MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

children

1 2 3 6

This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:

The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.

Specifically, the Minister directed the Council to undertake:

1) A review of the status of the reserved act in other Canadian jurisdictions,

2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and

3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.

In addition, the Minister requested the Council to seek written input on the issue from:

  • Manitoba Chiropractic Stroke Survivors
  • Manitoba Chiropractic Association
  • College of Physiotherapists of Manitoba
  • Manitoba Naturopathic Association
  • College of Physicians and Surgeons of Manitoba
  • other relevant interested parties as determined by the Council

… The review indicated that further research is required to:

  • strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
  • establish safety and efficacy of CSM in infants and children
  • assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.

… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.

Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:

  • Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
  • Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.

Chiropractic is hugely popular, we are often told. The fallacious implication is, of course, that popularity can serve as a surrogate measure for effectiveness. In the United States, chiropractors provided 18.6 million clinical services under Medicare in 2015, and overall spending for chiropractic services was estimated at USD $12.5 billion. Elsewhere, chiropractic seems to be less commonly used, and the global situation has not recently been outlined. The authors of this ‘global overview‘ might fill this gap by summarizing the current literature on the utilization of chiropractic services, reasons for seeking care, patient profiles, and assessment and treatment provided.

Systematic searches were conducted in MEDLINE, CINAHL, and Index to Chiropractic Literature from database inception to January 2016. Eligible articles

1) were published in English or French (not all that global then!);

2) were case series, descriptive, cross-sectional, or cohort studies;

3) described patients receiving chiropractic services;

4) reported on the following theme(s): utilization rates of chiropractic services; reasons for attending chiropractic care; profiles of chiropractic patients; or, types of chiropractic services provided.

The literature searches retrieved 328 studies (reported in 337 articles) that reported on chiropractic utilization (245 studies), reason for attending chiropractic care (85 studies), patient demographics (130 studies), and assessment and treatment provided (34 studies).

Globally, the median 12-month utilization of chiropractic services was 9.1% (interquartile range (IQR): 6.7%-13.1%) and remained stable between 1980 and 2015. Most patients consulting chiropractors were female (57.0%, IQR: 53.2%-60.0%) with a median age of 43.4 years (IQR: 39.6-48.0), and were employed.

The most common reported reasons for people attending chiropractic care were (median) low back pain (49.7%, IQR: 43.0%-60.2%), neck pain (22.5%, IQR: 16.3%-24.5%), and extremity problems (10.0%, IQR: 4.3%-22.0%). The most common treatment provided by chiropractors included (median) spinal manipulation (79.3%, IQR: 55.4%-91.3%), soft-tissue therapy (35.1%, IQR: 16.5%-52.0%), and formal patient education (31.3%, IQR: 22.6%-65.0%).

The authors concluded that this comprehensive overview on the world-wide state of the chiropractic profession documented trends in the literature over the last four decades. The findings support the diverse nature of chiropractic practice, although common trends emerged.

My interpretation of the data presented is somewhat different from that of the authors. For instance, I fail to share the notion that utilization remained stable over time.

The figure might not be totally conclusive, but I seem to detect a peak in 2005, followed by a decline. Also, as the vast majority of studies originate from the US, I find it difficult to conclude anything about global trends in utilization.

Some of the more remarkable findings of this paper include the fact that 3.1% (IQR: 1.6%-6.1%) of the general population sought chiropractic care for visceral/non-musculoskeletal conditions. Some of the reasons for attending chiropractic care reported by the paediatric population are equally noteworthy: 7% for infections, 5% for asthma, and 5% for stomach problems. Globally, 5% of all consultations were for wellness/maintenance. None of these indications is even remotely evidence-based, of course.

Remarkably, 35% of chiropractors used X-ray diagnostics, and only 31% did a full history of their patients. Spinal manipulation was used by 79%, 31% sold nutritional supplements to their patients, and 10% used applied kinesiology.

In general, this is an informative paper. However, it suffers from a distinct lack of critical input. It seems to skip over almost all areas that might be less than favourable for chiropractors. The reason for this becomes clear, I think, when we read the source of funding for the research: PJHB, AEB, SAM and SDF have received research funding from the Canadian national and provincial chiropractic organizations, either as salary support or for research project funding. JJW received research project funding from the Ontario Chiropractic Association, outside the submitted work. SDF is Deputy Editor-in-Chief for Chiropractic and Manual Therapies; however, he did not have any involvement in the editorial process for this manuscript and was blinded from the editorial system for this paper from submission to decision.

 

Words like these are sure to persuade me that this chiropractic conference announcement is an invitation to abandon reason and dive into pure, unappetising BS. Reading the full text confirms my suspicion; here are a few quotes:

… Chiropractic practitioners are blazing new trails in pediatrics, neurology, neuroplasticity, and multisensory integration, pushing the understanding and possibilities of greater health potential for [autistic] children. This first-ever chiropractic pediatric CE program, with an emphasis on autism, will open the door to more chiropractors serving this precious group of children, taking the daunting fear out of this neurodevelopmental disorder and replacing it with optimism and hope.

AutismOne Online Media Director Candyce Estave said: “As a chiropractor, you’ve already displayed the courage to pursue a better way for your practice and your patients. You’ve shown your patients how supporting the healthy terrain and flow of the body underlies maintaining good health. But what about what’s called ‘autism’? How do you help the multitude of children and families who would love to seek your services for that? You can learn how at the AutismOne 2018 Conference!”

Chiropractic emphasizes the inherent recuperative power of the body to heal itself when it is free of nervous system interference and given the right conditions. Led by Steve Tullius, DC, the Chiropractic Pediatric Continuing Education Credit Program will bring together the best information from the chiropractic and other healing communities to prepare the practicing chiropractor with up-to-the-minute information, confidence, and resources to help children with autism get better. The CE program is co-sponsored by Sherman College of Chiropractic.

Dr. Jeanne Ohm, chiropractor since 1981 and director of the International Chiropractic Pediatric Association since 2002 says, “This year’s AutismOne Conference will offer essential fundamentals in caring for children with these special needs. I encourage all chiropractors to expand their practices and offer their vital services to this growing population in such dire need.”

END OF QUOTES

Blazing new trails in pediatrics, neurology, neuroplasticity, and multisensory integration?

Vital services?

Are they claiming that freeing autistic children from ‘nervous system interference’ (with spinal ‘adjustments’ no doubt) cures autism?

Surely not!

This assumption would put chiropractic firmly into the category of anti-scientific quackery. Seen from this perspective, the little footnote to the announcement is rather hilarious:

“Professionals from other scientific disciplines are also welcome to attend.”

How often have we heard that chiropractic has moved on and has given up the concept of subluxation/malalignment? For sure there is no evidence for such nonsense, and it would be high time to give it up!  But, as has been argued here and elsewhere, if chiros give it up, what is there left? What then would differentiate them from physios ? The answer is not a lot.

In any case, chiros have by no means given up subluxation. One can argue this point ad nauseam; yet, most chiros remain in denial.

For this post, I have chosen a different approach to make my point. I simply went on twitter and had a look what messages chiros tweet. The impression I got is that the majority of chiros are totally immersed in subluxation. To provide some proof, I have copied a few images – if chiros do not listen to words, perhaps they understand pictures, I thought.

So, here we go – enjoy!

[please click to see them full size]

 

I just came across a new article entitled ” Vaccinated children four times more likely to suffer from ADHD, autism“. It was published in WDDTY, my favourite source of misleading information. Here it is:

Vaccinated children are nearly four times more likely to suffer from learning disabilities, ADHD and autism, a major new study has discovered—and they are six times more likely to suffer from one of these neuro-developmental problems if they were also born prematurely.

The vaccinated child is also more likely to suffer from otitis media, the ear infection, and nearly six times more likely to contract pneumonia.

But the standard childhood vaccines do at least do their job: the vaccinated child is nearly eight times less likely than the unvaccinated to develop chicken pox, and also less likely to suffer from whooping cough (pertussis).

Researchers from Jackson State University are some of the first to look at the long-term effects of vaccination. They monitored the health of 666 children for six years from the time they were six—when the full vaccination programme had been completed—until they were 12. All the children were being home-schooled because it was one of the few communities where researchers could find enough unvaccinated children for comparison; 261 of the children hadn’t been vaccinated and 208 hadn’t had all their vaccinations, while 197 had received the full 48-dose course.

The vaccinated were more likely to suffer from allergic rhinitis, such as hay fever, eczema and atopic dermatitis, learning disability, ADHD (attention-deficit, hyperactive disorder), and autism. The risk was lower among the children who had been partially vaccinated.

Vaccinated children were also more likely to have taken medication, such as an antibiotic, or treatment for allergies or for a fever, than the unvaccinated.

END OF QUOTE

I looked up the original study to check and found several surprises.

The first surprise was that the study was called a ‘pilot’ by its authors, even in the title of the paper: “Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children.”

The second surprise was that even the authors admit to important limitations of their research:

We did not set out to test a specific hypothesis about the association between vaccination and health. The aim of the study was to determine whether the health outcomes of vaccinated children differed from those of unvaccinated homeschool children, given that vaccines have nonspecific effects on morbidity and mortality in addition to protecting against targeted pathogens [11]. Comparisons were based on mothers’ reports of pregnancy-related factors, birth histories, vaccinations, physician-diagnosed illnesses, medications, and the use of health services. We tested the null hypothesis of no difference in outcomes using chi-square tests, and then used Odds Ratios and 96% Confidence Intervals to determine the strength and significance of the association…

What credence can be given to the findings? This study was not intended to be based on a representative sample of homeschool children but on a convenience sample of sufficient size to test for significant differences in outcomes. Homeschoolers were targeted for the study because their vaccination completion rates are lower than those of children in the general population. In this respect our pilot survey was successful, since data were available on 261 unvaccinated children…

Mothers’ reports could not be validated by clinical records because the survey was designed to be anonymous. However, self-reports about significant events provide a valid proxy for official records when medical records and administrative data are unavailable [70]. Had mothers been asked to provide copies of their children’s medical records it would no longer have been an anonymous study and would have resulted in few completed questionnaires. We were advised by homeschool leaders that recruitment efforts would have been unsuccessful had we insisted on obtaining the children’s medical records as a requirement for participating in the study.

A further potential limitation is under-ascertainment of disease in unvaccinated children. Could the unvaccinated have artificially reduced rates of illness because they are seen less often by physicians and would therefore have been less likely to be diagnosed with a disease? The vaccinated were indeed more likely to have seen a doctor for a routine checkup in the past 12 months (57.5% vs. 37.1%, p < 0.001; OR 2.3, 95% CI: 1.7, 3.1). Such visits usually involve vaccinations, which nonvaccinating families would be expected to refuse. However, fewer visits to physicians would not necessarily mean that unvaccinated children are less likely to be seen by a physician if their condition warranted it. In fact, since unvaccinated children were more likely to be diagnosed with chickenpox and whooping cough, which would have involved a visit to the pediatrician, differences in health outcomes are unlikely to be due to under-ascertainment.

The third surprise was that the authors were not at all as certain as WDDTY in their conclusions: “the study findings should be interpreted with caution. First, additional research is needed to replicate the findings in studies with larger samples and stronger research designs. Second, subject to replication, potentially detrimental factors associated with the vaccination schedule should be identified and addressed and underlying mechanisms better understood. Such studies are essential in order to optimize the impact of vaccination of children’s health.”

The fourth surprise was to find the sponsors of this research:

Generation Rescue is, according to Wikipedia, a nonprofit organization that advocates the incorrect view that autism and related disorders are primarily caused by environmental factors, particularly vaccines. These claims are biologically implausible and are disproven by scientific evidence. The organization was established in 2005 by Lisa and J.B. Handley. They have gained attention through use of a media campaign, including full page ads in the New York Times and USA Today. Today, Generation Rescue is known as a platform for Jenny McCarthy‘s autism and anti-vaccine advocacy.

The Children’s Medical Safety Research Institute (CMSRI) was, according to Vaxopedia, created by and is funded by the Dwoskin Family Foundation. It provides grants to folks who will do research on “vaccine induced brain and immune dysfunction” and on what they believe are other “gaps in our knowledge about vaccines and vaccine safety”, including:

While they claim that they are not an anti-vaccine organization, it should be noted that  Claire Dwoskin once said that “Vaccines are a holocaust of poison on our children’s brains and immune systems.”

Did I say SURPRISE?

I take it back!

When it comes to WDDTY, nothing does surprise me.

Today is ‘World Bedwetting Day’!

No, don’t laugh; the event is initiated and supported by the World Bedwetting Day Steering Committee, which consists of the International Children’s Continence Society (ICCS) and the European Society for Paediatric Urology (ESPU) along with professional groups across the globe (see website for details).

A good day to remember that the British Chiropractic Association once sued my friend Simon Singh because he had disclosed that they were happily claiming that chiropractic was an effective therapy for bedwetting (and a few other childhood problems). An equally good day to remind ourselves that most alternative therapies are highly effective for this condition. At least this is what practitioners will tell you. For instance:

“Stop, stop! This blog is about evidence!!!” I hear you shout impatiently.

Alright, here is a full and unabbreviated list of all alternative therapies that have been scientifically proven to work for bedwetting:

 

HAPPY BEDWETTING DAY EVERYBODY!

The aim of this paper was to systematically review surveys of 12-month prevalence of homeopathy use by the general population worldwide. Studies were identified via database searches to October 2015. Study quality was assessed using a six-item tool. All estimates were in the context of a survey which also reported prevalence of any complementary and alternative medicine use. A total of 36 surveys were included. Of these, 67% met four of six quality criteria.

Twelve-month prevalence of treatment by a homeopath was reported in 24 surveys of adults (median 1.5%, range 0.2–8.2%). Estimates for children were similar to those for adults. Rates in the USA, UK, Australia and Canada all ranged from 0.2% to 2.9% and remained stable over the years surveyed (1986–2012). Twelve-month prevalence of all use of homeopathy (purchase of over-the-counter homeopathic medicines and treatment by a homeopath) was reported in 10 surveys of adults (median 3.9%, range 0.7–9.8%) while a further 11 surveys which did not define the type of homeopathy use reported similar data. Rates in the USA and Australia ranged from 1.7% to 4.4% and remained stable over the years surveyed. The highest use was reported by a survey in Switzerland where homeopathy is covered by mandatory health insurance.

The authors concluded that each year a small but significant percentage of these general populations use homeopathy. This includes visits to homeopaths as well as purchase of over-the-counter homeopathic medicines.

These data thus indicate that the percentage of the adult general population using homeopathy over the previous 12 months was in the range of 0.7–9.8%, with a median estimate of 3.9%, and the percentage accessing treatment by a homeopath over the previous 12 months was in the range of 0.2–8.2%, with a median estimate of 1.5%. The data also suggest that, over the last few decades, use of homeopathy has remained fairly stable. These facts are in sharp contrast to the claims by homeopaths that:

  • Homeopathy is hugely popular.
  • Homeopathy is being used by more and more people across the globe.
  • Homeopathy is the medicine of the future.

The well-documented and undeniable unpopularity of homeopathy begs the question, I think, why so many people seem to get so excited about homeopathy. The level of usage is nothing to write home about! Therefore, why don’t we just put it down to an aberration like believing the earth is flat? Why don’t we just concede that some minor, harmless stupidity will always exist in some people’s minds?

Here are some reasons why:

  • It is not about the amount of people using homeopathy, but about the principle that any of the increasingly scarce public funds for healthcare are wasted on something as irrational and useless as homeopathy.
  • Homeopathy makes a mockery of EBM.
  • Homeopathy and homeopaths are by no means harmless.
  • Homeopaths tell too many lies to be allowed to get away with them.
  • Homeopathy and its followers systematically undermine rational thought.

 

 


You may recall, we have dealt with the JCAM many times before; for instance here, here, here and here. Now they have come out with another remarkable paper. This study – no, the authors called it a ‘pilot study’ – was to compare the efficacy of Emotional Freedom Techniques (EFT) with that of Cognitive-Behavioral Therapy (CBT) in reducing adolescent anxiety. Sixty-three American high-ability students in grades 6–12, ages 10–18 years, who scored in the moderate to high ranges for anxiety on the Revised Children’s Manifest Anxiety Scale-2 (RCMAS-2) were randomly assigned to one of three groups:

  • CBT (n = 21),
  • EFT (n = 21),
  • or waitlist control (n = 21).

EFT is an alternative therapy that incorporates acupoint stimulation. Students assigned to the CBT or EFT treatment groups received three individual sessions of the identified protocols from trained graduate counseling, psychology, or social work students enrolled at a large northeastern research university. The RCMAS-2 was used to assess preintervention and postintervention anxiety levels in participants.

EFT participants showed significant reduction in anxiety levels compared with the waitlist control group with a moderate to large effect size. CBT participants did not differ significantly from the EFT or control.

The authors concluded that EFT is an efficacious intervention to significantly reduce anxiety for high-ability adolescents.

They also state in their abstract that EFT is an evidence-based treatment for anxiety…

Are you happy with these conclusions?

Are you convinced that this trial lends itself to establish efficacy of anything?

Are you impressed with the trial design, the sample size, etc?

Are you sure that EFT is plausible, credible or evidence-based in any way?

No?

Me neither!

If you look up EFT, you will find that there is a surprising amount of papers on it. Most of them have one thing in common: they were published in highly dubious journals. The field does not inspire trust or competence. The authors of the study state that EFT is an easily implemented strategy that uses such techniques as awareness building, exposure, reframing of interpretation, and systematic desensitization, while teaching the participant to self-stimulate protocol-identified acupoints (i.e., acupuncture points) by tapping. The effectiveness of acupuncture for treating anxiety has been well documented. Rather than using acupuncture needles, EFT relies on the manual stimulation of the acupoints. A recent meta-analysis indicated that interventions using acupoint stimulation had a moderate effect size (Hedge’s g = −0.66 95% CI [−0.99, −0.33]) in reducing symptoms. In EFT, the client stimulates the protocol-identified acupoints by tapping on them. Preliminary studies have suggested that tapping and other alternative ways of stimulating acupuncture points to be as effective as acupuncture needling. The EFT protocol and identified acupoints that were used in this study are the ones recommended for research purposes by the Association for Comprehensive Energy Psychology…

Wikipedia tells us that “Emotional Freedom Techniques (EFT) is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy (TFT). It is best known through Gary Craig’s EFT Handbook, published in the late 1990s, and related books and workshops by a variety of teachers. EFT and similar techniques are often discussed under the umbrella term “energy psychology”. Advocates claim that the technique may be used to treat a wide variety of physical and psychological disorders, and as a simple form of self-administered therapy.[1] The Skeptical Inquirer describes the foundations of EFT as “a hodgepodge of concepts derived from a variety of sources, [primarily] the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body.” The existence of this life force is “not empirically supported”.[2] EFT has no benefit as a therapy beyond the placebo effect or any known-effective psychological techniques that may be provided in addition to the purported “energy” technique.[3] It is generally characterized as pseudoscience and it has not garnered significant support in clinical psychology.”

A recent systematic review of EFT concluded that “there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioral therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.”

Notwithstanding these and many other verdicts on EFT, we now are asked to agree with the new study that EFT IS EFFICACIOUS.

Is this a joke?

They want us to believe this on the basis of  a PILOT STUDY? Such studies are not even supposed to test efficacy! (Yet the authors of the trial state that this study was designed to meet the American Psychological Association (APA) Division 12 quality control criteria and the Consolidated Standards for Reporting Trials (CONSORT) criteria. I have to admit, they could have fooled me!)

No, it is not a joke, it is yet another nonsense from the ‘The Journal of Complementary and Alternative Medicine’ which, in my view, should henceforth be called THE JOURNAL OF ALTERNATIVE FACTS (JAF).

This new RCT was embargoed until today; so, I had to wait until I was able to publish my comments. Here are the essentials of the study:

The Swedish investigators compared the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres (CHCs). The study was designed as a multicentre, randomised controlled, single-blind, three-armed trial (ACU-COL) comparing two styles of acupuncture with no acupuncture, as an adjunct to standard care. Among 426 infants whose parents sought help for colic and registered their child’s fussing/crying in a diary, 157 fulfilled the criteria for colic and 147 started the intervention.

Parallel to usual care, study participants visited the study CHC twice a week for 2 weeks. Thus, all infants received usual care plus 4 extra visits to a CHC, during which parents met a nurse for 20–30 min and were able to discuss their infant’s symptoms. Together these were considered to represent gold standard care. The nurse listened, and gave evidence-based advice and calming reassurance. Breastfeeding mothers were encouraged to continue breastfeeding. At each visit, the study nurse carried the infant to a separate treatment room where they were left alone with the acupuncturist for 5 min.

The acupuncturist treated the baby according to group allocation and recorded the treatment procedures and any adverse events. Disposable stainless steel 0.20×13 mm Vinco needles (Helio, Jiangsu Province, China) were used. Infants allocated to group A received standardised MA at LI4. One needle was inserted to a depth of approximately 3 mm unilaterally for 2–5 s and then withdrawn without stimulation. Infants allocated to group B received semi-standardised individualised acupuncture, mimicking clinical TCM practice. Following a manual, the acupuncturists were able to choose one point, or any combination of Sifeng, LI4 and ST36, depending on the infant’s symptoms, as reported in the diary. A maximum of five insertions were allowed per treatment. Needling at Sifeng consisted of 4 insertions, each to a depth of approximately 1 mm for 1 s. At LI4 and ST36, needles were inserted to a depth of approximately 3 mm, uni- or bilaterally. Needles could be retained for 30 seconds. De qi was not sought, therefore stimulation was similarly minimal in groups A and B. Infants in group C spent 5 min alone with the acupuncturist without receiving acupuncture.

The effect of the two types of acupuncture was similar and both were superior to gold standard care alone. Relative to baseline, there was a greater relative reduction in time spent crying and colicky crying by the second intervention week (p=0.050) and follow-up period (p=0.031), respectively, in infants receiving either type of acupuncture. More infants receiving acupuncture cried <3 hours/day, and thereby no longer fulfilled criteria for colic, in the first (p=0.040) and second (p=0.006) intervention weeks. No serious adverse events were reported.

The authors concluded that acupuncture appears to reduce crying in infants with colic safely.

Notice that the investigators are cautious and state in the abstract that “acupuncture appears to reduce crying…” Their conclusions from the actual article are, however, quite different; here they state the following:

Among those initially experiencing excessive infant crying, the majority of parents reported normal values once the infant’s crying had been evaluated in a diary and a diet free of cow’s milk had been introduced. Therefore, objective measurement of crying and exclusion of cow’s milk protein are recommended as first steps, to avoid unnecessary treatment. For those infants that continue to cry >3 hours/day, acupuncture may be an effective treatment option. The two styles of MA tested in ACU-COL had similar effects; both reduced crying in infants with colic and had no serious side effects. However, there is a need for further research to find the optimal needling locations, stimulation and treatment intervals.

Such phraseology is much more assertive and seems to assume acupuncture caused specific therapeutic effects. Yet, I think, this assumption is not warranted.

In fact, I believe, the study shows almost the opposite of what the authors conclude. Both minimal and TCM acupuncture seemed to reduce the symptoms of colic compared to no acupuncture at all. I think, this confirms previous research showing that acupuncture is a ‘theatrical placebo’. The study was designed without an adequate placebo group. It would have been easy to use some form of sham acupuncture in the control group. Why did the authors not do that? Heaven knows, but one might speculate that they were aiming for a positive result – and what better way to ensure it than with a ‘no treatment’ control group?

There are, of course, numerous other flaws. For instance, Prof David Colquhoun FRS, Professor of Pharmacology at University College London, criticised the study because of its lousy statistics:

START OF QUOTE

“It is truly astonishing that, in the 21st century, the BMJ still publishes a journal devoted to a form of pre-scientific medicine which after more than 3000 trials has still not been able to produce convincing evidence of efficacy1. Like most forms of alternative medicine, acupuncture has been advocated for a vast range of problems, and there is little evidence that it works for any of them. Colic has not been prominent in these claims. What parent would think that sticking needles into their baby would stop it crying? The idea sounds bizarre. It is. This paper certainly doesn’t show that it works.

“The statistical analysis in the paper is incompetent. This should have been detected by the referees, but wasn’t.  For a start, the opening statement, ‘A two-sided P value ≤0.05 was considered statistically significant’ is simply unacceptable in the light of all recent work about reproducibility.  Still worse, Table 1 uses the description ‘statistical tendency towards significance (p=0.051–0.1)’.

“Worst of all, Table 1 reports 24 different P values, of which three are (just) below 0.05. Yet no correction has been used for multiple comparisons. This is very bad practice. It’s highly unlikely that, if the proper correction had been done, any of the results would have given a type 1 error rate below 5%.

“Even were it not for this, most of the ‘significant’ P values are marginal (only slightly less than 0.05).  It is now well known that the type 1 error rate gives an optimistic view. What matters is the false positive rate – the chance that a ‘significant’ result is a false positive.  A p-value close to 0.05 implies that there is at least a 30% chance that they are false positives.  If one thought, a priori, that the chance of colic being cured by sticking needles into a baby was less than 50%, the false positive rate could easily be greater than 80%2.  It is now recognised that this misinterpretation of p-values is a major contributor to the crisis of reproducibility.

“Other problems concern the power calculation.  A priori calculations of power are well-known to be overoptimistic, because small trials usually overestimate the effect size.  In this case the initial estimated sample size was not attained, and a rather mysterious recalculation of power was used.

“Another small problem: the discussion points out that ‘the majority of infants in this cohort did not have colic’.

“The nature of the control group is not very clear. An appropriate control might have been to cuddle the baby – this was used in a study in which another implausible treatment, chiropractic, was shown not to work.  This appears not to have been done.

“Lastly, p-values are reported in the text without mention of effect sizes. This is contrary to all statistical advice.

“In conclusion, the design of the trial is reasonable (apart from the control group) but the statistical analysis is appalling.  It’s very likely that there aren’t any real effects of acupuncture at all. This paper serves more to muddy the waters than to add useful information. It’s a model for the sort of mistakes that have led to the crisis in reproducibility.  The BMJ should not be publishing this sort of stuff, and the referees seem to have no understanding of statistics.”

END OF QUOTE

Despite these rather obvious – some would say fatal – flaws, the editor of ACUPUNCTURE IN MEDICINE (AIM) thought this trial to be so impressively rigorous that he issued a press-release about it. This, I think, is particularly telling, perhaps even humorous: it shows what kind of a journal AIM is, and also provides an insight into the state of acupuncture research in general.

The long and short of it is that conclusions about specific therapeutic effects of acupuncture are not permissible. We know that colicky babies respond even to minimal attention, and this trial confirms that even a little additional TLC in the form of acupuncture will generate an effect. The observed outcome is most likely unrelated to acupuncture.

The WDDTY is not my favourite journal – far from it. The reason for my dislike is simple: far too many of its articles are utterly misleading and a danger to public health. Take this recent one entitled ‘Paleo-type diet reversing Crohn’s and ulcerative colitis’, for instance:

START OF QUOTE
Crohn’s disease and ulcerative colitis are being reversed solely by diet—essentially a Paleo diet. The non-drug approach has been successful in 80 per cent of children who’ve been put on the special diet.

The diet—called the specific carbohydrate diet (SCD)—has been pioneered by Dr David Suskind, a gastroenterologist at Seattle Children’s Hospital. The diet excludes grains, dairy, processed foods and sugars, other than honey, and promotes natural, nutrient-rich foods, including vegetables, fruits, meats and nuts.

Children are going into complete remission after just 12 weeks on the diet, a new study has discovered. Ten children with inflammatory bowel disease (IBD)—an umbrella term for Crohn’s and ulcerative colitis—were put on the diet, and eight were completely symptom-free by the end of the study. Suskind started exploring a dietary approach to IBD because he became convinced that the standard medical treatment of steroids or other medication was inadequate. “For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease. Now we know that diet does have an impact, a strong impact. It works, and now there’s evidence,” he said.

END OF QUOTE

“For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease”.

Really?

In this case, I must have studied an entirely different subject all these years ago at university – I had been told it was medicine but perhaps…???…!!!

It took me some time to find the original paper – they cited a wrong reference (2017 instead of 2016). But eventually I located it. Here is its abstract:

GOAL:

To determine the effect of the specific carbohydrate diet (SCD) on active inflammatory bowel disease (IBD).

BACKGROUND:

IBD is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Diet is a potential therapeutic option for IBD based on the hypothesis that changing the fecal dysbiosis could decrease intestinal inflammation.

STUDY:

Pediatric patients with mild to moderate IBD defined by pediatric Crohn’s disease activity index (PCDAI 10-45) or pediatric ulcerative colitis activity index (PUCAI 10-65) were enrolled into a prospective study of the SCD. Patients started SCD with follow-up evaluations at 2, 4, 8, and 12 weeks. PCDAI/PUCAI, laboratory studies were assessed.

RESULTS:

Twelve patients, ages 10 to 17 years, were enrolled. Mean PCDAI decreased from 28.1±8.8 to 4.6±10.3 at 12 weeks. Mean PUCAI decreased from 28.3±23.1 to 6.7±11.6 at 12 weeks. Dietary therapy was ineffective for 2 patients while 2 individuals were unable to maintain the diet. Mean C-reactive protein decreased from 24.1±22.3 to 7.1±0.4 mg/L at 12 weeks in Seattle Cohort (nL<8.0 mg/L) and decreased from 20.7±10.9 to 4.8±4.5 mg/L at 12 weeks in Atlanta Cohort (nL<4.9 mg/L). Stool microbiome analysis showed a distinctive dysbiosis for each individual in most prediet microbiomes with significant changes in microbial composition after dietary change.

CONCLUSIONS:

SCD therapy in IBD is associated with clinical and laboratory improvements as well as concomitant changes in the fecal microbiome. Further prospective studies are required to fully assess the safety and efficacy of dietary therapy in patients with IBD.

What does this mean?

The WDDTY report bears very little resemblance to the journal article (let alone with the title of their article or any other published research by David Suskind).

How come?

I cannot be sure, but I would not be surprised to hear that the latter was ‘egged up’ to make the former appear more interesting.

If that is so, WDDTY are (once again) guilty of misleading the public to the point of endangering lives of vulnerable patients.

SHAME ON EVERY OUTLET THAT SELLS WDDTY, I’d say.

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