charlatan
When Harald Walach et al first published it, I did report about their paper entitled “Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo”. The objective of their analysis was to determine what contributes to the size of the placebo effect in clinical drug trials by meta-regressions of randomized placebo-controlled clinical trials.
Walach and his co-authors concluded that the high correlation of r= .73 between placebo improvement and treatment improvement rates is genuine and not explainable by study or disease characteristics. We conclude from our data that the placebo-effect is the major driver of treatment effects in clinical trials that alone explains 69% of the variance. This leaves only limited space for effects due to pharmacological substances. Context effects are more important than pharmacological ones in the conditions studied by us.
At the time, I called this SLOPPY SCIENCE and explained:
- The authors lumped together trials of various drugs as though they are a homogeneous entity in terms of effectiveness beyond placebo (which, of course, they are not).
- The placebo response is the measured improvement of a patient in a clinical trial after receiving a sham treatment. Yet, the authors claim “the placebo response in clinical trials has four components: regression to the mean (RTM), measurement artefacts, natural tendency (NT) of the disease, and the genuine placebo effect”. This is nonsense, and I even fear that the authors know it.
- The paper’s ‘highlight’ claims that contextual factors like expectations and doctor-patient interactions drive healing. Yet, these phenomena are seperate from the placebo-effect and were not the subject of this investigation.
- Correlation is not causation.
Now RETRACTION WATCH have published interesting news about Walach’s article:
… Stephen Rhodes, a researcher at University Hospitals Cleveland Medical Center in Ohio, criticized the study in a letter to the editor in February, citing a “number of errors that lead to some sweeping conclusions.” In the letter, Rhodes wrote those leaps “reflect a misunderstanding of what a ‘treatment effect’ is,” noting that in a placebo-controlled trial, the measure can’t be “due to placebo.”
We asked Gideon Meyerowitz-Katz, a sleuth and research fellow at the University of Wollongong in Australia, to take a look at the paper. Meyerowitz-Katz called the work “bizarre” and told us the results seem to indicate “simply being in a clinical trial is the main component of healing.” The studies included in the analysis had “very low average treatment effects,” meaning they didn’t show a huge benefit for the interventions tested. The clinical trials included had another issue: one was retracted in 2018 after journal editors realized all its participants had been enrolled and randomized on the same day. “I do not think that a meta-analysis which includes work retracted nearly a decade ago can be relied on as evidence,” Meyerowitz-Katz said. When he attempted to replicate the methods, Meyerowitz-Katz wasn’t able to do so. The researchers claimed to have taken one of the formulas from a previous paper; however, the referenced paper used a regression model, and the formula was not listed, he said. Meyerowitz-Katz also pointed out a potential undisclosed conflict of interest. Walach runs the Change Health Science Institute, which promotes “homeopathy and various COVID-19 conspiracy theories,” he said.
Walach, in response to Meyerowitz-Katz’s comments, called the term “conspiracy theory” “an analytically void terminology, because it is dependent on the political mainstream view, which is in turn dependent on political power.” He did not respond to any of Meyerowitz-Katz’s critiques of the paper.
Meyerowitz-Katz touched on many of the same issues Rhodes had raised in his letter. Rhodes questioned if the results really suggest there is “limited space for effects due to pharmacological substances,” quoting from the original paper. He also wrote by weighing clinical trials by study size rather than standard deviation, the researchers are “throwing information away.”
The researchers responded to Rhodes in their own letter to the editor, conceding they should have used “treatment response” rather than “treatment effect” in the title “to avoid confusion.” The authors also argued they had demonstrated “whenever a treatment is very effective, so is the improvement in the placebo group and vice versa.”
Retraction Watch sent questions to the Journal of Clinical Epidemiology, including the above critiques of the paper. Andrea Tricco, the co-editor-in-chief of the publication, told us the journal was investigating the concerns and was “treating this as a matter of highest urgency.” Stefan Schmidt, the corresponding author of the paper, told us his group has been asked to give “a detailed reply within 30 days.”
PS
I think it is only fair to add this note by RETRACTION WATCH:
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Donald Trump has recently made a range of nominations/appointments in the US health sector. They will influence conventional and so-called alternative medicine (SCAM) in the US and beyond. It therefore reasonable to look at the backgrounds and qualifications of these men and women and evaluate their suitability for these leadership roles.
In part 1 of this series, I discussed Robert F Kennedy Jr. and Dave Weldon; in part 2, we evaluated Janette Nesheiwat and Casey Means; in part 3, I looked at Marty Makary and Mehmet Oz. In the 4th and last part of the series, I discuss Jay Bhattacharya and Gustav Chiarello.
Jay Bhattacharya – Director of National Institutes of Health (NIH)
Jay Bhattacharya is a physician and health economist. He also is a critic of Fauci and a co-author of the infamous Great Barrington Declaration (2020), which advocated for “herd immunity” over lockdowns during the COVID-19 pandemic. His new role would involve overseeing the NIH’s $48 billion budget. According to Kennedy’s plan, he would redirect much of the NIH funding toward alternative health approaches.
As Bhattacharya has not managed large research institutions, his ability to lead NIH effectively might be limited. His economic perspective could prioritize cost-effective research, and his opposition to lockdowns may appeal to those skeptical of them.
In summary, Bhattacharya’s academic credentials make him a fairly reasonable choice for NIH director, but his unreasonable pandemic views and lack of large-scale administrative experience raise concerns about his ability to lead the NIH effectively and without major disruptions.
Gustav Chiarello – Assistant Secretary for Financial Resources (HHS)
Gustav Chiarello has degrees in economics, public policy, and law. He is/was the Senior Special Counsel to the House Judiciary Committee, former attorney at the Federal Trade Commission (FTC), and advisor to FTC Acting Chairman Maureen Ohlhausen during Trump’s first term. He has legal and policy experience as well as skills for overseeing HHS financial resources. However, his limited healthcare-specific experience may hinder his ability to address complex HHS budgeting challenges.
In summary, Chiarello appears competent for the new role. However, his lack of healthcare expertise may prove to be a drawback.
Context and concerns
A recurring theme across the mentioned nominees and appointments is their stance against vaccinations or public health mandates. This is already eroding trust in immunization programs, increasing infection rates and creating risks to public health. Another common concern is the lack experience of most individuals in managing large bureaucracies. This is likely lead to inefficiencies or mismanagement in crucial healthcare agencies.
The nominees/appointments will drive deregulation, reduce Medicaid funding and shift NIH research priorities toward alternative health. These changes are unlikely to generate improvements in US public health. Policies driven by misinformation or ideological agendas will lead to increased uninsured rates, reduced research funding, and public health setbacks.
The group’s competence is undermined by a pattern of vaccine skepticism, promotion of pseudoscience and limited administrative experience. The risks of disrupting scientific research, immunization programs, and healthcare access are real and substantial.
Because my expertise and understanding is limited to medicine, my discussions were confinded to the realm of healthcare. But Trump appointed people in all areas, of course. My limited expertise tells me that some of these have been even more disasterous than the ones we evaluated here. I have little doubt that Trump is about to change the world – and I fear that this will not be to the better.
Donald Trump has recently made a range of nominations/appointments in the US health sector. They will influence conventional and so-called alternative medicine (SCAM) in the US and beyond. It therefore seems worth to look at the backgrounds and qualifications of these men and women and critically evaluate their suitability for these leadership roles.
In part 1 of this series, I discussed Robert F Kennedy Jr. and Dave Weldon. In part 2 we evaluated Janette Nesheiwat and Casey Means. Today, I will look at Marty Makary and Mehmet Oz.
Marty Makary – Commissioner of Food and Drug Administration (FDA)
Marty Makary is a surgical oncologist at the Johns Hopkins University, member of the National Academy of Medicine, and author of two bestsellers. He also has published over 250 scientific papers and led World Health Organization patient safety initiatives. In addition, he has expertise in researching medical errors and healthcare transparency. Since his FDA role would involve regulating food safety, drugs, and vaccines, such experience can be relevant.
Yet, there are concerns: Makary opposed both COVID-19 vaccine mandates and child masking. He wrongly predicted herd immunity by April 2021. In an interview with CBS News, he said that the FDA was looking at updated coronavirus vaccines and there was “a bit of a public trust problem.” He has no experience running a large regulatory agency like the FDA.
In summary, Makary is among the more qualified of Trump’s nominees. However, his lack of regulatory experience and controversial views on aspects of the COVID-pandemic are reasons for concern.
Mehmet Oz – Administrator of Centers for Medicare & Medicaid Services (CMS)
Mehmet Oz has already featured several times on my blog, e.g.:
- Donald Trump nominated SCAM promoter, Mehmet Oz, to lead the Centers for Medicare and Medicaid Services (CMS)
- Columbia University cut ties with Dr. Mehmet Oz … or did they?
- Quackery promoter, Dr. Mehmet Oz, is running for the U.S. Senate
By training, Oz is a cardiothoracic surgeon and might thus be seem by some to be solidly grounded in evidence based medicine. However, as a talk show host and media personality, he promoted (for good money) every form of medical quackery under the sun. His wife is a Reiki healer, and it can be assumed that she influenced his descent into overt charlatanism. Rational thinkers view Oz as one of America’s foremost purveyor of medical nonsense.
Furthermore, Oz has no experience in managing large government agencies such as Medicare and Medicaid which, after all, serve over 100 million Americans. He therefore is a significant liability for the CMS, which administers a substantial portion of the federal budget.
In summary, Oz’s clinical expertise is dated and overshadowed by his lack of administrative experience as well as his long history of promoting (and profitting from) dangerous quackery. His appointment is likely to be a disaster and not in the interest of the US public.
Donald Trump has recently made a range of appointments in the health sector of the US. They will strongly influence conventional and so-called alternative medicine (SCAM) in the US as well as worldwide. It therefore seems worth to look at the backgrounds and qualifications of these men and women and critically evaluate their fit for leadership roles in healthcare. In part 1 of this series, we looked at Robert F.Kennedy Jr. and David Weldon. Now I will focus on Trumps nominations for Surgeon General
Janette Nesheiwat – Surgeon General
We featured Janette once before. She trained as a family and emergency medicine physician, became the medical director at CityMD and also a Fox News contributor. She has no significant public health leadership experience. As the Surgeon General, she would require shaping national health policy and communicating science to the public, areas where she has no training or experience. She also lacks expertise in public health and epidemiology. Her Fox News role and online vitamin sales raise doubts about her prioritization of evidence-based public health over media-driven health promotion. The Surgeon General is the nation’s leading spokesperson on public health, overseeing the U.S. Public Health Service Commissioned Corps and issuing science-based health advisories. Nesheiwat would be a disaster for such a position.
Nesheiwat’s nomination was eventually withdrawn by Trump. This suggests internal concerns about her fitness for the job.
Casey Means – Surgeon General
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.
Donald Trump has recently made a range of appointments in the health sector of the US. They will strongly influence conventional and so-called alternative medicine (SCAM) in the US as well as worldwide. It therefore seems worth to look at the backgrounds and qualifications of these men and women and critically evaluate their fit for leadership roles in healthcare.
In this series of posts, I intend to scrutinize them two by two:
Robert F. Kennedy Jr. – Secretary of Health and Human Services (HHS)
- RFKJr. is an environmental lawyer, former presidential candidate, vocal vaccine skeptic, critic of the pharmaceutical industry, and advocate of the long-debunked assumption that autism is caused by MMR vaccinations. He has no scientific, medical or public health education or training and is a prominent figure in the “Make America Healthy Again” (MAHA) movement, emphasizing chronic disease reduction and agency reform.
He lacks experience managing large bureaucracies or healthcare systems. He has no experience or expertise in running agencies like HHS, which oversees a $1.7 trillion budget and 80,000 employees.
Kennedy’s leadership undermines public trust in immunization programs, potentially increasing preventable disease outbreaks. He aims to purge staff at FDA and NIH and redirect half of NIH’s $48 billion budget to preventive, alternative, and holistic approaches. This will inevitably disrupt scientific research and weaken evidence-based policy-making. His lack of public health experience and unscientific views pose risks to healthcare access, reproductive rights, and innovation.
In summary, Kennedy’s lack of relevant experience and history of promoting misinformation make him a high-risk choice for HHS. His actions so far indicate that he will significantly disrupt US healthcare and cause long-term damage to the US and beyond. His appointment was not in the best interest of progress and the US public.
Dave Weldon – Director of Centers for Disease Control and Prevention (CDC)
Weldon is an internist, former Republican congressman, and Army veteran. He has 40 years of medical practice but limited public health leadership experience. Weldon’s congressional tenure focused on fiscal and social issues. He has no record of managing public health crises or large agencies. He has in the past endorsed debunked claims linking thimerosal, a mercury-based preservative for vaccines, to autism thus raising alarms about his alignment with anti-vaccine sentiments and hindering the CDC’s task of promoting immunization. Paul Offit has therefore criticized Weldon’s nomination, noting his lack of traditional public health training.
Trump’s statement that Weldon will “restore the CDC to its true purpose” suggests a focus on transparency and combating corruption. However, as there’s no compelling evidence of systemic corruption in the CDC, this seems akin to the promotion of a conspiracy theory.
In summary, Weldon’s lack of relevant experience and history of promoting misinformation make him an odd choice for the directorship of the CDC. It is to be feared that his appointment will weaken medical progress and the US healthcare system.
A Winnipeg woman is suing her chiropractor, claiming he injured her by tearing an artery during treatment and that she suffered a stroke as a result. The woman had been a patient at Maples Chiropractic in Winnipeg for some time, and she had previously indicated that she did not want the chiropractor treating or adjusting her neck. In May 2023, the patient suffered a right vertebral artery dissection as a result of treatment. “Due to this injury from the treatment, [the plaintiff] suffered a stroke,” says the statement of claim, filed late last month in Court of King’s Bench at Winnipeg.
Maples Chiropractic is claimed to have failed to give the patient immediate care to minimize the effects of her injury. The patient was admitted to hospital at the Health Sciences Centre. The allegations have not been tested in court and statements of defence have not yet been filed. The lawsuit names as defendants the chiropractor, Gilbert Miranda, and his company, Everybody Health Inc., which operates Maples Chiropractic. The lawyer for the plaintiff declined to comment on the case.
The claim states that the patient will need ongoing therapy, psychological treatment and medical attention. It seeks an unspecified amount in damages for the patient’s alleged pain and suffering, loss of income and loss of enjoyment of life. The chiropractor allegedly failed to warn the patient about the risks associated with the chiropractic treatment, “specifically failing to warn her that a stroke could occur from the treatment or from any injury caused by the treatment”. The claim states that the chiropractor was negligent for not obtaining informed consent from the plaintiff about the treatment in general, and specifically for the treatment that allegedly resulted in injury.
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Let me be clear: this case report – like so many similar ones – lacks important details and thus cannot be interpreted properly. Chiropractors will therefore claim – as they did so many times before – that the case does not amount to evidence. They will also pretend that chiropractic manipulations are safe and that there is no sound evidence to prove otherwise. They can make this claim because the chiropractic profession has – since ~120 years! – resisted adopting an adequate monitoring system for registering events like the one above.
And let me be clear again: such claims by chiropractors are based on self-interest and willful ignorance, polite expressions for ‘dishonesty’.
I suppose we all heard that DONALD TRUMP has recently turned his genius towards the film industry. Specifically, he wrote:
“The Movie Industry in America is DYING a very fast death. Other Countries are offering all sorts of incentives to draw our filmmakers and studios away from the United States. Hollywood, and many other areas within the U.S.A., are being devastated. This is a concerted effort by other Nations and, therefore, a National Security threat. It is, in addition to everything else, messaging and propaganda! Therefore, I am authorizing the Department of Commerce, and the United States Trade Representative, to immediately begin the process of instituting a 100% Tariff on any and all Movies coming into our Country that are produced in Foreign Lands. WE WANT MOVIES MADE IN AMERICA, AGAIN!”
Well done Donnie!
After this decisive move, the hero of the mentally challenged announced another, even more far-reaching and long-awaited measure:
“TARIFFS ON RATIONAL THOUGHT”
On his patform ‘UNTRUTH ASOCIAL’, Trump proclaimed:
Rational thinking in America is DYING a very fast death. Other Countries are offering all sorts of incentives to draw scientists and other experts away from the United States. Universities and many other areas within the U.S.A., are being devastated and pseudo-science is thriving as a result. This is a concerted effort by other Nations and, therefore, a National Security threat. It is, in addition to everything else, messaging and propaganda! Therefore, I am authorizing all my government Departments and other relevant bodies of the US administration, to immediately begin the process of instituting a 100% Tariff on any and all RATIONAL THOUGHTS coming into our Country that are produced in Foreign Lands. WE WANT SCIENCE MADE IN AMERICA, AGAIN!
Trump’s latest move earned criticism as soon as it became public. Democrats pointed out that it was Trump himself who had driven US scientists to seek employment outside their home country. A spokesperson of the Whit House responded with merely a two-word-statement:
FAKE NEWS!
Traditional Chinese Medicine (TCM) tends to prioritize inherent general immunity instead of vaccination, thereby contributing to widespread vaccine hesitancy or refusal amidst the general public. The objective of this investigation was to furnish evidence regarding the profiles and drivers of seasonal influenza vaccine hesitancy (IVH) among TCM clinicians. Between January and May 2022, the Chinese researchers conducted a nationwide survey in China with embedded an influenza vaccine hesitancy scale to 3085 registered clinicians (1013 TCM and 2072 Western medicine (WM) clinicians).
The results suggest that TCM clinicians exhibit lower possibility of influenza vaccine uptake and are less likely to recommend the immunisation to the patients. 58.3 % TCM clinicians and 52.3 % WM clinicians were categorized as being influenza vaccine hesitant. Compared to WM clinicians, TCM clinicians have lower confidence in vaccine (p < 0.001) and are less inclined to accept others’ vaccination recommendation (p < 0.001). Higher educational attainment in TCM (postgraduate: OR = 1.98, 95 %CI,1.30–3.02; doctor: OR = 2.20, 95 %CI, 1.28–3.77) and ignorance of influenza vaccination cost policy (OR = 1.76, 95 %CI, 1.18–2.63) are significantly associated with increased influenza vaccine hesitancy.
The authors concluded that the concerns and doubts towards influenza vaccine is highly prevalent in the Chinese clinicians, especially those practicing TCM. High TCM educational degrees and ignorance of influenza vaccination cost policies are two primary risk factors for developing influenza vaccine hesitancy.
The findings are, I think, far from surprising. There is plenty of evidence about the negative stance towards influenza and other vaccination that practitioners or proponents of so-called alternative medicine (SCAM) display, e.g.:
- Do views about so-called alternative medicine (SCAM), nature and god influence people’s vaccination intentions?
- Use of so-called alternative medicine (SCAM) and its association with SARS-CoV-2 vaccination status
- Chiropractors Aren’t The Solution To The Primary Care Shortage: the thorny issue of vaccination
- An osteopath and anti-vaccination activist received a well-deserved and long-overdue indefinite suspension
- Prison sentence for a German HEILPRAKTIKER who issued false vaccination certificates
- Interest in so-called alternative medicine is linked to vaccination coverage
- Naturopath jailed for selling fraudulent vaccination documents
- Vaccination rates of Canadian healthcare professionals: those of chiropractors and naturopaths are at the lowest
- A Professor for Integrative and Anthroposophical Medicine claims that severe adverse effects of COVID vaccinations are 40 times more frequent than officially recognized
- Preference of so-called alternative medicine predicts negative attitudes to vaccination
- Intelligence, Religiosity, SCAM, Vaccination Hesitancy – are there links?
- A well-known opponent of vaccination has died of COVID after self-treatment with MMS
- The International Chiropractors Association’s Statement on Vaccination
- A naturopath promoting fake news about COVID vaccinations
- More information on homeopaths’ and anthroposophic doctors’ attitude towards vaccinations
- The UK Society of Homeopaths, a hub of anti-vaccination activists?
- HOMEOPATHY = “the complete alternative to vaccination” ?!?!
- Are anthroposophy-enthusiasts for or against vaccinations?
- Far too many chiropractors believe that vaccinations do not have a positive effect on public health
- Naturopaths’ counselling against vaccinations could be criminally negligent
- HOMEOPATHS AGAINST VACCINATION: “The decision to vaccinate and how you implement that decision is yours and yours alone”
- Use of alternative medicine is associated with low vaccination rates
- Integrative medicine physicians tend to harbour anti-vaccination views
- Vaccination: chiropractors “espouse views which aren’t evidence based”
With so much evidence and unquestionable serious harm being caused by these SCAM anti-vaxxers, the obvious question is this:
WHY IS SO LITTLE BEING DONE ABOUT IT?
Yes, it’s CAW again!
How best should we celebrate?
- I could show you how often we had to discuss the harm chiropractic does to patients.
- I could tell you about the contraproductive advice chiropractors tend to issue to anyone who wants to hear it.
- I could list the fatalities chiropractic manipulations have caused.
- I could write about the unethical transgressions many chiropractors commit.
- I could elaborate on the financial fraud some chiropractors are involved in.
- I could write about the dishonest cherry-picking that chiropractors like to engage in.
But that would not be nice, and they would say that I have an axe to grind, a chip on my shoulder, that I am incompetent, don’t know what I am writing about, in the pocket of BIG PHARMA, etc.
So, I decided to celebrate the CAW by reporting on a chiropractic success story, a type of article that chiropractors like: a case report of a patient cured by chiropractic treatments.
Chronic low back pain (CLBP) has been the leading cause of disability globally for the past few decades, resulting in decreased quality of life physically and emotionally. This case report is, according to its authors, important in the medical literature to add to studies reporting successful conservative treatment of CLBP and chronic neck pain (CNP). Triage, diagnosis, and understanding of economical and conservative therapeutics can, the authors stress, benefit patients; providers as well as institutions and third party payors benefit from improved outcomes.
A 39-year old male presented with severe CLBP who had experienced no long-term success with prior chiropractic spinal manipulative therapy (SMT). After symptoms began to worsen in spite of receiving SMT, the patient sought treatment for his pain, abnormal spine alignment, and poor sagittal alignment at a local spine facility. History and physical examination demonstrated altered spine and postural alignment including significant forward head posture and reduced cervical and lumbar lordosis and coronal plane abnormalities. Treatment consisted of a multi-modal regimen focused on strengthening postural muscles, specific spine manipulation directed toward abnormal full-spine alignment, and specific Mirror Image traction aiming to improve spine integrity by realigning the spine toward a more normal position. The treatment consisted of 36 treatments over three months. All original tests and outcome measures were repeated following care.
Objective and subjective outcome measures, patient-reported outcomes, and radiographic mensuration demonstrated improvement at the conclusion of treatment and maintained at 1-year follow-up re-examination.
The authors concluded that this is case demonstrates that the CBP orthopedic chiropractic treatment approach may represent an effective method to treat abnormal spinal alignment and posture. This study adds to the literature regarding conservative methods of treating spine pain and spinal disorders.
What, you are NOT impressed?
- You even claim that the patient’s symptoms worsend despite long-term SMT?
- You insist that such a case poves nothing and certainly does not justify the conclusion?
- You point out that one of the authors is a compensated researcher for CBP Non-Profit, Inc., while another one is a compensated consultant and researcher for Chiropractic BioPhysics, NonProfit, Inc. and one is the CEO of Chiropractic BioPhysics® (CBP®)?
- And you note that this paper was funded by Chiropractic BioPhysics?
Let me tell you this: you are a spoilt sport! We are, after all, in the realm of chiropractic research where things are different. What is normally called promotion florishes here as research, and the rules of science, ethics or even common sense are suspended.
This cross-sectional meta-epidemiological study investigated the patient-reported acupuncture-related adverse events (A-AEs) in acupuncture randomised controlled trials (RCTs). All RCTs were included that used acupuncture as the intervention group to obtain the efficacy and/or safety of acupuncture therapy and that based the acupuncture therapy on Traditional Medicine theory.
The researchers assessed
- (1) the general characteristics of acupuncture RCTs;
- (2) the general characteristics of PROs;
- (3) the reporting scores of PROs by the Extension of Consolidated Standards of Reporting Trials of Patient-Reported Outcomes (CONSORT PRO Extension);
- (4) the general characteristic of A-AEs; (5) the incidence of A-AEs.
They included 476 RCTs; 296 (62.2%) used PROs as study outcomes, 272 (57.1%) reported safety outcomes. The Visual Analogue Scale (149, 23.7%) and the Pittsburgh Sleep Quality Index (42, 6.7%) were the most common PROs reported. The reporting of PROs was incomplete, with sufficiently reporting scores ranging from 2.7% to 97.6% across the CONSORT PRO Extension.
164 studies reported A-AEs, of which 141 reported specific details. The OR for the incidence of AEs in the acupuncture group compared to the control group was 1.434 (95% CI 1.148 to 1.793). The researchers identified 1277 reports of A-AEs, predominantly tissue injury (eg, haematoma, bleeding), irritation (eg, pain, post-acupuncture discomfort), with no reports of serious A-AEs. The reporting of A-AEs lacked details on the acquisition methods (15.5%), occurrence time (5.5%), A-AEs’ treatment (18.1%) and A-AEs’ recovery (19.7%). Studies that reported funding, registry information, acupuncturist qualifications and non-significant primary outcomes were associated with the A-AEs’ reporting, and the difference was statistically significant (p≤0.05).
The authors concluded that their study found that the reporting of PROs and A-AEs was insufficient in acupuncture RCTs. Future studies should clarify the clinical significance of using PROs as outcomes and report AEs comprehensively to provide patients with sufficient information on the benefits and harms of acupuncture treatments.
If you have followed my blog for any length of time, you will have seen numerous studies that show how poor the reporting of AEs is in trials of acupuncture and other forms of so-called alternative medicine (SCAM). This is not just regrettable, it is unethical, dangerous and amounts to scientific misconduct.
Based on such flawed evidence SCAM promoters claim that their treatments are quite safe. But because of the very inadequate reporting this assumption might well be wrong. Thus consumers are systematically being misled into making wrong, and in a worst case scenaario fatal, therapeutic decisions.
Imagine what scandal it would generate, if we found that studies of pharmaceuticals were systematically hiding AEs by simply not monitoring and reporting them!
