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

scientific misconduct

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In the realm of so-called alternative medicine (SCAM), we see a lot of papers that are bizarre to the point of being disturbing and often dangerous nonsense. Yesterday, I came across an article that fits this bill well; in fact, I have not seen such misleading BS for quite a while. Let me present to you the abstract of this paper:

Introduction

There has been accumulating interest in the application of biofield therapy as complementary and alternative medicine (CAM) to treat various diseases. The practices include reiki, qigong, blessing, prayer, distant healing, known as biofield therapies. This paper aims to state scientific knowledge on preclinical and clinical studies to validate its potential use as an alternative medicine in the clinic. It also provides a more in-depth context for understanding the potential role of quantum entanglement in the effect of biofield energy therapy.

Content

A comprehensive literature search was performed using the different databases (PubMed, Scopus, Medline, etc.). The published English articles relevant to the scope of this review were considered. The review gathered 45 papers that were considered suitable for the purpose. Based on the results of these papers, it was concluded that biofield energy therapy was effective in treating different disease symptoms in preclinical and clinical studies.

Summary

Biofield therapies offer therapeutic benefits for different human health disorders, and can be used as alternative medicine in clinics for the medically pluralistic world due to the growing interest in CAM worldwide.

Outlook

The effects of the biofield energy therapies are observed due to the healer’s quantum thinking, and transmission of the quantum energy to the subject leads to the healing that occurs spiritually through instantaneous communication at the quantum level via quantum entanglement.

The authors of this article are affiliated with Trivedi Global, an organisation that states this about ‘biofield energy’:

Human Biofield EBnergy has subtle energy that has the capacity to work in an effective manner. This energy can be harnessed and transmitted by the gifted into living and non-living things via the process of a Biofield Energy Healing Treatment or Therapy.

If they aleady know that “Biofield EBnergy has subtle energy that has the capacity to work in an effective manner”, I wonder why they felt the need to conduct this review. Even more wonderous is the fact that their review showed such a positive result.

How did they manage this?

The answer might lie in their methodology: they “gathered 45 papers that were considered suitable”. While scientists gather the totality of the available evidence (and assess it critically), they merely selected what was suitable for the purpose of generating a positive result. This must be the reason our two studies on the subject were discretely omitted:

Our 1st study

Purpose: Distant healing, a treatment that is transmitted by a healer to a patient at another location, is widely used, although good scientific evidence of its efficacy is sparse. This trial was aimed at assessing the efficacy of one form of distant healing on common skin warts.

Subjects and methods: A total of 84 patients with warts were randomly assigned either to a group that received 6 weeks of distant healing by one of 10 experienced healers or to a control group that received a similar preliminary assessment but no distant healing. The primary outcomes were the number of warts and their mean size at the end of the treatment period. Secondary outcomes were the change in Hospital Anxiety and Depression Scale and patients’ subjective experiences. Both the patients and the evaluator were blinded to group assignment.

Results: The baseline characteristics of the patients were similar in the distant healing (n = 41) and control groups (n = 43). The mean number and size of warts per person did not change significantly during the study. The number of warts increased by 0.2 in the healing group and decreased by 1.1 in the control group (difference [healing to control] = -1.3; 95% confidence interval = -1.0 to 3.6, P = 0.25). Six patients in the distant healing group and 8 in the control group reported a subjective improvement (P = 0.63). There were no significant between-group differences in the depression and anxiety scores.

Conclusion: Distant healing from experienced healers had no effect on the number or size of patients’ warts.

Our 2nd study

Spiritual healing is a popular complementary and alternative therapy; in the UK almost 13000 members are registered in nine separate healing organisations. The present randomized clinical trial was designed to investigate the efficacy of healing in the treatment of chronic pain. One hundred and twenty patients suffering from chronic pain, predominantly of neuropathic and nociceptive origin resistant to conventional treatments, were recruited from a Pain Management Clinic. The trial had two parts: face-to-face healing or simulated face-to-face healing for 30 min per week for 8 weeks (part I); and distant healing or no healing for 30 min per week for 8 weeks (part II). The McGill Pain Questionnaire was pre-defined as the primary outcome measure, and sample size was calculated to detect a difference of 8 units on the total pain rating index of this instrument after 8 weeks of healing. VASs for pain, SF36, HAD scale, MYMOP and patient subjective experiences at week 8 were employed as secondary outcome measures. Data from all patients who reached the pre-defined mid-point of 4 weeks (50 subjects in part I and 55 subjects in part II) were included in the analysis. Two baseline measurements of outcome measures were made, 3 weeks apart, and no significant differences were observed between them. After eight sessions there were significant decreases from baseline in McGill Pain Questionnaire total pain rating index score for both groups in part I and for the control group in part II. However, there were no statistically significant differences between healing and control groups in either part. In part I the primary outcome measure decreased from 32.8 (95% CI 28.5-37.0) to 23.3 (16.8-29.7) in the healing group and from 33.1 (27.2-38.9) to 26.1 (19.3-32.9) in the simulated healing group. In part II it changed from 29.6 (24.8-34.4) to 24.0 (18.7-29.4) in the distant healing group and from 31.0 (25.8-36.2) to 21.0 (15.7-26.2) in the no healing group. Subjects in healing groups in both parts I and II reported significantly more ‘unusual experiences’ during the sessions, but the clinical relevance of this is unclear. It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.

In addition, they, of course, also omitted many further studies by other investigators that failed to be positive. Considering this amount of cherry-picking, it is easy to understand how they arrived at their conclusion. It is all a question of chosing the right methodology!

A few decades ago, the cigarette industry employed this technique to show that smoking did not cause cancer! Luckily, we have since moved away from such pseudo-scientific ‘research’ – except, of course, in the realm of SCAM where it is still hughely popular.

In recent weeks and months, I have been thinking quite a lot about the various types of scientists. This is partly due to me finishing a book entitled: Bizarre Medical Ideas: … and the Strange Men Who Invented Them. Partly it is related to the sorry tale of the GWUP that I have been boring you with repeatedly here. As a consequence of my contemplations, I have added more categories to the usual two types of scientists.

1. SCIENTIST

Scientists gather information through observation and experimentation, formulate hypothesis, and then test them. They work in vastly different areas but have certain attitudes or qualities in common, e.g. critial thinking and an open mind. As scientists tend to publish their findings, a very simple (but not fool-proof) way to identify a scinetist is to look him/her up, for example by finding his/her H-Index. (The H-Index is defined as the maximum value of h such that the given author/journal has published at least h papers that have each been cited at least h times. For instance, if someone has 10 papers that were cited 10 times, his H-Index would be 10. If another scientist has 50 papers that were cited 50 times, his H-Index would be 50.)

2. PSEUDO-SCIENTIST

Pseudo-scientists are people who pretend to produce science but, in fact, they generate pseudoscience. The demarkation of pseudo-science from science is sometimes difficult, as we have seen several times on this blog, e.g.:

The pseudo-scientist does have no or just a few publications in the peer-reviewed literature and no H-Index to speak of.

3. WOULD-BE SCIENTIST

The term ‘would-be scientist’ is not one that is commonly used, nor is it one that has an accepted definition. The way I see it, would-be scientists are aspiring to become scientist. They are on the way to become a scientist but have not quite arrived yet. To the would-be scientist I say: good luck to you; I hope you make it and I look forward to reading about your scientific achievements. The would-be scientist is, however, not the topic of my post.

4. THE PREDEND-SCIENTIST

The predent-scientist (PS) is the one who I want to focus on here. He – yes, the PS is usually male – talks a lot about science; so much so that outsiders would get the impression that he actually is a scientist. Crucially, the PS himself has managed to delude himself to the point where believes to be a scientist.

While scientists tend to be media-shy, the PS enjoys the limelight to generate the impression of being a scientist. He talks eloquently and at length about science. Much of what he says or writes might even be correct. The PS is often quite well-versed and knows (most of) his stuff.

The crucial difference between the PS and the scientist is that the PS produces no or very little science; neither does he intend to. To identify the PS, an easy (but not fool-proof) method is to him look up. Typically, he has published several articles in the popoular press or books for the lay public, but – as he does not conduct scientific research – he does not generate papers in the peer-reviewed scientific literature. This void, however, has never stopped the PS from appearing in the media speaking about science, nor from occupying prominent positions in the world of science, nor from avidly rubbing shoulders with scientists. Few people see anything wrong with that, mainly because the PS has convinced them (most importantly himself) that he actually is a scientist. While the scientist is trained in doing science, the PS is trained in talking about science.

Don’t get me wrong, the PS can have his merits. He often presents science to the public more or less accurately and frequently is rhetorically superior to the scientist. I nevertheless have reservations about the PS (and the recent pandemic has shown us how dangerous PSs can beome). The questions to ask ourselves are the following:

  • Does PS have a truly open mind?
  • Can he set aside ideologies?
  • Will he change his opinion vis a vis new evidence?
  • Is he prepared to consider criticism?
  • Does he avoid ‘black and white’ thinking?
  • Is he sufficiently humble?
  • Is he honest with himself and others?

These questions refer to important attitudes that scientists learn – often the hard way – while doing science. If someone lacks this experience, such attitudes are likely to be under-developed. Perhaps, it all boils down to honesty: if a man who has never done any amount of science to speak of has convinced himself to be a scientist, he arguably is dishonest with himself and the public.

In order to make my points as clearly as possible, I admittedly caricaturized the extremes of a wider spectrum; my appologies for that. In reality, the different types of scientists rarely exist as entirely pure forms. Frequently, people are mixtures of two types, either because they did different things during different periods of their lives, or because they simply are hybrids.

To provide a few examples, let me show you 14 H-Indices (according to ‘Google Scholar’) of people (in alphabetical order) who you might have heard of, for instance, because they have featured on my blog. I leave it up to you to decide how well they fit in any of my three categories and who might qualify to be a PS.

  1. Fabrizio Benedetti – H-Index = 83
  2. David Colquhoun – H-Index = 78
  3. Ian Chalmers – H-Index = 84
  4. Michael Dixon – H-Index = 0
  5. David Gorski – H-Index = 30
  6. Holm Hümmler – H-Index = 0
  7. Ted Kaptchuk – H-Index = 103
  8. Jos Kleinjen – H-Index = 104
  9. Andreas Michalsen – H-Index = 0
  10. Michael Mosely – H-Index = 0
  11. Dana Ullman – H-Index = 0
  12. Dale Thompson (alias DC) – H-Index = 0
  13. Chris van Tulleken – H-Index = 0
  14. Harald Walach – H-Index = 9

My conclusion: the PS, a person who presents himself as a scientist without having done any meaningful amount of science himself, is a man who is not entirely honest. The H-Index can be helpful for identifying PSs. An index of zero, for instance, seems to send out a fairly clear message. In the case low indices, it is advisable to go one step further and study the actual articles That mede up the index. However, the H-Index tells us nothing about whether someone presents himself as a scientist; this information must be gleaned from the person him(her)self.

 

 

 

According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).

The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.

After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.

The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.

It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.

One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.

Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.

 

 

There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.

A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.

43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).

The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.

Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:

  • 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
  • 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
  • 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
  • 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
  • 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.

Sadly, this assumption is evidently mistaken.

The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.

The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.

Clinical trials should be about contributing to our knowledge and not about contributing to confusion.

This pilot study is “delving into the potential benefits of Reiki therapy as a complementary intervention for the treatment and management of stress and anxiety”.

A total of 31 volunteers self-reporting stress, anxiety, or psychological disorders were enrolled. Health-related quality of life (HRQoL) was assessed using the 36-Item Short Form Health Survey (SF-36) Questionnaire for anxiety and depression. Pre- and post-treatment HRQoL scores were meticulously compared, and the significance of the disparities in these scores was meticulously computed.

Analysis was restricted to volunteers who completed the 3-day Reiki sessions. Statistically significant enhancements were discerned across all outcome measures, encompassing positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (P<0.0001).

The authors concluded that the constancy and extensive scope of these improvements suggest that Reiki therapy may not only address specific symptoms but also contribute significantly to a predominant escalation of mental and physical health.

This study is almost comical.

Amongst all the many forms of so-called alternative medicine (SCAM), Reiki is perhaps the most ridiculous scam. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy. It is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind. There is no scientific basis for such notions, and reiki is therefore not plausible.

Reiki is used for a number of conditions, including the relief of stress, tension and pain. There have been several clinical trials testing its effectiveness. Those that are rigorous fail to show that the treatment is effective – and those that are dripping with bias, like the one discussed here, tend to produce false-positive results.

The present study has many flaws that are too obvious to even mention. While reading it, I asked myself the following questions:

  • How could a respectable university ever allow this pseudo-research to go ahead?
  • How could a respectable ethics committee ever permit it?
  • How could a respectable journal ever publish it?

The answers must be that, quite evidently, they are not respectable.

 

Supportive care is often assumed to be beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. The authors of this study hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited.

The main objective of this study therefore was to show that anxiety could be reduced after a touch-massage performed by a nurse trained in this therapy.

A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks. They were randomized into either a group receiving 15-minute touch-massage sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks.

In the treated group, anxiety was assessed before and after each touch-massage session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session.

Sixty-two patients were randomized. Touch-massage significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant.

The authors concluded that this study provides convincing evidence for integrating touch-massage in the treatment of patients in sterile hematology unit.

I find this conclusion almost touching (pun intended). The wishful thinking of the amateur researchers is almost palpable.

Yes, I mean AMATEUR, despite the fact that, embarrassingly, the authors are affiliated with prestigeous institutions:

  • 1Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France.
  • 2Université Paris Est, EA4391 Therapeutic and Nervous Excitability, Creteil, F-93000, France.
  • 3Nantes Université, CHU Nantes, Hematology Department, Nantes, F-44000, France.
  • 4Nantes Université, CHU Nantes, CRCI2NA – INSERM UMR1307, CNRS UMR 6075, Equipe 12, Nantes, F-44000, France.
  • 5Institut Curie, Paris, France.
  • 6Université Paris Versailles Saint-Quentin, Versailles, France.
  • 7Nantes Université, CHU Nantes, Direction de la Recherche et l’Innovation, Coordination Générale des Soins, Nantes, F-44000, France.
  • 8Methodology and Biostatistics Unit, DRCI CHU Nantes CHD Vendée, La Roche Sur Yon, F-85000, France.
  • 9Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France. [email protected].

So, why do I feel that they must be amateurs?

  • Because, if they were not amateurs, they would know that a clinical trial should not aim to show something, but to test something.
  • Also, if they were not amateurs, they would know that perhaps the touch-massage itself had nothing to do with the outcome, but that the attention, sympathy and empathy of a therapist or a placebo effect can generate the observed effect.
  • Lastly, if they were not amateurs, they would not speak of convincing evidence based on a single, small, and flawed study.

This review aimed to investigate and categorize the causes and consequences of ‘quack medicine’ in the healthcare.

A scoping review, using the 5 stages of Arksey and O’Malley’s framework, was conducted to retrieve and analyze the literature. International databases including the PubMed, Scopus, Embase and Web of Science and also national Iranian databases were searched to find peer reviewed published literature in English and Persian languages. Grey literature was also included. Meta-Synthesis was applied to analyze the findings through an inductive approach.

Out of 3794 initially identified studies, 30 were selected for this review. Based on the findings of this research, the causes of quackery in the health were divided into six categories:

  • political,
  • economic,
  • socio-cultural,
  • technical-organizational,
  • legal,
  • and psychological.

Additionally, the consequences of this issue were classified into three categories:

  • health,
  • economic,
  • and social.

Economic and social factors were found to have the most significant impact on the prevalence of quackery in the health sector. Legal and technical-organizational factors played a crucial role in facilitating fraudulent practices, resulting in severe health consequences.

The authors concluded that it is evident that governing bodies and health systems must prioritize addressing economic and social factors in combating quackery in the health sector. Special attention should be paid to the issue of cultural development and community education to strengthen the mechanisms that lead to the society access to standard affordable services. Efforts should be made also to improve the efficiency of legislation, implementation and evaluation systems to effectively tackle this issue.

The authors point out that, in the health systems, particularly those of developing countries, a phenomenon known as “Quack Medicine” has been a persistent problem, causing harm in various branches of health care services. They define quackery as unproven or fraudulent medical practices that have no scientifically plausible rationale behind them. Someone who does not have professional qualification, formal registration from a legitimated institution, or required knowledge of a particular branch of medicine but practices in the field of medicine, is a quack, according to the authors’ definition. Finally, they define quack medicine as a fraudulent practice of quacks claiming to possess the ability and experience to diagnose and treat diseases, and pretending that the medicine or treatment they provide are effective, generally for personal and financial gain.

The authors rightly point out that, in some countries, there may be a lack of willpower, determination and effort among political leaders to deal with and prevent fraud and charlatanism in various fields, especially in the health system. This can be due to conflict of interests, corruption network, or insufficient infrastructure and resources, such as financial capacity and human resources. In some cases, they stress, policy makers may choose to tolerate small levels of unproven medical practices if the cost of prosecuting and correcting the situation outweigh the financial benefits. This can lead to a cycle of continued fraud and a lack of effective interventions to address the issue. In many countries laws against quack medicine do exist. However, their effectiveness depends on proper and strict implementation. More efforts and measures must be taken to implement the existing laws. Inadequate enforcement of laws and approval of pseudo-medicine can result in people receiving improper care.

The authors recommend that the healthcare systems, prioritize addressing economic and sociocultural factors in order to effectively combat this issue. In developing solutions, attention must be given to cultural development and community education, and efforts should be made to strengthen mechanisms that provide access to affordable, standard healthcare services for all. Lastly, it is crucial to enhance the performance of systems responsible for legislation, implementation and evaluation of laws and regulations related to quack medicine.

Craniosacral therapy (CST) is a widely taught component of osteopathic medical education. It is included in the standard curriculum of osteopathic medical schools, despite controversy surrounding its use. This paper seeks to systematically review randomized clinical trials (RCTs) assessing the clinical effectiveness of CST compared to standard care, sham treatment, or no treatment in adults and children.

A search of Embase, PubMed, and Scopus was conducted on 10/29/2023 with no restriction placed on the date of publication. Additionally, a Google Scholar search was conducted to capture grey literature. Backward citation searching was also implemented. All RCTs employing CST for any clinical outcome were included. Studies not available in English as well as any studies that did not report adequate data for inclusion in a meta-analysis were excluded. Multiple reviewers were used to assess for inclusions, disagreements were settled by consensus. PRISMA guidelines were followed in the reporting of this meta-analysis. Cochrane’s Risk of Bias 2 tool was used to assess for risk of bias. All data were extracted by multiple independent observers. Effect sizes were calculated using a Hedge’s G value (standardized mean difference) and aggregated using random effects models.

The primary study outcome was the effectiveness of CST for selected outcomes as applied to non-healthy adults or children and measured by standardized mean difference effect size. Twenty-four RCTs were included in the final meta-analysis with a total of 1,613 participants. When results were analyzed by primary outcome, no significant effects were found. When secondary outcomes were included, results showed that only Neonate health, structure (g = 0.66, 95% CI [0.30; 1.02], Prediction Interval [-0.73; 2.05]) and Pain, chronic somatic (g = 0.34, 95% CI [0.18; 0.50], Prediction Interval [-0.41; 1.09]) showed statistically significant effects. However, wide prediction intervals and high bias limit the real-world implications of this finding.

The authors concluded that CST did not demonstrate broad significance in this meta-analysis, suggesting limited usefulness in patient care for a wide range of indications.

To this, one should perhaps add that CST is one of those forms of so-called alternative medicine (SCAM) that is utterly implausible; there is not conceivable mechanism by which CST might work other than a placebo effects. Therefore, the finding that it is ineffective (positive effects on secondary outcomes are most likely due to residual bias and possibly fraud) is hardly surprising. The most sensible conclusion, in my view, is that CST too ridiculous to merit further research because that would, in effect, be an unethical waste of resources.

He came to my attention via the sad story recently featured here about patients allegedly being harmed or killed in a Swiss hospital for so-called alternative medicine (SCAM). What I then learned about the doctor in charge of this place fascinated me:

Rau states about himself (my translation):

Early on, Dr Rau focused on natural therapies, in particular homeopathy and dietary changes. The healing success of his patients proved him right, so he studied alternative healing methods with leading practitioners. These included orthomolecular medicine, Chinese and Ayurvedic medicine and European holistic medicine. With his wealth of knowledge and over 30 years of experience, Dr Rau formed his own holistic theory of healing: Swiss Biological Medicine – Dr Rau’s Biological Medicine. It is based on the principles of detoxification, nutrition, digestion and sustainable strengthening of the immune system.

Career & studies:

  • Medical studies at the University of Bern
  • Final medical examinations in Switzerland and the USA
  • Subsequent work in rheumatology, internal and general medicine
  • Member of the Swiss Medical Association FMH since 1981
  • 1981 to 1992 conventional physician & medical director of a Swiss spa centre for rheumatology and rehabilitation medicine
  • 1983 to 1992 Doctor at a drug rehabilitation centre
  • 1992 to 2019 Establishment of the Paracelsus Clinic Lustmühle as medical director and partner
  • until 2020 Head of the academic network and training organisation “Paracelsus Academy”

Rau also states this:

  • 2019 mit dem Honorarprofessoren-Titel von der Europäischen Universität in Wien ausgezeichnet (2019, he was awarded the title of homorary professor at the European University in Vienna)

This puzzles me because there is no such institution as the ‘Europäische Universität in Wien’. There is a Central European University but this can hadly be it?!

Now, I am intrigued and see what the ‘honorary professor’ might have published. Sadly, there seems to be nothing on Medline except 2 interviews. In one interview, Rau explains (amongst other things) ‘live blood analysis’, a method that we have repeatedly discussed before (for instance, here and here):

Darkfield microscopy shows a lot. We take 1 drop of blood and look at it under a very large-scale magnification. The blood is life under the glass. Once it’s on the glass, there isn’t oxygen or light or heat. This is a giant stress for the blood. So we see how, over a time, the blood reacts to this stress, and how the blood cells tolerate the stress. You can see the changes. So we take a drop of blood that represents the organism and put it under stress and look at how the cells react to the stress, and then we can see the tolerance and the resistiveness of these cells. Do they have a good cell-membrane face? Do they have good energetic behavior? Do they clot together? Is there a chance for degenerative diseases? Is there a cancerous tendency in this blood? We see tendencies. And that’s what we are interested in, tendencies.

Question: If you saw a cancerous tendency, what would that look like?

Rau: Cancerous tendency is a change in the cells. They get rigid, so to say. They don’t react very well.

Question: And how long does blood live outside the body?

Rau: It can live for several days. But after 1 hour, the blood is already seriously changed. For example, a leukemia patient came to my clinic for another disease. But when we did darkfield, I found the leukemia. We saw that his white blood cells were atypical. Look at this slide—the fact that there are so many white blood cells together is absolutely unusual, and the fact that there are atypical white blood cells. This shows me that the patient has myeloid leukemia. The patient had been diagnosed as having rheumatoid lung pain, but it was absolutely not true. The real cause of his pain was an infiltration of the spinal bone by these lymphocytes.

This is, of course, complete nonsense. As I explained in my blog post, live blood analysis (LBA) is not plausible and there is no evidence to support the claims made for it. It also is by no means new; using his lately developed microscope, Antony van Leeuwenhoek observed in 1686 that living blood cells changed shape during circulation. Ever since, doctors, scientists and others have studied blood samples in this and many other ways.

New, however, is what today’s SCAM practitioners claim to be able to do with LBA. Proponents believe that the method provides information about the state of the immune system, possible vitamin deficiencies, amount of toxicity, pH and mineral imbalance, areas of concern and weaknesses, fungus and yeast infections, as well as just about everything else you can imagine.

LBA is likely to produce false-positive and false-negative diagnoses. A false-positive diagnosis is a condition which the patient does not truly have. This means she will receive treatments that are not necessary, potentially harmful and financially wasteful. A false-negative diagnosis would mean that the patient is told she is healthy, while in fact she is not. This can cost valuable time to start an effective therapy and, in extreme cases, it would hasten the death of that patient. The conclusion is thus clear: LBA is an ineffective, potentially dangerous diagnostic method for exploiting gullible consumers. My advice is to avoid practitioners who employ this technique.

And what does that say about ‘honorary professor’ Rau?

I think I let you answer that question yourself.

 

So-called alternative medicine (SCAM) interventions are often being discussed as possible treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This review aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review.

A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.

A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from neuropsychiatric disorders, olfactory dysfunction, cognitive impairment, fatigue, breathlessness, and mild-to-moderate lung fibrosis. The main interventions reported were self-administered transcutaneous auricular vagus nerve stimulation, neuro-meditation, dietary supplements, olfactory training, aromatherapy, inspiratory muscle training, concurrent training, and an online breathing and well-being program.

The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on SCAM for long COVID are warranted in the future.

The review’s aim is, in my view, nonsense. SCAM is a diverse field which means that the review must capture a wide range of therapies each represented by just one or two primary studies. In turn, this means that general conclusions across all SCAM will be highly questionable, if not misleading.

Furthermore, I find these conclusions odd and irresponsibly misleading. My main reason for this is the poor methodological quality of the primary studies:

  • Four trials were considered to have unknown bias risk for generating the random sequence due to insufficient information about the specific method of randomization used.
  • Only 5 of the trials provided appropriate random allocation concealment.
  • Only 5 trials were blinded to both participants and personnel.
  •  Three trials were rated as unknown risk of bias since insufficient information was provided.
  • Four trials failed to performed outcome assessment blinding.
  • One trial did not report detailed information about drop-out cases and was defined as high risk of bias. 
  • Three study protocols were unavailable and had relevant outcomes that were not reported in the pre-specified way.

Moreover, safety cannot possibly be reliably estimated on the basis of the data. And finally, the statement that SCAM interventions may be effective, as the authors put it, is in my view not a valid conclusion but a silly platitude.

I therefore suggest to re-formulate the conclusion of this review as follows:

At present there is no sound evidence to assume that any SCAM intervention is effective in the management of long COVID.

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