Monthly Archives: September 2025
Since about two days, social media are awash with statements claiming that the EU approved COVID-19 vaccines with zero or insufficient or incomplete safety checks. If true, this would be most concerning.
But is it?
The European Medicines Agency (EMA), which is responsible for evaluating and authorizing medicines in the EU, has stated that all approved COVID-19 vaccines underwent a rigorous scientific assessment of their safety, efficacy, and quality.
- Clinical Trials: Before approval, COVID-19 vaccines were tested in large-scale clinical trials involving tens of thousands of participants. These trials were designed to assess the vaccine’s safety, efficacy, and ability to generate an immune response.
- Rolling Reviews: To accelerate the process during the pandemic, the EMA used a “rolling review” procedure. This allowed them to evaluate data from ongoing clinical trials as it became available, rather than waiting for a complete data package. While this sped up the timeline, it did not compromise the standards for a thorough review.
- Continued Monitoring: After a vaccine was granted a conditional marketing authorization, the EMA and EU member states continued to closely monitor its safety. This “pharmacovigilance” system involves collecting and analyzing data on suspected side effects from various sources, including reports from patients, healthcare professionals, and ongoing studies.
- Benefit-Risk Assessment: The EMA’s approval process is always based on a benefit-risk assessment. This means that a vaccine is only approved if its overall benefits in preventing disease outweigh any potential risks of side effects. The vast majority of known side effects for COVID-19 vaccines are mild and short-lived, while the serious side effects are very rare.
- Transparency: The EMA has publicly shared information about its evaluations, the basis for its decisions, and regular safety updates to maintain transparency and build public trust.
So, are the statements that the EU approved COVID-19 vaccines with zero or insufficient or incomplete safety checks just lies?
Let’s say they are misunderstandings.
It all seems to go back to a European Parliament hearing on October 10, 2022, when a Pfizer official, Janine Small was asked by Dutch Member of European Parliament (MEP) Rob Roos a direct question: “Was the Pfizer Covid vaccine tested on stopping the transmission of the virus before it entered the market? If not, please say it clearly. If yes, are you willing to share the data with this committee? And I really want a straight answer, yes or no…” Janine Small’s response was, “Regarding the question around, um, did we know about stopping the immunization before it entered the market? No.” She then added that the company had to “move at the speed of science to really understand what is taking place in the market,” and that the company had to “do everything at risk” to provide a vaccine during the pandemic.
It seems clear that Janine Small meant “transmission” when she said “immunization”. The context of the question and her subsequent explanation makes this evident. The primary goal of the initial clinical trials was to determine, if the vaccine was safe and effective at preventing severe disease, hospitalization, and death from COVID-19. Measuring transmission is a much more complex metric that is often studied in post-market surveillance and real-world data, not in initial clinical trials.
The fact that the initial trials did not measure transmission was already public knowledge and was stated in the clinical trial protocols and regulatory filings. The EMA public assessment report, for instance, noted that the question of the vaccine’s efficacy in relation to viral transmission was “yet to be addressed.”
It has been reported that the US surgeon general nominee, Casey Means, earned hundreds of thousands of dollars promoting supplements and other health and wellness products, details likely to invite new scrutiny about potential conflicts of interest for the author and entrepreneur.
Means, a close ally of health secretary Robert F. Kennedy Jr. and the sister of White House adviser Calley Means, has not yet been scheduled to appear before Congress for her confirmation hearing. But a filing dated Sept. 10 and posted by the Office of Government Ethics suggests her nomination cleared conflict-of-interest checks within the federal government.
The supplements industry has ties with several members of the Trump administration, including Medicaid director Mehmet Oz and health adviser Calley Means. An AP investigation this summer found that Casey Means had repeatedly failed to disclose her partnerships with supplements companies and other businesses promoted in her
newsletter, social media accounts, and elsewhere.
Among the payments included in the new disclosures for newsletter sponsorship and partnership fees are $12,000 from herbal remedies firm Apothekary; $27,431 from algae supplements company ENERGYbits; $16,461 from fiber supplements company Florasophy; $27,000 from probiotics company Pendulum Therapeutics; $46,000 from
supplements company Pique; $536 from prenatal vitamin company WeNatal; and $16,104 from basil seed supplements company Basil Seed Works. Means received a total of more than $130,000 in sponsorship fees from supplement company Amazentis, including a $55,000 book tour sponsorship.
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In May this year, I wrote this about Means:
RFK Jr wrote on X: “The Surgeon General is a symbol of moral authority who stands against the financial and institutional gravities that tend to corporatize medicine. Casey Means was born to hold this job. She will provide our country with ethical guidance, wisdom, and gold-standard medical advice.” Yet her suitability for Surgeon General is a contentious issue.
Means holds a 2014 MD from Stanford University and a bachelor’s degree in human biology. She is an advocate for addressing chronic diseases through nutrition, exercise, and lifestyle changes. Her book “Good Energy”, co-authored with her brother Calley, argues that metabolic dysfunction is a root cause of most chronic illnesses. As a “wellness influencer”, Means has demonstrated an ability to communicate health concepts to a broad audience.
Critics point out that Means dropped out of her residency at Oregon Health & Science University months before completion. This means she is not board-certified and has very limited clinical experience; for instance, she never saw patients without supervision. Her medical license has been inactive since 2024, and she has done as good as no own original research. Unlike past Surgeons General, who had extensive backgrounds in public health administration and infectious disease, Means has no government or public health leadership experience. Her focus is on functional medicine and wellness, both areas that lack rigor and are close to quackery.
It gets worse: Means has expressed skepticism about vaccines, suggesting in a 2024 newsletter that the current vaccine schedule contributes to the decline of pediatric health. Her endorsement of dangerous nonsense like energy healing and raw milk seems worrying. Moreover, Means also co-founded Levels, a company selling continuous glucose monitors to non-diabetics, and markets supplements and other dubious health products. RFKJr’s claim that Means will offer “ethical guidance” seems particularly odd: she has no training in medical ethics and some of her past actions are outright unethical. Physicians like Dr. Neil Stone have therefore called Means “grossly underqualified”.
The Surgeon General must provide science-based guidance, oversee >6,000 officers, and address diverse and serious public health issues. Means’ inexperience and narrow focus limits her effectiveness. Crucially, her history of promoting of vaccine skepticism and quack medicine undermines trust in science-based policies.
In summary, Means seems wholly unsuited for the job of Surgeon General. In the interest of the US public health, her appointment should not be confirmed by the Senate.
SAY NO MORE!
I have written about the ex-doctor Wakefield several times before, e.g.:
- Ex-doctor Andrew Wakefield: “Better to die as a free man than live as a slave” (and get vaccinated against Covid-19)
- Andrew Wakefield, Donald Trump, SCAM, and the anti-vaccination cult
- Thanks a bunch, Wakefield & Co: outbreaks of measles are confirmed across England.
Knowing that he is a key figure in the US anti-vaxx cult, we would expect that he is currently heavily engaged in the activities around Secretary Robert F Kennedy Jr. But surprisingly, I have not heard him being metioned in this context. To be more precise, I have not heard about him at all in recent months!
This is not like the Wakefield we know; he used to search out the limelight whenever and whereever he could. What is happening?
The last time he was in the press seems to have made a major splash in the press was when his new film ‘PROTOCOL 7’ was released over a year ago. In an interview with Children’s Health Defense President Mary Holland, he then discussed this “Whistleblower Story,” which took on pharmaceutical giant Merck alleging fraud regarding the effectiveness of its mumps vaccine.
Here are some excerpts from this interview:
“If they come for us, they come for us, but we must never make a decision based in fear,” said Dr. Andrew Wakefield, reflecting on the risks of “taking on the might of Merck” with his upcoming film, “Protocol 7: A Whistleblower Story.” … Based on real-life events, the film offers a fictional take on pharmaceutical giant Merck’s alleged fraud regarding the effectiveness of its mumps vaccine. The film features a lawyer who is also the mother of a vaccine-injured child, a renegade doctor exiled from the medical profession, and a vaccine laboratory virologist turned corporate whistleblower… Over the years, Wakefield said he has become a “repository for whistleblowers” from federal agencies and the pharmaceutical industry. “Protocol 7” is based on one such case, which Wakefield decided to turn into a film after years of disappointment with the legal system and the pharmaceutical industry’s apparent ability to evade accountability. “It’s a story for this moment,” Wakefield said, noting how the experience with COVID-19 vaccines “has brought many, many, many people in the world to our side of this question, this debate … about vaccine safety.” However, Wakefield said many still believe “childhood vaccines are fine [because] ‘They’ve been tested.’” “This film kind of takes them back over the bridge to say, ‘No, guys, actually, this has been going on in the childhood vaccine program for many, many years,’” he said. “This is the way they behave. Please understand.” Wakefield credited films — especially when they are entertaining — with their ability to engage people in discussion and change minds “in a very short space of time.”
“Protocol 7” tells the fictional story of a mother’s journey as she fights for justice after her child experiences a catastrophic regression following multiple vaccinations in a single day. “It’s really a story that goes to the heart of a mother’s instinct” and her “trust in her innate knowledge of what happened to her child,” enabling her to overcome numerous conflicts, Wakefield said. Wakefield explained that the film’s fictional narrative is set against the backdrop of real-life allegations brought by whistleblowers who claimed Merck committed fraud by “deceiving the regulators and the public as to the effectiveness, the protectiveness of its vaccine.” He said that to meet regulatory requirements for its mumps vaccine, Merck had to either spend millions to create a new effective and safe version or “fake the data on the vaccine they had.”
“The levels of fraud have never really been denied by Merck,” Wakefield said. “What they said is it’s irrelevant because the FDA [U.S. Food and Drug Administration] knew about much of this and they allowed us to go on making the vaccine anyway.” The judge dismissed the lawsuit, originally filed U.S. District Court for the Eastern District of Pennsylvania, without deciding whether Merck had actually committed fraud. Instead, the judge ruled that the alleged fraud was not significant enough to the case to allow the lawsuit to proceed. The plaintiffs argued that Merck defrauded the Centers for Disease Control and Prevention (CDC), not the FDA, because the CDC’s Vaccines for Children program bought the vaccine. “That makes me very cross because the people who have been hurt by this are not the CDC — it’s the children of this country,” Wakefield told Holland.
But what is Wakefield up to since then? I would have been not surprised to see him as one of RFKJr’s advisors. Yet, this seems not to be the case. There seems to be a complete black-out. Even AI does not know what Wakefield is currently doing.
Do any of my readers know more?
In PART 2 of this series, I will try to explain (yet again) why we need to control for placebo effects, if we want to determine whether a treatment works or not.
You are ill, consult a doctor who gives you a treatment, and a little while later, you feel better. It is tempting to conclude that the treatment was effective – tempting but not necessarily correct!
The treatment might have been useless and a whole range of other factors might have been the cause of the improvement, not least the placebo effect. Put simply, the placebo effect is the phenomenon where a patient’s health improves after receiving an inert treatment, like a sugar pill or saline injection. The patient improves not because of any action of the medication but because he or she believes it will work.
So, if someone wants to do a clinical study where even an ineffective therapy appears to be effective, he or she merely needs to ‘forget’ to control for the placebo effect. There are many ways of achieving this; essentially they fall into two categories:
- No control group at all
So-called observational studies often have no control group at all. Similarly, case reports and case series lack this feature. This means that the observed outcome of such studies might be due to placebo or other non-specific effects rather than the administered therapy.
This simple fact is often swept under the carpet by enthusiastic researchers of so-called alternative medicine (SCAM) who are keep to demonstrate that their pet therapy works. Consequently, they conclude that their study proves or suggests the effectiveness of the administered treatment.
Such conclusions are not merely incorrect, they are also dangerous: they mislead consumers to make wrong therapeutic decisions. This can mean unnecessary expenses, loss of health or even life.
2. No control of placebo effects
A more intriguing way to cheat is to include a control group but to nevertheless fail to account for placebo effects. This too can be achieved in multiple ways.
For instance, consider a trial comparing one form of SCAM with another. Its results show that both generated similarly positive outcomes, and the authors conclude that both were effective. This is wrong because the positive outcome might not be due to the therapy itself but to the placebo effect that both froms of SCAM generated.
Alternatively, a researcher might run a clinical trial where a SCAM is compared to no therapy. Such studies will always generate positive results not necessarily because the treatment was effective, but simply because of the inevitable placebo effect associated even with ineffective therapies.
The most intriguing variation of this theme is the often-cited A+B versus B study design. To many, it looks rigorous but it does not control for placebo effects. If B is standard treatment and A is, for instance, acupuncture, it is clear that the often large placebo effect of acupuncture would make sure that the outcome is positive even if acupuncture is utterly useless to the condition in question.
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Am I saying that any of the above-named study designs are useless or dishonest?
No!
I am simply stressing that they do not control for placebo effects and therefore do not allow conclusions about the specific effects of the tested therapy. Nonetheless, they can produce other interesting findings.
What often renders them dishonest, misleading and potentially dangerous is any conclusion that states or suggests the effectiveness of the therapy. Sadly, in the realm of SCAM, this is precisely what normally happens.
And then there are those SCAM enthusiasts who argue that their SCAM is perfectly fine, even if it generates positive outcomes merely via a placebo effect. Without wanting to go yet again into details why they are mistaken, I’d just like to point out that these enthusiasts would then have to accept that the cream I can manufacture from the cuttings of my front lawn is an appropriate cure for their haemorrhoids, acne, psoriasis, varicose veins, skin infection, herpes, etc., etc.
Weleda is the anthroposophic firm, founded in 1921 by Ita Wegman, the lover of Rudolf Steiner, that produces anthroposophic and homeopathic remedies as well as cosmetic products. It has been reported that the company is to re-examine its Nazi-era history amid revelations that it benefited from gruesome human experiments in a Nazi concentration camp during the Holocaust.
The German historian Anne Sudrow exposed the Weleda experiments in a new book under the auspices of the Dachau memorial. In response to the revelations, the company, now headquartered in Arlesheim, Switzerland, said it will re-examine its Nazi-era history. An in-house study, published last year, failed to uncover Weleda’s role in human experiments.
As reports of the revelations emerged, the company denounced Nazism in a corporate statement. “At Weleda, we condemn the atrocities of National Socialism in the strongest possible terms,” it said. “Fascism, anti-Semitism, racism, or right-wing extremist ideology have no place in our company. Weleda is a place of humanity. ‘Never again’ expresses our stance.”
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I have not yet read Anne Sudrow’s book (it’s not yet available as a hard copy), but I fear that the above cited article is not entirely correct. I think it erroneously conflates two seperate experiements by Sigmund Rascher: the hypothermia experiments and the ones on the Weleda frostbite cream. The latter seemed to have been much smaller and did not cause a high number of fatalities. Importantly, the research was unethical, fraaudulent and lousy!
The other allegation, namely that anthroposophic or biodymamic agricultural research took place in the Dachau “herb garden”, an annexe of the concentration camp where inmates were cruelly exploited for slave labor, is to the best of my knowledge correct. This work was carried out, I think, under the supervision of ex-Weleda employees. The main aim was to grow plenty of medicinal plants and render the Third Reich independent from foreign supplies.
But don’t take my word for it; perhaps I am mistaken – I will report back once I have read the book.
The assassination of Charlie Kirk must be unreservedly condemned, and I would like to do this herewith. What followed this terrible event is, however, pathetic, to put it mildly.
I am sure that, before the fatal shooting, most people – I included – did not know much about Charlie. I had to look up what he stood for and what his agenda and opinions were. I was not impressed. Specifically on health related matters, I asked AI to provide me with a list of some of his key quotes. Here it is:
| Quote | Date / Event | Full Text / Context | Notes / Source |
|---|---|---|---|
| “Children are being treated like ‘lab rats’ for the COVID-19 vaccine.” | Oct. 27, 2021, The Charlie Kirk Show | “This is a guy who’s voting to approve the vaccine to be used on your children. ‘We’re never going to be able to learn about how safe the vaccine is until we start giving it. That’s the way it goes.’ So this is the equivalent … to treating your children like lab rats … Your children are going to be experimented on.” | Kirk argues that vaccine safety is unproven for children and implies children are being used in experiments. Media Matters |
| “Take the red pill on the vaccine.” | June 24, 2021, The Charlie Kirk Show | “We have gone right into the fray about whether or not vaccines should be mandatory. The answer is no. But why is it that our leaders are so intent on pushing vaccines towards young people … If you go down the rabbit hole and you take the red pill on the vaccine, you will have your eyes opened.” | He uses “red pill” metaphor to suggest uncovering truth, often conspiratorial framing. Media Matters |
| Against vaccine mandates / passports / medical apartheid | mid-2021 | “At Turning Point USA we are going to give everything we have to make sure that students are not going to have to live in a medical apartheid because they don’t want to get the vaccine.” Also: “It’s almost this apartheid-style open-air hostage situation, like oh you can have your freedom back if you get the jab.” | He equates mandates / requiring vaccination with segregation or coercion. Media Matters |
| On masking and vaccine mandates leading to loss of other freedoms | July 16, 2021, The Charlie Kirk Show | “If they can make you put a mask on, they’ll take your guns. They can make you take a vaccine, they control your children.” | This links mask mandates, vaccine mandates, and perceived overreach in authority. Media Matters |
| “You will never live in a society … and you won’t have a single gun death … it’s worth it.” | April 2023, after a mass shooting (Christian Covenant School in Nashville) | “You will never live in a society when you have an armed citizenry and you won’t have a single gun death,” … “I think it’s worth to have a cost of, unfortunately, some gun deaths every single year so that we can have the Second Amendment … That is a prudent deal.” | Although this is more about gun violence / rights than vaccines, it’s often grouped in health-related because of mortality implications. Firstpost+3mint+3Newsweek+3 |
| On being unvaccinated as the “natural state.” | Sept. 13, 2021, TPUSA Live Now | “By the way, you know you’re born unvaccinated. It’s kind of like the natural state.” | He frames unvaccinated status as a baseline or normative condition. Media Matters |
| On immune health / supplements etc. | In a transcript of “My Conversation with Dr. Pierre Kory and Dr. Chris Martenson” | “…the way you get past an infectious disease is you get plenty of rest. You make sure you’re not stressed out … your vitamin D levels are adequate. … Also want to make sure you have appropriate levels of serum, zinc and selenium … What we now know … these work really, really well.” | He’s endorsing non-vaccine measures (nutrition, immune health) as important. Charlie Kirk |
| Questioning booster pushes / vaccine pushes “despite data” | 2023, interview with Florida’s Surgeon General (Ladapo) | Kirk: “What is driving them to push the boosters despite data and shows that they can actually be harmful?” | Here he’s giving voice to concerns about booster vaccine safety/effectiveness. Human Events |
[From what I can see, his opinions on many other issues that are outside my area of expertise were even worse.]
To turn Charlie Kirk into a hero, icon, visionary etc. is just ridiculous, in my view. Yes, for a range of reasons, I am sorry that he got shot – just as sorry as for the numerous further violent death in the US. Gun violence has to stop; but so should the absurd theatre around this man’s death.
For lay people, it is never easy to interpret research studies. All too often, they report misleading results in such a way that it is not readily recognizable. As this is such a hugely important topic, I will (yet again) in a series of posts discuss the issue of
how to cheat with seemingly rigorous research.
There are, of course, numerous ways of cheating. My focus in this series will be on clinical research, particularly the type of research relevant to so-called alternative medicine (SCAM).
I use the verb ‘to cheat’, because often it involves a deliberate process of misleading the public. On other occasions, the process of misleading is perhaps not deliberate but caused by naivety or ignorance or the desire to prove the value of a SCAM.
The effects of misleading the public are the same regardless of whether the action was deliberate or not. Therefore I will not bother to differentiate between deliberate cheating and accidental misleading. The effects cause vulnerable people to make wrong therapeutic decisions, waste their funds, risk their health and in extreme cases lose their lives.
To explain all this potentially rather dry material to a lay person who may only have a faint idea about science can be tricky. I will do my best to explain potentially complicated methodological issues in simple terms. This can easily lead to over-simplifications; I will try to avoid those but ask for forgiveness, if I fail.
So, I hope that you will bear with me and find these posts not just relevant to SCAM and clinical research, but also interesting and perhaps even entertaining.
Please do give me feedback on how my handling of this task could be improved.
Aaron Siri, the personal lawyer/adviser of Robert F. Kennedy Jr., recently presented to the US Senate the unpublished (and thus not peer-reviewed) “Henry Ford Health System Analysis“. With a sample size of 18,468, the study is the largest vaccinated versus unvaccinated birth cohort study ever conducted in the US. Children were tracked from birth over a 10-year period, and their data were drawn from medical records. The frequencies of several common illnesses during the observation period were compared between the vaccinated and the unvaccinated goups.
The findings imply that vaccinated children have dramatically higher rates of common, chronic conditions than unvaccinated children. As could be expected, the news spread instantly and the worldwide anti-vaxx community was triumphant. Their long-held belief that vaccinations are detrimental to the health of children had finally been confirmed!
But it took only hours before serious doubts about the reliability of the data emerged. It was soon demonstrated that the study is full of fundamental errors, inconsistencies and findings that do not stand up under even the slightest scrutiny. Crucially, it did not show an association between vaccines and autism, which is, as we all know, the main claim of anti-vaxers.
The most obvious methodological problem with the study is detection bias. This occurs in case control studies when one group gets examined more frequently than the other. This must almost inevitably lead to more diagnoses regardless of actual disease rates. In the study, vaccinated children had substantially more health care visits than unvaccinated kids. In such a situation, conditions requiring clinical evaluation to diagnose — for instance, ADHD, learning disorders, speech delays, ear infections — will inevitably be recorded more often in the group that was investigated regularly than in the group that consulted physicians less frquently.
An example might explain: There was a 6-8-fold increase in ear infections among vaccinated children. This is highly unlikely to be a true result; it can, however, be explained by detection bias. Children who rarely sees a clinician will not have “otitis media” coded in their record, even if they have had ear pain. In other words, the study repeatedly conflates absence of diagnosis with absence of disease.
Another example: there were almost no cases of common conditions like ADHD and learning disabilities among the group of unvaccinated children. Yet, such a finding is an impossibility. Epidemiological data prove that these conditions affect roughly 11% and 9% of children, respectively. This can only mean that these illnesses went undiagnosed and unrecorded in unvaccinated children who rarely consulted a doctor.
As any first year Phd student should spot such fundamental flaws and overt inconcistencies, it is a huge embarrassment that RFKJr, his minions and the entire cult of anti-vaxx failed to spot and discuss them. They thoroughly invalidate the entire study as well as its conclusions.
For the world of anti-vaxx, the study presents a further big probem: if they accept its findings, they must also accept another of its results: there is no link between vaccination and autism. Will they now try to pretend that those findings that suit their ideology are real, while others that contradict their delusions are not?
If this study shows anything of value at all, it is this: peer-review is an indispensible process in science. Without it pseudo-science can far too easily masquarade as science. We all deserve better than a farcical political theater to mislead the public presented by malignant pseudo-scientists and ignorant anti-vaccination clowns. We deserve rigorous science and reliable results that approach the truth as closely as possible. The “Henry Ford Health System Analysis” had remained unpublished for a very good reason: it is misleading trash that makes RFKJr and his minions the laughing stock of the world of science.
The result of all this, I am afraid, is rather concerning: consumers are getting more and more confused, and the discussions about vaccines get less and less rational. As an example for the latter, let me quote a comment on ‘X’ by Dr Aseem Malhotra (yes, the guy who I have repeatedly blogged about and who recently claimed that COVID vaccines cause cancer): “Is it time to arrest all those using the term ‘anti – vaxxer’ because it’s a term of abuse, especially when used to describe someone vaccine injured, or has lost a relative or a child because of it ? It’s absolutely disgusting.”
Cancer patients frequently experience both physical and psychological challenges, including chronic pain and depression. While conventional treatments primarily often rely on pharmacological interventions, complementary approaches such as the Emotional Freedom Technique (EFT) do not and are claimed to help alleviate both physical and psychological distress.
This randomized clinical trial aimed to assess the effects of EFT on pain and depression in individuals with cancer. It was conducted in the oncology ward of a high-capacity hospital in eastern Turkey between December 2023 and March 2024. Seventy cancer patients were randomly assigned to either the EFT group (n = 35) or the control group (n = 35). The EFT group received four structured 30-min sessions over two weeks, led by a certified EFT practitioner, with symptom reassessment after each session. The control group received routine care. Data were collected using a Participant Information Form, the Beck Depression Inventory (BDI), and the Visual Analog Scale (VAS) before and after the intervention.
The results show that VAS scores in the EFT group significantly decreased from 4.82 ± 2.47 to 2.44 ± 1.97 (p < 0.05), whereas the control group showed a smaller reduction from 5.36 ± 2.42 to 4.25 ± 2.75 (p > 0.05). BDI scores in the EFT group improved significantly, decreasing from 31.44 ± 17.68 to 18.44 ± 7.0 (p < 0.05), while the control group’s scores increased from 27.94 ± 16.26 to 31.42 ± 12.65 (p > 0.05).
The authors conclused that these findings suggest that EFT was effective in significantly reducing both pain and depression levels in cancer patients.
We have encountered the EFT several times before, e.g.:
- Emotional Freedom Technique, a combination of two types of BS
- Emotional Freedom Techniques: More ‘alternative facts’ from ‘The Journal of Complementary and Alternative Medicine’
- Beware of the ‘new-born holists’
- Overcome the trauma of war with unproven treatments?
I had assumed it to be pure BS – but does this new study prove my assumption wrong?
Not really!
The trial is quite simply false-positive. The reason lies in the often-discussed A+B versus B design. It makes sure that even dubious BS like the EFT generates a positive result when tested in a seemingly rigorous study.
In view of this, let me re-phrase the conclusions by simplt adding two words:
these findings do not suggest that EFT was effective in significantly reducing both pain and depression levels in cancer patients.
Fatigue is often one of the most commonly reported symptoms in cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Thus, elective treatments for fatigue in older male cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong (TCQ), a mind-body exercise intervention, can improve physical and emotional health. Therefore, this study compared the efficacy of Tai Chi Qigong (TCQ) versus exercise intensity-matched (EIM) and usual care in older, male cancer survivors with fatigue.
The researchers conducted a three-arm, single-blind randomized controlled trial where older (55 + years), male cancer survivors with fatigue participated in usual care or one of two supervised group exercise programs: TCQ or EIM twice weekly for 12 weeks. Participants were followed up for 12 months. The primary outcome was patient-reported fatigue at 3-months post-intervention.
A cohort of men (n = 113) were enrolled (mean age: 69.1 (±7.0) years. In the primary outcome analysis, there were no significant within-arm or between-arm differences in fatigue (p-value, NS). However, the TCQ and EIM arms showed significant within-arm improvement in fatigue immediately post-intervention (p-value < 0.05). There were no differences in class attendance for either TCQ or EIM, with an average attendance rate of 78.4% and 76.8%, respectively.
The authors concluded that they found no significant or clinically meaningful improvements in fatigue for TCQ or EIM relative to usual care at the 3-month follow-up. However, significant improvements in fatigue were observed immediately after completion of the 12-week TCQ and EIM programs. This study suggests that TCQ and light intensity activity may lead to improvements in fatigue immediately after the group exercise program among older, fatigued male cancer survivors. However, the observed improvements did not persist beyond the program, suggesting that long-term maintenance may be required. Further testing is warranted in larger trials that include strategies to sustain both the behavior and the effects.
Tai chi is currently much-hyped. I have repeatedly stated that it is plausible to assume that excercise as positive effects on several levels. I have also doubted that there are huge differences between different typs of excercise.
This study is one of the few trials that tested tai chi against an intensity-matched conventional form of exercise. The results speak for themselves.
What matters most, I feel, is that patients find a form of exercise that suits them and is enjoyable. Whether this is an exotic or a conventional variation of the theme matters little. What counts is that patients are happy and therefore continue long-term.