Monthly Archives: September 2014
As a pharmacy professional, you must:
1. Make patients your first concern
2. Use your professional judgement in the interests of patients and the public
3. Show respect for others
4. Encourage patients and the public to participate in decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices.
Even though these 7 main principles were laid down by the UK General Pharmaceutical Council, they are pretty much universal and apply to pharmacists the world over.
On this blog, I have repeatedly criticised community pharmacists (here I am only discussing this branch of pharmacists) for selling remedies which are not just of debatable efficacy but which fly in the face of science and have been all but disproven. Recently, I came across this website of a working group of the Austrian Society of Pharmacists. It is in German, so I will translate a few sections for you.
They say that it is their aim to find “explanatory models for the mechanisms of action of homeopathy”. This is a strange aim, in my view, not least because there is no proven efficacy; why then search for a mechanism?
Things go from bad to worse when we consider the ‘Notfallapotheke’, the emergency kit which they recommend to consumers who might find themselves in desperate need for emergency care. It includes the following remedies, doses and indications:
Aconitum C 30 2 x 5 Glob, first remedy in cases of fever
Allium cepa C 12 3 x 5 Glob, hayfever or cold
Anamirta cocculusLM 12 : 2 x 5, travel sickness
Apis mellifica C 200 2 x 5 Glob, insect bites
Arnica C 200 1 x 5 Glob, injuries
Acidum arsenicosum C 12 3 – 5 x 5, food poisoning
Atropa belladonna C 30 2 x 5 Glob, high fever
Cephaelis ipecacuahna C 12 2 x 5 Glob, nausea and vomiting
Coffea arabica C 12 2 x 5 Glob, insomnia and restlessness
Euphrasia officinalis C 12 3 x 5 Glob, eye problems
Ferrum phosphoricum C 12 2 x 5 Glob, nose bleed
Lachesis muta C 30 1 x 5 Glob, infected wounds
Lytta vesicatoria C 200 1 – 2 x 5, burns,
Matricaria chamomilla C 30 1 x 3 Glob, toothache
Mercurius LM 12 2 x 5 Glob ear ache, weakness
Pulsatilla LM 12 2 x 5 Glob, ear ache, indigestion
Solanum dulcamara C12 3 x 5 Glob, cystitis
Strychnos nux vomica LM 12 2 x 5 Glob, hangover
Rhus toxicodendron C 200 2 x 5 Glob, rheumatic pain
Veratrum album C12, 3-5 x 3, watery diarrhoea, nausea, vomiting, circulatory problems, collapse.
I can well imagine that, after reading this, some of my readers are in need of some Veratrum album because of near collapse with laughter (or fury?).
We all know that most pharmacists sell such useless remedies; and we might pity them for such behaviour, as they claim they have no choice. But if pharmacists’ professional organisations put themselves so very clearly behind quackery thereby violating all ethical rules in the book, one is truly speechless.
Do I hear someone mutter “what has Austria to do with us?”?
Not a lot, perhaps – but have a look at the range of similar ‘homeopathic emergency kits’ sold outside Austria. Or be stunned by the plethora of homeopathic pharmacies across the globe here and UK-wide here. Or consider the fact that most non-homeopathic pharmacies in the world sell homeopathic remedies. Or let me remind you that a snapshot investigation into UK pharmacies revealed that 13 out of 20 pharmacisits failed to explain that there’s no clinical evidence that homeopathy works. Or be once again reminded that it is “the ethical role of the pharmacist is to give accurate, impartial information regarding the homeopathic therapy, the current scientific proof on their therapeutic effects, including the placebo effect.”
And what is the current scientific proof?
The most reliable verdict that I am aware of comes from the Australian ‘NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL’ (NHMRC) who have assessed the effectiveness of homeopathy. The evaluation concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”
I rest my case.
Many proponents of alternative medicine seem somewhat suspicious of research; they have obviously understood that it might not produce the positive result they had hoped for; after all, good research tests hypotheses and does not necessarily confirm beliefs. At the same time, they are often tempted to conduct research: this is perceived as being good for the image and, provided the findings are positive, also good for business.
Therefore they seem to be tirelessly looking for a study design that cannot ‘fail’, i.e. one that avoids the risk of negative results but looks respectable enough to be accepted by ‘the establishment’. For these enthusiasts, I have good news: here is the study design that cannot fail.
It is perhaps best outlined as a concrete example; for reasons that will become clear very shortly, I have chosen reflexology as a treatment of diabetic neuropathy, but you can, of course, replace both the treatment and the condition as it suits your needs. Here is the outline:
- recruit a group of patients suffering from diabetic neuropathy – say 58, that will do nicely,
- randomly allocate them to two groups,
- the experimental group receives regular treatments by a motivated reflexologist,
- the controls get no such therapy,
- both groups also receive conventional treatments for their neuropathy,
- the follow-up is 6 months,
- the following outcome measures are used: pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities,
- the results show that the reflexology group experience more improvements in all outcome measures than those of control subjects,
- your conclusion: This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.
Mission accomplished!
This method is fool-proof, trust me, I have seen it often enough being tested, and never has it generated disappointment. It cannot fail because it follows the notorious A+B versus B design (I know, I have mentioned this several times before on this blog, but it is really important, I think): both patient groups receive the essential mainstream treatment, and the experimental group receives a useless but pleasant alternative treatment in addition. The alternative treatment involves touch, time, compassion, empathy, expectations, etc. All of these elements will inevitably have positive effects, and they can even be used to increase the patients’ compliance with the conventional treatments that is being applied in parallel. Thus all outcome measures will be better in the experimental compared to the control group.
The overall effect is pure magic: even an utterly ineffective treatment will appear as being effective – the perfect method for producing false-positive results.
And now we hopefully all understand why this study design is so very popular in alternative medicine. It looks solid – after all, it’s an RCT!!! – and it thus convinces even mildly critical experts of the notion that the useless treatment is something worth while. Consequently the useless treatment will become accepted as ‘evidence-based’, will be used more widely and perhaps even reimbursed from the public purse. Business will be thriving!
And why did I employ reflexology for diabetic neuropathy? Is that example not a far-fetched? Not a bit! I used it because it describes precisely a study that has just been published. Of course, I could also have taken the chiropractic trial from my last post, or dozens of other studies following the A+B versus B design – it is so brilliantly suited for misleading us all.
On this blog, I have often pointed out how dismally poor most of the trials of alternative therapies frequently are, particularly those in the realm of chiropractic. A brand-new study seems to prove my point.
The aim of this trial was to determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with sub-acute and chronic back-related leg-pain (BRLP).
Patients aged 21 years or older with BRLP for least 4 weeks were randomised to receive 12 weeks of SMT plus HEA or HEA alone. Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. The primary outcome was subjective BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks.
Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
The authors conclude that, for patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
This is yet another pragmatic trial following the notorious and increasingly popular A+B versus B design. As pointed out repeatedly on this blog, this study design can hardly ever generate a negative result (A+B is always more than B, unless A has a negative value [which even placebos don’t have]). Thus it is not a true test of the experimental treatment but all an exercise to create a positive finding for a potentially useless treatment. Had the investigators used any mildly pleasant placebo with SMT, the result would have been the same. In this way, they could create results showing that getting a £10 cheque or meeting with pleasant company every other day, together with HEA, is more effective than HEA alone. The conclusion that the SMT, the cheque or the company have specific effects is as implicit in this article as it is potentially wrong.
The authors claim that their study was limited because patient-blinding was not possible. This is not entirely true, I think; it was limited mostly because it failed to point out that the observed outcomes could be and most likely are due to a whole range of factors which are not directly related to SMT and, most crucially, because its write-up, particularly the conclusions, wrongly implied cause and effect between SMT and the outcome. A more accurate conclusion could have been as follows: SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Because the trial design did not control for non-specific effects, the observed outcomes are consistent with SMT being an impressive placebo.
No such critical thought can be found in the article; on the contrary, the authors claim in their discussion section that the current trial adds to the much-needed evidence base about SMT for subacute and chronic BRLP. Such phraseology is designed to mislead decision makers and get SMT accepted as a treatment of conditions for which it is not necessarily useful.
Research where the result is known before the study has even started (studies with a A+B versus B design) is not just useless, it is, in my view, unethical: it fails to answer a real question and is merely a waste of resources as well as an abuse of patients willingness to participate in clinical trials. But the authors of this new trial are in good and numerous company: in the realm of alternative medicine, such pseudo-research is currently being published almost on a daily basis. What is relatively new, however, that even some of the top journals are beginning to fall victim to this incessant stream of nonsense.
A recent article by Frank King (DC, ND) caught my eye. In it, he praises homeopathy in glowing terms. First I was not sure whether he is pulling my leg; then I decided he was entirely serious. Am I mistaken?
Here is the crucial passage for you to decide:
Even though the founder of homeopathy lived more than 200 years ago, he wrote about genetics. Samuel Hahnemann, MD, not only emphasized the importance of natural healing methods, he also recognized the influence of genetics in some types of illnesses.
Hahnemann used the term miasm to refer to the source of chronic diseases. He recognized several miasms, such as psora (meaning “itch”), syphilis, tuberculosis, gonorrhea, and cancer. In addition to recognizing and naming these miasms, he developed homeopathic remedies to address and correct them.
When your patient treatment protocols reach a plateau with chiropractic and nutritional support, consider turning to the constitutional homeopathic remedies, miasms, and detoxification formulas. Toxins inhibit the body’s ability to heal by interfering with the normal nerve pathways.
For example: Due to the steady growth in heavy-metal exposure modern civilization has experienced since the Industrial Revolution, mercury could be considered a modern miasm. Animal studies indicate that mercury’s negative effects can carry through to future generations, just as some of the other miasms do.
Mercurius is homeopathically prepared mercury to help address the symptoms of mercury toxicity, which can manifest as slow thought processes, chilliness, weak digestion, sore throat, and night sweats.
This is just one of the more than 1,300 Homeopathic Pharmacopoeia of the United States ingredients recognized by the FDA.
Homeopathy can be the perfect complement to chiropractic care. It can correct the energetics (including the genetics) of the deepest areas of the body, mind, and emotions, where the hands of the chiropractor can’t reach.
In case you don’t know much about homeopathy, it is true that Hahnemann believed in ‘miasms’, i.e. noxious vapours as the cause of a disposition to certain diseases. Even by Hahnemann’s standards, it turned out to be one of his more crazy ideas. To claim that, by believing in miasms, he foresaw the science of genetics is more than a little far-fetched.
In case you are not sure what toxins do in our body, rest assured that only chiropractors believe they inhibit the body’s ability to heal by interfering with the normal nerve pathways.
And in case you think you suffer from slow thought processes, chilliness, weak digestion, sore throat, and night sweats and thus feel like rushing to the next pharmacy to buy some Mercurius, don’t! This would not eliminate any mercury from your body, it would just eliminate cash from your pocket (in that sense, homeopathy might indeed occasionally reach where the hands of the chiropractor can’t reach).
One can say a lot about alternative medicine, I think, but nobody can deny that it regularly provides us with perfect (unintentional) comedy.
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.
Chiropractors, like other alternative practitioners, use their own unique diagnostic tools for identifying the health problems of their patients. One such test is the Kemp’s test, a manual test used by most chiropractors to diagnose problems with lumbar facet joints. The chiropractor rotates the torso of the patient, while her pelvis is fixed; if manual counter-rotative resistance on one side of the pelvis by the chiropractor causes lumbar pain for the patient, it is interpreted as a sign of lumbar facet joint dysfunction which, in turn would be treated with spinal manipulation.
All diagnostic tests have to fulfil certain criteria in order to be useful. It is therefore interesting to ask whether the Kemp’s test meets these criteria. This is precisely the question addressed in a recent paper. Its objective was to evaluate the existing literature regarding the accuracy of the Kemp’s test in the diagnosis of facet joint pain compared to a reference standard.
All diagnostic accuracy studies comparing the Kemp’s test with an acceptable reference standard were located and included in the review. Subsequently, all studies were scored for quality and internal validity.
Five articles met the inclusion criteria. Only two studies had a low risk of bias, and three had a low concern regarding applicability. Pooling of data from studies using similar methods revealed that the test’s negative predictive value was the only diagnostic accuracy measure above 50% (56.8%, 59.9%).
The authors concluded that currently, the literature supporting the use of the Kemp’s test is limited and indicates that it has poor diagnostic accuracy. It is debatable whether clinicians should continue to use this test to diagnose facet joint pain.
The problem with chiropractic diagnostic methods is not confined to the Kemp’s test, but extends to most tests employed by chiropractors. Why should this matter?
If diagnostic methods are not reliable, they produce either false-positive or false-negative findings. When a false-negative diagnosis is made, the chiropractor might not treat a condition that needs attention. Much more common in chiropractic routine, I guess, are false-positive diagnoses. This means chiropractors frequently treat conditions which the patient does not have. This, in turn, is not just a waste of money and time but also, if the ensuing treatment is associated with risks, an unnecessary exposure of patients to getting harmed.
The authors of this review, chiropractors from Canada, should be praised for tackling this subject. However, their conclusion that “it is debatable whether clinicians should continue to use this test to diagnose facet joint pain” is in itself highly debatable: the use of nonsensical diagnostic tools can only result in nonsense and should therefore be disallowed.
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.
