MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

risk/benefit

On their website, the British Homeopathic Association (BHA) have launched their annual winter appeal. Its theme this year is ‘building a better future for homeopathy’. The appeal is aimed at the following specific goals:

  • Continuously fighting to retain NHS services in the UK by supporting local patients & groups and providing swift media responses employing experts in areas such as media, politics, law and reputation management for ultimate effectiveness. Currently undertaking a legal challenge to NHS England
  • Establishing charitable homeopathic clinics throughout the UK, with clinics currently in Norwich, York, Bath, Edinburgh and looking at developing other clinics in Liverpool, Wales, Oxford and London in 2018.
  • Making further investment to enhance our digital presence and promotion of key messages.
  • Continuoustly improving our website to make it the place for information on homeopathy from finding practitioners to finding the latest Health & Homeopathy online.
  • Investing in research and education to keep homeopathy strong in the long term, increasing the number of healthcare professionals using homeopathy in their everyday practice.
  • Taking homeopathy to the people and growing our community of supporters with public events, local events and national promotion.

I have to say, I find this almost touching in its naivety. I imagine another lobby group, say the cigarette industry, launching a winter appeal: BUILDING A BETTER FUTURE FOR CIGARETTES.

Do I hear you object?

Cigarettes are unhealthy and not a medical treatment!!!

Quite so! Homeopathy is also unhealthy and not a medical treatment, I would argue. Sure, highly dilute homeopathics do not kill you, but homeopathy easily can. We have seen this on this blog many times. Homeopathy kills when it is advocated and consequently used as an alternative therapy for a life-threatening disease; there is no question about it. And there also is no question about the fact that this happens with depressing regularity. If you doubt it, just read some of my previous posts on the subject.

In any case, an appeal by a medical association should not be for its own benefit (homeopathy); it should be for patients (patients tempted to try homeopathy), I would suggest. So, lets design the goals of an appeal for patients along the lines of the above appeal – except our appeal has to actually be in the best interest of vulnerable patients.

Here we go:

  • Continually fighting to stop homeopathy on the NHS. As homeopathy does not generate more good than harm (no ineffective therapy can ever do that), we have a moral, legal and ethical duty to use our scarce resources such that they create the maximum benefit; and this means we cannot use them for homeopathy.
  • Establishing charitable organisations that educate the public about science and evidence. Too many consumers are still falling victim to the pseudo-science of charlatans who mislead people for their own profit.
  • Making further investments to combating the plethora of unethical misinformation by self-interested quacks and organisations many of which even have charitable status.
  • Continually improving websites that truthfully inform the public, politicians, journalists and others about medicine, science and healthcare.
  • Investing in research and education to keep science and evidence-based medicine strong, for the benefit of vulnerable patients and in the interest of progress.
  • Taking the science agenda to the people and growing the community of science-literate supporters on a local, national and international level.

As I had to follow the lines of the BHA, these goals are regrettably not perfect – but I am sure they are a whole lot better than the BHA original!

This survey assessed chiropractic (DC) and naturopathic “doctors”‘ (ND) knowledge, attitudes, and behaviour with respect to the pediatric patients in their practice. Cross-sectional surveys were developed in collaboration with DC and ND educators. Surveys were sent to randomly selected DCs and NDs in Ontario, Canada in 2004, and a national online survey was conducted in 2014. Data were analyzed using descriptive statistics, t-tests, non-parametric tests, and linear regression.

Response rates for DCs were n = 172 (34%) in 2004, n = 553 (15.5%) in 2014, and for NDs, n = 171 (36%) in 2004, n = 162 (7%) in 2014. In 2014, 366 (78.4%) of DCs and 83 (61%) of NDs saw one or more paediatric patients per week. Paediatric training was rated as inadequate by most respondents in both 2004 and 2014, with most respondents (n = 643, 89.9%) seeking post-graduate training by 2014. About half of DCs (51.7% in 2004, 49.2% in 2014) and one fifth of NDs (21% in 2004 and 23% in 2014) reported they received no hands-on clinical paediatric training. Only a minority of practitioners felt their hands-on paediatric training was adequate (somewhat or very) for their needs: DCs: 10.6% in 2004, 15.6% in 2014; NDs: 10% in 2004 and 19% in 2014. Respondents’ comfort in treating children and youth is based on experience and post-graduate training. Both DCs and NDs that see children and youth in their practices address a broad array of paediatric health concerns, from well child care and preventative health, to mild and serious illness.

The authors included two ‘case studies’ of conditions frequently treated by DCs and NDs:

Case study 1: colic

DC practitioners’ primary treatment focus (314 respondents) would be to use spinal manipulation (78.3%) if physical assessment suggests utility, diet changes (14.6% for child, 6.1% for mom if breast feeding), and massage (16.9%). ND practitioners (95 respondents) would assess and treat primarily with diet changes (62% for child including prescribing probiotics; 48% for mom if breast feeding), homeopathy (46%), weak herbal or tea preparations (19%), and use topical castor oil (packs or massage) (18%). In 2014, 65.9% of DCs and 59% of NDs believe (somewhat or very much) that concurrent treatment by a medical practitioner would be of benefit; 64.0% of DCs and 60% of NDs would refer the patient to another health care practitioner (practitioner type not specified).

Case study 2: acute otitis media

In 2014, almost all practitioners identified this as otitis media (in 2004, the DCs had a profession-specific question); DCs were more cautious about the value of their care for it relative to the NDs (DCs, 46.2% care will help patient very much, NDs, 95%). For treatment, DCs would primarily use spinal manipulation (98.5%) if indicated after assessment, massage (19.5%), dietary modifications (17.6%), and 3.8% would specifically refer to an MD for an antibiotic prescription. ND-preferred treatments were NHP products (79%), dietary modifications (66%), ear drops (60%), homeopathic remedies (18%), and 10% would prescribe antibiotics right away or after a few days. In 2014, 86.3% of DCs and 75% of NDs believe the patient would benefit (somewhat or very much) from concurrent treatment by a conventional medical practitioner; 81.7% of DCs and 58% of NDs would refer the patient to another health care provider.

The authors concluded that although the response rate in 2014 is low, the concerns identified a decade earlier remain. The majority of responding DCs and NDs see infants, children, and youth for a variety of health conditions and issues, but self-assess their undergraduate paediatric training as inadequate. We encourage augmented paediatric educational content be included as core curriculum for DCs and NDs and suggest collaboration with institutions/organizations with expertise in paediatric education to facilitate curriculum development, especially in areas that affect patient safety.

I find these data positively scary:

  • Despite calling themselves ‘doctors’, they are nothing of the sort.
  • DCs and NCs are not adequately educated or trained to treat children.
  • They nevertheless often do so, presumably because this constitutes a significant part of their income.
  • Even if they felt confident to be adequately trained, we need to remember that their therapeutic repertoire is wholly useless for treating sick children effectively and responsibly.
  • Therefore, harm to children is almost inevitable.
  • To this, we must add the risk of incompetent advice from CDs and NDs – just think of immunisations.

The only conclusion I can draw is this: chiropractors and naturopaths should keep their hands off our kids!

This overview by researchers from that Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, UK, was aimed at summarising the current best evidence on treatment options for 5 common musculoskeletal pain presentations: back, neck, shoulder, knee and multi-site pain. Reviews and studies of treatments were considered of the following therapeutic options: self-management advice and education, exercise therapy, manual therapy, pharmacological interventions (oral and topical analgesics, local injections), aids and devices, other treatments (ultrasound, TENS, laser, acupuncture, ice / hot packs) and psychosocial interventions (such as cognitive-behavioural therapy and pain-coping skills).

Here are the findings for those treatments most relevant in alternative medicine (it is interesting that most alternative medicines were not even considered because of lack of evidence and that the team of researchers can hardly be accused of an anti-alternative medicine bias, since its senior author has a track record of publishing results favourable to alternative medicine):

EXERCISE

Current evidence shows significant positive effects in favour of exercise on pain, function, quality of life and work related outcomes in the short and long-term for all the musculoskeletal pain presentations (compared to no exercise or other control) but the evidence regarding optimal content or delivery of exercise in each case is inconclusive.

ACUPUNCTURE

The evidence from a good quality individual patient data meta-analysis suggests that acupuncture may be effective for short-term relief of back pain and knee pain with medium summary effect sizes respectively compared with usual care or no acupuncture. However, effects on function were reported to be minimal and not maintained at longer-term follow-up. Similarly for neck and shoulder pain, acupuncture was only found to be effective for short-term (immediately post-treatment and at short-term follow-up) symptom relief compared to placebo.

MANUAL THERAPY

Current evidence regarding manual therapy is beset by heterogeneity. Due to paucity of high quality evidence, it is uncertain whether the efficacy of manual therapy might be different for different patient subgroups or influenced by the type and experience of professional delivering the therapy. On the whole, the available evidence suggests that manual therapy may offer some beneficial effects on pain and function, but it may not be superior to other non-pharmacological treatments (e.g. exercise) for patients with acute or chronic musculoskeletal pain.

Overall. the authors concluded that the best available evidence shows that patients with musculoskeletal pain problems in primary care can be managed effectively with non-pharmacological treatments such as self-management advice, exercise therapy, and psychosocial interventions. Pharmacological interventions such as corticosteroid injections (for knee and shoulder pain) were shown to be effective treatment options for the short-term relief of musculoskeletal pain and may be used in addition to non-pharmacological treatments. NSAIDs and opioids also offer short-term benefit for musculoskeletal pain, but the potential for adverse effects must be considered. Furthermore, the optimal treatment intensity, methods of application, amount of clinical contact, and type of provider or setting, are unclear for most treatment options.

These findings confirm what we have pointed out many times before on this blog. There is very little that alternative therapies have to offer for musculoskeletal pain. Whenever it is possible, I would recommend exercise therapy initiated by a physiotherapist; it is inexpensive, safe, and at least as effective as acupuncture or chiropractic or osteopathy.

Practitioners of alternative medicine will, of course, not like this solution.

Acupuncturists may not be that bothered by such evidence: their focus is not necessarily on musculoskeletal but on a range of other conditions (with usually little evidence, I hasten to add).

But for chiropractors and osteopaths, this is much more serious, in my view. Of course, some of them also claim to be able to treat a plethora of non-musculoskeletal conditions (but there the evidence is even worse than for musculoskeletal pain, and therefore this type of practice is clearly unethical). And those who see themselves as musculoskeletal specialists have to either accept the evidence that shows little benefit and considerable risk of spinal manipulation, or go in a state of denial.

In the former case, the logical conclusion is to look for another job.

In the latter case, the only conclusion is that their practice is not ethical.

This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:

The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.

Specifically, the Minister directed the Council to undertake:

1) A review of the status of the reserved act in other Canadian jurisdictions,

2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and

3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.

In addition, the Minister requested the Council to seek written input on the issue from:

  • Manitoba Chiropractic Stroke Survivors
  • Manitoba Chiropractic Association
  • College of Physiotherapists of Manitoba
  • Manitoba Naturopathic Association
  • College of Physicians and Surgeons of Manitoba
  • other relevant interested parties as determined by the Council

… The review indicated that further research is required to:

  • strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
  • establish safety and efficacy of CSM in infants and children
  • assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.

… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.

Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:

  • Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
  • Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.

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.

This is the question asked by the American Chiropractic Association. And this is their answer [the numbers in square brackets were inserted by me and refer to my comments below]:

Chiropractic is widely recognized [1] as one of the safest drug-free, non-invasive therapies available for the treatment of neuromusculoskeletal complaints [2]. Although chiropractic has an excellent safety record [3], no health treatment is completely free of potential adverse effects. The risks associated with chiropractic, however, are very small [4]. Many patients feel immediate relief following chiropractic treatment [5], but some may experience mild soreness, stiffness or aching, just as they do after some forms of exercise [6]. Current research shows that minor discomfort or soreness following spinal manipulation typically fades within 24 hours [7]…

Some reports have associated high-velocity upper neck manipulation with a certain rare kind of stroke, or vertebral artery dissection [8]. However, evidence suggests that this type of arterial injury often takes place spontaneously in patients who have pre-existing arterial disease [9]. These dissections have been associated with everyday activities such as turning the head while driving, swimming, or having a shampoo in a hair salon [10]. Patients with this condition may experience neck pain and headache that leads them to seek professional care—often at the office of a doctor of chiropractic or family physician—but that care is not the cause of the injury. The best evidence indicates that the incidence of artery injuries associated with high-velocity upper neck manipulation is extremely rare—about one to three cases in 100,000 patients who get treated with a course of care [11]. This is similar to the incidence of this type of stroke among the general population [12]…

When discussing the risks of any health care procedure, it is important to look at that risk in comparison to other treatments available for the same condition [13]. In this regard, the risks of serious complications from spinal manipulation for conditions such as neck pain and headache compare very favorably with even the most conservative care options. For example, the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation [14]…

Doctors of chiropractic are well trained professionals who provide patients with safe, effective care for a variety of common conditions. Their extensive education has prepared them to identify patients who have special risk factors [15] and to get those patients the most appropriate care, even if that requires referral to a medical specialist [16].

END OF QUOTE

  1. Appeal to tradition = fallacy
  2. and every other condition that brings in cash.
  3. Not true.
  4. Probably not true.
  5. The plural of anecdote is anecdotes, not evidence.
  6. Not true, the adverse effects of spinal manipulation are different and more severe.
  7. Not true, they last 1-3 days.
  8. Not just ‘some reports’ but a few hundred.
  9. Which does not mean that spinal manipulation cannot provoke such events.
  10. True, but this does not mean that spinal manipulation cannot provoke such events.
  11. There are other estimates that gives much higher figures; without a proper monitoring system, nobody can provide an accurate incidence figure.
  12. Not true, see above.
  13. ‘Available’ is meaningless – ‘effective’ is what we need here.
  14. The difference between different treatments is not merely their safety but also their effectiveness; in the end it is the risk/benefit balance that determines their value.
  15. Not true, there are no good predictors to identify at-risk populations.
  16. Chiropractors are notoriously bad at referring to other healthcare professionals; they have a huge conflict of interest in keeping up their cash-flow.

So, is chiropractic a safe treatment?

My advice here is not to ask chiropractors but independent experts.

 

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!!!

I just came across a new article entitled ” Vaccinated children four times more likely to suffer from ADHD, autism“. It was published in WDDTY, my favourite source of misleading information. Here it is:

Vaccinated children are nearly four times more likely to suffer from learning disabilities, ADHD and autism, a major new study has discovered—and they are six times more likely to suffer from one of these neuro-developmental problems if they were also born prematurely.

The vaccinated child is also more likely to suffer from otitis media, the ear infection, and nearly six times more likely to contract pneumonia.

But the standard childhood vaccines do at least do their job: the vaccinated child is nearly eight times less likely than the unvaccinated to develop chicken pox, and also less likely to suffer from whooping cough (pertussis).

Researchers from Jackson State University are some of the first to look at the long-term effects of vaccination. They monitored the health of 666 children for six years from the time they were six—when the full vaccination programme had been completed—until they were 12. All the children were being home-schooled because it was one of the few communities where researchers could find enough unvaccinated children for comparison; 261 of the children hadn’t been vaccinated and 208 hadn’t had all their vaccinations, while 197 had received the full 48-dose course.

The vaccinated were more likely to suffer from allergic rhinitis, such as hay fever, eczema and atopic dermatitis, learning disability, ADHD (attention-deficit, hyperactive disorder), and autism. The risk was lower among the children who had been partially vaccinated.

Vaccinated children were also more likely to have taken medication, such as an antibiotic, or treatment for allergies or for a fever, than the unvaccinated.

END OF QUOTE

I looked up the original study to check and found several surprises.

The first surprise was that the study was called a ‘pilot’ by its authors, even in the title of the paper: “Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children.”

The second surprise was that even the authors admit to important limitations of their research:

We did not set out to test a specific hypothesis about the association between vaccination and health. The aim of the study was to determine whether the health outcomes of vaccinated children differed from those of unvaccinated homeschool children, given that vaccines have nonspecific effects on morbidity and mortality in addition to protecting against targeted pathogens [11]. Comparisons were based on mothers’ reports of pregnancy-related factors, birth histories, vaccinations, physician-diagnosed illnesses, medications, and the use of health services. We tested the null hypothesis of no difference in outcomes using chi-square tests, and then used Odds Ratios and 96% Confidence Intervals to determine the strength and significance of the association…

What credence can be given to the findings? This study was not intended to be based on a representative sample of homeschool children but on a convenience sample of sufficient size to test for significant differences in outcomes. Homeschoolers were targeted for the study because their vaccination completion rates are lower than those of children in the general population. In this respect our pilot survey was successful, since data were available on 261 unvaccinated children…

Mothers’ reports could not be validated by clinical records because the survey was designed to be anonymous. However, self-reports about significant events provide a valid proxy for official records when medical records and administrative data are unavailable [70]. Had mothers been asked to provide copies of their children’s medical records it would no longer have been an anonymous study and would have resulted in few completed questionnaires. We were advised by homeschool leaders that recruitment efforts would have been unsuccessful had we insisted on obtaining the children’s medical records as a requirement for participating in the study.

A further potential limitation is under-ascertainment of disease in unvaccinated children. Could the unvaccinated have artificially reduced rates of illness because they are seen less often by physicians and would therefore have been less likely to be diagnosed with a disease? The vaccinated were indeed more likely to have seen a doctor for a routine checkup in the past 12 months (57.5% vs. 37.1%, p < 0.001; OR 2.3, 95% CI: 1.7, 3.1). Such visits usually involve vaccinations, which nonvaccinating families would be expected to refuse. However, fewer visits to physicians would not necessarily mean that unvaccinated children are less likely to be seen by a physician if their condition warranted it. In fact, since unvaccinated children were more likely to be diagnosed with chickenpox and whooping cough, which would have involved a visit to the pediatrician, differences in health outcomes are unlikely to be due to under-ascertainment.

The third surprise was that the authors were not at all as certain as WDDTY in their conclusions: “the study findings should be interpreted with caution. First, additional research is needed to replicate the findings in studies with larger samples and stronger research designs. Second, subject to replication, potentially detrimental factors associated with the vaccination schedule should be identified and addressed and underlying mechanisms better understood. Such studies are essential in order to optimize the impact of vaccination of children’s health.”

The fourth surprise was to find the sponsors of this research:

Generation Rescue is, according to Wikipedia, a nonprofit organization that advocates the incorrect view that autism and related disorders are primarily caused by environmental factors, particularly vaccines. These claims are biologically implausible and are disproven by scientific evidence. The organization was established in 2005 by Lisa and J.B. Handley. They have gained attention through use of a media campaign, including full page ads in the New York Times and USA Today. Today, Generation Rescue is known as a platform for Jenny McCarthy‘s autism and anti-vaccine advocacy.

The Children’s Medical Safety Research Institute (CMSRI) was, according to Vaxopedia, created by and is funded by the Dwoskin Family Foundation. It provides grants to folks who will do research on “vaccine induced brain and immune dysfunction” and on what they believe are other “gaps in our knowledge about vaccines and vaccine safety”, including:

While they claim that they are not an anti-vaccine organization, it should be noted that  Claire Dwoskin once said that “Vaccines are a holocaust of poison on our children’s brains and immune systems.”

Did I say SURPRISE?

I take it back!

When it comes to WDDTY, nothing does surprise me.

We have repeatedly discussed on this blog the fact that many alternative practitioners are advising their patients against vaccinations, e. g.:

There is little doubt that this phenomenon contributes to low immunisation rates. This, in turn, is a contributing factor to outbreaks of measles and other infectious diseases. The website of the European Centre for Disease Prevention and Control has recently published data on measles outbreaks in Europe:

Bulgaria: There is an increase by three cases since 21 July 2017. Since the beginning of 2017 and as of 16 July, Bulgaria reported 166 cases. During the same time period in 2016 Bulgaria reported one case.

France: On 27 July 2017 media quoting the French Minister of Health reported the death of a 16-year-old unvaccinated girl. She had fallen sick in Nice and died on 27 June 2017 in Marseille.

Germany: There is an increase by four cases since the last report on 21 July 2017. Since the beginning of 2017 and as of 26 July, Germany reported 801 cases. During the same time period in 2016 Germany reported 187 cases.

Italy: There is an increase by 170 cases since 21 July 2017. Since the beginning of 2017 and as of 25 July, Italy reported 3 842 cases, including three deaths. Among the cases, 271 are healthcare workers. The median age is 27 years, 89% of the cases were not vaccinated and 6% received only one dose of vaccine.

Romania: There is an increase by 229 cases, including one additional death, since 21 July 2017. Since 1 January 2016 and as of 21 July 2017, Romania reported 8 246 cases, including 32 deaths. Cases are either laboratory-confirmed or have an epidemiological link to a laboratory-confirmed case. Infants and young children are the most affected groups. Timis, in the western part of the country closest to the border with Serbia, is the most affected district with 1 215 cases. Vaccination activities are ongoing in order to cover communities with suboptimal vaccination coverage.

Spain: There is an increase by seven cases since 14 July 2017. Since the beginning of 2017 and as of 25 July, Spain reported 145  measles cases.

United Kingdom: Public Health Wales reported two additional cases related to the outbreak in Newport and Torfaen, bringing the total to ten cases related to this outbreak. In England and Wales there is an increase by 76 cases since 21 July 2017. Since the beginning of 2017 and as of 23 July 2017, England and Wales reported 922 cases. In the same time period in 2016, they reported 946 cases.

In addition to the updates listed above ECDC produces a monthly measles and rubella monitoring report with surveillance data provided by the member states through TESSy. The last report was published on 11 July 2017 with data up to 31 May 2017.

Measles outbreaks continue to occur in EU/EEA countries. There is a risk of spread and sustained transmission in areas with susceptible populations. The national vaccination coverage remains less than 95% for the second dose of MMR in the majority of EU/EEA countries. The progress towards elimination of measles in the WHO European Region is assessed by the European Regional Verification Commission for Measles and Rubella Elimination (RVC). Member States of the WHO European Region are making steady progress towards the elimination of measles. At the fifth meeting of the RVC for Measles and Rubella in October 2016, of 53 countries in the WHO European Region, 24 (15 of which are in the EU/EEA) were declared to have reached the elimination goal for measles, and 13 countries (nine in the EU/EEA) were deemed to have interrupted endemic transmission for between 12 and 36 months, meaning they are on their way to achieving the elimination goal. However, six EU/EEA countries were judged to still have endemic transmission: Belgium, France, Germany, Italy, Poland and Romania. More information on strain sequences would allow further insight into the epidemiological investigation.

All EU/EEA countries report measles cases on a monthly basis to ECDC and these data are published every month. Since 10 March 2017, ECDC has been reporting measles outbreaks in Europe on a weekly basis and monitoring worldwide outbreaks on a monthly basis through epidemic intelligence activities. ECDC published a rapid risk assessment on 6 March.

END OF QUOTE

Personally, I believe that it is high time to stop the rhetoric and actions of the anti-vaccination movements. This includes educating alternative practitioners and their patients. If necessary, we need regulation that prohibits their dangerous and unethical activities.

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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