MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

systematic review

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The ‘Dr Rath Foundation’ just published a truly wonderful (full of wonders) article about me. I want to publicly congratulate the author: he got my name right [but sadly not much more]. Here is the opening passage of the article which I encourage everyone to read in full [the numbers in square brackets refer to my comments below].

Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science? [1]

Professor Edzard Ernst, a retired German [2] physician and academic, has recently [3] become a prominent advocate of plans that could potentially outlaw [4] the entire profession of naturopathic doctors [5] in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense” [6]. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own [7], Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others [8].

  1. When I was appointed at Exeter to research alternative medicine in 1993, I had already been a full professor at Hannover, Germany and subsequently at Vienna, Austria. If anything, coming to Exeter was a big step down in terms of ‘career’, salary, number of co-workers etc. (full details in my memoir)
  2. I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
  3. I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
  4. This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
  5. ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
  6. This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
  7. Since I am researching alternative medicine, I have conducted and published about 40 ‘scientific trials’, and before that time (1993) I have published about the same number again in various other fields.
  8. This refers to systematic reviews which, by definition, include all the studies available on a defines research question, regardless of their conclusion (their aim is to minimise random and selection biases)  .

I hope you agree that these are a lot of mistakes (or are these even lies?) in just a short paragraph.

Now you probably ask: who is Dr Rath?

Many reader of this blog will have heard of him. This is what the Guardian had to say about this man:

Matthias Rath, the vitamin campaigner accused of endangering thousands of lives in South Africa by promoting his pills while denouncing conventional medicines as toxic and dangerous, has dropped a year-long libel action against the Guardian and been ordered to pay costs.

A qualified doctor who is thought to have made millions selling nutritional supplements around the globe through his website empire, Rath claimed his pills could reverse the course of Aids and distributed them free in South Africa, where campaigners, who have won a hard-fought battle to persuade the government to roll out free Aids drugs to keep millions alive, believe Rath’s activities led to deaths.

The Dr Rath Foundation focuses its promotional activities on eight countries – the US, the UK, Germany, the Netherlands, South Africa, Spain, France and Russia – claiming that his micronutrient products will cure not just Aids, but cancer, heart disease, strokes and other illnesses…

I am sure you now understand why I am rather proud of being defamed by this source!

 

 

Dr Peter Fisher (I have mentioned him several times before, see for instance here, here and here) claimed in his recent editorial (Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017) – not yet available on Medline) that 43 systematic reviews of homeopathy have so far been published, and stated that “of these 21 were clearly or tentatively positive and 9 inconclusive”. In my book, this would mean that the majority of systematic reviews fail to be clearly positive. But Fisher seems to view this mini-statistic as a proof of homeopathy’s efficacy.

As evidence for his statement, Fisher cites this article from his own journal (‘Homeopathy’). However, the paper actually says this: “A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy’s clinical effectiveness; the other 20 were negative or non-conclusive.”

Odd?

Confused by this contradiction, I try to dig deeper. Medline provides currently 66 hits when searching systematic reviews of homeopathy. But this figure includes papers that are not really systematic reviews and excludes some relevant articles that are not Medline-listed.

The NHMRC report which Fisher also cites (see below) considered 57 systematic reviews of homeopathy. In his editorial, Fisher stated that the NHMRC report “seems to have missed some systematic reviews of homeopathy”. This can only mean that Fisher knows of more than 57 reviews. Why then does he claim that there are just 43?

Odd?

Yes, but Fisher’s editorial seems odd in several other ways as well.

  • He accuses the NHMRC-authors of ‘malpractice’.
  • He finds ‘shocking evidence of bias’.
  • He alleges that the EASAC-report ‘cherry-picks evidence’.
  • He accuses the EASAC-authors of ‘abuse of authority’.

Definitely odd!

Why does Dr Peter Fisher go this far, why is he so very aggressive?

I know Peter quite well. He is usually a fairly calm and collected sort of person who is not prone to irrational outbursts. This behaviour is therefore out of character.

So, why?

The only explanation that I have for his strange behaviour is that he feels cornered, has run out of rational arguments, and senses that homeopathy is now on its last leg.

What do you think?

The British press recently reported that a retired bank manager (John Lawler, aged 80) died after visiting a chiropractor in York. This tragic case was published in multiple articles, most recently in THE SUN. Personally, I find this regrettable – not the fact that the press warns consumers of chiropractic, but the tone and content of the articles.

Let me explain this by citing the one in THE SUN of today. Here is the critical bit that concerns me:

Ezvard Ernst, Emeritus Professor of Complementary Medicine at Exeter University, published a study showing at least 26 people had died as a result. He said: “The evidence is not in favour of chiropractic treatments. Nobody knows how many have suffered severe complications or died.” Edvard Ernst, Professor of Complementary Medicine, says many have suffered complications or died from chiropractors treatments… A study from Exeter University shows at least 26 people have died as a result of treatment.

And what is wrong with this?

The answer is lots:

  • My first name is consistently misspelled (a triviality, I agree).
  • I am once named as Emeritus Professor and once as Professor of Complementary Medicine. The latter is wrong (another triviality, perhaps, but some of my more demented critics have regularly accused me of carrying wrong titles)
  • The mention of 26 deaths after chiropractic treatments is problematic and arguably misleading (see below).
  • Our ‘study’ was not a study but a systematic review (another triviality?).

Now you probably think I am being pedantic, but I feel that the article is regrettable not so much by what it says but by what it fails to say. To understand this better, I will below copy my emails to the journalist who asked for help in researching this article.

  • My email of 17/10 answering all 7 of the journalist’s specific questions:
  • 1. Why are you sceptical of chiropractic?
  • I have researched the subject for more than 2 decades, and I know that the evidence is not in favour of chiropractic
  • 2. How many people do you believe have died in Britain as a result of being treated by a chiropractor? If it’s not possible to say, can you estimate?
  • nobody knows how many patients have suffered severe complications or deaths. there is no system to monitor such events that is comparable to the post-marketing surveillance of conventional medicine. we did some research and found that the under-reporting of cases of severe complications was close to 100% in the UK.
  • 3. What is so dangerous about chiropractic? Is there a particular physical treatment than endangers life?
  • manipulations that involve rotation and over-extension of the upper spine can lead to a vertebral artery breaking up. this causes a stroke which sometimes is fatal.
  • 4. Is the industry well regulated?
  • UK chiropractors are regulated by the General Chiropractic Council. it is debatable whether they are fit for purpose (see here:http://edzardernst.com/2015/02/the-uk-general-chiropractic-council-fit-for-purpose/)
  • 5. Should we be suspicious of claims that chiropractic can cure things like IBS and autism?
  • such claims are not based on good evidence and therefore misleading and unethical. sadly, however, they are prevalent.
  • 6. Who trains chiropractors?
  • there are numerous colleges that specialise in that activity.
  • 7. Is it true Prince Charles is to blame for the rise in popularity/prominence of chiropractic?
  • I am not sure. certainly he has been promoting all sorts of unproven treatments for decades.
  • My email of 18/10 answering 3 further specific questions
  • 1. Would you actively discourage anyone from being treated by a chiropractor?
    yes, anyone I feel responsible for
    2. Are older people particularly at risk or could one wrong move affect anyone?
    older people are at higher risk of bone fractures and might also have more brittle arteries prone to dissection
    3. If someone has, say, a bad back or stiff neck what treatment would you recommend instead of chiropractic?
    I realise every case is different, but you are sceptical of all complementary treatments (as I understand it) so what would you suggest instead?
    I would normally consider therapeutic exercises and recommend seeing a good physio.
  • 3. My email of 23/10 replying to his request for specific UK cases
  • the only thing I can offer is this 2001 paper
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1297923/
  • where we discovered 35 cases seen by UK neurologists within the preceding year. the truly amazing finding here was that NONE of them had been reported anywhere before. this means under-reporting was exactly 100%.

END OF QUOTES
I think that makes it quite obvious that much relevant information never made it into the final article. I also know that several other experts provided even more information than I did which never appeared.

The most important issues, I think, are firstly the lack of a monitoring system for adverse events, secondly the level of under-reporting and thirdly the 50% rate of mild to moderate adverse-effects. Without making these issues amply clear, lay readers cannot possibly make any sense of the 26 deaths. More importantly, chiropractors will now be able to respond by claiming: 26 deaths compare very favourably with the millions of fatalities caused by conventional medicine. In the end, the message that will remain in the heads of many consumers is this: CONVENTIONAL MEDICINE IS MUCH MORE DANGEROUS THAN CHIROPRACTIC!!! (The 1st comment making this erroneous point has already been published: Don’t be stupid Andy. You wanna discuss how many deaths occur due to medication side effects and drug interactions? There is a reason chiros have the lowest malpractice rates.)

Don’t get me wrong, I am not accusing the author of the SUN-article. For all I know, he has filed a very thoughtful and complete piece. It might have been shortened by the editor who may also have been the one adding the picture of the US starlet with her silicone boobs. But I am accusing THE SUN of missing a chance to publish something that might have had the chance of being a meaningful contribution to public health.

Perhaps you still think this is all quite trivial. Yet, after having experienced this sort of thing dozens, if not hundreds of times, I disagree.

Gastro-oesophageal reflux disease (GORD) is a common, benign condition. It can be treated by changing eating habits or drugs. Many alternative therapies are also on offer, for instance, acupuncture. But does it work? Let’s find out.

The objective of this meta-analysis was to explore the effectiveness of acupuncture for the treatment of gastro-oesophageal reflux disease (GORD). Four English and four Chinese databases were searched through June 2016. Randomised controlled trials investigating the effectiveness of manual acupuncture or electroacupuncture (MA/EA) for GORD versus or as an adjunct to Western medicine (WM) were selected.

A total of 12 trials involving 1235 patients were included. The results demonstrated that patients receiving MA/EA combined with WM had a superior global symptom improvement compared with those receiving WM alone  with no significant heterogeneity. Recurrence rates of those receiving MA/EA alone were lower than those receiving WM  with low heterogeneity, while global symptom improvement (six studies) and symptom scores (three studies) were similar. Descriptive analyses suggested that acupuncture also improves quality of life in patients with GORD.

The authors concluded that this meta-analysis suggests that acupuncture is an effective and safe treatment for GORD. However, due to the small sample size and poor methodological quality of the included trials, further studies are required to validate our conclusions.

I am glad the authors used the verb ‘suggest’ in their conclusions. In fact, even this cautious terminology is too strong, in my view. Here are 9 reasons why:

  1. The hypothesis that acupuncture is effective for GORD lacks plausibility.
  2. All the studies were of poor or very poor methodological quality.
  3. All but one were from China, and we know that all acupuncture trials from this country are positive, thus casting serious doubt on their validity.
  4. Six trials had the infamous ‘A+B versus B’ design which never generates a negative result.
  5. There was evidence of publication bias, i. e. negative trials had disappeared and were thus not included in the meta-analysis.
  6. None of the trials made an attempt to control for placebo effects by using a sham-control procedure.
  7. None used patient-blinding.
  8. The safety of a therapy cannot be assessed on the basis of 12 trials
  9. Seven studies failed to report adverse effects, thus violating research ethics.

Considering these facts, I think that a different conclusion would have been more appropriate:  this meta-analysis provides no good evidence for the assumption that acupuncture is an effective and safe treatment for GORD.

Reiki has been on my mind repeatedly (see for instance here, here, here and here). It is one of those treatments that are too crazy for words and too implausible to mention. Yet a new paper firmly claims that it is more than a placebo.

This review evaluated clinical studies of Reiki to determine whether there is evidence for Reiki providing more than just a placebo effect. The available English-language literature of Reiki was reviewed, specifically for

  • peer-reviewed clinical studies,
  • studies with more than 20 participants in the Reiki treatment arm,
  • studies controlling for a placebo effect.

Of the 13 suitable studies,

  • 8 demonstrated Reiki being more effective than placebo,
  • 4 found no difference but had questionable statistical resolving power,
  • one provided clear evidence for not providing benefit.

The author concluded that these studies provide reasonably strong support for Reiki being more effective than placebo. From the information currently available, Reiki is a safe and gentle “complementary” therapy that activates the parasympathetic nervous system to heal body and mind. It has potential for broader use in management of chronic health conditions, and possibly in postoperative recovery. Research is needed to optimize the delivery of Reiki.

These are truly fantastic findings! Reiki is more than a placebo – would have thought so? Who would have predicted that something as implausible as Reiki would one day be shown to work?

Now let’s start re-writing the textbooks of physics and therapeutics and research how we can optimize the delivery of Reiki.

Hold on – not so quick! Here are a few reasons why we might be sceptical about the validity of this review:

  • It was published in one of the worst journals of alternative medicine.
  • The author claimed to include just clinical trials but ended up including non-clinical studies and animal studies.
  • Four trials were not double-blind.
  • There was no critical assessment of the studies methodological quality.
  • The many flaws of the primary studies were not mentioned in this review.
  • Papers not published in English were omitted.
  • The author who declared no conflict of interest has this affiliation: “Australasian Usui Reiki Association, Oakleigh, Victoria, Australia”.

I think we can postpone the re-writing of textbooks for a little while yet.

Mastitis is a common disease in dairies. Numerous non-antimicrobial drugs and treatment strategies have been recommended for this condition. Homeopaths in particular have long claimed that their highly diluted remedies are an effective option, and I have reported repeatedly about the evidence – see here, here, and here, for instance. Even though it is far from positive, evangelic homeopaths like our friend Dana Ullman or naïve quackery-fans like Prince Charles claim that it is “as effective as antibiotics, the mastitis treatment of choice”.

So, who is right?

I am biased, homeopaths insist.

Ullman is a joke, any rational thinker must admit.

Prince Charles? … no comment.

What we need is an independent body to look at the data.

A new systematic review did exactly that. Its authors are highly respected and come from institutions that are not likely to promote bogus claims:

  • Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
  • Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
  • Canadian Bovine Mastitis and Milk Quality Research Network, Canada
  • Canadian Bovine Mastitis and Milk Quality Research Network, Canada
  • Sherbrooke Research and Development Centre, Agriculture and Agri-Food Canada
  • Canadian Bovine Mastitis and Milk Quality Research Network, Canada
  • Département de Pathologie et Microbiologie, Faculté de Médecine Vétérinaire, Université de Montreal, Canada.

It was performed with studies written in English or French selected from CAB Abstracts, PubMed, and Web of Science. All treatments other than conventional antimicrobials for clinical mastitis during lactation were retained. Only studies comparing the treatment under investigation to a negative or positive control, or both, were included. Outcomes evaluated were clinical and bacteriological cure rates and milk production. Selection of the study, data extraction, and assessment of risk of bias was performed by 3 reviewers. Assessment of risk of bias was evaluated using the Cochrane Collaboration tool for systematic review of interventions.

A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and one was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on non-inferiority or non-superiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis.

The authors concluded that homeopathic treatments are not efficient for management of clinical mastitis.

Will this finally stop homeopaths from claiming that their placebos work for mastitis?

I would not count on it!

Insomnia is a ‘gold standard’ indication for alternative therapies of all types. In fact, it is difficult to find a single of these treatments that are not being touted for this indication. Consequently, it has become a nice little earner for alternative therapists (hence ‘gold standard’).

But how good is the evidence suggesting that any alternative therapy is effective for insomnia?

Whenever I have discussed this issue on my blog, the conclusion was that the evidence is less than convincing or even negative. Similarly, whenever I conducted proper systematic reviews in this area, the evidence turned out to be weak or negative. Here are four of the conclusions we drew at the time:

“But this ERNST fellow cannot be trusted, he is not objective!”, I hear some of my detractors shout.

But is he really?

Would an independent, high-level panel of experts arrive at more positive conclusions?

Let’s find out!

This European guideline for the diagnosis and treatment of insomnia recently provided recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations.

The findings and recommendations are as follows:

  • Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence).
  • A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).
  • Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence).
  • Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).

I think, I can rest my case.

Shinrin-yoku means “taking in the forest atmosphere” or “forest bathing.” It was developed in Japan during the 1980s and has, according to its proponents, become a cornerstone of preventive health care and healing in Japanese medicine. Researchers primarily in Japan and South Korea have established a robust body of scientific literature on the health benefits of spending time under the canopy of a living forest… there have been many scientific studies that are demonstrating the mechanisms behind the healing effects of simply being in wild and natural areas. (some of this research is available here). For example, many trees give off organic compounds that support our “NK” (natural killer) cells that are part of our immune system’s way of fighting cancer.

The claimed benefits of Shinrin-yoku are remarkable:

  • Boosted immune system functioning, with an increase in the count of the body’s Natural Killer (NK) cells.
  • Reduced blood pressure
  • Reduced stress
  • Improved mood
  • Increased ability to focus, even in children with ADHD
  • Accelerated recovery from surgery or illness
  • Increased energy level
  • Improved sleep
  • Deeper and clearer intuition
  • Increased flow of energy
  • Increased capacity to communicate with the land and its species
  • Increased flow of eros/life force
  • Deepening of friendships
  • Overall increase in sense of happiness

But is any of this really true?

The aim of this state-of-the-art review was to summarise empirical research conducted on the physiological and psychological effects of Shinrin-Yoku. Research published from 2007 to 2017 was considered. A total of 64 studies met the inclusion criteria. According to the authors, they show that health benefits associated with the immersion in nature continue to be currently researched. Longitudinal research, conducted worldwide, is needed to produce new evidence of the relationships associated with Shinrin-Yoku and clinical therapeutic effects. Nature therapy as a health-promotion method and potential universal health model is implicated for the reduction of reported modern-day “stress-state” and “technostress.”

Odd?

Yes!

A look at the primary studies reveals that they are usually small and of poor quality.

Perhaps a brand new  review aimed more specifically at evaluating preventive or therapeutic effects of Shinrin-Yoku on blood pressure can tell us more. The authors considered all published, randomized, controlled trials, cohort studies, and comparative studies that evaluated the effects of the forest environment on changes in systolic blood pressure. Twenty trials involving 732 participants were reviewed. Systolic and diastolic blood pressure of patients submitted to the forest environment was significantly lower than that of controls. The authors concluded that this systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.

I find this paper odd as well:

  • it lacks important methodological detail;
  • the authors included not just controlled clinical trials but all sorts of ‘studies’;
  • there is no assessment of the methodological rigor of the primary trials (from what I could see, they were mostly too poor to draw any conclusions from them).

What does all of this mean?

I have no problems in assuming that relaxation in a forest is beneficial in many ways and a nice experience.

But why call this a therapy?

It is relaxation!

Why make so many unsubstantiated claims?

And why study it in such obviously flawed ways?

All this does, I fear, is giving science a bad name.

The UK ‘Faculty of Homeopathy’ (FoH) is the professional body of British doctors who specialise in homeopathy. As doctors, FoH members have been to medical school and should know about evidence, science etc., I had always thought. But perhaps I was mistaken?

The FoH has a website with an interesting new post entitled ‘Scientific evidence and Homeopathy’. Here I have copied the section on CLINICAL TRIALS OF HOMEOPATHY. I have read it several times and must admit: it is a masterpiece, in my view – not a masterpiece in accurate reporting, but a masterpiece in misleading the public. The first and most obvious thing that struck me is the fact that is cites not a single clinical trial. But read for yourself (the numbers in round brackets were inserted by me and refer to my comments below):

START OF QUOTE

By August 2017 1,138 clinical trials of homeopathy had been published (1). Details can be found on the CORE-HOM database also maintained by the Carstens Foundation and accessible without charge: http://archiv.carstens-stiftung.de/core-hom

Four (2) systematic review/meta-analyses of homeopathy for all conditions have been published.[26],[27],[28]  Of these, three (3) reached a positive conclusion: that there is evidence that homeopathy is clinically effective (4). The exception is the review by Shang et al.46  This meta-analysis was controversial, particularly because its conclusions were based on only eight clinical trials whose identity was concealed until several months after the publication, precluding informed examination of its results (5) (6). The only undisputed conclusion (7) of this paper is that clinical trials of homeopathy are of higher quality than matched trials of conventional medicine: of 110 clinical trials each of homeopathy and conventional medicine, 21 trials of homeopathy but only 9 trials of conventional medicine were of ‘higher quality’.[29] [30]

A leading Swedish medical researcher (8) remarked: To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be dis­regarded.  Alternatively, flawed statistical methods had to be applied.”[31] Higher quality equates to less risk of bias, Mathie et al analysed randomized clinical trials of individualized homeopathy, showing that the highest quality trials yielded positive results (9).[32]

Systematic reviews of randomized controlled trials of homeopathy in specific clinical situations have also yielded positive results, including: allergies and upper respiratory tract infections (2 systematic reviews),[33],[34] (10) (11) Arnica in knee surgery,[35] (12) Childhood diarrhoea,[36] Post-operative ileus,[37] (13) Rheumatic diseases,[38] (14) Seasonal allergic rhinitis (hay fever) (2 systematic reviews),[39] [40] (15) (16) and vertigo.[41] (17)

END OF QUOTE

MY COMMENTS:

  1. This is a wild exaggeration which was made possible by counting all sorts of clinical reports as ‘clinical trials’. A clinical trial  “follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes.” This would exclude most observational studies, case series, case reports. However, the figure cited here includes such reports.
  2. The author cites only three!
  3. Does the author mean ‘two’?
  4. This is not quite true! I have dedicated an entire post to this issue.
  5. True, the Shang meta-analysis has been criticised – but exclusively by homeopaths who, for obvious reasons, were unable to accept its negative findings. In fact, it is a solid piece of research.
  6. Why does the author not mention the most recent systematic review of homeopathy?  Perhaps because it concluded: Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
  7. Really? Undisputed? Even by the logic of the author’s last sentence, this would be disputed.
  8. The ‘leading researcher’ is Prof Hahn who has featured many times on my blog. He seems to be more than a little unhinged when it comes to the topic of homeopathy.
  9. The author forgot to mention that Mathie – who was sponsored by the British Homeopathic Association – included this little caveat in his conclusions: The low or unclear overall quality of the evidence prompts caution in interpreting the findings.
  10. Reference 33 is the infamous ‘Swiss report’ that has been shown to be fatally flawed over and over again.
  11. Reference 34 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  12. This review concluded: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial. Only a deluded homeopath can call this a ‘positive result’.
  13. This is a systematic review by my team. It showed that several flawed trials produced a false positive result, while the only large multicentre trial was negative. Our conclusions therefore include the statement that  several caveats preclude a definitive judgment. Only a deluded homeopath can call this a ‘positive result’.
  14. This reference refers to the following abstract: Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide. Only a deluded homeopath can call this a ‘positive result’.
  15. The first reference refers to a paper where the author analysed three of his own studies.
  16. Reference 40 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  17. This reference refers to a review of Vertigoheel@ that includes observational studies. One of its authors was an employee of the manufacturer of the product. Vertigoheel is not a homeopathic remedy (it does not adhere to the ‘like cures like’ principle) but a homotoxicologic product. Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel. Our own systematic review of RCTs of homotoxicology included 7 trials which were mostly of a high methodological standard, according to the Jadad score. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest. Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

So!

What do we make of all this?

To say that it is disappointing would, I think, be an understatement. The FoH is not supposed to be a lobby group of amateurs ignorant of science and evidence; it is a recognised professional organisation who must behave ethically. Patients and consumers should be able to trust the FoH. The fact that the FoH publish misinformation on such a scale should, in my view, be a matter for the General Medical Council.

On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that

  • mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
  • serious adverse effects are being reported regularly;
  • the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
  • the consequences can be permanent neurological deficits and even deaths;
  • under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
  • there is no system to accurately monitor the risks;
  • chiropractors are in denial of these problems.

Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.

The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%  of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.

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