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

scientific misconduct

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The London-based ‘International Federation of Aromatherapists‘ claims that:

medical research has now recognised that emotional support is vital in maintaining good mental health. Wellbeing needs to encourage pleasant emotions of contentment and calmness, enabling feelings of relaxation, inner peace and feelings of optimism.

The simple act of caring touch (massage) using essential oils is a highly effective way to target symptoms of stress and anxiety and the following are a list of some of the most effective:

• Clary sage (Salvia sclarea)
• Neroli (Citrus aurantium var amara flos)
• Lavender (Lavandula angustifolia)
• Roman Chamomile (Chamaemelum nobile)
• Rose (Rosa damascena)
• Ylang ylang (Cananga odorata)
• Sweet orange (Citrus sinensis)
• Mandarin (Citrus nobilis)
• Petitgrain (Citrus aurantium var amara fol)
• Geranium (Pelargonium graveolens)
• Frankincense (Boswellia sacra)

“Caring touch using essential oils is a highly effective way to target symptoms of stress and anxiety”? And what about the list of the “most effective oils”? I concucted a few ‘rough and ready’ Medline searches and fear that there are some corrections in order.

  • Clary sage (Salvia sclarea): no sound evidence for the the above claims.
  • Neroli (Citrus aurantium var amara flos): only very limited evidence for the above claims.
  • Lavender (Lavandula angustifolia): limited evidence exists (e.g. here).
  • Roman Chamomile (Chamaemelum nobile): limited evidence exists (e.g. here).
  • Rose (Rosa damascena): limited evidence exists (e.g.here).
  • Ylang ylang (Cananga odorata): limited evidence exists (e.g. here).
  • Sweet orange (Citrus sinensis): very limited evidence exists (e.g. here).
  • Mandarin (Citrus nobilis): the only study I found was negative.
  • Petitgrain (Citrus aurantium var amara fol): no sound evidence for the the above claims.
  • Geranium (Pelargonium graveolens): no sound evidence for the the above claims.
  • Frankincense (Boswellia sacra): no sound evidence for the the above claims.

So, for once there actually is some (albeit not convincing) evidence which should be good news for fans of aromatherapy/essential oils.

Why then does the International Federation of Aromatherapists not just go with the existing evidence?

Why do they claim things that are not true?

Why do they bring aromatherapy in more than necessary disrepute?

But perhaps they can prove my review of the evidence to be incomplete and can add convincing trial data to it?

Watch this space.

 

As pointed out previously on this blog, unethical research practices are prevalent in China, but little research has focused on the causes of these practices.

Drawing on the criminology literature on organisational deviance, as well as the concept of cengceng jiama, which illustrates the increase of pressure in the process of policy implementation within a top-down bureaucratic hierarchy, this article develops an institutional analysis of research misconduct in Chinese universities. It examines both universities and the policy environment of Chinese universities as contexts for research misconduct. Specifically, this article focuses on China’s Double First-Class University Initiative and its impact on elite universities that respond to the policy by generating new incentive structures to promote research quality and productivity as well as granting faculties and departments greater flexibility in terms of setting high promotion criteria concerning research productivity. This generates enormous institutional tensions and strains, encouraging and sometimes even compelling individual researchers who wish to survive to decouple their daily research activities from ethical research norms. The article is written based on empirical data collected from three elite universities as well as a review of policy documents, universities’ internal documents, and news articles.

The interviewer, sociologist Zhang Xinqu, and his colleague Wang Peng, a criminologist, both at the University of Hong Kong, suggest that researchers felt compelled, and even encouraged, to engage in misconduct to protect their jobs. This pressure, they conclude, ultimately came from a Chinese programme to create globally recognized universities. The programme prompted some Chinese institutions to set ambitious publishing targets, they say. In 2015, the Chinese government introduced the Double First-Class Initiative to establish “world-class” universities and disciplines. Universities selected for inclusion in the programme receive extra funding, whereas those that perform poorly risk being delisted, says Wang.

Between May 2021 and April 2022, Zhang conducted anonymous virtual interviews with 30 faculty members and 5 students in the natural sciences at three of these elite universities. The interviewees included a president, deans and department heads. The researchers also analysed internal university documents.

The university decision-makers who were interviewed at all three institutes said they understood it to be their responsibility to interpret the goals of the Double First-Class scheme. They determined that, to remain on the programme, their universities needed to increase their standing in international rankings — and that, for that to happen, their researchers needed to publish more articles in international journals indexed in databases such as the Science Citation Index. As the directive moved down the institutional hierarchy, pressure to perform at those institutes increased. University departments set specific and hard-to-reach publishing criteria for academics to gain promotion and tenure. Some researchers admitted to engaging in unethical research practices for fear of losing their jobs. In one interview, a faculty head said: “If anyone cannot meet the criteria [concerning publications], I suggest that they leave as soon as possible.”

Zhang and Wang describe researchers using services to write their papers for them, falsifying data, plagiarizing, exploiting students without offering authorship and bribing journal editors. One interviewee admitted to paying for access to a data set. “I bought access to an official archive and altered the data to support my hypotheses.” An associate dean emphasized the primacy of the publishing goal. “We should not be overly stringent in identifying and punishing research misconduct, as it hinders our scholars’ research efficiency.”

The larger problem, says Xiaotian Chen, a library and information scientist at Bradley University in Peoria, Illinois, is a lack of transparency and of systems to detect and deter misconduct in China. Most people do the right thing, despite the pressure to publish, says Chen, who has studied research misconduct in China. The pressure described in the paper could just be “an excuse to cheat”.

_________________________

It is hard not to be reminded of what I reported in a recent post where it has been announced that a Chinese acupuncture review was retracted:

The research “Acupuncture for low back and/or pelvic pain during pregnancy: a systematic review and meta-analysis of randomised controlled trials,” published in the open access journal BMJ Open in 2022, has been retracted.

This research was press released in November 2022 under the title of “Acupuncture can relieve lower back/pelvic pain often experienced during pregnancy.”

Following publication of the research, various issues concerning its design and reporting methods came to light, none of which was amenable to correction, prompting the decision to retract.

The full wording of the retraction notice, which will be published at 23.30 hours UK (BST) time Tuesday 11 June 2024, is set out below:

“After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.” doi:10.1136/bmjopen-2021-056878ret

Please ensure that you no longer cite this research in any future reporting.

____________________________

After studying Chinese TCM papers for more than 30 years, I feel increasingly concerned about the tsumani of either very poor quality or fabricated research coming out of China. For more details, please read the following posts:

 

 

Due to the unclear risk level of adverse events (AEs) associated with high-velocity, low-amplitude (HVLA) cervical manipulation, the aim of this study was to extract available information from randomized clinical trials (RCTs) and thereby synthesize the comparative risk of AEs following cervical manipulation to that of various control interventions.

 A systematic literature search was conducted in the PubMed and Cochrane databases. This search included RCTs in which cervical HVLA manipulations were applied and AEs were reported. Two independent reviewers performed the study selection, the methodological quality assessment, and the GRADE approach. Incidence rate ratios (IRR) were calculated. The study quality was assessed by using the risk of bias 2 (RoB-2) tool, and the certainty of evidence was determined by using the GRADE approach.

Fourteen articles were included in the systematic review and meta-analysis. The pooled IRR indicates no statistically significant differences between the manipulation and control groups. All the reported AEs were classified as mild, and none of the AEs reported were serious or moderate.

The authors concluded that HVLA manipulation does not impose an increased risk of mild or moderate AEs compared to various control interventions. However, these results must be interpreted with caution, since RCTs are not appropriate for detecting the rare serious AEs. In addition, future RCTs should follow a standardized protocol for reporting AEs in clinical trials.

I am more than a little puzzled by this paper. To explain why, I best show you our systematic review of a closely related subject:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

So, AEs are known to get seriously (and unethically) neglected in RCTs of chiropractic. Therefore, it must be expected that the new review finds only few of them in RCTs. No big deal! But why then conclude that HVLA manipulations do not impose an increased risk? Why do the authors claim that “case reports … do not imply causal relationships”? Why not be honest and simply state that RCTs are an inadequate tool for assessing the risks of spinal manipulation? And why ignore our review which, after all, is highly relevant and was published in a most visible journal? Did they perhaps read it and then decided to ignore it because it would have rendered their whole approach idiotic?

I don’t know the answer to any of these questions. What I do know, however, is that this new review arrives at a utterly misleading and possibly harmful conclusion. It thus is a significant disservice to our need to making progress in this important area.

I know, I have mentioned my concerns before about research into so-called alternative medicine (SCAM) from China, e.g.:

In 2018, China became the country that produces more scientific papers than any other. At present, China’s output stands at over one million articles per year. Yes, I do find this worrying!

On 2/4/2024, I did a few very simple Medline searches. I feel that the findings are remarkable.

Clinical trials of TCM

Between 2000 and 2023 ~ 8000

2000 = 8

2010 = 157

2020 = 1 192

Systematic reviews of TCM

2000 = 1

2010 = 26

2020 = 1 222

This near explosive rate of growth could, of course, be good news. But it isn’t because – as shown here so often before – the findings of Chinese research are worringly unreliable.

As if to confirm my point about the dominance of China, this paper has just been published:

Background: Neuropathic pain (NP) is a common type of pain in clinic. Due to the limited effect of drug treatment, many patients with NP are still troubled by this disease. In recent years, complementary and alternative therapy (CAT) has shown good efficacy in the treatment of NP. As the interest in CAT for NP continues to grow, we conducted a bibliometric study of publications on CAT treatment for NP. The aim of this study is to analyze the development overview, research hotspots and future trends in the field of CAT and NP through bibliometric methodology, so as to provide a reference for subsequent researchers.

Methods: Publications on CAT in the treatment of NP from 2002 to 2022 were retrieved from the Web of Science Core Collection. Relevant countries, institutions, authors, journals, keywords, and references were analyzed bibliometrically using Microsoft Excel 2021, bibliometric platform, VOSviewer, and CiteSpace.

Results: A total of 898 articles from 46 countries were published in 324 journals, and they were contributed by 4455 authors from 1102 institutions. The most influential country and institution are China (n = 445) and Kyung Hee University (n = 63), respectively. Fang JQ (n = 27) and Evidence-Based Complementary and Alternative Medicine (n = 63) are the author and journal with the most publications in this field. The clinical efficacy, molecular biological mechanisms and safety of CAT for NP are currently hot directions. Low back pain, postherpetic neuralgia, acupuncture, and herbal are the hot topics in CAT and NP in recent years.

Conclusion: This study reveals the current status and hotspots of CAT for NP. The study also indicates that the effectiveness and effect mechanism of acupuncture or herbs for treating emotional problems caused by low back pain or postherpetic neuralgia may be a trend for future research.

China is increasingly dominating SCAM research and we all know – or should know by now (see above) – that the results of this research are misleading. I cannot understand why so few people seem to think this is alarming.

 

 

Acute tonsillitis, which includes tonsillopharyngitis, is a common condition, particularly in childhood. It is mostly caused by a viral infection. Symptomatic treatment is of high importance. But which treatment is effective and which isn’t?

For this expert consensus, 53 physicians from Germany, Spain, Netherlands, Switzerland, Austria, and Hungary with at least one year of experience in anthroposophic paediatric medicine were invited to participate in an online Delphi process. The process comprised 5 survey rounds starting with open-ended questions and ending with final statements, which need 75% agreement of experts to reach consensus. Expert answers were evaluated by two independent reviewers using MAXQDA and Excel.

Response rate was between 28% and 45%. The developed recommendation included 15 subtopics. These covered clinical, diagnostic, therapeutic and psychosocial aspects of acute tonsillitis. Six subtopics achieved a high consensus (>90%) and nine subtopics achieved consensus (75-90%). The panel felt that AM was an adequate therapy for acute tonsillitis.

The authors of this paper concluded that the clinical recommendation for acute tonsillitis in children aims to simplify everyday patient care and provide decision-making support when considering and prescribing anthroposophic therapies. Moreover, the recommendation makes AM more transparent for physicians, parents, and maybe political stakeholders as well.

I found it hard to decide whether to cry or to laugh while reading this paper.

Experience in anthroposophic paediatric medicine does not make anyone an expert in anything other than BS.

Expert consensus and clinical guidelines are not conducted by assembling a few people who all are in favour of a certain therapy while ignoring the scientific evidence.

AM for acute tonsillitis in children is nonsense, whatever these pseudo-experts claim.

Imagine we run a Delphi process with a few long-standing members of ‘the flat earth society’ and ask them to tell us about the shape of the earth …

…I rest my case.

Prof Michael Frass is the undisputed star amongst researchers of homeopathy. Here are the awards and achievements that he mentions on his website:

  • 1994 until 2019Head, Special Outpatient Clinic “Homeopathy in Malignant Diseases”, Department of Internal Medicine I, General Hospital of the City of Vienna
  • 1992 until Feb. 2004Director, Intensivstation 13.i2, Klinik für Innere Medizin I
  • 1994 until 1998 Medical Director Maimonides Center
  • since May 1994Vice President of the “Medical Society for Classical Homeopathy” (ÄKH)
  • since Oct. 1995Head of the Working Group for Homeopathy of the ÄKH in Vienna
  • since Jan. 1998 Speaker of the ÄKH at training courses
  • 1999 – 2012Training Officer of the Austrian Society for Internal and General Intensive Care Medicine (ÖGIAIM)
  • 2001 until 2019 Coordinator of the lecture series “Selected chapters and scientific discussion of complementary medicine methods”, Med. Univ. Vienna, VO 560480
  • May 2002 – Dec. 2005Director of the Ludwig Boltzmann Institute for Homeopathy
  • since June 2003Member of the Scientific Advisory Board of the Vienna International Academy of Holistic Medicine
  • 2004 until 2019Expert in Airway Management and Homeopathy in Intensive Care Medicine at the Center of Excellence in Internal Critical Care Medicine (CEMIC).
  • 2005 until 2019Coordinator of the free elective “Homeopathy”, Med. Univ. Vienna, VO 562 923
  • since June 2005Director, Institute for Homeopathy Research
  • 2006 until 2019Member of the planning area + lecturer for the line element “Interdisciplinary Patient Management” (compulsory lecture for medical students)
  • since June 2006President of the Austrian Umbrella Association for Medical Holistic Medicine.
  • since Nov. 2010Chairman of the Scientific Society for Homeopathy (WissHom)

Many of my readers will remember the case of the Prof. Frass et al study of homeopathy for cancer. On this blog, we have seen several articles about it:

The study and the suspicion of scientific misconduct it raised eventually resulted in an official complaint by the Viennese Medical School to the authority that deals with suspicions of publication fraud, the ‘Austrian Agency for Scientific Integrity’. It took a very long time, but recently they have published their final on-line summary of their assessment of the case; here is my translation:

Enquiry A 2021/10:
After an Austrian university was informed externally and by name of possible scientific misconduct in a study and the resulting publication, the institution concerned submitted the already publicised suspected case in the field of applied natural sciences to the OeAWI with a request for examination by the Commission.

After establishing sufficient suspicion of various violations of good scientific practice, the Commission declared itself responsible and initiated proceedings. In the course of this, the principal investigator was given the opportunity to submit a written statement and to provide the Commission for Research Integrity Annual Report 2022 material that would help to clarify the facts of the case, which the accused submitted in large quantities.

In a very complex, comprehensive investigation, which required, among other things, the on-site inspection of original documents, the Commission was able to substantiate the suspicion of data falsification, fabrication and manipulation. In a final statement, the study director, who no longer works for the university in question, and the numerous co-authors were informed in detail about the course and results of the commission’s investigation and informed of the recommendations to the university and journal.  The Commission recommended that the university concerned should consider investigating its own responsibilities and act accordingly, and that the publication should be withdrawn as a matter of urgency. The journal responsible for the publication was asked to withdraw the publication on the basis of the findings of the investigation.

Nobody who has studied the Frass paper in some detail can be surprised by the verdict. I do applaud the ‘Austrian Agency for Scientific Integrity’ for their work. Yet, I do also have some criticism: health fraud on the scale of Frass can easily costs lives. I find it therefore unacceptable that the verdict took so long to get published.

Even worse is, in my view, the fact that the journal, ‘Oncologist’, is still offering this paper today, albeit with this ‘expression of concern’:

This is an Expression of Concern regarding: Michael Frass, Peter Lechleitner, Christa Gründling, Claudia Pirker, Erwin Grasmuk-Siegl, Julian Domayer, Maximilian Hochmair, Katharina Gaertner, Cornelia Duscheck, Ilse Muchitsch, Christine Marosi, Michael Schumacher, Sabine Zöchbauer-Müller, Raj K. Manchanda, Andrea Schrott, Otto Burghuber, Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study, The Oncologist, Volume 25, Issue 12, December 2020, Pages e1930–e1955, https://doi.org/10.1002/onco.13548

In August 2022, the journal editors received credible information from the Austrian Agency for Research Integrity about potential data falsification and data manipulation in this article.*** While The Oncologist editorial team investigates and communicates with the corresponding author, the editors are publishing this Expression of Concern to alert readers that, pending the outcome and review of a full investigation, the research results presented may not be reliable.

Cancer patients will thus still read the dangerously misleading conclusions of the Frass fabrication: “Quality of life (QoL) improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumor entities are warranted.” And lives of cancer patients remain needlessly at risk. In my view, this is seriously unethical.

***As far as I know, they received credible information from others long before that!

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.

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