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

clinical trial

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To accuse anyone of an abuse of science is a hefty charge, I know. In the case of proponents of so-called alternative medicine (SCAM) doing science, it is, however, often justified. Let me explain this by using the example of chiropractors (I could have chosen homeopathy, faith heaalers, acupuncturists or almost any other type of SCAM professional, but in recent times it was the chiros who provided the clearest examples of abuse).

Science can be seen as a set of tools that is used to estabish the truth. In therapeutics, science is employed foremost to answer three questions:

  1. Is the therapy plausible?
  2. Is the therapy effective?
  3. Is the therapy safe?

The way to answer them is to falsify the underlying hypotheses, i.e. to demonstrate that:

  1. The therapy is not plausible.
  2. The therapy is not effective.
  3. The therapy is not safe.

Only if rigorous attempts at falsifying these hypotheses have falied can we conclude that:

  1. The therapy is plausible.
  2. The therapy is effective.
  3. The therapy is safe.

I know, this is rather elementary stuff. It is taught during the first lessons of any decent science course. Yet, proponents of SCAM are either not being properly taught or they are immune to even the most basic facts about science. On this blog, we regularly have the opportunity to observe exactly that when we read and are bewildered by the comments made by SCAM proponents. This is often clearest in the case of chiropractors.

  1. They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is plausible.
  2. They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is effective.
  3. They cherry-pick the evidence to persuade us that their hallmark intervention, spinal manipulation, is safe.

If they conduct research, they set up their investigations in such a way that they confirm their beliefs:

  1. Spinal manipulations are plausible.
  2. Spinal manipulations are effective.
  3. Spinal manipulations are safe.

In other words, they do not try to falsify hypotheses, but they do their very best to confirm them. And this, I am afraid, is nothing other than an abuse of science.

QED

And how can the average consumer (who may not always be in a position to realize whether a study is reliable or not) tell when such abuse of science is occurring? How can he or she decide who to trust and who not?

A simplest but sadly not fool-proof advice might consist in 2 main points:

  1. Never rely on a single study.
  2. Check whether there is a discrepancy in the results and views of SCAM proponents and independent experts; e.g.:
    • Chiropractors claim one thing, while independent scientists disagree or are unconvinced.
    • Homeopath claim one thing, while independent scientists disagree or are unconvinced.
    • Acupuncturists claim one thing, while independent scientists disagree or are unconvinced.
    • Energy healers claim one thing, while independent scientists disagree or are unconvinced.
    • Naturopaths claim one thing, while independent scientists disagree or are unconvinced.
    • Etc., etc.

In all of those cases, your alarm bells should ring and it might be wise to be cautious and avoid the treatment in question.

Yesterday, I stumbled across this remarkable notice. As it is in German, I took the libery of translating it for you:

Am 6. April 2024 war es wieder soweit: Die ÖGHM und die Schwabe Austria GmbH luden zur Verleihung des mit 4.000,- Euro dotierten Dr. Peithner Preises ein.

Dieses Mal wurde der Forschungspreis für die zwei eingereichte Arbeiten „Recommendations in the design and conduction of randomized controlled trials in human and veterinary homoeopathic medicine“ und „Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine“ an Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni und Petra Weiermayer vergeben.

Wir freuen uns sehr und gratulieren den Preisträger:innen zum verdienten Erfolg. Ein herzliches Dankeschön geht auch an die ÖGHM und die Schwabe Austria, die nicht nur mit diesem traditionellen Forschungspreis die Wissenschaft unterstützt.

Here is my translation:

On 6 April 2024, the time had come again: the ‘Austrian Society for Homeopathic Medicine’ (ÖGHM) and Schwabe Austria GmbH hosted the award ceremony for the Dr Peithner Prize, which is endowed with 4,000 euros.

This time, the research prize was awarded to Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni and Petra Weiermayer for the two submitted papers “Recommendations in the design and conduction of randomised controlled trials in human and veterinary homoeopathic medicine” and “Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine”.

We are delighted and congratulate the prizewinners on their well-deserved success. A big thank you also goes to the ÖGHM and Schwabe Austria, who support science with this traditional research prize.

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And where is the irony?

Firstly, homeopaths are not exactly the experts on how to conduct research.

Secondly, there are recommendations and guidelines for conducting clinical research (e.g. here), and there is no reason for homeopathy to not to adopt those.

Thirdly, and most importantly, to award a prize to Michael Frass for telling us how to do research is more than a little ironic. If anything, Frass could teach us a thing or two about how to falsify, fabricate and manipulate research results!

Of all the many forms of so-called alternative medicine (SCAM), Reiki is perhaps the one that has the least plausibility. It assumes that a Reiki healer can send healing energy into the body of a patient which, in turn, stimulates the self-healing ability of the body and thus cures illness. Neither the source of the energy, its nature, or its effects have ever been convincingly demonstrated. These facts, however, do not stop enthusiasts to conduct clinical trials of Reiki.

The aim of this randomised clinical trial was to investigate the effect of the application of Reiki on fatigue and sleep quality in people with MS. A total of 60 people (control group = 30, intervention group = 30) participated in this study. Personal Information Form, Piper Fatigue Scale (PFS) and Pittsburg Sleep Quality Index (PSQI) were used as endpoints.

It was found that the PFS and PSQI total and subcomponent scores of the intervention group decreased after Reiki compared to the control group and this was statistically significant (p<0.05). The study showed that Reiki was significantly effective in improving fatigue and sleep quality in people with MS.

The authors concluded that, as Reiki is a simple, inexpensive and accessible method, it was suggested that its use in the management of MS should be encouraged and maintained in nursing practice.

In the introduction, the authors state this:

Reiki is a non-invasive, low-cost, easy-to-apply practice with no side effects and no negative effects on the existing treatment, and prevents acute and chronic conditions. It is frequently preferred in rehabilitation centres, emergency care units, nursing homes, elderly care centres, paediatrics, psychiatry, obstetrics and gynaecology clinics. Reiki can be applied by trained practitioners such as health professionals who have received first level reiki training in hospitals and clinics, caregivers or patients themselves. Reiki can be administered from with the patient or remotely when the patient and practitioner are in separate locations. Both types of Reiki are based on the premise of a universal source of healing energy that the Reiki practitioner can channel through intention.

For me, this begs the questions:

  • If all of this were true, why do we need a study?
  • If anyone believes such BS, are they the ideal people to conduct a study of Reiki?

Anyway, we should ask why this study generated a positive result. The most plausible explanation is that, as the study was not blind, the Reiki healers managed to maximise patient expectation. This, in turn, has generated a placebo respose which affected the subjective outcome measures. In other words, Reiki has no specific effect but patients tend to improve because of non-specific effects.

Post-COVID-19 fatigue is becoming increasingly common as the pandemic evolves. Plenty of so-called alternative medicines (SCAMs) are on offer, including homeopathy. But is homeopathy really helpful?

This trial attempted to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults.

A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences.

Group differences in both the primary (FAS total: F1, 58 = 14.356, p &lt; 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p &lt; 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups.

The authors concluded that IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.

A glance at the authors’ affiliations is, I think, revealing:

  • 1Department of Organon of Medicine and Homeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.
  • 2Department of Pathology and Microbiology, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
  • 3The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
  • 4Department of Practice of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
  • 5Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.

We are currently being bombarded with false-positive homeopathy trials from India. Why am I sure that the trial is false-positive? Well, I am not sure, of course. But I have suspicions:

  1. Homeopathy is not a plausible form of SCAM.
  2. The most reliable studies fail to show that is is more than a placebo.
  3. The journal that published this paper is 3rd class; if the findings were valid, they would get published in one of the top science journals.
  4. The authors were clearly biased and even admitted as much; they stated that they wanted “to identify the preliminary evidence of the efficacy” of IHM. But this is not how unbiased researcher conduct clinical trials. Such investigations are for testing hypotheses and not for identifying effects.
  5. Most importantly, the trial design is flawed. Even the authors realize this, and the 1st sentence of the conclusions should therefore have been far less definitive.

And what are the main flaws?

As far as I can see they were:

  • The sample size was to small for a far-reaching conclusion.
  • The study was not double blind. In other words the therapists had the opportunity to exert their influence on the patient to produce the desired outcome. Occam’s Razor demands that we assume this to be the real explanation of the positive effects observed here.

In view of all this, I suggest to change the conclusions as follows:

IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults which most likely is not due to the efficacy of the treatment applied but to the residual bias not controlled for in this study.

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”.

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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.

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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:

 

 

In November 2022, we discussed a dodgy acupuncture review. Let me show you my post from back then again:

Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.

The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.

Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture

  • relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
  • improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
  • improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).

There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).

The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.

What should we make of this paper?

In case you are in a hurry: NOT A LOT!

In case you need more, here are a few points:

  • many trials were of poor quality;
  • there was evidence of publication bias;
  • there was considerable heterogeneity within the studies.

The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.

Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.

Dishonest researchers?

Biased reviewers?

Incompetent editors?

Truly unbelievable!!!

In consideration of these points, let me rephrase the conclusions:

The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.

PS

I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!

Now, it has been announced that the paper has been 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.

One down, dozens of further SCAM papers to go!

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.

We have discussed the LIGHTNING PROCESS before:

Now, the BBC reports that it is promoted as a treatment of Long-COVID. Oonagh Cousins was offered a free place on a course run by the Lightning Process, which teaches people they can rewire their brains to stop or improve long Covid symptoms quickly. Ms Cousins, who contracted Covid in March 2020, said it “exploits” people.

Ms Cousins had reached a career goal many athletes can only dream of – being selected for the Olympics – when she developed long Covid. By the time the cancelled 2020 Olympic Games in Tokyo were rescheduled for 2021, Ms Cousins was too ill to take part. When she went public with her struggles, she was approached by the Lightning Process. It offered her a free place on a three-day course, which usually costs around £1,000.

“They were trying to suggest that I could think my way out of the symptoms, basically. And I disputed that entirely,” the former rower said. “I had a very clearly physical illness. And I felt that they were blaming my negative thought processes for why I was ill.” She added: “They tried to point out that I had depression or anxiety. And I said ‘I’m not, I’m just very sick’.

In secret recordings by the BBC, coaches can be heard telling patients that almost anyone can recover from long Covid by changing their thoughts, language and actions. Over three days on Zoom, the course taught the ritual that forms the basis of the programme. Every time you experience a symptom or negative thought, you say the word “stop”, make a choice to avoid these symptoms and then do a positive visualisation of a time you felt well. You do this while walking around a piece of paper printed with symbols – a ritual the BBC was told to do as many as 50 times a day.

In some cases the Lightning Process has encouraged participants to increase their activity levels without medical supervision, against official advice – which could make some more unwell, according to NHS guidelines. Lightning Process founder, Dr Phil Parker, who’s not a medical doctor but has a PhD in psychology of health, told us his course was “not a mindset or positive thinking approach,” but one that uses “the brain to influence physiological changes”, backed by peer-reviewed evidence. The coach on the course the BBC attended said “thoughts about your symptoms, your worry about whether it’s ever going to go – that’s what keeps the neurology going. Being in those kind of thoughts is what’s maintaining your symptoms. They’re not caused by a physical thing any more.”

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As I pointed out previously, The Lightning Process  (LP) is a therapy based on ideas from osteopathy, life coaching, and neuro-linguistic programming. LP is claimed to work by teaching people to use their brains to “stimulate health-promoting neural pathways”.

LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns, and physical movements with the aim of improving a more appropriate response to situations.

Proponents of the ‘LP’ in Norway claim that 90% of all ME patients get better after trying it. However, such claims seem to be more than questionable.

  • In the Norwegian ME association’s user survey from 2012 with 1,096 participants, 164 ME patients stated that they had tried LP. 21% of these patients experienced improvement or great improvement and 48% got worse or much worse.
  • In Norway’s National Research Center in Complementary and Alternative Medicine, NAFKAM’s survey from 2015 amongst 76 patients 8 had a positive effect and 5 got worse or much worse.
  • A survey by the Norwegian research foundation, published in the journal Psykologisk, with 660 participants, showed that 62 patients had tried LP, and 5 were very or fairly satisfied with the results.

Such figures reflect the natural history of the condition and are no evidence that the LP works.

Is there any evidence supporting the LP specifically for long COVID?

My Medline search retrieved just one single paper. Here is the abstract:

As a result of the COVID-19 pandemic, Long COVID (LC) is now prevalent in many countries. Little evidence exists regarding how this chronic condition should be treated, but guidelines suggest for most people it can be managed symptomatically in primary care. The Lightning Process is a trademarked positive psychology focused self-management programme which has shown to be effective in reducing fatigue and accompanying symptoms in other chronic conditions including Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. Here we outline its novel application to two patients with LC who both reported improvements in fatigue and a range of physical and emotional symptoms post-treatment and at 3 months follow-up.

Well, that surely convinced everyone! Except me and, of course, anyone else who can think critically.

So, I look further and find this on the company’s website:

Do you know how it feels to…

  • …be exhausted and tired no matter how much rest you get?
  • …be stuck with re-occurring pain, health symptoms and issues?
  • …get so stressed by almost everything?
  • …feel low and upset much of the time?
  • …want a better life and health but just can’t find anything that works?

If any, or all, of these sound familiar then the Lightning Process, designed by Phil Parker, PhD, could be the answer that you’re looking for.  There are lots of ways you can find out more about the suitability of the Lightning Process for you, have a look through below…

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Let me try to summarise:

  • The LP is promoted as a cure for long-Covid.
  • There is no evidence that LP is effective for it.
  • The claim is that it has been shown to work for ME.
  • There is no evidence that LP is effective for it.
  • A 3-day course costs £1 000.
  • Their website claims it is good for practically everyone.

Does anyone think that LP or its promoters are remotely serious?

This Phase IV randomized, double-blind, placebo-controlled clinical trial was “designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia”.

The study was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment.

In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505-0.773, Student’s t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student’s t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment.

The authors concluded that the trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia.

The very first thing one notices is the aim of the study. According to its authors, it was “designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia“. Any group of researchers that is unaware of the fact that clinical trials are for TESTING and not for DEMONSTRATING should, in my view, be sent straight back to school. And while they are at it, they might as well take with them the editor of the journal as well as the peer-reviewers of the paper.

As it happens, I have published a post about Neurodoron before. Here is a short section from it:

Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. One tablet of this anthroposophic remedy contains the following active ingredients:

83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,

83.3 mg Kalium phosphoricicum trit. D6,

8.3 mg Ferrum-Quarz trit. D2.

Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms…

Apart from its above-mentioned aim, the new study is remarkable in one further aspect: in its conclusion, it makes a big deal out of the ‘good news’ that Neurodoron safe. As the trial was not designed to test safety, this can only be seen as an attempt to hide (as well as possible) the fact that the remedy turned out to be ineffective.

Why would researchers try to distract the reader from the main message of their work? The answer might lie in the affiliation of two of the authors: Clinical Research, Weleda AG, Schwäbisch Gmünd, Germany.

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