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

bias

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I have written about this more often than I care to remember, and today I do it again.

Why?

Because it is important!

Chiropractic is not effective for kids, and chiropractic is not harmless for kids – what more do we need to conclude that chiropractors should not be allowed anywhere near them?

And most experts now agree with this conclusion; except, of course, the chiropractors themselves. This recent article in THE CHRONICLE OF CHIROPRACTIC is most illuminating in this context:

It was only a matter of time before the attack on the chiropractic care of children spread to the United States from Australia and Canada and its also no surprise that insurance companies would jump on the bandwagon first.  According to Blue Cross and Blue Shield Children under the age of 5 years should not receive chiropractic care (spinal manipulation) ” . . . because the skeletal system is not mature at this time.”

The Blues further contend that:

“Serious adverse events may be associated with pediatric spinal manipulation in children under the age of 5 years due to the risks of these procedures in children this age.”

The Blues claims that their determination is based on standards of care – though they do not state which ones.

“This determination was based on standards of care in pediatric medicine as well as current medical evidence.”

This is not the first time Blue Cross attacked the chiropractic care of children. In 2005 CareFirst Blue Cross claimed that:

“Spinal manipulation services to treat children 12 years of age and younger, for any condition, is considered experimental and investigational.”

The ridiculous and false claims by Blue Cross come on the heels of a ban placed on spinal manipulation of infants by the Chiropractic Board of Australia (see related story) and attacks on chiropractors who care for children in Canada by chiropractic regulatory boards there.

There is in fact plenty of evidence to support the chiropractic care of infants and children and there are practice guidelines (the highest level on the research hierarchy pyramid) that support such care.

The real issue is not whether or not evidence exists to support the chiropractic care of children – the real issue is power and the lack of any necessity for evidence for those with the power.

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END OF QUOTE

What can we learn from this outburst?

  1. Chiropractors often take much-needed critique as an ‘attack’. My explanation for this phenomenon is that they sense how wrong they truly are, get defensive, and fear for their cash-flow.
  2. When criticised, they do not bother to address the arguments. This, I believe, is again because they know they are in the wrong.
  3. Chiropractors are in denial as to what they can and cannot achieve with their manipulations. My explanation for this is that they might need to be in denial – because otherwise they would have to stop practising.
  4. They often insult criticism as ridiculous and false without providing any evidence. The likely explanation is that they have no reasonable evidence to offer.
  5. All they do instead is stating things like ‘there is plenty of evidence’. They don’t like to present the ‘evidence’ because they seem to know that it is worthless.
  6. Lastly, in true style, they resort to conspiracy theories.

To any critical thinker their behaviour thus makes one conclusion virtually inescapable: DON’T LET A CHIROPRACTOR NEAR YOUR KIDS!

The journal NATURE has just published an excellent article by Andrew D. Oxman and an alliance of 24 leading scientists outlining the importance and key concepts of critical thinking in healthcare and beyond. The authors state that the Key Concepts for Informed Choices is not a checklist. It is a starting point. Although we have organized the ideas into three groups (claims, comparisons and choices), they can be used to develop learning resources that include any combination of these, presented in any order. We hope that the concepts will prove useful to people who help others to think critically about what evidence to trust and what to do, including those who teach critical thinking and those responsible for communicating research findings.

Here I take the liberty of citing a short excerpt from this paper:

CLAIMS:

Claims about effects should be supported by evidence from fair comparisons. Other claims are not necessarily wrong, but there is an insufficient basis for believing them.

Claims should not assume that interventions are safe, effective or certain.

  • Interventions can cause harm as well as benefits.
  • Large, dramatic effects are rare.
  • We can rarely, if ever, be certain about the effects of interventions.

Seemingly logical assumptions are not a sufficient basis for claims.

  • Beliefs alone about how interventions work are not reliable predictors of the presence or size of effects.
  • An outcome may be associated with an intervention but not caused by it.
  • More data are not necessarily better data.
  • The results of one study considered in isolation can be misleading.
  • Widely used interventions or those that have been used for decades are not necessarily beneficial or safe.
  • Interventions that are new or technologically impressive might not be better than available alternatives.
  • Increasing the amount of an intervention does not necessarily increase its benefits and might cause harm.

Trust in a source alone is not a sufficient basis for believing a claim.

  • Competing interests can result in misleading claims.
  • Personal experiences or anecdotes alone are an unreliable basis for most claims.
  • Opinions of experts, authorities, celebrities or other respected individuals are not solely a reliable basis for claims.
  • Peer review and publication by a journal do not guarantee that comparisons have been fair.

COMPARISONS:

Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance).

Comparisons of interventions should be fair.

  • Comparison groups and conditions should be as similar as possible.
  • Indirect comparisons of interventions across different studies can be misleading.
  • The people, groups or conditions being compared should be treated similarly, apart from the interventions being studied.
  • Outcomes should be assessed in the same way in the groups or conditions being compared.
  • Outcomes should be assessed using methods that have been shown to be reliable.
  • It is important to assess outcomes in all (or nearly all) the people or subjects in a study.
  • When random allocation is used, people’s or subjects’ outcomes should be counted in the group to which they were allocated.

Syntheses of studies should be reliable.

  • Reviews of studies comparing interventions should use systematic methods.
  • Failure to consider unpublished results of fair comparisons can bias estimates of effects.
  • Comparisons of interventions might be sensitive to underlying assumptions.

Descriptions should reflect the size of effects and the risk of being misled by chance.

  • Verbal descriptions of the size of effects alone can be misleading.
  • Small studies might be misleading.
  • Confidence intervals should be reported for estimates of effects.
  • Deeming results to be ‘statistically significant’ or ‘non-significant’ can be misleading.
  • Lack of evidence for a difference is not the same as evidence of no difference.

CHOICES:

What to do depends on judgements about the problem, the relevance (applicability or transferability) of evidence available and the balance of expected benefits, harm and costs.

Problems, goals and options should be defined.

  • The problem should be diagnosed or described correctly.
  • The goals and options should be acceptable and feasible.

Available evidence should be relevant.

  • Attention should focus on important, not surrogate, outcomes of interventions.
  • There should not be important differences between the people in studies and those to whom the study results will be applied.
  • The interventions compared should be similar to those of interest.
  • The circumstances in which the interventions were compared should be similar to those of interest.

Expected pros should outweigh cons.

  • Weigh the benefits and savings against the harm and costs of acting or not.
  • Consider how these are valued, their certainty and how they are distributed.
  • Important uncertainties about the effects of interventions should be reduced by further fair comparisons.

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END OF QUOTE

I have nothing to add to this, except perhaps to point out how very relevant all of this, of course, is for SCAM and to warmly recommend you study the full text of this brilliant paper.

The ‘College of Medicine and Integrated Health’ (CMIH) has been the subject of several previous blog posts (see for instance here, here and here). Recently, they have come up with something new that, in my view, deserves a further comment.

The new ‘SELF CARE TOOL KIT’ began, according to the CMIH, in 2009 with a national multi-centre project commissioned by the UK Department of Health, to consider the best way to integrate self care into family practice. The project involved two large family health centres and two university departments. One output was the Self Care Library (SCL).

The Self Care Library (SCL) is an online patient resource providing free evidence-based information about self-care.  The funding for the SCL did, however, not survive, and the facility was assigned to the CMIH. Thanks to funding from ‘Pukka Herbs Vitamins, Herbal Remedies & Health Supplements‘, the CMIH was able to transfer the content and to begin updating entries. Simon Mills, the coordinator of the original project who is now employed by Pukka, has led this transformation and helped the College set up the new parent portal, Our Health Directory.

The Self Care Toolkit is thus the new SCL. All concerned with this project are experienced in clinical practice and can separate the theory from real life needs. We all have academic lives as well so can be hard-nosed with the evidence base as well.

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The above text is essentially based on the information provided by the CMIH. A few critical remarks and clarifications might therefore be in order:

  • What does ‘separate the theory from real life needs’ mean? Does it mean that the scientific evidence can be interpreted liberally (see below)?
  • Is it a good idea to have a commercial sponsor for such a project?
  • Is it wise that the main person in charge is on the payroll of a manufacturer of dietary supplements?
  • Is there any oversight to minimise undue bias and prevent the public from being misled?
  • Is it really true that all people involved have academic lives? Simon Mills (who once was a member of my team) has no longer an academic appointment, as far as I know.

But, you are right, these are perhaps mere trivialities. Let’s see what the ‘Self Care Tool Kit’ actually delivers. I have chosen the entry on DEPRESSION to check its validity. Here it is:

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It isn’t likely that taking extra vitamins will make much difference to low mood or depression. It is true that many people don’t get quite enough B, C and D vitamins in their food. And it’s also true that the brain and nervous system need these vitamins. Because they don’t get stored in the body, our daily diet has to supply them. Research has shown that people with low blood levels of the B vitamin folic acid are more likely to be depressed and less likely to do well on anti-depressant medicines. So, if you are eating a very poor diet, taking extra vitamins just might help. It’s also worth remembering that alcohol, refined sugars, nicotine and caffeine all take these vitamins out of the body. Yet most people who feel depressed probably won’t benefit from taking vitamins alone. To ensure that you get a good balance of these vitamins, try to eat more whole-foods, fruits, vegetables, nuts and seeds.

Some people say that taking high doses of vitamin C (1-2 g and more a day) helps lift their mood. There is a little research to support this and none showing that high doses of vitamin C actually help clinical depression. Vitamin C levels fall after surgery or inflammatory disease. The body needs more vitamin C when coping with stress, pregnancy and breast feeding. Aspirin, tetracycline and contraceptive pills take vitamin C out of the body. Smokers also need extra vitamin C because nicotine removes it. Fresh fruit and vegetables are the best sources of vitamin C.

Doctors are increasingly concerned about low vitamin D, especially in the Asian community. A lack of vitamin D can lead to depression. Oily fish and dairy products are good sources of vitamin D, and sunlight helps the body make vitamin D. Do you get enough sunshine and eat a good diet? It is estimated that worldwide over 1 billion people get too little vitamin D.

Evidence
Taking supplements of vitamins B and D might help some people, whose diet is poor, but more research is needed.

Safety
Very high doses of vitamins and minerals can upset the body and cause side-effects. Get medical advice if you intend to take large doses. To ensure that you get a good balance of these vitamins, try to eat more whole-foods, fruits, vegetables, nuts and seeds.

Cost
If your diet is poor and you don’t get into the sun, ask your doctor about a vitamin D blood test. If it’s normal, there’s no point in taking vitamin D. If it’s low, your GP will prescribe it for you or you can buy a vitamin D supplement.

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In my view, this text begs several questions:

1) Am I right in thinking that phraseology such as the one below will encourage patients suffering from depression to try the supplements mentioned?

  • people with low blood levels of the B vitamin folic acid are more likely to be depressed and less likely to do well on anti-depressant medicines..
  • Some people say that taking high doses of vitamin C (1-2 g and more a day) helps lift their mood…
  • There is a little research to support this and none showing that high doses of vitamin C actually help clinical depression…
  • A lack of vitamin D can lead to depression.
  • Taking supplements of vitamins B and D might help some people…
  • … your GP will prescribe it for you or you can buy a vitamin D supplement.

2) How does that tally with the latest evidence? For instance:

3) The CMIH state: ‘This site gives you information NOT medical advice.’  But, in view of the actual text above, is this true?

4) Depression is a life-threatening condition. Is there a risk that patients trust the CMHI’s (non-) advice and commit suicide because of its ineffectiveness?

5) Do Pukka, the sponsor of all this, happen to supply most of the self care remedies promoted in the ‘Self Care Tool Kit’?

The answer to the last question, I am afraid, is YES!

The World Federation of Chiropractic, Strategic Plan 2019-2022 has just been published. It is an odd document that holds many surprises. Sadly, none of them are positive.

As the efficacy and safety of chiropractic spinal manipulations, the hallmark treatment that close to 100% of all chiropractic patients receive, are more than a little doubtful, one would expect that such a strategy would focus on the promotion of rigorous clinical research to create more certainty in these two important areas. If you are like me and were hoping for a firm commitment to such activities, you will be harshly disappointed.

Already in the introduction, the WFC sets an entirely different agenda:

We believe that everyone deserves access to chiropractic. We believe in chiropractors being accessible throughout the world. We believe that societies can thrive where chiropractors are available as a part of people’s health care teams.

If you are not put off by such self-serving, nauseous nonsense and read on, you find what the WFC call the ‘FOUR STRATEGIC PILLARS’

  1. SUPPORT
  2. EMPOWERMENT
  3. PROMOTION
  4. ADVANCEMENT

The text supporting the first three pillars consists of insufferable platitudes, and I will therefore not burden you with it. But the title of No4 did raise my hopes of finding something along the lines of an advancement of the evidence-base of chiropractic. Sadly, this turned out to be over-optimistic. Here is the 4th pillar in its full beauty:

Advancing the chiropractic profession together under the banner of evidence-based, people-centered, interprofessional and collaborative care.

Around the world health is delivered according to prevailing societal, cultural and political factors. These social determinants mean that chiropractors must adapt to the environment in which they practice.

As a global federation we must continuously strive to advance awareness of chiropractic under a banner of ethical, evidence-based, people-centered care.

Through consensus-building, shared understanding and respectful dialogue with partners in the health system, chiropractic should become a valued partner in contributing enhanced population health.

Throughout our 7 world regions, we must advance public utilization of chiropractors to optimize the health of nations.

Through the identification of common values and a commitment to patient-centered care, we can advance the identity of chiropractors as spinal health care experts in the health care system.

The WFC will:

– Advance awareness of chiropractic among the general public, within health systems and among health professionals.

– Advance access to chiropractors for all people and broaden the integration of chiropractic services

– Advance interprofessional collaboration and the integration of chiropractic into health systems

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END OF QUOTE

The essence of the WFC strategy for the next 3 years thus seems to be as follows:

  1. Avoid any discussion about the lack of evidence of chiropractic.
  2. Promote chiropractic to the unsuspecting public at all cost.
  3. Make sure chiropractors’ cash flow is healthy.

There are some commentators on this blog who regularly try to make us believe that chiropractic is about to reform, leave obsolete concepts behind, and become a respectable, ethical and evidence-based healthcare profession. After reading the appalling drivel the WFC call their ‘strategic plan’, I am not optimistic that they are correct.

An article in the Sydney Morning Herald might be interesting to some readers. It informs us that, after more than 25 years of running, the University of Technology Sydney (UTS) intends to stop offering its degree in Traditional Chinese Medicine (TCM). A review of the Chinese Medicine Department found it should be wound up at the end of 2021 because

  • it was no longer financially viable,
  • did not produce enough research,
  • and did not fit with the “strategic direction” of the science faculty.

The UTS’s Chinese medicine clinic, which offers acupuncture and herbal treatments, would also close. Students who don’t finish by the end of 2021 will either move to another health course, or transfer to another university (Chinese medicine is also offered by the University of Western Sydney, RMIT in Melbourne, and several private colleges).

TCM “is a historical tradition that pre-dated the scientific era,” said the president of Friends of Science, Associate Professor Ken Harvey. “There’s nothing wrong with looking at that using modern scientific techniques. The problem is people don’t, they tend to teach it like it’s an established fact. If I was a scientifically-orientated vice chancellor I would worry about having a course in my university that didn’t have much of a research profile in traditional Chinese medicine.”

But a spokesman for the University of Technology Sydney said the debate over the scientific validity of Chinese medicine had nothing to do with the decision, and was “in no way a reflection of an institutional bias against complementary health care”. Personally, I find this statement surprising. Should the scientific validity of a subject not be a prime concern of any university?

In this context, may I suggest that the UTS might also have a critical look at their ‘AUSTRALIAN RESEARCH CENTRE IN COMPLEMENTARY AND INTEGRATIVE MEDICINE‘. They call themselves ‘the first centre worldwide dedicated to public health and health services research on complementary and integrative medicine’. Judging from the centre director’s publications, this means publishing one useless survey after another.

Acupuncture is effective in alleviating angina when combined with traditional antianginal treatment, according to a study published today in JAMA Internal Medicine. Researchers conducted a 20-week randomized clinical trial at 5 clinical centres in China. Patients with chronic, stable angina (a serious symptom caused by coronary heart disease) were randomly assigned to 4 groups:

  1. acupuncture on acupoints in the disease-affected meridian,
  2. acupuncture on a non-affected meridian,
  3. sham acupuncture,
  4. waitlist group that did not receive acupuncture.

All participants also received recommended antianginal medications. Acupuncture was given three times each week for 4 weeks. Patients were asked to keep a diary to record angina attacks. 398 patients were included in the intention-to-treat analysis. Greater reductions in angina attacks occurred in those who received acupuncture at acupoints in the disease-affected meridian compared with those in the nonaffected meridian group, the sham acupuncture group and the wait list group.

“Acupuncture was safely administered in patients with mild to moderate angina”, Zhao et al wrote. “Compared with the [control] groups, adjunctive acupuncture showed superior benefits … Acupuncture should be considered as one option for adjunctive treatment in alleviating angina.”

This study is well-written and looks good – almost too good to be true!

Let me explain: during the last 25 years, I must have studied several thousand clinical trials of SCAM, and I think that, in the course of this work, I have developed a fine sense for detecting trials that are odd or suspect. While reading the above RCT, my alarm-bells were ringing loud and clear.

The authors claim they have no conflicts of interest. This may well be true as far as financial conflicts of interest are concerned, but I have long argued that, in SCAM, ideological conflicts are much more powerful than financial ones. If we look at some of the authors’ affiliations, we get a glimpse of this possibility:

  • Acupuncture and Tuina School, Chengdu University o fTraditional Chinese Medicine, Chengdu, Sichuan, China
  • Department of Acupuncture, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
  • Acupuncture and Tuina School, Hunan University of  Traditional Chinese Medicine, Changsha, Hunan, China
  • Acupuncture and Tuina School, Guiyang University of Traditional Chinese Medicine, Guiyang, Guizhou, China
  • Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China
  • Acupuncture and Tuina School, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China

I have reported repeatedly that several independent analyses have shown that as good as no TCM studies from China ever report negative results. I have also reported that data falsification is said to be rife in China.

I am aware, of course, that these arguments are hardly evidence-based and therefore amount to mere suspicions. So, let me also mention a few factual points about the new trial:

  • The study was concluded 4 years ago; why is it published only now?
  • The primary outcome measure was entirely subjective; an objective endpoint would have been valuable.
  • Patient blinding was not checked but would have been important.
  • The discussion is devoid of any critical input; this is perhaps best seen when looking at the reference list. The authors cite none of the many critical analyses of acupuncture.
  • The authors did actually not use normal acupuncture but electroacupuncture. One would have liked to see a discussion of effects of the electrical current versus those of acupuncture.
  • The therapists were not blinded (when using electroacupuncture, this would have been achievable). Therefore, one explanation for the outcome is lies in the verbal/non-verbal communication between therapists and patients.
  • Acupuncture was used as an add-on therapy, and it is conceivable that patients in the acupuncture group were more motivated to take their prescribed medications.
  • The costs for 12 sessions of acupuncture would have been much higher (in the UK) than those for an additional medication.
  • The practicality of consulting an acupuncturist three times a week need to be addressed.
  • The long-term effects of acupuncture on angina pectoris (which is a long-term condition) are unknown.

Coming back to my initial point about the reliability of the data, I feel that it is important to not translate these findings into clinical routine without independent replications by researchers from outside China who are not promoters of acupuncture. Until such data are available, I believe that acupuncture should NOT be considered as one option for adjunctive treatment in alleviating angina.

An article in the ‘Chronicle of Chiropractic’ defends the currently much debated chiropractic care for children. It is authored by ‘ChiroFuture‘, a Risk Purchasing Group founded by chiropractors. Here is the unabridged article (the references were added by me and refer to my comments below):

The chiropractic care of children has been the subject of increased media attention and scrutiny following decisions by chiropractic regulatory boards in Europe, Australia and Canada. These decisions were not based on science, research or data but rather a purposeful misrepresentation of the concept of evidence informed practice (1) and its application coupled with compelled speech.

As with the chiropractic care of adults, an evidence informed perspective (2) respects the needs and wants of parents for the care of their child, the published research evidence and the clinical expertise of chiropractors in the care of children.

ChiroFutures Malpractice Program does not base its malpractice insurance rates on the age of the patients a chiropractor sees.  In fact, we are not aware of any actuarial data showing an increase in adverse events from the tens of millions of pediatric chiropractic visits per year (3). The vast majority of claims or incidents alleging chiropractic negligence involve adult patients (4).

What chiropractors do is minimally invasive and typically nothing else but their hands are used to gently ease any obstruction to the functioning of the patient’s nervous system (5). Since the nervous system controls and coordinates all functions of the body it is important to be sure it is functioning as best it can with no obstructions and no matter the disease afflicting the patient.

State and provincial laws, federal governments, international, national and state chiropractic organizations and chiropractic educational institutions all support the role and responsibility of chiropractors in the management of children’s health (6). The rationale for chiropractic care of children is supported by published protocols that are safe, efficacious, and valid (7). The scientific literature is sufficiently supportive of the usefulness of these protocols in regard to the chiropractic care of children (8).

Those contending that there is no evidence supporting the safety and efficacy of the chiropractic care of children demonstrate a complete disregard for the evidence and scientific facts related to the chiropractic care of children (9).

ChiroFutures encourages and supports a shared decision making process between doctors (10) and patients regarding health needs. As a part of that process, patients have a right to be informed about the state of their health as well as the risks, benefits and alternatives related to care. Any restriction on that dialogue or compelled statements inconsistent with the doctrine of informed consent present a threat to public health (11).

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Here are my comments:

  1. Why ‘evidence informed’ and not evidence-based’? The term ‘evidence informed’ is popular with SCAM practitioners. Barratt and Hodson noted, “The evidence-informed practitioner carefully considers what research evidence tells them in the context of a particular child, family or service, and then weighs this up alongside knowledge drawn from professional experience and the views of service users to inform decisions about the way forward.”  This seems to imply that the two terms are synonymous. However, in reality they are not.
  2. Does that mean that ‘evidence-informed’ is defined as the practice wanted by patients, regardless of the evidence?
  3. There is no post-marketing surveillance in chiropractic. Therefore we do not have reliable data on adverse events.
  4. That might be true but it is unclear what it tells us. It might simply mean that chiropractors treat more adults than children.
  5. There is no good evidence to show that the function of the nervous system can be enhanced by manual therapy.
  6. Provincial laws and federal governments might tolerate but I don’t think they ‘support’ the role and responsibility of chiropractors. That chiropractic organisations support it surprises nobody.
  7. This sentence does not make sense to me. The facts, however, are clear: there is no sound rational for chiropractic manipulations and they are neither efficacious nor totally safe for children.
  8. The scientific evidence does not show that chiropractic care is effective for any paediatric condition.
  9. I think the complete disregard is shown not by critics but by the authors of these lines.
  10. Calling chiropractors ‘doctors’ gives the impression they have  been to medical school and is therefore misleading the public.
  11. The threat to public health are those chiropractors who advise parents not to immunise their children.

Perhaps ChiroFuture need to brush up on their knowledge of the evidence. Chiropractic has no place in the healthcare of children. Parents should be warned!

Cupping is a so-called alternative medicine (SCAM) that has existed in several ancient cultures. It recently became popular when US Olympic athletes displayed cupping marks on their bodies, and it was claimed that cupping is used for enhancing their physical performance. There are two distinct forms: dry and wet cupping.

Wet cupping involves scarring the skin with a sharp instrument and then applying a cup with a vacuum to suck blood from the wound. It can thus be seen (and was traditionally used) as a form of blood-letting. Wet cupping is being recommended by enthusiasts for a wide range of conditions. But does it work?

This study compared the effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain (PNSLBP). In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping or conventional treatment. The wet-cupping group was treated with two separate sessions (4 weeks in total) on the inter-scapular and sacrum area. In the conventional treatment group, patients were conservatively treated using rest (6 weeks) and oral medications (3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index (ODI), and pain intensity using Visual Analogue Scale (VAS), respectively.
The results show that there was no significant difference in demographic characteristics (age, gender, and body mass index) between the two groups. Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits. The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly superior compared to the conventional treatment group. The final ODI scores in the wet-cupping and conventional groups were 16.7 ± 5.7 and 22.3 ± 4.5, respectively (P<0.01).

The authors concluded that wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy.

Perhaps the authors were joking? In any case, their conclusions cannot be taken seriously. Why? There are several reasons, but the most obvious ones are:

  1. There was no adequate control of the presumably substantial placebo effects of wet cupping.
  2. The control group received a treatment that is known to be ineffective or even detrimental.

For people with acute low back pain, advice to rest in bed is less effective than advice to stay active. Thus comparing wet cupping to a control group treated with bed rest is bound to generate a false-positive outcome for wet cupping.

My final point is perhaps the most important: wet cupping can lead to serious complication, and I therefore do not recommend it to anyone – other than masochists, perhaps.

In Switzerland, so-called alternative medicine (SCAM) is officially recognised within the healthcare system and mainly practised in conjunction with conventional medicine. So far no research has been published into the attitude towards, training in and offer of SCAM among paediatricians in Switzerland. This survey addresses this gap by investigating these topics with an online survey of paediatricians in Switzerland.

It employed a 19-item, self-reporting questionnaire among all ordinary and junior members of the Swiss Society of Paediatrics (SSP). A comparison of the study sample with the population of all paediatricians registered with the Swiss Medical Association (FMH) allowed an assessment of the survey’s representativeness. The data analysis was performed on the overall group level as well as for predefined subgroups (e.g. sex, age, language, workplace and professional experience).

A total of 1890 paediatricians were approached and 640, from all parts of Switzerland, responded to the survey (response rate 34%). Two thirds of respondents were female, were aged between 35 and 55 years, trained as paediatric generalist and worked in a practice. Apart from young paediatricians in training, the study sample was representative of all Swiss paediatricians.

According to the authors’ statistics, the results suggest that

  • 23% had attended training in SCAM, most frequently in phytotherapy, homeopathy, acupuncture/traditional Chinese medicine (TCM) and anthroposophic medicine
  • 8% had a federal certificate in one or more SCAM methods.
  • 44% did not routinely ask their patients about their use of SCAM.
  • 84% did not offer SCAM.
  • 65% were interested in SCAM courses and training.
  • 16% provided SCAM services to their patients.
  • 97% were asked by patients/parents about SCAM therapies.
  • More than half of the responding paediatricians use SCAM for themselves or their families.
  • 42% were willing to contribute to paediatric SCAM research.

The authors concluded that in a representative sample of paediatricians in Switzerland, the overall attitude towards SCAM was positive, emphasised by great interest in SCAM training, willingness to contribute to SCAM research and, in particular, by the high rate of paediatricians using SCAM for themselves and their families. However, given the strong demand for SCAM for children, the rate of paediatricians offering SCAM is rather low, despite the official recognition of SCAM in Switzerland. Among the various reasons for this, insufficient knowledge and institutional barriers deserve special attention. The paediatricians’ great interest in SCAM training and support for SCAM research offer key elements for the future development of complementary and integrative medicine for children in Switzerland.

SCAM suffers from acute survey mania. I am anxiously waiting for a survey of SCAM use in left-handed, diabetic policemen in retirement from Devon. But every other variation of the theme has been exploited. And why not? It provides the authors with a most welcome addition to their publication list. And, of course, it lends itself very nicely to SCAM-promotion. Sadly, there is not much else that such surveys offer.

Except perhaps for an opportunity to do an alternative evaluation of their results. Here is an assessment the devil’s advocate in me proposes. Based on the reasonable assumption that those 34% of paediatricians who responded did so because they had an interest in SCAM, and the 64% who did not reply couldn’t care less, it is tempting to do an analysis of the entire population of Swiss paediatricians. Here are my findings:

  • Hardly anyone had attended training in SCAM.
  • Hardly anyone had a federal certificate in one or more SCAM methods.
  • Very few did not routinely ask their patients about their use of SCAM.
  • Hardly anyone offered SCAM.
  • Very few were interested in SCAM courses and training.
  • Hardly anyone provided SCAM services to their patients.
  • Quite a few were asked by patients/parents about SCAM therapies.
  • Very few paediatricians use SCAM for themselves or their families.
  • Few were willing to contribute to paediatric SCAM research.

These results might be closer to the truth but they have one very important drawback: they do not lend themselves to drawing the SCAM-promotional conclusions formulated by the authors.

Oh Yes, reality can be a painful thing!

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

_________________________________________________________

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.

____________________________________________________________________

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.

_________________________________________________________________

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.

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