MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bogus claims

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How many times have we heard from practitioners of alternative medicine, particularly chiropractors, that their patients are more severely ill than those of conventional clinicians. The claim is usually that they have tried all that conventional medicine can offer and eventually, as a last resort, they turn to the alternatives.

But is this true? If so, it would explain why these patients do no better or even worse than those treated conventionally.

Here is a new article that goes some way in addressing these issues.

For this study, Danish chiropractors and general practitioners recruited adult patients seeking care for low back pain (LBP). Extensive baseline questionnaires were obtained and descriptive analyses were performed to define the differences between the two populations.

Questionnaires were returned from 934 patients in chiropractic practice and 319 patients from general practice. Four out of five patients had previous episodes, one-fourth were on sick leave, and the LBP considerably limited daily activities. The general practice patients were slightly older and less educated, more often female, and generally worse on all disease-related parameters than chiropractic patients. All the disease specific parameters showed a statistically significant difference between general and chiropractic practice. Patients in general practice were generally more severely affected. They had higher pain intensity (mainly for leg pain), longer pain duration, more previous episodes, more sick leave, more activity limitation on the disability scale, slightly higher level of depression, slightly more fear-avoidance beliefs, and a poorer self-reported general health. All these differences were statistically significant.

The authors concluded that LBP in primary care was recurrent, causing sick leave and activity limitations. There were clear differences between the chiropractic and general practice populations in this study.

I know, I know: these findings are from Denmark and therefore they cannot be generalised to other countries. However, the authors point out that similar findings have been reported from the US. Furthermore the observations relate to chiropractors and must not be applied to other alternative practitioners. Nevertheless they do show that, in this specific scenario, patients opting for the alternative are not more but less severely ill.

The next time an alternative practitioner claims ‘my patients have worse outcomes because they are sicker’, I will insist on seeing the evidence before I believe it.

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.

Naturopathy can be defined as ‘an eclectic system of health care that uses elements of complementary and conventional medicine to support and enhance self-healing processes’. This basically means that naturopaths employ treatments based on those therapeutic options that are seen as natural, e. g. herbs, water, exercise, diet, fresh air, heat and cold – but occasionally also acupuncture, homeopathy and manual therapies. If you are tempted to see a naturopath, you might want to consider the following 7 points:

  1. In many countries, naturopathy is not a protected title; this means your naturopaths may have some training but this is not obligatory. Some medical doctors also practice naturopathy, and in some countries there are ‘doctors of naturopathy’ (these practitioners tend to see themselves as primary care physicians but they have not been to medical school).
  2. Naturopathy is steeped in the obsolete concept of vitalism which has been described as the belief that “living organisms are fundamentally different from non-living entities because they contain some non-physical element or are governed by different principles than are inanimate things.”
  3. While there is some evidence to suggest that some of the treatments used by naturopaths are effective for treating some conditions, this is by no means the case for all of the treatments in question.
  4. Naturopathy is implicitly based on the assumption that natural means safe. This notion is clearly wrong and misleading: not all the treatments used by naturopaths are strictly speaking natural, and very few are totally free of risks.
  5. Many naturopaths advise their patients against conventional treatments such as vaccines or antibiotics.
  6. Naturopaths tend to believe they can cure all or most diseases. Consequently many of the therapeutic claims for naturopathy found on the Internet and elsewhere are dangerously over-stated.
  7. The direct risks of naturopathy depend, of course, on the modality used; some of them can be considerable. The indirect risks of naturopathy can be even more serious and are mostly due to naturopathic treatments replacing more effective conventional therapies in cases of severe illness.

Aromatherapy is one of the most popular of all alternative therapies. It is most certainly a very agreeable experience. But is it more that a bit of pampering? Does it cure any diseases?

If you believe aromatherapists, their treatment is effective for almost everything. And, of course, there are studies to suggest that, indeed, it works for several conditions. But regular readers of this blog will by now know that it is a bad idea to go by just one single trial; we always must rely on the totality of the most reliable evidence. In other words, we must look for systematic reviews. Recently, such an article has been published.

The aim of this review was to systematically assess the effectiveness of aromatherapy for stress management. Seven databases were searched from their inception through April 2014. RCTs testing aromatherapy against any type of control intervention in healthy but stressed persons assessing stress and cortisol levels were considered. Two reviewers independently performed the selection of the studies, data abstraction and validations. The risk of bias was assessed using Cochrane criteria.

Five RCTs met the authors’ inclusion criteria. Most of the RCTs had high risk of bias. Four RCTs tested the effects of aroma inhalation compared with no treatment, no aroma, and no odour oil. The meta-analysis of these data suggested that aroma inhalation had favourable effects on stress management. Three RCTs tested aroma inhalation on saliva or serum cortisol level compared to controls, and the meta-analysis of these data failed to show significant difference between two groups

The authors concluded that there is limited evidence suggesting that aroma inhalation may be effective in controlling stress. However, the number, size and quality of the RCTs are too low to draw firm conclusions.

This is by no means the only systematic review of this area. In fact, there are so many that, in 2012, we decided to do an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Our conclusion: due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.

So, what does all of this mean? I think it indicates that most of the claims made by aromatherapists are not evidence-based. Or, to express it differently: aromatherapy is hardly more than a bit of old-fashioned pampering – nothing wrong with that, of course, as long as you don’t fall for the hype of those who promote it.

This investigation was aimed at examining the messages utilised by the chiropractic profession around issues of scope and efficacy through website communication with the public. For this purpose, the authors submitted the website content of 11 major Canadian chiropractic associations and colleges, and of 80 commercial clinics to a mixed-methods analysis. Content was reviewed to quantify specific health conditions described as treatable by chiropractic care. A qualitative textual analysis identified the primary messages related to evidence and efficacy utilised by the websites.

The results show that chiropractic was claimed to be capable of addressing a wide range of health issues. Quantitative analysis revealed that association and college websites identified a total of 41 unique conditions treatable by chiropractic, while private clinic websites named 159 distinct conditions. The most commonly cited conditions included back pain, headaches/migraines and neck pain. Qualitative analysis revealed three prominent themes drawn upon in discussions of efficacy and evidence: grounded in science, the conflation of safety and efficacy and “natural” healing.

The authors concluded that the chiropractic profession claims the capacity to treat health conditions that exceed those more traditionally associated with chiropractic. Website content persistently declared that such claims are supported by research and scientific evidence, and at times blurred the lines between safety and efficacy. The chiropractic profession may be struggling to define themselves both within the paradigm of conventional science as well as an alternative paradigm that embraces natural approaches.

These findings strike me as being similar to the ones we published 4 years ago. At this stage, we had conducted a review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States. The outcome measures were claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment: asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain.

At the time, we concluded that the majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

Comparing the two studies, what should we conclude? Of course, the new investigation was confined to Canada; we therefore cannot generalise its results to other countries. Nevertheless it provides a fascinating insight into the (lack of) development of chiropractic in this part of the world. My conclusion is that, at least in Canada, there is very little evidence that chiropractic is about to become an ethical and evidence-based profession.

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.

Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.

  1. Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
  2. We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
  3. Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
  4. The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
  5. The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
  6. Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
  7. Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.

While the previous post was about seeing a traditional herbalist (who prescribe their own herbal mixtures, tailor-made for each individual patient), this post provides essential information for those consumers who are tempted to take a commercially available herbal remedy available in pharmacies, health food shops, over the Internet etc. These remedies are usually bought by consumers and then be self-administered, or (less frequently) they might be prescribed/recommended/sold by a clinician such as a doctor, naturopath, chiropractor etc. Typically, they contain just one (or relatively few) herbal extracts and are used under similar assumptions as conventional medicines: one (hopefully well-tested) remedy is employed for treating a defined condition, diagnosed according to validated and generally accepted criteria (for instance, St John’s Wort for depression or Devil’s claw for back pain). This approach is sometimes referred to as ‘rational phytotherapy’ – it is certainly more rational than the traditional herbalism referred to in my previous post. The manufacture, promotion and sale of commercial herbal remedies (in many countries marketed as ‘dietary supplements’) has grown into a multi-billion dollar industry.

Here are a few essentials you ought to know before you decide to take such an herbal remedy:

  1. Many people claim that herbal medicine is effective because many of our modern drugs are based on plants. The latter part of this claim is true, of course, but this does not necessarily mean that herbal remedies are effective. The drugs derived from plants contain one single, well-defined, extensively researched molecule (by definition, this makes them conventional drugs and not herbal remedies), while herbal remedies are based on entire (parts of) plants; thus they contain many pharmacologically active molecules. This often means that it is difficult or impossible to tell what dose of which ingredient is being administered and what pharmacological actions can be expected.
  2. Even though national regulations differ greatly, herbal remedies generally do not have to be supported by evidence for efficacy in order to be legally available. This means that a given remedy might or might not have been tested in clinical trials to determine whether it works for the condition advertised. In fact, only very few (less than 30, I estimate) herbal remedies are supported by sound evidence for efficacy; thousands do not meet this criterion.
  3. The extremely wide-spread notion that herbal remedies are by definition natural and therefore safe is nothing but a promotional myth. Plants contain many chemicals which can have pharmacological activity. This means they might be therapeutic, but it also means that they might be toxic (traditionally the most powerful poisons originated from the plant kingdom). If anyone uses the ‘natural = safe fallacy’ remind him/her of hemlock, poison ivy etc.
  4. In addition to potential toxicity of an herbal ingredient, there are other important safety issues to be considered. Most importantly, herbal remedies can interact with prescribed medicines. For instance, St John’s Wort (one of the best-studied herbal remedies in this respect) powerfully interacts with about 50% of all prescription drugs – in fact, it lowers their level in the blood which means that a patient on anti-coagulants would lose her anti-coagulant protection and might suffer from a (potentially fatal) blood clot.
  5. In many countries, including the US, the regulation of herbal remedies is so lax, that there is no guarantee that an herbal remedy which is being legally sold is safe. The regulators are only allowed to intervene once there are reports of adverse effects. This means that the burden of proof of safety is effectively reversed which obviously exposes consumers to incalculable risks.
  6. The quality of the herbal product is equally poorly regulated in most countries. A plethora of investigations in the US, for instance, has shown that the dose of the herbal ingredient printed on the label of a commercial product can range virtually from 0 – 100%. Similarly there is little safe-guard that the ingredients listed on the label correspond to the ones in the preparation. This means that it is worth purchasing not just well-researched herbal remedies but also those marketed by high quality manufacturers via respectable outlets.
  7. Any regulation of herbal remedies, even the European one that is often praised as protecting consumers adequately, is null and void once consumers go on the Internet and purchase their herbal remedies from one of the many dubious sources found there in truly alarming profusion. Bogus claims, inferior quality and even outright dangerous products abound, and it is often impossible to tell the acceptable from the fraudulent product.

I recently tweeted the following short text: “THIS IS HOW HOMEOPATHY CAN KILL MILLIONS” and provided a link to a website where a homeopaths advocated using homeopathy to control blood sugar levels in diabetic patients. The exact text I objected to is reproduced below:

“Management of Blood sugar

The commonly used remedies are Uranium Nitricum, Phosphoric Acid, Syzygium Jambolanum, Cephalandra Indica etc. These are classical Homeopathic remedies. These are used in physiologically active doses such as Mother tincture, 3x etc. depending up on the level of the blood sugar and the requirement of the patient. Several pharmaceutical companies have also brought in propriety medicines with a combination of the few Homeopathic medicines. Biochemic remedies which is a part of Homeopathy advocates Biocombination No 7 as a specific for Diabetes. Another Biochemic medicine Natrum Phos 3x is widely used with a reasonable success in controlling the blood sugar. Scientific studies on the impact of homeopathic medicines in bringing down blood sugar are limited, but many of the above remedies have some positive effects either as a stand-alone remedy or as an adjunct along with other medications.”

A clearly annoyed homeopath responded by tweeting: “homeopathy has been a favorite complement to diabetes treatment for over 200 yrs. Your evidence of the contrary is?”

So I better explain to her what I mean, and as this cannot be done in 140 characters, I do it with this post instead.

The claim expressed on the website is not that homeopathy can complement diabetes treatment; the claim is clearly that it can be a sole treatment and a replacement of conventional anti-diabetic treatment. There is, of course, no evidence at all for that. If patients put this claim to the test, many will die. Because there are many millions of diabetics worldwide, this claim has the potential to kill millions. In other words, my initial tweet was perhaps blunt but certainly correct.

Now to the notion of homeopathy as a ‘complement to diabetes treatment': do I have evidence to the contrary? I think that is entirely the wrong question. The true question here is whether homeopaths who claim that homeopathic remedies can be an effective adjunct to conventional anti-diabetic treatments have any evidence for their claim (after all, in health care, as in most other walks of life, it is the one who makes a claim who has to prove it, not the one who doubts it!). So, is there good evidence?

To the best of my knowledge, the answer is NO!

If you disagree, please show me the evidence.

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