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

methodology

Functional Neurology (FN) is an approach used by some chiropractors. One website proudly proclaims that Functional Neurology, sometimes referred to as Chiropractic Neurology, is a term used to describe a variety of evidence-based treatments relating to neurological disorders. And another one informs us that Functional neurology, aka chiropractic neurology, is a healthcare discipline that utilizes neuroplasticity and contemporary clinical neuroscience to both evaluate and rehabilitate patients that suffer from a complex neurological condition or simply want to optimize their performance. A comprehensive neurological examination is performed in order to determine which area of the nervous system is not functioning appropriately. A customized therapy program is then tailored to address each person’s individualized neurological dysfunction.

The specific therapeutic claims that are being made for FN by chiropractors are impressive. The following list is a non-exhaustive attempt to document some of the conditions which functional neurologists claim to be able to treat: ADD/ADHD, Alzheimer’s, Anxiety disorders, Asperger’s Syndrome, Autism, Balance disorders, Blackouts, Blindness, Brain Aging issues, Canal stenosis, Cerebellar disorders,Chronic pain disorders, Cervical myelopathy, Coma, Complex regional pain syndromes, Concentration issues, Depression, Diplopia, Dizziness, Double vision, Dyslexia, Dystonia, Epilepsy, Fainting, Headaches, Heart arrhythmias, Irritable bowel syndrome, Learning difficulties, Memory issues, Mental Health, Migraines, Motion sickness, Movement disorders, Multiple sclerosis, Neglect syndromes, Numbness, Parkinson’s disease, Peripheral neuropathies, Radicular/nerve root conditions, Reflex sympathetic dystrophy, Sexual dysfunction, Sleep apnea, Sleep problems, Snoring, Speech problems, Spinal cord compression, Squints/skew deviations of the eyes, Strokes, Syncope, Tinnitus, Tics, Tourette’s, Tremors, Vertigo and Visual disturbances.

Is any of this backed up by evidence?

A review of FN included 9 articles. The included studies were conducted on adults or children, symptomatic or not, and investigated various interventions consisting of single or multiple stimuli, of varied nature, all primarily said to be provided to stimulate brain areas. Conditions included attention deficit disorders, attention deficit and hyperactivity disorders, autism-spectrum disorders, cortical visual impairment, traumatic brain injury, and migraine. Balance and the “blind spot” were investigated in healthy subjects. Major design and methodological issues were identified in all 9 studies; only 4 were considered as (potentially) appropriate for further scrutiny.

The authors concluded that no robust evidence could be found in relation to the effect or benefit of the tested FN interventions.

In a nutshell: FN is yet another addition to chiro-quackery.

Dr Jens Behnke has attracted my attention several times before (most recently here and here). Today I have decided to admit him into my ‘ALTERNATIVE MEDICINE HALL OF FAME’.

He finds himself in the company of giants:

John Weeks (editor of JCAM)

Deepak Chopra (US entrepreneur)

Cheryl Hawk (US chiropractor)

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

Why does Behnke deserve this honour?

Because, 4 years ago, he made his doctorate under the supervision of Prof Harald Walach, pseudoscientist of the year 2012 and proven teller of falsehoods?

No, there are better reasons.

On Twitter, Behnke describes himself as a research consultant for homeopathy at the Karl and Veronica Carstens-Foundation: Evidence based medicine, CAM, clinical and basic research, health. The Carstens Stiftung say he is ‘programme director integrative medicine’. On facebook, he is merely ‘ ‘Referent of  ‘Redaktion Natur und Medizin’. And on ‘Research Gate’ he lists 12 areas of skills and expertise:

Evidence Based Medicine
Medical & Health Profession Education
Meta-Analysis
Observational Studies
Science Communication
Social Media
Randomized Control Trials
Clinical Research
Philosophy Of Science
Complementary & Alternative Medicine
Integrative Medicine
Homeopathy

If this is not impressive, I don’t know what is! Particularly, if one knows that he is not a medical doctor at all!!!

So, let’s look at the list to decide whether he deserves the honour of becoming a member of my ‘HALL OF FAME’. Specifically, let’s check how many Medline-listed articles he has to his name in each of the above areas:

Evidence Based Medicine = 0
Medical & Health Profession Education = 0
Meta-Analysis = 0
Observational Studies = 0
Science Communication = 0
Social Media = 0
Randomized Control Trials = 0
Clinical Research = 0
Philosophy Of Science = 0
Complementary & Alternative Medicine = 0e
Integrative Medicine = 0
Homeopathy = 0

(No, you don’t need to praise me for my detailed, time-consuming research. It was not difficult and very quick: Jens Behnke, the ‘research consultant, has precisely zero Medline-listed publications).
So has Behnke ever conducted:

  • a meta-analysis? No
  • an observational study? I don’t think so
  • a randomised trial? No
  • any other clinical research? No

In the past, I tended to admit to my HALL OF FAME mainly those SCAM researchers who had published plenty of papers but had no study to their name that drew a negative conclusion. Behnke is not in that league. He is nevertheless worthy for his highly elaborate concept. Remember, he is a ‘research consultant in homeopathy’, and homeopathy obeys different rules than any other form of quackery. One of its axioms holds that LESS IS MORE. And considering this principle, Behnke surely must be THE expert! No publication, in homeopathic logic, evidently means that he is better than anyone else.

So, a warm welcome to our new member Jens Behnke: MAY YOUR UNPRODUCTIVITY AS A EXPERT IN 12 DIFFERENT FIELDS OF INQUIRY LAST FOR MANY MORE YEARS!

And congratulations also to the Carstens Stiftung who have so far spent 36 000 000 Euro on SCAM-research and pay Behnke’s salary as ‘research consultant’: I am sure you guys deserve him!

PS

In case Dr Behnke reads this: it is an internationally accepted standard of honesty and transparency that someone who has a doctor title and works in or comments on medical matters makes it clear that he/she is not medically trained or experienced, that in fact he/she is not a medical doctor. If not, one might think that this person is deliberately trying to mislead the public.

Dry needling (DN), also known as myofascial trigger point dry needling, is a SCAM similar to acupuncture. It involves the use of solid filiform needles or hollow-core hypodermic needles and is usually employed for treating muscle pain. Instead of sticking them into acupuncture points, like with acupuncture, they are inserted into myofascial trigger points usually identified by palpation. There are some theories how DN might work, but whether it is clinically effective remains unclear.

This single-blind RCT determined, if the addition of upper quarter DN to a rehabilitation protocol is more effective in improving ROM, pain, and functional outcome scores when compared to a rehabilitation protocol alone after shoulder stabilization surgery. Thirty-nine post-operative shoulder patients were randomly allocated into two groups: (1) standard of care rehabilitation (control group) (2) standard of care rehabilitation plus dry needling (experimental group). Patient’s pain, ROM, and functional outcome scores were assessed at baseline (4 weeks post-operative), and at 8 weeks, 12 weeks, and 6 months post-operative.

Of 39 enrolled patients, 20 were allocated to the control group and 19 to the experimental group. At six-month follow up, there was a statistically significant improvement in shoulder flexion ROM in the control group. Aside from this, there were no significant differences in outcomes between the two treatment groups. Both groups showed improvement over time. No adverse events were reported.

The authors concluded that dry needling of the shoulder girdle in addition to standard of care rehabilitation after shoulder stabilization surgery did not significantly improve shoulder ROM, pain, or functional outcome scores when compared with standard of care rehabilitation alone. Both group’s improvement was largely equal over time. The significant difference in flexion at the six-month follow up may be explained by additional time spent receiving passive range of motion (PROM) in the control group. These results provide preliminary evidence that dry needling in a post-surgical population is safe and without significant risk of iatrogenic infection or other adverse events.

How odd!

This trial followed the infamous A+B versus B design. As [A+B] is more than [B] alone, one would have expected that the experimental group has a better outcome than the control group.

But this was not the case!

Why?

Theoretically it can mean one of two things:

  1. DN did not even convey a placebo effect.
  2. DN had a negative effect on the outcome.

Yesterday’s blog disclosed the fact that the German ‘Natur und Medizin’, an organisation of the ‘Carstens Stiftung’, had published slanderous lies about me. Consequently, I published an ‘open letter’ urging them to correct their mistake so that they would spare us the agony and cost of using legal action.

I never doubted for a minute that they would do this (I do not assume they are stupid, just a tiny bit dishonest) – and, as it turned out, I was correct. Here is a reminder of what they had originally published:

… er ist dafür bekannt, dass er kein gutes Haar an komplementären Therapieverfahren lässt. Notfalls greift er auch zu absichtlichen Falschdarstellungen[17], erfindet Daten[18] oder behauptet einfach, klinische Studien, die nicht die Negativ-Ergebnisse erbringen, die er erwartet, seien schlicht und ergreifend Betrug.[19]…

My rough translation:

… he [Edzard Ernst] is known for not finding anything positive in SCAM. If all else fails, he uses deliberate misrepresentation [17], invents data [18], or simply claims that clinical trials which did not generate the negative findings he expected are simply falsifications [19]…

The corrected new text passage is a little longer and now reads as follows (my rough translation):

… he [Edzard Ernst] is known for not finding anything positive in SCAM. Analyses of his publications by independent scientists draw the conclusion that he represents case-reports demonstrably wrongly [17] and that he arbitrarily alters or omits data [18]. He claims occasionally that high-quality studies of SCAM which do not generate the negative findings he expected appeared to be scientifically sound, but are nevertheless not believable [19]…

… er ist dafür bekannt, dass er kein gutes Haar an komplementären Therapieverfahren lässt. Analysen seiner Publikationen durch unabhängige Wissenschaftler gelangen zu der Schlussfolgerung, dass er Fallberichte nachweislich falsch darstelle[17] und Daten willkürlich verändere oder auslasse[18]. Er selbst behauptet mitunter über methodisch hochwertige Studien zur Komplementärmedizin, die nicht die Negativ-Ergebnisse erbringen, die er erwartet, sie sähen zwar nach wissenschaftlichen Maßstäben überzeugend aus, seien aber dennoch ‚unglaubwürdig‘.[19]… 

I would like to take this occasion to sincerely thank the ‘Natur und Medizin’ and the ‘Carstens Stiftung’ for this – much obliged guys, you made my day!

  • They have shown wisdom in not wasting money on expensive lawyers (even though my brother, who is a lawyer, might have enjoyed the windfall).
  • They have shown courage to hide behind papers like the one by Robert Hahn which have been discussed on this blog and elsewhere and found to be deluded.
  • They have shown strength by not meekly apologising to me about their attempt to slander me and my work.
  • They show leadership and innovative spirit by employing Jens Behnke, the author of the above lines, who does not seem to let the truth get in the way of a good story.

Last not least, my personal thanks to dear Jens (after your generosity, I am thinking about dedicating an entire blog post to you; your employer needs to know what a genius they have in you – watch this space) for yet again having demonstrated that the phenomenon known as ERNST’ S LAW is 100% correct.

A team of chiropractic researchers conducted a review of the safety of spinal manipulative therapy (SMT) in children under 10 years. They aimed to:

1) describe adverse events;

2) report the incidence of adverse events;

3) determine whether SMT increases the risk of adverse events compared to other interventions.

They searched MEDLINE, CINAHL, and Index to Chiropractic Literature from January 1, 1990 to August 1, 2019. Eligible studies were case reports/series, cohort studies and randomized controlled trials. Studies of high and acceptable methodological quality were included.

Most adverse events are mild (e.g., increased crying, soreness). One case report describes a severe adverse event (rib fracture in a 21-day-old) and another an indirect harm in a 4-month-old. The incidence of mild adverse events ranges from 0.3% (95% CI: 0.06, 1.82) to 22.22% (95% CI: 6.32, 54.74). Whether SMT increases the risk of adverse events in children is unknown.

The authors concluded that the risk of moderate and severe adverse events is unknown in children treated with SMT. It is unclear whether SMT increases the risk of adverse events in children < 10 years.

Thanks to their ingenious methodology, the authors managed to miss 11 of the 13 studies included in the review by Vohra et al which reported 9 serious adverse events and 20 cases of delayed diagnosis associated with SMT. Another review reported 15 serious adverse events and 775 mild to moderate adverse events following manual therapy. As far as I can see, the authors of the new review make just one reasonable point:

We recommend the implementation of a population-based active surveillance program to measure the incidence of severe and serious adverse events following SMT treatment in this population.

In the absence of such a surveillance system, any incidence figures are not just guess-work but also a depiction of the tip of a much bigger iceberg. So, why do the authors of this review not make this point clearly and powerfully? Why does the review read mostly like an attempt to white-wash a thorny subject? Why do they not provide a breakdown of the adverse events according to profession? The answer to these questions can be found at the very end of the paper:

This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.

This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and funding from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.

I have often felt that chiropractic is similar to a cult. An investigation by cult members into the dealings of a cult is not the most productive of concepts, I guess.

It has been reported that, in China, patients affected by the coronavirus are being treated with Traditional Chinese Medicine (TCM). Treatments in Wuhan hospitals combine TCM and western medicines, said Wang Hesheng, the new health commission head in Hubei, the province at the centre of the epidemy. He said TCM was applied on more than half of confirmed cases in Hubei. “Our efforts have shown some good result,” Wang said at a press conference on Saturday. Top TCM-experts have been sent to Hubei for “research and treatment,” he said. Some 2,200 TCM workers have been sent to Hubei, Wang said.

Another website confirmed that TCM has been applied to more than half of the confirmed patients of corona or COVID-19 infection in Hubei. It’s also used in the prevention and control of COVID-19 at the community level. “Since the beginning of the outbreak, the government has attached importance to both TCM and Western medicine by mobilizing the strongest scientific research and medical forces in both fields to treat the patients,” said Wang Hesheng. “By coordinating the resources of traditional Chinese and Western medicine, we strive to improve the cure rate and reduce fatalities by the greatest possible amount to effectively safeguard the safety and health of the people,” Wang noted.

China Daily added that many of the medical workers also have participated in the fight against the SARS outbreak in 2003, said Huang Luqi, president of China Academy of Chinese Medical Sciences. Three national-level TCM teams, organized by the National Administration of Traditional Chinese Medicine, also have been dispatched to Hubei, said Huang, head of the TCM team at Wuhan Jinyintan Hospital.

The TCM workers have treated 248 confirmed and suspected novel coronavirus patients, and 159 of them have shown improvement and 51 have been discharged from the hospital, Huang said at a daily news conference in Wuhan. More than 75 percent of novel coronavirus patients in Hubei, and more than 90 percent of patients in other regions of the country, have received TCM treatment, he said. “We hope that Hubei province and Wuhan city can increase the use of TCM in treating confirmed and suspected novel coronavirus patients,” Huang said. TCM can shorten the course of disease for patients with severe symptoms, reduce the possibility of mild infections becoming severe, help with patient recovery and disease prevention and offer psychological support to patients, he noted.

__________________________________________________________________

No information is available on the nature of the TCM treatments used. Moreover, the reported response rate (159 of 248) sounds far from encouraging to me. In fact, it could reflect merely the natural history of the disease or might even hide a detrimental effect of TCM on the infection. What we need are controlled studies, without them, reports like the ones above are mere useless and potentially harmful propaganda for boosting China’s TCM-trade.

Today is Valentine’s Day, a good moment to take a critical look at some of the libido-boosters so-called alternative medicine (SCAM) has to offer. The Internet offers plenty; this website, for instance, advertises over 20 different natural (mostly botanical) products. But such sites are typically thin on evidence.

A quick Medline search locates plenty of research. Much of it seems to be on rats which is not so relevant – unless, of course, your husband is a rat. In terms of clinical trials, Medline too is not all that informative. Here are some of the studies I found:

Eurycoma longifolia is reputed as an aphrodisiac and remedy for decreased male libido. A randomized, double-blind, placebo controlled, parallel group study was carried out to investigate the clinical evidence of E. longifolia in men. The 12-week study in 109 men between 30 and 55 years of age consisted of either treatment of 300 mg of water extract of E. longifolia (Physta) or placebo. Primary endpoints were the Quality of Life investigated by SF-36 questionnaire and Sexual Well-Being investigated by International Index of Erectile Function (IIEF) and Sexual Health Questionnaires (SHQ); Seminal Fluid Analysis (SFA), fat mass and safety profiles. Repeated measures ANOVA analysis was used to compare changes in the endpoints. The E. longifolia (EL) group significantly improved in the domain Physical Functioning of SF-36, from baseline to week 12 compared to placebo (P = 0.006) and in between group at week 12 (P = 0.028). The EL group showed higher scores in the overall Erectile Function domain in IIEF (P < 0.001), sexual libido (14% by week 12), SFA- with sperm motility at 44.4%, and semen volume at 18.2% at the end of treatment. Subjects with BMI ≥ 25 kg/m(2) significantly improved in fat mass lost (P = 0.008). All safety parameters were comparable to placebo.

Yoga is a popular form of complementary and alternative treatment. It is practiced both in developing and developed countries. Use of yoga for various bodily ailments is recommended in ancient ayvurvedic (ayus = life, veda = knowledge) texts and is being increasingly investigated scientifically. Many patients and yoga protagonists claim that it is useful in sexual disorders. We are interested in knowing if it works for patients with premature ejaculation (PE) and in comparing its efficacy with fluoxetine, a known treatment option for PE.  Aim: To know if yoga could be tried as a treatment option in PE and to compare it with fluoxetine.  Methods: A total of 68 patients (38 yoga group; 30 fluoxetine group) attending the outpatient department of psychiatry of a tertiary care hospital were enrolled in the present study. Both subjective and objective assessment tools were administered to evaluate the efficacy of the yoga and fluoxetine in PE. Three patients dropped out of the study citing their inability to cope up with the yoga schedule as the reason.  Main outcome measure: Intravaginal ejaculatory latencies in yoga group and fluoxetine control groups.  Results: We found that all 38 patients (25-65.7% = good, 13-34.2% = fair) belonging to yoga and 25 out of 30 of the fluoxetine group (82.3%) had statistically significant improvement in PE.  Conclusions: Yoga appears to be a feasible, safe, effective and acceptable nonpharmacological option for PE. More studies involving larger patients could be carried out to establish its utility in this condition.

Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) are known to cause secondary sexual dysfunction with prevalence rates as high as 50%-90%. Emerging research is establishing that acupuncture may be an effective treatment modality for sexual dysfunction including impotence, loss of libido, and an inability to orgasm.  Objectives: The purpose of this study was to examine the potential benefits of acupuncture in the management of sexual dysfunction secondary to SSRIs and SNRIs.  Subjects: Practitioners at the START Clinic referred participants experiencing adverse sexual events from their antidepressant medication for acupuncture treatment at the Mood and Anxiety Disorders, a tertiary care mood and anxiety disorder clinic in Toronto.  Design: Participants received a Traditional Chinese Medicine assessment and followed an acupuncture protocol for 12 consecutive weeks. The acupuncture points used were Kidney 3, Governing Vessel 4, Urinary Bladder 23, with Heart 7 and Pericardium 6. Participants also completed a questionnaire package on a weekly basis.  Outcomes measured: The questionnaire package consisted of self-report measures assessing symptoms of depression, anxiety, and various aspects of sexual function.  Results: Significant improvement among male participants was noted in all areas of sexual functioning, as well as in both anxiety and depressive symptoms. Female participants reported a significant improvement in libido and lubrication and a nonsignificant trend toward improvement in several other areas of function.  Conclusions: This study suggests a potential role for acupuncture in the treatment of the sexual side-effects of SSRIs and SNRIs as well for a potential benefit of integrating medical and complementary and alternative practitioners.

The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment.  Participants and design: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan®, Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants’ sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation.  Results: 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared with the placebo group (Р<0.0001). For intention-to-treat (ITT) there was a statistically significant difference in change from baseline of IIEF scores. The difference between TT and placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically significant difference between TT and placebo was found for Intercourse Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour of TT. There were no differences in the incidence of adverse events (AEs) between the two groups and the therapy was well tolerated. There were no drug-related serious AEs. Following the 12-week treatment period, significant improvement in sexual function was observed with TT compared with placebo in men with mild to moderate ED. TT was generally well tolerated for the treatment of ED.

What makes me suspicious about these trials is that:

  • they are mostly on the flimsy side,
  • there are as good as no independent replications,
  • they all report positive outcomes. I was unable to find a single study where the authors concluded: SORRY, BUT THIS STUFF IS USELESS!

Disappointed with the quality and the content of the existing trials, I am now off to buy some oysters!

In 2011, the following leading researchers of so-called alternative medicine (SCAM) – no I was not invited – had a meeting in Italy, did a brainstorm and decided what we would need to know about SCAM by 2020 (today, in other words):

They proposed 6 core areas of research that should be investigated to achieve a robust knowledge base and to allow stakeholders to make informed decisions:

  1. Research into the prevalence of SCAM in Europe: Reviews show that we do not know enough about the circumstances in which SCAM is used by Europeans. To enable a common European strategic approach, a clear picture of current use is of the utmost importance.
  2. Research into differences regarding citizens’ attitudes and needs towards SCAM: Citizens are the driver for CAM utilization. Their needs and views on SCAM are a key priority, and their interests must be investigated and addressed in future SCAM research.
  3. Research into safety of SCAM: Safety is a key issue for European citizens. SCAM is considered safe, but reliable data is scarce although urgently needed in order to assess the risk and cost-benefit ratio of SCAM.
  4. Research into the comparative effectiveness of SCAM: Everybody needs to know in what situation SCAM is a reasonable choice. Therefore, we recommend a clear emphasis on concurrent evaluation of the overall effectiveness of SCAM as an additional or alternative treatment strategy in real-world settings.
  5. Research into effects of context and meaning: The impact of effects of context and meaning on the outcome of SCAM treatments must be investigated; it is likely that they are significant.
  6. Research into different models of SCAM health care integration: There are different models of SCAM being integrated into conventional medicine throughout Europe, each with their respective strengths and limitations. These models should be described and concurrently evaluated; innovative models of SCAM provision in health care systems should be one focus for SCAM research.

‘Look, half the work is done! All you need to do is fill in the top part so we can legally say the bottom part.’

The researchers then added:

We also propose a methodological framework for SCAM research. We consider that a framework of mixed methodological approaches is likely to yield the most useful information. In this model, all available research strategies including comparative effectiveness research utilising quantitative and qualitative methods should be considered to enable us to secure the greatest density of knowledge possible. Stakeholders, such as citizens, patients and providers, should be involved in every stage of developing the specific and relevant research questions, study design and the assurance of real-world relevance for the research.

Furthermore, structural and sufficient financial support for research into SCAM is needed to strengthen SCAM research capacity if we wish to understand why it remains so popular within the EU. In order to consider employing SCAM as part of the solution to the health care, health creation and self-care challenges we face by 2020, it is vital to obtain a robust picture of SCAM use and reliable information about its cost, safety and effectiveness in real-world settings. We need to consider the availability, accessibility and affordability of SCAM. We need to engage in research excellence and utilise comparative effectiveness approaches and mixed methods to obtain this data.

Our recommendations are both strategic and methodological. They are presented for the consideration of researchers and funders while being designed to answer the important and implicit questions posed by EU citizens currently using SCAM in apparently increasing numbers. We propose that the EU actively supports an EU-wide strategic approach that facilitates the development of SCAM research. This could be achieved in the first instance through funding a European SCAM coordinating research office dedicated to foster systematic communication between EU governments, public, charitable and industry funders as well as researchers, citizens and other stakeholders. The aim of this office would be to coordinate research strategy developments and research funding opportunities, as well as to document and disseminate international research activities in this field.

With the aim to develop sustainability as second step, a European Centre for SCAM should be established that takes over the monitoring and further development of a coordinated research strategy for SCAM, as well as it should have funds that can be awarded to foster high quality and robust independent research with a focus on citizens health needs and pan-European collaboration.

We wish to establish a solid funding for SCAM research to adequately inform health care and health creation decision-making throughout the EU. This centre would ensure that our vision of a common, strategic and scientifically rigorous approach to SCAM research becomes our legacy and Europe’s reality. We are confident that our recommendations will serve these essential goals for EU citizens.

As I know all of the members of the panel personally, I am not surprised by the content of this document. That does not mean, however, that I do not find it remarkable. In my view, it is remarkable because of the nature of the 6 items that we allegedly need to know by 2020, and because of the fact that, even though none of them seem particularly demanding, today we have clarity or sound information on none of them. I also thought that both the research topics and the research methods were on the woolly side and, to a large degree, avoided what would be standard in conventional medicine. The ‘vision’ of the 13 researchers thus turns out to be the view of 13 partially sighted people on an array of platitudes.

Being just a bit sarcastic, the document could be seen as a plea for letting SCAM researchers:

  • continue to play on their far from level playing field,
  • use their preferred and largely inadequate methodologies,
  • pretend they do cutting edge science,
  • continue to avoid the real issues,
  • enjoy a life free of demanding challenges,
  • have pots of EU money for doing largely useless work.

In a word, I am confident that their recommendations would not have served any essential goals for EU citizens.

Hurray, homeopaths have a new study to be jubilant about!

But how far can we trust its findings?

Let’s have a look.

The aim of this study was to evaluate the effects of homeopathy (H) as an adjunct to non-surgical periodontal therapy (NSPT) in individuals with type 2 diabetes (DMII) and chronic periodontitis (CP). Eighty individuals with CP and DM II participated in this randomized, double-blind, placebo-controlled study. They were randomly divided into two groups: control group (CG) and the test group (TG), and both groups received the NSPT. TG also received homeopathic therapy, including Berberis, Mercurius solubilis/Belladonna/Hepar sulphur and Pyrogenium, while CG received placebo, while the TG received placebos. Clinical and laboratorial examinations were evaluated at baseline and after 1, 6 and 12 months of treatment.

Both groups showed significant improvement throughout the study for most of the parameters studied, but TG presented a significative gain of clinical attachment at 1 and 12 months compared to CG. Mean glucose and glycated haemoglobin significantly decreased in both groups after 6 and 12 months. However, there was a significant further reduction of these parameters in TG, as compared to CG.

The authors concluded that homeopathy as supplement of NSPT may further improve health condition, including glycemic control, in DMII patients with CP.

Over the years, I have learnt how to ‘sniff out’ studies that are odd. This is one of them, I fear; it smells strangely ‘fishy’.

Here are some of the reasons why I remain sceptical:

  1. There does not seem to be an approval by an ethics committee.
  2. I also could also not find any mention of informed consent.
  3. There is no mention of conflicts of interest
  4. Neither is the source of funding disclosed.
  5. There were zero drop-outs which I find hard to believe.
  6. The trial started in 2013, but was published only recently.
  7. The treatment with homeopathy lacks biological plausibility.
  8. The authors conducted > 50 tests for statistical significance without correcting for multiple testing.
  9. The clinical relevance of the findings is unclear.

Even if we accepted the results of this study, we would require at least one independent replication before we allow them to influence our clinical practice.

I have been sceptical about Craniosacral Therapy (CST) several times (see for instance here, here and here). Now, a new paper might change all this:

The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.

Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.

Compared to treatment as usual, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
  • disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).

Compared to manual/non-manual sham, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
  • disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;

Compared to active manual treatments, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
  • disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .

At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.

The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.

Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:

  1. The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
  2. Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
  3. The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
  4. This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
  5. One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
  6. The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
  7. Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.

Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.

So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

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