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

bias

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I reported about the activities of Eurocam before (see here) and I was distinctly underwhelmed with this quackery lobby group. Now they have published a press release about a ‘worldwide declaration’ in favor of integrated medicine. Here is my translation of the press release (I will comment on the actual declaration at a later stage):

With a declaration, Eurocam and the European Federation of Homeopathic Patient’s Association, among others, call for an open scientific discourse, more research funds, and more promotion of young researchers in the field of integrative medicine. The declaration is supported by the German Central Association of Homeopathic Physicians and the Homeopathy Research Institute (HRI), among others. Integrative medicine combines conventional and complementary elements in health care for the benefit of patients. The goal is patient-centred and holistic health care. Already 130 organisations have committed themselves to these goals in the medical care of the population in the Declaration.

Integrative medicine integrates complementary and conventional methods

In addition, the Declaration advocates health care that takes the whole person into account in its psychological, mental, social and spiritual dimensions. Integrative medicine in the sense of the Declaration is patient-centred and supports the body’s own regulatory abilities. In addition, it is participatory and respects individual decisions with regard to medical care. It is committed to the evidence of medical procedures, which is based on experience, patient preferences and research findings. It incorporates cultural diversity and regional differences as well as the concepts of community health and planetary health. Integrative medicine uses natural and sustainable resources and integrates complementary and conventional medical procedures.

Integrative medicine: Opportunities especially for chronic diseases and side effects

The supporters of the Declaration see opportunities for integrative medicine above all in chronic and non-communicable diseases, as well as in the frequent side effects of conventional therapies and increasing antibiotic resistance. Conventional medicine is characterised by fragmentation and divisional thinking within medical care, as well as by the increasing specialisation of the health professions. The holistic view of the patient is thus left out. Against this backdrop, the Declaration advocates anchoring integrative medicine as a legal entitlement in health care and integrating it into national health care systems. International training standards should be adapted with integrative medicine in mind, and research projects should be promoted. At the same time, balanced and high-quality patient information is needed.

________________________________

This press release requires a few short comments, in my view:

  • “Integrative medicine combines conventional and complementary elements in health care for the benefit of patients.” Anyone who cares to research for longer than 10 minutes will find that very often the complementary elements are unproven and disproven treatments.
  • “The goal is patient-centred and holistic health care.” By integrating unproven and disproven treatments into routine care, medicine cannot become more patient-centred but must get less effective and more expensive.
  • “The Declaration advocates health care that takes the whole person into account in its psychological, mental, social and spiritual dimensions.” Any good healthcare aims at doing this.
  • “Individual decisions with regard to medical care” are respected in all forms of healthcare.
  • “Side effects of conventional therapies and increasing antibiotic resistance” are regrettable phenomena and much research is going on to minimize them. So-called alternative medicine (SCAM) has not yet been shown to offer a single solution to these problems.
  • “The holistic view of the patient is left out” in conventional medicine. One of the most popular fallacies with SCAM advocates is the strawman fallacy.

I find the text almost comical. It reveals thought processes that lack even the most fundamental rules of logic. One really does get the impression that it had been written by people who are deplorably naive, misinformed, and quite frankly stupid.

 

All healthcare professionals have an ethical obligation to be truthful and act in the best interest of the patient by adhering to the best available evidence. Providing false or misleading information to patients or consumers is thus a breach of medical ethics. In Canada, the authorities have started taking action against nurses that violate these ethical principles.

Now it has been reported that a former registered nurse in West Kelowna has been suspended for four weeks after giving a vulnerable client anti-vaccine information and recommending “alternative pseudoscience” treatments.

According to the terms of a consent agreement posted on the B.C. College of Nurses and Midwives site, Carole Garfield was under investigation for actions that happened in September 2021. The college claims that Garfield contacted the client when she was off duty, using her personal mobile phone and email to give information against the COVID-19 vaccine and recommending so-called alternative medicine (SCAM). The exact nature of the “pseudoscience modalities” Garfield recommended to the client was not listed in the college’s notice.

Garfield’s nursing licence was cancelled back in April, according to the college’s registry. It’s unclear how exactly the four-week suspension will be applied. In addition to her month-long suspension and a public reprimand, Garfield is not allowed to be the sole nurse on duty for six months. She will also be given education about ethics, boundaries, and client confidentiality, as well as the province’s professional nursing standards. “The inquiry committee is satisfied that the terms will protect the public,” read a statement from the college.

In my view, it is high time for professional bodies to act against healthcare professionals who issue misleading information to their patients. In the realm of so-called alternative medicine (SCAM), issuing false or misleading information is extremely common and causes untold harm. Such harm would be largely preventable if the professional bodies in charge would start acting responsibly in the best interest of patients. It is high time that they follow the Canadian example!

As numerous of my posts have demonstrated, chiropractic manipulations can cause severe adverse effects, including deaths. Several hundred have been documented in the medical literature. When discussing this fact with chiropractors, we either see denial or we hear the argument that such events are but extreme rarities. To the latter, I usually respond that, in the absence of a monitoring system, nobody can tell how often serious adverse events happen. The resply often is this:

You are mistaken because the Royal College of Chiropractors’ UK-based Chiropractic Patient Incident Reporting and Learning System (CPiRLS) monitors such events adequately. 

I have heard this so often that it is time, I feel, to have a look at CPiRLS. Here is what it says on the website:

CPiRLS is a secure website which allows chiropractors to view, submit and comment on patient safety incidents.

Access to CPiRLS

CPiRLS is currently open to all UK-based chiropractors, all ECU members and members of the Chiropractic and Osteopathic College of Australasia. To access the secure area of the CPiRLS website, please click the icon below and insert the relevant CPiRLS username and password when prompted.

In the UK, these can normally be found on your Royal College of Chiropractors’ membership card unless the details are changed mid-year. Alternatively, email admin@rcc-uk.org from your usual email address and we will forward the details.

Alternatively, in the UK and overseas, secure access details can be obtained from your professional association.

National associations and organisations wishing to use CPiRLS, or obtain trial access to the full site for evaluation purposes, should contact The Royal College of Chiropractors at chiefexec@rcc-uk.org

Please click the icon below to visit the CPiRLS site.

Yes, you understood correctly. The public cannot access CPiRLS! When I click on the icon, I get this:

Welcome to CPiRLS

CPiRLS, The Chiropractic Patient Incident Reporting and Learning System – is an online reporting and learning forum that enables chiropractors to share and comment on patient safety incidents.

The essential details of submitted reports are published on this website for all chiropractors to view and add comments. A CPiRLS team identifies trends among submitted reports in order to provide feedback for the profession. Sharing information in this way helps to ensure the whole profession learns from the collective experience in the interests of patients.

All chiropractors are encouraged to adopt incident reporting as part of a blame-free culture of safety, and a routine risk management tool.

CPiRLS is secure and anonymous. There is no known way that anyone reporting can be identified, nor do those running the system seek to identify you. For this security to be effective, you require a password to participate.

Please note that reporting to CPiRLS is NOT a substitute for the reporting of patient safety incidents to your professional association and/or indemnity insurers.

So, how useful is CPiRLS?

Can we get any information from CPiRLS about the incidence of adverse effects?

No!

Do we know how many strokes or deaths have been reported?

No!

Can chiropractors get reliable information from CPiRLS about the incidence of adverse effects?

No, because reporting is not mandatory and the number of reports cannot relate to incidence.

Are chiropractors likely to report adverse effects?

No, because they have no incentive and might even feel that it would give their profession a bad name.

Is CPiRLS transparent?

No!

Is CPiRLS akin to postmarketing surveillance as it exists in conventional medicine?

No!

How useful is CPiRLS?

I think I let my readers answer this question.

 

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.”

According to the authors of this study, research is lacking regarding osteopathic approaches in treating polycystic ovary syndrome (PCOS), one of the prevailing endocrine abnormalities in reproductive-aged women. Limited movement of pelvic organs can result in functional and structural deficits, which can be resolved by applying visceral manipulation (VM). Already with these two introductory sentences, I have problems. But for the moment, we can leave this aside and have a look at their trial.

The study was aimed at analyzing the effect of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.

Thirty Egyptian women with PCOS, with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, prospectively participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group received the same hypocaloric diet plus VM to the pelvic organs and their related structures, according to assessment findings, for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months of treatments.

A total of 30 patients were included, with baseline mean age, weight, BMI, and menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.

The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.

VM involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) mostly from outside the body, but sometimes, the therapist also puts his/her fingers into the patient’s vagina. It was developed by the osteopath Jean-Piere Barral. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations. According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone, and motion of the viscera and their connective tissues. The idea is that these gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.

I don’t see any reason to believe the concepts of VM are plausible. Thus I find the hypothesis of this trial extremely far-fetched. The results are equally unconvincing. As we have often discussed, the ‘A+B vs B’ design cannot prove a causal relationship between the intervention and the outcome.

The most likely explanation for the findings is that the patients receiving VM experienced or merely reported improvements because the extra attention of mildly invasive treatments produced a powerful placebo effect. To put it bluntly: this is a poor, arguably unethical study where over-enthusiastic researchers reach a conclusion that is not supported by the data.

In Austria, even some of the most blatant quackery continues to be supported by the country’s medical association. This has been notorious for a very long time, and many rational doctors have opposed this nonsense. Now my friends and colleagues have courageously sent an open letter to the President of the Austrian Medical Association. In order to support their efforts, I have taken the liberty of translating it:

Dr. Johannes Steinhart
President of the Austrian Medical Association
Weihburggasse 10-12
1010 Vienna

 

Dear President Steinhart,

 

In 2014 we founded the “Initiative for Scientific Medicine” with the aim of counteracting the support of pseudo-medicine by medical associations and the Ministry of Health.

We (www.initiative-wissenschaftliche-medizin.at) have been demanding for years that the Austrian Medical Association distance itself from irrational, predominantly esoteric pseudo-medicine and refrain from awarding diplomas in them. We also made these demands on behalf of the supporters of the initiative (currently 1142 supporters, of which 495 are female doctors and 230 natural scientists) during a discussion with the former president Wechselberger in 2015 (unfortunately unsuccessful at the time).

We would like to draw your attention to a resolution of the German Medical Congress 2022 on homeopathy and a court ruling in the first instance in Germany on the subject of bioresonance, which show that our neighbours have obviously begun to treat pseudomedicine for what it is, namely sham medicine.

The 126th German Medical Congress 2022 in Bremen has, among other things, passed a long overdue resolution. The additional title “homeopathy” was deleted from the (model) further training regulations. Prior to this decision, 12 of 17 state medical associations had already taken this decision themselves.

In May 2022 in Reutlingen, two managing directors of a company producing and selling bioresonance devices were sentenced to 2 and 3 years in prison and a fine of 2.5 million euros, and the former sales director to 90 days’ imprisonment for commercial fraud and violation of the Therapeutic Products Advertising Act. The verdict is not yet legally binding. Unfortunately, many Austrian doctors also practice this pseudo-medicine method.

The fact that many colleagues offer esoteric, pseudo-medical “therapies” without proven benefits to their patients and can refer to diplomas and accredited further training courses of the Medical Association/Academy of Physicians is difficult for us to understand, especially in view of the fact that the majority of the accredited further training courses are of high scientific quality. A medical association that argues that such pseudo-medical practices “should better remain in the hands of doctors (as “healers”)” contradicts the principles of evidence-based medicine to which the medical association always refers. The corona pandemic has shown us all the damage potential of science denial.

We believe that the time has also come for the Austrian Medical Association to come clean. We call on the Austrian Medical Association to unreservedly declare its support for scientific medicine, to clearly distance itself from pseudo-medicine, to suspend the awarding of diplomas in pseudo-medicine methods that are far removed from science, and to end the accreditation of pseudo-medicine training courses by the Medical Academy.

We are publishing this open letter on our website and will also publish your reply if you so wish.

 

With collegial greetings

Dr. Theodor Much, Specialist in Dermatology and Venereology, Baden near Vienna
DDr. Viktor Weisshäupl, retired specialist in anaesthesiology and intensive care medicine, Vienna

DIARALIA is a homeopathic remedy for the symptomatic treatment of acute transient diarrhea. It is produced by Boiron, the world’s largest manufacturer of homeopathic remedies. This is how it is currently advertised:

Instructions DIARALIA

Dosage DIARALIA

Adults and children from 6 years

Lozenge 1, 4 to 6 times a day, for a maximum of three days of treatment.
Discontinue treatment as soon as symptoms disappear.

Method and route of administration DIARALIA
Sublingual (tablet to dissolve under the tongue)
In children 18 months to 6 years: dissolve the tablet in a little water before use, because of the risk of aspiration. As soon as the permitted age, dissolve the tablets under the tongue.

Duration of treatment DIARALIA
The duration of treatment should not exceed one week.

In case of overdose DIARALIA

If you have taken more DIARALIA orodispersible tablets that you don” should have:

Consult your doctor or pharmacist immediately.
In case of failure of one or more doses of DIARALIA

If you miss a dose of DIARALIA orodispersible tablets:

Do not take a double dose to make up for the dose that you forgot to take

Pregnancy and lactation with DIARALIA
Ask your doctor or pharmacist before taking any medicine.

In the absence of experimental and clinical data, and as a precautionary measure, the use of this drug should be avoided during pregnancy and lactation.

Composition DIARALIA

Excipients with known effect: This medicinal product contains lactose,
Active substances:
For a 300 mg tablet
Arsenicum album 9CH 1mg
China rubra 5CH 1mg
Podophyllum peltatum 9 CH 1mg
Excipients: sucrose, lactose monohydrate, magnesium stearate

Cons-indication DIARALIA

N” Never use DIARALIA orodispersible tablets:
· In children under 18 months.
· If you are allergic (hypersensitive) to the active substances or to any of the ingredients in CORYZALIA orodispersible tablets.

Possible interactions with DIARALIA

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

This medication is to be taken between meals.

Adverse DIARALIA

Like all medicines, DIARALIA orodispersible tablets may cause side effects, although not everybody will not matter.
If you notice any side effects not listed in this leaflet, or if the side effects gets serious, please tell your doctor or pharmacist.

Storage conditions DIARALIA

Store at a temperature not exceeding 30 ° C

Precautions and warnings DIARALIA

This medication should not be used in case of vomiting, high fever, blood in the stool.
Any significant diarrhea exposed to the risk of dehydration requiring appropriate rehydration.
If diarrhea persists beyond 3 days, a medical consultation is necessary.
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine
Use of this medicine is not recommended in patients with galactose intolerance, a Lapp lactase deficiency or malabsorption syndrome glucose or galactose (rare hereditary diseases).

But is there any evidence that DIARALIA works?

I’m glad you asked!

I looked far and wide but found none (if a reader knows of a clinical trial, please let me know).

Jenifer Jacobs (JJ) published a review of 3 studies – all her own! – and concluded that the results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness. So, some homeopathy fans might claim there is good evidence. But I dispute that.

We all know, of course, that diarrhea can be a symptom of a range of serious conditions. Thus, one should not joke about it. On the contrary, one should diagnose the reason for the symptom and treat it adequately.  And one should certainly not advertise unproven treatments for it; one could even go one step further and claim that anyone who does that is fraudulently endangering the health of the often all too gullible consumer.

Trevor Zierke is a D.C. who published several videos that have gone viral after saying that “literally 99% of my profession” is a scam. “When I say almost all the usual lines chiropractors tell you are lies, I mean almost all of them,” he stated. Zierke then went on to give examples of issues chiropractors allegedly make up, including someone’s spine being “misaligned,” tension on nerves causing health problems, and someone having back pain because their hips are off-center. “Almost all of these aren’t true,” he concluded.

In a follow-up video, he claimed that the reasons most people are told they need to go to a chiropractor are “overblown or just flat out lies proven wrong by research.” He also noted that, while there are many scams, that “doesn’t mean you can’t get help from a chiropractor.”

In a third TikTok video, Zierke offered some valid reasons to see a chiropractor. He said that one can seek help from a chiropractor if one has musculoskeletal pain that has been ongoing for more than one to two days, and that’s about it. He stated that issues that a chiropractor couldn’t really fix include “GI pain, hormonal issues, nutrition,” among others.

In comments, users were largely supportive of Zierke’s message.

One said: “As a physiotherapist, I’ve been trying to tell this but I don’t want to like offend any chiropractor in doing so,” a commenter shared.

“Working in a chiropractic office, this is fair,” a further user wrote. “I have issues that I know an adjustment will help & other pain that would be better stretched/released.”

In an email, Zierke reiterated the intention of his videos: “I would just like to clarify that chiropractors, in general, are not a scam or are inherently scammers (I myself am a practicing chiropractor), but rather a lot of very popular sales tactics, phrases, and wording used to imply patients need treatment, and methods of treatment, have never been proven to be true,” he explained. “When chiropractors say & use these methods stating things that are not factually true—I believe it’s scammy behavior and practices. There are still a lot of very good, honest, and integral chiropractors out there,” he concluded. “They can provide a lot of help and relief to patients. But that’s unfortunately not the majority, and I’ve heard too many stories of people falling victim to some of these scam-like tactics from bad apple chiropractors.”

None of what DC Zierke said can surprise those who have been following my blog. On the contrary, I could add a few recent posts to his criticism of chiropractic, for example:

I rest my case.

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!

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.

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