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

children

If you talk to advocates of homeopathy, you are bound to hear claims that are false or misleading; in fact, you hear them so regularly that you might begin to doubt the truth. For those who have such doubts or are in need of some correct counter-arguments, I have listed here those 12 bogus claims which, in my experience, are most common together with short, suitable, and factual rebuttals.

1) THERE IS NOTHING MYSTERIOUS ABOUT HOMEOPATHY’S MODE OF ACTION, IT WORKS LIKE VACCINATIONS

This argument is used by enthusiasts in response the fact that most homeopathic remedies are too highly diluted to have pharmacological effects. Vaccines are also highly diluted and they are, of course, very effective; therefore, so the bogus notion, there is nothing odd about homeopathy.

The argument is wrong on several levels; the easiest way to refute, I think, it is to point out that vaccines contain measurable amounts of material and lead to measurable changes in the immune system. By contrast, the typical homeopathic remedy (beyond the C12 potency) contains not a single molecule of an active substance and leads to no measurable changes in any system.

2) SIGNIFICANTLY MORE CONTROLLED CLINICAL TRIALS OF HOMEOPATHY ARE POSITIVE THAN NEGATIVE

Several websites of homeopathic organisations make this claim and even provide simple statistics to back it up. Consequently, many homeopathy fans have adopted it.

The statistics they present show that x % of studies are positive, y % are negative and z % are neutral; the whole point is that x is larger than y. The percentage figures may even be correct but they rely on the spurious definitions used: positive = superior to placebo, negative = placebo superior to homeopathy, neutral = no difference between homeopathy and placebo. The latter category was created so that homeopathy comes out trumps.

For all intents and purposes, a study where the experimental treatment is no better than placebo is not a study neutral but a negative result. Thus the negative category in such statistics must be y + z which is, of course, larger than x. In other words, the majority of trials is, in truth, negative.

3) HOMEOPATHY IS SUPPORTED BY NOBEL PRIZE WINNERS

I don’t know of a single Nobel Prize winner who has stated or implied that homeopathy works better than a placebo. Some have tried to find a mechanism of action for homeopathy by doing some basic research and have published theories about it. None of those has been accepted by science.

And if there ever should be a Nobel Prize winner or similarly brilliant person who supports homeopathy, this would merely show that even bright individuals can make mistakes!

4) HOMEOPATHY IS SAFE

Tell that to the child that has just been reported to have died because her parents used homeopathy for an ear infection which (could have been easily treated with antibiotics but) degenerated into a brain abscess with homeopathic therapy. There are many more such tragic cases than I care to remember.

The risks of homeopathy are, of course, minor compared to many conventional treatments, but the risk/benefit balance of homeopathy can never be positive because, unlike those high risk conventional treatments, it has no benefit.

5) HOMEOPATHY DOES NOT LEND ITSELF TO BEING TESTED IN CLINICAL TRIALS

The best way to disprove this argument is to point out that ~ 250 controlled clinical trials are currently available. Every homeopath on the planet boasts about clinical trials – provided they are positive.

6) HOMEOPATHY WORKS VIA QUANTUM ENTANGLEMENT

I do not understand quantum mechanics and, I suspect, neither do the homeopaths who use this argument. But physicists who do understand this subject well are keen to stress that homeopathy cannot be explained in this way.

7) THERE IS NO PROOF THAT HOMEOPATHY DOES NOT WORK

The absence of evidence is not the same as evidence of absence, homeopaths like to exclaim. And they are, of course, correct! However, they forget that, science cannot prove a negative and that, in routine health care, we do not even look for a proof of ineffectiveness. We use those treatments that have a positive proof of effectiveness – everything else is irresponsible.

8) EVEN IF HOMEOPATHY WERE JUST A PLACEBO, IT STILL HELPS PATIENTS AND IS THEREFORE A USEFUL TREATMENT

It is true, of course, that placebo effects can help patients. But it is not true that, for generating a placebo response, we need a placebo. If a clinician administers an effective treatment with compassion, the patient will benefit from a placebo response plus from the specific effects of the treatment. Only giving placebos is therefore tantamount to cheating the patient.

9) THERE IS A WORLDWIDE CONSPIRACY AGAINST HOMEOPATHY

In a way, this argument merely suggests that homeopathic remedies are ineffective in treating paranoia. I have not ever seen a jot of evidence for it – and neither can anyone who uses this claim produce any.

10) YOU NEED TO BE A HOMEOPATH TO BE ABLE TO UNDERSTAND AND ADEQUATELY JUDGE THE VALUE OF HOMEOPATHY

With this notion, homeopaths want to claim that the critics of homeopathy are incompetent. It is like saying that only people who believe in god are allowed to criticise religion. By definition, homeopaths are believers, and therefore they are unlikely to be free of bias when judging the value of homeopathy. Homeopathy is a health technology that must be evaluated like all other health technologies: by independent scientists who know their job.

11) HOMEOPATHY HAS BEEN PROVEN TO WORK FOR LITTLE CHILDREN AND ANIMALS

The argument here is that animals and children cannot possibly respond to placebo. Therefore homeopathy must be more than a placebo.

This notion is twice wrong. Firstly, both animals and children can respond to placebo, if only ‘by proxy’, i.e. via their carers. Secondly, if we consider the totality of the reliable data, we find that neither for children nor for animals is the evidence convincingly positive.

12) HOMEOPATHY HAS BEEN USED VERY SUCCESSFULLY IN MAJOR EPIDEMICS, AND THAT FACT IS PROOF ENOUGH FOR ITS EFFICACY

Yes, there are some rather fascinating historical accounts which homeopaths interpret in this fashion. But if we look a little closer, we invariably find explanations which are much more plausible than the assumption of homeopathy’s effectiveness. Epidemiological observations of this nature can almost never establish cause and effect, and the clinical outcome could have been due to a myriad of confounders unrelated to homeopathy.

In the world of homeopathy, the truth is often much weirder than fiction. Take this recent article, for instance; it was published by the famous lay homeopath Alan Schmukler in the current issue of ‘HOMEOPATHY 4 EVERYONE’.

Before you read the text in question, it might be relevant to explain who Schmukler is: he attended Temple University, where he added humanistic psychology to his passions. After graduating Summa Cum Laude, Phi Beta Kappa and President’s Scholar, he spent several years doing workshops in human relations. Alan also studied respiratory therapy and worked for three years at Einstein Hospital in Philadelphia. Those thousands of hours in the intensive care and emergency rooms taught him both the strengths and limitations of conventional medicine. Schmukler learned about homeopathy in 1991 when he felt he had been cured of an infection with Hepar sulph. He later founded the Homeopathic Study Group of Metropolitan Philadelphia, giving free lectures and hosting the areas best homeopaths to teach. He also helped found and edit Homeopathy News and Views, a popular culture newsletter on homeopathy. He taught homeopathy for Temple University’s Adult Programs, and has been either studying, writing, lecturing or consulting on homeopathy since 1991. He wrote Homeopathy An A to Z home Handbook, which is now available in five languages. Alan Schmukler has been practicing homeopathy for more than two decades and is Chief Editor of Hpathy.com and of Homeopathy4Everyone. He says that his work as Editor is one of his most rewarding experiences.

Now, brace yourself, here is the promised text/satire (in bold); I promise, I did not change a single word:

EIGHT REASONS TO VACCINATE YOUR CHILD

  1. Your child is deficient in Mercury, Aluminum, Formaldehyde, viruses, foreign DNA or other ingredients proven to cause neurological damage.
  2. Your child has an excess of healthy, functioning brain cells.
  3. You need more cash. The National Vaccine Injury Compensation program has paid out 2.8 billion dollars to parents of children injured or killed by vaccines.
  4. You and your husband are feeling alienated and you need a crisis to bring you together.
  5. You believe that pharmaceutical conglomerates which earn billions from vaccines are more credible than consumer groups.
  6. You think thousands of parents who report that their children became autistic two weeks after vaccination are lying.
  7. You don’t see a problem in logic when the government tells you that vaccines work, but that vaccinated children can catch diseases from unvaccinated children.
  8. You think the government should dictate which healing methods you and your children are allowed to use.

Funny? No!

Bad taste? Very much so!

Barmy? I think so!

Dangerous? Yes!

Irresponsible? Most certainly!

Unethical? Yes!

Characteristic for lay homeopathy? Possibly!

As I grew up in Germany, it was considered entirely normal that I was given homeopathic remedies when ill. I often wondered whether, with the advent of EBM, this has changed. A recent paper provides an answer to this question.

In this nationwide German survey, data were collected from 3013 children on their utilization of medicinal products, including homeopathic and other alternative remedies.

In all, 26% of the reported 2489 drugs were from the realm of alternative medicine. The 4-week prevalence for homeopathy was 7.5%. Of the drugs identified as alternative, 53.7% were homeopathic remedies, and 30.8% were herbal drugs. Factors associated with higher medicinal use of alternative remedies were female gender, residing in Munich, and higher maternal education. A homeopathy user utilized on average homeopathic remedies worth EUR 15.28. The corresponding figure for herbal drug users was EUR 16.02, and EUR 18.72 for overall medicinal CAM users. Compared with data from 4 years before, the prevalence of homeopathy use had declined by 52%.

The authors concluded that CAM use among 15-year-old children in the GINIplus cohort is popular, but decreased noticeably compared with children from the same cohort at the age of 10 years. This is possibly mainly because German health legislation normally covers CAM for children younger than 12 years only.

The survey shows that homeopathy is still a major player in the health care of German children. From the point of view of a homeopath, this makes a lot of sense: children are supposed to respond particularly well to homeopathy. But is that really true? The short answer is NO.

Our systematic review of all relevant studies tells it straight: The evidence from rigorous clinical trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.

In other words, the evidence is very much at odds with the practice. This begs the question, I think, HOW SHOULD WE INTERPRET THIS DISCREPANCY?

A few possibilities come into mind, and I would be grateful to hear from my readers which they think might be correct:

  • Homeopathy is used as a ‘benign placebo’ [clinicians know that most paediatric conditions are self-limiting and thus prefer to give placebos rather than drugs that can cause adverse effects].
  • Doctors prescribe homeopathy mainly because the kids’ parents insist on them.
  • Doctors believe that homeopathic remedies are more than just placebos [in which case they are clearly ill-informed].
  • German doctors do not believe in scientific evidence and prefer to rely on their intuition.
  • This high level of homeopathy usage misleads the next generation into believing in quackery.
  • It amounts to child abuse and should be stopped.

In the past, I have been involved in several court cases where patients had complained about mistreatment by charlatans. Similarly I have acted as an expert witness for the General Medical Council in similar circumstances.

So, it is true, quacks are sometimes being held to account by their victims. But, generally speaking, patients seem to complain very rarely when they fall in the hands of even the most incompetent of quacks.

Here is one telling reminder showing how long it can take until a complaint is finally filed.

Dr Julian Kenyon is, according to his websitean integrated medicine physician and Medical Director of the Dove Clinic for Integrated Medicine, Winchester and London. Dr Julian Kenyon is Founder-Chairman of the British Medical Acupuncture Society in 1980 and Co-Founder of the Centre for the Study of Complementary Medicine in Southampton and London where he worked for many years before starting The Dove Clinic in 2000. He is also Founder/President of the British Society for Integrated Medicine and is an established authority in the field of complementary treatment approaches for a wide range of medical conditions. He has written approximately 20 books and has had many academic papers published in peer review journals* and has several patents to his name. He graduated from the University of Liverpool with a Bachelor of Medicine and Surgery and subsequently with a research degree, Doctor of Medicine. In 1972, he was appointed a Primary Fellow of the Royal College of Surgeons, Edinburgh.

*[I found only 4 on Medline]

Kenyon has been on sceptics’ radar for a very long time. For instance, he is one of the few UK doctors who use ‘LIVE BLOOD ANALYSIS’, a bogus diagnostic method that can harm patients through false-negative or false-positive diagnoses. A 2003 undercover investigation for BBC 1 South’s ‘Inside Out’ accused Dr Julian Kenyon of using yet another spurious diagnostic test at his clinic near Winchester. Kenyon has, for many years, been working together with George Lewith, another of the country’s ‘leading’ complementary doctors. In 1994, the two published an article about their co-operation; here is its abstract:

This paper outlines the main research effort that has taken place within the Centre for the Study of Complementary Medicine over the last 10 years. It demonstrates the Centre’s expertise and interest in a whole variety of areas, including the social implications and development of complementary medicine, clinical trial methodology, the evaluation of complementary medical machinery, the effects of electromagnetic fields on health and the investigation of the subtle energetic processes involved in complementary medicine. Our future plans are outlined.

Lewith and Kenyon have been using a technique called electrodermal testing for more than 20 years. Considering the fact that the two doctors authored a BMJ paper which concluded that electrodermal machines couldn’t detect environmental allergies, this seems more than a little surprising.

Using secret filming, ‘Inside Out’ showed Dr Kenyon testing a six-year-old boy and then deciding that he is sensitive to dust mites. Later, Dr Kenyon insists that he made his diagnosis purely on the boy’s symptoms and that he didn’t use the machine to test for dust mites. The BBC then took the boy for a conventional skin prick test, which suggested he didn’t have any allergies at all. But Dr Kenyon then says the conventional test may not be accurate: “He may be one of the 10% who actually are negative to the skin tests but benefit from measures to reduce dust mite exposure.”

Despite this very public disclosure, Kenyon was able to practice unrestrictedly for many years.

In December 2014, it was reported in the Hampshire Chronicle that Dr Kenyon eventually did, after a complaint from a patient, end up in front of the General Medical Council’s conduct tribunal. The panel heard that, after a 20-minute consultation, which cost £300, Dr Kenyon told one terminally-ill man with late-stage cancer: “I am not claiming we can cure you, but there is a strong possibility that we would be able to increase your median survival time with the relatively low-risk approaches described here.” He also made bold statements about the treatment’s supposed benefits to an undercover reporter who posed as the husband of a woman with breast cancer.

After considering the full details of the case, Ben Fitzgerald, for the General Medical Council, had called for Dr Kenyon to be suspended, but the panel’s chairman Dr Surendra Kumar said Dr Kenyon’s misconduct was not serious enough to warrant a ban. The panel eventually imposed restrictions on Kenyon’s licence lasting for 12 months.

I estimate that patients are exposed to quackery from doctors and alternative practitioners thousands of times every day. Why then, I ask myself, do so few of them complain? Here are some of the possible answers to this important question:

  • They do not dare to.
  • They feel embarrassed.
  • They don’t know how to.
  • They cannot be bothered and fear the agro.
  • They fail to identify quackery and fall for the nonsense they are being told.
  • They even might perceive benefit from treatments which, in fact, are pure quackery.

Whatever the reasons, I think it is regrettable that not far more quacks are held to account – regardless of whether the charlatan in question as studied medicine or not. If you disagree, consider this: not filing a complaint means that many more patients will be put at risk.

Adults using unproven treatments is one thing; if kids do it because they are told to, that is quite another thing. Children are in many ways more vulnerable than grown-ups and they usually cannot give fully informed consent. It follows that the use of such treatments for kids can be a delicate and complex matter.

A recent systematic review was aimed at summarizes the international findings for prevalence and predictors of complementary and alternative medicine (CAM) use among children/adolescents. The authors systematically searched 4 electronic databases (PubMed, Embase, PsycINFO, AMED; last update in 07/2013) and reference lists of existing reviews and all included studies. Publications without language restriction reporting patterns of CAM utilization among children/adolescents without chronic conditions were selected for inclusion. The prevalence rates for overall CAM use, homeopathy, and herbal drug use were extracted with a focus on country and recall period (lifetime, 1 year, current use). As predictors, the authors extracted socioeconomic factors, child‘s age, and gender.

Fifty-eight studies from 19 countries could be included in the review. There were strong variations regarding study quality. Prevalence rates for overall CAM use ranged from 10.9 – 87.6 % for lifetime use, and from 8 – 48.5 % for current use. The respective percentages for homeopathy (highest in Germany, United Kingdom, and Canada) ranged from 0.8 – 39 % (lifetime) and from 1 – 14.3 % (current). Herbal drug use (highest in Germany, Turkey, and Brazil) was reported for 0.8 – 85.5 % (lifetime) and 2.2 – 8.9 % (current) of the children/adolescents. Studies provided a relatively uniform picture of the predictors of overall CAM use: higher parental income and education, older children. But only a few studies analyzed predictors for single CAM modalities.

The authors drew the following conclusion: CAM use is widespread among children/adolescents. Prevalence rates vary widely regarding CAM modality, country, and reported recall period.

In 1999, I published a very similar review; at the time, I found just 10 studies. Their results suggested that the prevalence of CAM use by kids was variable but generally high. CAM was often perceived as helpful. Insufficient data existed about safety and cost. Today, the body of surveys monitoring CAM use by children seems to have grown almost six-fold, and the conclusions are still more or less the same – but have we made progress in answering the most pressing questions? Do we know whether all these CAM treatments generate more good than harm for children?

Swiss authors recently published a review of Cochrane reviews which might help answering these important questions. They performed a synthesis of all Cochrane reviews published between 1995 and 2012 in paediatrics that assessed the efficacy, and clinical implications and limitations of CAM use in children. Main outcome variables were: percentage of reviews that concluded that a certain intervention provides a benefit, percentage of reviews that concluded that a certain intervention should not be performed, and percentage of studies that concluded that the current level of evidence is inconclusive.

A total of 135 reviews were included – most from the United Kingdom (29/135), Australia (24/135) and China (24/135). Only 5/135 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26/135 (19.4%) issued a conditional positive recommendation, and 9/135 (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased during three, a priori-defined, time intervals (1995-2000: 15/27 [55.6%]; 2001-2006: 33/44 [75%]; and 2007-2012: 47/64 [73.4%]). The three most common criticisms of the quality of the studies included were: more research needed (82/135), low methodological quality (57/135) and small number of study participants (48/135).

The Swiss authors concluded that given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.

And what about the risks?

To determine the types of adverse events associated with the use of CAM that come to the attention of Australian paediatricians. Australian researchers conducted a monthly active surveillance study of CAM-associated adverse events as reported to the Australian Paediatric Surveillance Unit between January 2001 and December 2003. They found 39 reports of adverse events associated with CAM use, including four reported deaths. Reports highlighted several areas of concern, including the risks associated with failure to use conventional medicine, the risks related to medication changes made by CAM practitioners and the significant dangers of dietary restriction. The reported deaths were associated with a failure to use conventional medicine in favour of a CAM therapy.

These authors concluded that CAM use has the potential to cause significant morbidity and fatal adverse outcomes. The diversity of CAM therapies and their associated adverse events demonstrate the difficulty addressing this area and the importance of establishing mechanisms by which adverse effects may be reported or monitored.

So, we know that lots of children are using CAMs because their parents want them to. We also know that most of the CAMs used for childhood conditions are not based on sound evidence. The crucial question is: can we be sure that CAM for kids generates more good than harm? I fear the answer is a clear and worrying NO.

Guest post by Jan Oude-Aost

ADHD is a common disorder among children. There are evidence based pharmacological treatments, the best known being methylphenidate (MPH). MPH has kind of a bad reputation, but is effective and reasonably safe. The market is also full of alternative treatments, pharmacological and others, some of them under investigation, some unproven and many disproven. So I was not surprised to find a study about Ginkgo biloba as a treatment for ADHD. I was surprised, however, to find this study in the German Journal of Child and Adolescent Psychiatry and Psychotherapy, officially published by the “German Society of Child and Adolescent Psychiatry and Psychotherapy“ (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie und Psychotherapie). The journal’s guidelines state that studies should provide new scientific results.

The study is called “Ginkgo biloba Extract EGb 761® in Children with ADHD“. EGb 761® is the key ingredient in “Tebonin®“, a herbal drug made by “Dr. Wilma Schwabe GmbH“. The abstract states:

One possible treatment, at least for cognitive problems, might be the administration of Ginkgo biloba, though evidence is rare.This study tests the clinical efficacy of a Ginkgo biloba special extract (EGb 761®) (…) in children with ADHD (…).

Eine erfolgversprechende, bislang kaum untersuchte Möglichkeit zur Behandlung kognitiver Aspekte ist die Gabe von Ginkgo biloba. Ziel der vorliegenden Studie war die Prüfung klinischer Wirksamkeit (…) von Ginkgo biloba-Extrakt Egb 761® bei Kindern mit ADHS.“ (Taken from the English and German abstracts.)

The study sample (20!) was recruited among children who “did not tolerate or were unwilling“ to take MPH. The unwilling part struck me as problematic. There is likely a strong selection bias towards parents who are unwilling to give their children MPH. I guess it is not the children who are unwilling to take MPH, but the parents who are unwilling to administer it. At least some of these parents might be biased against MPH and might already favor CAMmodalities.

The authors state three main problems with “herbal therapy“ that require more empirical evidence: First of all the question of adverse reactions, which they claim occur in about 1% of cases with “some CAMs“ (mind you, not “herbal therapy“). Secondly, the question of drug interactions and thirdly, the lack of information physicians have about the CAMs their patients use.

A large part of the study is based on results of an EEG-protocol, which I choose to ignore, because the clinical results are too weak to give the EEG findings any clinical relevance.

Before looking at the study itself, let’s look at what is known about Ginkgo biloba as a drug. Ginkgo is best known for its use in patients with dementia, cognitive impairment und tinnitus. A Cochrane review from 2009 concluded:

There is no convincing evidence that Ginkgo biloba is efficacious for dementia and cognitive impairment“ [1].

The authors of the current Study cite Sarris et al. (2011), a systematic review of complementary treatment of ADHD. Sarris et al. mention Salehi et al. (2010) who tested Ginkgo against MPH. MPH turned out to be much more effective than Ginkgo, but Sarris et al. argue that the duration of treatment (6 weeks) might have been too short to see the full effects of Ginkgo.

Given the above information it is unclear why Ginkgo is judged a “possible“ treatment, properly translated from German even “promising”, and why the authors state that Ginkgo has been “barely studied“.

In an unblinded, uncontrolled study with a sample likely to be biased toward the tested intervention, anything other than a positive result would be odd. In the treatment of autism there are several examples of implausible treatments that worked as long as parents knew that their children were getting the treatment, but didn’t after proper blinding (e.g. secretin).

This study’s aim was to test clinical efficacy, but the conclusion begins with how well tolerated Ginkgo was. The efficacy is mentioned subsequently: “Following administration, interrelated improvements on behavioral ratings of ADHD symptoms (…) were detected (…).“ But the way they where “detected“ is interesting. The authors used an established questionnaire (FBB-HKS) to let parents rate their children. Only the parents. The children and their teachers where not given the FBB-HKS-questionnaires, inspite of this being standard clinical practice (and inspite of giving children questionnaires to determine changes in quality of life, which were not found).

None of the three problems that the authors describe as important (adverse reactions, drug interactions, lack of information) can be answered by this study. I am no expert in statistics but it seems unlikely to me to meaningfully determine adverse effects in just 20 patients especially when adverse effects occur at a rate of 1%. The authors claim they found an incidence rate of 0,004% in “700 observation days“. Well, if they say so.

The authors conclude:

Taken together, the current study provides some preliminary evidence that Ginkgo biloba Egb 761® seems to be well tolerated in the short term and may be a clinically useful treatment for children with ADHD. Double-blind randomized trials are required to clarify the value of the presented data.

Given the available information mentioned earlier, one could have started with that conclusion and conducted a double blind RCT in the first place!

Clinical Significance

The trends of this preliminary open study may suggest that Ginkgo biloba Egb 761® might be considered as a complementary or alternative medicine for treating children with ADHD.“

So, why do I care? If preliminary evidence “may suggest“ that something “might be considered“ as a treatment? Because I think that this study does not answer any important questions or give us any new or useful knowledge. Following the journal’s guidelines, it should therefore not have been published. I also think it is an example of bad science. Bad not just because of the lack of critical thinking. It also adds to the misinformation about possible ADHD treatments spreading through the internet. The study was published in September. In November I found a website citing the study and calling it “clinical proof“ when it is not. But child psychiatrists will have to explain that to many parents, instead of talking about their children’s health.

I somehow got the impression that this study was more about marketing than about science. I wonder if Schwabe will help finance the necessary double-blind randomized trial…

[1] See more at: http://summaries.cochrane.org/CD003120/DEMENTIA_there-is-no-convincing-evidence-that-ginkgo-biloba-is-efficacious-for-dementia-and-cognitive-impairment#sthash.oqKFrSCC.dpuf

The chiropractic profession have been reminded time and times again that their claim to be able to effectively treat paediatric conditions is bogus. Many experts have asked them to produce some compelling evidence or stop this dangerous nonsense. Yet most of them seem to remain in denial, famously documented by the British Chiropractic Association suing Simon Singh for libel after he disclosed that they happily promote bogus treatments.

Some chiropractors now say that things have changed and that chiropractors are finally getting their act together. If that is true, progress must be painfully slow – so slow, in fact, that it is hard to see it at all. There are still far too many chiropractors who carry on just as before. There are hundreds, if not thousands of articles promoting chiropractic for childhood conditions; a very basic Google search for ‘chiropractic for children’ returns more than 7 million hits many of which advertise this sort of approach. Take this website, for instance; it makes its bogus claims entirely unabashed:

Even as an infant your child may have spinal nerve stress, known as subluxations. Although subluxations may not be painful, they can pose serious threats to your child’s development. If your baby was in a difficult position in the womb, or experienced a traumatic birth they may have developed subluxations. A common condition attributed to subluxations in children is known as Blocked Atlantal Nerve Syndrome. This condition may be the primary cause of ear and upper respiratory infections, and chronic tonsillitis.

Even regular childhood activities such as tumbles taken while learning to walk and run, bike riding, and participation in sports can also cause stress on your child’s body. Emotional stress and trauma may also be a cause of subluxations. Unless they are corrected they can affect future nerve function and the development of your child’s nervous system. They can also cause problems as your child grows and develops into adulthood.

With regular chiropractic care your child may be at less risk for common childhood disease such as colds and fevers. Some children show a marked improvement in asthma symptoms with regular chiropractic care and nutritional counselling. While chiropractors do no treat disease or sickness, they can identify and remove subluxations which interfere with your child’s natural ability to heal. By removing this stress from your child’s spinal system their immune system may function more efficiently and your child may have a better defense to disease. Their overall health may improve as their natural healing power is released. Children who receive regular chiropractic care may also be able to handle emotional and physical stress better and this care may contribute to their natural development.

Your child is never too young to start chiropractic care. Well-child care starts are early as the first month of life. Doctors use a very gentle pressure to treat children (no more pressure than picking up a tomato in the grocery store) and their treatments are very soothing to your child. After their first visit it is recommended that they receive treatments every three months up to age three, and then every six to 12 month after that. You may also want to visit your chiropractor after major milestones in your child’s life such as learning to sit up, crawl, and walk. They should also be seen if they experience any falls or trauma, and if you notice any balance issues they may be experiencing. These may include head tilting and limping.

Pediatric chiropractic care has many benefits. Children as young as infants may see an improvement in their development and overall health with regular care. Doctors of chiropractic take a proactive approach to health by striving to return and maintain your body’s natural balance. If you are looking for an alternative or supplement to traditional medical care, look into chiropractic care for your entire family.

Just a few rotten apples!… the apologists would probably say. But this is clearly not true. I find it even hard to locate the non-rotten apples in this decomposing and disgusting mess. More importantly, if it were true that things were now changing, one would expect that the progressive sections of the chiropractic profession protest regularly, sharply and effectively to shame the many charlatans amongst their midst. Crucially, one would expect the chiropractic professional organisations  to oust their bogus members systematically and swiftly.

The sad truth, however, is that none of this is really happening – certainly not in the US or the UK. On the contrary, organisations like THE INTERNATIONAL PEDIATRIC ASSOCIATION, books entitled CHIROPRACTIC PEDIATRICS, and periodicals like the JOURNAL OF PEDIATRIC, MATERNAL AND FAMILY CHIROPRACTIC remain popular and respected within the chiropractic profession. A few lip-services here and there, yes. But truly effective action? No!

The tolerance of quackery, I would argue, must be one of the most important hallmarks of a quack profession.

Acute tonsillitis (AT) is an upper respiratory tract infection which is prevalent, particularly in children. The cause is usually a viral or, less commonly, a bacterial infection. Treatment is symptomatic and usually consists of ample fluid intake and pain-killers; antibiotics are rarely indicated, even if the infection is bacterial by nature. The condition is self-limiting and symptoms subside normally after one week.

Homeopaths believe that their remedies are effective for AT – but is there any evidence? A recent trial seems to suggest there is.

It aimed, according to its authors, to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa.

The double-blind, placebo-controlled RCT was a 6-day “pilot study” and included 30 children aged 6 to 12 years, with acute viral tonsillitis. Participants took two tablets 4 times per day. The treatment group received lactose tablets medicated with the homeopathic complex (Atropa belladonna D4, Calcarea phosphoricum D4, Hepar sulphuris D4, Kalium bichromat D4, Kalium muriaticum D4, Mercurius protoiodid D10, and Mercurius biniodid D10). The placebo consisted of the unmedicated vehicle only. The Wong-Baker FACES Pain Rating Scale was used for measuring pain intensity, and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms.

The results showed that the treatment group had a statistically significant improvement in the following symptoms compared with the placebo group: pain associated with tonsillitis, pain on swallowing, erythema and inflammation of the pharynx, and tonsil size.

The authors drew the following conclusions: the homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis. No patients reported any adverse effects. These preliminary findings are promising; however, the sample size was small and therefore a definitive conclusion cannot be reached. A larger, more inclusive research study should be undertaken to verify the findings of this study.

Personally, I agree only with the latter part of the conclusion and very much doubt that this study was able to “determine the efficacy” of the homeopathic product used. The authors themselves call their trial a “pilot study”. Such projects are not meant to determine efficacy but are usually designed to determine the feasibility of a trial design in order to subsequently mount a definitive efficacy study.

Moreover, I have considerable doubts about the impartiality of the authors. Their affiliation is “Department of Homoeopathy, University of Johannesburg, Johannesburg, South Africa”, and their article was published in a journal known to be biased in favour of homeopathy. These circumstances in itself might not be all that important, but what makes me more than a little suspicious is this sentence from the introduction of their abstract:

“Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children, offering earlier symptom resolution, cost-effectiveness, and fewer adverse effects.”

A useful alternative to conventional medications (there are no conventional drugs) for earlier symptom resolution?

If it is true that the usefulness of homeopathic remedies has been established, why conduct the study?

If the authors were so convinced of this notion (for which there is, of course, no good evidence) how can we assume they were not biased in conducting this study?

I think that, in order to agree that a homeopathic remedy generates effects that differ from those of placebo, we need a proper (not a pilot) study, published in a journal of high standing by unbiased scientists.

My 2008 evaluation of chiropractic concluded that the concepts of chiropractic are not based on solid science and its therapeutic value has not been demonstrated beyond reasonable doubt. It also pointed out that the advice of chiropractors often is dangerous and not in the best interest of the patient: many chiropractors have a very disturbed attitude towards immunisation: anti-vaccination attitudes till abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit.

In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)

D. D. Palmer’s son, B. J. Palmer (after literally walking [actually it was driving] over his father’s body)  provided a much more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)

Such sentiments and opinions are still prevalent in the chiropractic profession – but today they are expressed in a far less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.

Not all chiropractors share such opinions. The chiropractic profession is currently divided over the issue of immunisation. Some chiropractors now realise that immunisations have been one of the most successful interventions ever for public health. Many others, however, do still vehemently adhere to the gospel of the Palmers.  Statements like the following abound:

Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….

Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?

Yes, I do agree: the position of far too many chiropractors is ‘crystal clear’ – unfortunately it is also dangerously wrong.

The question whether infant colic can be effectively treated with manipulative therapies might seem rather trivial – after all, this is a benign condition which the infant quickly grows out of. However, the issue becomes a little more tricky, if we consider that it was one of the 6 paediatric illnesses which were at the centre of the famous libel case of the BCA against my friend and co-author Simon Singh. At the time, Simon had claimed that there was ‘not a jot of evidence’ for claiming that chiropractic was an effective treatment of infant colic, and my systematic review of the evidence strongly supported his statement. The BCA eventually lost their libel case and with it the reputation of chiropractic. Now a new article on this intriguing topic has become available; do we have to reverse our judgements?

The aim of this new systematic review was to evaluate the efficacy or effectiveness of manipulative therapies for infantile colic. Six RCTs of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions were included with a total of 325 infants. Of the 6 included studies, 5 were “suggestive of a beneficial effect” and one found no evidence of benefit. Combining all the RCTs suggested that manipulative therapies had a significant effect. The average crying time was reduced by an average of 72 minutes per day. This effect was sustained for studies with a low risk of selection bias and attrition bias. When analysing only those studies with a low risk of performance bias (i.e. parental blinding) the improvement in daily crying hours was no longer statistically significant.

The quality of the studies was variable. There was a generally low risk of selection bias but a high risk of performance bias. Only one of the studies recorded adverse events and none were encountered.

From these data, the authors drew the following conclusion: Parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not and this difference was statistically significant. Most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias the results did not reach statistical significance.

Does that mean that chiropractic does work for infant colic? No, it does not!

The first thing to point out is that the new systematic review included not just RCTs of chiropractic but also osteopathy and cranio-sacral therapy.

The second important issue is that the effects disappear, once performance bias is being accounted for which clearly shows that the result is false positive.

The third relevant fact is that the majority of the RCTs were of poor quality. The methodologically best studies were negative.

And the fourth thing to note is that only one study mentioned adverse effects, which means that the other 5 trials were in breach of one of rather elementary research ethics.

What makes all of this even more fascinating is the fact that the senior author of the new publication, George Lewith, is the very expert who advised the BCA in their libel case against Simon Singh. He seems so fond of his work that he even decided to re-publish it using even more misleading language than before. It is, of course, far from me to suggest that his review was an attempt to white-wash the issue of chiropractic ‘bogus’ claims. However, based on the available evidence, I would have formulated conclusions which are more than just a little different from his; something like this perhaps:

The current best evidence suggests that the small effects that emerge when we pool the data from mostly unreliable studies are due to bias and therefore not real. This systematic review therefore fails to show that manipulative therapies are effective. It furthermore points to a serious breach of research ethics by the majority of researchers in this field.

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