MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

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Chiropractors may not be good at treating diseases or symptoms, but they are certainly good at promoting their trade. As this trade hardly does more good than harm, one could argue that chiropractors are promoting bogus and potentially harmful treatments to fill their own pockets.

Does that sound too harsh? If you think so, please read what Canadian researchers have just published:

This study aimed to investigate the presence of critiques and debates surrounding efficacy and risk of Spinal Manipulative Therapy (SMT) on the social media platform Twitter. Specifically, it examined whether there is presence of debate and whether critical information is being widely disseminated.

An initial corpus of 31,339 tweets was compiled through Twitter’s Search Application Programming Interface using the query terms “chiropractic,” “chiropractor,” and “spinal manipulation therapy.” Tweets were collected for the month of December 2015. Post removal of tweets made by bots and spam, the corpus totalled 20,695 tweets, of which a sample (n=1267) was analysed for sceptical or critical tweets.

The results showed that there were 34 tweets explicitly containing scepticism or critique of SMT, representing 2.68% of the sample (n=1267). As such, there is a presence of 2.68% of tweets in the total corpus, 95% CI 0-6.58% displaying explicitly sceptical or critical perspectives of SMT. In addition, there are numerous tweets highlighting the health benefits of SMT for health issues such as attention deficit hyperactivity disorder (ADHD), immune system, and blood pressure that receive scant critical attention. The presence of tweets in the corpus highlighting the risks of “stroke” and “vertebral artery dissection” is also minute (0.1%).

The authors drew the following conclusions: In the abundance of tweets substantiating and promoting chiropractic and SMT as sound health practices and valuable business endeavors, the debates surrounding the efficacy and risks of SMT on Twitter are almost completely absent. Although there are some critical voices of SMT proving to be influential, issues persist regarding how widely this information is being disseminated.

I have no doubt that this paper will be sharply criticised by chiropractors, other manipulators and lobbyists of quackery. Yet I think it is an interesting and innovative approach to describe what is and is not being said on public media. The fact that chiropractors hardly ever publicly criticise or challenge each other on Twitter or elsewhere for even the most idiotic claims is, in my view, most telling.

Few people would doubt that such platforms have become hugely important in forming public opinions, and it seems safe to assume that consumers views about SMT are strongly influenced by what they read on Twitter. If we accept this position, we also have to concede that Twitter et al. are a potential danger to public health.

The survey is, however, not flawless, and the authors are the first to point that out: Given the nature of Twitter discussions and the somewhat limited access provided by Twitter’s API, it can be challenging to capture a comprehensive collection of tweets on any topic. In addition, other potential terms such as “chiro” and “spinal adjustment” are present on Twitter, which may produce datasets with somewhat different results. Finally, although December 2015 was chosen at random, there is nothing to suggest that other time frames would be significantly similar or different. Despite these limitations, this study highlights the degree to which discussions of risk and critical views on efficacy are almost completely absent from Twitter. To this I would add that a comparison subject like nursing or physiotherapy might have been informative, and that somehow osteopaths have been forgotten in the discussion.

The big question, of course, is: what can be done about creating more balance on Twitter and elsewhere? I wish I had a practical answer. In the absence of such a solution, all I can offer is a plea to everyone who is able of critical thinking to become as active as they can in busting myths, disclosing nonsense and preventing the excesses of harmful quackery.

Let’s all work tirelessly and effectively for a better and healthier future!

Low back pain (LBP) is a ‘minor complaint’ in the sense that it does not cost patients’ lives. At the same time, LBP is amongst the leading causes of disability and one of the most common reasons for patients to seek primary care. Chiropractors, osteopaths, physical therapists and general practitioners are among those treating LBP patients, but there is only limited evidence regarding the effectiveness offered by these provider groups.

The aim of this systematic review was to estimate the clinical effectiveness and to systematically review economic evaluations of chiropractic care compared to other commonly used approaches among adult patients with non-specific LBP.

A comprehensive search strategy was conducted to identify 1) pragmatic randomized clinical trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. The primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine estimates of effect sizes. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized.

Six RCTs and three full economic evaluations were included. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). The authors found similar effects for chiropractic care and the other types of care. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Highly divergent conclusions (favours chiropractic, favours medical care, equivalent options) were noted for economic evaluations of chiropractic care compared to medical care.

The authors drew the following conclusions: moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.

This is a thorough and timely review. Its results are transparent and clear, however, its conclusions are, in my view, more than a little odd.

Let me try to re-formulate them such that they are better supported by the actual data: There is no good evidence to suggest that chiropractic care is better or worse that conventional therapeutic approaches currently used for LBP. The pooled sample size dimensions too small to allow any statements about the risks of the various approaches. The data are also too weak for any pronouncements on the relative cost-effectiveness of the various options. Given these limitations, the decision which approach to use should be based on a more comprehensive analysis of the therapeutic risks.

The point I am trying to make is quite simple:

  • The fact that RCTs fail to show adverse effects could be due to the small collective sample size and/or to the well-known phenomenon that, in well-controlled trials, adverse effects tend to be significantly rarer than in routine care.
  • Hundreds of serious adverse events have been reported after chiropractic spinal manipulations; to these we have to add the fact that ~50% of all chiropractic patients suffer from transient, mild to moderate adverse effects after spinal manipulations.
  • If we want to generate a realistic picture of the safety of a therapy, we need to include case-reports, case-series and other non-RCT evidence.
  • Conventional treatments of LBP may not be free of adverse effects, but some are relatively safe.
  • It seems reasonable, necessary and ethical to consider a realistic picture of the relative risks when deciding which therapy amongst equally (in)effective treatments might be best.

To me, all this seems almost painfully obvious, and I ask myself why the authors of this otherwise sound review failed to consider such thoughts. As one normally is obliged to, the authors included a section about the limitations of their review:

Our review has limitations. First, we did not search the grey literature for clinical effectiveness studies. McAuley et al. showed that the inclusion of results from the grey literature tend to decrease effectiveness estimates in meta-analyses because the unpublished studies tend to report smaller treatment effects. Second, critical appraisal requires scientific judgment that may vary among reviewers. This potential bias was minimized by training reviewers to use a standardized critical appraisal tool and using a consensus process among reviewers to reach decisions regarding scientific admissibility. Most of the original between-group differences and pooled estimates in our meta-analysis did not favour a specific provider group, and we believe it is unlikely that the inclusion of unpublished grey literature would change our conclusions. Third, the low number of clinical trials prevents us from conducting a meaningful investigation for publication bias. Fourth, the majority of the included clinical effectiveness studies (three out of five) and all three economic evaluations were conducted in the United States. Caution should therefore be used when generalizing our findings to other settings or jurisdictions. With respect to economic evaluations in particular, local healthcare systems and insurance plans may have a higher impact on cost than the type of healthcare provider.

Remarkably, this section does not mention their useless assessment of the risks with one word. Why? One answer might be found in the small-print of the paper:

The authors … have the following competing interests: MAB: Personal fees from Ordre des chiropraticiens du Québec for one teaching presentation, outside the submitted work. MJS: Position at the Nordic Institute of Chiropractic and Clinical Biomechanics is funded by the Danish Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication. RBDS: Nothing to disclose. JB: Nothing to disclose. PH: Nothing to disclose. AB: Position at the School of Physical and Occupational Therapy at McGill University is funded by the Canadian Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication.

After > 200 years of existence, homeopathy still remains unproven – in fact, most rational thinkers would call it disproven. Today only homeopaths doubt this statement; they work hard to find a water-tight proof that might show the doubters to be wrong.

What is better suited for this purpose than a few rigorous animal experiments?

Engystol® is a popular homeopathic product promoted as an anti-viral agent manufactured by Heel GmbH, Baden-Baden, Germany. In several in vivo and in vitro studies, it apparently affected an immune response. This new study was to “evaluate the innate and adaptive immuno-modulatory effects of oral Engystol® (1 or 10 tablets/L water consumed), prior to and post antigenic challenge in a mouse model with a well-characterized and clinically measureable immune system.”

The investigators first evaluated the murine immune response when oral Engystol® was given alone for 28 days. to mice. The animals were then challenged with an antigen-specific H5N1 HA vaccine while on Engystol® for an additional 33 days. Serum and supernatants from cultured splenic lymphocytes were collected and screened with a 32-cytokine panel. Serum vaccine epitope-specific IgG titers plus T cell and B cell phenotypes from splenic tissue were also evaluated.

The results showed that Engystol® alone did not alter immunity. However, upon vaccine challenge, Engystol® decreased CD4+/CD8+ ratios, altered select cytokines/chemokines, and anti-H5N1 HA IgG titers were increased in the group of mice receiving 10 tablet/L.

The authors concluded that “these data suggest that Engystol® can modulate immunity upon antigenic challenge.”

Engystol is being advertised as “a homeopathic preparation which has been scientifically proven to significantly reduce the duration and severity of symptoms during an acute viral infection and help protect from subsequent infections.” I was unable find good evidence for this claim and therefore have to assume that it is bogus. The only human trial I was able to locate was this one:

OBJECTIVE:

To compare the effects of a complex homeopathic preparation (Engystol; Heel GmbH, Baden-Baden, Germany) with those of conventional therapies with antihistamines, antitussives, and nonsteroidal antiinflammatory drugs on upper respiratory symptoms of the common cold in a setting closely related to everyday clinical practice.

DESIGN:

Nonrandomized, observational study over a treatment period of maximally two weeks.

SETTING:

Eighty-five general and homeopathic practices in Germany.

PARTICIPANTS:

Three hundred ninety-seven patients with upper respiratory symptoms of the common cold.

INTERVENTIONS:

Engystol-based therapy or common over-the-counter treatments for the common cold. Patients receiving this homeopathic treatment were allowed other short-term medications, but long-term use of analgesics, antibiotics, and antiinflammatory agents was not permitted. Patients were allowed nonpharmacological therapies such as vitamins, thermotherapies, and others.

MAIN OUTCOME MEASURES:

The effects of treatment were evaluated on the variables fatigue, sensation of illness, chill/tremor, aching joints, overall severity of illness, sum of all clinical variables, temperature, and time to symptomatic improvement.

RESULTS:

Both treatment regimens provided significant symptomatic relief, and this homeopathic treatment was noninferior in a noninferiority analysis. Significantly more patients (P < .05) using Engystol-based therapy reported improvement within 3 days (77.1% vs 61.7% for the control group). No adverse events were reported in any of the treatment groups.

CONCLUSION:

This homeopathic treatment may be a useful component of an integrated symptomatic therapy for the common cold in patients and practitioners choosing an integrative approach to medical care.

Let me comment on the human study first. It is an excellent example of the bias that can be introduced by non-randomization. The patients in the homeopathic group obviously were those who chose to be treated homeopathically. Consequently they had high expectations in this therapy. Consequently they reported better results than the control group. In other words the reported outcomes have nothing to do with the homeopathic remedy.

But what about the animal study? Animals, we hear so often, do not exhibit a placebo response. Does that render this investigation any more reliable?

The answer, I am afraid is no.

The animal study in question had no control group at all. Therefore a myriad of factors could have caused the observed result. This study is very far from a poof of homeopathy!

But even if the findings of the two studies had not been the result of bias and confounding, I would be more than cautious about viewing them as anything near conclusive. The reason lies in the nature of this particular homeopathic remedy.

Engystol® contains Vincetoxicum hirundinaria (D6), Vincetoxicum hirundinaria (D10), Vincetoxicum hirundinaria (D30), sulphur (D4) and sulphur (D10). In other words, it is one of those combination remedies which are not sufficiently dilute to be devoid of active molecules. Sulphur D4, for instance, means that the remedy contains one part of sulphur in 10 000 parts of diluent. It is conceivable, even likely that such a concentration might affect certain immune parameters, I think.

And my conclusion from all this?

The proof of homeopathy – if it ever came – would need to be based on investigations that are more rigorous than these two rather pathetic studies.

I have moaned about the JACM several times on this blog (for instance here). It is a very poor journal, in my view, but it nevertheless is important because it is the one with the highest impact factor in this field. Despite all this I missed something important that recently happened to the JACM: a few months ago, it got a new editor in chief: John Weeks.

Had I been more attentive, I would have known this already in May when Weeks wrote in the HuffPo this: “I was asked a month ago, out of the blue, if I would like to become editor-in-chief of the first peer-reviewed, indexed journal in what is now the “integrative health and medicine” field. The journal was born 20 years ago when — as my father would have put it — “integrative medicine” was hardly a gleam in anyone’s eye. The publication is the Journal of Alternative and Complementary Medicine.”

I have a vague memory of meeting him once at a conference and sitting next to him during a dinner. For those who haven’t heard of him, here is how he once described himself:

I have been involved as an organizer-writer in the emerging fields of complementary, alternative and integrative medicine since 1983. Happily, I have learned some things. I was once called an “expert in alternative medicine” by Medical Economics and later an “alternative care (integration) expert” by Modern Healthcare. The name-calling was proud-making, even if I was so-dubbed by reporters who were on their first forays into the field.

Both anointed me before I went on sabbatical in Costa Rica and later Nicaragua with my family in 2002. Part of the reason for sabbatical was that whatever expertise I may have developed often ran frustratingly short of being able to offer robust, successful business models with readers and clients. More than once I counseled people against the initiatives they planned. Trends taught me to recognize the invisible handwriting of a sure failure event behind the bubbling enthusiasm of an initiate. I needed a break from the work. My family and I took it!

I was away from the United States for three years. I had my hand back in things for the last 2.5 years. I assisted a philanthropist on her integrative medicine investments in community clinics, CAM schools and academic health centers. From early 2004 forward, and out of home offices in Monteverde, Costa Rica, and then Granada, Nicaragua, I helped organize and direct the National Education Dialogue to Advance Integrated Health Care: Creating Common Ground

END OF QUOTE

Is Weeks going to be a good editor who throws out all the trash that JACM has been publishing on a far too regular basis? Well, the good news, I suppose, is that he cannot possibly be worse than his predecessor. Perhaps we should see for ourselves what the new man thinks and writes. Here is an excerpt from his recent editorial on the question of medical errors in conventional medicine and the role of integrative medicine in this difficult issue:

[A] whole-system solution to medical errors suggests many roles for traditional, alternative, complementary, and integrative approaches and practices. First, better use of these new therapies and provider types expands the tools and strategies for keeping the locus of care out in communities instead of in the problematic hospital environment. One of the commentators at Medscape for instance pointed out that when it comes to “errors” that lead to death, the most significant culprits are the errors individuals make in living the standard U.S. life-style. A starting place in limiting medical deaths is for us to take better care of ourselves. We’ll be less likely to need treatment or to be admitted if we do. The across-the-board engagement by multiple integrative and traditional medicine practitioners with life-style medicine, there are clearly important roles for integrative and traditional practices and practitioners.

More evidence that integrative practice keeps people healthy and out of hospitals would be useful. Our research needs to capture these life-changing outcomes better. The values movement is toward primary care and community medicine. Outpatient care offers a home-field advantage for traditional medical systems and licensed integrative health practitioners, from yoga and massage therapists to acupuncture and Oriental medicine specialists and integrative, chiropractic, and naturopathic doctors. And when people are admitted to hospitals, broader integrative teams need to be available to catch, hold, and treat the whole person and help keep them from being biomedically reduced. Such efforts would be served by research data that measure quadruple-aim outcomes. Think patient experience, enhancing life-style skills, faster healing times, diminished hospital stays, and more pleasure of practitioners in their caregiving. Some have begun gathering these outcomes. We need bushels more. We’ll also have a growing need for reports that delineate processes and obstacles overcome in highly functioning integrative care teams.

The whole-system response to medical deaths is opening minds and doors to integrative practices and to leadership from the integrative community. In one remarkable example, the state of Oregon is seeking to reduce the morbidity and mortality associated with opioids through prioritizing the care of chiropractors, acupuncturists, and massage and yoga therapists. To maximize our effectiveness as agents of change in helping create health in those we serve, more of us need to study up on the emerging language, goals, and methods of the value-based movement, then match up to these aims in our study designs and selections of outcomes. Advancing whole-person care and linking to the emerging values appear to be our best opportunities to help shape the path away from death and toward safety and health.

END OF QUOTE

Impressed? Me neither!

In my view, this reads like an accumulation of platitudes, wishful thinking and uncritical waffling. The passage that I found positively worrying was this one: More evidence that integrative practice keeps people healthy and out of hospitals would be useful. Our research needs to capture these life-changing outcomes better. The editor of a medical journal should, I think, know that research is not for confirming beliefs but for testing hypotheses. In all this verbose rambling, I really cannot find a good reason why integrative medicine might have a role in reducing medical errors. More worrying still, I cannot find a trace of critical thinking.

As I was writing this, I remembered more about the only personal encounter I had with Weeks years ago. For some reason we talked about THE ‘textbook’ of naturopaths, entitled THE TEXTBOOK OF NATURAL MEDICINE. I remember explaining to Weeks that it contained a lot of factual errors and outright nonsense. He very much disputed my view, seemed to take it personally, and even got quite stroppy. In the end, we agreed to disagree.

Neither this episode nor indeed the editorial are all that important – we will simply have to wait and see how the JACM does under its new editor.

This article in THE DAILY MAIL caught my eye. It’s about ear-candles, a subject we have discussed before on this blog. Apparently, the ‘TV doctor’ Dawn Harper was had to apologise after recommending ear candling for clearing ears of wax. This prompted various protests from listeners of her programme one of whom even called Dr Harper a ‘dangerous quack’. Dr  Harper apologised to listeners by saying: ‘It was recommended to me by an ENT surgeon but seems to have fallen from favour. I’ll discuss next week.’

One would think that this is a non-story, but not for THE DAILY MAIL. The paper continues by citing my article published in 2004:

Edzard Ernst, an expert in the study of alternative medicine and former professor at the University of Exeter, has published an article entitled ‘Ear candles: a triumph of ignorance over science’ and said there is no evidence they work.

He said a study of ear candles show that its ‘mode of action is implausible and demonstrably wrong’ while there was ‘no data to suggest that it is effective for any condition’.

He added: ‘The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.’

He also points to a number of cases in which patients suffered injuries from the practice, including one woman, from London, who suffered hearing loss and another who burned a hole in her ear.

This seems fairly correct, except the quotes must be straight from my paper, because no MAIL journalist actually talked to me. This means that phraseology like ‘he said’ and ‘he added’ is misleading. But this is not what irritates me about the article (I have had enough contact with journalists to get excited about trivialities); the annoying bit, in my view, is what follows:

Ironically since the publication of Professor Ernst’s paper in 2004 ear candles have become more, not less, popular.

The manager of St James’ Beauty, a clinic that provides the treatment in London, said: ‘Everybody says they do work. Quite a lot comes out of the ears which is amazing.

‘People say their sinuses improve and their senses are better.

‘We don’t have very many, about one a month. But it does have a strong following because it’s been around for such a long time.’

Lynne Hatcher, a complementary health practitioner from Wolverhampton, claims ear candles are ‘a pleasant and non-invasive treatment of the ears, used to treat a variety of conditions’.

Writing on her website she adds: ‘This is an ancient and natural therapy handed down by many civilisations. It is believed that the Ancient Greeks used ear candles, initially probably for cleansing, purifying and healing on a spiritual basis, but much later on a purely physical basis.’

I know, journalists feel the need to create balance, and therefore always quote the ‘other side’. But there are instances where what they perceive as balance is really inappropriately false balance. In the above incidence, the MAIL quoted a total of 3 people they consider to be experts. My paper summarized the known facts. The MAIL then ‘balanced’ them with the opinions of two people who earn their money with ear-candles. Consequently, the article gives the impression that ear-candling is probably quite good after all. In truth, this is not creating balance but introducing bias.

This would, of course, be utterly trivial – if it would be an exception. But it is much more the rule, I am afraid. I have seen this hundreds of times in alternative medicine:

  • a journalist phones me to ask me for a quote,
  • I volunteer a factual quote that is easy to understand for a lay-person,
  • the journalist then phones several quacks who contradict the facts based on their opinions,
  • the quotes are then published such that the quacks have the last word,
  • the resulting article is published and turns out to be a promotion of quackery.

This is maddening, of course, but sometimes, it also has its humorous side: in the above case, THE MAIL starts by repeating the allegation against the TV-doctor being a quack; as the article progresses it becomes clear that the true quack is THE DAILY MAIL.

Since several years, there has been an increasingly vociferous movement within the chiropractic profession to obtain limited prescription rights, that is the right to prescribe drugs for musculoskeletal problems. A recent article by Canadian and Swiss chiropractors is an attempt to sum up the arguments for and against this notion. Here I have tried to distil the essence of the pros and contras into short sentences.

 1) Arguments in favour of prescription rights for chiropractors

1.1 Such privileges would be in line with current evidence-based practice. Currently, most international guidelines recommend, alongside prescription medication, a course of manual therapy and/or exercise as well as education and reassurance as part of a multi-modal approach to managing various spine-related and other MSK conditions.

1.2 Limited medication prescription privileges would be consistent with chiropractors’ general experience and practice behaviour. Many clinicians tend to recommend OTC medications to their patients in practice.

1.3 A more comprehensive treatment approach offered by chiropractors could potentially lead to a reduction in healthcare costs by providing additional specialized health care options for the treatment of MSK conditions. Namely, if patients consult one central practitioner who can effectively address and provide a range of treatment modalities for MSK pain-related matters, the number of visits to providers might be reduced, thereby resulting in better resource allocation.

1.4 Limited medication prescription rights could lead to improved cultural authority for chiropractors and better integration within the healthcare system.

1.5 With these privileges, chiropractors could have a positive influence on public health. For instance, analgesics and NSAIDs are widely used and potentially misused by the general public, and users are often unaware of the potential side effects that such medication may cause.

2) Arguments against prescription rights for chiropractors

2.1 Chiropractors and their governing bodies would start reaching out to politicians and third-party payers to promote the benefits of making such changes to the existing healthcare system.

2.2 Additional research may be needed to better understand the consequences of such changes and provide leverage for discussions with healthcare stakeholders.

2.3 Existing healthcare legislation needs to be amended in order to regulate medication prescription by chiropractors.

2.4 There is a need to focus on the curriculum of chiropractors. Inadequate knowledge and competence can result in harm to patients; therefore, appropriate and robust continuing education and training would be an absolute requirement.

2.5 Another important issue to consider relates to the divisiveness around this topic within the profession. In fact, some have argued that the right to prescribe medication in chiropractic practice is the profession’s most divisive issue. Some have argued that further incorporation of prescription rights into the chiropractic scope of practice will negatively impact the distinct professional brand and identity of chiropractic.

2.6 Such privileges would increase chiropractors’ professional responsibilities. For example, if given limited prescriptive authority, chiropractors would be required to recognize and monitor medication side effects in their patients.

2.7 Prior to medication prescription rights being incorporated into the chiropractic scope of practice worldwide, further discussions need to take place around the breadth of such privileges for the chiropractic profession.

In my view, some of these arguments are clearly spurious, particularly those in favour of prescription rights. Moreover, the list of arguments against this notion seems a little incomplete. Here are a few additional ones that came to my mind:

  • Patients might be put at risk by chiropractors who are less than competent in prescribing medicines.
  • More unnecessary NAISDs would be prescribed.
  • The vast majority of the drugs in question is already available OTC.
  • Healthcare costs would increase (just as plausible as the opposite argument made above, I think).
  • Prescribing rights would give more legitimacy to a profession that arguably does not deserve it.
  • Chiropractors would then continue their lobby work and soon demand the prescription rights to be extended to other classes of drugs.

I am sure there are plenty of further arguments both pro and contra – and I would be keen to hear them; so please post yours in the comments section below.

In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.

According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”

The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”

This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.

Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.

As has been discussed on this blog many times before, the chiropractic profession seems to be in a bit of a crisis (my attempt at a British understatement). The Australian chiropractor, Bruce Walker, thinks that, with the adoption of his ten point plan, “the chiropractic profession has an opportunity to turn things around within a generation. Importantly, it has an obligation to the public and to successive generations of chiropractors ahead of it. By embracing this plan the profession can be set on a new path, a new beginning and a new direction. This plan should be known as the new chiropractic.”

And now you are. of course, dying to hear this 10 point plan – well, here it is [heavily abbreviated, I am afraid (the footnotes [ ] and the comments referring to them are mine)]:

  1. There is a need to improve pre professional education for chiropractors.
    Universities or private colleges?
    Chiropractic education should where possible be conducted at universities [1] and this does not mean small single purpose institutions that are deemed universities in name only. Why is this recommended? Primarily because unlike some private colleges, government funded universities insist on intellectual evidence based rigour [2] in their learning and teaching and importantly require staff to be research active. Chiropractic courses need to have an underpinning pedagogy that insists that content [3] is taught in the context of the evidence [4] and that students obtain the necessary training to question and critically appraise [5]…
    Accreditation problems
    Underpinning chiropractic education is program accreditation and this is also in need of review particularly where vitalistic subluxation [6] based courses have been legitimised by the accreditation process…
    Hospital training
    Chiropractic education should also involve specifically relevant hospital access or work experience such as hospital rounds so that students can observe patients that are truly unwell and observe the signs and symptoms taught in their theory classes. Hospital rounds would also allow chiropractic students to interact with other health providers and increase the likelihood of legitimate partnership and respect between health professions [7].
    Who should teach chiropractic students?…
  2. There is a need to establish a progressive identity.
    Chiropractors need to become solely musculoskeletal practitioners with a special emphasis on spinal pain [8]. If the profession becomes the world’s experts in this area it will command the respect deserved [9]. Importantly it will not be seen as a collective of alternative medicine practitioners with a strange belief system [10]…
  3. The profession should develop a generalised special interest.
    …Chiropractic as a profession should also develop a special interest area in the health sciences that can make a worldwide contribution to other related health sciences. This could be either research based or clinically based or indeed both. Some possibilities are: the further development and refinement of evidence based practice [11], improved posture through motor control, musculoskeletal care for the aged and elderly, improving bone density or the very important area of translating research into practice via implementation science. Whatever chosen we need to develop a special interest that sets us apart as experts in a distinctive area [12].
  4. Marginalisation of the nonsensical elements within the profession.
    As professionals chiropractors should not tolerate colleagues or leadership in the profession who demonstrate aberrant ideas. If colleagues transgress the boundaries or professionalism they should be reported to authorities and this should be followed up with action by those authorities [13]…
  5. The profession and individual practitioners should be pro public health.
    It is important to speak up openly in favour of evidence-based public health measures and to join public health associations and agencies [14]…  For example, chiropractors promoting anti-vaccination views need to be countered [15]…
  6. Support legitimate organised elements of the profession.
    Practitioners should support and become involved in chiropractic organisations that are clearly ethical and evidence based [16] and add value to them…
    …Regular collective professional advertising of the benefits of chiropractic for back pain, for example, is a worthy undertaking but the advertisements or media offerings must be evidence based [17].
  7. The profession should strive to improve clinical practice.
    Chiropractors contribute to the public health by the aggregated benefit of positive outcomes to health from their clinical practices [18]… Where restrictive practice laws relating to chiropractors prescribing medication exist the profession should seek to overturn them [19]…
  8. The profession should embrace evidence based practice.
    EBP is the amalgam of best scientific evidence plus clinical expertise plus patient values and circumstances. So what could be missing from this equation? It is clear that in the opinion of a sizable minority of the profession the elements that are missing are “practitioner ideology” and “practitioner values and circumstances”. These additional self- serving and dangerous notions should not be entertained. The adoption of evidence based practice is critical to the future of chiropractic and yet there is resistance by elements within the profession. Soft resistance occurs with attempts to change the name of “Evidence-based practice” (EBP) to “Evidence-informed practice” (EIP). It is worth noting that currently there are over 13,000 articles listed in PUBMED on EBP but less than 100 listed on EIP. So why are some of our profession so keen to use this alternate and weaker term?
    Hard resistance against EBP occurs where it is stated that the best evidence is that based on practice experience and not research. This apparently is known as Practice Based Evidence (PBE) and has a band of followers [20]…
  9. The profession must support research.Research needs to become the number one aspiration of the profession. Research informs both practice and teaching. Without research the profession will not progress. Sadly, the research contribution by the chiropractic profession can only be described as seed like. Figure 1 is a comparison of articles published in the past 45 years by decade using the key words “Physiotherapy” or “Physical Therapy” versus “Chiropractic” (source PUBMED). The Y axis is the number of articles published and the X axis is the decade, the red represents physiotherapy articles, the blue chiropractic. The difference is stark and needs urgent change [21].If the profession at large ignores research whether in its conduct, administration or its results the profession will wither on the vine [22]…
  10. Individual chiropractors need to show personal leadership to effect change.
    Change within the profession will likely only occur if individual chiropractors show personal leadership….
    As part of this personal leadership it will be critical to speak out within the profession. Speak out and become a mentor to less experienced colleagues [23]…
[1] I do wonder whether the ambition to be university-based is not more the hope for recognition than anything else.

[2] The lack of ‘intellectual evidence based rigor’ in chiropractic might prevent from being accepted by universities.

[3] What content?

[4] What evidence?

[5] If one critically assesses chiropractic, it very quickly falls apart.

[6] Subluxation does not need to be reviewed, it needs to be scrapped once and for all.

[7] Again I wonder whether this ambition is about anything else than gaining acceptance and recognition.

[8] In what way would they then differ from physiotherapists?

[9] Same point as in 1 and 7.

[10] The strangest belief system must be that of chiropractic!

[11] This is almost comical! Chiropractic is clearly much further away from evidence practice than chiropractors are aware. In my view, this statement reveals an embarrassing degree of delusion.

[12] To me, this sounds embarrassingly naïve.

[13] If such transgressions were reported in all instances, there would be only very few chiropractors left with a clean slate, I fear.

[14] The profession has a very poor track when it comes to public health measures; as back pain specialists they also would not be in a key position for such a task.

[15] I fear there are far too many anti-vaccination chiros for this to be a realistic prospect.

[16] There is plenty of evidence to show that chiropractic is often neither ethical nor evidence-based.

[17] Advertising is ethically problematic; responsible physicians are extremely cautious and restricted in this respect.

[18] What is this supposed to mean? It sounds politically correct but seems to be little more than a platitude.

[19] So, the future of chiropractic lies in prescribing medicines?

[20] These ‘followers’ are people who want to introduce double standards in healthcare – hardly anything worthy of consideration, I think.

[21] To understand this figure better, we need to know that physiotherapy is, compared to most other areas of healthcare, also not a very research-active field.

[22] But that’s precisely what chiropractors have been doing for the last 100 years!

[23] If you want to know how chiropractors receive a colleague who ‘speaks out’, you only need to read some of the comments Preston Long attracted with his guest post on this blog.

Anyone you thinks that with such a strategy “the chiropractic profession has an opportunity to turn things around within a generation” is, in my view, naïve and deluded. The 10 points are not realistic and woefully incomplete. The most embarrassing omission is a clear statement that chiropractors are fully dedicated to making sure that they serve the best interest of their patients by doing more good than harm.

Cranio-sacral therapy has been a subject on this blog before, for instance here, here and here. The authors of this single-blind, randomized trial explain in the introduction of their paper that “cranio-sacral therapy is an alternative and complementary therapy based on the theory that restricted movement at the cranial sutures of the skull negatively affect rhythmic impulses conveyed through the cerebral spinal fluid from the cranium to the sacrum. Restriction within the cranio-sacral system can affect its components: the brain, spinal cord, and protective membranes. The brain is said to produce involuntary, rhythmic movements within the skull. This movement involves dilation and contraction of the ventricles of the brain,  which produce the circulation of the cerebral spinal fluid. The theory states that this fluctuation mechanism causes reciprocal tension within the membranes, transmitting motion to the cranial bones and the sacrum. Cranio-sacral therapy and cranial osteopathic manual therapy originate from the observations made by William G. Sutherland, who said that the bones of the human skeleton have mobility. These techniques are based mainly on the study of anatomic and physiologic mechanisms in the skull and their relation to the body as a whole, which includes a system of diagnostic and therapeutic techniques aimed at treatment and prevention of diseases. These techniques are  based on the so-called primary respiratory movement, which is manifested in the mobility of the cranial bones, sacrum,  dura, central nervous system, and cerebrospinal fluid. The main difference between the two therapies is that cranial osteopathy, in addition to a phase that works in the direction of the lesion (called the functional phase), also uses a phase that worsens the injury, which is called structural phase.”

With this study, the researchers wanted to evaluate the effects of cranio-sacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. Sixty-four patients with chronic non-specific low back pain were assigned to an experimental group receiving 10 sessions of craniosacral therapy, or to the control group receiving 10 sessions of classic massage. Craniosacral therapy took 50 minutes and was conducted as follows: With pelvic diaphragm release, palms are placed in transverse position on the superior aspect of the pubic bone, under  the L5–S1 sacrum, and finger pads are placed on spinal processes.  With respiratory diaphragm release, palms are placed transverse under T12/L1 so that the spine lies along the start of fingers and the border of palm, and the anterior hand is placed on the breastbone. For thoracic inlet release, the thumb and index finger are placed on the opposite sides of the clavicle, with the posterior hand/palm of the hand cupping C7/T1. For the hyoid release, the thumb and index finger are placed on the hyoid, with the index finger on the occiput and the cupping finger pads on the cervical vertebrae. With the sacral technique for stabilizing L5/sacrum, the fingers contact the sulcus and the palm of the hand is in contact with the distal part of the sacral bone. The non-dominant hand of the therapist rested over the pelvis, with one hand on one iliac crest and the elbow/forearm of the other side over the other iliac crest. For CV-4 still point induction, thenar pads are placed under the occipital protuberance, avoiding mastoid sutures.  Classic massage protocol was compounded by the following sequence techniques of soft tissue massage on the  low back: effleurage, petrissage, friction, and kneading. The maneuvers are performed with surface pressure, followed by deep pressure and ending with surface pressure again. The techniques took 30 minutes.

Disability (Roland Morris Disability Questionnaire RMQ, and Oswestry Disability Index) was the primary endpoint. Other outcome measures included the pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical analyses of interstitial fluid. All outcomes were measured at baseline, after treatment, and one-month follow-up.

No statistically significant differences were seen between groups for the main outcome of the study, the RMQ. However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p ≤ 0.008), hemoglobin oxygen saturation (p ≤ 0.028), and systolic blood pressure (p ≤ 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage.

The authors concluded that 10 sessions of cranio-sacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain.

Given the results of this study, the conclusion is surprising. The primary outcome measure failed to show an inter-group difference; in other words, the results of this RCT were essentially negative. To use secondary endpoints – most of which are irrelevant for the study’s aim – in order to draw a positive conclusion seems odd, if not misleading. These positive findings are most likely due to the lack of patient-blinding or to the 200 min longer attention received by the verum patients. They are thus next to meaningless.

In my view, this publication is yet another example of an attempt to turn a negative into a positive result. This phenomenon seems embarrassingly frequent in alternative medicine. It goes without saying that it is not just misleading but also dishonest and unethical.

Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.

And, of course, we don’t want to listen to just any odd homeopath, we want true experts to tell us the truth – for instance, experts like Dr. R.K. Manchanda, Deputy Director(Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi and Dr. Surinder Verma, Assistant Director (Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi. They authored an article which states the following:

There are about 25 homoeopathic drugs available for the treatment of dengue fever. These are Aconite., Arnica, Arsenic-alb., Arum-tri., Baptisia., Belladonna., Bryonia., Cantharis., China officinalis Colocynthis., Eupatorium perfoliatum., Ferrum metallicum., Gelsemium., Hamamelis., Ipecac., Lachesis, Merc-sol, Nux vomica., Podophyllum., Rhus toxicodendron., Rhus-venenata., Sanicula., Secale cornutum and Sul-acidum. These drugs had been successfully used by various homeopaths across the globe for its treatment and management. In 1996 during the epidemic of dengue in Delhi Eupatorium perfoliatum was found most effective.

Sadly, the article does not provide any evidence. A quick Medline search located one (!) single trial on the subject. Here is the abstract:

A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.

This is a 2007 study by a well-known US homeopath. Its results fail to confirm that homeopathy is effective for Dengue. So, surely the homeopathic community has since stopped claiming that homeopathy is an option for this infection!

No, you guessed correctly, they continue claiming that homeopathy works for Dengue. Currently, there are about half a million websites doing exactly that. An example is this article published YESTERDAY (!):

Alopathy is no more the only solution for Dengue these days. Especially in a place like Bengaluru where doctors and medicines are both expensive, residents have now turned to a cheaper and an effective alternative-Homeopathy to combat Dengue.People have been milling Homeopathy clinics and hospitals for an antidote. Dr Sudhir Babu of Javaji Advanced Homeopathy said, “People ask for some cure to keep the disease at bay. We do in fact have medicines to help build immunity against the ailment.”The dosage is for four or five days and is taken daily. Homeopathy has now become a trusted alternative in the field of medicine, especially because of its easy acceptibility among children and adults. According to a survey by IMRB, 100% people know about this form of medicine and 92% perceive it as a reputed form of treatment. The medicines that are administered depending on the symmptoms of Dengue Fever are Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia Alba, Cantharis, Cinchona Officinalis, Eupatorium Perfoliatum, Gelsemium, Ipecacuanha, Nux Vomica, Rhus Toxicodendron and Rhus Venenata.

What I found particularly impressive here is the way popularity has been used to replace evidence. This, I think, begs several questions:

  • How long will homeopaths continue treating self-limiting conditions to claim success based no nothing but their natural history?
  • How long will they continue to lie to the public?
  • How long will they refuse to learn from the evidence?
  • How long will they ignore even the most fundamental rules of medical ethics?
  • How long will we let them get away with all this?
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