evidence
The German Heilpraktiker (a phenomenon vaguely equivalent to the ‘naturopath’ in English speaking countries) has become a fairly regular feature on this blog – see, for instance here, here, and here. The nationally influential German Medical Journal, a weekly publication of the German Medical Association, recently published an article about the education of this profession.
In it, we are told that the German Ministry of Health has drafted a 9-page document to unify the examination of the Heilpraktiker throughout Germany. The German Medical Association, however, are critical about the planned reform. The draft document suggest that, in future, all Heilpraktiker should pass an exam consisting of 60 multiple choice questions, in addition to an oral examination in which 4 candidates are being interviewed simultaneously for one hour. The draft also stipulates that Heilpraktiker may only practice such that they present no danger for public health and only use methods they muster.
The German Medical Association feel that these reforms do not go far enough. They claim that the authors of the draft have ‘totally misunderstood the complexity of the medical context, particularly the amount of necessary knowledge necessary for risk-minimisation in clinical practice’. They furthermore feel that the document is ‘an effort that is in every respect insufficient for protecting the public or individuals from the practice of the Heilpraktiker’. They also state that it is unclear how the document might provide a means to test Heilpraktiker in respect of risk-minimisation. The Medical Association demands that ‘the practice of certain therapies by Heilpraktiker must be forbidden. Finally, they say that ‘the practice of invasive methods and the treatment of caner by Heilpraktiker must be urgently prohibited’.
The German Heilpraktiker has been a subject of much public debate recently, not least after the ‘Muenster Group’ suggested a comprehensive reform. (I reported about this at the time.)
For those who can read German, the original article from the German Medical Journal is copied below:
Das Bundesministerium für Gesundheit (BMG) will gemeinsam mit den Ländern die Heilpraktikerüberprüfung bundesweit vereinheitlichen und Patienten besser schützen. Dafür haben Bund und Länder einen neunseitigen Entwurf erarbeitet. Die Bundesärztekammer (BÄK) zeigt sich angesichts der Pläne besorgt und übt deutliche Kritik.
Der Entwurf sieht vor, dass zur Überprüfung der Kenntnisse von Heilpraktikern künftig eine Prüfung verpflichtend sein soll. Diese soll aus 60 Multiple-Choice-Fragen bestehen, von denen der Anwärter innerhalb von zwei Stunden 45 korrekt ankreuzen muss. Darüber hinaus ist ein mündlicher Prüfungsteil von einer Stunde vorgesehen – bei vier Prüflingen gleichzeitig.
Zusätzlich stellt der Entwurf klar, dass Heilpraktiker nur in dem Umfang Heilkunde ausüben dürfen, in dem von ihrer Tätigkeit keine Gefahr für die Gesundheit der Bevölkerung oder für Patientinnen und Patienten ausgeht. Sie müssten zudem „eventuelle Arztvorbehalte beachten und sich auf die Tätigkeiten beschränken, die sie sicher beherrschen“, heißt es in der Präambel des Bund-Länder-Entwurfes, der dem Deutschen Ärzteblatt vorliegt.
Der Bundesärztekammer geht der Text nicht weit genug. Die Autoren der Leitlinie für die Prüfung haben laut BÄK „die Komplexität des medizinischen Kontextes“ völlig verkannt, „insbesondere das Ausmaß des notwendigen medizinischen Wissens, das für eine gefahrenminimierte Ausübung der Heilkunde notwendig ist“, so die Kammer weiter. Die jetzt vorgelegten Leitlinien für die Überprüfung stelle „eine in jeder Hinsicht unzureichende Maßnahme zum Schutz der Bevölkerung oder gar einzelner Patienten vor möglichen Gesundheitsgefahren durch die Tätigkeit von Heilpraktikern dar.
Es sei nicht nachvollziehbar, „wie auf der Grundlage dieser Leitlinien eine Überprüfung von Heilpaktikeranwärtern unter dem Aspekt einer funktionierenden Gefahrenabwehr erfolgen soll“, so die Kammer weiter. Sie fordert, dass Heilpraktikern bestimmte Tätigkeiten verboten werden. „Konkret sieht die Bundesärztekammer insbesondere den Ausschluss aller invasiven Maßnahmen sowie der Behandlung von Krebserkrankungen als zwingend notwendig an“, heißt es in der Stellungnahme.
Der Bund-Länder-Entwurf ist Ergebnis einer Debatte darüber, was Heilpraktiker dürfen oder künftig nicht (mehr) dürfen sollten und wie die Regeln für den Gesundheitsberuf aussehen. Eine Expertengruppe, der „Münsteraner Kreis“, hatte unlängst Vorschläge für eine umfassende Reform erarbeitet. Das Thema war zuletzt in der Öffentlichkeit und auch der Ärzteschaft heftig diskutiert worden.
END OF QUOTE
So, how well should alt med practitioners be educated and trained?
The answer depends, I think, on what precisely they are allowed to do. Medical responsibility must always be matched to medical competence. If a massage therapist merely acts on the instructions of a doctor, she does not need to know the differential diagnosis of a headache, for instance.
If, however, practitioners independently diagnose diseases (and alt med practitioners often do exactly that!), they must have a knowledge-base similar to that of a GP. If they use potentially harmful treatments (and which therapy does not have the potential to do harm?), they must be aware of the evidence for or against these interventions, as well as the evidence for all other therapeutic options for the conditions in question. Again, this would mean having a knowledge close to GP-level. If there is a mismatch between responsibility and competence (as very often is the case), patients are exposed to avoidable risks.
It is clear from these considerations that an exam with 60 multiple-choice questions followed by an hour-long interview is woefully inadequate for testing whether a practitioner has sufficient medical competence to independently care for patients. It is also clear, I think, that practitioners who regularly diagnose and treat patients – usually without any supervision – ought to have an education that covers much of what doctors learn while in medical school. Finally, it is clear that even after an adequate education, practitioners need to gather experience and work under supervision for some time before they can responsibly practice independently.
In any case, uncritically teaching obsolete notions of vitalism, yin and yang, subluxation, detox, potentisation, millennia of experience etc. is certainly not good enough. Education has to be based on sound evidence; if not, it is not education but brain-washing. And the result would be that students do not become responsible healthcare professionals but irresponsible charlatans.
Of course, alt med practitioners will argue that these arguments are merely the expression of medics defending their lucrative patch. But even if this were true (which, in my view, it is not), it would not absolve them from the moral, ethical and legal duty to demonstrate that their educational standards are sufficiently rigorous to avoid harm to their patients.
In a nutshell: an education in nonsense must result in nonsense.
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.
The nonsense that some naturopaths try to tell the public never ceases to amaze me. This article is a good example: a “naturopathic doctor” told a newspaper that “We do have a reputation associated with cancer, but we don’t treat cancer. We use highly intelligent computer software to find out what is wrong with the body at a scientific level, and we simply correct that, and the people who do that, they cure their own cancer.” As far as he is concerned, “The only hope for cancer is alternative medicine… When you look at the medical texts, the scientific literature, what is used, the chemotherapy and the radiation, they cannot cure cancer,” he said.
Through artificial intelligence, he said that he simply teaches people how to heal. Clients are hooked up to a computer that reads their body and gives a printout of what needs to be done to correct the abnormalities. “It looks at the abnormalities in the energetic pathways, abnormalities in nutritional status, and abnormalities in the toxic load of the body and how much it can carry. Once these things are identified and you actually put the patient on a path, they go out and heal themselves. I have nothing to do with it,” he said.
Before you discard this neuropath as an unimportant nutter, consider that this article is a mere example. There are thousands more.
This website, for instance, gives the impression of being much more official and trustworthy by adopting the name of CANCER TREATMENT CENTERS OF AMERICA. But the claims are just as irresponsible:
… natural therapies our naturopathic medicine team may recommend include:
- Herbal and botanical preparations, such as herbal extracts and teas
- Dietary supplements, such as vitamins, minerals and amino acids
- Homeopathic remedies, such as extremely low doses of plant extracts and minerals
- Physical therapy and exercise therapy, including massage and other gentle techniques used on deep muscles and joints for therapeutic purposes
- Hydrotherapy, which prescribes water-based approaches like hot and cold wraps, and other therapies
- Lifestyle counseling, such as exercise, sleep strategies, stress reduction techniques, as well as foods and nutritional supplements
- Acupuncture, to help with side effects like nausea and vomiting, dry mouth, hot flashes and insomnia
- Chiropractic care, which may include hands-on adjustment, massage, stretching, electronic muscle stimulation, traction, heat, ice and other techniques.
END OF QUOTE
And, would you believe it, there even is a NATUROPATHIC CANCER SOCIETY. They proudly claim that: Naturopathic medicine works best to eliminate:
END OF QUOTE
Vis a vis this plethora of irresponsible and dangerous promotion of quackery by naturopathic charlatans, I feel angry, sad and powerless. I know that my efforts to prevent cancer patients going to an early grave because of such despicable actions are bound to be of very limited success. But that does not mean that I will stop trying to tell the truth:
THERE IS NOT A JOT OF EVIDENCE THAT NATUROPATHY CAN CURE CANCER. SO, PLEASE DO NOT GO DOWN THIS ROUTE!
PS: …and no, I am not paid by BIG PHARMA or anyone else to say so.
Herbal and homeopathic lobby groups have petitioned to stop NHS England from removing herbal and homeopathic medicines: NHS England is consulting on recommendations to remove herbal and homeopathic medicines from GP prescribing. The medicines cost very little and have no suitable alternatives for many patients. Therefore we call on NHS England to continue to allow doctors to prescribe homeopathy and herbal medicine. The petition received around 16 500 signatures.
Now the UK government has responded. I take the liberty of posting the full response below:
Information from NHS England (NHSE) shows that in 2015, the cost for all prescriptions dispensed in primary care, not including any dispensing costs or fees, was £9.27 billion, a 4.7% increase on the previous year. Due to the increasing cost, NHSE is leading a review of medicines which can be considered as being of low clinical value and develop new guidance for Clinical Commissioning Groups (CCGs).
On 21 July, NHSE launched a three month consultation on the draft guidance on low value prescription items which is based on the latest clinical evidence, including that from the National Institute of Health and Care Excellence (NICE). Careful consideration has been given to ensure that particular groups of people are not disproportionately affected, and that principles of best practice on clinical prescribing are adhered to.
The commissioning guidance, upon which NHSE is consulting, will be addressed to CCGs to support them to fulfil their duties around the appropriate use of prescribing resources. This will need to be taken into account by CCGs in adopting or amending their own local guidance to their clinicians in primary care.
The aim of this consultation is to provide individuals with information about the proposed national guidance and to seek people’s views about the proposals. NHSE welcomes the views of the public, patients, clinicians, commissioners and providers through this consultation process to help inform the final guidance. The consultation ends on 21 October. Links to the consultation can be found here:
https://www.england.nhs.uk/2017/07/medicine-consultation/ and
https://www.engage.england.nhs.uk/consultation/items-routinely-prescribed/
It is the responsibility of local NHS organisations to make decisions on the commissioning and funding of any healthcare treatments for NHS patients, such as homeopathy, taking account of issues to do with safety, clinical and cost-effectiveness and the availability of suitably qualified and regulated practitioners.
Complementary and alternative medicine (CAMs) treatments can, in principle, feature in a range of services offered by local NHS organisations. A treating clinician would take into account an individual’s circumstances and medical history in deciding what would be the most appropriate treatment for their condition. CCGs will have specific policies on the commissioning and funding of CAMs, and may have also developed local policies on priorities with regards to the funding of treatments. A GP would have to work within such policies in providing any treatments on the NHS.
The Department of Health supports an approach to evidence-based prescribing which does not support the commissioning of services which are not clinically and cost effective. We are not aware of any evidence that demonstrates the therapeutic effectiveness of homeopathic products. The National Institute for Health and Care Excellence (NICE) does not currently recommend that homeopathy should be used in the treatment of any health condition, whilst primary care prescribing data shows that there has been a significant decline in the prescribing of homeopathic products over the last 10 years. Furthermore, a good number of NHS organisations are reviewing their funding of homeopathic treatments and some have already stopped funding such treatment altogether.
Department of Health
END OF QUOTE
This hardly needs a comment. Perhaps just this:
I find phraseology such as “We are not aware of any evidence that demonstrates the therapeutic effectiveness of homeopathic products” regrettable. It enables homeopaths and their supporters to counter that the government or anyone else who use this argument are ill-informed. There are, of course, quite a few positive trials of homeopathy. To deny it is a mistake, in my view, and one that would be easily avoidable.
I would have formulated this sentence differently: “We are not aware that the totality of the reliable evidence demonstrates the therapeutic effectiveness of homeopathic products”.
That is a correct and relevant statement.
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.
We all know Epsom salt, don’t we? This paper provides an interesting history of it: The purgative effect of the waters of Epsom, in southern England, was first discovered in the early seventeenth century. Epsom subsequently developed as one of the great English spas where high society flocked to take the medicinal waters. The extraction of the Epsom Salts from the spa waters and their chemical analysis, the essential feature of which was magnesium sulphate, were first successfully carried out by Doctor Nehemiah Grew, distinguished as a physician, botanist and an early Fellow of the Royal Society. His attempt to patent the production and sale of the Epsom Salts precipitated a dispute with two unscrupulous apothecaries, the Moult brothers. This controversy must be set against the backcloth of the long-standing struggle over the monopoly of dispensing of medicines between the Royal College of Physicians and the Worshipful Society of Apothecaries of London.
Epsom salt has the reputation of being very safe. But unfortunately, even something as seemingly harmless as Epsom salt can become dangerous in the hand of people who have little understanding of physiology and medicine. Indian doctors have just published a paper in (‘BMJ Case Reports’) with the details of a 38-year-old non-alcoholic, non-diabetic man suffering from gallstones. The patient was prescribed three tablespoons of Epsom salt to be taken with lukewarm water for 15 days for ‘stone dissolution’ by a ‘naturopathy practitioner’. He subsequently developed loss of appetite and darkening of urine from the 12th day of treatment and jaundice from the second day after treatment completion. The patient denied fevers, skin rash, joint pains, myalgia, abdominal pain, abdominal distension and cholestatic symptoms.
Examination revealed a deeply icteric patient oriented to time, place and person without an enlarged liver or stigmata of chronic liver disease. Liver function tests were abnormal, and a liver biopsy revealed sub-massive necrosis with dense portal-based fibrosis, mixed portal inflammation, extensive peri-venular canalicular and hepatocellular cholestasis with macro-vesicular steatosis and peri-sinusoidal fibrosis (suggestive of steato-hepatitis) without evidence of granulomas, inclusion bodies or vascular changes suggestive of acute drug-induced liver injury.
After discontinuation of Epsom salt and adequate hydration, the patient had an uneventful recovery with normalisation of liver function tests after 38 days. The Roussel Uclaf Causality Assessment score was strongly suggestive of Epsom salt-induced liver injury.
I was invited to provide a comment and stated that, in my view, this case reminds us:
1) that naturopaths prescribe a lot of nonsense,
2) that not everything which is promoted as natural is safe,
3) that treatments which apparently have ‘stood the test of time’ can still be rubbish, and
4) that even a relatively harmless remedy can become life-threatening, if one takes it at a high dose for a prolonged period of time.
Naturopaths have advocated Epsom salt for gall-bladder problems since centuries, yet there is no good evidence that it works. It is time that alternative practitioners abide by the rules of evidence-based medicine.
A quick Medline search reveals that there is only one further report of a serious adverse effect after Epsom salt intake: a case of fatal hypermagnesemia caused by an Epsom salt enema. A 7-year-old male presented with cardiac arrest and was found to have a serum magnesium level of 41.2 mg/dL (33.9 mEq/L) after having received an Epsom salt enema earlier that day. The medical history of Epsom salt, the common causes and symptoms of hypermagnesemia, and the treatment of hypermagnesemia are reviewed. The easy availability of magnesium, the subtle initial symptoms of hypermagnesemia, and the need for education about the toxicity of magnesium should be of interest to physicians.
… and to alternative practitioners, I hasten to add.
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!
The European Academies Science Advisory Council (EASAC) is an umbrella organization representing 29 national and international scientific academies in Europe, including the Royal Society (UK) and Royal Swedish Academy of Sciences. One of its aims is to influence policy and regulations across the European Union. Now, the EASAC has issued an important and long-awaited verdict on homeopathy:
The EASAC is publishing this Statement to build on recent work by its member academies to reinforce criticism of the health and scientific claims made for homeopathic products. The analysis and conclusions are based on the excellent science-based assessments already published by authoritative and impartial bodies. The fundamental importance of allowing and supporting consumer choice requires that consumers and patients are supplied with evidence-based, accurate and clear information. It is, therefore, essential to implement a standardised, knowledge-based regulatory framework to cover product efficacy, safety and quality, and accurate advertising practices, across the European Union (EU). Our Statement examines the following issues:
- Scientific mechanisms of action—where we conclude that the claims for homeopathy are implausible and inconsistent with established scientific concepts.
- Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect.
There are related concerns for patient-informed consent and for safety, the latter associated with poor quality control in preparing homeopathic remedies. Promotion of homeopathy—we note that this may pose significant harm to the patient if incurring delay in seeking evidence-based medical care and that there is a more general risk of undermining public confidence in the nature and value of scientific evidence. Veterinary practice—we conclude similarly that there is no rigorous evidence to
substantiate the use of homeopathy in veterinary medicine and it is particularly worrying when such products are used in preference to evidence-based medicinal products to treat livestock infections. We make the following recommendations.
1. There should be consistent regulatory requirements to demonstrate efficacy, safety and quality of all products for human and veterinary medicine, to be based on verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of this evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product.
2. Evidence-based public health systems should not reimburse homeopathic products and practices unless they are demonstrated to be efficacious and safe by rigorous testing.
3. The composition of homeopathic remedies should be labelled in a similar way to other health products available: that is, there should be an accurate, clear and simple description of the ingredients and their amounts present in the formulation.
4. Advertising and marketing of homeopathic products and services must conform to established standards of accuracy and clarity. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence.
END OF QUOTE
No comment needed!!!
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:
- The evidence for acupuncture as a treatment of insomnia is plagued by important limitations, e.g. the poor quality of most primary studies and some systematic reviews. Those that are sensitive to such limitations, fail to arrive at a positive verdict about the effectiveness of acupuncture.
- We conclude that, because of the paucity and of the poor quality of the data, the evidence for the effectiveness of auricular acupuncture for the symptomatic treatment of insomnia is limited. Further, rigorously designed trials are warranted to confirm these results.
- The evidence for valerian as a treatment for insomnia is inconclusive.
- Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders. (FACT, 2011, 16:195-99)
“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.
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.
