politics
There is a broad, growing, international consensus that homeopathy is a placebo therapy. Even the Germans who have been notoriously fond of their homeopathic remedies are now slowly beginning to accept this fact. But now, a dispute has started to smolder in Germany’s southwest about further training for doctors in homeopathy. In July, the representative assembly of the Baden-Württemberg Medical Association decided to remove the additional title of homeopathy from the further training regulations of doctors. However, the local health ministry has legal control over the medical association and must therefore review the decision, and the minister (Manne Lucha), a member of the Green Party, has stated that he considers the deletion to be wrong.
In a further deepening of the conflict, it has been reported that the chairwoman of the Green Party, Lena Schwelling, considers the ongoing controversy over homeopathy to be exaggerated and wants to preserve people’s freedom of choice. She said she agrees with Health Minister Manne Lucha that naturopathy and homeopathy are important issues for many people. “There is freedom of choice of doctor and therapy in this country. And if people want to choose it, I think they should be allowed to do so.” She also said continuing education for homeopathy for physicians should remain.
Schwelling spoke out against omitting homeopathy from the benefits catalog of the statutory health insurance funds, as demanded by the German Liberal Party, for example: “We are talking about about 0.003 percent of the total costs of the statutory health insurance funds, which flow into homeopathic medicines and treatments. If you saw that as a homeopathic medicine, that would also be at the detection limit, that’s how little money it is. It’s so diluted and so little in this overall budget that it’s not worth arguing about. That’s why I’m very surprised at the crusade some are waging against the issue of homeopathy.”
Recently, a dispute has been smoldering in the southwest about continuing education for homeopathy. The representative assembly of the Baden-Württemberg Medical Association decided in July to remove the additional title of homeopathy from the continuing education regulations. The local health minister, Lucha, has legal oversight of the medical association and must review the amendment statute. However, the minister has already stated that he believes the deletion is wrong.
In response, Schwelling stated it is a “normal process” for the ministry to review what the medical association has proposed. He added that it was perfectly clear that “further training in homeopathy is additional training and does not replace medical studies. Of course, homeopathic doctors also prescribe antibiotics when indicated. An important point why homeopathy should remain in the canon is that you then have the established control mechanisms, for example, in further education.”
In a previous post, I explained that anthroposophic education was founded by Steiner in 1919 to serve the children of employees of the Waldorf-Astoria cigarette factory in Stuttgart, Germany. Pupils of Waldorf or Steiner schools, as they are also frequently called, are encouraged to develop independent thinking and creativity, social responsibility, respect, and compassion.
Waldorf schools implicitly infuse spiritual and mystic concepts into their curriculum. Like some other alternative healthcare practitioners – for instance, doctors promoting integrative medicine, chiropractors, homeopaths, and naturopaths – doctors of anthroposophic medicine tend to advise against childhood immunizations. For this and other reasons, Waldorf schools have long attracted criticism.
Now it has been reported that the district government of Münster has withdrawn the school permit of a Waldorf school in Rheine, Germany, because of “serious deficiencies in the teaching operation”. For the 71 children, school operation ends with the start of the fall vacations at the beginning of October, as the district government announced on Tuesday. Already since the end of 2020 there had been numerous complaints. The school board had not succeeded in eliminating the deficiencies, a proper operation is currently and prospectively not guaranteed.
The list of problems described by the district government is long: there were repeated violations in the health protection of children. A spokesman for the district government said that there had been massive and repeated violations of Corona’s protective measures. In addition, there was a risk of accidents in the playground. The school board had also been unable to stop the misconduct of individual teachers, the district government criticized. “In addition, there is an insufficient supply of teachers, school organizational deficits and a massively disturbed school peace,” it said.
In the end, the basis of trust required for continued operation of the school was no longer given, so the school permit had to be revoked for the sake of the children. “This is an absolutely exceptional case,” the spokesman said. It is presumably the first case under the jurisdiction of the Münster district government, he added.
Le Figaro reported that France’s medical appointment booking service ‘Doctolib’ is being accused of promoting so-called alternative medicine (SCAM) on its platform. “Measures will be taken soon. Several options are on the table, we do not exclude anything,” announced Doctolib after declaring during the day on its Twitter account the immediate suspension of some profiles.
Health professionals and patients have been criticizing the platform for allowing its users to make appointments with practitioners claiming to be naturopaths and some offering dangerous quackery. Naturopathy is not recognized in France and is sometimes considered to be linked to charlatanism.
A member of the office for the control of conspiracies, Tristan Mendès France, had found a practitioner promoting urine therapy via Doctolib. “The presence of these individuals on a service that puts patients and health professionals in touch with each other gives them totally unjustified credit and endorsement,” stated a Twitter account aimed at informing “about the dangers of certain pseudo-alternatives in terms of health and nutrition”.
Amongst the questioned profiles were the naturopaths Thierry Casasnovas and Irène Grosjean, two influential personalities in the naturopathic world who are discredited in the health world. “We would like to point out that it is impossible for a patient to make an [appointment] on Doctolib in a practitioner not referenced by the Ministry of Health, without having expressly sought to do so,” Doctolib defended its position stating that it would proceed to checks on practitioners “whose actions would be dangerous or condemnable by law” and who would have been the subject of complaints on social media.
97%” of practitioners signed up with Doctolib are registered with the Ministry of Health,” the company claimed. According to Doctolib, only 3% of its practitioners are therefore from the realm of SCAM: sophrologists, hypnotherapists, naturopaths. In France, these practitioners are not regulated and do not have the status of health professional, but they are nevertheless legal. The appointments made on Doctolib with such practitioners represent “0.3% of the totality” of the volume recorded on the platform.
The CEO of Doctolib, Stanislas Niox-Chateau, said that he was responding to a request from patients and refused to position his site as a simple directory of the Ministry of Health: “The demand is there. It is not up to us to say whether these activities are effective or useful. They are legal, so we have no reason to prevent practitioners from being listed on our site.”
As so often in the realm of SCAM, the dispute seems to be one between ethical/moral responsibilities and commercial interests of the parties involved.
An article in THE TIMES seems worth mentioning. Here are some excerpts:
… Maternity care at Nottingham University Hospitals NHS Trust (NUH) is the subject of an inquiry, prompted by dozens of baby deaths. More than 450 families have now come forward to take part in the review, led by the expert midwife Donna Ockenden. The trust now faces further scrutiny over its use of aromatherapy, after experts branded guidelines at the trust “shocking” and not backed by evidence. Several bereaved families have said they recall aromatherapy being heavily promoted at the trust’s maternity units.
It is being prosecuted over the death of baby Wynter Andrews just 23 minutes after she was born in September 2019. Her mother Sarah Andrews wrote on Twitter that she remembered aromatherapy being seen as “the answer to everything”. Internal guidelines, first highlighted by the maternity commentator Catherine Roy, suggest using essential oils if the placenta does not follow the baby out of the womb quickly enough… the NUH guidelines say aromatherapy can help expel the placenta, and suggest midwives ask women to inhale oils such as clary sage, jasmine, lavender or basil, while applying others as an abdominal compress. They also describe the oils as “extremely effective for the prevention of and, in some cases, the treatment of infection”. The guidelines also suggest essential oils to help women suffering from cystitis, or as a compress on a caesarean section wound. Nice guidelines for those situations do not recommend aromatherapy…
The NUH adds frankincense “may calm hysteria” and is “recommended in situations of maternal panic”. Roy said: “It is shocking that dangerous advice seemed to have been approved by a team of healthcare professionals at NUH. There is a high tolerance for pseudoscience in NHS maternity care … and it needs to stop. Women deserve high quality care, not dangerous quackery.” …
________________________________
The journalist who wrote the article also asked me for a comment, and I emailed her this quote: “Aromatherapy is little more than a bit of pampering; no doubt it is enjoyable but it is not an effective therapy for anything. To use it in medical emergencies seems irresponsible to say the least.” The Times evidently decided not to include my thoughts.
Having now read the article, I checked again and failed to find good evidence for aromatherapy for any of the mentioned conditions. However, I did find an article and an announcement both of which are quite worrying, in my view:
Aromatherapy is often misunderstood and consequently somewhat marginalized. Because of a basic misinterpretation, the integration of aromatherapy into UK hospitals is not moving forward as quickly as it might. Aromatherapy in UK is primarily aimed at enhancing patient care or improving patient satisfaction, and it is frequently mixed with massage. Little focus is given to the real clinical potential, except for a few pockets such as the Micap/South Manchester University initiative which led to a Phase 1 clinical trial into the effects of aromatherapy on infection carried out in the Burns Unit of Wythenshawe Hospital. This article discusses the expansion of aromatherapy within the US and follows 10 years of developing protocols and policies that led to pilot studies on radiation burns, chemo-induced nausea, slow-healing wounds, Alzheimers and end-of-life agitation. The article poses two questions: should nursing take aromatherapy more seriously and do nurses really need 60 hours of massage to use aromatherapy as part of nursing practice?
My own views on aromatherapy are expressed in our now not entirely up-to-date review:
Aromatherapy is the therapeutic use of essential oil from herbs, flowers, and other plants. The aim of this overview was to provide an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Several SRs of aromatherapy have recently been published. Due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
In this context, it might also be worth mentioning that we warned about the frequent usage of quackery in midwifery years ago. Here is our systematic review of 2012 published in a leading midwifery journal:
Background: in recent years, several surveys have suggested that many midwives use some form of complementary/alternative therapy (CAT), often without the knowledge of obstetricians.
Objective: to systematically review all surveys of CAT use by midwives.
Search strategy: six electronic databases were searched using text terms and MeSH for CAT and midwifery.
Selection criteria: surveys were included if they reported quantitative data on the prevalence of CAT use by midwives.
Data collection and analysis: full-text articles of all relevant surveys were obtained. Data were extracted according to pre-defined criteria.
Main results: 19 surveys met the inclusion criteria. Most were recent and from the USA. Prevalence data varied but were usually high, often close to 100%. Much use of CATs does not seem to be supported by strong evidence for efficacy.
Conclusion: most midwives seem to use CATs. As not all CATs are without risks, the issue should be debated openly.
I am tired of saying ‘I TOLD YOU SO!’ but nevertheless find it a pity that our warning remained (yet again) unheeded!
Cannabis use is a frequently-discussed subject, not just in the realm of so-called alternative medicine (SCAM). In general, SCAM advocates view it as an herbal medicine and recommend it for all sorts of conditions. They also often downplay the risks associated with cannabis use. Yet, these risks might be substantial.
Cannabis potency, defined as the concentration of Δ9-tetrahydrocannabinol (THC), has increased internationally, which could increase the risk of adverse health outcomes for cannabis users. The first systematic review of the association of cannabis potency with mental health and addiction was recently published in ‘The Lancet Psychiatry’.
The authors searched Embase, PsycINFO, and MEDLINE (from database inception to Jan 14, 2021). Included studies were observational studies of human participants comparing the association of high-potency cannabis (products with a higher concentration of THC) and low-potency cannabis (products with a lower concentration of THC), as defined by the studies included, with depression, anxiety, psychosis, or cannabis use disorder (CUD).
Of 4171 articles screened, 20 met the eligibility criteria:
- eight studies focused on psychosis,
- eight on anxiety,
- seven on depression,
- and six on CUD.
Overall, higher potency cannabis, relative to lower potency cannabis, was associated with an increased risk of psychosis and CUD. Evidence varied for depression and anxiety. The association of cannabis potency with CUD and psychosis highlights its relevance in healthcare settings, and for public health guidelines and policies on cannabis sales.
The authors concluded that standardisation of exposure measures and longitudinal designs are needed to strengthen the evidence of this association.
The fact that cannabis use increases the risk of psychosis has long been general knowledge. The notion that the risk increases with increased potency of cannabis seems entirely logical and is further supported by this systematic review. Perhaps it is time to educate the public and make cannabis users more aware of these risks, and perhaps it is time that SCAM proponents negate the harm cannabis can do.
About a year ago, I reported last on the situation of homeopathy in France. Now it might be time for another update. The end of the reimbursement of homeopathy was, of course, a heavy blow for the laboratories concerned, especially Boiron and Weleda.
Are these firms now going bust?
Is the French public missing homeopathy?
The cessation of reimbursement took place in two steps: in 2020, the reimbursement rate was reduced to 15 % and expired completely in 2021. The new director of Weleda France, Ludovic Rassat, explains that, in 2020, when the reimbursement was reduced to 15 %, the impact on sales was just 20 %. The decrease was limited because of the supplementary health insurance which 80 % of French people have still supplemented the reimbursement up to 100 %. In 2021, this generosity stopped and the reimbursement fell from 100 to 0 %. This led to a 60 % drop in sales and to losses of 13 million Euros for Weleda France.
According to an Ipsos survey commissioned by Boiron Laboratories in October 2018, 70 % of all French used homeopathy to relieve their first symptoms, 74 % thought homeopathic remedies were effective and 71 % thought homeopathy was a good complement to conventional treatments. One might, therefore, have assumed that French consumers would continue using their beloved remedies despite the cessation of reimbursement. However, this was not the case. The most obvious explanation for this phenomenon, I think, is that the above-mentioned survey had generated false-positive results and that people correctly judged homeopathic remedies to be superfluous.
Faced with unsustainable losses, the French manufacturers of homeopathic products are now forced to react. A press release by Weleda France from 4 July 2022 stated that “This project would result in the discontinuation of pharmaceutical production and medical information in France and the closure of the Weleda division. This would result in the cessation of production activities at the Huningue site and an adjustment of the organisation of activities at headquarters. In total, 127 jobs could be cut at Weleda France.” If this step is taken as planned, Weleda France will have to earn its money purely on its cosmetic and anthroposophical products, according to the director.
In 2019, Laboratoires Boiron owned 4 production laboratories and 28 distribution facilities in France. In March 2020, the company announced that it had decided to cut 646 jobs in France and close 13 of its 31 sites, due to the poor economic results that followed the cessation of reimbursement of its products by the social security system. Following the decision by the Minister of Health, Agnès Buzyn, to stop the reimbursement of homeopathic preparations by the social security system, Boiron announced that the Montrichard site in the Loir-et-Cher region had not managed to find a buyer. As a result, the site, which employed around 80 people, closed on 31 December 2021.
And the French consumers?
Are they missing homeopathy?
Are they suffering from homeopathy withdrawal?
Are they more frequently ill without homeopathy?
Are they switching to more expensive conventional drugs?
I currently spend much of my time in France and cannot say that I have noticed any of this. On the contrary, most people I talk to are delighted that homeopathy is no longer reimbursed. But this is no evidence, of course. I am unable to find any reliable data to answer the above questions.
When the French health minister decided against homeopathy two years ago, she said: “It’s possible to leave the doctor’s office without a prescription! Let’s take advantage of this debate on homeopathy to reflect more broadly on our use of medicine. The ultimate goal is to consume less.” She was correct, it seems.
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.
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.
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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:
- The current evidence on acupuncture for oligoasthenozoospermia is inadequate to draw a solid conclusion due to the poor methodological quality. Rigorous full-scale RCTs are needed to validate the therapeutic efficacy and safety of acupuncture in treating oligoasthenozoospermia.
- The current evidence showing that acupuncture might improve poor semen quality is insufficient because of the small number of studies, inadequacy of procedures and/or insufficient information for semen analysis, high levels of heterogeneity, high risk of bias, and poor quality of reporting. Further large, well-designed RCTs are required.
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.
