Edzard Ernst

MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

It has been reported that a recent inspection from the Care Quality Commission (CQC) found that the diagnostic imaging service at AECC University College in Parkwood Road, Bournemouth, requires improvement in three out of four areas – including patient safety. This is surprising not least because the AECC prides itself on being “a leading higher education institution in healthcare disciplines, nationally and internationally recognised for quality and excellence.”

The unannounced inspection in May this year resulted in several demands for the service to improve upon. For example, the CQC report said staff “did not receive all of the training they needed to keep patients safe” and that patient chaperones “did not receive chaperone training”. Moreover, managers were reported as not always ensuring staff were competent to operate certain equipment. In fact, there was no record of staff competencies which meant inspectors “could not tell if staff had been trained to use equipment”. General cleanliness was also found lacking in relation to certain procedures, namely no sink in any of the site’s nine ultrasound rooms (including those for transvaginal scans) – meaning staff carrying out ultrasound scanning did not have access to a clinical handwashing facility.

The CQC states on its website that it “is the independent regulator of health and adult social care in England. We make sure health and social care services provide people with safe, effective, compassionate, high-quality care and we encourage care services to improve. We monitor, inspect and regulate services. Then we publish what we find, including performance ratings, to help people choose care. Where we find poor care, we will use our powers to take action.”

No doubt, these are laudable aims. What I find, however, disappointing is that the CQC’s inspection of the AECC did not question the nature of some of the courses taught by the AECC. Earlier this year, I reported in a blog post that the AECC has announced a new MSc ‘Musculoskeletal Paediatric Health‘. This motivated me to look into the evidence for such a course. This is what I found with several Medline searches (date of the review on chiropractic for any pediatric conditions, followed by its conclusion + link [so that the reader can look up the evidence]):

2008

I am unable to find convincing evidence for any of the above-named conditions. 

2009

Previous research has shown that professional chiropractic organisations ‘make claims for the clinical art of chiropractic that are not currently available scientific evidence…’. The claim to effectively treat otitis seems to
be one of them. It is time now, I think, that chiropractors either produce the evidence or abandon the claim.

2009

The … evidence is neither complete nor, in my view, “substantial.”

2010

Although the major reason for pediatric patients to attend a chiropractor is spinal pain, no adequate studies have been performed in this area. It is time for the chiropractic profession to take responsibility and systematically investigate the efficiency of joint manipulation of problems relating to the developing musculoskeletal system.

2018

Some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

What seems to emerge is rather disappointing:

  1. There are no really new reviews.
  2. Most of the existing reviews are not on musculoskeletal conditions.
  3. All of the reviews cast considerable doubt on the notion that chiropractors should go anywhere near children.

But perhaps I was too ambitious. Perhaps there are some new rigorous clinical trials of chiropractic for musculoskeletal conditions. A few further searches found this (again year and conclusion):

2019

We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant.

2018

Adding manipulative therapy to other conservative care in school children with spinal pain did not result in fewer recurrent episodes. The choice of treatment-if any-for spinal pain in children therefore relies on personal preferences, and could include conservative care with and without manipulative therapy. Participants in this trial may differ from a normal care-seeking population.

I might have missed one or two trials because I only conducted rather ‘rough and ready’ searches, but even if I did: would this amount to convincing evidence? Would it be good science?

No! and No!

So, why does the AECC offer a Master of Science in ‘Musculoskeletal Paediatric Health’?

____________________

Isn’t that a question the CQC should have asked?

Olivia Newton-John, actress, singer, and advocate of so-called alternative medicine (SCAM) has died following a lengthy battle with breast cancer. Her husband announced her death yesterday: “Dame Olivia Newton-John (73) passed away peacefully at her Ranch in Southern California this morning, surrounded by family and friends,” the post read. “We ask that everyone please respect the family’s privacy during this very difficult time. Olivia has been a symbol of triumphs and hope for over 30 years sharing her journey with breast cancer. Her healing inspiration and pioneering experience with plant medicine continues with the Olivia Newton-John Foundation Fund, dedicated to researching plant medicine and cancer.”

Olivia was born on 26 September 1948 in Cambridge, UK. She came from a remarkable family. Her maternal grandfather was the Nobel Prize-winning physicist Max Born. She was thus the niece of my late friend Gustav Born. Newton-John’s father was an MI5 officer on the Enigma project at Bletchley Park who took Rudolf Hess into custody during World War II. After the war, he became the headmaster of the Cambridgeshire High School for Boys. He then took up a post in Australia, and young Olivia grew up down under. After starting out as a singer, she had her breakthrough with the film ‘Grease’ which brought her world fame.

Olivia was first diagnosed with breast cancer over 30 years ago and became an outspoken advocate of SCAM. Her cancer came back twice, and in 2017, she was diagnosed to have bone metastases. Meanwhile, she had married John Easterling, the boss of a natural remedy company, in an Incan spiritual ceremony in Peru.

In 2017, she said, “I decided on my direction of therapies after consultation with my doctors and natural therapists and the medical team at my Olivia Newton-John Cancer Wellness and Research Centre in Melbourne”. The Olivia Newton-John Cancer Wellness & Research Centre is a treatment centre of Austin Health, an Australian public hospital. They say that “anyone with a referral from their doctor can be treated here, regardless of the stage of their treatment or insurance status. At the ONJ Centre your care is built around your individual needs. This includes your physical, psychological and emotional health. Every patient is surrounded by a multidisciplinary team of cancer specialists, allied health and wellbeing therapists. Your dedicated treatment team work together to guide you through your optimal treatment pathway. Learn more about the cancer treatments we deliver at the ONJ Centre, how we support you through your care, and find answers to commonly asked questions.”

Their therapies include acupuncture and several other alternatives used for palliation, but the site seems refreshingly free of false claims and quackery. On their website, they say that “palliative care assists patients who have a life limiting illness to be as symptom free as possible. We work with you to meet your emotional, spiritual and practical needs in a holistic way. Our support is also extended to your family and carers.”

Olivia Newton-John’s history with SCAM is revealing. It seems that, by initially using SCAM instead of conventional treatments for her breast cancer in 1992, she worsened her prognosis. When the cancer returned, she opted for the best conventional oncology on offer. Yet, her liking for SCAM had not disappeared. Since 2017, she seems to have used cannabis and other SCAMs as add-ons to conventional medicine. Sadly, she had learned her lesson too late: alternative cancer treatments are a dangerous myth.

Should Acupuncture-Related Therapies be Considered in Prediabetes Control?

No!

If you are pre-diabetic, consult a doctor and follow his/her advice. Do NOT do what acupuncturists or other self-appointed experts tell you. Do NOT become a victim of quackery.

But the authors of a new paper disagree with my view.

So, let’s have a look at the evidence.

Their systematic review was aimed at evaluating the effects and safety of acupuncture-related therapy (AT) interventions on glycemic control for prediabetes. The Chinese researchers searched 14 databases and 5 clinical registry platforms from inception to December 2020. Randomized controlled trials involving AT interventions for managing prediabetes were included.

Of the 855 identified trials, 34 articles were included for qualitative synthesis, 31 of which were included in the final meta-analysis. Compared with usual care, sham intervention, or conventional medicine, AT treatments yielded greater reductions in the primary outcomes, including fasting plasma glucose (FPG) (standard mean difference [SMD] = -0.83; 95% confidence interval [CI], -1.06, -0.61; P < .00001), 2-hour plasma glucose (2hPG) (SMD = -0.88; 95% CI, -1.20, -0.57; P < .00001), and glycated hemoglobin (HbA1c) levels (SMD = -0.91; 95% CI, -1.31, -0.51; P < .00001), as well as a greater decline in the secondary outcome, which is the incidence of prediabetes (RR = 1.43; 95% CI, 1.26, 1.63; P < .00001).

The authors concluded that AT is a potential strategy that can contribute to better glycemic control in the management of prediabetes. Because of the substantial clinical heterogeneity, the effect estimates should be interpreted with caution. More research is required for different ethnic groups and long-term effectiveness.

But this is clearly a positive result!

Why do I not believe it?

There are several reasons:

  • There is no conceivable mechanism by which AT prevents diabetes.
  • The findings heavily rely on Chinese RCTs which are known to be of poor quality and often even fabricated. To trust such research would be a dangerous mistake.
  • Many of the primary studies were designed such that they failed to control for non-specific effects of AT. This means that a causal link between AT and the outcome is doubtful.
  • The review was published in a 3rd class journal of no impact. Its peer-review system evidently failed.

So, let’s just forget about this rubbish paper?

If only it were so easy!

Journalists always have a keen interest in exotic treatments that contradict established wisdom. Predictably, they have been reporting about the new review thus confusing or misleading the public. One journalist, for instance, stated:

Acupuncture has been used for thousands of years to treat a variety of illnesses — and now it could also help fight one of the 21st century’s biggest health challenges.

New research from Edith Cowan University has found acupuncture therapy may be a useful tool in avoiding type 2 diabetes.

The team of scientists investigated dozens of studies covering the effects of acupuncture on more than 3600 people with prediabetes. This is a condition marked by higher-than-normal blood glucose levels without being high enough to be diagnosed as diabetes.

According to the findings, acupuncture therapy significantly improved key markers, such as fasting plasma glucose, two-hour plasma glucose, and glycated hemoglobin. Additionally, acupuncture therapy resulted in a greater decline in the incidence of prediabetes.

The review can thus serve as a prime example for demonstrating how irresponsible research has the power to mislead millions. This is why I have often said that poor research is a danger to public health.

And what can be done about this more and more prevalent problem?

The answer is easy: people need to behave more responsibly; this includes:

  • trialists,
  • review authors,
  • editors,
  • peer-reviewers,
  • journalists.

Yes, the answer is easy in theory – but the practice is far from it!

Warning: Exceptionally, this post is not on so-called alternative medicine but on a different scam.

The current issue of the BMJ carries an editorial that is worth quoting on my blog, I think. I have never made a secret of the fact that I am against Brexit. In fact, I re-took German nationality because of it. Therefore, I am in agreement with Kamran Abbasi, the BMJ editor and author of the editorial. Here are what I consider the two most important paragraphs from his article:

… In the absence of public debate and meaningful data six years after the UK’s Brexit referendum, we asked Richard Vize to examine the effects of Brexit on health and care (doi:10.1136/bmj.o1870).20 The news isn’t all bad, although there isn’t much good. Brexit hasn’t brought about a cut in NHS funding but did fail to deliver the £350m weekly windfall that Boris Johnson and others promised. The European Working Time Directive remains in place, and the predicted “stampede” of European doctors leaving the NHS hasn’t happened. But the impacts on social care and lower paid staff are harming delivery of care in an increasingly multidisciplinary service.

Health technology, life science industries, and research, where integration with Europe was greatest and benefits most obvious, are being damaged. Promises to cut red tape have created new complexities and been tarnished by suspect procurement practices at the height of the pandemic (doi:10.1136/bmj.o1893).21 Perhaps the most damning legacy of Brexit, however, is the state of unreadiness it created for a pandemic that required utmost readiness. Whether or not you agree Brexit was the right decision, you should at least agree that it is a decision worthy of question, analysis, and redoubled effort if the signs are good and possibly even reversal if the damage is too great.

This quote probably makes more sense if one also reads the paper referenced in its 2nd link. So, please allow me to quote from this article as well:

… In a highly critical report, the Commons Public Account Committee accuses the Department of Health and Social Care of “woefully inadequate record keeping” and failing to meet basic requirements to publicly report ministers’ external meetings or deal with potential conflicts of interest when awarding testing contracts to the company.

The committee said that large gaps in the document trail meant it was impossible to say the contracts were awarded properly in the way that would be expected, even allowing for the exceptional circumstances and accelerated processes in place at the time. The first contract, for £132m, was awarded at the height of the covid pandemic in March 2020, when the department had suspended the normal requirements for competition between suppliers in the award of government contracts.

The report noted that officials were aware of contacts between Matt Hancock, the then health and social care secretary, and Owen Paterson, a Conservative MP and paid consultant for Randox, and of hospitality that Hancock received from Randox’s founder Peter Fitzgerald in 2019, but failed to identify any conflicts of interest before awarding the first contract.

The department set up a “VIP lane,” through which suppliers put forward by officials, MPs, ministers, or Number 10 would be given priority. Suppliers coming through priority routes were awarded £6bn out of the total £7.9bn of testing contracts awarded between May 2020 and March 2021, the committee noted…

This is by no means all, and I do encourage you to read these articles in full. Once you have, you might ask yourself as I do:

Has Britain become a banana republic?

The ‘My Resilience in Adolescence (MYRIAD) Trial’evaluated the effectiveness and cost-effectiveness of SBMT compared with teaching-as-usual (TAU).

MYRIAD was a parallel group, cluster-randomised controlled trial. Eighty-five eligible schools consented and were randomized 1:1 to TAU (43 schools, 4232 students) or SBMT (42 schools, 4144 students), stratified by school size, quality, type, deprivation, and region. Schools and students (mean (SD); age range=12.2 (0.6); 11–14 years) were broadly UK population-representative. Forty-three schools (n=3678 pupils; 86.9%) delivering SBMT, and 41 schools (n=3572; 86.2%) delivering TAU, provided primary end-point data. SBMT comprised 10 lessons of psychoeducation and mindfulness practices. TAU comprised standard social-emotional teaching. Participant-level risk for depression, social-emotional-behavioural functioning and well-being at 1 year follow-up were the co-primary outcomes. Secondary and economic outcomes were included.

An analysis of the data from 84 schools (n=8376 participants) found no evidence that SBMT was superior to TAU at 1 year. Standardised mean differences (intervention minus control) were: 0.005 (95% CI −0.05 to 0.06) for risk for depression; 0.02 (−0.02 to 0.07) for social-emotional-behavioural functioning; and 0.02 (−0.03 to 0.07) for well-being. SBMT had a high probability of cost-effectiveness (83%) at a willingness-to-pay threshold of £20 000 per quality-adjusted life year. No intervention-related adverse events were observed.

The authors concluded that the findings do not support the superiority of SBMT over TAU in promoting mental health in adolescence.

Even though the results are negative, MYRIAD must be praised for its scale and rigor, and for highlighting the importance of large, well-designed studies before implementing measures of this kind on a population basis. Co-author Tim Dalgliesh, director of the Cambridge Centre for Affective Disorders, said: “For policymakers, it’s not just about coming up with a great intervention to teach young people skills to deal with their stress. You also have to think about where that stress is coming from in the first place.”

“There had been some hope for an easy solution, especially for those who might develop depression,” says Til Wykes, head of the School of Mental Health and Psychological Sciences at the Institute of Psychiatry, Psychology, and Neuroscience, King’s College London. “There may be lots of reasons for developing depression, and these are probably not helped by mindfulness,” she says. “We need more research on other potential factors that might be modified, and perhaps this would provide a more targeted solution to this problem.”

Personally, I feel that mindfulness has been hyped in recent years. Much of the research that seemed to support it was less than rigorous. What is now needed is a realistic approach based on sound evidence and critical thinking.

For many years, Dr. Natalie Grams-Nobmann provided evidence-based medical information on social media – including on homeopathy, other forms of so-called alternative medicine, and more recently the COVID pandemic. These activities deservedly earned her plenty of praise but sadly they also made her the target of intolerant, occasionally aggressive people who disagree with the evidence. As I mentioned in yesterday’s post, Natalie has recently deleted her Twitter account. To explain her decision, she gave an interview to Marc Zimmer, MDR AKTUELL. With Natalie’s permission, I have translated sections of it and re-publish them here:

Q: What do you think about the case of your Austrian colleague?
A: The case has affected and frightened me terribly. I followed Kellermayr’s work and everything that came afterward. It is simply a terrible example of how little protection one has as a doctor or vaccination educator on social media. It also is a terrible example of how this “hate” does not stay in the realm of social media but spills over into real life. And that we have nothing to counter this “hate”.

Q: You yourself have also drawn consequences and deleted your Twitter account. Can you explain this step?
A: After seven years of vaccination education and medical education on social media, I thought I couldn’t take it anymore. I can’t stand looking into this hell where people celebrate the death of another human being, the suicide of another human being – and see that as an admission of guilt of this really threatened and persecuted doctor and rise above it like that. I think that when even the death of a human being is no longer free of gloating and hatred, then ideology is above everything. I didn’t know how to deal with it anymore. And, of course, it also scared me. I think my death would be celebrated in the same way, and I find that terribly frightening in human terms.

Q: To what extent have you experienced threats so far?
A: … I’ve experienced an incredible amount of different forms of hate – be it threats, insults, slander, or persecution. This has also spilled over into real life for me. I have sometimes given lectures under police protection. I am very glad that it is still sensible to wear a mask in public spaces…  I think that in some cases it really is a life-threatening fear that you have to endure when you speak out on social or other media about vaccination protection or about protective measures. A lot of what you hear has to be reported and followed up. It is not the case that the internet is a lawless space or that my inbox simply has to swallow every insult in the world…

Q: You mentioned the platforms. What about politics? Do you feel supported enough by it and by the authorities?
A: No, not at all and that was certainly the case with the Austrian colleague. In desperation and panic, people turn to the police, and of course, there are individual female officers who react in an excellent way. But I have also heard things like: “Well, then don’t go out in public. Why do you do that? You’re doing it voluntarily, so you have to put up with it”. Or they say that it’s freedom of expression, that everyone is allowed to say anything… If no more discourse is possible, what am I supposed to do? I would like to be able to ensure that I remain objective, that I provide information and do not insult anyone. At the moment I simply don’t see myself in a position to do that because of the many threats.

Q: What do you wish from politics?
A: I would like politicians to draw the right conclusions from this: not just those who shout the loudest must be listened to. The ones who are silenced should be heard as well.

This “silencing” that I have been following throughout the pandemic is a terrible thing. The best and most factual discussants are disappearing more and more from the platforms. I haven’t insulted or threatened or unobjectively excoriated anyone in all my time on social media. Of course, you are allowed to make a joke or use satire. But you’re not allowed to put another person down. And the very people who have always managed to remain objective – despite the well-known strains during the pandemic – are now leaving and this should alarm us all.

____________________

I do, of course, understand and respect Natalie’s decisions. Nevertheless, I am sad that she is partly withdrawing from public life. I feel that, in these difficult times, we need everyone who can contribute to more responsible information for the public. We must try to balance irrationality with rationality. Natalie is particularly gifted in doing just that (she is much more gentle and empathetic in the face of adversity than I, for instance). My hope, therefore, is that things improve, hatred recedes, and she is able to return to public life soon. Regardless of what she decides, I wish her well.

For more than seven months, the Austrian general practitioner, Dr. Lisa-Maria Kellermayr, received death threats and was verbally attacked by the anti-vaccination cult. She eventually closed her practice, no longer wanted to leave the house, and apparently lost the courage to live. Last Friday, she was found dead in her practice in Seewalchen on Attersee. The public prosecutor’s office in Wels confirmed that there were no signs of foul play. Letters of farewell had been found. It is generally assumed that, in her desperation, Kellermayr took her own life. A friend tweeted: “In the end, she begged for help – from politicians, from the police, from her medical association. It never came. The police and the medical association would mock her. They said Dr Kellermayrjust wants to seek the limelight. Politicians ignored her. Now she is dead.”

The GP had closed her practice at the end of June, only temporarily, she said initially, because she could no longer afford the costs for her security, including a bodyguard. She did not feel sufficiently protected by the police. “For more than 7 months, we have been receiving death threats from the Covid measure opponents and vaccination opponents scene at irregular intervals,” Kellermayr tweeted. Threats went as far as predicting a “massacre” in her practice. In one of the threatening letters, the author described in detail how he would first torture and then murder the doctor and her practice staff.

At the end of July, she closed her practice for good. For the doctor, who loved her profession, it was a terrible decision. “I put so much money and energy into it,” she told ‘Der Spiegel’ just one day before her death. By her own account, she had at that stage invested around 100,000 Euros in security measures.

It is claimed that Kellermayr was badly let down by the Austrian authorities. On Austrian radio, the police even stated that Kellermayr merely sought the limelight to further her career. Now an official complaint has been filed charging the authorities with neglect.

Unbelievably, the despicable agitation of the anti-vaccination cult continues even after Kellermayr’s death. Most of the agitators remain anonymous. But some are also agitating publicly, for instance, on Twitter: Harald Laatsch, an AfD member of parliament in Berlin, wrote that the doctor was a vaccination propagandist and probably “no longer wanted to live with the heavy guilt”.

After Kellermayr’s suicide, well-known German Twitter users are withdrawing from the platform. The Würzburg lawyer Chan-jo Jun turned his back on Twitter last Friday stating: “If I tweet about certain people, I get warnings in my letterbox the next day. I am reaching my limits. I’m now leaving the field to others. Until I find a concept of how an objective exchange can take place in social media.”

Doctor Natalie Grams, a well-known critic of homeopathy, is also closing her Twitter account. She plans to continue her commitment to evidence-based medicine with the help of her podcast, Grams explained in her farewell tweet.

Others reached a different conclusion. Dr. Christian Luebbers tweeted this (my translation): “Of course, I also considered deactivating my account here. However, I came to the conclusion not to do so and continue to educate people about pseudo-medicine and vaccination. I see this as necessary moral courage and will not leave the field to hate.” Personally, I agree with him.

I would like to use the tragic occasion of Dr. Kellermyr’s death as an opportunity for making a plea. It is high time that intolerance, aggression, violence, and hatred stop. Please, let us all calm down and discuss with dignity and respect whatever issues we might have. Please, let this terrible death remind us that we are all human beings. Please, let it be a lesson to all of us.

 

I have often called out unreliable or fraudulent research in the realm of Traditional Chinese Medicine (TCM). I think it is important to do so because the abundance of scientific misconduct is such that it has become a danger to public health. Today, I present yet another example:

This recent review claimed to summarize the evidence on TCM in treating MI, the clinical evaluations of TCM in treating male infertility (MI), and the molecular mechanisms of TCM effects. I was alerted to the fact that the authors cite a paper on acupuncture that I had co-authored. Here is the section in question from the review:

Acupuncture is one of the therapeutic techniques that are part of TCM. Acupuncture is a non-invasive technique and is regarded as free of risk if performed by trained personnel [35]. One of the advantages of acupuncture was that the incidence of adverse effects was substantially lower than that of many drugs or other accepted [35]. Acupuncture has been used in the treatment of male and female infertility and in assisted reproductive technology treatments for many years. A total of 100 patients with MI who met the diagnostic criteria were randomly divided into two groups [7]. Half of the patients received acupuncture treatment, and the other half received placebo acupuncture. After 10 weeks treatment, acupuncture successfully improved the indicators of the semen, including the spermatozoa survival rate, b-level activity rate, sperm density, sperm activity rate. A total of 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of acupuncture and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture [36]. Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler essence injection to acupoints and oral administration of Chinese materia medica, 142 cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective and 21 cases (7.1%) ineffective [37]. The therapeutic effect of the combination of these three treatments was satisfactory.

Ref 7

Emerging evidence has shown that cell-cell interactions between testicular cells, in particular at the Sertoli cell-cell and Sertoli-germ cell interface, are crucial to support spermatogenesis. The unique ultrastructures that support cell-cell interactions in the testis are the basal ES (ectoplasmic specialization) and the apical ES. The basal ES is found between adjacent Sertoli cells near the basement membrane that also constitute the blood-testis barrier (BTB). The apical ES is restrictively expressed at the Sertoli-spermatid contact site in the apical (adluminal) compartment of the seminiferous epithelium. These ultrastructures are present in both rodent and human testes, but the majority of studies found in the literature were done in rodent testes. As such, our discussion herein, unless otherwise specified, is focused on studies in testes of adult rats. Studies have shown that the testicular cell-cell interactions crucial to support spermatogenesis are mediated through distinctive signaling proteins and pathways, most notably involving FAK, Akt1/2 and Cdc42 GTPase. Thus, manipulation of some of these signaling proteins, such as FAK, through the use of phosphomimetic mutants for overexpression in Sertoli cell epithelium in vitro or in the testis in vivo, making FAK either constitutively active or inactive, we can modify the outcome of spermatogenesis. For instance, using the toxicant-induced Sertoli cell or testis injury in rats as study models, we can either block or rescue toxicant-induced infertility through overexpression of p-FAK-Y397 or p-FAK-Y407 (and their mutants), including the use of specific activator(s) of the involved signaling proteins against pAkt1/2. These findings thus illustrate that a potential therapeutic approach can be developed to manage toxicant-induced male reproductive dysfunction. In this review, we critically evaluate these recent findings, highlighting the direction for future investigations by bringing the laboratory-based research through a translation path to clinical investigations.

This paper does not relate to the statement it is meant to support by the review authors.

Ref 35

The review by Qin et al (1) includes 5 trials none of which should have been included in a quality metaanalysis as the methodology was unconvincing: In the trial by Alraek et al., patients were randomised to receive either acupuncture or no treatment. This means that no attempt was made to control for the effects of placebo or extra attention. Therefore, this study does not demonstrate an effect of acupuncture as the outcome could be due to non-specific effects unrelated with this therapy. By contrast, the trial by Aune et al. did attempt to control for placebo effects by using a sham control group. Sham acupuncture was given using six needles superficially inserted in the calves, thighs or abdomen outside known acupuncture points or meridians. Needles were not manipulated in the sham group. Sham or placebo controls have the purpose of rendering patients unaware of whether they receive the real or the sham treatment. The method used here cannot achieve this aim; patients would be easily able to tell which intervention they received. In other words, this study also did not adequately control for placebo effects. The remaining three trials are all not Medline-listed, authored by Chinese investigators and published in inaccessible journals. This should disqualify them from inclusion as they were unverifiable by the peer review process. According to the published table, they were equivalence trials of acupuncture versus antibiotics with a sample size around 30. This means they are grossly underpowered and thus unable to generate reliable results. Unless BJOG peer reviewers could see the primary articles, or be provided with translations from Chinese, the systematic review should not have been accepted. The “many eyes of science” requires transparency, testing, challenge and verification. Although in the past, inconclusive results of acupuncture have not been thought to be due to Chinese influence (2), it has been noted that virtually all recent published acupuncture trials are “positive” (3), raising questions of publication and other biases. Our colleagues are under tremendous pressure to publish, but we do them no favours by effectively lowering the standard of scientific peer review. Elite journals too have an obligation to train and reiterate about publication ethics and sound scientific writing (4). As none of the primary studies convincingly demonstrated that acupuncture is an effective therapy for recurrent urinary tract infections, no positive conclusion was warranted. Although Qin et al. did state that the risk of bias of the included trials was generally high or unclear (1), the BJOG nevertheless allowed them to turn massive uncertainty into relatively firm, positive conclusions in the abstract (“Acupuncture appeared to be beneficial for treatment and prophylaxis of rUTIs”) and tweetable abstract (“This review found that acupuncture may improve treatment and prevent recurrence of urinary tract infection in women”), thus leading to excited media headlines that inevitably mislead the public. ‘May’ is a weasel word which should be avoided as it is unfalsifiable (for example, pigs do not fly but they ‘may’ fly in the future). The definite, straightforward conclusion must be “There is no good evidence to support the use of acupuncture for the treatment and prophylaxis of recurrent UTIs”. It is not acceptable to give international credibility to an implausible modality that no objective, independent high-quality review has found effective beyond placebo (5). The dampening accompanying mini-commentary (6) does not undo the damage.
The review should be withdrawn while the primary papers are translated for peer reviewers to examine, the above limitations discussed in the text, and the positive ‘spin’ in conclusions corrected. These improvements would consolidate the researchers’ probity and justify the accolade of BJOG publication.

Our letter to the editor does not bear any relation to the statement it is meant to support by the review authors.

Ref 36

In this first prospective, randomized, single-blind, placebo-controlled study, 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of traditional Chinese medicine (TCM) and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A–C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.

This small study is far from convincing and does not lend itself to far-reaching conclusions

Ref 37

Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler
essence injection to acupoints and oral administration of Chinese materia medica, 142
cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective
and 21 cases (7.1%) ineffective. The therapeutic effect of the combination of these three
treatments was satisfactory.

This study had no control group and used two different therapies. Therefore, it does not allow any conclusion about the effectiveness of acupuncture.

____________________

Perhaps you feel that these errors are trivial. But I would disagree. The review authors’ praise of acupuncture for MI is misplaced and will mislead the public. There are plenty of reviews on the subject, and those that are not overtly biased arrive at conclusions like these:

So, how did this sloppy review come about?

Its authors are affiliated to the TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China, and the Tea Research Institute, Sichuan Academy of Agricultural Sciences, Chengdu 610066, China. A footnote tells us that their review was supported by the National Natural Science Foundation of China [No. 81973647] and the Xinglin scholar discipline promotion talent program of Chengdu University of traditional Chinese medicine [No. BSH2021018]. This sounds respectable enough.

The journal that published the review is ‘Pharmacological Research – Modern Chinese Medicine‘. Its stated aims are as follows: The journal publishes articles reporting on advances in our comprehension of mechanism and safety in experimental pharmacology and clinical efficacy and safety of pharmacologically active substances, including compound prescriptions, utilized in Traditional Chinese Medicine applying modern scientific research methods. Studies reporting also on the mechanisms of actions of the active substance(s) investigated are encouraged.

The editors in chief of the journal are Guan-Hua Du, PhD, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica, Beijing, China and Emilio Clementi, M.Mus, MD, PhD, University of Milan, Milan, Italy. No doubt, these are respectable scientists. And because they are, they should make sure that what they publish is correct – a criterion this recent review clearly does not meet.

I had totally forgotten this amusing little episode: According to THE GUARDIAN, Jacob Rees-Mogg (JRM) once tweeted that I should be locked up in the Tower of London!

If you are not from the UK, you may not know this Member of Parliament. So, let me explain.

JRM is the MP for North East Somerset and currently the ‘Minister for Brexit Opportunities and Government Efficiency’. His personal net worth is estimated to be well over £100 million. I probably don’t need to add much more about JRM; there is plenty about him on the Internet and on social media, for instance, this little gem:

Some of JRM’s medically relevant voting records are revealing:

  • He voted against raising welfare benefits five times in 2013.
  • He voted against higher benefits over long periods for those unable to work as a result of an illness or disability: 14 votes over 5 years.
  • Between 2012-2016, he voted 52 times to reduce the spending on welfare benefits.
  • He voted to exempt pubs and clubs where food is not served from the smoking ban in October 2010.
  • He voted against a law to make private vehicles smoke-free if a child is present.
  • He voted against allowing terminally ill people to be given assistance in ending their lives.

Wikipedia mentions that Rees-Mogg is against abortion in all circumstances, stating: “life begins at the point of conception. With same-sex marriage, that is something that people are doing for themselves. With abortion, that is what people are doing to the unborn child.” In September 2017, he expressed “a great sadness” on hearing about how online retailers had reduced pricing of emergency contraception. 

In October 2017, it was reported that Somerset Capital Management, of which Rees-Mogg was a partner, had invested £5m in Kalbe Farma, a company that produces and markets misoprostol pills designed to treat stomach ulcers but widely used in illegal abortions in Indonesia. Rees-Mogg defended the investment by arguing that the company in question “obeys Indonesian law so it’s a legitimate investment and there’s no hypocrisy. The law in Indonesia would satisfy the Vatican”. Several days later, it was reported that the same company also held shares in FDC, a company that sold drugs used as part of legal abortions in India. Somerset Capital Management subsequently sold the shares it had held in FDC. Rees-Mogg said: “I am glad to say it’s a stock that we no longer hold. I would not try to defend investing in companies that did things I believe are morally wrong”.

In a nutshell, JRM seems to stand for pretty much everything that I am against. But that is no reason to send me to the Tower of London. So, what exactly was JRM referring to when he wanted me locked up?

The Guardian article explains: At a press conference to mark his retirement [Ernst] agreed with a Daily Mail reporter’s suggestion that the Prince of Wales is a “snake-oil salesman”. In the living room of his house in Suffolk he unpacks the label with the precision on which he prides himself. “He’s a man, he owns a firm that sells this stuff, and I have no qualms at all defending the notion that a tincture of dandelion and artichoke [Duchy Herbals detox remedy] doesn’t do anything to detoxify your body and therefore it is a snake oil.” Far from regretting the choice of words and the controversy it has generated, he appears to relish it.

Looking back at all this bizarre story, I am surprised that JRM did not advocate chopping my head off in the Tower of London. He must have been in a benevolent mood that day!

The interest in the medicinal properties of honey is lively. A recent review, for instance, concluded that honey is a safe natural substance, effective in the inhibition of bacterial growth and the treatment of a broad range of wound types, including burns, scratches, diabetic boils (Skin abscesses associated with diabetic), malignancies, leprosy, fistulas, leg ulcers, traumatic boils, cervical and varicose ulcers, amputation, burst abdominal wounds, septic and surgical wounds, cracked nipples, and wounds in the abdominal wall. Honey comprises a wide variety of active compounds, including flavonoids, phenolic acid, organic acids, enzymes, and vitamins, that may act to improve the wound healing process. Tissue-engineered scaffolds have recently attracted a great deal of attention, and various scaffold fabrication techniques are being researched.

But there is also reason to be cautious. The U.S. Food and Drug Administration (FDA) posted warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing found that product samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

“Tainted honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., “Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective, FDA-approved treatments.”

Today’s warning letters outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.

The warning letters were issued to:

Companies marketing food products containing tadalafil and/or sildenafil violate federal law. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. In some cases, product claims reference diseases that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.

The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.

If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.

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