I just came across this hilarious yet revealing article by Italian authors defending homeopathy. It is far too remarkable to keep it for myself, and I therefore decided to quote its abstract here in full:
Throughout its over 200-year history, homeopathy has been proven effective in treating diseases for which conventional medicine has little to offer. However, given its low cost, homeopathy has always represented a serious challenge and a constant threat to the profits of drug companies. Moreover, since drug companies represent the most relevant source of funding for biomedical research worldwide, they are in a privileged position to finance detractive campaigns against homeopathy by manipulating the media as well as academic institutions and the medical establishment. The basic argument against homeopathy is that in some controlled clinical trials (CCTs), comparison with conventional treatments shows that its effects are not superior to those of placebo. Against this thesis we argue that a) CCT methodology cannot be applied to homeopathy, b) misconduct and fraud are common in CCTs, c) adverse drug reactions and side effects show that CCT methodology is deeply flawed, d) an accurate testing of homeopathic remedies requires more sophisticated techniques, e) the placebo effect is no more “plausible” than homeopathy, and its real nature is still unexplained, and f) the placebo effect is nevertheless a “cure” and, as such, worthy of further investigation and analysis. It is concluded that no arguments presently exist against homeopathy and that the recurrent campaigns against it represent the specific interests of the pharmaceutical industry which, in this way, strives to protect its profits from the “threat” of a safer, more effective, and much less expensive treatment modality.
Despite (or is it because?) of such nonsense, homeopathy seems to be very popular, especially in the treatment of small children, and particularly for conditions where conventional medicine has no effective treatment. Teething problems are thus an ideal target for the homeopathic industry.
A survey of British GPs found that the most frequently prescribed homeopathic remedies were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. Similarly, the Avon-study suggested that homeopathic Chamomillia is popular to alleviate the pain of teething. And prominent homeopaths recommend that “teething often responds to Chamomilla.“
One website also recommends Chamomilla as well as several other homeopathic remedies leaving little doubt about their efficacy:
Chamomilla 6c: When teething is very painful and the child becomes quite cranky, satisfied with nothing and pacified only by being carried, then Chamomilla may help. Sometimes, the child seeking some relief from the discomfort will demand one thing after another, rejecting each one when it does not give relief. Children who could benefit from this remedy are very irritable, with a cry that sounds as if they are in pain. Chamomilla 6c can be taken every thirty minutes, up to six times per day, while symptoms persist.
Mercurius sol 6c: This remedy may be of help in cases where teething is accompanied by excessive salivation and drooling. In addition, the gums are likely to be red and sore, and the child may have diarrhea with a foul smell to it. Mercurius sol 6c can be taken four to six times per day for two to three days; its use should be discontinued when the symptoms diminish.
>Belladonna 30c: For children who tend to develop a fever with a flushed, red face when they are cutting teeth, Belladonna may be a good choice. Often the eyes have a glassy look due to the dilation of the pupils. The child may be irritable and crying as if angry. Belladonna 30c can be taken every thirty minutes up to four times per day, while symptoms continue.
Aconite napellus 30c: When the symptoms come on quickly and include physical and mental restlessness, this remedy may be useful. The affected gums will be hot, swollen, and inflamed and there may also be an earache with aversion to loud noises. The condition may come on following exposure to cold, dry winds. Try Aconite napellus 30c every hour for up to six times per day.
Calcarea carbonica 6c: When children are finally cutting teeth that have been late in erupting, Calcarea carbonica could be helpful. This remedy is often helpful with “late bloomers,” babies who develop a little more slowly, crawling, walking, and cutting teeth on their own schedule, weeks or months later than some other babies or toddlers. Children likely to benefit from Calcarea carbonica often have sweaty heads and feet and may have a tendency to develop cradle cap or yeast infections. With teething, they often do not show the extreme irritability that calls for Chamomilla, or the fever that indicates Belladonna, but they may have teeth that seem permanently on the verge of breaking through the surface. Calcarea carbonica 6c can be taken three times per day, for up to ten days; its use should be discontinued when symptoms improve.
Given this level of assurance, it not really surprising that manufacturers of homeopathic remedies want to profit from all this. Anxious mothers must seem like sitting ducks to the homeopathic industry.
Camilia, a homeopathic teething remedy that contains Chamomillia in the 9c potency from Boiron, the world’s largest producer of homeopathic products, will be launched shortly in the UK. The PR-agency in charge of the UK campaign to promote camilia announced that they will focus on a “national awareness drive through earned and paid-for media along with influencer engagement.” The agency is also responsible for re-building the brand’s website and implementing a strategy to drive discovery online. Amanda Meyrick of Clarion Communications, said: “Launching a product into a new market gives us the opportunity to work in partnership from the beginning to establish Camilia in the UK, and we are looking forward to seeing the results of our planning and creativity.” Remarkably, nobody seems to mention efficacy as a factor in the promotion of camilia.
However, the product is already available in the US, and from the US website we learn that this remedy “temporarily relieves symptoms of teething, including painful gums and irritability.” So, there are clear claims of efficacy after all!
Boiron is not the only firm who aim to profit from the vast market of teething problems. Nelson’s Teetha, for instance, is already available in the UK. Each 300mg sachet of TEETHA contains “the active ingredient of Chamomilla 6c.” Even Boots, the UK’s ‘trusted’ high street pharmacy, sell a product called ‘TEETHING PAIN RELIEF’ which also contains Chamomilla 6c, its only ‘active’ ingredient. Even the name of their product carries a therapeutic claim for efficacy, in my view.
But hold on! A 6c dilution equals one ml of plant extract diluted in 1 000 000 000 litres of water (add 6 zeros to that figure for the Boiron product)!!! Is that really going to alleviate teething problems?
Of course not!, you will say. Dilutions of this nature will do nothing whatsoever.
But they are not just dilutions, they are potentiations! would the homeopaths counter; they have been succussed at each dilution step, and this process transfers a vital force from the Chamomilla extract to the remedy. Yes, of course, how could I forget – it’s homeopathy where LIKE CURES LIKE and people believe in the tooth fairy.
But this does not make any sense either!
Chamomillia is nothing other than chamomile, a plant known to sooth through its anti-inflammatory actions. So, in highly diluted homeopathic products, the actions of this plant should be reversed according to the ‘like cures like’ principle. That means that these teething products, according to homeopathic ‘logic’, is not for treating inflamed gums but for treating the absence of inflammation.
My mind boggles because nothing seems to make sense any more:
- according to real science (or just common sense), the dilutions are far to high to have any effect at all,
- according to homeopathic ‘logic’, these products should, if anything, produce inflammation and not alleviate it,
- according to the best clinical evidence, homeopathic remedies are not effective for teething; I am not aware of a single rigorous trial that would show its efficacy, and current reviews do not recommend homeopathy for teething problems,
- regardless of all this and despite of regulations prohibiting it, therapeutic claims are being made for these over-priced placebos.
IT’S HOMEOPATHY STUPID!
Most pharmacies worldwide sell any bogus treatment to their unsuspecting customers, it seems – as long as it makes a profit, anything goes! Not in New Zealand!
The New Zealand’s Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics 2011 section 6.9 requires of pharmacists that:
“YOU MUST… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.”
This instruction was the basis for a complaint against a New Zealand pharmacy selling a homeopathic remedy against jet lag called “No-Jet-Lag”. The New Zealand Advertising Standards Authority (ASA) considered the complaint and decided to uphold it. The complaint, which was lodged with the ASA by the Society for Science Based Healthcare in July 2014, alleged that the advertisement’s claims about the product that “It Really Works” for “Homeopathic Jet Lag Prevention” were unsubstantiated and misleading.
In defence of their advertising, the manufacturer of the product, Miers Laboratories, submitted a study they had conducted with their product. However, the Advertising Standards Complaints Board ruled that: “the trial population in the pilot study was small, the methodology was not robust and the results had not been published or peer reviewed. The Complaints Board also noted the study was an in-house trial conducted by the Advertiser rather than independent research…Given the weaknesses in the study, the majority of the Complaints Board said the Advertiser had not satisfactorily substantiated the claim the product “really works” and, as such, the Complaints Board said the advertisement had the potential to mislead consumers. Consequently, the Complaints Board said the advertisement did not observe a high standard of social responsibility required of advertisements of this type.”
However, today I found the following text still on the website of the company: Jet lag is the curse of modern jet travel, but it doesn´t have to spoil your trip. The unique homeopathic remedy No-Jet-Lag helps ensure holiday enjoyment and working efficiency even after long airline flights. No-Jet-Lag is raved about by satisfied travellers globally, including business executives, sports teams, tour operators, and flight crews. It is safe, easy to take, and proven effective in tests.
Are the days of “No-Jet-Lag” counted?
Why do not all countries’ pharmacists have such codes of ethics?
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.
For every condition which is not curable by conventional medicine there are dozens of alternative treatments that offer a cure or at least symptomatic relief. Multiple sclerosis (MS) is such a disease. It is hard to find an alternative therapy that is not being promoted for MS.
Acupuncture is, of course, no exception. It is widely promoted for treating MS symptoms and many MS patients spend lots of money hoping that it does. The US ‘National MS Society’, For instance claim that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression. There is no evidence, however, that acupuncture can reduce the frequency of MS exacerbations or slow the progression of disability. And the ‘British Acupuncture Council’ state that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression.
Such claims seem a little over-optimistic; let’s have a look what the evidence really tells us.
The purpose of this brand-new review was to assess the literature on the effectiveness of acupuncture for treating MS. A literature search resulted in 12 peer-reviewed articles on the subject that examined the use of acupuncture to treat MS related quality of life, fatigue, spasticity, and pain. The majority of the studies were poorly designed-without control, randomization, or blinding. Description of the subjects, interventions, and outcome measures as well as statistical analysis were often lacking or minimal.
The authors concluded that although many of the studies suggested that acupuncture was successful in improving MS related symptoms, lack of statistical rigor and poor study design make it difficult to draw any conclusions about the true effectiveness of this intervention in the MS population. Further studies with more rigorous designs and analysis are needed before accurate claims can be made as to the effectiveness of acupuncture in this population.
And what about other alternative therapies? Our own systematic review of the subject included 12 randomized controlled trials: nutritional therapy (4), massage (1), Feldenkrais bodywork (1), reflexology (1), magnetic field therapy (2), neural therapy (1) and psychological counselling (2). But the evidence was not compelling for any of these therapies, with many trials suffering from significant methodological flaws. There is evidence to suggest some benefit of nutritional therapy for the physical symptoms of MS. Magnetic field therapy and neural therapy appear to have a short-term beneficial effect on the physical symptoms of MS. Massage/bodywork and psychological counselling seem to improve depression, anxiety and self-esteem.
That was some time ago, and it is therefore reasonable to ask: has the evidence changed? Thankfully, the ‘American Academy of Neurology’ has just published the following guidelines entitles complementary and alternative medicine in multiple sclerosis:
Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.
Interestingly, on yesterday it was announced that the NHS in Wales has just made available a cannabis-based spray for MS-sufferers (I should mention that most cannabis-based preparations are not full plant extracts and thus by definition not herbal but conventional medicines).
It would be wonderful, if other alternative therapies were of proven benefit to MS-sufferers. But sadly, this does not seem to be the case. I think it is better to be truthful about this than to raise false hopes of desperate patients.
Have you noticed?
Homeopaths, acupuncturists, herbalists, reflexologists, aroma therapists, colonic irrigationists, naturopaths, TCM-practitioners, etc. – they always smile!
I think I might know the answer. Here is my theory:
Alternative practitioners have in common with conventional clinicians that they treat patients – lots of patients, day in day out. This wears them down, of course. And sometimes, conventional clinicians find it hard to smile. Come to think of it, alternative practitioners seem to have it much better. Let me explain.
Whenever a practitioner (of any type) treats a patient, one of three outcomes is bound to happen:
- the patient gets better,
- the patients roughly remains how she was and experiences no improvement,
- the patient gets worse.
In scenario one, everybody is happy. Both alternative and conventional practitioners will claim with a big smile that their treatment was the cause of the improvement. There is a difference though: the conventional practitioner who adheres to the principles of evidence-based medicine will know that the assumption is likely to be true, while the alternative practitioner is probably just guessing. In any case, as long as the patient gets better, all is well.
In scenario two, most conventional clinicians will get somewhat concerned and find little reason to smile. Not so the alternative practitioner! He will have one of several explanations why his therapy has not produced the expected result all of which allow him to carry on smiling smugly. He might, for instance, explain to his patient:
- You have to give it more time; another 10-20 treatment sessions and you will be as right as rain (unfortunately, further sessions will come at a price).
- This must be because of all those nasty chemical drugs that you took for so long – they block up your system, you know; we will have to do some serious detox to get rid of all this poison (of course, at a cost).
- You must realize that, had we not started my treatment when we did, you would be much worse by now, perhaps even dead.
In scenario three, any conventional clinician would have stopped smiling and begun to ask serious, self-critical questions about his diagnosis and treatment. Not so the alternative practitioner. He will point out with a big smile that the deterioration of the symptoms only appears to be a bad sign. In reality it is a very encouraging signal indicating that the optimal treatment for the patient’s condition has finally been found and is beginning to work. The acute worsening of the complaints is merely an ‘aggravation’ or’ healing crisis’. Such a course of events had to be expected when true healing of the root cause of the condition is to be achieved. The thing to do now is to continue with several more treatments (at a cost, of course) until deep healing from within sets in.
Many of us want the cake and eat it – but alternative practitioners, it seems to me, have actually achieved this goal. No wonder they smile!
Yesterday, BBC NEWS published the following interesting text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day:
Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in.
“He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it.”
Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.***
“I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved.
“And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.
*** obviously there is no homeopathic remedy for megalomania (but that’s a different story)
SPECTACULARLY GOOD RESULTS?
Let’s have a look at the ‘trial’ and its results. An easily accessible report provides the following details about it:
From February 2007 to February 2008, Get Well UK ran the UK’s first government-backed complementary therapy pilot. Sixteen practitioners provided treatments including acupuncture, osteopathy and aromatherapy, to more than 700 patients at two GP practices in Belfast and Derry.
The BBC made an hour long documentary following our trials and tribulations, which was broadcast on BBC1 NI on 5 May 2008.
Aims and Objectives
The aim of the project was to pilot services integrating complementary medicine into existing primary care services in Northern Ireland. Get Well UK provided this pilot project for the Department for Health, Social Services and Public Safety (DHSSPS) during 2007.
The objectives were:
- To measure the health outcomes of the service and monitor health improvements.
- To redress inequalities in access to complementary medicine by providing therapies through the NHS, allowing access regardless of income.
- To contribute to best practise in the field of delivering complementary therapies through primary care.
- To provide work for suitably skilled and qualified practitioners.
- To increase patient satisfaction with quick access to expert care.
- To help patients learn skills to improve and retain their health.
- To free up GP time to work with other patients.
- To deliver the programme for 700 patients.
The results of the pilot were analysed by Social and Market Research, who produced this report.
The findings can be summarised as follows:
Following the pilot, 80% of patients reported an improvement in their symptoms, 64% took less time off work and 55% reduced their use of painkillers.
In the pilot, 713 patients with a range of ages and demographic backgrounds and either physical or mental health conditions were referred to various complementary and alternative medicine (CAM) therapies via nine GP practices in Belfast and Londonderry. Patients assessed their own health and wellbeing pre and post therapy and GPs and CAM practitioners also rated patients’ responses to treatment and the overall effectiveness of the scheme.
• 81% of patients reported an improvement in their physical health
• 79% reported an improvement in their mental health
• 84% of patients linked an improvement in their health and wellbeing directly to their CAM treatment
• In 65% of patient cases, GPs documented a health improvement, correlating closely to patient-reported improvements
• 94% of patients said they would recommend CAM to another patient with their condition
• 87% of patient indicated a desire to continue with their CAM treatment
Painkillers and medication
• Half of GPs reported prescribing less medication and all reported that patients had indicated to them that they needed less
• 62% of patients reported suffering from less pain
• 55% reported using less painkillers following treatment
• Patients using medication reduced from 75% before treatment to 61% after treatment
• 44% of those taking medication before treatment had reduced their use afterwards
Health service and social benefits
• 24% of patients who used health services prior to treatment (i.e. primary and secondary care, accident and emergency) reported using the services less after treatment
• 65% of GPs reported seeing the patient less following the CAM referral
• Half of GPs said the scheme had reduced their workload and 17% reported a financial saving for their practice
• Half of GPs said their patients were using secondary care services less.
Impressed? Well, in case you are, please consider this:
- there was no control group
- therefore it is not possible to attribute any of the outcomes to the alternative therapies offered
- they could have been due to placebo-effects
- or to the natural history of the disease
- or to regression towards the mean
- or to social desirability
- or to many other factors which are unrelated to the alternative treatments provided
- most outcome measures were not objectively verified
- the patients were self-selected
- they would all have had conventional treatments in parallel
- this ‘trial’ was of such poor quality that its findings were never published in a peer-reviewed journal
- this was not a ‘trial’ but a ‘pilot study’
- pilot studies are not normally for measuring outcomes but for testing the feasibility of a proper trial
- the research expertise of the investigators was close to zero
- the scientific community merely had pitiful smiles for this ‘trial’ when it was published
- neither Northern Ireland nor any other region implemented the programme despite its “spectacularly good results”.
So, is the whole ‘trial’ story an utterly irrelevant old hat?
Certainly not! Its true significance does not lie in the fact that a few amateurs are trying to push bogus treatments into the NHS via the flimsiest pseudo-research of the century. The true significance, I think, is that it shows how Prince Charles, once again, oversteps the boundaries of his constitutional role.
Auricular acupuncture (AA), according to the ‘COLLEGE OF AURICULAR ACUPUNCTURE’, has its origins in Modern Europe. In 1957 Dr. Paul Nogier, a neurologist from Lyons in France, observed a locum doctor treating sciatica by cauterizing an area of the ear. This prompted extensive research culminating in the development of the somatopic correspondence of specific parts of the body to the ear based upon the concept of an inverted foetus. Dr. Nogier believed that pain and other symptoms in the body could be alleviated by needling, massaging or electronically stimulating the corresponding region of the ear. Auricular Acupuncture is a specialized complementary therapy where acupuncture points on the outer ear are treated, using either needles or acupunctoscopes (electrical location and stimulation machines) to help relieve many chronic complaints. There are over 200 acupuncture points on the ear, each point named after an area of our anatomy. The outer ear acts like a switchboard to the brain. Each acupuncture point being treated, triggers electrical impulses from the ear via the brain, to the specific part of the body being treated.
Sounds odd? Well, that’s because it is odd!
But just because something is odd does not mean it is ineffective – so, what does the reliable evidence tell us? Here are some conclusions from systematic reviews:
All of these analyses point out that the quality of the studies is usually very poor, and stress that more and better research is required. It is therefore interesting to note that a new study has just been published. Perhaps it could settle the question about the effectiveness of AA?
The aim of this study was 1) to evaluate whether auricular acupuncture effective for reducing health care provider stress and anxiety and 2) to determine, if auricular acupuncture impacts provider capacity for developing caring relationships with patients. Pre-intervention and post-intervention surveys were evaluated to see, if auricular acupuncture was associated with changes in State-Trait Anxiety Inventory (STAI), Professional Quality of Life, and Caring Ability Inventory scores. The results indicate that, compared with baseline, participants had a significant reduction in state anxiety (STAI), trait anxiety (STAI), burnout, and secondary traumatic stress scores (Professional Quality of Life). Significant increases were noted in courage and patience, two dimensions of the Caring Ability Inventory.
From these findings, the authors conclude that auricular acupuncture is an effective intervention for the relief of stress/anxiety in providers and supports heightened capacity for caring.
Sounds odd again? Yes, because it is odd!
I would argue that a study of any controversial therapy that has already been tested repeatedly in poor quality trials must have sufficient scientific rigor to advance the field of inquiry. If it does not fulfil this criterion, it is quite simply not ethical. The new study does not even have a control group; we can therefore not begin to tell whether the observed outcomes were due to non-specific effects, the natural history of the condition or regression towards the mean (to mention but a few of the possible sources of bias). To conclude that AA is ‘an effective intervention’ is therefore utterly barmy.
All of this could be entirely trivial and inconsequential. I am afraid, however, that it is not. Alternative medicine is littered with such unethically flawed research conducted by naïve and clueless pseudo-scientists who arrive at outrageous conclusions. This relentless flow of false-positive findings misleads consumers, health care professionals, decision makers and everyone else to draw the wrong conclusions about bogus therapies. And, in the end, this sort of thing even does a grave disfavour to any branch of alternative medicine that might have some degree of respectability.
IT IS HIGH TIME THAT THIS NONSENSE STOPS! IT BORDERS ON SCIENTIFIC MISCONDUCT.
Boiron is the world’s biggest producer of homeopathic remedies. It also is a firm that is relatively active in research into homeopathy. Here is one of their investigations which I find most remarkable.
This study was designed to describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for influenza-like illness (ILI) or ear nose and throat ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments.
The introduction of the article includes interesting information; it informs us that, although homeopathy is more popular in Europe than in the Unites States, sales of homeopathic medicines in the United States grew by more than 1,000% in the late 1970s and early 1980s and continue to grow. In parallel, the number of physicians specializing in homeopathy doubled between 1980 and 1982. In 2003, sales of homeopathic medicines in the United States were estimated to be between $300 and $450 million, with an average growth rate of approximately 8% per year. Homeopathic drugs are among the top 10 nonprescription products sold in the category of analgesics to treat coughs, colds, and flu. The sale of homeopathic medicines in the United States is controlled by the Food, Drug, and Cosmetic Act and regulations issued by the U.S Food and Drug Administration (FDA). Homeopathic medicines in the United States are subject to well-controlled regulatory processes that closely resemble those used for allopathic medicines. FDA regulations for the sale of homeopathic medicines in the United States state that they can only be sold without prescription if they are for self-limiting conditions such as the common cold…
Am I mistaken, or does that paragraph read a bit like a text written by the marketing team of Boiron wanting to establish their products in the US?
Anyway, the methodology and results of the study are described in the abstract as follows:
A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi- factorial logistic regression analysis.
A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P less than 0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P less than 0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients.
From these findings, the authors draw the following conclusions: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.
And, to make perfectly clear what all this is about, the first sentence of the ‘discussion’ puts it to the point by stating that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders.
As I have heard it said that Boiron seems to have the nasty habit of threatening their critics with legal action, I ought to be quite cautious in my assessment of this ‘masterpiece of promotion’. Yet a few comments must surely be permitted.
‘To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines’ is not what I personally find an interesting subject of research, nor is it anything that will affect health care meaningfully, I think. Yet ‘to investigate the effectiveness of these treatments’ is certainly interesting and important. I will therefore focus on this second aim of the study.
Hold on, was this really a ‘study’? On closer inspection, it seemed much more like a survey. People who felt that they were suffering from ILI and ENT disorders and thus went to a pharmacy to buy something for their problem were offered either homeopathic or conventional medicines. Those who accepted either of the recommendations were asked to fill out some self-assessment forms and received a phone call three days later to check their symptoms. 94% of all patients in the homeopathy group took homeopathic medicine in combination with ‘allopathic’ medicine (it is interesting, perhaps even telling, that this term used by the authors was invented by Hahnemann as an insult to conventional medicine!). There was no examination by a doctor to verify what condition the survey-participants were truly suffering from, and there was no verification that the information provided during the follow-up telephone call was in any way real. The most frequently recommended homeopathic medicine was Anas barbariae 200C (Oscillococcinum) which is Boiron’s famous homeopathically diluted (about one molecule per universe, I guess) duck-liver heavily promoted in France against colds and similar conditions.
As it turns out, those survey-participants who accepted the homeopathic recommendation were significantly younger than those who accepted the recommendation for a conventional treatment (many surveys confirm that younger people are more prone to trying alternative medicine than older ones). It stands to reason, that the younger (and therefore fitter) patients were in better general health and therefore might recover quicker than the older ones. But, in fact, they did not!
Could this be due to the homeopathic remedies actually delaying recovery? Of course not! Who would be silly enough to claim that homeopathy could have this (or any other) effect? According to the authors, it is due to the fact that this group ‘had more severe symptoms than those recommended allopathic medicine’. But, as I said, we have to take their word for it; there is no independent verification of this. It would, of course, be quite ridiculous to postulate that those survey-participants accepting homeopathy were also a little more introspective or concerned about their own health (perhaps even more gullible) and thus claimed more severe symptoms!
And what about the authors’ conclusion that clinical improvement was comparable in both treatment groups? Well, this is more than a little problematic, in my view: first, we have no independent verification of the ‘improvement’ in either group. Second, we don’t know that the conventional treatments actually worked, and it could well be that both approaches were similarly ineffective, and that the observed outcomes are merely a reflection of the natural history of the condition. And third, one might expect the homeopathic (younger) group to do not similarly well but slightly better, simply because the natural history of the illness would tend to be more benign in younger people.
Before I finish,I should make a brief comment about the authors’ courageous statement that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders. I think, for the reasons I already provided, this is extremely doubtful. In my view, more critical scientists would have phrased the conclusions differently:
THIS SURVEY SHOWS THAT EVALUATING THE EFFECTIVENESS OF MEDICAL INTERVENTIONS REQUIRES A MORE RIGOROUS METHODOLOGY THAN THAT OF A SURVEY.
But perhaps this would be asking a little too much of the authors; after all, at the end of the article, we find this telling footnote: Laboratoires Boiron provided financial support for the study. Cognet-Dementhon, Thevenard, Duru, and Allaert received consulting fees from Laboratoires Boiron for this study. Danno and Bordet are employees of Laboratoires Boiron.
Guest post by Michelle Dunbar
According to the CDC, more than 30,000 people died as a result of a drug overdose in 2010. Of those deaths none were attributed to marijuana. Instead the vast majority were linked to drugs that are legally prescribed such as opiates, anti-depressants, anti-psychotics, tranquilizers and benzodiazepines. As misuse and abuse of prescription medications continues to rise, the marijuana legalization debate is also heating up.
Nearly 100 years of propaganda, fear mongering and blatant misinformation regarding marijuana has taken its toll on our society. As the veil of lies surrounding marijuana is being lifted, more and more people are pushing for legalization. Marijuana is now legal for both medicinal and recreational use in two states and other states are introducing legislation of their own. Marijuana is approved for medicinal use with a prescription in 21 states and also Washington, D.C. with most other states expected to introduce legislation to approve use for medicinal purposes in the next few years.
Last year Dr. Sanjay Gupta, the medical correspondent for CNN, aired a controversial documentary, “Weed”, where he showed various promising medicinal uses for marijuana. He admits that he was wrong for many years about marijuana legalization, and after doing his own extensive research he is encouraged by the many real life cases he has seen where people with chronic, serious medical issues have been and continue to be helped by marijuana. He noted that marijuana does not have the dangerous side effects that many prescription medications do and that it is actually safer than many drugs being prescribed today. Dr. Gupta said in the program that there is not one documented case where death was due to marijuana overdose and he is right.
But as with any systematic paradigm shift, there will always be those whose minds are closed to change. So as the march toward legalization continues, there is new anti-legalization propaganda being written and spread through mainstream and social media. There have been multiple reports out of Colorado that there are now deaths attributed to marijuana overdose. Some say children were involved which automatically evokes feelings of fear in parents across the country. But when I tried to find more reliable sources to verify these articles, none existed. The AP reported on April 2 that a Wyoming college student jumped to his death in Colorado after eating a marijuana cookie while on Spring Break in Colorado. The autopsy listed marijuana intoxication as a “significant contributing factor” in the teen’s death. (Gurman)
Like alcohol, Colorado bans the sale of marijuana and marijuana edibles to people under the age of 21. But much like alcohol, teens that want to get it will always find a way. This young man was just 19, and his death has been ruled accidental. While it is true his death is tragic, is it a reason to reverse the course with marijuana? If you believe this is the case then you must consider the real dangers posed by alcohol. Many people who would like to see marijuana legalized say that it is much safer than the legal drug alcohol. Based solely on the numbers of hospitalizations and deaths, especially with young people, they would be right.
According to an article posted on Forbes.com in March of this year, “1,825 college students between the ages of 18 and 24 die each school year from alcohol-related unintentional injuries.” The author, Dr. Robert Glatter, MD attributes these deaths to one of the leading health risks facing our young people, and that is binge drinking. This number is quite small in comparison to emergency room visits and hospitalizations of young people that are a direct result of alcohol use.
Taking the most heat are the marijuana edibles that are now for sale in states where marijuana has become legal. The concern is that children are eating marijuana laced candy and baked goods and becoming ill. This would seem to be confirmed by an article in USA Today that reported that calls to the Rocky Mountain Poison Control is Colorado regarding marijuana ingestion in children had risen to 70 cases last year. While they admitted that this number was low, it was the rapid rise from years previous that caused concern. To put this in perspective, there are approximately 1.4 million pediatric poisonings each year involving prescription medications not including marijuana. (Henry, et.al) That is an average of approximately 28,000 calls per state. Tragically several hundreds of these cases result in deaths of these children, with the highest rates of death involving narcotics, sedatives and anti-depressants. (Henry, et.al.)
Of those 70 cases reported in Colorado involving marijuana, none resulted in death. The results are quite clear marijuana is as safe as prescription drugs are dangerous. For those who want to weigh in on the marijuana legalization debate, it is important to do your research, look at the big picture and put everything in perspective. Alcohol is legal and heavily regulated, yet its use is linked to thousands of deaths each year. Prescription drugs are legal and heavily regulated, yet they too are linked to thousands of deaths each year. Marijuana, on the other hand, is not legal and not available in much of the country, and thus far has not caused one death from overdose ever.
Additionally, research is showing marijuana has promise in treating many diseases more effectively and safely than dangerous prescription medications being used today. From cancer to epilepsy to depression and anxiety, to chronic autoimmune diseases, scientists are just scratching the surface when it comes to the potential life-changing and perhaps even, life-saving uses for marijuana.
Drug Overdose in the United States: Fact Sheet. (2014, February 10). Centers for Disease Control and Prevention. Retrieved May 4, 2014, from http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html
Glatter, R. (2014, March 11). Spring Break’s Greatest Danger. Forbes. Retrieved May 5, 2014, from http://www.forbes.com/sites/robertglatter/2014/03/11/spring-breaks-greatest-danger/
Gurman, S. (2014, April 2). Young man leaps to death after eating pot-laced cookie. USA Today. Retrieved May 5, 2014, from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edible-death-colorado-denver/7220685/
Henry, K., & Harris, C. R. (2006). Deadly Ingestions. Pediatric Clinics of North America, 53(2), 293-315.
Hughes, T. (2014, April 2). Colo. Kids getting into parents’ pot-laced goodies. USA Today. Retrieved May 5, 2014 from http://www.usatoday.com/story/news/nation/2014/04/02/marijuana-pot-edibles-colorado/7154651/
I am constantly on the look-out for good studies of alternative medicine, particularly those that yield positive findings. The trouble is that there aren’t many of those; studies tend to be either good or positive. Could this one be an exception?
The aim of this brand-new trial was to determine, if dietary supplements of glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain in patients with knee osteoarthritis. It was designed as a double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45–75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both of these dietary supplements (n=151) or placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0–10) was self-reported in a participant diary for 7 days every 2 months over 1 year.
The results indicate that, after adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberden’s nodes), allocation to the dietary supplement combination (glucosamine–chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm 0.20 mm); no significant structural effect for the single treatment allocations was detected. All 4 groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period.
The authors drew the following conclusions: allocation to the glucosamine–chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo.
This study has many strengths: it addresses a relevant research question, has a sufficiently large sample size, includes a long follow-up, and is well reported. So, it is a good study of an alternative therapy that is used by many patients. But did it really produce a positive result, i.e. findings which suggest that the tested treatments are effective? The answer seems ‘yes and no’. The combined, regular intake of both supplements caused less joint space narrowing which is a good objective sign of reduced disease activity. However, this was not paralleled by a reduction in pain that was better than that on placebo.
So, if you are a fan of glucosamine/chondroitin supplements, you will be pleased with this study, but if you are not in favour of such medications or do not have the spare cash to afford the considerable costs, you might say: I told you, they are pretty useless!