MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

1 2 3 15

Dietary supplements (DS) are heavily promoted usually with the claim that they have stood the test of time and that they are natural and hence harmless. Unsurprisingly, their use has become very wide-spread. A new study determined the use of DSs, factors associated with DS use, and reasons for use among U.S. college students.

College students (N = 1248) at 5 U.S. universities were surveyed. Survey questions included descriptive demographics, types and frequency of DS used, reasons for use and money spent on supplements. Supplements were classified using standard criteria. Logistic regression analyses examined relationships between demographic and lifestyle factors and DS use.

Sixty-six percent of college students surveyed used DS at least once a week, and 12% consumed 5 or more supplements a week. Forty-two percent used multivitamins/multiminerals, 18% vitamin C, 17% protein/amino acids and 13% calcium at least once a week. Factors associated with supplement use included dietary patterns, exercise, and tobacco use. Students used supplements to promote general health (73%), provide more energy (29%), increase muscle strength (20%), and enhance performance (19%).

The authors of this survey concluded that college students appear more likely to use DS than the general population and many use multiple types of supplements weekly. Habits established at a young age persist throughout life. Therefore, longitudinal research should be conducted to determine whether patterns of DS use established early in adulthood are maintained throughout life. Adequate scientific justification for widespread use of DS in healthy, young populations is lacking.

Another new study investigated the use of DSs in 334 dancers from 53 countries, who completed a digitally based 35-question survey detailing demographic information and the use of DSs. Supplement use was prevalent amongst this international cohort, with 48% reporting regular DSs use. Major motives for supplement use were to improve health, boost immunity, and reduce fatigue. Forty-five percent believed that dancing increased the need for supplementation, whilst 30% recognized that there were risks associated with DSs.

The most frequently consumed DSs were vitamin C (60%), multivitamins (67%), and caffeine (72%). A smaller group of participants declared the use of whey protein (21%) or creatine (14%). Supplements were mainly obtained from pharmacies, supermarkets, and health-food stores. Dancers recognized their lack of knowledge in DSs use and relied on peer recommendations instead of sound evidence-based advice from acknowledged nutrition or health care professionals.

The authors concluded that this study demonstrates that DSs use is internationally prevalent amongst dancers. Continued efforts are warranted with regard to information dissemination.

Finally, a third study investigated use of DSs in patients in Japan. This survey was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about DSs. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using DSs, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses.

The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used DSs to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using DSs concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention DSs use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with DSs.

The authors concluded that communication between patients and physicians is important to avoid health problems associated with the use of DSs.

There is little doubt, DSs are popular with all sorts of populations and have grown into a multi billion dollar industry. There is also no doubt that the use of only very few DSs are evidence-based (and if so, in only relatively rare situations). And there can be no doubt that many DSs can do harm. What follows is simple: for the vast majority of DSs the benefits do not demonstrably out-weigh the risks.

If that is true, we have to ask ourselves: Why are they so popular?

The answer, I think, is because of the very phenomenon I am constantly trying to fight on this blog – IRRESPONSIBLE CHARLATANS PULLING WOOL OVER CONSUMERS EYES.

Guest post by Pete Attkins

Commentator “jm” asked a profound and pertinent question: “What DOES it take for people to get real in this world, practice some common sense, and pay attention to what’s going on with themselves?” This question was asked in the context of asserting that personal experience always trumps the results of large-scale scientific experiments; and asserting that alt-med experts are better able to provide individulized healthcare than 21st Century orthodox medicine.

What does common sense and paying attention lead us to conclude about the following? We test a six-sided die for bias by rolling it 100 times. The number 1 occurs only once and the number 6 occurs many times, never on its own, but in several groups of consecutive sixes.

I think it is reasonable to say that common sense would, and should, lead everyone to conclude that the die is biased and not fit for its purpose as a source of random numbers.

In other words, we have a gut feeling that the die is untrustworthy. Gut instincts and common sense are geared towards maximizing our chances of survival in our complex and unpredictable world — these are innate and learnt behaviours that have enabled humans to survive despite the harshness of our ever changing habitat.

Only very recently in the long history of our species have we developed specialized tools that enable us to better understand our harsh and complex world: science and critical thinking. These tools are difficult to master because they still haven’t been incorporated into our primary and secondary formal education systems.

The vast majority of people do not have these skills therefore, when a scientific finding flies in the face of our gut instincts and/or common sense, it creates an overwhelming desire to reject the finding and classify the scientist(s) as being irrational and lacking basic common sense. It does not create an intense desire to accept the finding then painstakingly learn all of the science that went into producing the finding.

With that in mind, let’s rethink our common sense conclusion that the six-sided die is biased and untrustworthy. What we really mean is that the results have given all of us good reason to be highly suspicious of this die. We aren’t 100% certain that this die is biased, but our gut feeling and common sense are more than adequate to form a reasonable mistrust of it and to avoid using it for anything important to us. Reasons to keep this die rather than discard it might be to provide a source of mild entertainment or to use its bias for the purposes of cheating.

Some readers might be surprised to discover at this point that the results I presented from this apparently heavily-biased die are not only perfectly valid results obtained from a truly random unbiased die, they are to be fully expected. Even if the die had produced 100 sixes in that test, it would not confirm that the die is biased in any way whatsoever. Rolling a truly unbiased die once will produce one of six possible outcomes. Rolling the same die 100 times will produce one unique sequence out of the 6^100 (6.5 x 10^77) possible sequences: all of which are equally valid!

Gut feeling plus common sense rightfully informs us that the probability of a random die producing one hundred consecutive sixes is so incredibly remote that nobody will ever see it occur in reality. This conclusion is also mathematically sound: if there were 6.5 x 10^77 people on Earth, each performing the same test on truly random dice, there is no guarantee that anyone would observe a sequence of one hundred consecutive sixes.

When we observe a sequence such as 2 5 1 4 6 3 1 4 3 6 5 2… common sense informs us that the die is very likely random. If we calculate the arithmetic mean to be very close to 3.5 then common sense will lead us to conclude that the die is both random and unbiased enough to use it as a reliable source of random numbers.

Unfortunately, this is a perfect example of our gut feelings and common sense failing us abysmally. They totally failed to warn us that the 2 5 1 4 6 3 1 4 3 6 5 2… sequence we observed had exactly the same (im)probability of occurring as a sequence of one hundred 6s or any other sequence that one can think of that doesn’t look random to a human observer.

The 100-roll die test is nowhere near powerful enough to properly test a six-sided die, but this test is more than adequately powered to reveal some of our cognitive biases and some of the deficits in our personal mastery of science and critical thinking.

To properly test the die we need to provide solid evidence that it is both truly random and that its measured bias tends towards zero as the number of rolls tends towards infinity. We could use the services of one testing lab to conduct billions of test rolls, but this would not exclude errors caused by such things as miscalibrated equipment and experimenter bias. It is better to subdivide the testing across multiple labs then carefully analyse and appropriately aggregate the results: this dramatically reduces errors caused by equipment and humans.

In medicine, this testing process is performed via systematic reviews of multiple, independent, double-blind, placebo-controlled trials — every trial that is insufficiently powered to add meaningfully to the result is rightfully excluded from the aggregation.

Alt-med relies on a diametrically opposed testing process. It performs a plethora of only underpowered tests; presents those that just happen to show a positive result (just as a random die could’ve produced); and sweeps under the carpet the overwhelming number of tests that produced a negative result. It publishes only the ‘successes’, not its failures. By sweeping its failures under the carpet it feels justified in making the very bold claim: Our plethora of collected evidence shows clearly that it mostly ‘works’ and, when it doesn’t, it causes no harm.

One of the most acidic tests for a hypothesis and its supporting data (which is a mandatory test in a few branches of critical engineering) is to substitute the collected data for random data that has been carefully crafted to emulate the probability mass functions of the collected datasets. This test has to be run multiple times for reasons that I’ve attempted to explain in my random die example. If the proposer of the hypothesis is unable to explain the multiple failures resulting from this acid test then it is highly likely that the proposer either does not fully understand their hypothesis or that their hypothesis is indistinguishable from the null hypothesis.

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

A German homeopathic journal, Zeitschrift Homoeopathie, has just published the following interesting article entitled HOMEOPATHIC DOCTORS HELP IN LIBERIA. It provides details about the international team of homeopaths that travelled to Liberia to cure Ebola. Here I take the liberty of translating it from German into English. As most of it is fairly self-explanatory, I abstain from any comments of my own – however, I am sure that my readers will want to add their views.

In mid-October, an international team of 4 doctors travelled to the West African country for three weeks. The mission in a hospital in Ganta, a town with about 40 000 inhabitants on the border to Guinea, ended as planned on 7 November. The exercise was organised by the World Association of Homeopathic Doctors, the Liga Medicorum Homoeopathica Internationalis (LMHI), with support of by the German Central Association of Homeopathic Doctors. The aim was to support the local doctors in the care of the population and, if possible, also to help in the fight against the Ebola epidemic. The costs for the three weeks’ stay were financed mostly through donations from homeopathic doctors.

“We know that we were invited mainly as well-trained doctors to Liberia, and that or experience in homeopathy was asked for only as a secondary issue”, stresses Cornelia Bajic, first chairperson of the DZVhA (German Central Association of Homeopathic Doctors). The doctors from India, USA, Switzerland and Germany were able to employ their expertise in several wards of the hospital, to help patients, and to support their Liberian colleagues. It was planned to use and document the homeopathic treatment of Ebola-patients as an adjunct to the WHO prescribed standard treatment. “Our experience from the treatment of other epidemics in the history of medicine allows the conclusion that a homeopathic treatment might significantly reduce the mortality of Ebola patients”, judges Bajic. The successful use of homeopathic remedies has been documented for example in Cholera, Diphtheria or Yellow Fever.

Overview of the studies related to the homeopathic treatment of epidemics

In Ganta, the doctors of the LMHI team treated patients with “at times most serious diseases, particularly inflammatory conditions, children with Typhus, meningitis, pneumonias, and unclear fevers – each time only under the supervision of the local doctor in charge”, reports Dr Ortrud Lindemann, who also worked obstetrically in Ganta. The medical specialist reports after her return: “When we had been 10 days in the hospital, the successes had become known, and the patients stood in queues to get treated by us.” The homeopathic doctors received thanks from the Ganta hospital for their work, it was said that it had been helpful for the patients and a blessing for the employees of the hospital.

POLITICAL CONSIDERATIONS MORE IMPORTANT THAN MEDICAL TREATMENT? 

This first LMHI team of doctors was forbidden to care for patients from the “Ebola Treatment Unit”. The decision was based on an order of the WHO. A team of Cuban doctors was also waiting in vain for being allowed to work. “We are dealing here with a dangerous epidemic and a large number of seriously ill patients. And despite a striking lack of doctors in West Africa political considerations are more important than the treatment of these patients”, criticises the DZVhA chairperson Bajic. Now a second team is to travel to Ganta to support the local doctors.

The volume of medical research, as listed on Medline, is huge and increases steadily each year. This phenomenon can easily be observed with simple Medline searches. If we use search terms related to conventional medicine, we find near linear increases in the number of articles (here I do not make a distinction between types of articles) published in each area over time, invariably with a peak in 2013, the last year for which Medline listing is currently complete. Three examples will suffice:

PHARMACOTHERAPY        117 414 articles in 2013

PHARMACOLOGY               210 228 articles in 2013

ADVERSE EFFECTS              86 067 articles in 2013

Some of the above subjects are obviously heavily industry-dependent and thus perhaps not typical of the volume of research in health care generally. Let’s therefore look up three fields where there is no such powerful industry to support research:

PSYCHOTHERAPY              7 208 articles in 2013

PHYSIOTHERAPY                7 713 articles in 2013

SURGERY                           154 417 articles in 2013

Now, if we conduct similar searches for topics related to alternative medicine, the picture changes in at least three remarkable ways: 1) there is no linear increase of the volume per year; instead the curves look flat and shapeless (the only exception is ‘herbal medicine’ where the increase even looks exponential). 2) The absolute volume does not necessarily peak in 2013 (exceptions are ‘acupuncture’ and ‘herbal medicine’). 3) The number of articles in the year with the most articles (as listed below) is small or even tiny:

ACUPUNCTURE                    1 491 articles in 2013

CHIROPRACTIC                      283 articles in 2011

HERBAL MEDICINE           2 503 articles in 2013

HOMEOPATHY                        233 articles in 2005

NATUROPATHY                         69 articles in 2010

You may think: so what? But I find these figures intriguing. They demonstrate that the research output in alternative medicine is minimal compared to that in conventional medicine.  Moreover, they imply that this output is not only not increasing steadily, as it is in conventional medicine, but in the case of chiropractic, homeopathy and naturopathy, it has recently been decreasing.

To put this into context, we need to know that:

  1. there is a plethora of journals dedicated to alternative medicine which are keen to publish all sorts of articles,
  2. the peer-review process of most of these journals seems farcically poor,
  3. as a result, the quality of the research into alternative medicine is often dismal, as regularly disclosed on this blog,
  4. enthusiasts of alternative medicine often see rigorous research into their subject as a dangerous threat: it might disprove their prior beliefs.

In their defence, proponents of alternative medicine would probably claim that the low volume of research is due to a severe and unfair lack of funding. However, I fail to see how this can be the sole or even the main explanation: areas of conventional medicine that do not have industry support seem to manage a much higher output than alternative medicine (and I should stress that I have chosen 5 sections within alternative medicine that are associated with the highest number of articles per year). Research in these areas is usually sponsored by charitable and government sources, and it needs to be stressed that these are open to any researcher who submits good science.

What follows, I think, is simple: in general, alternative medicine advocates have little interest in research and even less expertise to conduct it.

Reiki is a form of energy healing that evidently has been getting so popular that, according to the ‘Shropshire Star’, even stressed hedgehogs are now being treated with this therapy. In case you argue that this publication is not cutting edge when it comes to reporting of scientific advances, you may have a point. So, let us see what evidence we find on this amazing intervention.

A recent systematic review of the therapeutic effects of Reiki concludes that the serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness. High-quality randomized controlled trials are needed to address the effectiveness of Reiki over placebo. Considering that this article was published in the JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, this is a fairly damming verdict. The notion that Reiki is but a theatrical placebo recently received more support from a new clinical trial.

This pilot study examined the effects of Reiki therapy and companionship on improvements in quality of life, mood, and symptom distress during chemotherapy. Thirty-six breast cancer patients received usual care, Reiki, or a companion during chemotherapy. Data were collected from patients while they were receiving usual care. Subsequently, patients were randomized to either receive Reiki or a companion during chemotherapy. Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4. Reiki was rated relaxing and caused no side effects. Both Reiki and companion groups reported improvements in quality of life and mood that were greater than those seen in the usual care group.

The authors of this study conclude that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.

This is an odd conclusion, if there ever was one. Clearly the ‘companionship’ group was included to see whether Reiki has effects beyond simply providing sympathetic attention. The results show that this is not the case. It follows, I think, that Reiki is a placebo; its perceived relaxing effects are the result of non-specific phenomena which have nothing to do with Reiki per se. The fact that the authors fail to spell this out more clearly makes me wonder whether they are researchers or promoters of Reiki.

Some people will feel that it does not matter how Reiki works, the main thing is that it does work. I beg to differ!

If its effects are due to nothing else than attention and companionship, we do not need ‘trained’ Reiki masters to do the treatment; anyone who has time, compassion and sympathy can do it. More importantly, if Reiki is a placebo, we should not mislead people that some super-natural energy is at work. This only promotes irrationality – and, as Voltaire once said: those who make you believe in absurdities can make you commit atrocities.

After yesterday’s post mentioning ‘biopuncture’, I am sure you are all dying to know what this mysterious treatment might be. A website promoting biopuncture tells us (almost) all we need to know:

Biopuncture is a therapy whereby specific locations are injected with biological products. The majority of the products are derived from plants. Most of these injections are given into the skin or into muscles. Products commonly used in Biopuncture are, for example, arnica, echinacea, nux vomica and chamomile. Arnica is used for muscle pain, nux vomica is injected for digestive problems, echinacea is used to increase the natural defense system of the body. Biopuncturists always inject cocktails of natural products. Lymphomyosot is used for lymphatic drainage, Traumeel for inflammations and sports injuries, Spascupreel for muscular cramps. Injections with antiflogistics, hyaluronic acid, blood platelets, blood, procaine, ozon, cortisone or vitamin B are not considered as Biopuncture…

How can such a small dose influence your body and stimulate healing? Scientists don’t have the final proof yet, but they postulate that these injections are working through the stimulation of the immune system (which is in fact your defense system). Let’s compare it with a vaccination. When you receive a tetanus vaccination, only small amounts of a particular product are necessary to stimulate the immune system against lockjaw. In other words, just a few injections can protect your body for years…

An important issue in Biopuncture is the detoxification of the body. It literally means “cleaning the body” from all the toxins that have accumulated: for example from the environment (air pollution, smoking), from bad nutrition, or from medication (e.g., antibiotics and steroids you’ve taken). These toxins can block your defense system. Some injections work specifically on the liver and others on the kidneys. Cleaning up the lymphatic system with Lymphomyosot is considered very important in Biopuncture. It is like taking the leaves out of the gutter. The down side of such an approach is that old symptoms (which have been suppressed earlier on) may come to the surface again. But that is sometimes part of the healing strategy of the body…

That sounds strange, to say the least. But remember: strange treatments might still work! The question is therefore: IS BIOPUNCTURE AN EFFECTIVE THERAPY? If you ask it to Dr Oz, the answer would be a resounding YES – but let’s not ask Oz, let’s try to find some reliable evidence instead. In my quest to locate such evidence, I came across claims like these.

Examples of some acute conditions we treat with biopuncture: 

  • Knee and ankle sprains
  • Muscle sprains- quadriceps, hamstring, adductors, rotator cuff
  • Whiplash 

Examples of some chronic conditions we treat with biopuncture: 

  • Headaches
  • Achilles tendinitis
  • Tennis elbow
  • Chronic arthritis of the knee, hip, shoulder
  • Back pain
  • Myofascial pains
  • Irritable bowel syndrome
  • TMJ syndrome

Somehow I had the feeling that this was more than a little too optimistic, and I decided to conduct a rudimentary Medline search. The results were sobering indeed: not a single clinical trial seems to be available that supports any of the claims that are being made for biopuncture.

So, what should we conclude? I don’t know about you, but to me it seems that biopuncture is quackery at its purest.

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.

Rigorous research into the effectiveness of a therapy should tell us the truth about the ability of this therapy to treat patients suffering from a given condition — perhaps not one single study, but the totality of the evidence (as evaluated in systematic reviews) should achieve this aim. Yet, in the realm of alternative medicine (and probably not just in this field), such reviews are often highly contradictory.

A concrete example might explain what I mean.

There are numerous systematic reviews assessing the effectiveness of acupuncture for fibromyalgia syndrome (FMS). It is safe to assume that the authors of these reviews have all conducted comprehensive searches of the literature in order to locate all the published studies on this subject. Subsequently, they have evaluated the scientific rigor of these trials and summarised their findings. Finally they have condensed all of this into an article which arrives at a certain conclusion about the value of the therapy in question. Understanding this process (outlined here only very briefly), one would expect that all the numerous reviews draw conclusions which are, if not identical, at least very similar.

However, the disturbing fact is that they are not remotely similar. Here are two which, in fact, are so different that one could assume they have evaluated a set of totally different primary studies (which, of course, they have not).

One recent (2014) review concluded that acupuncture for FMS has a positive effect, and acupuncture combined with western medicine can strengthen the curative effect.

Another recent review concluded that a small analgesic effect of acupuncture was present, which, however, was not clearly distinguishable from bias. Thus, acupuncture cannot be recommended for the management of FMS.

How can this be?

By contrast to most systematic reviews of conventional medicine, systematic reviews of alternative therapies are almost invariably based on a small number of primary studies (in the above case, the total number was only 7 !). The quality of these trials is often low (all reviews therefore end with the somewhat meaningless conclusion that more and better studies are needed).

So, the situation with primary studies of alternative therapies for inclusion into systematic reviews usually is as follows:

  • the number of trials is low
  • the quality of trials is even lower
  • the results are not uniform
  • the majority of the poor quality trials show a positive result (bias tends to generate false positive findings)
  • the few rigorous trials yield a negative result

Unfortunately this means that the authors of systematic reviews summarising such confusing evidence often seem to feel at liberty to project their own pre-conceived ideas into their overall conclusion about the effectiveness of the treatment. Often the researchers are in favour of the therapy in question – in fact, this usually is precisely the attitude that motivated them to conduct a review in the first place. In other words, the frequently murky state of the evidence (as outlined above) can serve as a welcome invitation for personal bias to do its effect in skewing the overall conclusion. The final result is that the readers of such systematic reviews are being misled.

Authors who are biased in favour of the treatment will tend to stress that the majority of the trials are positive. Therefore the overall verdict has to be positive as well, in their view. The fact that most trials are flawed does not usually bother them all that much (I suspect that many fail to comprehend the effects of bias on the study results); they merely add to their conclusions that “more and better trials are needed” and believe that this meek little remark is sufficient evidence for their ability to critically analyse the data.

Authors who are not biased and have the necessary skills for critical assessment, on the other hand, will insist that most trials are flawed and therefore their results must be categorised as unreliable. They will also emphasise the fact that there are a few reliable studies and clearly point out that these are negative. Thus their overall conclusion must be negative as well.

In the end, enthusiasts will conclude that the treatment in question is at least promising, if not recommendable, while real scientists will rightly state that the available data are too flimsy to demonstrate the effectiveness of the therapy; as it is wrong to recommend unproven treatments, they will not recommend the treatment for routine use.

The difference between the two might just seem marginal – but, in fact, it is huge: IT IS THE DIFFERENCE BETWEEN MISLEADING PEOPLE AND GIVING RESPONSIBLE ADVICE; THE DIFFERENCE BETWEEN VIOLATING AND ADHERING TO ETHICAL STANDARDS.

“Dr” Brian Moravec is a chiropractor from the US; he has a website where he describes himself and his skills as follows: I attended Chiropractic College and I am a graduate of Palmer College of Chiropractic in Davenport Iowa. I earned a Bachelor of Science degree as well as my Doctor of Chiropractic degree from Palmer College, which is the first chiropractic college in the world and the origin of our profession. I also attend continuing education seminars designed to keep doctors current with regard to clinical chiropractic, technique and nutrition.

The key to overall health and wellness is to have a healthy nervous system and that is what I do as a chiropractor – I make sure that your spine is functioning at its best so that your nervous system functions at its best. When the nervous system is functioning at 100%, you are a healthier individual that experiences a higher quality of life and health. I know this to be true in myself, my family and my patients.

I go to great lengths to provide my patients with the best chiropractic care I can give. I work with my patients to design a treatment plan that will be effective for their particular condition and specific to their needs. We utilize manual and low force techniques (safe and effective for newborns to seniors), to correct sublaxations in the spine. Chiropractic adjustments remove nerve interference, which allows the body to perform at its best again. I also am available for consultations on nutrition and diet, dietary supplementation and how to minimize the wear and tear on your spine.

[Emphases are mine]

What he does not state is the fact that he also is a nifty e-mail writer!

To my great surprise, I received an e-mail from him which is far too good to be kept for myself. So I decided to share it with my readers; here it is in its full and unabbreviated beauty:

its interesting to see someone with your education, and is a self proclaimed “expert” on alternative medicine, promote so much misinformation with regard to chiropractic care.   fortunately you look old.  and soon will be gone.  I always refer to the few of you anti chiropractic fools left here as “dinosaurs”.   the proof is in the pudding my “friend”.  chiropractic works and will continue to be here for centuries more.   you and others with much much more power than you (the AMA for example) have tried to perpetuate lies and squash chiropractic.  you fail, and they failed, because whatever better serves mankind will stand the test of time.   you’re a dying breed edzard.  thank God.
yours in health,

brian moravec d.c.

I am encouraged to see that he recognises my education but do wonder why his upbringing obviously failed so dismally teach him even a minimum of politeness, tact, or critical thinking. It is disappointing, I think, that he does not even mention what he perceives as my lies about his beloved chiropractic. So sad, I am sure it would have been fun to debate with him.

1 2 3 15
Recent Comments
Click here for a comprehensive list of recent comments.
Categories