MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk

A new joint position statement of the Italian Society of Diabetology (SID) and of the Italian Society for the Study of Arteriosclerosis (SISA) has recently been published. In the context of this blog, it seems relevant enough for its summary to be reproduced here:

Evidence showed that LDL-cholesterol lowering is associated with a significant cardiovascular risk reduction. The initial therapeutic approach to hypercholesterolaemia includes dietary modifications but the compliance to recommendations is often inadequate. Some dietary components with potential cholesterol-lowering activity are present in small amounts in food. Therefore, in recent years the use of “nutraceuticals” (i.e., nutrients and/or bioactive compounds with potential beneficial effects on human health) has become widespread. Such substances may be added to foods and beverages, or taken as dietary supplements (liquid preparations, tablets, capsules). In the present manuscript, the cholesterol-lowering activity of some nutraceuticals (i.e. fiber, phytosterols, soy, policosanol, red yeast rice and berberine) will be discussed along with: 1) the level of evidence on the cholesterol-lowering efficacy emerging from clinical trial; 2) the possible side effects associated with their use; 3) the categories of patients who could benefit from their use.

DATA SYNTHESIS:

Based on the current literature, the cholesterol-lowering effect of fiber, phytosterols and red yeast rice is consistent and supported by a good level of evidence. Over berberine, there is sufficient evidence showing significant cholesterol-lowering effects, although the results come from studies carried out almost exclusively in Asian populations. Data on the effects of soy are conflicting and, therefore, the strength of recommendation is quite low. The evidence on policosanol is inconclusive.

CONCLUSION:

Although health benefits may arise from the use of nutraceuticals with cholesterol-lowering activity, their use might be also associated with possible risks and pitfalls, some of which are common to all nutraceuticals whereas others are related to specific nutraceuticals.

END OF QUOTE

Many advocates of alternative medicine are highly sceptical of the value of statins. Yet, it seems clear that statins exert considerably larger effects on our lipid profile than nutraceuticals. So, why not use the treatment that is best documented and most efficacious? One answer could lie in the well-known adverse effects of statins. However, can we be sure that nutraceuticals are devoid of serious side-effects? I am not sure that we can: statins have been fully investigated, and we therefore are well-informed about their risks. Nutraceuticals, by contrast, have not been monitored in such detail, and their safety profile is therefore not as well-understood.

Other advocates of alternative medicine argue that cholesterol (I use the term simplistically without differentiating between the ‘good and bad’ cholesterol) has been hyped by the pharmaceutical industry and is, in truth, not nearly as important a risk factor as we have been led to believe. This line of thought would consequently deny the need to lower elevated cholesterol levels and therefore negate the need for cholesterol-lowering treatments. This stance may be popular, particularly in the realm of alternative medicine, but, to the best of my knowledge, it is erroneous.

Obviously, the first line treatment for people with pathological lipid profiles is the adoption of different life-styles, particularly in terms of nutrition. This may well incorporate some of the nutraceuticals mentioned above. If that strategy is unsuccessful in normalizing our blood lipids – and it often is – we should consider the more effective conventional medications; and that unquestionably includes statins.

I do not expect that everyone reading these lines will agree with me, yet, after studying the evidence, this is my honest conclusion – and NO, I am not paid or otherwise rewarded by the pharmaceutical industry or anyone else!

 

I am sure this  FDA press-release will interest many readers (we reported about this case before):

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall. The FDA recommends that consumers stop using these products marketed by Hyland’s immediately and dispose of any in their possession. In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. ”We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething products to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

END OF PRESS RELEASE

Well, this will be irritating to many homeopathy-fans, not least to our friend Dana Ullman. He likes to publish articles alleging that the US authorities have recently taken to being ever so unfair to the homeopathic industry. I commented recently on his paper entitled “Extreme Bias in FTC’s Ruling on Homeopathic Medicine” where he displays the well-known biases and ignorance of his trade in exemplary fashion, including the often firm anti-vaccination stance of homeopaths. Dana can also not resist claiming that ‘the Swiss government’s “Health Technology Assessment” on homeopathic medicine is much more comprehensive than any previous governmental report written on this subject to date’ and – how could it be otherwise? – is sufficient proof that homeopathy works.

In case you believe in what Ullman says, you ought to read the intriguing evidence about Ullman after being called as an expert witness in an US class action. On this occasion, the judge stated:

The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted.
[…]
Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.(Rosendez v. Green Pharmaceuticals)

Say no more!

We have repeatedly discussed the risks of chiropractic spinal manipulation (see, for instance here, here and here). Some chiropractors seem to believe that using a hand-held manipulator, called ‘activator’, better controls the forces used on the spine and therefore is safer. This recent paper raises doubts on this hypothesis.

A neurosurgeon from Florida published the case-report of a 75-year-old active woman who presented to a local hospital emergency room with a 3-day history of the acute onset of severe left temporal headache, initially self-treated with non-steroidals, to which they were resistant. Additional complaints included some vague right eye blurring of vision and a mild speech disturbance. Her primary-care physician had ordered an outpatient MRI, which was interpreted as showing a small sub-acute left posterior temporal lobe haemorrhage. He then referred her to the emergency room where she was categorized as a “stroke alert” and evaluated according to the hospital “stroke-alert” protocol.

There was no prior history of migraine, but some mild treated hypertension. The patient subsequently gave a history of chronic neck and back pain, but no headache, for which she had intermittently received chiropractic adjustments. Her current problem started after an activator treatment to the base of the left side at the junction of the skull with the upper cervical spine. She became concerned enough a few days later, because of the persistence of unremitting headache, to contact her primary-care physician. The patient was not taking any anticoagulants or antiplatelet agents and had a relatively unremarkable past medical and surgical history. Although she did not have a formal visual field examination or an ophthalmology consultation, she was found to have an incomplete right homonymous hemi-anopsia on clinical exam by the neurologist.

Based on MRI characteristics, the haemorrhage was determined to be primarily subarachnoid and displacing but not involving any brain parenchyma, and without any extra-axial component. After a 4-day hospitalization for evaluation and observation, the patient was discharged, neurologically improved in terms of visual and speech symptoms as well as headache complaints, to outpatient follow-up. She has remained well with resolution of imaging abnormalities and no reoccurrence of symptoms.

The authors explain how difficult it is to prove specific causation in such cases. It is frequently inferred by epidemiological reasoning or evidence. While there are other potential causes of the haemorrhage that occurred in this case, none is as or more likely than the activator stimulus. In support of the activator as the cause of the haemorrhage, the symptoms began almost immediately after the activator treatment (a temporal relationship), the area to which the activator was applied is almost directly superficial to the area of haemorrhage (a spatial relationship), the anatomic location of this haemorrhage is statistically unusual for any underlying and/or preexisting conditions, including stroke. The MRI confirmed that there was no infarction underlying the area of haemorrhage. The MRA disclosed no dissections or vascular lesions present. The only mechanisms left are trauma or cryptic vascular lesion that ruptured, obliterated itself, and occurred coincident to the activator stimulus. Although Activator stimulus is not high energy, it nonetheless was targeted to the cervico-occipital junction, an area where neural tissue is among the most vulnerable and least protected and closest to the skin (as opposed to the lower cervical or any of the thoracic or lumbar spine). There are many articles that make reference to minor or trivial head injury as a likely cause of intracranial haemorrhage.

The author concluded that he was unable to find a single documented case in which a brain hemorrhage in any location was reported from activator treatment. As such, this case appears to represent the first well-documented and reported brain hemorrhage plausibly a consequence of activator treatment. In the absence of any relevant information in the chiropractic or medical literature regarding cerebral hemorrhage as a consequence of activator treatment, this case should be instructive to the clinician who is faced with a diagnostic dilemma and should not forget to inquire about activator treatment as a potential cause of this complication. Our case had a benign course, but we do not rule out a more serious or potentially dangerous clinical course or adverse outcome. This is of heightened concern in the elderly and/or those with treatment-induced coagulopathy or platelet inhibition.

In light of all of the difficulties inherent in linking chiropractic treatments, including activator treatments, with serious neurological events, it is very possible that intracranial hemorrhage is far more frequent than reported. Several articles comment on the likelihood that complications of this type are almost certainly underreported. Most of the incidents mentioned in case series or surveys had never been previously reported. Neurologists, neurosurgeons, and chiropractors should be more vigilant both in the application and evaluation of these methods in all patients who report new neurologic-type symptoms following a manipulation (including an activator application) to the occiput or the cranio-cervical junction.

I think that case-report speaks for itself.

Chiropractors will, of course, argue (yet again) that:

  • conventional treatments cause much more harm,
  • spinal manipulation is highly effective,
  • such complications are extreme rarities,
  • the risk/benefit profile of spinal manipulation is positive,
  • some studies have failed to show a risk of spinal manipulation,
  • case-reports cannot establish causality.

We have rehearsed these arguments ad nauseam on this blog. The bottom line is well-expressed in the above conclusions: it is very possible that intracranial hemorrhage is far more frequent than reported. And that obviously applies to all other types of complications after chiropractic treatments.

First she promoted vaginal steam baths and now Gwyneth Paltrow claims that putting a ball of jade (which you can order from her online-business, if you happen to have the cash) in their vaginas is good for women.

Yes, I kid you not; this is what she states on her website:

The strictly guarded secret of Chinese royalty in antiquity—queens and concubines used them to stay in shape for emperors—jade eggs harness the power of energy work, crystal healing, and a Kegel-like physical practice. Fans say regular use increases chi, orgasms, vaginal muscle tone, hormonal balance, and feminine energy in general. Shiva Rose has been practicing with them for about seven years, and raves about the results; we tried them, too, and were so convinced we put them into the goop shop. Jade eggs’ power to cleanse and clear make them ideal for detox…

But if you think that Gwyneth is somehow fixated on her feminine parts, you are probably mistaken. She is much more versatile than that and seems to employ her vagina merely for drumming up publicity for her business. If you browse her site, you find no end of baffling, vagina-unrelated wonders and purchasable products from the world of alternative medicine.

Here are just two further examples.

Flower  remedies

A flower essence is a bioenergetic preparation. Through the use of sunlight and water, we are able to capture the energy of a flower and use it for healing purposes: A freshly harvested flower is placed on the surface of water for a specific length of time and exposed to sunlight, resulting in the vibrational imprint of the flower in water. The flower essence is then used as an energetic remedy, with each flower having its own range of unique therapeutic benefits.

Vibrational imprint?

Unique therapeutic benefit?

Pull the other one! The truth about (Bach) flower remedies is much simpler: they are expensive placebos.

A method for getting rid of the parasites we allegedly all suffer from

…an eight-day, mono-diet goat-milk cleanse—accompanied by a specific vermifuge made of anti-parasitic herbs—is the most successful treatment. Parasites primarily live in the mucus lining of the gut system, where they feed on nutrients before they enter the body. Think of the goat milk as bait—parasites come out of the gut lining to drink the milk, which they love, but they also consume the vermifuge, which will eventually eradicate them. On top of being highly effective, this method is a much more gentle medicine than bombarding them—and your body—with a harsh drug.

Are they for real?

This is pure and potentially very dangerous, unethical nonsense!

Oh sorry – I forgot: we now must call it differently now: we are obviously dealing with Gwyeneth’s ‘alternative facts’.

The Committees of Advertising Practice (CAP) write and maintain the UK Advertising Codes, which are administered by the Advertising Standards Authority. On their website, the CAP recently published an updated advertising code for naturopathy. As we have regularly discussed the fact that the public is being frequently misled in this area, I consider the code important in the context of this blog. I therefore take the liberty of repeating it here – not least in the hope that this helps preventing misinformation in the future [the numbers in square brackets refer to me footnotes below].

START OF QUOTE

What is Naturopathy?

Naturopathy is a holistic [1] approach to healthcare that uses a combination of one or more different disciplines (for example herbal medicine or hydrotherapy) and a healthy lifestyle [2] in order to gain and maintain a healthy body [3].

What claims are likely to be acceptable?

The promotion of a healthy [4] lifestyle is likely to acceptable as are claims that go no further than those commonly accepted for healthy [4] eating, sleeping well, taking exercise and the like.

What claims are likely to be problematic?

The ASA and CAP have not yet been provided with evidence which demonstrates that Naturopathy can be used to treat medical conditions (Rule 12.1).  Therefore, any claims that go beyond accepted claims for a healthy [4] lifestyle are likely to be problematic [5] unless they are supported by a robust body of evidence.  In 2013, the ASA ruled against claims on a marketer’s website which said that Naturopathy could be used to treat acute and chronic illness and disease because the marketer had not provided any evidence in support of their claims (CNM The College of Naturopathic Medicine Ltd, 13 March 2013).

What about serious medical conditions?

Claims to offer treatment on conditions for which medical supervision should be sought [6] are likely to be considered to discourage essential treatment unless that treatment is carried out under the supervision of a suitably qualified health professional (Rule 12.2).

END OF QUOTE

Naturopathy has been the subject of my posts before – see for instance here, here, here, here and here. Naturopathy can be dangerous to the point where it can kill the patient – see for instance here and here. Therefore it is important that advertising gets regulated. To make it very clear: the above statement by the CAP is, in my view, a step in the right direction, and I encourage alternative practitioners to look up the equivalent CAP documents for their specific therapy.

Having said that, I still feel the need to make a few comments:

  1. It is misleading to call naturopathy ‘holistic’. This is often factually incorrect and also gives the impression that conventional medicine is not holistic – see also here.
  2. Are we sure that all lifestyles promoted by naturopaths are, in fact, healthy?
  3. Maintaining a healthy body is naturopathy speak for DISEASE PREVENTION. Who decides what is effective prevention? On what evidence? How come many naturopaths are against the most effective means of prevention of all times – vaccination?
  4. Who decides what is ‘healthy’? On what evidence?
  5. Why ‘problematic’? Are they not wrong or bogus or false or fraudulent or criminal?
  6. Are there conditions for which medical supervision should not be sought? Which are they?

Not being a native English speaker, I was not entirely sure what precisely slapping means. A dictionary informed me that it stands for “hitting somebody/something with the flat part of your hand”. And ‘slapping therapy’? What on earth is that? It occurred to me that there might be several types of slapping therapy.

HITTING SOMEONE WHO DISAGREES

Yes, it might be therapeutic to do that! Imagine you discuss with someone and realize that you do not have very good arguments to defend an irrational position. Eventually, you are cornered and angry. All you can think of is to slap your opponent.

No, not very constructive, but all too human, I suppose.

This sort of thing has happened to me several times during discussions at conferences: my opponents went so mad that I saw them clinching their fists or raising their hands. Fortunately, I can run quite fast and (so far) always managed to avoid the impending physical violence.

INSULTING SOMEONE WHO DISAGREES

That sort of thing happens regularly. I have written posts about the phenomenon here, here, here and here, for instance. If you read the comments sections of this blog, you regrettably find plenty of examples.

If I am honest, I must admit that, on some occasions, I have in desperation joined into such mud-battles. I am not proud of it but sometimes it just happens. We are all just human, and it certainly feels therapeutic to be rude to someone who is a continuous and deplorable nuisance by hurling insults at opponents.

Having made this confession, I must stress (again) that, on this blog, we ought to avoid this sort of slapping therapy. In the long run, it is unhelpful and only escalates the aggression.

KINKY SLAPPING

When I googled ‘slapping’ I was referred to all sorts of sleazy websites which were essentially displaying maso-sadistic pornography that involved one person slapping another for sexual pleasure. Personally, I do not get a kick out of this type of slapping therapy and find it sad that some people obviously do.

PAIDA

Paida is the form of slapping therapy that recently made headlines and which therefore prompted this post. Paida in Chinese means to slap your body. Sure enough, the TCM people have made it into an alternative treatment which is usually called SLAPPING THERAPY (what will they think of next? you may well ask!). Already the sexual version of slapping therapy was not really funny, but this certainly is where the satire stops!

Hongchi Xiao, a Chinese-born investment banker, popularised this treatment some time ago. It involves slapping the body surface with a view of stimulating the flow of ‘chi’. Slapping therapists – no, they are not called ‘slappers’!!! – believe that this ritual restores health and eliminates toxins. In fact, they claim that the bruises which patients tend to develop after their treatment are the visible signs of toxins coming to the surface.

The treatment is not based on evidence — I know of not even a single clinical trial showing that it works — and it is certainly not agreeable. But at least it’s safe! No, you’d be wrong to think so: if slapping therapy, or any other bizarre and useless intervention is being employed as a replacement for treating a serious condition, it inevitably becomes life-threatening.

Recently, it was reported that a woman from East Sussex died after receiving slapping therapy; other fatalities have been documented previously. The latest victim had been suffering from diabetes and was led to believe that Paida was an effective treatment for her condition. Consequently, she discontinued her medication, a decision which eventually killed her.

Deaths after apparently harmless alternative treatments are being reported with depressing regularity. However, much more often, the resulting harm is not quite so dramatic, simply because the conditions treated are fortunately not life-threatening. In such cases, the ineffectiveness of the treatment does not lead to disaster, but it nevertheless causes unnecessary expense and prolongation of suffering.

We live in a time where we are constantly being told, for instance by ‘experts’ like Prince Charles, that we ought to be respectful towards ancient traditions of healthcare. So, let’s be clear: I am all for respect towards other cultures, but in medicine there should be limits. I do not see any benefit in either respecting or implementing ancient, obsolete notions of life energies, meridians, toxins and other disproven assumptions of alternative practitioners. They originate from a pre-scientific era and have been disproven. They do not belong in modern treatment manuals; at best, they belong in the history books of medicine.

 

 

 

WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):

The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.

The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.

Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”

The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.

People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.

END OF QUOTE

And what is wrong with this article?

The answer is quite a lot:

  1. The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
  2. The research itself is not described in a way that it would be possible to evaluate.
  3. The sample size of what seems to have been a case-control study was tiny.
  4. The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
  5. I was not able to find the publication on Medline, based on the information given.

Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.

 

Dietary and herbal supplements (DHS) are currently popular. They are being promoted as being natural and therefore safe – an assumption that is clearly wrong: some DHS can contain toxic substances or they might cause interactions with drugs or other DHS.

This study explored whether adverse events were actually associated with such interactions and examined specific characteristics among inpatient DHS users prone to such adverse events. It was designed as a cross-sectional survey of 947 patients hospitalized in 12 departments of a tertiary academic medical centre in Haifa, Israel. It evaluated the rate of DHS use among inpatients, the potential for interactions, and actual adverse events during hospitalization associated with DHS use. It also assessed whether DHS consumption was documented in patients’ medical files. Statistical analysis was used to delineate DHS users at risk for adverse events associated with interactions with conventional drugs or other DHS.

The results show that about half of all patients took DHS. In 17 (3.7%) of the 458 DHS users, an adverse event may have been caused by DHS-drug-DHS interactions. According to the Drug Interaction Probability Scale, 14 interactions “probably” caused the adverse events, and 11 “possibly” caused them. Interactions occurred more frequently in older patients (p = 0.025, 95% CI: 2.26-19.7), patients born outside Israel (p = 0.025, 95% CI: 0.03-0.42), those with ophthalmologic (p = 0.032, 95% CI: 0.02-0.37) or gastrointestinal (p = 0.008, 95% CI: 0.05-0.46) comorbidities, and those using higher numbers of DHS (p < 0.0001, 95% CI: 0.52-2.48) or drugs (p = 0.027, 95% CI: 0.23-3.77).

The authors concluded that approximately one in 55 hospitalizations in this study may have been caused by adverse events associated with DHS-drug-DHS interactions. To minimize the actual occurrence of adverse events, medical staff education regarding DHS should be improved.

This seems to be a good study and it generated interesting findings on an important topic.

Why do I have nevertheless a problem with it?

The answer is simple but not pleasant: very similar results have been published almost simultaneously in more than one journal. The link above is to an article in the BR J CLIN PHARMACOL of October this year. The following text is from the abstract of an article in INTERN EMERG MED also of October this year:

Of 927 patients who agreed to answer the questionnaire, 458 (49.4 %) reported the use of 89 different DHS. Potential DHS-DHS interactions were identified in 12.9 % of DHS users. Three interactions were associated with the actual occurrence of adverse events. Patients at risk of DHS-DHS interactions included females (p = 0.026) and patients with greater numbers of concomitant medications (p < 0.0001) and of consumed DHS (p < 0.0001). In 88.9 % of DHS users, DHS use was not reported in medical files and only 18 % of the DHS involved in interactions were documented. Potential DHS-DHS interactions are common in inpatients, and may lead to hospitalization or worsen existing medical conditions. The causal relationship between potential interactions and actual adverse events requires further study.

END OF QUOTE

And to my surprise, I also found a third article also from the October issue of INTERN EMERG MED reporting on this survey. Here is part of its abstract:

DHS users were determined via a questionnaire. The Natural Medicine database was used to search for potential DHS-drug interactions for identified DHS, and the clinical significance was evaluated using Lexi-interact online interaction analysis. Medical files were assessed for documentation of DHS use. Univariate and multivariate logistic regression analyses were used to characterize potential risk factors for DHS-drug interactions. Of 927 patients consenting to answer the questionnaire, 458 (49 %) reported DHS use. Of these, 215 (47 %) had at least one potential interaction during hospitalization (759 interactions). Of these interactions, 116 (15 %) were potentially clinically significant. Older age [OR = 1.02 (1.01-1.04), p = 0.002], males [OR = 2.11 (1.35-3.29), p = 0.001] and increased number of used DHS [OR = 4.28 (2.28-8.03), p < 0.001] or drugs [OR = 1.95 (1.17-3.26), p = 0.011] were associated with potential interactions in DHS users. Physicians documented only 16.5 % of DHS involved in these interactions in patients’ medical files. In conclusion, a substantial number of inpatients use DHS with potential interactions with concomitant medications. Medical staff should be aware of this, question patients on DHS usage and check for such interactions.

END OF QUOTE

What is the difference between the three articles? The first one in INTERN EMERG MED authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potential DHS-DHS interactions among inpatients”. The second one in INTERN EMERG MED also authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potentially dangerous interactions of DHS with prescribed medications among inpatients”. Finally the one in BR J CLIN PHARMACOL also authored by Levy I, Attias S, Ben-Arye E, Goldstein L, Schiff E  assessed in addition the interactions between DHS and prescription drugs.

Dual publications are usually considered to be a violation of research ethics. Publication of different aspects of one single data-set in multiple articles is called ‘salami-slicing’ and is often considered to be poor form.

My question to you, the reader of this post, is: What type of scientific misconduct do we have here?

The risks of consulting a chiropractor have regularly been the subject of this blog (see for instance here, here and here). My critics believe that I am alarmist and have a bee in my bonnet. I think they are mistaken and believe it is important to warn the public of the serious complications that are being reported with depressing regularity, particularly in connection with neck manipulations.

It has been reported that the American model Katie May died earlier this year “as the result of visiting a chiropractor for an adjustment, which ultimately left her with a fatal tear to an artery in her neck” This is the conclusion drawn by the L.A. County Coroner.

katie-may-ist-mit-34-jahre-gestorben

According to Wikipedia, Katie tweeted on January 29, 2016, that she had “pinched a nerve in [her] neck on a photoshoot” and “got adjusted” at a chiropractor. She tweeted on January 31, 2016 that she was “going back to the chiropractor tomorrow.” On the evening of February 1, 2016, May “had begun feeling numbness in a hand and dizzy” and “called her parents to tell them she thought she was going to pass out.” At her family’s urging, May went to Cedars Sinai Hospital; she was found to be suffering a “massive stroke.” According to her father, she “was not conscious when we got to finally see her the next day. We never got to talk to her again.” Life support was withdrawn on February 4, 2016.

Katie’s death certificate states that she died when a blunt force injury tore her left vertebral artery, and cut off blood flow to her brain. It also says the injury was sustained during a “neck manipulation by chiropractor.” Her death is listed as accidental.

Katie’s family is said to be aware of the coroner’s findings. They would not comment on whether they or her estate would pursue legal action.

The coroner’s verdict ends the uncertainty about Katie’s tragic death which was well and wisely expressed elsewhere:

“…The bottom line is that we don’t know for sure. We can’t know for sure. If you leave out the chiropractic manipulations of her neck, her clinical history—at least as far as I can ascertain it from existing news reports—is classic for a dissection due to neck trauma. She was, after all, a young person who suffered a seemingly relatively minor neck injury that, unbeknownst to her, could have caused a carotid artery dissection, leading to a stroke four or five days later… Thus, it seems to be jumping to conclusions for May’s friend Christina Passanisi to say that May “really didn’t need to have her neck adjusted, and it killed her.” … Her two chiropractic manipulations might well have either worsened an existing intimal tear or caused a new one that led to her demise. Or they might have had nothing to do with her stroke, her fate having been sealed days before when she fell during that photoshoot. There is just no way of knowing for sure. It is certainly not wrong to suspect that chiropractic neck manipulation might have contributed to Katie May’s demise, but it is incorrect to state with any degree of certainty that her manipulation did kill her.”

My conclusions are as before and I think they need to be put as bluntly as possible: avoid chiropractors – the possible risks outweigh the documented benefits – and if you simply cannot resist consulting one: DON’T LET HIM/HER TOUCH YOUR NECK!

Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.

Yet acupuncture is precisely the therapy such patients might be tempted to employ.

Why?

Because irresponsible or criminally naïve acupuncturists advertise it!

Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….

I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:

Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.

In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:

Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.

However, this does not deter them to conclude on a positive note:

In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.

So, why do I find this irresponsibly and dangerously misleading?

Here a just a few reasons why this meta-analysis should not be trusted:

  • There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
  • The primary studies all look extremely weak; this means they are likely to be false-positive.
  • They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
  • All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.

My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.

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