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

EBM

One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

This press-release caught my attention:

Following the publication in Australia earlier this year of a video showing a chiropractor treating a baby, the Health Minster for the state of Victoria called for the prohibition of chiropractic spinal manipulation for children under the age of 12 years. As a result, an independent panel has been appointed by Safer Care Victoria to examine the evidence and provide recommendations for the chiropractic care of children.

The role of the panel is to (a) examine and assess the available evidence, including information from consumers, providers, and other stakeholders, for the use of spinal manipulation by chiropractors on children less than 12 years of age and (b) provide recommendations regarding this practice to the Victorian Minister for Health.
Members of the public and key stakeholders, including the WFC’s member for Australia, the Australia Chiropractors Association (AusCA), were invited to submit observations. The AusCA’s submission can be read here

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This submission turns out to be lengthy and full of irrelevant platitudes, repetitions and nonsense. In fact, it is hard to find in it any definitive statements at all. Here are two sections (both in bold print) which I found noteworthy:

1. There is no need to restrict parental or patient choice for chiropractic care for children under 12 years of age as there is no evidence of harm. There is however, expressed outcome of benefit by parents70 who actively choose chiropractic care for their children … 

No evidence of harm? Really! This is an outright lie. Firstly, one has to stress that there is no monitoring system and that therefore we simply do not learn about adverse effects. Secondly, there is no reason to assume that the adverse effects that have been reported in adults are not also relevant for children. Thirdly, adverse effects in children have been reported; see for instance here. Fourthly, we need to be aware of the fact that any ineffective therapy causes harm by preventing effective therapies from being applied. And fifthly, we need to remember that some chiropractors harm children by advising their parents against vaccination.

2. Three recent systematic reviews have focused on the effectiveness of manual therapy for paediatric conditions. For example, Lanaro et al. assessed osteopathic manipulative treatment for use on preterm infants. This systematic review looked at five clinical trials and found a reduction of length of stay and costs in a large population of preterm infants with no adverse events (96).

Carnes et al.’s 2018 systematic review focused on unsettled, distressed and excessively crying infants following any type of manual therapy. Of the seven clinical trials included, five involved chiropractic manipulative therapy; however, meta-analyses of outcomes were not possible due to the heterogeneity of the clinical trials. The review also analysed an additional 12 observational studies: seven case series, three cohort studies, one service evaluation survey, and one qualitative study. Overall, the systematic review concluded that small benefits were found. Additionally, the reporting of adverse events was low. Interestingly, when a relative risk analysis was done, those who had manual therapy were found to have an 88% reduced risk of having an adverse event compared to those who did not have manual therapy (97).

A third systematic review by Parnell Prevost et al. in 2019 evaluated the effectiveness of any paediatric condition following manual therapy of any type and summarizes the findings of studies of children 18 years of age or younger, as well as all adverse event information. While mostly inconclusive data were found due to lack of high-quality studies, of the 32 clinical trials and 18 observational studies included, favourable outcomes were found for all age groups, including improvements in suboptimal breastfeeding and musculoskeletal conditions. Adverse events were mentioned in only 24 of the included studies with no serious adverse events reported in them (98).

(96) Lanaro D, Ruffini N, Manzotti A, Lista G. Osteopathic manipulative treatment showed reduction of length of stay and costs in preterm infants: A systematic review and meta-analysis. Medicine (Baltimore). 2017; 96(12):e6408 10.1097/MD.0000000000006408.

(97) Carnes D, Plunkett A, Ellwood J, Miles C. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses. BMJ Open 2018;8:e019040. doi:10.1136/bmjopen-2017-019040.

(98) Parnell Prevost et al. 2019.

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And here are my comments:

(96) Lanaro et al is about osteopathy, not chiropractic (4 of the 5 primary trials were by the same research group).

(97) The review by Carnes et al has been discussed previously on this blog. This is what I wrote about it at the time:

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

(98) Parnell et al was easy to find despite the incomplete reference in the submission. This paper has also been discussed previously. Here is my post on it:

This systematic review is an attempt [at] … evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

      • attention deficit hyperactivity disorder (ADHD),
      • autism,
      • asthma,
      • cerebral palsy,
      • clubfoot,
      • constipation,
      • cranial asymmetry,
      • cuboid syndrome,
      • headache,
      • infantile colic,
      • low back pain,
      • obstructive apnoea,
      • otitis media,
      • paediatric dysfunctional voiding,
      • paediatric nocturnal enuresis,
      • postural asymmetry,
      • preterm infants,
      • pulled elbow,
      • suboptimal infant breastfeeding,
      • scoliosis,
      • suboptimal infant breastfeeding,
      • temporomandibular dysfunction,
      • torticollis,
      • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

      • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
      • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
      • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
      • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
      • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

      1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
      2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
      3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

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The ACA’s submission ends with the following conclusion:

The Australian Chiropractors Association (ACA) intent is to improve the general health of all Australians and the ACA supports the following attributes to achieve this:

      • The highest standards of ethics and conduct in all areas of research, education and practise
      • Chiropractors as the leaders in high quality spinal health and wellbeing
      • A commitment to evidence-based practice – the integration of best available research evidence, clinical expertise and patient values
      • The profound significance and value of patient-centred chiropractic care in healthcare in Australia.
      • Inclusiveness and collaborative relationships within and outside the chiropractic profession…

After reading through the entire, tedious document, I arrived at the conclusion that

THIS SUBMISSION CAN ONLY BE A CALL FOR THE PROHIBITION OF CHIROPRACTIC SPINAL MANIPULATION FOR CHILDREN.

The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

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On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

My friend and colleague Willem Betz has died on 8 June 2019. He was a physician and professor emeritus at the Belgian university Vrije Universiteit Brussel. Willem was a leading sceptic and a founding member of the Belgian sceptic organization SKEPP.

After having worked 20 years as a general practitioner, he made a career change and became a teacher of general practice and a researcher. As a clinician, he received training in several alternative therapies and practiced them of a short while. Soon, he started questioning the validity of these methods and thus became a dedicated sceptic. He served SKEPP as vice-president and as president and became a fellow of the Committee for Scientific Inquiry.

His last paper was published less than a year ago. Here is its abstract:

Conventional treatment of multiple sclerosis (MS) is often disappointing. As a result, some of these patients seek salvation in traditional and complementary medicine (T&CM). The aim of this study is to describe how many patients with MS use T&CM and what their motives and expectations are in doing so. Methods. Ninety-nine patients with diagnosed MS, attending the service of ambulatory revalidation of the National Clinic for Multiple Sclerosis in Melsbroek (Belgium) were included in February 2004 in this retrospective study. All patients had MS resulting in motoric or psychosocial symptoms. The disability was not quantified for this study. Participants were interviewed by means of a structured questionnaire on their current treatment of MS including T&CM. Results. In total 44% of the participants had experiences with T&CM. The most frequently used T&CM were homeopathy and acupuncture. Participants using conventional treatment were more satisfied with the support (p=0.006) and the treatment outcome (0.018) than T&CM users. The use of T&CM was not related to gender, education, living conditions, causal treatment such as disease modifying-therapy (DMT), grade of disability or subtype of the disease. Conclusion. Patients diagnosed with MS seek hope in T&CM such as homeopathy or acupuncture. The results of this study suggest that MS patients need more professional support in their personal search for alternative therapies. Key point. 50% of patients diagnosed with multiple sclerosis search relief in traditional and complementary medicine such as homeopathy or acupuncture. These patients often feel compelled to try every opportunity to heal, often stimulated or urged on by friends or relatives. Multiple sclerosis patients are more satisfied with their conventional treatment than with the traditional and complementary medicine.

Through his personality, enthusiasm, analytical mind, humour and dedication, Willem has inspired an entire generation of sceptics. We will miss you Willem.

A new paper reminds us that so-called alternative medicine (SCAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of SCAM may cause harm to patients through interactions with prescribed medications or by patients choosing to forego evidence-based care. SCAM may also put financial strain on patients as most SCAM expenditures are paid out-of-pocket.

Despite these drawbacks, patients continue to use SCAM due to a range of reasons, e.g. media promotion of SCAM therapies, dissatisfaction with conventional healthcare, a desire for more holistic care. Given the increasing demand for SCAM, many medical institutions now offer SCAM services. Several leaders of SCAM centres based at a highly respected academic medical institution have publicly expressed anti-vaccination views, and non-evidence-based philosophies run deep within SCAM.

Although there are financial incentives for institutions to provide SCAM, it is important to recognize that this legitimizes SCAM and may cause harm to patients. The poor regulation of SCAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy.

As I have tried to point out many times, the potential for harm caused by the increasing integration of SCAM can thus be summarised as follows:

  1. direct harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture;
  2. direct harm through the use of bogus diagnostic techniques;
  3. direct harm by using materials from endangered species;
  4. indirect harm through incompetent advice such as recommendation not to immunize or discontinue prescribed medications;
  5. neglect due to using SCAM instead of an effective therapy for a serious condition;
  6. harm due to medicalising trivial states of reduced well-being;
  7. financial harm due to the costs of SCAM;
  8. harm through making a mockery of evidence-based medicine;
  9. harm caused by undermining rational thinking in the society at large;
  10. harm caused by inhibiting medical progress and research.

In case you see other ways in which SCAM can cause harm, please let me know by posting a comment.

One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.

An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).

P: I often feel quite low, do you think I need some treatment for depression?

O: That depends on whether you are truly depressed or just a bit under the weather.

P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.

O: I understand, that’s not an unusual thing in your situation.

P: Someone told me about MBCT, and I wonder what you think about it.

O: Yes, I happen to know about this approach, but I’m not sure it would help you.

P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.

O: Yes, that’s true; MBCT is quite safe.

P: So, why are you against it?

O: I am not against it; I just doubt that it is the best treatment for you.

P: Why?

O: Because there is little evidence for it and even less for someone like you.

P: But I have seen some studies that seem to show it works.

O: I know, there have been trials but they are not very reliable.

P: But the therapy has not been shown to be ineffective, has it?

O: No, but the treatment is not really for your condition.

P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?

O: No, I am telling you that this treatment is not supported by good evidence.

P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!

O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.

P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?

O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.

P: But if I want to try it?

O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.

P: Fine, in this case, I will give it a go.

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Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)

The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.

As the discussion goes on, the gap is not closing but seems to be widening.

What can be done about it?

I wish I knew the answer!

Do you?

Chiropractic spinal manipulative therapy (CSMT) for migraine?

Why?

There is no good evidence that it works!

On the contrary, there is good evidence that it does NOT work!

A recent and rigorous study (conducted by chiropractors!) tested the efficacy of chiropractic CSMT for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3). The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment. The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was sustained throughout the RCT. The authors concluded that the effect of CSMT observed in our study is probably due to a placebo response.

One can understand that, for chiropractors, this finding is upsetting. After all, they earn a good part of their living by treating migraineurs. They don’t want to lose patients and, at the same time, they need to claim to practise evidence-based medicine.

What is the way out of this dilemma?

Simple!

They only need to publish a review in which they dilute the irritatingly negative result of the above trial by including all previous low-quality trials with false-positive results and thus generate a new overall finding that alleges CSMT to be evidence-based.

This new systematic review of randomized clinical trials (RCTs) evaluated the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability.

The searches identified 6 RCTs eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. The results showed that spinal manipulation reduced migraine days with an overall small effect size as well as migraine pain/intensity.

The authors concluded that spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Bob’s your uncle!

Perhaps not perfect, but at least the chiropractic profession can now continue to claim they practice something akin to evidence-based medicine, while happily cashing in on selling their unproven treatments to migraineurs!

But that’s not very fair; research is not for promotion, research is for finding the truth; this white-wash is not in the best interest of patients! I hear you say.

Who cares about fairness, truth or conflicts of interest?

Christine Goertz, one of the review-authors, has received funding from the NCMIC Foundation and served as the Director of the Inter‐Institutional Network for Chiropractic Research (IINCR). Peter M. Wayne, another author, has received funding from the NCMIC Foundation and served as the co‐Director of the Inter‐Institutional Network for Chiropractic Research (IINCR)

And who the Dickens are the  NCMIC and the IINCR?

At NCMIC, they believe that supporting the chiropractic profession, including chiropractic research programs and projects, is an important part of our heritage. They also offer business training and malpractice risk management seminars and resources to D.C.s as a complement to the education provided by the chiropractic colleges.

The IINCR is a collaborative effort between PCCR, Yale Center for Medical Informatics and the Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School. They aim at creating a chiropractic research portfolio that’s truly translational. Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic Christine Goertz, DC, PhD (PCCR) is the network director. Peter Wayne, PhD (Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School) will join Anthony J. Lisi, DC (Yale Center for Medical Informatics and VA Connecticut Healthcare System) as a co-director. These investigators will form a robust foundation to advance chiropractic science, practice and policy. “Our collective efforts provide an unprecedented opportunity to conduct clinical and basic research that advances chiropractic research and evidence-based clinical practice, ultimately benefiting the patients we serve,” said Christine Goertz.

Really: benefiting the patients? 

You could have fooled me!

In a previous post, I have tried to explain that someone could be an expert in certain aspects of homeopathy; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the research of homeopathy.

But can anyone really be an expert in homeopathy in a more general sense?

Are homeopaths experts in homeopathy?

OF COURSE THEY ARE!!!

What is he talking about?, I hear homeopathy-fans exclaim.

Yet, I am not so sure.

Can one be an expert in something that is fundamentally flawed or wrong?

Can one be an expert in flying carpets?

Can one be an expert in quantum healing?

Can one be an expert in clod fusion?

Can one be an expert in astrology?

Can one be an expert in telekinetics?

Can one be an expert in tea-leaf reading?

I am not sure that classical homeopaths can rightfully called experts in classical homeopathy (there are so many forms of homeopathy that, for the purpose of this discussion, I need to focus on the classical Hahnemannian version).

An expert is a person who is very knowledgeable about or skilful in a particular area. An expert in any medical field (say neurology, gynaecology, nephrology or oncology) would need to have sound knowledge and practical skills in areas including:

  • organ-specific anatomy,
  • organ-specific physiology,
  • organ-specific pathophysiology,
  • nosology of the medical field,
  • disease-specific diagnostics,
  • disease-specific etiology,
  • disease-specific therapy,
  • etc.

None of the listed items apply to classical homeopathy. There are no homeopathic diseases, homeopathy is largely detached from knowledge in anatomy, physiology and pathophysiology, homeopathy disregards the current knowledge of etiology, homeopathy does not apply current criteria of diagnostics, homeopathy offers no rational mode of action for its interventions.

An expert in any medical field would need to:

  • deal with facts,
  • be able to show the effectiveness of his methods,
  • be part of an area that makes progress,
  • benefit from advances made elsewhere in medicine,
  • would associate with other disciplines,
  • understand the principles of evidence-based medicine,
  • etc.

None of these features apply to a classical homeopath. Homeopaths substitute facts for fantasy and wishful thinking, homeopaths cannot rely on sound evidence regarding the effectiveness of their therapy, classical homeopaths are not interested in progressing their field but religiously adhere to Hahnemann’s dogma, homeopaths do not benefit from the advances made in other areas of medicine, homeopaths pursue their sectarian activities in near-complete isolation, homeopaths make a mockery of evidence-based medicine.

Collectively, these considerations would seem to indicate that an expert in homeopathy is a contradiction in terms. Either you are an expert, or you are a homeopath. To be both seems an impossibility – or, to put it bluntly, an ‘expert’ in homeopathy is an adept in nonsense and a virtuoso in ignorance.

The PGIH (currently chaired by the Tory MP David Tredinnick) was founded in 1992 (in the mid 1990, they once invited me to give a lecture which I did with pleasure). Its overriding aim is to bring about improvements in patient care. The PGIH have conducted a consultation that involved 113 SCAM-organisations and other stakeholders. The new PGIH-report is based on their feedback and makes 14 recommendations. They are all worth studying but, to keep this post concise, I have selected the three that fascinated me most:

Evidence Base and Research

NICE guidelines are too narrow and do not fit well with models of care such as complementary, traditional and natural therapies, and should incorporate qualitative evidence and patient outcomes measures as well as RCT evidence. Complementary, traditional and natural healthcare associations should take steps to educate and advise their members on the use of Measure Yourself Medical Outcome Profiles (MYMOP), and patient outcome measures should be collated by an independent central resource to identify for what conditions patients are seeking treatment, and with what outcomes.

Cancer Care

Every cancer patient and their families should be offered complementary therapies as part of their treatment package to support them in their cancer journey. Cancer centres and hospices providing access to complementary therapies should be encouraged to make wider use of Measure Yourself Concerns and Wellbeing (MYCaW) to evaluate the benefits gained by patients using complementary therapies in cancer support care. Co-ordinated research needs to be carried out, both clinical trials and qualitative studies, on a range of complementary, traditional and natural therapies used in cancer care support.

Cost Savings

The government should run NHS pilot projects which look at non-conventional ways of treating patients with long-term and chronic conditions affected by Effectiveness Gaps, such as stress, arthritis, asthma and musculoskeletal problems, and audit these results against conventional treatment options for these conditions to determine whether cost savings and better patient outcomes could be achieved.

END OF QUOTE

Here are a few brief comments on those three recommendations.

Evidence base and research

NICE guidelines are based on rigorous assessments of efficacy, safety and costs. Such evaluations are possible for all interventions, including SCAM. Qualitative data are useless for this purpose. Outcome measures like the MYMOP are measures that can and are used in clinical trials. To use them outside clinical trials would not provide any relevant information about the specific effects of SCAM because this cannot account for confounding factors like the natural history of the disease, regression towards the mean, etc. The entire paragraph disclosed a remarkable level of naivety and ignorance about research on behalf of the PGIH.

Cancer care

There is already a significant amount of research on SCAM for cancer (see for instance here). It shows that no SCAM is effective in curing any form of cancer, and that only very few SCAMs can effectively improve the quality of life of cancer patients. Considering these facts, the wholesale recommendation of offering SCAM to cancer patients can only be characterised as dangerous quackery.

Cost savings

Such a pilot project has already been conducted at the behest of Price Charles (see here). Its results show that flimsy research will generate flimsy findings. If anything, a rigorous trial would be needed to test whether more SCAM on the NHS saves or costs money. The data currently available suggests that the latter is the case (see also here, here, here, here, etc.).

Altogether, one gets the impression that the PGIH need to brush up on their science and knowledge (if they invite me, I’d be delighted to give them another lecture). As it stands, it seems unlikely that their approach will, in fact, bring about improvements in patient care.

The German Association of Medical Homeopaths (Deutscher Zentralverein homöopathischer Ärzte (DZVhÄ)) have recently published an article where, amongst other things, they lecture us about evidence-based medicine (EBM). If you feel that this might be a bit like an elephant teaching Fred Astaire how to step-dance, you could have a point. Here is their relevant paragraph:

… das Konzept der modernen Evidenzbasierte Medizin nach Sackett [stützt sich] auf drei Säulen: auf die klinischen Erfahrung der Ärzte, auf die Werte und Wünsche des Patienten und auf den aktuellen Stand der klinischen Forschung. Homöopathische Ärzte wehren sich gegen einen verengten Evidenzbegriff der Kritiker, der Evidenz allein auf die Säule der klinischen Forschung bzw. ausschließlich auf RCT verengen möchte und die anderen beiden Säulen ausblendet. Experten schätzen, dass bei einer solchen Auffassung von EbM rund 70 Prozent aller Leistungen der GKV nicht evidenzbasiert sei. Nötiger als eine Homöopathie-Debatte hat die deutsche Ärzteschaft aus unserer Sicht eine klare Verständigung darüber, welcher Evidenzbegriff nun gilt.

For those who cannot understand the full splendour of their argument because of the language problem, I translate as literally as I can:

… the concept of the modern EBM according to Sackett is based on three pillars: on the clinical experience of the doctors, on the values and wishes of the patient and on the current state of the clinical research. Homeopaths defend themselves against the narrowed understanding of ‘evidence’ of the critics which aims at narrowing evidence solely to the pillar of the clinical research or exclusively to RCT, while eliminating the other two pillars. Experts estimate that, with such an view of EBM, about 70% of all treatments reimbursed by our health insurances would not be evidence-based. We feel that we more urgently need a clear understanding which evidence definition applies than a debate about homeopathy.

END OF MY TRANSLATION

So, where is the hilarity in this?

I don’t know about you, but I find the following things worth a giggle:

  1. ‘narrowed understanding of evidence’ – this is a classical strawman; non-homeopaths tend to apply Sackett’s definition which states that ‘evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical experience with the best available external clinical evidence from systematic research‘;
  2. as we see, Sackett’s definition is quite different from the one cited by the homeopaths;
  3. the three pillars cited by the homeopaths are those subsequently developed for Evidence Based Practice (EBP) and include: A) patient values, B) clinical expertise and C) external best evidence;
  4. as we see, these three pillars are also not quite the same as those suggested by the homeopaths;
  5. non-homeopaths do certainly not aim at eliminating the ‘other two pillars’;
  6. current best evidence clearly includes much more than just RCTs – to mention RCTs in this context therefore suggests that the ones guilty of narrowing anything might, in fact, be the homeopaths;
  7. even if it were true that 70% of reimbursable treatments are not evidence-based, this would hardly be a good reason to employ homeopathic remedies of which 100% are not even remotely evidence-based;
  8. unbeknown to the German homeopaths, the discussion about a valid definition of EBM has been intense, is as old as EBM itself, and would by now probably fill a mid-size library;
  9. this discussion does, however, in no way abolish the need to bring the debate about homeopathy to the only evidence-based conclusion possible, namely the discontinuation of reimbursement of this and all other bogus therapies.

In conclusion, I do thank the German homeopaths for being such regular contributors to fun and hilarity. I shall miss them, once they have fully understood EBM and are thus compelled to stop prescribing placebos.

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