Guest post by Tobias Katz
What do we know?
Taken from the BMJ (Ref 1): ICNARC latest report 31/12/21 showed that the proportion of patients admitted to critical care in December 2021 with confirmed covid-19 who were unvaccinated was 61%.
Prevention of infection
The government’s week 45 Covid surveillance report (Ref 3) is clear that vaccination prevention of infection (positive PCR, for Delta) effectiveness is estimated at 65% for Oxford-AstraZeneca and 80% for Pfizer.
Prevention of transmission
The Lancet’s (Ref 4) paper, suggests once infected, initial viral load is similar for vaccinated and unvaccinated individuals, suggesting likely equal chance of transmitting on the virus.
Protection of the individual
Ref 3, is clear cut that vaccination protects individuals from hospitalisation and severe infection (for Delta).
(Omicron) “Among those who had received 2 doses of AstraZeneca, there was no effect against Omicron from 20 weeks after the second dose. Among those who had received 2 doses of Pfizer or Moderna effectiveness dropped from around 65-70% down to around 10% by 20 weeks after the 2nd dose. 2 to 4 weeks after a booster dose vaccine effectiveness ranged from around 65 to 75%, dropping to 55 to 70% at 5 to 9 weeks and 40-50% from 10+ weeks after the booster.” (Ref 2)
Effectiveness here is measured by admission to hospital and shows the necessity for booster jabs when fighting Omicron.
Who are Dr James and Dr Malhotra?
Steven James, consultant anaesthetist, has recently been in the news for confronting Sajid Javid RE mandatory vaccinations for hospital and nursing staff. “The science isn’t strong enough” to support the policy he stated and “I’ve got antibodies”, suggesting that he’s as protected as he would be if he had a vaccine.
Aseem Malhotra, who goes by the name of ‘lifestylemedicinedoctor’ on Instagram is an extremely controversial cardiology consultant who seems to be Djokovic’s biggest fan and whose tweets are passionately quoted and forwarded by anti-vaxxers.
With tweets such as “Mark my words, with everything we know and don’t know about the current vaccine Novak Djokovic will ultimately be proven to be on the right side of history #BadPharma #truth #transparency #InformedConsent”:
Mark my words, with everything we know and don’t know about the current vaccine Novak Djokovic will ultimately be proven to be on the right side of history #BadPharma #truth #transparency #InformedConsent
— Dr Aseem Malhotra (@DrAseemMalhotra) January 9, 2022
And a retweet: “Dr Jordan Peterson Oh well. It’s just fertility. Women’s Periods May Be Late After Coronavirus Vaccination, Study Suggests”; he stirs the cooking pot of anti-establishment rhetoric and only deepens an already fractured relationship between doctors and their patients caused by the pandemic.
Oh well. It's just fertility. Women’s Periods May Be Late After Coronavirus Vaccination, Study Suggests https://t.co/ndQC9QgwMH
— Dr Jordan B Peterson (@jordanbpeterson) January 8, 2022
You’d think a mature, well-researched doctor would be able to tell the difference between the menstrual cycle and becoming fertile. You’d also hope he would not be short-sighted enough to support one of the most anti-science/anti-conventional medicine public figures in the world (see here)… Alas, no.
I feel as though both of these figures need to be reminded of their ethical duty of candour as doctors and reminded that their public actions have consequences. I may not completely disagree with Dr James (RE mandatory vaccinations) but the way in which he conducted himself during this nationally broadcasted video left many shaking with rage as it undermines many of his health professional colleagues. Me, included.
When a doctor appears on national news, opposing [mandatory] vaccination and offering incorrect explanations of why this is so, it should be obvious to them that their opinion will inevitably act as anti-vaccine propaganda, whether meant for this or not.
Malhotra’s ideas (cutting back on statins, healthy diet etc.) are often worth consideration/evaluation and as a new-age medical ‘influencer’ with 130k+ followers on Twitter, with ample publications behind him, he deserves to be listened to. Not necessarily agreed with, but listened to. But he also has a duty as a doctor to guard against complacency. Similar to James’ public actions, Malhotra’s tweets that are so one-sided give a biased, inaccurate and frankly dangerous view on the efficacy and safety profile of COVID vaccinations that have been safely and effectively used in millions of people to prevent hospitalisations. Is he doing it for the views? The hits? The likes? The retweets? To have people recognise him for his Pioppi diet?
What should we do?
Doctors, including James and Malhotra have an ethical responsibility not to spread imperfect information to a wide-receiving audience where their actions can be misconstrued and misrepresented so easily. Doing so may bolster anti-vaccine views, cause less ‘on-the-fence’ people to get the jabs and essentially lead to more preventable deaths.
More and more we are seeing social media take over and often act as the public’s primary source of news. More doctors than ever are now in the [social] media limelight. Some, such as Dr Alex George (mental health advocate) are promoting health responsibly. Others, seek to undermine it. In an era when Joe Rogan has more daily views than Fox News’ Tucker Carlson, to ignore and not rebut [health] social media giants like Malhotra would just worsen the situation. Malhotra and James need to be challenged by the scientific community, as the BBC so brilliantly did here.
If doctors want to become socialite Instagram influencers, they must do this without complacency. I think this means being responsible when offering controversial and potentially public health implicating opinions where evidence isn’t clear cut.
Using all the possible information above, as the vaccines are not 100% without risk, transmission is not completely cut post-vaccine and as we have a decent-ish way of monitoring infection (lateral flows and PCRs), I feel as though mandating vaccines for all NHS staff is currently unjust. I see Steve’s point. But I’d be extremely careful in how I’d make this point. And certainly not on live Sky News when the nation is watching, where it will inevitably be seized upon by the anti-vax community.
Saying this, the data is pretty clear that there is evidence that the vaccines offer protection against infection, reducing viral load quicker once infected and against hospitalisation and so if you’re a rational doctor who thinks that at least one time your lateral flow test may give a false negative, it makes complete sense to get your vaccine to protect your patients…
I came across this article via a German secondary report about it entitled “Scientists discover what else protects from severe symptoms” (Forscher finden heraus, was noch vor schweren Symptomen schützt). The article rightly stressed that vaccination is paramount and then explains that, once you have caught COVID, nutrition can prevent serious symptoms.
Even though I rarely discuss standard nutritional issues on my blog (nutrition belongs to mainstream not so-called alternative medicine [SCAM], in my view), this subject did attract my attention. Here are the essentials of the original scientific paper:
Australian scientists studied the association between habitual frequency of food intake of certain food groups during the COVID-19 pandemic and manifestations of COVID-19 symptoms in adult outpatients with suspected SARS-CoV-2 infection. They included 236 patients who attended an outpatient clinic for suspected COVID-19 evaluation. Severity of symptoms, habitual food intake frequency, demographics and Bristol chart scores were obtained before diagnostic confirmation with real-time reverse transcriptase PCR using nasopharyngeal swab.
The results of the COVID-19 diagnostic tests were positive for 103 patients (44%) and negative for 133 patients (56%). In the SARS-CoV-2-positive group, symptom severity scores had significant negative correlations with the habitual intake frequency of specific food groups. Multivariate binary logistic regression analysis adjusted for age, sex, and occupation confirmed that SARS-CoV-2-positive patients showed a significant negative association between having higher symptom severity and the habitual intake frequency of legumes and grains, bread, and cereals.
The authors concluded that an increase in habitual frequency of intake of ‘legumes’, and ‘grains, bread and cereals’ food groups decreased overall symptom severity in patients with COVID-19. This study provides a framework for designing a protective diet during the COVID-19 pandemic and also establishes a hypothesis of using a diet-based intervention in the management of SARS-CoV-2 infection, which may be explored in future studies.
So, the authors seem to think that they found a causal relationship: A CHANGE IN DIET DECREASES SYMPTOMS. In different sections of the article, they seem to confirm this notion, and they state that they tested the hypothesis of the effect of diet on SARS-CoV-2 infection symptom severity.
Yey, the investigation was merely a correlative study that cannot establish cause and effect. There are many other variables that might be linked to dietary habits which could be the true cause of the observed phenomenon (or contributors to it).
What’s the harm? If the article makes people adopt a healthier diet, all is pukka!
Perhaps, in this case, that might be true (even though one could argue that this paper might support anti-vax notions arguing that vaccination is not important if it is possible to prevent severe symptoms through dietary changes). But the confusion of correlation with causality is both frequent and potentially harmful. And it is unquestionably poor science!
I feel that we need to be concerned about the fact that even reputable journals let such things pass – not least because the above example shows what the popular press subsequently can make of such misleading messages.
The global market for dietary supplements has grown continuously during the past years. In 2019, it amounted to around US$ 353 billion. The pandemic led to a further significant boost in sales. Evidently, many consumers listened to the sly promotion by the supplement industry. Thus they began to be convinced that supplements might stimulate their immune system and thus protect them against COVID-19 infections.
During the pre-pandemic years, the US sales figures had typically increased by about 5% year on year. In 2020, the increase amounted to a staggering 44 % (US$435 million) during the six weeks preceding April 5th, 2020 relative to the same period in 2019. The demand for multivitamins in the US reached a peak in March 2020 when sales figures had risen by 51.2 %. Total sales of vitamins and other supplements amounted to almost 120 million units for that period alone. In the UK, vitamin sales increased by 63 % and, in France, sales grew by around 40–60 % in March 2020 compared to the same period of the previous year.
Vis a vis such impressive sales figures, one should ask whether dietary supplements really do produce the benefit that consumers hope for. More precisely, is there any sound evidence that these supplements protect us from getting infected by COVID-19? In an attempt to answer this question, I conducted several Medline searches. Here are the conclusions of the relevant clinical trials and systematic reviews that I thus found:
- KSK (a polyherbal formulation from India’s Siddha system of medicine) significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings.
- There is currently insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment of COVID-19.
- Herbal supplements may help patients with COVID-19, zinc sulfate is likely to shorten the duration of olfactory dysfunction. DS therapy and herbal medicine appear to be safe and effective adjuvant therapies for patients with COVID-19. These results must be interpreted with caution due to the overall low quality of the included trials. More well-designed RCTs are needed in the future.
- No significant difference with vitamin-D supplementation on major health related outcomes in COVID-19.
- there is not enough evidence on the association between individual zinc status and COVID-19 infections and mortality.
- Omega-3 supplementation improved the levels of several parameters of respiratory and renal function in critically ill patients with COVID-19.
- A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.
- In this 2-sample MR study, we did not observe evidence to support an association between 25OHD levels and COVID-19 susceptibility, severity, or hospitalization. Hence, vitamin D supplementation as a means of protecting against worsened COVID-19 outcomes is not supported by genetic evidence.
- These antiviral and immune-modulating activities and their ability to stimulate interferon production recommend the use of probiotics as an adjunctive therapy to prevent COVID-19. Based on this extensive review of RCTs we suggest that probiotics are a rational complementary treatment for RTI diseases and a viable option to support faster recovery.
- In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care.
- These findings neither support nor refute the claim that 3M3F alters the severity of COVID-19 or alleviates symptoms. More rigorous studies are required to properly ascertain the potential role of Chinese Herbal Medicine in COVID-19.
- NSO (Nigella sativa oil) supplementation was associated with faster recovery of symptoms than usual care alone for patients with mild COVID-19 infection. These potential therapeutic benefits require further exploration with placebo-controlled, double-blinded studies.
- The clinical application of LQ (Lianhua Qingwen Granules or Capsules ) on the treatment of COVID-19 has significant efficacy in improving clinical symptoms and reducing the rate of clinical change to severe or critical condition. Nevertheless, due to the limited quantity and quality of the included studies, more and higher quality trials with more observational indicators are expected to be published.
- The study identified some important potential traditional Indian medicinal herbs such as Ocimum tenuiflorum, Tinospora cordifolia, Achyranthes bidentata, Cinnamomum cassia, Cydonia oblonga, Embelin ribes, Justicia adhatoda, Momordica charantia, Withania somnifera, Zingiber officinale, Camphor, and Kabusura kudineer, which could be used in therapeutic strategies against SARS-CoV-2 infection.
- Shenhuang Granule is a promising integrative therapy for severe and critical COVID-19.
- Low-certainty or very low-certainty evidence demonstrated that oral CPM (Chinese patent medicine) may have add-on potential therapeutic effects for patients with non-serious COVID-19. These findings need to be further confirmed by well-designed clinical trials with adequate sample sizes.
- XYP (Xiyanping) injection is safe and effective in improving the recovery of patients with mild to moderate COVID-19. However, further studies are warranted to evaluate the efficacy of XYP in an expanded cohort comprising COVID-19 patients at different disease stages.
- Our meta-analysis of RCTs indicated that LH (Lianhuaqingwen) in combination with usual treatment may improve the clinical efficacy in patients with mild or moderate COVID-19 without increasing adverse events. However, given the limitations and poor quality of included trials in this study, further large-sample RCTs or high-quality real-world studies are needed to confirm our conclusions.
- Reduning injection might be effective and safe in patients with symptomatic COVID-19.
- In light of the safety and effectiveness profiles, LH (Lianhuaqingwen) capsules could be considered to ameliorate clinical symptoms of Covid-19.
- QPT (Qingfei Paidu Tang) was associated with a substantially lower risk of in-hospital mortality, without extra risk of acute liver injury or acute kidney injury among patients hospitalized with COVID-19.
- This community-based RCT found that the use of a herbal medicine therapy (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) could significantly reduce the risks of the common cold among community-dwelling residents, suggesting that herbal medicine may be a useful approach for public health intervention to minimize preventable morbidity during COVID-19 outbreak.
- Based on unresolved controversies and inconclusive findings, it could be said that generally, a single and specific therapeutics to COVID-19 is still a mirage.
- Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients.
Does the evidence justify the boom in sales of dietary supplements?
More specifically, is there good evidence that the products the US supplement industry is selling protect us against COVID-19 infections?
No, I don’t think so.
So, what precisely is behind the recent sales boom?
It surely is the claim that supplements protect us from Covid-19 which is being promoted in many different ways by the industry. In other words, we are being taken for a (very expensive) ride.
Last week, a naturopath who has been practicing naturopathy for more than three years, appeared in the Paris High Court. He is accused of “illegal practice of medicine” and of “usurpation of the title of doctor” after two of his cancer patients died.
Charles B. was diagnosed with testicular cancer in 2016 but wanted to avoid traditional medicine. In March 2017, he consulted the naturopath, Miguel B., who studied for fourteen years in the United States and has a degree in biochemistry and a doctorate in molecular medicine. He knew that his qualifications did not allow him to practice in France and presented himself as a naturopath. Knowing about his client’s cancer, Miguel B. drew up a health plan for him that included numerous fasts and purges to detox his body.
In the following months, the cancer spreads to the lungs and brain. Charles B. wrote to his naturopath in early February: “Great pain, don’t know what to do”. The naturopath continued his advice: “You should go on a diet, rest and purge in the evening. In court, Charles B.’s father recalled a conversation between his son and Miguel B. during which the latter had said to Charles B.: “It would be a pity if you were to undergo this chemotherapy.” On 22 February 2018, now weighing only 59 kg, Charles B. finally decided to start chemotherapy. But it was already too late, and he died on 18 December 2018, at the age of 41, of a cancer from which more than 98% of patients usually recover. Charles B.’s wife stated that the naturopath had told her husband that he would not need chemotherapy. She believes that the defendant is “responsible and even guilty” of her husband’s death.
The family of another patient of Miguel B. has also joined the case. Catherine F., who had been suffering from cervical cancer, died at the age of 39. She had followed, among other treatments, a fast recommended by the naturopath and was one of 149 further patients whose list was found on a USB stick belonging to the defendant.
In so-called alternative medicine (SCAM), we have numerous diets that are either promoted for specific conditions or that are popular in a more general sense. Meat-free forms of nutrition can perhaps not be characterised as SCAM, but they are certainly popular with consumers as well as practitioners of SCAM. It is often said that meat-free diets are healthy, but few entusiasts like to consider that it might be associated with health risks.
This study tested whether vegetarianism and veganism are risk factors for bone factures in a prospective cohort with a large proportion of non-meat eaters.
In EPIC-Oxford, dietary information was collected at baseline (1993–2001) and at follow-up (≈ 2010). Participants were categorised into four diet groups at both time points (with 29,380 meat eaters, 8037 fish eaters, 15,499 vegetarians, and 1982 vegans at baseline in analyses of total fractures). Outcomes were identified through linkage to hospital records or death certificates until mid-2016. The risks were calculated of total (n = 3941) and site-specific fractures (arm, n = 566; wrist, n = 889; hip, n = 945; leg, n = 366; ankle, n = 520; other main sites, i.e. clavicle, rib, and vertebra, n = 467) by diet group over an average of 17.6 years of follow-up.
Compared with meat eaters and after adjustment for socio-economic factors, lifestyle confounders, and body mass index (BMI), the risks of hip fracture were higher in
- fish eaters (hazard ratio 1.26; 95% CI 1.02–1.54),
- vegetarians (1.25; 1.04–1.50),
- vegans (2.31; 1.66–3.22).
This was equivalent to rate differences of 2.9 (0.6–5.7), 2.9 (0.9–5.2), and 14.9 (7.9–24.5) more cases for every 1000 people over 10 years, respectively. The vegans also had higher risks of total (1.43; 1.20–1.70), leg (2.05; 1.23–3.41), and other main site fractures (1.59; 1.02–2.50) than meat eaters. Overall, the significant associations appeared to be stronger without adjustment for BMI and were slightly attenuated but remained significant with additional adjustment for dietary calcium and/or total protein. No significant differences were observed in risks of wrist or ankle fractures by diet group with or without BMI adjustment, nor for arm fractures after BMI adjustment.
The authors concluded that non-meat eaters, especially vegans, had higher risks of either total or some site-specific fractures, particularly hip fractures. This is the first prospective study of diet group with both total and multiple specific fracture sites in vegetarians and vegans, and the findings suggest that bone health in vegans requires further research.
The effect is by no means large, and I doubt that it will persuade many non-meat eaters to change their diet. However, perhaps the study can serve as a reminder that people who avoid meat might some lack essential nutrients and that they should therefore consider making sure that no deficiencies can develop.
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.
I know of one patient who turned to the Gerson Therapy having been told that she was suffering from terminal cancer and would not survive another course of chemotherapy. Happily, seven years later she is alive and well. So therefore it is vital that, rather than dismissing such experiences, we should further investigate the beneficial nature of these treatments.
HRH The Prince of Wales (2004)
I was reminded of this embarrassing (because displaying profound ignorance) quote when I looked at the website of the ‘GERSON SUPPORT GROUP UK‘ where it is prominently cited. Under the heading ‘SCIENCE & CLINICAL RATIONAL’ the site offers a long article about the Gerson therapy (GT). Allow me to show you a few quotes from it:
Dr Max Gerson’s therapy is based on the belief that insufficient nutrients within the cells and an accumulation of toxins in the tissues lead to a breakdown in healthy cellular function which, if left unchecked, can trigger cancer.
That is interesting, I find, because the statement clearly admits that the GT is not an evidence-based therapy but a belief-based treatment.
The therapy that he developed uses a restrictive, plant-based diet and specific supplements to boost healthy cellular function; and various detoxification procedures, including coffee enemas, to eliminate waste products.
The claims hidden in this sentence remain unproven. There is no evidence that cellular fuction is boosted, nor that the procedures eliminate toxins.
… we only need to look at communities across the globe which exist in a pre-industrialised state to see that, whilst they might be more likely to die from pneumonia or tuberculosis, rates of degenerative illness are a fraction of those in the ‘developed‘ world. The age-adjusted death rate from breast cancer is less than 2 per 100,000 of the population in Thailand, Sri Lanka and El Salvador and around 33 per 100,000 in the UK, US, The Netherlands and numerous other affluent, Western countries.
Correlation is not causation! Pre-industrial societies also watch less TV, eat less ice-cream, read less fashion magazines, etc., etc. Are these habits also the cause of cancer?
… migrant studies show that within two generations the cancer rates of migrants increase rapidly towards Western rates, again underlining the assertion that cancer is caused primarily by diet and lifestyle rather than ‘faulty’ genes.
In no way is this an argument for eating raw vegetable and taking your coffee via the rectum.
In the German scientific golden age of the 1920s and 30s…
Golden age for what, for fascists?
Gerson had used a restricted diet to cure himself of migraines. He then helped another patient to reverse tuberculosis, and many others to reverse a variety of degenerative illnesses, all by similar means. He later developed his therapy to the point where he was able to help individuals reverse cancer.
In this case, Max Gerson was ignorant of the fact that experience and evidence are two fundamentally different things.
Max Gerson developed his therapy in an iterative way, starting with a restrictive plant-based diet, adding vitamins, minerals and enzymes to encourage the oxygenation of the cells and then introducing the coffee enemas to aid detoxification of waste products. What is fascinating is that science has subsequently explained the mechanism of action behind some of his theories. (See Biochemical Basis to the Therapy).
Science has not explained the mechanism of action, not least because the action has never been verified. There are no robust clinical trials of Gerson’s therapy. Evidently, 100 years were not enough to conduct any – or perhaps the proponents know only too well that they would not generate the results they hoped?
Equally interesting is that in 2012 Dr Thomas Seyfried published the results of many years research in Cancer as a Metabolic Disease.
Really? On Medline, I find only two cancer-related papers for Seyfried T. 2012:
Thus, nearly a century after their original proposition that the fundamental cause of cancer was faulty cellular metabolism, it seems that doctors Otto Warburg and Max Gerson might be vindicated.
No, to ‘vindicate’ a therapeutic suggestion one needs several rigorous clinical trials. And for the GT, they remain absent.
So, what does the GT amount to?
- proponents had ~100 years to produce evidence;
- they failed to do so;
- thus the therapy is at best unproven;
- it is also biologically implausible;
- moreover, it is expensive;
- crucially it is not free of serious adverse effects;
- it is promoted only by those who seem to make money from it.
The only controlled clinical trial of a Gerson-like therapy that I know of is this one (rarely cited by Gerson fans):
Conventional medicine has had little to offer patients with inoperable pancreatic adenocarcinoma; thus, many patients seek alternative treatments. The National Cancer Institute, in 1998, sponsored a randomized, phase III, controlled trial of proteolytic enzyme therapy versus chemotherapy. Because most eligible patients refused random assignment, the trial was changed in 2001 to a controlled, observational study.
All patients were seen by one of the investigators at Columbia University, and patients who received enzyme therapy were seen by the participating alternative practitioner. Of 55 patients who had inoperable pancreatic cancer, 23 elected gemcitabine-based chemotherapy, and 32 elected enzyme treatment, which included pancreatic enzymes, nutritional supplements, detoxification, and an organic diet. Primary and secondary outcomes were overall survival and quality of life, respectively.
At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. Kaplan-Meier analysis found a 9.7-month difference in median survival between the chemotherapy group (median survival, 14 months) and enzyme treatment groups (median survival, 4.3 months) and found an adjusted-mortality hazard ratio of the enzyme group compared with the chemotherapy group of 6.96 (P < .001). At 1 year, 56% of chemotherapy-group patients were alive, and 16% of enzyme-therapy patients were alive. The quality of life ratings were better in the chemotherapy group than in the enzyme-treated group (P < .01).
Among patients who have pancreatic cancer, those who chose gemcitabine-based chemotherapy survived more than three times as long (14.0 v 4.3 months) and had better quality of life than those who chose proteolytic enzyme treatment.
Considering all this, I believe, it would be hard to name a cancer quackery that is less credible than the GT.
The ketogenic diet (KD) 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. KD is 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.
However, these indications are not supported by good evidence.
A side effect of KD is “keto flu,” a syndrome of transient symptoms generally reported as occurring within the first few weeks of adhering to the diet. These symptoms can feel similar to the flu and are caused by the body adapting to a new diet consisting of very little carbohydrates.
Ketones are by-products of fat breakdown and become the main energy source when following the KD. Normally, fat is reserved as a secondary fuel source to use when glucose is not available. This switch to burning fat for energy is called ketosis. It occurs during specific circumstances, including starvation, fasting … or KD. The KD reduces carbohydrates typically to under 50 grams per day. This drastic reduction may cause withdrawal-like symptoms, similar to those experienced when weaning off an addictive substance.
A recent paper aimed to characterize the pattern of symptoms, severity and time course of keto flu as related by users of online forums. Online forums referring to “keto flu,” “keto-induction,” or “keto-adaptation” in the URL were identified. Passages describing personal experiences of keto flu were categorized with reference to pattern of symptoms, severity, time course, and remedies proposed.
The search criteria identified 75 online forums, 43 met inclusion criteria and contained 448 posts from 300 unique users. Seventy-three made more than one post (mean 3.12, range 2-11). Descriptors of personal experience of keto flu, reported by 101 of 300 users, included 256 symptom descriptions involving 54 discrete symptoms. Commonest symptoms were “flu,” headache, fatigue, nausea, dizziness, “brain fog,” gastrointestinal discomfort, decreased energy, feeling faint and heartbeat alterations.
Symptom reports peaked in the first and dwindled after 4 weeks. Resolution of keto flu symptoms was reported by 8 users between days 3 and 30 (median 4.5 ). Severity of symptoms, reported by 60 users in 40 forums, was categorized as mild (N = 15), moderate (N = 23), or severe (N = 22). Eighteen remedies were proposed by 121 individual users in 225 posts. The following treatments were most frequently recommended (numbers represent the number of times of each recommendation was made):
|Increase sodium intake||58|
|Supplement with electrolytes||38|
|Drink broth (including bone broth, stock cubes)||27|
I find this paper interesting, not least because of the unusual methodological approach. It seems to confirm that, even though the KD is often recommended as safe, it is associated with significant side-effects. One adverse effect remained unmentioned, while leading to more people discontinuing the diet than any other side-effect: the fact that the diet is quite unpalatable on the long-run and soon puts people off eating. This, of course, might be one mechanism by which KD leads to weight loss.
Spermidine is a polyamine which is a natural component of our cells. It has its name from the fact that it was first found in sperm. It can also be found in varying concentrations in different fruits, vegetables, meat and cheese. About one third of the spermidine levels in our body is produced by our own cells, the rest is absorbed through food and certain bacteria found in our digestive tract. A balanced diet can therefore help maintain high levels of spermidine.
There has been a flurry of research into spermidine, not least because epidemiologic evidence supports to the concept that nutrition rich in spermidine is linked to increased survival in humans. Unsurprisingly, many spermidine supplements are now available for sale (at around £50 for one month’s supply). In order to check whether there is any clinical evidence to suggest that they are effective, I ran a quick Medline search for placebo-controlled, double-blind RCTs. I found 4 such studies; here are their abstracts:
Introduction: Nutritional intervention with the natural polyamine spermidine, an autophagy-enhancing agent, can prevent memory loss in aging model organisms. This is the first human study to evaluate the impact of spermidine supplementation on memory performance in older adults at risk for the development of Alzheimer’s disease.
Methods: Cognitively intact participants with subjective cognitive decline (n = 30, 60-80 years of age) were included in this three-months, randomized, placebo-controlled, double-blind Phase IIa pilot trial with a spermidine-rich plant extract supplement. Effects of intervention were assessed using the behavioral mnemonic similarity task, measured at baseline and post-intervention visits. Data analysis was focused on reporting and interpreting effectiveness based on effect sizes.
Results: Memory performance was moderately enhanced in the spermidine group compared with placebo at the end of intervention [contrast mean = .17, 95% confidence interval (CI): -.01, .35, Cohen’s d = .77, 95% CI: 0, 1.53]. Mnemonic discrimination ability improved in the spermidine-treated group with a medium effect size (mean difference = -.11, 95% CI: -.19, -.03, Cohen’s d = .79, 95% CI: .01, 1.55). A similar effect was not found in the placebo-treated group (mean difference = .07, 95% CI: -.13, .27, Cohen’s d = -.20, 95% CI: -.94, .54).
Discussion: In this pilot trial, nutritional spermidine was associated with a positive impact on memory performance in older adults with subject cognitive decline. The beneficial effect might be mediated by stimulation of neuromodulatory actions in the memory system. A follow-up Phase IIb randomized controlled trial will help validate the therapeutic potential of spermidine supplementation and delineate possible neurophysiological mechanisms of action.
Supplementation of spermidine, an autophagy-inducing agent, has been shown to protect against neurodegeneration and cognitive decline in aged animal models. The present translational study aimed to determine safety and tolerability of a wheat germ extract containing enhanced spermidine concentrations. In a preclinical toxicity study, supplementation of spermidine using this extract did not result in morbidities or changes in behavior in BALBc/Rj mice during the 28-days repeated-dose tolerance study. Post mortem examination of the mice organs showed no increase in tumorigenic and fibrotic events. In the human cohort (participants with subjective cognitive decline, n=30, 60 to 80 years of age), a 3-month randomized, placebo-controlled, double-blind Phase II trial was conducted with supplementation of the spermidine-rich plant extract (dosage: 1.2 mg/day). No differences were observed between spermidine and placebo-treated groups in vital signs, weight, clinical chemistry and hematological parameters of safety, as well as in self-reported health status at the end of intervention. Compliance rates above 85% indicated excellent tolerability. The data demonstrate that spermidine supplementation using a spermidine-rich plant extract is safe and well-tolerated in mice and older adults. These findings allow for longer-term intervention studies in humans to investigate the impact of spermidine treatment on cognition and brain integrity.
Recently, it was demonstrated that spermidine-induced autophagy reduces the risk of cardiovascular disease in mice. Intestinal bacteria are a major source of polyamines, including spermidine. We previously reported that the intake of both Bifidobacterium animalis subsp. lactis (Bifal) and arginine (Arg) increases the production of putrescine, a spermidine precursor, in the gut. Here, we investigated the effects of Bifal and Arg consumption on endothelial function in healthy subjects. Healthy individuals with body mass index (BMI) near the maximum value in the “healthy” range (BMI: 25) (n = 44) were provided normal yogurt containing Bifal and Arg (Bifal + Arg YG) or placebo (normal yogurt) for 12 weeks in this randomized, double-blinded, placebo-controlled, parallel-group comparative study. The reactive hyperemia index (RHI), the primary outcome, was measured using endo-peripheral arterial tone (EndoPAT). The change in RHI from week 0 to 12 in the Bifal + Arg YG group was significantly higher than that in the placebo group, indicating that Bifal + Arg YG intake improved endothelial function. At week 12, the concentrations of fecal putrescine and serum putrescine and spermidine in the Bifal + Arg YG group were significantly higher than those in the placebo group. This study suggests that consuming Bifal + Arg YG prevents or reduces the risk of atherosclerosis.
Background: Spermidine has been shown both in vitro and in mice models to have an anagen-prolonging effect on hair follicles (HFs).
Objectives: To evaluate the effects of a spermidine-based nutritional supplement on the anagen phase of HFs in healthy human subjects in a randomized, double-blind, placebo-controlled trial.
Methods: One hundred healthy males and females were randomized to receive a tablet containing a spermidine-based nutritional supplement or a placebo once daily for 90 days. At the beginning and the end of the treatment period, 100 HFs were plucked and subjected to microscopic evaluation to determine the number of anagen V-VI HFs, and immunohistochemical examination was performed to quantify the Ki-67 and c-Kit levels in the hair bulbs. Pull test was performed after three and six months.
Results: The spermidine-based nutritional supplement increased the number of anagen V-VI HFs after three months of treatment, accompanied by increased Ki-67, a marker for cellular proliferation, and decreased c-Kit, a marker for apoptosis, levels. All results were also significantly better when compared to the placebo group. The pull test remained negative after six months in all patients receiving the spermidine supplement, while 68% of the subjects in the placebo group had a positive pull test.
Conclusions: This preliminary study shows that a spermidine-based nutritional supplement can prolong the anagen phase in humans, and therefore might be beneficial for hair loss conditions. Further studies are needed to evaluate its effects in specific different clinical settings.
I could certainly do with a few more hair on my head.
And living longer with less cognitive decline would also be not a bad prospect.
Do I therefore rush to the next health food shop to buy a spermidine supplement?
Yes, the evidence – particularly the pre-clinical one – is fascinating. But it seems to me that a normal diet will provide all the spermidine I need (and for £50 I can buy a lot of good food).
The researchers identified the top 100 best-selling books and assessed for both the claims they make in their summaries and the credentials of the authors. Weight loss was a common theme in the summaries of nutritional best-selling books. In addition to weight loss, 31 of the books promised to cure or prevent a host of diseases, including diabetes, heart disease, cancer, and dementia.
The nutritional advice given to achieve these outcomes varied widely in terms of which types of foods should be consumed or avoided and this information was often contradictory between books. Recommendations regarding the consumption of carbohydrates, dairy, proteins, and fat in particular differed greatly between books.
To determine the qualifications of each author in making nutritional claims, the highest earned degree and listed occupations of each author was researched and analyzed. Out of 83 unique authors, 33 had an M.D. or Ph.D degree. Twenty-eight of the authors were physicians, three were dietitians, and other authors held a wide range of jobs, including personal trainers, bloggers, and actors. Of 20 authors who had or claimed university affiliations, seven had a current university appointment that could be verified online in university directories.
The authors concluded that this study illuminates the range of the incongruous information being dispersed to the public and emphasizes the need for future efforts to improve the dissemination of sound nutritional advice.
The authors also provide a ‘sample of claims that appear disputable and/or unsubstantiated according to our expertize and opinion’:
1. “Carbs are destroying your brain”—Grain Brain
2. “Have high blood pressure? Hibiscus tea can work better than a leading hypertensive drug-and without the side effects. Fighting off liver disease? Drinking coffee can reduce liver inflammation. Battling breast cancer? Consuming soy is associated with prolonged survival.”—How Not to Die
3. “Zero Belly diet attacks fat on a genetic level, placing a bull’s-eye on the fat cells that matter most: visceral fat, the type of fat ensconced in your belly.”—Zero Belly Diet
4. “SKIP THE CRUNCHES: They just build muscle under the fat…LESS (EXERCISE) IS MORE”—This Is Why You’re Fat (And How to Get Thin Forever)
5. “Eating pasta, bread, potato, and pizza will actually make you happier, healthier, and thinner—for good”—The Carb Lovers Diet
6. “Skip breakfast, stop counting calories, eat high levels of healthy saturated fat, work out and sleep less, and add smart supplements”—The Bulletproof Diet
7. “Modern “improvements” to our food supply—including refrigeration, sanitation, and modified grains—have damaged our intestinal health. Dr. Axe offers simple ways to get these needed microbes, from incorporating local honey and bee pollen into your diet to forgoing hand sanitizers and even ingesting a little probiotic-rich soil”—Eat Dirt
8. “Overeating doesn’t make you fat; the process of getting fat makes you overeat.”—Always Hungry?
9. “Do you have an overall sense of not feeling your best, but it has been going on so long it’s actually normal to you? You may have an autoimmune disease, and this book is the “medicine” you need.”—The Immune System Recovery Plan
10. “Shows you how to grow new receptors for your seven metabolic hormones, making you lose weight and feel great fast!”—The Hormone Reset Diet
11. “The world’s foremost expert on the therapeutic use of culinary spices, takes an in-depth look at 50 different spices and their curative qualities, and offers spice “prescriptions”–categorized by health condition–to match the right spice to a specific ailment.”—Healing Spices
12. “The idea that people simply eat too much is no longer supported by science”—The Adrenal Reset Diet
13. “Most of us think God is not concerned with what we eat, but the Bible actually offers great insight and instruction about the effects of food on our bodies”—Let Food Be Your Medicine
14. “Dieters can actually lose weight by eating foods, nutrients, teas, and spices that change the chemical balance of the brain for permanent weight loss—a major factor contributing to how quickly the body ages. In fact, everyone can take years off their age by changing their brain chemistry.”—Younger (Thinner) You Diet
15. “Weight gain is not about the food, but about the body’s environment. Excess weight is a result of the body being in a toxic, inflammatory state. If your body is not prepared or ‘primed’ for weight loss, you will fight an uphill biochemical battle”—The Prime
16. “Throwing ice cubes in your water to make it more “structured”. Skipping breakfast, as it could be making you fat. Eating up to 75 percent of your calories each day in fat for optimal health, reduction of heart disease, and cancer prevention”—Effortless Healing
To call these statements ‘disputable’ must be the understatement of the year!
I have long been concerned about the dangerous rubbish published in so-called ‘self-help books’. In 1998, we assessed for the first time the quality of books on so-called alternative medicine (SCAM) [Int J Risk Safety Med 1998, 11: 209-215. [for some reason, this article is not Medline-listed]. We chose a random sample of 6 such books all published in 1997, and we assessed their contents according to pre-defined criteria. The findings were sobering: the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.
In 2006, we conducted a similar investigation the results of which we reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE. This time, we selected 7 best-sellers in SCAM and scrutinised them in much the same way. We found that almost every treatment seemed to be recommended for almost every condition. There was no agreement between the different books which therapy might be effective for which condition. Some treatments were even named as indications for a certain condition, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:
- addictions: 120 different treatments
- arthritis: 131 different treatments
- asthma: 119 different treatments
- cancer: 133 different treatments
This experience, which we published as a chapter in the above-mentioned book entitled AN EPITAPH TO OPINION-BASED MEDICINE, confirmed our suspicion that books on SCAM are a major contributor to the misinformation in this area.
The new paper by Ioannidis et al adds substantially to all this. It shows that the problem is wide-spread and has not gone away. Since such books have a huge readership, they are a danger to public health. Now that the problem has been identified and confirmed, it is high time, I think, that we do something about it … but I wish I knew what.