MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: September 2016

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!

WARNING: THIS MIGHT MAKE YOU LAUGH OUT LOUDLY AND UNCONTROLLABLY.

Deepak Chopra rarely publishes in medical journals (I suppose, he has better things to do). I was therefore intrigued when I saw a recent article of which he is a co-author.

The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.

The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.

Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.

Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.

The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.

This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation. Deepak Chopra is the co-founder of The Chopra Center for Wellbeing.

Did I promise too much?

Isn’t this paper hilarious?

Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better.

This is hardly something one needs to write home about; and certainly nothing to do a study on!

But which journal would publish such unadulterated advertising?

On this blog, I have mentioned the JACM several times before. Recently, I wrote about the new man in charge of it. I concluded stating WATCH THIS SPACE.

I think the wait is now over – this paper is from the latest issue of the JACM, and I am sure we all agree that the new editor has just shown us of what he is made and where he wants to take his journal.

Just as I thought that this cannot get any better, it did! It did so in the form of a second paper which is evidently reporting from the same ‘study’. Here is its abstract unaltered in its full beauty:

The effects of integrative medicine practices such as meditation and Ayurveda on human physiology are not fully understood. The aim of this study was to identify altered metabolomic profiles following an Ayurveda-based intervention. In the experimental group, 65 healthy male and female subjects participated in a 6-day Panchakarma-based Ayurvedic intervention which included herbs, vegetarian diet, meditation, yoga, and massage. A set of 12 plasma phosphatidylcholines decreased (adjusted p < 0.01) post-intervention in the experimental (n = 65) compared to control group (n = 54) after Bonferroni correction for multiple testing; within these compounds, the phosphatidylcholine with the greatest decrease in abundance was PC ae C36:4 (delta = -0.34). Application of a 10% FDR revealed an additional 57 metabolites that were differentially abundant between groups. Pathway analysis suggests that the intervention results in changes in metabolites across many pathways such as phospholipid biosynthesis, choline metabolism, and lipoprotein metabolism. The observed plasma metabolomic alterations may reflect a Panchakarma-induced modulation of metabotypes. Panchakarma promoted statistically significant changes in plasma levels of phosphatidylcholines, sphingomyelins and others in just 6 days. Forthcoming studies that integrate metabolomics with genomic, microbiome and physiological parameters may facilitate a broader systems-level understanding and mechanistic insights into these integrative practices that are employed to promote health and well-being.

Now that I managed to stop laughing about the first paper, I am not just amused but also puzzled by the amount of contradictions the second article seems to cause. Were there 65 or 69 individuals in the experimental group? Was the study randomised, quasi-randomised or not randomised? All of these versions are implied at different parts of the articles. It turns out that they randomised some patients, while allocating others without randomisation – and this clearly means the study was NOT randomised. Was the aim of the study ‘to identify altered metabolomic profiles following an Ayurveda-based intervention’ or ‘to examine the effects of a comprehensive residential mind–body program on well-being’?

I am sure that others will find further contradictions and implausibilites, if they look hard enough.

The funniest inconsistency, in my opinion, is that Deepak Chopra does not even seem to be sure to which university department he belongs. Is it the ‘Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.’ as indicated in the 1st paper or is it the ‘Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California, USA’ as listed in the 2nd article?

Does he know from which planet he is?

 

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.

At first, I thought this survey would be yet another of those useless and boring articles that currently seem to litter the literature of alternative medicine. It’s abstract seemed to confirm my suspicion: “Fifty-two chiropractors in Victoria, Australia, provided information for up to 100 consecutive encounters. If patients attended more than once during the 100 encounters, only data from their first encounter were included in this study. Where possible patient characteristics were compared with the general Australian population…” But then I saw that the chiropractors were also asked to record their patients’ main complaints. That, I thought, was much more interesting, and I decided to do a post that focusses on this particular point.

The article informs us that 72 chiropractors agreed to participate (46 % response rate of eligible chiropractors approached). During the study, 20 (28 %) of these chiropractors withdrew and did not provide any data. Fifty two chiropractors (72 % of those enrolled) completed the study, providing information for 4464 chiropractor-patient encounters. Of these, 1123 (25 %) encounters were identified as repeat patient encounters during the recording period and were removed from further analyses, leaving 3287 unique patients.

The results that I want to focus on indicated that chiropractors give the following reasons for treating patients:

  • maintenance: 39%
  • spinal problems: 33%
  • neck problems: 18%
  • shoulder problems: 6%
  • headache: 6%
  • hip problems: 3%
  • leg problems: 3%
  • muscle problems: 3%
  • knee problems: 2%

(the percentage figures refer to the percentages of patients with the indicated problem)

Yes, I know, there is lots to be criticised about the methodology used for this survey. But let’s forget about this for the moment and focus on the list of reasons or indications which these chiropractors give for treating patients. For which of these is there enough evidence to justify this decision and the fees asked for the interventions? Here is my very quick run-down of the evidence:

  • maintenance: no good evidence.
  • spinal problems: if they mean back pain by this nebulous term, an optimist might grant that there is some promising but by no means conclusive evidence.
  • neck problems: again some promising but by no means conclusive evidence.
  • shoulder problems: no good evidence.
  • headache: again some promising but by no means conclusive evidence
  • hip problems: no good evidence.
  • leg problems: no good evidence.
  • muscle problems: no good evidence.
  • knee problems: no good evidence.

As I said, this is merely a very quick assessment. I imagine that many chiropractors will disagree with it – and I invite them to present their evidence in the comments section below. However, if I am correct (or at least not totally off the mark), this new survey seems to show that most of the things these chiropractors do is not supported by good evidence. One could be more blunt and phrase this differently:

  • these chiropractors are misleading their patients;
  • they are not behaving ethically;
  • they are not adhering to EBP.

Yes, we (I mean rationalists who know about EBM) did suspect this all along – but now we can back it up with quite nice data from a recent survey done by chiropractors themselves.

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.

For some time now, the research activity in and around alternative medicine has been seemingly buoyant. In each of the last 4 years, Medline listed around 2 000 articles is the category of ‘complementary alternative medicine’. This will surely look impressive to many!

Why then did I write ‘seemingly’? To comprehend this a little better, we should have some comparisons. Here are numbers of Medline-listed articles published in 2015 for a few other areas:

  • Surgery: 176 277
  • Psychology: 65 679
  • Internal medicine: 36 998
  • Obstetrics/gynaecology: 13 818
  • Pharmacology: 194 322
  • Paediatrics: 30 646

Now you see, I hope, why the 2 049 Medline-listed articles in the category of ‘complementary alternative medicine’ are only seemingly impressive. But what about specific alternative therapies? Here are numbers of Medline-listed articles published in 2015 for some major alternative treatments:

  • Homeopathy: 181
  • Herbal medicine: 1 572
  • Chiropractic: 314
  • Acupuncture: 1 784
  • Naturopathy: 45
  • Dietary supplements: 5 199

These figures are perhaps interesting but not easy to interpret. They might indicate that certain sections of alternative medicine are more open to scientific scrutiny than others. Or do they show that for some areas there are more research funds and expertise than others? I am not sure I know the answer.

If we look a little closer at the research activity in defined alternative therapies, we are bound to get disappointed. I have recently done this for homeopathy and for acupuncture and reached rather gloomy conclusions.

In the case of homeopathy the were:

  1. The research activity into homeopathy is currently very subdued.
  2. Arguably the main research question of efficacy does not seem to concern researchers of homeopathy all that much.
  3. There is an almost irritating abundance of papers that are data-free and thrive on opinion (my category of ‘other papers’).
  4. Given all this, I find it hard to imagine that this area of investigation is going to generate much relevant new knowledge or clinical progress.

And in the case of acupuncture, I stated:

  • Too little research is focussed on the two big questions: efficacy and safety.
  • In relation to the meagre output in RCTs, there are too many systematic reviews.
  • As long as we cannot be sure that acupuncture is more than a placebo, all these pre-clinical studies seem a bit out of place.
  • The vast majority of the articles were in low or very low impact journals.
  • There was only one paper that I would consider outstanding.

And what about the quality of the research into alternative medicine?

Well, this is a sad and depressing tale! If you doubt it, read my previous post or indeed any of the other ~500 which I have written on this particular subject in the past.

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.

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