supplements
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
We have discussed the currently fashionable herbal remedy, ‘kratom‘, before:
Inadequate regulation of Kratom supplements put consumers at risk
News about Kratom: the herb was recently (semi-)legalized in Thailand
Kratom: a ‘herbal drug’ with the potental to do more harm than good
A quick recap:
Kratom is made of the leaves of Mitragyna speciosa, a tree endogenous to parts of Southeast Asia. It has been used traditionally for its stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. By the early 2000s, kratom was increasingly used in the US as a substitute for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There are numerous assessments where people have been unable to stop using kratom and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.
Now it has been reported that the family of a Florida woman who died in 2021 after ingesting kratom has been awarded more than $11m from a distributor of the herbal extract. “There is of course no amount of money that will make up for the pain and suffering that Ms Talavera’s children are enduring because of their mother’s death,” Middlebrooks wrote in court records addressing the sanction against Kratom Distro. “The law nonetheless recognizes that the defendant must pay something, however inadequate.”
The US Drug Enforcement Agency in 2016 had imposed its strictest restrictions on kratom, which is made from the leaves of an evergreen tree and is often used by people to self-treat pain, anxiety, depression, and opioid addiction as well as withdrawal. There was an intense, immediate public backlash to that approach, however, and it prompted the DEA to rescind its prohibition of kratom, which is sold in stores and online.
The US Food and Drug Administration nonetheless has warned consumers over possible safety and addiction risks associated with kratom, and it has spoken in favor of more research aimed at gaining a better understanding of “the substance and its components”.
Friends of Talavera, a resident of the Florida community of Boynton Beach, introduced her to kratom years before her death. Her family said she regarded it as a safe, natural supplement and had taken some after buying it online from the Kratom Distro when her partner and the father of her youngest child – Biagio Vultaggio – found her unconscious in the living room on 20 June 2021. The 39-year-old Talavera was face down on the ground next to an open bag of a kratom derivative marketed as a “space dust”, her family has said. Vultaggio called paramedics, and they took Talavera to a hospital where she was pronounced dead. An autopsy later listed Talavera’s cause of death as acute intoxication from mitragynine, the main kratom component. The local coroner wrote in a report that “at high concentrations, mitragynine produces opioid-like effects, such as respiratory failure”.
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Kratom Disro claims that 
Product Consistency
- Our kratom powder is sourced directly from Indonesia monthly. Your order was literally on a farm in Indonesia two months ago. No old powder.
- Our kratom extracts are produced in the US by a licensed chemist and a professionally trained staff.
- We only use delicious flavors and quality ingredients.
Complete Transparency
- Every batch of products we receive is lab tested and will not ship out without meeting our meticulous quality standards.
- Current labs – We will never show you an out-of-date lab with our products.
- Guaranteed purity levels and free of all toxins.
Get It When You Want It
- Many orders shipped same day.
- USPS shipping on all orders under 6 pounds.
- Larger orders can ship USPS Priority for a small additional charge.
_________________________________
Back to the above lawsuit:
One of the attorneys for Talavera’s family, Tamara Williams, said in a statement that the judgment won by her clients “should be a wakeup call to the kratom industry”. Williams’s law firm had also recently won a $2.5m jury verdict against a kratom manufacturer in Washington state after a separate lawsuit alleging wrongful death. A colleague of Williams called on government officials to take steps “to protect other families from having to deal with unnecessary kratom overdose deaths”.
Sobrenix (Kudzu, Milk Thistle, B Vitamins & More) is “designed to reduce alcohol cravings and help you detoxify your body so you can successfully manage alcohol consumption. Even better, taken before drinking, Sobrenix’s ingredients help you stop before you’ve had too much. DETOXIFY YOUR BODY with a powerful formula that combines herbs and nutrients that support liver health, curb cravings, and help you wake up without a nasty hangover. Sobrenix kick-starts the detoxification process with essential herbs like Milk Thistle and Chanca Piedra. Additionally, the formula contains the critical B-Vitamins that alcohol washes away so you can wake up happy and healthy again!”
Yes, you suspected correctly: this is pure BS!
Not only that but the Federal Trade Commission is taking action under the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act of 2018 (OARFPA) against the makers of Sobrenix. According to the FTC’s complaint, the makers, a company, Rejuvica, and its owners, Kyle Armstrong and Kyle Dilger, made numerous unsubstantiated and false claims about Sobrenix and used paid endorsers in deceptively formatted advertising. The defendants also used bogus review sites to deceive consumers about their products.
As a result of the FTC’s suit, the defendants have agreed to a proposed court order that would permanently ban them from making any unsubstantiated claims about healthcare products or services, as well as require them to pay $650,000 to the FTC to be used for providing refunds to consumers.
“We will not tire in our pursuit of those who prey on individuals struggling with alcohol or other substance use disorders,” said Samuel Levine, Director of the Bureau of Consumer Protection. “This case evidences the breadth of the FTC’s authority to pursue such wrongdoing under both the FTC Act and OARFPA.”
The FTC charges that the defendants marketed Sobrenix with messages like:
- “STRUGGLING TO CONTROL YOUR ALCOHOL CONSUMPTION? Sobrenix is designed to reduce alcohol cravings and help you detoxify your body so you can successfully manage alcohol consumption. Even better, taken before drinking, Sobrenix’s ingredients help you stop before you’ve had too much.”
The FTC charges that Rejuvica and its owners lacked adequate evidence to support these claims. The complaint charges that Rejuvica, Armstrong, and Dilger violated both the FTC Act and OARFPA. The proposed order contains a total monetary judgment of $3,247,737, which is partially suspended based on the defendants’ inability to pay the full amount. The defendants will be required to pay $650,000 to the FTC to be used to refund consumers. If the defendants are found to have lied to the FTC about their financial status, the full judgment will be immediately due.
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A few short comments might be in order:
- Regulators have the duty to protect consumers from false health claims.
- It is commendable that some authorities sometimes do their duty and go after some of the people responsible for making false claims related to dietary supplements.
- Such actions should, however, occur MUCH more often.
- They ought to happen also in countries other than the US.
- Similar actions should be initiated against ALL false claims made for healthcare products and services.
- This means that all practitioners of so-called alternative medicine (SCAM) would need to review their advertising, websites, etc., and erase therapeutic claims that are not supported by evidence.
- This would unquestionably amount to an enormously valuable service to public health.
- Most countries already have legislation that would make such steps possible; my question, therefore, is this:
WHY ARE CONSUMERS NOT ADEQUATELY PROTECTED BY THEIR NATIONAL REGULATORS FROM CHARLATANS WHO SELL INEFFECTIVE AND OFTEN DANGEROUS SCAMs AT HIGH COSTS?
The website of the World Federation of Chiropractic (WFC) points out that public health is defined by the WHO as follows:
“Activities to strengthen public health capacities and service aim to provide conditions under which people can maintain to be healthy, improve their health and wellbeing, or prevent the deterioration of their health. Public health focuses on the entire spectrum of health and wellbeing, not only the eradication of particular diseases.”
The WFC then continues stating this:
As primary contact health professionals, chiropractors can play an important role as public health advocates. This can range from providing support and advice on health matters such as physical activity, diet, and fitness as well as lifestyle choices such as injury prevention and avoiding tobacco use. Chiropractors can also play a role in counselling patients and communities on the benefits of public health measures, especially as this relates to immediate health needs of each region.
I think that this might merit a few comments.
- Physical activity is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Diet is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Fitness is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Lifestyle choice is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Injury prevention is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Avoiding tobacco use is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Counseling is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
So, what is the real contribution of chiropractors to public health?
- Chiropractors tend to advise their clients against vaccinations.
- Some mislead the public by claiming they boost immunity and prevent serious infections.
- Many undermine evidence-based medicine by promoting obsolete myths such as ‘the innate’ or subluxations.
- Many sell supplements that could interact with prescription drugs.
- Many make bogus health claims for profit.
I would therefore argue that, on balance, the contribution of chiropractors to public health might be considerable …
sadly, however, it goes in the wrong direction.
Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
REFLEXOLOGY for female infertility?
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
“A Nutrient Mix Designed at the Dr. Rath Research Institute is Effective Against Different Types of Coronavirus.” With these words (and the picture below), the ‘Dr. Rath Research Institute’ recently announced its sensational finding on Twitter.
Clicking on the link they provided, got me to the following article:
In this new study we wanted to find out whether certain natural substances could help fight against SARS-CoV-2 (the virus that causes COVID-19), and another type of coronavirus known as HCoV-229E which infects humans and is associated with the common cold and its symptoms.
The importance of the study relates to the fact that COVID-19 is still a big problem, especially for older people and those with weak immune systems. Current approaches using RNA- and DNA -based vaccines are not effective in preventing the infection and spread of SARS-CoV-2, or its variants such as Omicron. The anti-viral drugs used against the pandemic are similarly not fully effective. It is therefore important to develop other approaches, especially those involving safe, natural substances, that could be used alongside or instead of conventional treatments.
For the study, scientists at the Dr. Rath Research Institute used a combination of natural substances including vitamin C, polyphenols, and other nutrients. They gave the nutrient mix to mice infected with one or other of the two types of coronaviruses, to see if it could reduce the numbers of viral particles and spike proteins in the animals’ lungs.
Based on our earlier work using human cells growing in culture we already knew that the combination of nutrients in this mixture was effective in controlling key cellular mechanisms of SARS-CoV-2 infection, including inhibiting the multiplication of the virus.
We had found that the nutrient mix could inhibit an enzyme, RNA-dependent RNA polymerase (RdRp), which is needed for a virus to make copies of itself. The mix was also effective in preventing viral spike protein from binding to cell surfaces and entering cells. It additionally worked in decreasing the number of so-called ACE2 receptor proteins, which are expressed by cells in the lungs, blood vessels, and other organs, and that help the virus to get into cells.
In this latest study the nutrient mix was administered daily to mice infected with either SARS-CoV-2 or HCoV-229E, to see if it could reduce infectivity in terms of the amounts of viral particles and spike proteins found in the lungs. Infected mice in the control group were fed a normal diet without nutrient supplementation. The amounts of viral particles and spike proteins in the lungs were evaluated using special molecular-based tests. We also examined the effects of the nutrient mix on the presence of immune cells in the lungs, as an indication of tissue inflammation.
The results showed that, compared to mice in the control group, the nutrients significantly reduced the amounts of viral particles and spike proteins in the lungs of infected mice. Moreover, the mix was equally effective in mice infected with either of the two types of coronaviruses. This indicates that the nutrients affected common mechanisms of infection and were not specific to a particular type of virus. It also explains the results of our previous studies, which showed that the nutrient mix was effective in stopping SARS-CoV-2 and several of its mutated forms, including Omicron variants, from entering the cells.
Crucially, we found the nutrient mix affected not only the virus itself; it also reduced the ability of the virus to enter cells by decreasing the number of ACE2 receptors on cell surfaces. In the presence of inflammation, which is commonly associated with infections, there were similarly less ACE2 receptors on cells. Nutrient anti-inflammatory effects were also observed in the lung tissue of the mice.
In conclusion, our study showed that the nutrient mix could help reduce the infectivity of SARS-CoV-2 and the associated common cold virus HCoV-229E in mice at different stages of infectivity. The fact that different mechanisms were affected simultaneously demonstrates the superior efficacy of nutrients compared to drugs, the latter of which usually target only a single mechanism and allow the virus to escape by mutating.
The unique composition and efficacy of our nutrient mix has been awarded US and international patents. While more research is needed in order to fully confirm its efficacy in human clinical trials, the application of this safe micronutrient combination as soon as possible should ultimately benefit people worldwide and save on healthcare costs.
So, the claim that a Nutrient Mix is “Effective Against Different Types of Coronavirus” rests on some lousy experiments on rats?
Might we call this misleading or dishonest?
And what is the Dr. Rath Research Institute?
Could it belong to the Dr. Rath Foundation?
The very foundation that once published this about me:
Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science?
Professor Edzard Ernst, a retired German physician and academic, has recently become a prominent advocate of plans that could potentially outlaw the entire profession of naturopathic doctors in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense”. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own, Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others.
SAY NO MORE!
This randomized, double-blind, placebo-controlled trial investigated whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events.
A total of 21 315 participants aged 60-84 years were enrolled. Exclusion criteria were self-reported hypercalcemia, hyperparathyroidism, kidney stones, osteomalacia, sarcoidosis, taking >500 IU/day supplemental vitamin D, or being unable to give consent because of language or cognitive impairment.
The trial participants received 60 000 IU/month of vitamin D3 (n=10 662) or placebo (n=10 653) taken orally for up to five years. 16 882 participants completed the intervention period: placebo 8270 (77.6%); vitamin D 8552 (80.2%). The main outcome for this analysis was the occurrence of a major cardiovascular event, including myocardial infarction, stroke, and coronary revascularisation, determined through linkage with administrative datasets. Each event was analyzed separately as secondary outcome. Flexible parametric survival models were used to estimate hazard ratios and 95% confidence intervals.
21 302 people were included in the analysis. The median intervention period was five years. 1336 participants experienced a major cardiovascular event (placebo 699 (6.6%); vitamin D 637 (6.0%)). The rate of major cardiovascular events was lower in the vitamin D group than in the placebo group (hazard ratio 0.91, 95% confidence interval 0.81 to 1.01), especially among those who were taking cardiovascular drugs at baseline (0.84, 0.74 to 0.97; P for interaction=0.12), although the P value for interaction was not significant (<0.05). Overall, the difference in standardized cause-specific cumulative incidence at five years was −5.8 events per 1000 participants (95% confidence interval −12.2 to 0.5 per 1000 participants), resulting in a number needed to treat to avoid one major cardiovascular event of 172. The rate of myocardial infarction (hazard ratio 0.81, 95% confidence interval 0.67 to 0.98) and coronary revascularisation (0.89, 0.78 to 1.01) was lower in the vitamin D group, but there was no difference in the rate of stroke (0.99, 0.80 to 1.23). The incidence of adverse events was similar in the two groups.
The authors concluded that vitamin D supplementation might reduce the incidence of major cardiovascular events, particularly myocardial infarction and coronary revascularisation. This protective effect could be more marked in those taking statins or other cardiovascular drugs at baseline. Subgroup analyses in other large trials might help to clarify this issue. In the meantime, these findings suggest that conclusions that vitamin D supplementation does not alter risk of cardiovascular disease are premature.
This is an impressive study and a disappointing result. That vitamin D supplementation might reduce the incidence of major cardiovascular events was known before; thus we would not have needed such an expensive study to arrive at this conclusion. That the protective effect might be more marked in patients taking statins or other cardiovascular drugs seems odd, in my view. Could it be, I ask myself, that the protective effect is unrelated to cardiovascular drugs but simply more marked in those individuals who are at a higher than average risk of cardiovascular events?
In any case, the protective effect is small and seems to be of questionable clinical relevance.
The current secondary analysis based on the WHO database (VigiBase) of individual case safety reports (ICSRs) focuses on the suspected cutaneous adverse drug reactions (ADRs) linked to traditional medicines (TMs).
All the ICSRs reported between 1st January 2016 and 30th June 2021 from the UN Asia region in VigiBase where at least one TM was suspected to cause cutaneous ADRs were included in the study. Data regarding demographic details, suspected drug, adverse reaction as per MedDRA term, the seriousness of the reaction, de-challenge, re-challenge, and clinical outcome for suspected cutaneous ADRs associated with TM were obtained from VigiBase and analyzed for frequency of reported events and suspected medicines.
A total of 3,523 ICSRs with 5,761 ADRs related to “skin and subcutaneous tissue disorders” were included in the analysis. Amongst these, 6.8% of ICSRs were reported as serious.
The most common ADRs were:
- pruritus (29.6%),
- rash (20.3%),
- urticaria (18.9%),
- hyperhidrosis (3.3%).
Artemisia argyi H.Lév. and Vaniot. (14.9%), Ginkgo biloba L. (5.1%), Vitis vinifera L. (4%), Vitex agnus-castus L. (3.8%), Silybum marianum (L.), Gaertn (3.5%), and Viscus album L. (2.7%) were some commonly suspected TMs for cutaneous ADRs. There were 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported with TMs during the study period. Death was reported in 5 ICSRs.
The authors concluded that TMs are linked with various cutaneous ADRS ranging from pruritus to toxic epidermal necrolysis which may have serious consequences. TMs listed as suspected offending agents in this analysis, should be kept in mind while dealing with suspected cutaneous ADRs. Clinicians should be more vigilant in detecting and reporting events associated with TMs.
Herbal remedies have a reputation for being time-tested, gentle, harmless, and benign. Reports such as this one might make us doubt this cliche. More importantly, they should force us to ask whether the remedy we are tempted to try truly does generate more good than harm. In most instances, I fear, the answer is not positive.
Maintenance of cognitive abilities is of critical importance to older adults, yet only a few effective strategies to slow down cognitive decline currently exist. Multivitamin supplementation is used to promote general health; however, it is unclear whether it favorably affects cognition in older age. This study aimed to examine the effect of daily multivitamin/multimineral supplementation on memory in older adults.
The Cocoa Supplement and Multivitamin Outcomes Study Web (COSMOS-Web) ancillary study (NCT04582617) included 3562 older adults. Participants were randomly assigned to a daily multivitamin supplement (Centrum Silver) or placebo and evaluated annually with an Internet-based battery of neuropsychological tests for 3 y. The prespecified primary outcome measure was change in episodic memory, operationally defined as immediate recall performance on the ModRey test, after 1 y of intervention. Secondary outcome measures included changes in episodic memory over 3 y of follow-up and changes in performance on neuropsychological tasks of novel object recognition and executive function over 3 y.
Compared with placebo, participants randomly assigned to multivitamin supplementation had significantly better ModRey immediate recall at 1 y, the primary endpoint (t(5889) = 2.25, P = 0.025), as well as across the 3 y of follow-up on average (t(5889) = 2.54, P = 0.011). Multivitamin supplementation had no significant effects on secondary outcomes. Based on a cross-sectional analysis of the association between age and performance on the ModRey, it was estimated that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 y of age-related memory change.
The authors concluded that daily multivitamin supplementation, compared with placebo, improves memory. Multivitamin supplementation holds promise as a safe and accessible approach to maintaining cognitive health in older age.
These findings are surprising, not least because similar studies have thus far failed to demonstrate such effects. A 2013 trial, for instance, concluded that, in male physicians aged 65 years or older, long-term use of a daily multivitamin did not provide cognitive benefits.
Judging from the abstract alone (unfortunately, I have no access to the full paper), this seems to be a rigorous trial. It was conducted by multiple researchers of high standing. One is therefore inclined to believe the results.
Yet, one might be wise to be cautious.
Provided that a full analysis of the study does not identify major flaws, I would still want to 1) have a plausible explanation as to the mode of action and 2) see an independent replication before I accept the findings.
PS
The study was partly funded by the National Institutes of Health. The vitamins were provided by Pfizer Inc. and Haleon, the makers of the supplement used in the study.
PPS
I have now seen the full paper [thank you Dan] and can confirm that the study was of high quality. Yet, it also has limitations, of course, e.g.:
- the effect size is modest;
- the study population is selected and thus the results are not generalizable;
- the outcome measures were assessed remotely;
- the success of blinding was not checked [I find it conceivable that some trial participants tried to find out what they were taking, e.g. by tasting the pills].
A regional court in the Bavarian city of Ingolstadt has sentenced a natural healing practitioner, i.e. Heilpraktiker, and her supplier to jail for fraud. The pair were found to have deceived patients suffering from terminal cancer to put their faith in a remedy that they touted as a miracle cure. The practitioner was jailed for three years for her part in the scam, while the supplier was sentenced to six years and nine months.
The defendants in the case were a 57-year-old Heilpraktiker from the town of Schrobenhausen and a 68-year-old businessman from Ingolstadt who supplied the preparation. Both defendants were said to have promoted the remedy BG-Mun, saying that it could quickly cure cancer without any evidence of this being the case.
The court heard that patients paid up to €6,000 for the remedy. According to the court, the practitioner had boasted of “great successes” with one patient, Sabine H., who had acquired the remedy and stopped her course of chemotherapy at the defendant’s advice. The court was told that the pair would have known at this point that the substance would have no effect. A drug researcher from the University of Bremen had described the defendants’ actions as “profiteering” from the suffering of desperate patients. “Ultimately, it is a hustle against those who really are clutching at straws when it comes to their illness,” he said.
Even after the death of former patients, the defendants continued to promote their bogus remedy, the prosecutor emphasized. The Heilpraktiker advised several patients to rely exclusively on BG-Mun for their treatment and to discontinue the chemotherapy advised by orthodox medicine.
The defense lawyers demanded a comprehensive acquittal for both clients. The central argument: Both the Heilpraktiker and the entrepreneur had tried BG-Mun on themselves, found it helpful and therefore believed in its effect. The two had therefore acted without any intention to deceive. Without an intention to deceive, however, there is no fraud. In addition, BG-Mun had only ever been advertised as a “component in an overall therapy” and never as a sole medicine. According to the defense lawyers, BG-Mun is a means of alternative medicine and “therefore does not belong to evidence-based medicine”. In the opinion of the lawyers, empirical effectiveness, therefore, does not have to be proven. The public prosecutor, on the other hand, quoted experts who say that BG-Mun is a protein solution that has no effect whatsoever against cancer and is also not approved as a medicine.
Elsewhere it had been reported that the court also dealt with the charge of misuse of title, specifically with the fact that the Heilpraktiker used the title of professor orally and also on advertising flyers. The title of professor comes from an educational institution in the USA, which itself is not recognized as a university in the USA. The German Conference of Ministers of Education and Cultural Affairs does not recognize this title in this country and calls it a “decorative certificate”.
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What I find particularly fascinating about this case is that the defense lawyers claimed, that BG-Mun is a means of alternative medicine and “therefore does not belong to evidence-based medicine”. This type of argument crops up regularly when quacks go to trial. I am not a legal expert and can thus only judge it from a medical point of view. Medically speaking, I find it hard to think of an argument that is more ridiculous than this one. To me, it seems like saying: “I am a charlatan and therefore you cannot judge by by the standards of regular healthcare.”
The second argument of the defense is hardy any better: “I was convinced that it worked, therefore, my prescribing it was honest and correct.” Imagine a doctor saying such nonsense! The argument makes a mockery of evidence by replacing it with belief. I am glad that the German court did not fall for such pseudo-arguments.
