MD, PhD, FMedSci, FSB, FRCP, FRCPEd

misleading consumers

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Many experts are critical about the current craze for dietary supplements. Now a publication suggests that it is something that can save millions.

This article examines evidence suggesting that the use of selected dietary supplements can reduce overall disease treatment-related hospital utilization costs associated with coronary heart disease (CHD) in the United States among those at a high risk of experiencing a costly, disease-related event.

Results show that:

  • the potential avoided hospital utilization costs related to the use of omega-3 supplements at preventive intake levels among the target population can be as much as $2.06 billion on average per year from 2013 to 2020. The potential net savings in avoided CHD-related hospital utilization costs after accounting for the cost of omega-3 dietary supplements at preventive daily intake levels would be more than $3.88 billion in cumulative health care cost savings from 2013 to 2020.
  • the use of folic acid, B6, and B12 among the target population at preventive intake levels could yield avoided CHD-related hospital utilization costs savings of an average savings of $1.52 billion per year from 2013 to 2020. The potential net savings in avoided CHD-related health care costs after accounting for the cost of folic acid, B6, and B12 utilization at preventive daily intake levels would be more than $5.23 billion in cumulative health care cost net savings during the same period.

The authors conclude that targeted dietary supplement regimens are recommended as a means to help control rising societal health care costs, and as a means for high-risk individuals to minimize the chance of having to deal with potentially costly events and to invest in increased quality of life.

These conclusions read like a ‘carte blanche’ for marketing all sorts of useless supplements to gullible consumers. I think we should take them with more than a pinch of salt.

To generate results of this nature, it is necessary to make a number of assumptions. If the assumptions are wrong, so will be the results. Furthermore, we should consider that the choice of supplements included was extremely limited and highly selected. Finally, we need to stress that the analysis related to a very specific patient group and not to the population at large. In view of these facts, caution might be advised in taking this analysis as being generalizable.

Because of these caveats, my conclusion would have been quite different: provided that the assumptions underlying these analyses are correct, the use of a small selection of dietary supplements by patients at risk of CHD might reduce health care cost.

Kinesiology tape is all the rage. Its proponents claim that it increases cutaneous stimulation, which facilitates motor unit firing, and consequently improves functional performance. But is this just clever marketing, wishful thinking or is it true? To find out, we need reliable data.

The current trial results are sparse, confusing and contradictory. A recent systematic review indicated that kinesiology tape may have limited potential to reduce pain in individuals with musculoskeletal injury; however, depending on the conditions, the reduction in pain may not be clinically meaningful. Kinesiology tape application did not reduce specific pain measures related to musculoskeletal injury above and beyond other modalities compared in the context of included articles. 

The authors concluded that kinesiology tape may be used in conjunction with or in place of more traditional therapies, and further research that employs controlled measures compared with kinesiology tape is needed to evaluate efficacy.

This need for further research has just been met by Korean investigators who conducted a study testing the true effects of KinTape by a deceptive, randomized, clinical trial.

Thirty healthy participants performed isokinetic testing of three taping conditions: true facilitative KinTape, sham KinTape, and no KinTape. The participants were blindfolded during the evaluation. Under the pretense of applying adhesive muscle sensors, KinTape was applied to their quadriceps in the first two conditions. Normalized peak torque, normalized total work, and time to peak torque were measured at two angular speeds (60°/s and 180°/s) and analyzed with one-way repeated measures ANOVA.

Participants were successfully deceived and they were ignorant about KinTape. No significant differences were found between normalized peak torque, normalized total work, and time to peak torque at 60°/s or 180°/s (p = 0.31-0.99) between three taping conditions. The results showed that KinTape did not facilitate muscle performance in generating higher peak torque, yielding a greater total work, or inducing an earlier onset of peak torque.

The authors concluded that previously reported muscle facilitatory effects using KinTape may be attributed to placebo effects.

The claims that are being made for kinesiology taping are truly extraordinary; just consider what this website is trying to tell us:

Kinesiology tape is a breakthrough new method for treating athletic sprains, strains and sports injuries. You may have seen Olympic and celebrity athletes wearing multicolored tape on their arms, legs, shoulders and back. This type of athletic tape is a revolutionary therapeutic elastic style of support that works in multiple ways to improve health and circulation in ways that traditional athletic tapes can’t compare. Not only does this new type of athletic tape help support and heal muscles, but it also provides faster, more thorough healing by aiding with blood circulation throughout the body.

Many athletes who have switched to using this new type of athletic tape report a wide variety of benefits including improved neuromuscular movement and circulation, pain relief and more. In addition to its many medical uses, Kinesiology tape is also used to help prevent injuries and manage pain and swelling, such as from edema. Unlike regular athletic taping, using elastic tape allows you the freedom of motion without restricting muscles or blood flow. By allowing the muscles a larger degree of movement, the body is able to heal itself more quickly and fully than before.

Whenever I read such over-enthusiastic promotion that is not based on evidence but on keen salesmanship, my alarm-bells start ringing and I see parallels to the worst type of alternative medicine hype. In fact, kinesiology tapes have all the hallmarks of alternative medicine and its promoters have, as far as I can see, all the characteristics of quacks. The motto seems to be: LET’S EARN SOME MONEY FAST AND IGNORE THE SCIENCE WHILE WE CAN.

The UK ‘Society of Homeopaths’ just proudly made this announcement: “From today, patients will be able to choose a homeopath belonging to a register vetted and approved by the Professional Standards Authority for Health and Social Care (PSA). The Society of Homeopaths’ voluntary register has been accredited under a new scheme set up by the Department of Health and administered by an independent body, accountable to Parliament.”

No, it is not April fools day, but it is clearly time to rejoice and to start believing in homeopathy. Not an easy task, you might say; perhaps this new and equally amazing article outlining 10 reasons to love homeopathy will make it a little more feasible (as it is pure comedy gold, I have only shortened it very slightly)?

1. For Love: Love your family, love thy neighbor, love your homeopath. Even if you don’t need a homeopath, your aunt, your grandmother, or grandchild might…

2. For money. Homeopathic medicines are generally less expensive than patent medicines, which have prices driven by profit, not by cost nor benefit…

3. For your bodies, minds, spirits, and communities. Homeopathy works… How is it possible that everyone can find instances where a homeopathic doctor was able to solve a problem…?

4. Because you are royalty. Kings and queens have used homeopathy – with positive effects. The Queen of England, Queen Elizabeth II has a personal physician – a homeopath. She has used homeopathic medicines for her pets as well. If it’s good enough for royalty, it’s good enough for you.

5. Because someday you might need a chiropractor, a Traditional Chinese Medicine Practitioner, Acupuncturist, an Osteopathic Doctor, an Ayurvedic practitioner, or even a midwife. …Attacking homeopathy, suggesting it be banned, is a first step in the wrong direction. Many medical disciplines are attacked independently, with a goal to remove them all from your market, your freedom to choose. If we ban homeopaths, ask yourself – who’s next?

6. For Your Freedoms: Freedom to choose Homeopathy. Freedom to choose your medicines and treatments. There are many who might prefer that you have fewer freedoms, especially those with something to sell. There are many nonsense restrictions on your freedom to choose, and freedoms avoid, specific medical treatments. It’s your body, your mind, your spirit, and your life. You have the right to choose…

7. For your symptoms. The medical model classifies all symptoms as indications of illness. It does not recognize that symptoms can be indications of healthiness, and seldom recognizes that symptoms can be indications of healing or fighting illness. Homeopathy looks at symptoms from a completely different viewpoint… 

8. For your health. Today, it’s illegal to market a product that claims to ‘improves your health’, without reference to illness. All ‘health claims’ must reference ‘a disease or health related condition’. It is illegal to sell a ‘health product’ without a reference to scientific studies of ‘illness’. Medicine, is blind to health. Homeopathy challenges many medical dogmas, opening a door open to a more comprehensive, broader, more clear view of healthiness – not just illness.

9. For your Doctor. Whether your doctor is a homeopath or not, she might need access to homeopathic ideas and medicines. Homeopathy is practiced by many doctors, dentists, naturopaths, chiropractors, acupuncturists, physician assistants, nurses, even veterinarians, and more. If homeopathy is banned, these medical professionals will be limited, or forced to hide their beliefs and activities.

10. For science. Some argue that homeopathy cannot pass the tests of science. These are people who do not understand science. Science does not find truths, it asks questions and seeks answers. The answers it finds, if they are useful, raise higher, more important questions. When science is stifled, when science becomes illegal, we all lose.

This is all so very sweet that I almost hesitate to bring you back to reality. But I have to, this is no blog for dreamers!

Here is a reminder what level-headed, independent and thorough experts have to say about homeopathy; I am sorry, if their statement comes a bit like a cold shower to the irrationalists: the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”

So, what should we make of the UK government’s decision to register homeopaths? Personally, I now look forward to the day when parliament starts discussing the new London airport for flying carpets – but, as always, I look forward to your answers.

Most of the underlying assumptions of alternative medicine (AM) lack plausibility. Whenever this is the case, so the argument put forward by an international team of researchers in a recent paper, there are difficulties involved in obtaining a valid statistical significance in clinical studies.

Using a mostly statistical approach, they argue that, since the prior probability of a research hypothesis is directly related to its scientific plausibility, the commonly used frequentist statistics, which do not account for this probability, are unsuitable for studies exploring matters in various degree disconnected from science. Any statistical significance obtained in this field should be considered with great caution and may be better applied to more plausible hypotheses (like placebo effect) than the specific efficacy of the intervention.

The researchers conclude that, since achieving meaningful statistical significance is an essential step in the validation of medical interventions, AM practices, producing only outcomes inherently resistant to statistical validation, appear not to belong to modern evidence-based medicine.

To emphasize their arguments, the researchers make the following additional points:

  • It is often forgotten that frequentist statistics, commonly used in clinical trials, provides only indirect evidence in support of the hypothesis examined.
  • The p-value inherently tends to exaggerate the support for the hypothesis tested, especially if the scientific plausibility of the hypothesis is low.
  • When the rationale for a clinical intervention is disconnected from the basic principles of science, as in case of complementary alternative medicines, any positive result obtained in clinical studies is more reasonably ascribable to hypotheses (generally to placebo effect) other than the hypothesis on trial, which commonly is the specific efficacy of the intervention.
  • Since meaningful statistical significance as a rule is an essential step to validation of a medical intervention, complementary alternative medicine cannot be considered evidence-based.

Further explanations can be found in the discussion of the article where the authors argue that the quality of the hypothesis tested should be consistent with sound logic and science and therefore have a reasonable prior probability of being correct. As a rule of thumb, assuming a “neutral” attitude towards the null hypothesis (odds = 1:1), a p-value of 0.01 or, better, 0.001 should suffice to give a satisfactory posterior probability of 0.035 and 0.005 respectively.

In the area of AM, hypotheses often are entirely inconsistent with logic and frequently fly in the face of science. Four examples can demonstrate this instantly and sufficiently, I think:

  • Homeopathic remedies which contain not a single ‘active’ molecule are not likely to generate biological effects.
  • Healing ‘energy’ of Reiki masters has no basis in science.
  • Meridians of acupuncture are pure imagination.
  • Chiropractic subluxation have never been shown to exist.

Positive results from clinical trials of implausible forms of AM are thus either due to chance, bias or must be attributed to more credible causes such as the placebo effect. Since the achievement of meaningful statistical significance is an essential step in the validation of medical interventions, unless some authentic scientific support to AM is provided, one has to conclude that AM cannot be considered as evidence-based.

Such arguments are by no means new; they have been voiced over and over again. Essentially, they amount to the old adage: IF YOU CLAIM THAT YOU HAVE A CAT IN YOUR GARDEN, A SIMPLE PICTURE MAY SUFFICE. IF YOU CLAIM THERE IS A UNICORN IN YOUR GARDEN, YOU NEED SOMETHING MORE CONVINCING. An extraordinary claim requires an extraordinary proof! Put into the context of the current discussion about AM, this means that the usual level of clinical evidence is likely to be very misleading as long as it totally neglects the biological plausibility of the prior hypothesis.

Proponents of AM do not like to hear such arguments. They usually insist on what we might call a ‘level playing field’ and fail to see why their assumptions require not only a higher level of evidence but also a reasonable scientific hypothesis. They forget that the playing field is not even to start with; to understand the situation better, they should read this excellent article. Perhaps its elegant statistical approach will convince them – but I would not hold my breath.

Bach Flower Remedies are the brain child of Dr Edward Bach who, as an ex-homeopath, invented his very own highly diluted remedies. Like homeopathic medicines, they are devoid of active molecules and are claimed to work via some non-defined ‘energy’. Consequently, the evidence for these treatments is squarely negative: my systematic review analysed the data of all 7 RCTs of human patients or volunteers that were available in 2010. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. I concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.

But now, a new investigation has become available. The aim of this study was to evaluate the effect of Bach flower Rescue Remedy on the control of risk factors for cardiovascular disease in rats.

A randomized longitudinal experimental study was conducted on 18 Wistar rats which were randomly divided into three groups of six animals each and orogastrically dosed with either 200μl of water (group A, control), or 100μl of water and 100μl of Bach flower remedy (group B), or 200μl of Bach flower remedy (group C) every 2 days, for 20 days. All animals were fed standard rat chow and water ad libitum.

Urine volume, body weight, feces weight, and food intake were measured every 2 days. On day 20, tests of glycemia, hyperuricemia, triglycerides, high-density lipoprotein (HDL) cholesterol, and total cholesterol were performed, and the anatomy and histopathology of the heart, liver and kidneys were evaluated. Data were analyzed using Tukey’s test at a significance level of 5%.

No significant differences were found in food intake, feces weight, urine volume and uric acid levels between groups. Group C had a significantly lower body weight gain than group A and lower glycemia compared with groups A and B. Groups B and C had significantly higher HDL-cholesterol and lower triglycerides than controls. Animals had mild hepatic steatosis, but no cardiac or renal damage was observed in the three groups.

From these results, the authors conclude that Bach flower Rescue Remedy was effective in controlling glycemia, triglycerides, and HDL-cholesterol and may serve as a strategy for reducing risk factors for cardiovascular disease in rats. This study provides some preliminary “proof of concept” data that Bach Rescue Remedy may exert some biological effects.

If ever there was a bizarre study, it must be this one:

  • As far as I know, nobody has ever claimed that Rescue Remedy modified cardiovascular risk factors.
  • It seems debatable whether the observed changes are all positive as far as the cardiovascular risk is concerned.
  • It seems odd that a remedy that does not contain active molecules is associated with some sort of dose-effect response.
  • The modification of cardiovascular risk factors in rats might be of little relevance for humans.
  • A strategy for reducing cardiovascular risk factors in rats seems a strange idea.
  • Even the authors cannot offer a mechanism of action [other than pure magic].

Does this study tell us anything of value? The authors are keen to point out that it provides a preliminary proof of concept for Rescue Remedy having biological effects. Somehow, I doubt that this conclusion will convince many of my readers.

Medical treatments with no direct effect, such as homeopathy, are surprisingly popular. But how does a good reputation of such treatments spread and persist? Researchers from the Centre for the Study of Cultural Evolution in Stockholm believe that they have identified the mechanism.

They argue that most medical treatments result in a range of outcomes: some people improve while others deteriorate. If the people who improve are more inclined to tell others about their experiences than the people who deteriorate, ineffective or even harmful treatments would maintain a good reputation.

They conducted a fascinating study to test the hypothesis that positive outcomes are overrepresented in online medical product reviews, examined if this reputational distortion is large enough to bias people’s decisions, and explored the implications of this bias for the cultural evolution of medical treatments.

The researchers compared outcomes of weight loss treatments and fertility treatments as evidenced in clinical trials to outcomes reported in 1901 reviews on Amazon. Subsequently, in a series of experiments, they evaluated people’s choice of weight loss diet after reading different reviews. Finally, a mathematical model was used to examine if this bias could result in less effective treatments having a better reputation than more effective treatments.

The results of these investigations confirmed the hypothesis that people with better outcomes are more inclined to write reviews. After 6 months on the diet, 93% of online reviewers reported a weight loss of 10 kg or more, while just 27% of clinical trial participants experienced this level of weight change. A similar positive distortion was found in fertility treatment reviews. In a series of experiments, the researchers demonstrated that people are more inclined to begin a diet that was backed by many positive reviews, than a diet with reviews that are representative of the diet’s true effect. A mathematical model of medical cultural evolution suggested that the size of the positive distortion critically depends on the shape of the outcome distribution.

The authors concluded that online reviews overestimate the benefits of medical treatments, probably because people with negative outcomes are less inclined to tell others about their experiences. This bias can enable ineffective medical treatments to maintain a good reputation.

To me, this seems eminently plausible; but there are, of course, other reasons why bogus treatments survive or even thrive – and they may vary in their importance to the overall effect from treatment to treatment. As so often in health care, things are complex and there are multiple factors that contribute to a phenomenon.

Cardiovascular (and most other types of) patients frequently use herbal remedies in addition to their prescribed medicines. Can this behaviour create problems? Many experts think so.

The aim of a new study was to investigate the effect of herbal medicine use on medication adherence of cardiology patients. All patients admitted to the outpatient cardiology clinics, who had been prescribed at least one cardiovascular drug before, were asked to complete a questionnaire. Participants were asked if they have used any herbals during the past 12 months with an expectation of beneficial effect on health. Medication adherence was measured by using the Morisky Scale. High adherence was defined as a Morisky score lower than 2 and a score of 2 or more was seen as low adherence.

A total of 390 patients participated in this study; 29.7% of them had consumed herbals in the past 12 months. The median Morisky score was significantly higher in herbal users than non-users. The number of herbals used was moderately correlated with the Morisky score. In stepwise, multivariate logistic regression analysis, herbal use was significantly associated with low medication adherence.

From these findings, the authors conclude that herbal use was found to be independently associated with low medication adherence in our study population.

So far, the main known risk of herbal medicine use was the possibility that there might be herb-drug interactions. To the best of my knowledge, nobody has yet studied the possibility that herbal medicine users might neglect to take their prescribed drugs. The results of this investigation are somewhat worrying but they do make sense. Some patients who buy and take herbal remedies might think that they do not need to regularly take their prescribed medications because they already take herbal medicine which takes care of their health problem. They might even have been told by their herbalist that the herbal remedies suffice.

If that is so, and if the phenomenon can be confirmed in further investigations, it should be relevant not just in cardiology but in all fields of medicine. And if that is true for herbal remedies, it might also be the case for other types of alternative medicine. In other words, alternative medicine use might be a marker for poor adherence to prescribed medication. I feel that this hypothesis merits further study.

It goes without saying that poor adherence to prescribed drugs can be a very dangerous habit. Clinicians should therefore warn their patients and tell them that herbal remedies are no replacement of prescription drugs.

In 2004, I published an article rather boldly entitled ‘Ear candles: a triumph of ignorance over science’. Here is its summary:

Ear candles are hollow tubes coated in wax which are inserted into patients’ ears and then lit at the far end. The procedure is used as a complementary therapy for a wide range of conditions. A critical assessment of the evidence shows that its mode of action is implausible and demonstrably wrong. There are no data to suggest that it is effective for any condition. Furthermore, ear candles have been associated with ear injuries. The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.

Sadly, since the publication of this paper, ear candles have not become less but more popular. There are about 3 000 000 websites on the subject; most are trying to sell products and make claims which are almost comically misguided; three examples have to suffice:

I said ALMOST comical because such nonsense has, of course a downside. Not only are consumers separated from their cash for no benefit whatsoever, but they are also exposed to danger; again, three examples from the medical literature might explain:

  • Otolaryngologists from London described a case of ear candling presenting as hearing loss, and they concluded that this useless therapy can actually cause damage to the ears.
  • A 50-year-old woman presented to her GP following an episode of ear candling. After 15 minutes, the person performing the candling burned herself while attempting to remove the candle and spilled candle wax into the patient’s right ear canal. On examination, a piece of candle wax was found in the patient’s ear, and she was referred to the local ear, nose, and throat department. Under general aesthetic, a large mass of solidified yellow candle wax was removed from the deep meatus of the ear. The patient had a small perforation in her right tympanic membrane. Results of a pure tone audiogram showed a mild conductive hearing loss on the right side. At a follow-up appointment 1 month later, the perforation was still there, and the patient’s hearing had not improved.
  • case report of a 4-year-old girl from New Zealand was published. The patient was diagnosed to suffer from otitis media. During the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.

I should stress that we do not know how often such events happen; there is no monitoring system, and one might expect that the vast majority of cases do not get published. Most consumers who experience such problems, I would guess, are far to embarrassed to admit that they have been taken in by this sort of quackery.

It was true 10 yeas ago and it is true today: ear candles are a triumph of ignorance over science. But also they are a victory of gullibility over common sense and the unethical exploitation of naive hope by greedy frauds.

General practitioners (GPs) play an important role in advising patients on all sorts of matters related to their health, and this includes, of course, the possible risks of electromagnetic fields (EMF). Their views on EMF are thus relevant and potentially influential.

A team of German and Danish researchers therefore conducted a survey comparing GPs using conventional medicine (COM) with GPs using complementary and alternative medicine (CAM) concerning their perception of EMF risks. A total of 2795 GPs drawn randomly from lists of German GPs were sent an either long or short self-administered postal questionnaire on EMF-related topics. Adjusted logistic regression models were fitted to assess the association of an education in alternative medicine with various aspects of perceiving EMF risks.

Concern about EMF, misconceptions about EMF, and distrust toward scientific organizations are more prevalent in CAM-GPs. CAM-GPs more often falsely believed that mobile phone use can lead to head warming of more than 1°C, more often distrusted the Federal Office for Radiation Protection, were more often concerned about mobile phone base stations, more often attributed own health complaints to EMF, and more often reported at least 1 EMF consultation. GPs using homeopathy perceived EMF as more risky than GPs using acupuncture or naturopathic treatment.

The authors concluded that concern about common EMF sources is highly prevalent among German GPs. CAM-GPs perceive stronger associations between EMF and health problems than COM-GPs. There is a need for evidence-based information about EMF risks for GPs and particularly for CAM-GPs. This is the precondition that GPs can inform patients about EMF and health in line with current scientific knowledge.

True, the evidence is somewhat contradictory but the majority of independent reviews seem to suggest that EMF constitute little or no health risks. In case you don’t believe me, here are a few conclusions from recent reviews:

But even if someone wants to err on the safe side, and seriously considers the possibility that EMF sources might have the potential to harm our health, a general distrust in scientific organizations, and wrong ideas about modern technologies such as mobile phones are hardly very helpful – in fact, I find them pretty worrying. To learn that CAM-GPs are more likely than COM-GPs to hold such overtly anti-scientific views does not inspire me with trust; to see that homeopaths are the worst culprits is perhaps not entirely unexpected. Almost by definition, critical evaluation of the existing evidence is not a skill that is prevalent amongst homeopaths – if it were, there would be no homeopaths!

Twenty years ago, when I started my Exeter job as a full-time researcher of complementary/alternative medicine (CAM), I defined the aim of my unit as applying science to CAM. At the time, this intention upset quite a few CAM-enthusiasts. One of the most prevalent arguments of CAM-proponents against my plan was that the study of CAM with rigorous science was quite simply an impossibility. They claimed that CAM included mind and body practices, holistic therapies, and other complex interventions which cannot not be put into the ‘straight jacket’ of conventional research, e. g. a controlled clinical trial. I spent the next few years showing that this notion was wrong. Gradually and hesitantly CAM researchers seemed to agree with my view – not all, of course, but first a few and then slowly, often reluctantly the majority of them.

What followed was a period during which several research groups started conducting rigorous tests of the hypotheses underlying CAM. All too often, the results turned out to be disappointing, to say the least: not only did most of the therapies in question fail to show efficacy, they were also by no means free of risks. Worst of all, perhaps, much of CAM was disclosed as being biologically implausible. The realization that rigorous scientific scrutiny often generated findings which were not what proponents had hoped for led to a sharp decline in the willingness of CAM-proponents to conduct rigorous tests of their hypotheses. Consequently, many asked whether science was such a good idea after all.

But that, in turn, created a new problem: once they had (at least nominally) committed themselves to science, how could they turn against it? The answer to this dilemma was easier that anticipated: the solution was to appear dedicated to science but, at the same time, to argue that, because CAM is subtle, holistic, complex etc., a different scientific approach was required. At this stage, I felt we had gone ‘full circle’ and had essentially arrived back where we were 20 years ago - except that CAM-proponents no longer rejected the scientific method outright but merely demanded different tools.

A recent article may serve as an example of this new and revised stance of CAM-proponents on science. Here proponents of alternative medicine argue that a challenge for research methodology in CAM/ICH* is the growing recognition that CAM/IHC practice often involves complex combination of novel interventions that include mind and body practices, holistic therapies, and others. Critics argue that the reductionist placebo controlled randomized control trial (RCT) model that works effectively for determining efficacy for most pharmaceutical or placebo trial RCTs may not be the most appropriate for determining effectiveness in clinical practice for either CAM/IHC or many of the interventions used in primary care, including health promotion practices. Therefore the reductionist methodology inherent in efficacy studies, and in particular in RCTs, may not be appropriate to study the outcomes for much of CAM/IHC, such as Traditional Korean Medicine (TKM) or other complex non-CAM/IHC interventions—especially those addressing comorbidities. In fact it can be argued that reductionist methodology may disrupt the very phenomenon, the whole system, that the research is attempting to capture and evaluate (i.e., the whole system in its naturalistic environment). Key issues that surround selection of the most appropriate methodology to evaluate complex interventions are well described in the Kings Fund report on IHC and also in the UK Medical Research Council (MRC) guidelines for evaluating complex interventions—guidelines which have been largely applied to the complexity of conventional primary care and care for patients with substantial comorbidity. These reports offer several potential solutions to the challenges inherent in studying CAM/IHC. [* IHC = integrated health care]

Let’s be clear and disclose what all of this actually means. The sequence of events, as I see it, can be summarized as follows:

  • We are foremost ALTERNATIVE! Our treatments are far too unique to be subjected to reductionist research; we therefore reject science and insist on an ALTERNATIVE.
  • We (well, some of us) have reconsidered our opposition and are prepared to test our hypotheses scientifically (NOT LEAST BECAUSE WE NEED THE RECOGNITION THAT THIS MIGHT BRING).
  • We are dismayed to see that the results are mostly negative; science, it turns out, works against our interests.
  • We need to reconsider our position.
  • We find it inconceivable that our treatments do not work; all the negative scientific results must therefore be wrong.
  • We always said that our treatments are unique; now we realize that they are far too holistic and complex to be submitted to reductionist scientific methods.
  • We still believe in science (or at least want people to believe that we do) - but we need a different type of science.
  • We insist that RCTs (and all other scientific methods that fail to demonstrate the value of CAM) are not adequate tools for testing complex interventions such as CAM.
  • We have determined that reductionist research methods disturb our subtle treatments.
  • We need pragmatic trials and similarly ‘soft’ methods that capture ‘real life’ situations, do justice to CAM and rarely produce a negative result.

What all of this really means is that, whenever the findings of research fail to disappoint CAM-proponents, the results are by definition false-negative. The obvious solution to this problem is to employ different (weaker) research methods, preferably those that cannot possibly generate a negative finding. Or, to put it bluntly: in CAM, science is acceptable only as long as it produces the desired results.

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