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

clinical trial

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Bioresonance is an alternative therapeutic and diagnostic method employing a device developed in Germany by the scientology member Franz Morell in 1977. The bioresonance machine was further developed and marketed by Morell’s son in law Erich Rasche and is also known as ‘MORA’ therapy (MOrell + RAsche). Bioresonance is based on the notion that one can diagnose and treat illness with electromagnetic waves and that, via resonance, such waves can influence disease on a cellular level. Bioresonance instruments are akin to the scientologists’ ‘E-meter’ which essentially consists of an electronic circuit measuring skin conductivity.

Until recently, just three studies of bioresonance had been published.

  1. The first was from Germany and suggested that it is effective for treating GI symptoms. This trial was, however, tiny and its findings are likely to be false-positive.
  2. The second study is from Turkey and suggested that it works for smoking cessation. It is a ‘pilot study’ that has never been followed by a definitive trial.
  3. The third trial was a double-blind, parallel group study in children with long-lasting atopic dermatitis. Over a period of 1.5 year, 32 children were randomised to receive conventional inpatient therapy and either a putatively active or a sham (placebo) bioresonance treatment. Short- and long-term outcome within 1 year were assessed by skin symptom scores, sleep and itch scores, blood cell activation markers of allergy, and a questionnaire. The results showed that bioresonance had no effect on the outcome.

Now a most ingenious study can be added to this list. Unfortunately, I was published in German, but bear with me, I will explain below. First the original abstract for those who can read German:

Hintergrund

Trotz aller Aufklärungsarbeit wird die Bioresonanz weiter benutzt. Seit einigen Jahren sind modifizierte Geräte auf dem Markt, die auch in Reformhäusern zum Einsatz kamen.

Methoden

Zwei moderne Bioresonanzgeräte, Bioscan-SWA und Vieva Vital-Analyser, wurden untersucht: Neun freiwillige Probanden (vier Frauen, fünf Männer), zwei männliche Patienten, eine Leiche, jeweils frischer Leberkäse (Fleischbrät) und ein feuchtes Tuch nahmen teil. Unter gleichen oder fingierten Angaben von Namen, Geburtsdatum, Geschlecht, Körpergröße und Gewicht der Probanden beziehungsweise Patienten wurden wiederholt Einzelmessungen und Vergleichsuntersuchungen von Proband/Patient, Leberkäse und feuchtem Tuch durchgeführt (nach den Angaben der Hersteller).

Ergebnisse

Bestehende Diagnosen schwer erkrankter Patienten wurden nicht erkannt, der Leiche beste Gesundheit neben einer Fülle potenzieller Gesundheitsrisiken attestiert, ebenso wie allen Probanden. Messungen an frischem Leberkäse sowie an einem feuchten Tuch unter verschiedenen Angaben zu Alter, Geschlecht, Körpergröße, Gewicht und Namen führten zu unterschiedlichsten Befunden mit relativen Standardabweichungen bis über 200 %. Andererseits waren Ergebnisse, die unter gleichen Probanden- beziehungsweise Patientendaten am feuchten Tuch und dem Fleischbrät gewonnen wurden, nahezu identisch mit denen, die von den Probanden beziehungsweise Patienten erzielt wurden.

Schlussfolgerung

Die Gerätschaften waren nicht imstande, die jeweiligen Testmaterialien zu unterscheiden. Es wird vermutet, dass die Überbrückung der beiden Pole der Untersuchungssonde durch schwach leitende Materialien eine Software aktiviert, die gesundheitsrelevante Befunde erzeugt. Wir empfehlen als einfache Tests für die Validität von Bioresonanzergebnissen den Leberkäse- oder verwandte Tests.

And here is my explanation.

The study tested the diagnostic validity of two different bioresonance machines commercially available in Germany. The tests were carried out on:

  • 9 healthy volunteers
  • 2 seriously ill patients
  • 1 human corpse
  • 1 liver pate
  • 1 wet towel

The results show that the bioresonance method

  • failed to diagnose serious diseases in the patients,
  • produced a clean bill of health for the corpse,
  • diagnosed a host of health risks in the volunteers,
  • produced variable results for the liver pate and the wet towel with standard deviations for repeated tests exceeding 200%,
  • generated no real differences between the wet towel and the healthy volunteers.

This study was published in 2019. It would be interesting to monitor whether the sales figures for bioresonance machines will now dwindle. Even though I am an incorrigible optimist, I shall not hold my breath.

Resveratrol is one of the most popular dietary supplements. It is an antioxidant found in red grape skin, Japanese knotweed, blueberries and other berries. Resveratrol is available as dietary supplements from red wine extracts, grape seed extracts, Japanese knotweed extracts and other plants. The amount and purity of resveratrol in supplements varies significantly; absorption in the gut is low.

While, for many supplements, there is no or very little research, this one has a huge amount. So, has reseveratrol any proven health effects demonstrated in clinical trials?

The answer is encouraging.

This abstract provides a useful summary:

Resveratrol is a polyphenolic nutraceutical that exhibits pleiotropic activities in human subjects. The efficacy, safety, and pharmacokinetics of resveratrol have been documented in over 244 clinical trials, with an additional 27 clinical trials currently ongoing. Resveretrol is reported to potentially improve the therapeutic outcome in patients suffering from diabetes mellitus, obesity, colorectal cancer, breast cancer, multiple myeloma, metabolic syndrome, hypertension, Alzheimer’s disease, stroke, cardiovascular diseases, kidney diseases, inflammatory diseases, and rhinopharyngitis. The polyphenol is reported to be safe at doses up to 5 g/d, when used either alone or as a combination therapy. The molecular basis for the pleiotropic activities of resveratrol are based on its ability to modulate multiple cell signaling molecules such as cytokines, caspases, matrix metalloproteinases, Wnt, nuclear factor-κB, Notch, 5′-AMP-activated protein kinase, intercellular adhesion molecule, vascular cell adhesion molecule, sirtuin type 1, peroxisome proliferator-activated receptor-γ coactivator 1α, insulin-like growth factor 1, insulin-like growth factor-binding protein 3, Ras association domain family 1α, pAkt, vascular endothelial growth factor, cyclooxygenase 2, nuclear factor erythroid 2 like 2, and Kelch-like ECH-associated protein 1. Although the clinical utility of resveratrol is well documented, the rapid metabolism and poor bioavailability have limited its therapeutic use. In this regard, the recently produced micronized resveratrol formulation called SRT501, shows promise. This review discusses the currently available clinical data on resveratrol in the prevention, management, and treatment of various diseases and disorders. Based on the current evidence, the potential utility of this molecule in the clinic is discussed.

This is a comprehensive review but it fails to critically assess the quality of the clinical trials. Once we do that, we are likely to get disappointed. Many studies are just not up to the mark.

And if we consult a Cochrane review, our enthusiasm for resveratrol disappears completely: Currently, research is insufficient for review authors to evaluate the safety and efficacy of resveratrol supplementation for treatment of adults with T2DM [type 2 diabetes mellitus]. The limited available research does not provide sufficient evidence to support any effect, beneficial or adverse, of four to five weeks of 10 mg to 1000 mg of resveratrol in adults with T2DM. Adequately powered RCTs reporting patient-relevant outcomes with long-term follow-up periods are needed to further evaluate the efficacy and safety of resveratrol supplementation in the treatment of T2DM.

So, for the time being, I might just continue to obtain my resveratrol in very small but regular doses from red wine, I think.

 

 

Yes, this blog is about so-called alternative medicine (SCAM) – but today is an exception.

There has been much news coverage of potential treatments of coronavirus. Some of the candidates such as hydroxychloroquine, have even been tested in clinical trials. However, due to the preliminary nature of these studies, the value of of the drugs remains uncertain.

What is needed in our present dire situation is a large and rigorous trial of already licensed drugs that might have a positive effect. With a bit of luck, such a study could save thousands of lives.

Unfortunately, setting up a trial of this nature is difficult and takes time.

Now the UK’s government has announced that the world’s largest randomised clinical trial of potential coronavirus treatments has been running since 19 March. It was designed, planned, approved and implemented in record time. The study is aimed at testing several promising treatments. If the findings are positive, they will be given to NHS patients as quickly as possible.

Almost 1,000 patients from 132 different UK hospitals have to date been recruited. The trial is testing a number of medicines recommended by an expert panel advising the Chief Medical Officer for England. They include:

  • Lopinavir-Ritonavir, commonly used to treat HIV
  • Dexamethasone, a type of steroid use in a range of conditions to reduce inflammation
  • Hydroxychloroquine, a treatment for malaria

Adult patients who have been admitted to hospital with COVID-19 are being invited to take part. The trial is designed such that, as further promising drugs are identified, they can be added to the study within days. Patients who volunteer are randomly allocated to

  1. standard care alone,
  2. or to standard of care plus one of the additional drugs.

The data will be analysed on a rolling basis so that any beneficial treatments are identified as soon as possible.

This study seems like an excellent idea. I do hope it is successful and manages to find a drug that increases the chances of survival. I keep my fingers crossed.

 

PS

Please note that the scientists did not include homeopathy or other SCAMs into their trial.

During the last 30 years, I must have read a few thousand studies of so-called alternative medicine (SCAM). Some made me angry because of their methodological flaws or wrong conclusions. A few impressed me. Many made me giggle. But none has ever caused me to laugh out so long as this one entitled ‘A STUDY ON THE PROPHYLACTIC EFFICACY OF HOMOEOPATHIC PREVENTIVE’.

Here is its abstract:

Homoeopathy has established its supremacy in the control of infectious viral diseases. The widespread acclaim in this regard is now supported by this study. The study was conducted in the Chikungunya fever hit areas of Kerala. The genus epidemicus was selected after detailed analysis of the first cases of Chikungunya. This preventive medicine was widely distributed in the disease prevalent areas. A survey was conducted for the evaluation of prophylactic efficacy. The study showed a very high significant effect of Homeopathic medicine in the prevention of Chikungunya fever.

You are, of course, correct to defend the Indian authors: it is unfair to judge a study purely on its abstract. So, let’s have a look at the rest. After a lengthy introduction, the heart of the full paper discloses the amazing details of the study.

Here I present the unabridged text of the study; the only part I have omitted is the introduction:

Aims and Objectives

1. To assess the efficacy of Homoeopathic medicine in the prevention of Chikungunya.
2. To determine the magnitude of incidence, clinical features, mortality , social & economic impact of the Chikungunya epidemic.

Conclusion

The Homoeopathic preventive medicine distributed for Chikungunya epidemic was highly effective.

THAT’S ALL!

My critics regularly display a lot of imagination. For instance, some come up with the claim that I have never done any original research.

Well, I have!

How much?

A lot.

The precise answer depends on how you define original research.

Usually, my detractors then focus on clinical trials. Prof Ernst can only criticise and find fault in studies of so-called alternative medicine (SCAM) published by others, they claim, but he never did a single clinical trial in his life!

Well, I have!

The allegation came up recently in a legal case that I am involved in, and I was asked to prove that it is false. I skimmed through my files and found something that I had almost forgotten about. Until my retirement in 2012, I had kept a record entitled THE EVIDENCE, A DOCUMENTATION OF OUR CLINICALLY RELEVANT RESEARCH. The document is based on 470 of our published articles and 35 of our clinical trials (I do not know many SCAM-researchers who have done more).

For the legal case, I also did a Medline-search to get the links of clinical trials including the ones before the Exeter job. The list is quite incomplete but, for what it’s worth, here it is:

  1. Placebo-controlled, double-blind study of haemodilution in peripheral arterial disease Ernst E, et al. Lancet 1987 – Clinical Trial. PMID 2885450
  2. Regular sauna bathing and the incidence of common colds Ernst E, et al. Ann Med 1990 – Clinical Trial. PMID 2248758
  3. A single blind randomized, controlled trial of hydrotherapy for varicose veins Ernst E, et al. Vasa 1991 – Clinical Trial. PMID 1877335
  4. Effects of felodipine ER and hydrochlorothiazide on blood rheology in essential hypertension–a randomized, double-blind, crossover study Koenig W, et al. J Intern Med 1991 – Clinical Trial. Among authors: Ernst E. PMID 2045762
  5. Does pentoxifylline prolong the walking distance in exercised claudicants? A placebo-controlled double-blind trial Ernst E, et al. Angiology 1992 – Clinical Trial. PMID 1536472
  6. Exercise therapy for osteoporosis: results of a randomised controlled trial Preisinger E, et al. Br J Sports Med 1996 – Clinical Trial. Among authors: Ernst E. PMID 8889112 Free PMC article.
  7. Randomized trial of acupuncture for nicotine withdrawal symptoms White AR, et al. Arch Intern Med 1998 – Clinical Trial. Among authors: Ernst E. PMID 9818805
  8. Randomized, double-blind trial of chitosan for body weight reduction Pittler MH, et al. Eur J Clin Nutr 1999 – Clinical Trial. Among authors: Ernst E. PMID 10369493 Free article
  9. A randomized trial of distant healing for skin warts Harkness EF, et al. Am J Med 2000 – Clinical Trial. Among authors: Ernst E. PMID 10781776
  10. Can singing exercises reduce snoring? A pilot study Ojay A and Ernst E. Complement Ther Med 2000 – Clinical Trial. PMID 11068344
  11. A blinded investigation into the accuracy of reflexology charts White AR, et al. Complement Ther Med 2000 – Clinical Trial. Among authors: Ernst E. PMID 11068346
  12. Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial White AR, et al. Cephalalgia 2000 – Clinical Trial. Among authors: Ernst E. PMID 11128820
  13. Spiritual healing as a therapy for chronic pain: a randomized, clinical trial Abbot NC, et al. Pain 2001 – Clinical Trial. Among authors: Ernst E. PMID 11240080
  14. Randomised controlled trial of reflexology for menopausal symptoms Williamson J, et al. BJOG 2002 – Clinical Trial. Among authors: Ernst E. PMID 12269681 Free article.
  15. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials Park J, et al. Acupunct Med 2002 – Clinical Trial. Among authors: Ernst E. PMID 12512790
  16. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery Stevinson C, et al. J R Soc Med 2003 – Clinical Trial. Among authors: Ernst E. PMID 12562974 Free PMC
  17. Randomized, double-blind, placebo-controlled trial of autologous blood therapy for atopic dermatitis Pittler MH, et al. Br J Dermatol 2003 – Clinical Trial. Among authors: Ernst E. PMID 12588384
  18. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial White A, et al. Thorax 2003 – Clinical Trial. Among authors: Ernst E. PMID 12668794 Free PMC article.
  19. Multiple n = 1 trials in the identification of responders and non-responders to the cognitive effects of Ginkgo biloba Canter PH and Ernst E. Int J Clin Pharmacol Ther 2003 – Clinical Trial. PMID 12940592
  20. Effectiveness of artichoke extract in preventing alcohol-induced hangovers: a randomized controlled trial Pittler MH, et al. CMAJ 2003 – Clinical Trial. Among authors: Ernst E. PMID 14662662 Free PMC article.
  21. Autogenic training reduces anxiety after coronary angioplasty: a randomized clinical trial Kanji N, et al. Am Heart J 2004 – Clinical Trial. Among authors: Ernst E. PMID 14999212
  22. Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre? Wilcock A, et al. Palliat Med 2004 – Clinical Trial. Among authors: Ernst E. PMID 15198118
  23. Randomised controlled trial of magnetic bracelets for relieving pain in osteoarthritis of the hip and knee Harlow T, et al. BMJ 2004 – Clinical Trial. Among authors: Ernst E. PMID 15604181 Free PMC article.
  24. Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial Park J, et al. Arch Intern Med 2005 – Clinical Trial. Among authors: Ernst E. PMID 16186474
  25. Autogenic training to reduce anxiety in nursing students: randomized controlled trial Kanji N, et al. J Adv Nurs 2006 – Clinical Trial. Among authors: Ernst E. PMID 16553681
  26. Autogenic training to manage symptomology in women with chest pain and normal coronary arteries Asbury EA, et al. Menopause 2009 – Clinical Trial. Among authors: Ernst E. PMID 18978640
  27. The effects of triple therapy (acupuncture, diet and exercise) on body weight: a randomized, clinical trial Nourshahi M, et al. Int J Obes (Lond) 2009 – Clinical Trial. Among authors: Ernst E. PMID 19274056

Five things I like about the list:

  1. It is long.
  2. It displays a wide variety of subjects.
  3. It hardly depicts me as a ‘pharma shill’.
  4. Most of the trials were published in top journals (suggesting they were of decent quality).
  5. It reminds me how much fun these studies often were (I wrote a chapter about No13 in my memoir, and I could write [very amusing] short stories about No 20 and [less funny but baffling] about No 17 and 23)

So, the next time they claim ‘Prof Ernst never did any clinical trials’, I will be able to shut them up by simply showing them this post.

I am looking forward to it!

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.

It seems that some people are pushing the notion that Boiron’s homeopathic product

Oscillococcinum®

might be helpful for the prevention and/or treatment of the Corona virus infection. To get an idea how implausible this assumption is, read my previous post on the subject.

The website of Boiron, the producer of the product, seems undeterred by plausibility and states the following:

Clinical studies show Boiron Oscillococcinum (Oscillo®) reduces the duration and severity of flu-like symptoms when taken at the onset of symptoms.1-2 Oscillo does not cause drowsiness and has no known or reported drug interactions.

Uses*

  • Temporarily relieves flu-like symptoms such as body aches, headache, fever, chills and fatigue
  • Non-drowsy; no drug interactions
  • Easy-to-take, quick-dissolving pellets
  • For everyone 2 years of age and older
  • Make sure your patients always have Oscillococcinum on hand—it works best when taken at the first sign of symptoms. Help your patients feel better before they feel worse.

While this text does not state that Oscillococcinum works for the coronavirus, one could easily read it as implying it, particularly if one also considers this tweet:

Oscillococcinum USA
@OscilloUSA
Getting sick when travelling can ruin the best of vacations. Take non-drowsy Oscillococcinum the moment you feel body aches, headache, fever, chills or fatigue coming on. http://bit.ly/2BGCmCz
________________________________________________________________________________
On the Internet we find many much more direct claims. Take this website, for instance:

The commonly indicated Homeopathic remedies for Coronavirus are: –
• OSCILLOCOCCINUM
• Arsenic Album
• INFLUENZINUM

**However, for best results contact a Qualified Homeopathic doctor so that correct medicines can be prescribed.

And even some politicians promote such irresponsible nonsense.

________________________________________________________________________________

All the claims about Oscillococcinum have one thing in common: they are not evidence based! Any notion that it might work against the coronavirus is pure fantasy. And the above statement by Boiron is based on two cherry-picked studies. The totality of the evidence, however, does not show that Oscillococcinum is effective. The current Cochrane review says about its effectiveness: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).

The reason, I guess, why this conclusion is not more forthright stating THERE IS NO GOOD EVIDENCE THAT OSCILLOCOCCINUM HAS ANY EFFECT can be found in the list of conflicts of interest of the paper’s authors:

All three review authors are research‐active in the field of homeopathy. They were members of the International Scientific Committee for Homeopathic Investigations (ISCHI), whose membership also included two employees of Boiron (the manufacturers of Oscillococcinum®), and whose committee activities ceased in July 2013. Progress with the Cochrane Review on Oscillococcinum® was presented briefly at ISCHI meetings in 2010 and 2011. The drafting of this Cochrane Review was carried out independently of those communications and of the authors’ other ongoing research activity. ISCHI has not run or sponsored any research on Oscillococcinum®.

Robert T Mathie: Dr Mathie is Research Development Adviser, British Homeopathic Association. He was a member of the International Scientific Committee on Homeopathic Investigations, which ceased its committee activities in July 2013. Joyce Frye: Part of Dr Frye’s salary was supported by a research grant from the Standard Homeopathic Company, paid to her employer, the Center for Integrative Medicine, Department of Family Medicine, University of Maryland, USA. Support ended in June 2013 when Dr Frye resigned from the University of Maryland. Standard Homeopathic Company does not manufacture Oscillococcinum or any similar product, and had no interest in the outcome of the review. Dr Frye received honoraria from the International Scientific Committee on Homeopathic Investigations, which was dissolved in July 2013. Peter Fisher: I am Expert Adviser on Complementary and Alternative Medicine to the National Institute for Health and Clinical Excellence (NICE), which may take an interest in the evidence in this review. I am Editor in Chief of an international, peer‐reviewed journal dedicated to homeopathy. All payments and reimbursements for lectures have been from universities or professional or learned societies. None of these lectures has been dedicated to the subject of this review. Some meetings have been supported by grants from commercial interests, including the manufacturer of the product that is the subject of the review.

So, to be clear: oscillococcinum does not help against the corona or any other virus. Those who claim otherwise are either mistaken, or have a commercial interest, or both.

It is not often that a top journal reports a trial of a (mostly) herbal remedy. For this reason alone, this Italian study (published in the Journal of the American Heart Association) is remarkable.

Sixty‐nine uncontrolled hypertension patients, aged 40 to 68 years, on antihypertensive medication were enrolled in 2 double‐blind studies. In the first study, 45 were randomized to placebo or a new nutraceutical combination named AkP05. Blood pressure (BP), endothelial function, and circulating nitric oxide were assessed before and at the end of 4 weeks of treatment. In the second study, 24 patients were randomized to diuretic or AkP05 for 4 weeks and underwent a cardiopulmonary exercise test to evaluate the effects of AkP05 on functional capacity of the cardiovascular, pulmonary, and muscular systems. Furthermore, vascular and molecular studies were undertaken on mice to characterize the action of the single compounds contained in the AkP05 nutraceutical combination.

AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O2 uptake, stress tolerance, and maximal power output. In mice, AkP05 reduced BP and improved endothelial function, evoking increased nitric oxide release through the PKCα/Akt/endothelial nitric oxide synthase pathway and reducing reactive oxygen species production via NADPH‐oxidase inhibition. These effects were mediated by synergism of the single compounds of AkP05.

The authors concluded that this is the first study reporting positive effects of a nutraceutical combination on the vasculature and exercise tolerance in treated hypertensive patients. Our findings suggest that AkP05 may be used as an adjunct for the improvement of cardiovascular protection and to better control BP in uncontrolled hypertension.

These are good studies, it seems. However, I am puzzled by the authors’ conclusions:

  1. I very much doubt that this is the first such study.
  2. The studies did not test AkP05 ‘as an adjunct’, so their findings cannot suggest that it should be used as such.

And now you are, of course, all dying to learn what this new wonder nutraceutical contains. It is a mixture of Bacopa monnieri, extract of Ginkgo biloba leaves, extract of green tea leaves, and phosphatidylserine and is manufactured by Damor Farmaceutici, Italy.

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.

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