captain needs to know now whether to prepare for an emergency stop in Newfoundland or to fly on. It is your decision.”
I had problems thinking clearly. What was best? The patient was clearly dying and there was nothing I could do about it. I replied by asking them to give me 5 minutes while I tried my best. But what could I do? I decided that I could do nothing but hold the patient’s hand and let him die in peace.
The Stewardesses watched me doing this and must have thought that I was trying some sort of energy healing, perhaps Reiki. This awkward situation continued for several minutes until – out of the blue – I felt a regular, strong pulse. Evidently, the pacemaker had started functioning again. It did not last long until the patient’s color turned pink and he began to talk. I instructed the pilot to continue our path to Toronto.
After I had remained with the patient for another 10 minutes or so, the Stewardesses came and announced: “We have moved your things into 1st class; like this, you can keep an eye on him.” The rest of the journey was uneventful – except the Stewardesses came repeatedly giving me bottles of champagne and fine wine to take with me into Toronto. And each time they politely asked whether my healing method would not also work for the various ailments they happened to suffer from – varicose veins, headache, PMS, fatigue …
So, here is my message to all the fellow energy healers out there:
We honor the creator’s design.
We know of the potential of the body is limitless.
Remember, you did not choose energy healing.
Energy healing chose you.
You were called for a time like this.
In case you are beginning to wonder whether I have gone round the bend, the answer is NO! I am not an energy healer. In fact, I am as much NOT an energy healer, as the chiropractor in the above story has NOT saved the life of his patient. Chiropractors and stewardesses, it seems to me, have one thing in common: they do not understand much about medicine.
On arrival in Toronto, the patient was met by a team of fully equipped medics. I explained what had happened and they took him off to the hospital. As far as I know, he made a full recovery after the faulty pacemaker had been replaced. After my return to the UK, British Airways sent me a huge hamper to thank me.
Enthusiasts of so-called alternative medicine (SCAM) seem remarkably often those who deny the evidence related to the dire consequences of a COVID-19 infection. Consequently, they also deny the value of COVID vaccinations. Because on this blog we have had so many examples of this phenomenon, let me today show an interesting study that might give them food for thought.
The cardiovascular complications of acute coronavirus disease 2019 (COVID-19) are well described, but the post-acute cardiovascular manifestations of COVID-19 have not yet been comprehensively characterized. The authors of this study used national healthcare databases from the US Department of Veterans Affairs to build a cohort of 153,760 individuals with COVID-19, as well as two sets of control cohorts with 5,637,647 (contemporary controls) and 5,859,411 (historical controls) individuals, to estimate risks and 1-year burdens of a set of pre-specified incident cardiovascular outcomes.
The results show that beyond the first 30 d after infection, individuals with COVID-19 are at increased risk of incident cardiovascular disease spanning several categories, including cerebrovascular disorders, dysrhythmias, ischemic and non-ischemic heart disease, pericarditis, myocarditis, heart failure, and thromboembolic disease. These risks and burdens were evident even among individuals who were not hospitalized during the acute phase of the infection and increased in a graded fashion according to the care setting during the acute phase (non-hospitalized, hospitalized, and admitted to intensive care).
Risks and 12-month burdens of incident post-acute COVID-19 cardiovascular outcomes compared with the contemporary control cohort.
Outcomes were ascertained 30 d after the COVID-19-positive test until the end of follow-up. COVID-19 cohort (n = 153,760) and contemporary control cohort (n = 5,637,647). Adjusted HRs and 95% CIs are presented. The length of the bar represents the excess burden per 1,000 persons at 12 months, and associated 95% CIs are also shown.
The authors concluded that the results provide evidence that the risk and 1-year burden of cardiovascular disease in survivors of acute COVID-19 are substantial. Care pathways of those surviving the acute episode of COVID-19 should include attention to cardiovascular health and disease.
I know, this is a case-control study and correlation is not causation. But to investigate the possibility of a causal link further, the authors also tested the robustness of results in several sensitivity analyses involving the outcomes of MACE and any cardiovascular outcome. The sensitivity analyses were performed in comparisons involving COVID-19 versus the contemporary control and COVID-19 versus the historical control and, additionally, COVID-19 by care setting versus both controls.
(1) To test whether the inclusion of additional algorithmically selected covariates would challenge the robustness of study results, they selected and used 300 high-dimensional variables (instead of the 100 used in the primary analyses) to construct the inverse probability weighting.
(2) They then also tested the results in models specified to include only pre-defined covariates (that is, without the inclusion of algorithmically selected covariates) to build the inverse probability weighting.
(3) They changed the analytic approach by using the doubly robust method (instead of the inverse weighting method used in primary analyses) to estimate the magnitude of the associations between COVID-19 exposure and the pre-specified outcomes.
All sensitivity analyses yielded results consistent with those produced using the primary approach. This means that it is likely that the cause of the outcomes was the COVID-19 exposure.
How often have we seen advocates of SCAM argue against vaccination by pointing to the risk of myocarditis and other cardiovascular conditions, no matter how minuscule that risk truly is? This study quantifies the relative risk of several different cardiovascular outcomes after COVID-19 infection and the risk of myocarditis clearly stands out. I hope that the findings of this important study will make the COVID deniers reconsider their attitude.