MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

Discussions about the dietary supplements are often far too general to be truly useful, in my view. For a meaningful debate, we need to define what supplement we are talking about and make clear what condition it is used for. A recent paper meets these criteria well and is therefore worth a mention.

The review was aimed at addressing the controversy regarding the optimal intake, and the role of calcium supplements in the treatment and prevention of osteoporosis. The authors demonstrate that most studies on the subject show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg per day .

The authors argue that supplements are therefore not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses.

These facts, the authors argue, must be balanced against the possible harm. The risks of regularly taking calcium supplements include an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention.

The authors draw the following detailed conclusions: “Concern regarding the safety of calcium supplements has led to recommendations that dietary calcium should be the primary source, and supplements reserved only for those who are unable to achieve an adequate dietary intake. The current recommendations for intakes of 1000–1200 mg day−1 are not firmly based on evidence. The longitudinal bone densitometry studies reviewed here, together with the new data included in this review relating to total body calcium, suggest that intakes in women consuming only half these quantities are satisfactory and thus, they do not require additional supplementation. The continuing preoccupation with calcium nutrition has its origin in a period when calcium balance was the only technique available to assess dietary or other therapeutic effects on bone health. We now have persuasive evidence from direct measurements of changes in bone density that calcium balance does not reflect bone balance. Bone balance is determined by the relative activities of bone formation and bone resorption, both of which are cellular processes. The mineralization of newly formed bone utilizes calcium as a substrate, but there is no suggestion that provision of excess substrate has any positive effect on either bone formation or subsequent mineralization.

Based on the evidence reviewed here, it seems sensible to maintain calcium intakes in the region of 500–1000 mg day−1 in older individuals at risk of osteoporosis, but there seems to be little need for calcium supplements except in individuals with major malabsorption problems or substantial abnormalities of calcium metabolism. Because of their formulation, costs and probable safety issues, calcium supplements should be regarded as pharmaceutical agents rather than as part of a standard diet. As such, they do not meet the standard cost–benefit criteria for pharmaceutical use and are not cost-effective. If an individual’s fracture risk is sufficient to require pharmaceutical intervention, then safer and more effective measures are available which have been subjected to rigorous clinical trials and careful cost–benefit analyses. Calcium supplements have very little role to play in the prevention or treatment of osteoporosis.”

Clear and useful words indeed! I wish there were more articles like this in the never-ending discussion about the complex subject of dietary supplements.

If you talk to advocates of homeopathy, you are bound to hear claims that are false or misleading; in fact, you hear them so regularly that you might begin to doubt the truth. For those who have such doubts or are in need of some correct counter-arguments, I have listed here those 12 bogus claims which, in my experience, are most common together with short, suitable, and factual rebuttals.

1) THERE IS NOTHING MYSTERIOUS ABOUT HOMEOPATHY’S MODE OF ACTION, IT WORKS LIKE VACCINATIONS

This argument is used by enthusiasts in response the fact that most homeopathic remedies are too highly diluted to have pharmacological effects. Vaccines are also highly diluted and they are, of course, very effective; therefore, so the bogus notion, there is nothing odd about homeopathy.

The argument is wrong on several levels; the easiest way to refute, I think, it is to point out that vaccines contain measurable amounts of material and lead to measurable changes in the immune system. By contrast, the typical homeopathic remedy (beyond the C12 potency) contains not a single molecule of an active substance and leads to no measurable changes in any system.

2) SIGNIFICANTLY MORE CONTROLLED CLINICAL TRIALS OF HOMEOPATHY ARE POSITIVE THAN NEGATIVE

Several websites of homeopathic organisations make this claim and even provide simple statistics to back it up. Consequently, many homeopathy fans have adopted it.

The statistics they present show that x % of studies are positive, y % are negative and z % are neutral; the whole point is that x is larger than y. The percentage figures may even be correct but they rely on the spurious definitions used: positive = superior to placebo, negative = placebo superior to homeopathy, neutral = no difference between homeopathy and placebo. The latter category was created so that homeopathy comes out trumps.

For all intents and purposes, a study where the experimental treatment is no better than placebo is not a study neutral but a negative result. Thus the negative category in such statistics must be y + z which is, of course, larger than x. In other words, the majority of trials is, in truth, negative.

3) HOMEOPATHY IS SUPPORTED BY NOBEL PRIZE WINNERS

I don’t know of a single Nobel Prize winner who has stated or implied that homeopathy works better than a placebo. Some have tried to find a mechanism of action for homeopathy by doing some basic research and have published theories about it. None of those has been accepted by science.

And if there ever should be a Nobel Prize winner or similarly brilliant person who supports homeopathy, this would merely show that even bright individuals can make mistakes!

4) HOMEOPATHY IS SAFE

Tell that to the child that has just been reported to have died because her parents used homeopathy for an ear infection which (could have been easily treated with antibiotics but) degenerated into a brain abscess with homeopathic therapy. There are many more such tragic cases than I care to remember.

The risks of homeopathy are, of course, minor compared to many conventional treatments, but the risk/benefit balance of homeopathy can never be positive because, unlike those high risk conventional treatments, it has no benefit.

5) HOMEOPATHY DOES NOT LEND ITSELF TO BEING TESTED IN CLINICAL TRIALS

The best way to disprove this argument is to point out that ~ 250 controlled clinical trials are currently available. Every homeopath on the planet boasts about clinical trials – provided they are positive.

6) HOMEOPATHY WORKS VIA QUANTUM ENTANGLEMENT

I do not understand quantum mechanics and, I suspect, neither do the homeopaths who use this argument. But physicists who do understand this subject well are keen to stress that homeopathy cannot be explained in this way.

7) THERE IS NO PROOF THAT HOMEOPATHY DOES NOT WORK

The absence of evidence is not the same as evidence of absence, homeopaths like to exclaim. And they are, of course, correct! However, they forget that, science cannot prove a negative and that, in routine health care, we do not even look for a proof of ineffectiveness. We use those treatments that have a positive proof of effectiveness – everything else is irresponsible.

8) EVEN IF HOMEOPATHY WERE JUST A PLACEBO, IT STILL HELPS PATIENTS AND IS THEREFORE A USEFUL TREATMENT

It is true, of course, that placebo effects can help patients. But it is not true that, for generating a placebo response, we need a placebo. If a clinician administers an effective treatment with compassion, the patient will benefit from a placebo response plus from the specific effects of the treatment. Only giving placebos is therefore tantamount to cheating the patient.

9) THERE IS A WORLDWIDE CONSPIRACY AGAINST HOMEOPATHY

In a way, this argument merely suggests that homeopathic remedies are ineffective in treating paranoia. I have not ever seen a jot of evidence for it – and neither can anyone who uses this claim produce any.

10) YOU NEED TO BE A HOMEOPATH TO BE ABLE TO UNDERSTAND AND ADEQUATELY JUDGE THE VALUE OF HOMEOPATHY

With this notion, homeopaths want to claim that the critics of homeopathy are incompetent. It is like saying that only people who believe in god are allowed to criticise religion. By definition, homeopaths are believers, and therefore they are unlikely to be free of bias when judging the value of homeopathy. Homeopathy is a health technology that must be evaluated like all other health technologies: by independent scientists who know their job.

11) HOMEOPATHY HAS BEEN PROVEN TO WORK FOR LITTLE CHILDREN AND ANIMALS

The argument here is that animals and children cannot possibly respond to placebo. Therefore homeopathy must be more than a placebo.

This notion is twice wrong. Firstly, both animals and children can respond to placebo, if only ‘by proxy’, i.e. via their carers. Secondly, if we consider the totality of the reliable data, we find that neither for children nor for animals is the evidence convincingly positive.

12) HOMEOPATHY HAS BEEN USED VERY SUCCESSFULLY IN MAJOR EPIDEMICS, AND THAT FACT IS PROOF ENOUGH FOR ITS EFFICACY

Yes, there are some rather fascinating historical accounts which homeopaths interpret in this fashion. But if we look a little closer, we invariably find explanations which are much more plausible than the assumption of homeopathy’s effectiveness. Epidemiological observations of this nature can almost never establish cause and effect, and the clinical outcome could have been due to a myriad of confounders unrelated to homeopathy.

Recently, I was sent an interesting press release; here it is in full:

A new study has shed light on how cancer patients’ attitudes and beliefs drive the use of complementary and alternative medicine. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings may help hospitals develop more effective and accessible integrative oncology services for patients.

Although many cancer patients use complementary and alternative medicine, what drives this usage is unclear. To investigate, a team led by Jun Mao, MD and Joshua Bauml, MD, of the Abramson Cancer Center at the University of Pennsylvania’s Perelman School of Medicine, conducted a survey-based study in their institution’s thoracic, breast, and gastrointestinal medical oncology clinics.

Among 969 participants surveyed between June 2010 and September 2011, patients who were younger, those who were female, and those who had a college education tended to expect greater benefits from complementary and alternative medicine. Nonwhite patients reported more perceived barriers to the use of complementary and alternative medicine compared with white patients, but their expectations concerning the medicine’s benefits were similar. Attitudes and beliefs about complementary and alternative medicine were much more likely to affect patients’ use than clinical and demographic characteristics.

“We found that specific attitudes and beliefs — such as expectation of therapeutic benefits, patient-perceived barriers regarding cost and access, and opinions of patients’ physician and family members — may predict patients’ use of complementary and alternative medicine following cancer diagnoses,” said Dr. Mao. “We also found that these beliefs and attitudes varied by key socio-demographic factors such as sex, race, and education, which highlights the need for a more individualized approach when clinically integrating complementary and alternative medicine into conventional cancer care.”

The researchers noted that as therapies such as acupuncture and yoga continue to demonstrate clinical benefits for reducing pain, fatigue, and psychological distress, the field of integrative oncology is emerging to bring complementary and alternative medicine together with conventional care to improve patient outcomes. “Our findings emphasize the importance of patients’ attitudes and beliefs about complementary and alternative medicine as we seek to develop integrative oncology programs in academic medical centers and community hospitals,” said Dr. Bauml. “By aligning with patients’ expectations, removing unnecessary structural barriers, and engaging patients’ social and support networks, we can develop patient-centered clinical programs that better serve diverse groups of cancer patients regardless of sex, race, and education levels.”

And here is the abstract of the actual article:

BACKGROUND:

Complementary and alternative medicine (CAM) incorporates treatments used by cancer survivors in an attempt to improve their quality of life. Although population studies have identified factors associated with its use, to the best of the authors knowledge, assessment of why patients use CAM or the barriers against its use have not been examined to date.

METHODS:

The authors conducted a cross-sectional survey study in the thoracic, breast, and gastrointestinal medical oncology clinics at an academic cancer center. Clinical and demographic variables were collected by self-report and chart abstraction. Attitudes and beliefs were measured using the validated Attitudes and Beliefs about CAM (ABCAM) instrument. This instrument divides attitudes and beliefs into 3 domains: expected benefits, perceived barriers, and subjective norms.

RESULTS:

Among 969 participants (response rate, 82.7%) surveyed between June 2010 and September 2011, patient age ≤65 years, female sex, and college education were associated with a significantly greater expected benefit from CAM (P<.0001 for all). Nonwhite patients reported more perceived barriers to CAM use compared with white patients (P<.0001), but had a similar degree of expected benefit (P = .76). In a multivariate logistic regression analysis, all domains of the ABCAM instrument were found to be significantly associated with CAM use (P<.01 for all) among patients with cancer. Attitudes and beliefs regarding CAM explained much more variance in CAM use than clinical and demographic variables alone.

CONCLUSIONS:

Attitudes and beliefs varied by key clinical and demographic characteristics, and predicted CAM use. By developing CAM programs based upon attitudes and beliefs, barriers among underserved patient populations may be removed and more patient centered care may be provided.

Why do I find this remarkable?

The article was published in the Journal CANCER, one of the very best publications in oncology. One would therefore expect that it contributes meaningfully to our knowledge. Remarkably, it doesn’t! Virtually every finding from this survey had been known or is so obvious that it does not require research, in my view. The article is an orgy of platitudes, and the press release is even worse.

But this is not what irritates me most with this paper. The aspect that I find seriously bad about it is its general attitude: it seems to accept that alternative therapies are a good thing for cancer patients which we should all welcome with open arms. The press release even states that, as therapies such as acupuncture and yoga continue to demonstrate clinical benefits for reducing pain, fatigue, and psychological distress, the field of integrative oncology is emerging to bring complementary and alternative medicine together with conventional care to improve patient outcomes.

I might be a bit old-fashioned, but I would have thought that, before we accept treatments into clinical routine, we ought to demonstrate that they generate more good than harm. Should we not actually show beyond reasonable doubt that patients’ outcomes are improved before we waffle about the notion? Is it not our ethical duty to analyse and think critically? If we fail to do that, we are, I think, nothing other than charlatans!

This article might be a mere triviality – if it were not symptomatic of what we are currently witnessing on a truly grand scale in this area. Integrative oncology seems fast to deteriorate into a paradise for pseudoscience and quacks.

On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.

Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.

Let me know what you think about it:

http://www.shawnalli.com/james-randi-disingenuous-legacy.html

It’s quite long so save it for a rainy day.

So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”

It’s always nice to know how open-minded skeptical organizations are.

Hopefully you can add a bit more.

Sincerely,

Shawn

Yes, indeed, I can but try to add a bit more!

However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:

Homeopathy & Acupuncture:

A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.

Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).

But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).

I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).

Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.

While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).

A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch. [29] (9) I recommend readers take a look at:

The facts about an ingenious homeopathic experiment that was not completed due to the “tricks” of Mr. James Randi.

Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).

The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:

Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. [30]

Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.

A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).

In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:

Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. [31]

It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. [32]

Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. [33]

In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. [34]

In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. [35]

In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. [36]

In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. [37]

In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. [38]

While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.

Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).

Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).

Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).

It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).

END OF ALLI’S TEXT

And here are my numbered comments:

(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.

(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.

(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.

(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.

(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)

(6) No serious scientist attaches ‘ridicule and vilification’ to it.

(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.

(8) Ethics demand that patients require the best available treatment; homeopathy does not fall into this category.

(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.

(10) So far, we have seen no evidence for this statement.

(11) Which ones? No examples are provided.

(12) Yet another statement without evidence – potentially libellous.

(13) Conclusion before any evidence; sign for a closed mind?

(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.

(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?

(16) But did they argue this? Where is the evidence to support this statement?

(17) Non-evidence-based accusations.

(18) Classic fallacy.

(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.

(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.

(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.

(22) Overt contradiction to what Alli just stated about acupuncture.

(23) To me, this seems rather nonsensical and a hindrance to progress.

In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.

To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.

Yoga is a popular form of alternative medicine. Evidence for its effectiveness is scarce and generally far from convincing. But at least it is safe! At least this is what yoga enthusiasts would claim. Unfortunately, this is not entirely true; adverse events have also been reported with some regularity. Their frequency is, however, not known.

A new study was aimed at filling this gap. It was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.

The subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.

Among 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.

The authors concluded that the results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.

I find these findings interesting and thought-provoking. The main question that they raise is, I think, the flowing: ARE THERE ANY CONDITIONS FOR WHICH YOGA DEMONSTRABLY GENERATES MORE GOOD THAN HARM?

Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.

The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.

Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.

The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.

Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.

American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.

Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.

The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.

I know what my chiropractic friends will respond to this post:

  • I am alarmist,
  • I cherry-pick articles that are negative for their profession,
  • these cases are extreme rarities,
  • conventional medicine is much more dangerous.

To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.

Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?

Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?

Here is another short passage from my new book A SCIENTIST IN WONDERLAND. It describes the event where I was first publicly exposed to the weird and wonderful world of alternative medicine in the UK. It is also the scene which, in my original draft, was the very beginning of the book.

I hope that the excerpt inspires some readers to read the entire book – it currently is BOOK OF THE WEEK in the TIMES HIGHER EDUCATION!!!

… [an] aggressive and curious public challenge occurred a few weeks later during a conference hosted by the Research Council for Complementary Medicine in London. This organization had been established a few years earlier with the aim of conducting and facilitating research in all areas of alternative medicine. My impression of this institution, and indeed of the various other groups operating in this area, was that they were far too uncritical, and often proved to be hopelessly biased in favour of alternative medicine. This, I thought, was an extraordinary phenomenon: should research councils and similar bodies not have a duty to be critical and be primarily concerned about the quality of the research rather than the overall tenor of the results? Should research not be critical by nature? In this regard, alternative medicine appeared to be starkly different from any other type of health care I had encountered previously.

On short notice, I had accepted an invitation to address this meeting packed with about 100 proponents of alternative medicine. I felt that their enthusiasm and passion were charming but, no matter whom I talked to, there seemed to be little or no understanding of the role of science in all this. A strange naïvety pervaded this audience: alternative practitioners and their supporters seemed a bit like children playing “doctor and patient”. The language, the rituals and the façade were all more or less in place, but somehow they seemed strangely detached from reality. It felt a bit as though I had landed on a different planet. The delegates passionately wanted to promote alternative medicine, while I, with equal passion and conviction, wanted to conduct good science. The two aims were profoundly different. Nevertheless, I managed to convince myself that they were not irreconcilable, and that we would manage to combine our passions and create something worthwhile, perhaps even groundbreaking.

Everyone was excited about the new chair in Exeter; high hopes and expectations filled the room. The British alternative medicine scene had long felt discriminated against because they had no academic representation to speak of. I certainly did sympathize with this particular aspect and felt assured that, essentially, I was amongst friends who realized that my expertise and their enthusiasm could add up to bring about progress for the benefit of many patients.
During my short speech, I summarized my own history as a physician and a scientist and outlined what I intended to do in my new post—nothing concrete yet, merely the general gist. I stressed that my plan was to apply science to this field in order to find out what works and what doesn’t; what is safe and what isn’t. Science, I pointed out, generates progress through asking critical questions and through testing hypotheses. Alternative medicine would either be shown by good science to be of value, or it would turn out to be little more than a passing fad. The endowment of the Laing chair represented an important mile-stone on the way towards the impartial evaluation of alternative medicine, and surely this would be in the best interest of all parties concerned.

To me, all this seemed an entirely reasonable approach, particularly as it merely reiterated what I had just published in an editorial for The Lancet entitled “Scrutinizing the Alternatives”.

My audience, however, was not impressed. When I had finished, there was a stunned, embarrassed silence. Finally someone shouted angrily from the back row: “How did they dare to appoint a doctor to this chair?” I was startled by this question and did not quite understand. What had prompted this reaction? What did this audience expect? Did they think my qualifications were not good enough? Why were they upset by the appointment of a doctor? Who else, in their view, might be better equipped to conduct medical research?

It wasn’t until weeks later that it dawned on me: they had been waiting for someone with a strong commitment to the promotion of alternative medicine. Such a commitment could only come from an alternative practitioner. A doctor personified the establishment, and “alternative” foremost symbolized “anti-establishment”. My little speech had upset them because it confirmed their worst fears of being annexed by “the establishment”. These enthusiasts had hoped for a believer from their own ranks and certainly not for a doctor-scientist to be appointed to the world’s first chair of complementary medicine. They had expected that Exeter University would lend its support to their commercial and ideological interests; they had little understanding of the concept that universities should not be in the business of promoting anything other than high standards.

Even today, after having given well over 600 lectures on the topic of alternative medicine, and after coming on the receiving end of ever more hostile attacks, aggressive questions and personal insults, this particular episode is still etched deeply into my memory. In a very real way, it set the scene for the two decades to come: the endless conflicts between my agenda of testing alternative medicine scientifically and the fervent aspirations of enthusiasts to promote alternative medicine uncritically. That our positions would prove mutually incompatible had been predictable from the very start. The writing had been on the wall—but it took me a while to be able to fully understand the message.

On 1/12/2014 I published a post in which I offered to give lectures to students of alternative medicine:

Getting good and experienced lecturers for courses is not easy. Having someone who has done more research than most working in the field and who is internationally known, might therefore be a thrill for students and an image-boosting experience of colleges. In the true Christmas spirit, I am today making the offer of being of assistance to the many struggling educational institutions of alternative medicine .

A few days ago, I tweeted about my willingness to give free lectures to homeopathic colleges (so far without response). Having thought about it a bit, I would now like to extend this offer. I would be happy to give a free lecture to the students of any educational institution of alternative medicine.

I did not think that this would create much interest – and I was right: only the ANGLO-EUROPEAN COLLEGE OF CHIROPRACTIC has so far hoisted me on my own petard and, after some discussion (see comment section of the original post) hosted me for a lecture. Several people seem keen on knowing how this went; so here is a brief report.

I was received, on 14/1/2015, with the utmost kindness by my host David Newell. We has a coffee and a chat and then it was time to start the lecture. The hall was packed with ~150 students and the same number was listening in a second lecture hall to which my talk was being transmitted.

We had agreed on the title CHIROPRACTIC: FALLACIES AND FACTS. So, after telling the audience about my professional background, I elaborated on 7 fallacies:

  1. Appeal to tradition
  2. Appeal to authority
  3. Appeal to popularity
  4. Subluxation exists
  5. Spinal manipulation is effective
  6. Spinal manipulation is safe
  7. Ad hominem attack

Numbers 3, 5 and 6 were dealt with in more detail than the rest. The organisers had asked me to finish by elaborating on what I perceive as the future challenges of chiropractic; so I did:

  1. Stop happily promoting bogus treatments
  2. Denounce obsolete concepts like ‘subluxation’
  3. Clarify differences between chiros, osteos and physios
  4. Start a culture of critical thinking
  5. Take action against charlatans in your ranks
  6. Stop attacking everyone who voices criticism

I ended by pointing out that the biggest challenge, in my view, was to “demonstrate with rigorous science which chiropractic treatments demonstrably generate more good than harm for which condition”.

We had agreed that my lecture would be followed by half an hour of discussion; this period turned out to be lively and had to be extended to a full hour. Most questions initially came from the tutors rather than the students, and most were polite – I had expected much more aggression.

In his email thanking me for coming to Bournemouth, David Newell wrote about the event: The general feedback from staff and students was one of relief that you possessed only one head, :-). I hope you may have felt the same about us. You came over as someone who had strong views, a fair amount of which we disagreed with, but that presented them in a calm, informative and courteous manner as we did in listening and discussing issues after your talk. I think everyone enjoyed the questions and debate and felt that some of the points you made were indeed fair critique of what the profession may need to do, to secure a more inclusive role in the health care arena.

 
As you may have garnered from your visit here, the AECC is committed to this task as we continue to provide the highest quality of education for the 21st C representatives of such a profession. We believe centrally that it is to our society at large and our communities within which we live and work that we are accountable. It is them that we serve, not ourselves, and we need to do that as best we can, with the best tools we have or can develop and that have as much evidence as we can find or generate. In this aim, your talk was important in shining a more ‘up close and personal’ torchlight on our profession and the tasks ahead whilst also providing us with a chance to debate the veracity or otherwise of yours and ours differing positions on interpretation of the evidence.

My own impression of the day is that some of my messages were not really understood, that some of the questions, including some from the tutors, seemed like coming from a different planet, and that people were more out to teach me than to learn from my talk. One overall impression that I took home from that day is that, even in this college which prides itself of being open to scientific evidence and unimpressed by chiropractic fundamentalism, students are strangely different from other health care professionals. The most tangible aspect of this is the openly hostile attitude against drug therapies voiced during the discussion by some students.

The question I always ask myself after having invested a lot of time in preparing and delivering a lecture is: WAS IT WORTH IT? In the case of this lecture, I think the answer is YES. With 300 students present, I am fairly confident that I did manage to stimulate a tiny bit of critical thinking in a tiny percentage of them. The chiropractic profession needs this badly!

 

– Chronic low back pain (CLBP) is a condition which affects so many people that it represents a huge burden to individual patients’ suffering as well as to society in terms of loss of work time and increased economic cost. The number of therapies that have been claimed to be effective for CLBP can hardly be counted. Two of the most common treatments are spinal manipulation and exercise.

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with CLBP. Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review.

A search of the current literature was conducted using a keyword process in CINAHL, Cochrane Register of Controlled Trials Database, Medline, and Embase. The searches included studies available up to August 2014. Studies were included based on PICOS criteria 1) individuals with CLBP defined as lasting 12 weeks or longer; 2) spinal manipulation performed by a health care practitioner; 3) prescribed exercise for the treatment of CLBP and monitored by a health care practitioner; 4) measurable clinical outcomes for reducing pain, disability or improving function; 5) randomized controlled trials. The methodological quality of all included articles was determined using the criteria developed and used by the Physiotherapy Evidence Database (PEDro).

Only three RCTs met the inclusion criteria of this systematic review. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term.

The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Whenever there are uncounted treatments for a given condition, one has to ask oneself whether they are all similarly effective or equally ineffective. The present review does unfortunately not answer this question, but I fear the latter might be more true than the former.

Considering how much money we spend on treating CLBP, it is truly surprising to see that just three RCTs are available comparing two of the most commonly used treatments for this condition. Equally surprising is the fact that we simply cannot tell, on the basis of these data, which of the two therapies is more effective.

What consequences should we draw from this information. Obviously we need more high quality trials. But what should we do in the meantime?

Whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently)  is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of CLBP – and consequently consulting a chiropractor should not be the first choice for CLBP patients.

Few subjects make chiropractors more uneasy than a discussion of the safety of their spinal manipulations. Many chiropractors flatly deny that there are any risks at all. However, the evidence seems to tell a different story.

The purpose of a new review was to summarise the literature for cases of adverse events in infants and children treated by chiropractors or other manual therapists, identifying treatment type and if a preexisting pathology was present. English language, peer-reviewed journals and non-peer-reviewed case reports discussing adverse events (ranging from minor to serious) were systematically searched from inception of the relevant searchable bibliographic databases through March 2014. Articles not referring to infants or children were excluded.

Thirty-one articles met the selection criteria. A total of 12 articles reporting 15 serious adverse events were found. Three deaths occurred under the care of various providers (1 physical therapist, 1 unknown practitioner, and 1 craniosacral therapist) and 12 serious injuries were reported (7 chiropractors/doctors of chiropractic, 1 medical practitioner, 1 osteopath, 2 physical therapists, and 1 unknown practitioner). High-velocity, extension, and rotational spinal manipulation was reported in most cases, with 1 case involving forcibly applied craniosacral dural tension and another involving use of an adjusting instrument. Underlying preexisting pathology was identified in a majority of the cases.

The authors concluded that published cases of serious adverse events in infants and children receiving chiropractic, osteopathic, physiotherapy, or manual medical therapy are rare. The 3 deaths that have been reported were associated with various manual therapists; however, no deaths associated with chiropractic care were found in the literature to date. Because underlying preexisting pathology was associated in a majority of reported cases, performing a thorough history and examination to exclude anatomical or neurologic anomalies before applying any manual therapy may further reduce adverse events across all manual therapy professions.

This review is a valuable addition to our knowledge about the risks of spinal manipulations. My own review summarised 26 deaths after chiropractic manipulations. In several of these instances, the age of the patient had not been reported. Therefore the above conclusion (no deaths associated with chiropractic) seems a little odd.

The following text is a shortened version of the discussion of my review which, I think, addresses most of the pertinent issues.

 numerous deaths have been associated with chiropractic. Usually high-velocity, short-lever thrusts of the upper spine with rotation are implicated. They are believed to cause vertebral arterial dissection in predisposed individuals which, in turn, can lead to a chain of events including stroke and death. Many chiropractors claim that, because arterial dissection can also occur spontaneously, causality between the chiropractic intervention and arterial dissection is not proven. However, when carefully evaluating the known facts, one does arrive at the conclusion that causality is at least likely. Even if it were merely a remote possibility, the precautionary principle in healthcare would mean that neck manipulations should be considered unsafe until proven otherwise. Moreover, there is no good evidence for assuming that neck manipulation is an effective therapy for any medical condition. Thus, the risk-benefit balance for chiropractic neck manipulation fails to be positive.

Reliable estimates of the frequency of vascular accidents are prevented by the fact that underreporting is known to be substantial. In a survey of UK neurologists, for instance, under-reporting of serious complications was 100%. Those cases which are published often turn out to be incomplete. Of 40 case reports of serious adverse effects associated with spinal manipulation, nine failed to provide any information about the clinical outcome. Incomplete reporting of outcomes might therefore further increase the true number of fatalities.

This review is focussed on deaths after chiropractic, yet neck manipulations are, of course, used by other healthcare professionals as well. The reason for this focus is simple: chiropractors are more frequently associated with serious manipulation-related adverse effects than osteopaths, physiotherapists, doctors or other professionals. Of the 40 cases of serious adverse effects mentioned above, 28 can be traced back to a chiropractor and none to a osteopath. A review of complications after spinal manipulations by any type of healthcare professional included three deaths related to osteopaths, nine to medical practitioners, none to a physiotherapist, one to a naturopath and 17 to chiropractors. This article also summarised a total of 265 vascular accidents of which 142 were linked to chiropractors. Another review of complications after neck manipulations published by 1997 included 177 vascular accidents, 32 of which were fatal. The vast majority of these cases were associated with chiropractic and none with physiotherapy. The most obvious explanation for the dominance of chiropractic is that chiropractors routinely employ high-velocity, short-lever thrusts on the upper spine with a rotational element, while the other healthcare professionals use them much more sparingly.

[REFERENCES FOR THE ABOVE STATEMENTS CAN BE FOUND IN MY REVIEW]
Recent Comments

Note that comments can now be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories