On FACEBOOK I recently found this advertisement posted by ‘LifeCell Health’
Guys, weight loss starts at our gut. The reishi mushroom targets this key area of the body and promotes weight loss in a unique way, by changing our gut bacteria to digest food in a manner that improves weight loss and can even prevent weight gain. By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers a blend of weight loss mushrooms like no other: Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms. Each mushroom has been the subject of several in-vivo studies proving their efficacy when it comes to weight loss.
Why Mushrooms Work.
Reishi: Prevents weight gain by altering bacteria inside the digestive system
Shiitake: Helps the body develop less fat by nourishing good gut bacteria.
Turkey Tail: Reduces inflammation and helps prevent weight gain.
That sounded interesting, I thought, and I investigated a bit further. On the website of the firm, I found this text:
By combining 3 of the most researched mycological species on the planet, LifeCell Myco+ delivers an organic wellness formula unlike any other. Improve gut health, speed up weight loss, enhance immune function, natural energy and more with our blend of Reishi, Turkey Tail, and Shiitake mushrooms.
Keeping a healthy balance of beneficial bacteria in your gut is critical for maintaining a strong immune system. Your gut bacteria interact with immune cells and directly impact your immune response. Turkey tail mushrooms contain prebiotics, which help nourish these helpful bacteria. An 8-week study in 24 healthy people found that consuming 3,600 mg of PSP extracted from turkey tail mushrooms per day led to beneficial changes in gut bacteria and suppressed the growth of the possibly problematic E. coli and Shigella bacteria.
Next, I conducted a few Medline searches but was unable to find any trial data suggesting that any of the three mushrooms or their combination might reduce body weight. So, I wrote to the company:
I am intrigued by your product MYCO +. Would you be kind enough to send me the studies showing that it can reduce body weight?
What followed was a bizarre correspondence with several layers of administrators in the firm. They all said that I should discuss this with the next higher person. So, I asked myself up the hierarchy of LiveCell. The last email I received was this one:
Good morning Edzark,
Thank you for your email and I hope you are enjoying your day.
It is great to hear that you are interested in our LifeCell Myco. I have forwarded your request for additional information and once received I will be sure to forward the information to you.
What do I conclude from this experience?
Apart from being unable to get my name right, the people responsible at ‘LifeCell Health’ seem also not able to send me the evidence I asked for. This, I fear, means that there is no such evidence which means the claims are unsubstantiated. Scientifically, this might amount to misconduct; legally, it could be fraudulent.
But I am, of course, no lawyer and therefore leave it to others to address the legal issues.
If anyone happens to know of some evidence, please let me know and I will correct my post accordingly.
Withania somnifera, commonly known as Ashwagandha, is a plant belonging to the family of Solanaceae. It is widely used in Ayurvedic medicine. The plant is promoted as an immunomodulator, anti-inflammatory, anti-stress, anti-Parkinson, anti-Alzheimer, cardioprotective, neural and physical health enhancer, neuro-defensive, anti-diabetic, aphrodisiac, memory-boosting, and ant-cancer remedy. It contains diverse phytoconstituents including alkaloids, steroids, flavonoids, phenolics, nitrogen-containing compounds, and trace elements.
But how much of the hype is supported by evidence? Unsurprisingly, there is a shortage of good clinical trials. Yet, during the last few years, a surprising number of reviews of the accumulating evidence have emerged:
- One review suggested that pre-clinical, as well as clinical studies, suggest the effectiveness of Withania somnifera (L.) against neurodegenerative disease.
- A further review suggested a potential role of W. somnifera in managing diabetes.
- A systematic review of 5 clinical trials found that W. somnifera extract improved performance on cognitive tasks, executive function, attention, and reaction time. It also appears to be well tolerated, with good adherence and minimal side effects.
- Another systematic review included 4 clinical trials and reported significant improvements in serum hormonal profile, oxidative biomarkers, and antioxidant vitamins in seminal plasma. No adverse effects were reported in infertile men taking W. somnifera treatment.
- Another review concluded that the root of the Ayurvedic drug W. somnifera (Aswagandha) appears to be a promising safe and effective traditional medicine for management of schizophrenia, chronic stress, insomnia, anxiety, memory/cognitive enhancement, obsessive-compulsive disorder, rheumatoid arthritis, type-2 diabetes and male infertility, and bears fertility promotion activity in females adaptogenic, growth promoter activity in children and as adjuvant for reduction of fatigue and improvement in quality of life among cancer patients undergoing chemotherapy.
- A systematic review of 13 RCTs found that Ashwagandha supplementation was more efficacious than placebo for improving variables related to physical performance in healthy men and women.
- Another systematic review concluded that Ashwagandha supplementation might improve the VO2max in athletes and non-athletes.
This certainly looks as though that this plant is worthy of further study. But I can never help feeling a bit skeptical when I hear of such a multitude of benefits without evidence for adverse effects (other than minor upset stomach, nausea, and drowsiness).
Ever since I published a post about the irresponsible and aggressive advertising campaign of LYMA (“the world’s 1st super-supplement”), I am pursued by them with emails informing me about the wonders of this supplement. Here is one I received recently:
Here at LYMA we are firm believers that optimal productivity depends on good quality sleep and your day is only as good as the previous night.
Suffering from bad sleep is debilitating whether it’s ourselves or we’re watching someone we love suffer, the search for good rest is something we’re all united in.
Energy levels, positive mindset and strong cognitive function all come from sleep, which is why we spent so long formulating the LYMA supplement. Our patented KSM-66® Ashwagandha is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world. The hefty combination of purity and potency make it unrivalled in its ability to reduce inflammation, neutralise anxiety and promote deep, restful sleep, night after night.
Thousands of customers have told us that after years of bad sleep, they’re finally getting the rest they need and feeling transformed as a result. In fact, it’s one of the very first benefits most people notice. We’re happy to hear it.
And the knock-on effects of a good night’s sleep in how we feel, how we perform and our overall health are far reaching. Which is why we are so delighted to welcome Michael Grandner, world-renowned sleep expert and Director of the Behavioural Sleep Medicine Clinic, Arizona to the LYMA team.
Michael is one of the most cited sleep experts in the world and has himself published over 175 articles on issues relating to sleep and health. We plan on tapping into every area of his expertise to understand our own sleep habits and how we can all become the best at rest.
To introduce Michael to the LYMA community we’re hosting a seminar dedicated to understanding sleep on Tuesday 22nd June…
I was tempted to discard all this as rather pathetic advertising hype. But then I had second thoughts. This text does after all make several medical claims, and the question is: ARE THEY SUPPORTED BY EVIDENCE?
It claims that KSM-66® Ashwagandha:
- is the highest-quality, zero toxicity, concentrated Ashwagandha root in the world.
- That the hefty combination of purity and potency makes it unrivalled in its ability to reduce inflammation.
- That the product neutralises anxiety.
- That it promotes deep, restful sleep, night after night.
I ran a few searches to find out whether there is any sound evidence for any of these claims.
- There seem to be several supplements that contain,KSM-66® Ashwagandha’. The impression that LYMA is the only one is thus wrong. Zero toxicity must also be wrong; not even water has zero toxicity. In fact, epigastric pain/discomfort and loose stools were reported as most common (>5%); and giddiness, drowsiness, hallucinogenic, vertigo, nasal congestion (rhinitis), cough, cold, decreased appetite, nausea, constipation, dry mouth, hyperactivity, nocturnal cramps, blurring of vision, hyperacidity, skin rash and weight gain have all been associated with the herbal remedy. Moreover, if it is true that Ashwagandha stimulates the immune system, it might cause problems for people with autoimmune diseases.
- I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha reduces inflammatory conditions in humans.
- I found a study concluding that Ashwagandha given as an adjunct offered some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. Yet, I found no compelling evidence from clinical trials to show that KSM-66® Ashwagandha as a single supplement reduces anxiety in otherwise healthy individuals.
- A 2021 study suggested that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Yet the authors cautioned that additional clinical trials are required to generalize the outcome.
So, what does that tell us?
It could mean that:
- My searches were not sufficiently thorough and that I have missed compelling evidence. If so, I would appreciate, if the LYMA promoters would show me their evidence so that I can assess it.
- The LYMA people are irresponsible and mislead the public with untenable claims.
I am looking forward to their response.
Due to polypharmacy and the rising popularity of so-called alternative medicines (SCAM), oncology patients are particularly at risk of drug-drug interactions (DDI) or herb-drug interactions (HDI). The aims of this study were to assess DDI and HDI in outpatients taking oral anticancer drugs.
All prescribed and non-prescribed medications, including SCAMs, were prospectively collected by hospital pharmacists during a structured interview with the patient. DDI and HDI were analyzed using four interaction software programs: Thériaque®, Drugs.com®, Hédrine, and Memorial Sloan Kettering Cancer Center (MSKCC) database. All detected interactions were characterized by severity, risk, and action mechanism. The need for pharmaceutical intervention to modify drug use was determined on a case-by-case basis.
A total of 294 patients were included, with a mean age of 67 years [55-79]. The median number of chronic drugs per patient was 8 [1-29] and 55% of patients used at least one SCAM. At least 1 interaction was found for 267 patients (90.8%): 263 (89.4%) with DDI, 68 (23.1%) with HDI, and 64 (21.7%) with both DDI and HDI. Only 13% of the DDI were found in Thériaque® and Drugs.com® databases, and 125 (2.5%) were reported with a similar level of risk on both databases. 104 HDI were identified with only 9.5% of the interactions found in both databases. 103 pharmaceutical interventions were performed, involving 61 patients (20.7%).
The authors concluded that potentially clinically relevant drug interactions were frequently identified in this study, showing that several databases and structured screening are required to detect more interactions and optimize medication safety.
These data imply that DDIs are more frequent than HDIs. This does, however, not tell us which are more important. One crucial difference between DDIs and HDIs is that the former are usually known to the oncology team who should thus be able to prevent them or deal with them appropriately; in contrast, HDIs are often not known to the oncology team because many patients fail to disclose the fact that they take herbal remedies. Some forget, some do not think of herbals as medicine, others may be worried about their physician’s reaction.
It follows that firstly, conventional healthcare practitioners should always ask about the usage of herbal remedies, and secondly, they need to be informed about which herbal remedy might interact with which drug. The first can easily be implemented into routine history-taking; the second is more problematic, not least because our knowledge about HDIs is still woefully incomplete. In view of this, it might often be wise to tell patients to stop taking herbal remedies while they are on prescription drugs.
A low intake of selenium has been associated with increased cardiovascular mortality in some epidemiological studies. This could be reduced by supplementation with selenium and coenzyme Q10. D-dimer, a fragment of fibrin mirroring fibrinolysis, is a biomarker of thromboembolism, increased inflammation, endothelial dysfunction and is associated with cardiovascular mortality in ischemic heart disease.
The objective of this trial was to examine the impact of selenium and coenzyme Q10 on the level of D-dimer, and its relationship to cardiovascular mortality. D-dimer was measured in 213 individuals at the start and after 48 months of a randomised double-blind placebo-controlled trial with selenium yeast (200 µg/day) and coenzyme Q10 (200 mg/day) (n = 106) or placebo (n = 107). The follow-up time was 4.9 years.
All included individuals were low in selenium (mean 67 μg/L, SD 16.8). The differences in D-dimer concentration were evaluated by the use of T-tests, repeated measures of variance, and ANCOVA analyses. At the end, a significantly lower D-dimer concentration was observed in the active treatment group in comparison with those on placebo (p = 0.006). Although D-dimer values at baseline were weakly associated with high-sensitive CRP, while being more strongly associated with soluble tumour necrosis factor receptor 1 and sP-selectin, controlling for these in the analysis there was an independent effect on D-dimer.
In participants with a D-dimer level above median at baseline, the supplementation resulted in significantly lower cardiovascular mortality compared to those on placebo (p = 0.014). All results were validated with a persisting significant difference between the two groups.
The authors concluded that supplementation with selenium and coenzyme Q10 in a group of elderly low in selenium and coenzyme Q10 prevented an increase in D-dimer and reduced the risk of cardiovascular mortality in comparison with the placebo group. The obtained results also illustrate important associations between inflammation, endothelial function and cardiovascular risk.
These results are interesting and potentially important. The authors agree that their study is not fully conclusive: “Even if the size of the study population is small, we regard the results as being interesting from a scientific point of view, and for hypothesis-generating. The included participants represented a relatively narrow age stratum, so it is not possible to extrapolate the results to other age groups without uncertainty. Finally, as the evaluated population consisted of Caucasians who were low in selenium and coenzyme Q10, it is not necessarily true that the obtained results could be extrapolated to another population.” It might furthermore be of interest to note that part of the analysis cost was supported by grants from Pharma Nord Aps, Denmark, the County Council of Östergötland, Linköping University.
What is needed next, I think, are independent replications. Also of interest would be to determine whether the effects are due to the selenium, or the Q10, or both. And finally, one must caution consumers to not overdose on selenium which could have a host of negative effects on health.
Many chiropractors seem to view the present pandemic as a business opportunity and make no end of false claims to attract customers. This has now been outlawed in the US. Medscape reported that a US district court will decide whether a chiropractor who is charged with 10 counts of making false marketing claims related to COVID-19 will be the first person convicted under a new federal law.
On his website, chiropractor ‘Dr.’ Eric Neptune advertises his services as follows:
Have you ever been told by your medical doctor that you or a member of your family had a specific disease, syndrome, or sickness? Did your doctor then recommend a drug or surgery to fix the issue, or tell you that you would have to live with it for the rest of your life? If so, you are not alone!
Nepute Wellness Center is unlike any medical clinic you may have been to. The clinic team is focused on finding and fixing the CAUSE of your problem vs. seeking out and treating only the SYMPTOMS. Nepute Wellness Center is equipped with state-of-the-art diagnostic equipment and testing, as well as medical doctors, nurses, and chiropractors who have been uniquely trained to treat your whole body, regardless of age, and return your body to a healthy balance so that it can heal itself the way God intended.
If you are tired of trying to treat your symptoms using prescription and over-the-counter pills, or even considering surgery, then Nepute Wellness Center may be right for you! Or like many, you want to be proactive with your health and prevent sickness and disease before you begin to suffer any symptoms, allowing you to live the full life you deserve, then make Nepute Wellness Center your partner in health!
Already over a year ago, Eric Nepute, the owner of Quickwork, based in St. Louis, Missouri, managed to make headlines. He had recorded a video that racked up more than 21 million views and suggested that drinking tonic water would prevent COVID-19 infections. Now, Mr. Neptune is the first person charged by the Federal Trade Commission (FTC) under the new COVID- 19 Consumer Protection Act. His company which has several locations in St. Louis County advertised its vitamin D and zinc products on social media and the internet as drugs that could treat or prevent COVID-19 claiming that their products are “more effective than the available COVID-19 vaccines”.
The FTC warned Nepute’s company in May 2020 about making unsubstantiated claims for other products regarding efficacy against COVID-19 and advised him to immediately stop making claims that were not supported by scientific evidence. However, Nepute seemed undeterred.
The FTC is seeking to fine Nepute and Quickwork up to US$43,792 for each violation of the COVID-19 Consumer Protection Act. In addition, the FTC seeks to bar the company from making health claims unless they are true and can be substantiated by scientific evidence.
Through his attorney, Neptune told the local NBC TV news affiliate, “I feel that I have not done anything wrong. I encourage everyone to live a healthy lifestyle during this unprecedented time. My attorneys are reviewing the complaint and I have no further comments at this time.”
The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.
The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.
Here are 6 results that I found noteworthy:
- Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
- Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
- Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
- Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
- Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
- Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.
Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:
- Do you believe in the concept of subluxation?
- Do you treat conditions other than spinal problems?
- How frequently do you use spinal manipulations?
- How often do you see adverse effects of spinal manipulation?
- Do you obtain informed consent from all patients?
- How often do you refer patients to medical doctors?
- Do you advise in favour of vaccinations?
- Do you follow the rules of evidence-based medicine?
- Do you offer advice about prescribed medications?
- Which supplements do you recommend?
- Do you recommend maintenance treatment?
I wonder why they were not included.
The Chinese have made several attempts to persuade us that their traditional remedies are effective for COVID-19 infections. Here is yet another one. This review summarised the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. All clinical studies of the therapeutic effects and safety of CHM for COVID-19 were included. The authors
- summarized the general characteristics of included studies,
- evaluated the methodological quality of the randomized controlled trials (RCTs) using the Cochrane risk of bias tool,
- analyzed the use of CHM,
- used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM.
A total of 58 clinical studies were identified including;
- 10 RCTs,
- 1 non-randomized controlled trials,
- 11 retrospective studies with a control group,
- 12 case-series,
- 24 case-reports.
All of the studies had been performed in China. No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection, or prescribed herbal decoction were:
- Lianhua Qingwen granule/capsule,
- Xuebijing injection,
- Maxing Shigan Tang.
The pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), indicating that CHM plus conventional western therapy appeared to be better than conventional western therapy alone in reducing aggravation rate.
In addition, compared with conventional western therapy, CHM plus conventional western therapy had the potential advantages in increasing the recovery rate and shortening the duration of fever, cough, and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement.
For adverse events, the pooled data showed that there were no statistical differences between the CHM and the control groups.
The authors concluded that current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.
One of the principles to remember here is this: RUBBISH IN, RUBBISH OUT. If you meta-analyze primary data that are rubbish, your findings can only be rubbish as well.
All one needs to know about the primary data entered into the present analysis is that there were no rigorous RCTs… not one! That means the evidence is, as the authors rightly but modestly conclude of LOW CERTAINTY. My conclusions would have been a little different:
- In terms of safety, the dataset is too small and unreliable to make any judgment.
- In terms of efficacy, there is no sound data that CHM has a positive effect.
As I don’t live in the UK at present, I miss much of what the British papers report about so-called alternative medicine (SCAM). Therefore, I am a bit late to stumble over an article on the business activities of our Royals. It brought back into memory a little tiff I had with Prince Charles.
The article in the Express includes the following passage:
The UK’s first professor of complementary medicine, Edzard Ernst, dubbed the Duchy Originals detox tincture — which was being sold on the market at the time — “outright quackery”.
The product, called Duchy Herbals’ Detox Tincture, was advertised as a “natural aid to digestion and supports the body’s elimination processes” and a “food supplement to help eliminate toxins and aid digestion”.
The artichoke and dandelion mix cost £10 for a 50ml bottle.
Yet, Professor Ernst said Charles and his advisers seemed to be ignoring the science in favour of relying on “make-believe” and “superstition”, and said the suggestion that such products could remove bodily toxins was “implausible, unproven and dangerous”.
He noted: “Prince Charles thus financially exploits a gullible public in a time of financial hardship.”
This passage describes things accurately but not completely. What actually happened was this:
Unbeknown to me and with the help of some herbalists, Duchy Originals had developed the ‘detox tincture’ during a time when I was researching the evidence about ‘detox’. Eventually, my research was published as a review of the detox concept:
Background: The concept that alternative therapies can eliminate toxins and toxicants from the body, i.e. ‘alternative detox’ (AD) is popular.
Sources of data: Selected textbooks and articles on the subject of AD.
Areas of agreement: The principles of AD make no sense from a scientific perspective and there is no clinical evidence to support them.
Areas of controversy: The promotion of AD treatments provides income for some entrepreneurs but has the potential to cause harm to patients and consumers.
Growing points: In alternative medicine, simplistic but incorrect concepts such as AD abound. AREAS TIMELY FOR RESEARCH: All therapeutic claims should be scientifically tested before being advertised-and AD cannot be an exception.
When I was asked by a journalist what I thought about Charles’ new ‘detox tincture’, I told her that it was not supported by evidence which clearly makes it quackery. I also joked that Duchy Originals could thus be called ‘Dodgy Originals’. The result was this newspaper article and a subsequent media storm in the proverbial teacup.
At Exeter University, I had just fallen out of favor because of the ‘Smallwood Report’ and the complaint my involvement in it prompted by Charles’ first private secretary (full story in my memoir). After the ‘Dodgy Originals story’ had hit the papers, I was summoned ominously to my dean, Prof John Tooke, who probably had intended to give me a dressing down of major proportions. By the time we were able to meet, a few weeks later, the MHRA had already reprimanded Duchy Originals for misleading advertising which took most of the wind out of Tooke’s sail. The dressing down thus turned into something like “do you have to be so undiplomatic all the time?”.
Several months later, I was invited by the Science Media Centre, London, to give a lecture on the occasion of my retirement (Fiona Fox, the head of the SMC, had felt that, since my own University does not have the politeness to run a valedictory lecture for me, she will organize one for journalists). In that short lecture, I tried to summarize 19 years of research which inevitably meant briefly mentioning Charles and his foray into detox.
When I had finished, there were many questions from the journalists. Jenny Hope from the Daily Mail asked, “You mentioned snake-oil salesmen in your talk, and you also mentioned Prince Charles and his tinctures. Do you think that Prince Charles is a snake-oil salesman?” My answer was brief and to the point: “Yes“. The next day, this was all over the press. The Mail’s article was entitled ‘Charles? He’s just a snake-oil salesman: Professor attacks prince on ‘dodgy’ alternative remedies‘.
The advice of Tooke (who by then had left Exeter) to be more diplomatic had evidently not borne fruits (but the tinctures were discreetly taken off the market).
Diplomatic or honest?
This has been a question that I had to ask myself regularly during my 19 years at Exeter. For about 10 years, I had tried my best to walk the ‘diplomatic route’. When I realised that, in alternative medicine, the truth is much more important than diplomacy, I gradually changed … and despite all the hassle and hardship it brought me, I do not regret the decision.
As we have often discussed, proponents of so-called alternative medicine (SCAM), have an unfortunate tendency to mislead the public about vitamins and other supplements. Consequently, there is much uncertainty in many people’s minds. It is, therefore, all the more important to highlight new information that might counter this phenomenon.
This study tested whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. It was designed as a multicenter, single health system randomized clinical factorial open-label trial and enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020.
Patients were randomized in a 1:1:1:1 allocation ratio to receive either:
- zinc gluconate (50 mg),
- ascorbic acid (8000 mg),
- both of these agents,
- standard care only.
The treatments lasted 10 days.
The primary endpoint was the number of days required to reach a 50% reduction in symptoms, including the severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary endpoints included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements.
A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary endpoint. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups.
The authors concluded that, 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.
This study has several limitations (and its authors are laudably frank about them):
- Its sample size is small.
- It has no placebo control group.
- It is open-label.
- Patients were not masked to which therapy they received.
The trial nevertheless adds important information about the value of using zinc or vitamin C or both in the management of COVID patients.