Homeopathy seems to attract some kind of miracle worker. Elsewhere I have, for instance, reported the curious case of Prof Claudia Witt who published more than anyone on homeopathy in recent years without hardly ever arriving at a negative conclusion. Recently, I came across a researcher with an even better track record: Prof Michael Frass.
Wikipedia describes his achievements as follows: “Michael Frass studied medicine from 1972 to 1978 at the Medical University of Vienna followed by visits abroad at the Pasteur Institute, Paris and at the Porter Memorial Hospital (USA). Since March 2004 he directs the Outpatients Unit of Homeopathy for Malign Diseases at the Department Clinic for Internal of Medicine I at the Medical University of Vienna. Since 2005 Frass also works as a coordinator of the lecture series Homeopathy at the Medical University of Vienna. Beginning with the winter semester 2001/02 he is the coordinator of a lecture series Basics and practise of complementary medical methods at the Medical University of Vienna. From 2002 to 2005 he led the Ludwig Boltzmanm Institute of Homeopathy. Since 2005 Frass is president of the Institute for Homeopathic Research. Actually he works at the Division of Oncology at the Department of Medicine I in Vienna. He is First Chairman of the Scientific Society for Homeopathy (WissHom), founded in 2010, president of the Umbrella organization of Austrian Doctors for Holistic Medicine.”
He directs the WHAT? The Outpatients Unit of Homeopathy for Malign Diseases at the Department Clinic for Internal of Medicine I at the Medical University of Vienna? This is my former medical school, and I had no idea that such a unit even existed – but, of course, I left in 1993 for Exeter (a few months ago, I followed an invitation to give a lecture on homeopathy at the Medical University of Vienna ; sadly neither Prof Frass nor anyone of his team attended).
And what about the Scientific Society for Homeopathy? I am sure that the name of this organisation will make some people wonder. From the society’s website, we learn that “the intention of WissHom is to contribute to the progress of medicine and to the collective good. To this end, WissHom intents to further develop homeopathy both practically and theoretically. It will be WissHom’s task to breathe life into this committed objective.”
Breathing life into homeopathy seems exactly what Prof Frass does. He seems to have found his way to homeopathy relatively late in his career (the 1st Medline-listed article was published only in 2003) but he has nevertheless published many studies on this subject (I use the term ‘study’ here to describe both clinical, pre-clinical and basic research papers); in total, I found 12 such articles on Medline. They cover extremely diverse areas and a wide range of methodologies. Yet they all have one remarkable feature in common: they arrive at positive conclusions.
You find this hard to believe? Join the club!
But it is undeniably true, here are the conclusions (or the bit that comes close to a conclusion) from the Medline-listed abstracts (only the headings in capital letters are mine, and they simply depict the nature of the paper)
Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.
Based on the 2 cases, including 1 extreme situation, we suggest that adjunctive homeopathic treatment has a role in the treatment of acute Amanita phalloides-induced toxicity following mushroom poisoning. Additional studies may clarify a more precise dosing regimen, standardization, and better acceptance of homeopathic medicine in the intensive care setting.
Extended survival time in this sample of cancer patients with fatal prognosis but additive homeopathic treatment is interesting. However, findings are based on a small sample, and with only limited data available about patient and treatment characteristics. The relationship between homeopathic treatment and survival time requires prospective investigation in larger samples possibly using matched-pair control analysis or randomized trials.
The symptoms of patients undergoing homeopathic treatment were shown to improve substantially and conventional medication dosage could be substantially reduced. While the real-life effect assessed indicates that there is a potential for enhancing therapeutic measures and reducing healthcare cost, it does not allow to draw conclusions as to the efficacy of homeopathic treatment per se.
The data suggest that both drugs prepared in ethanolic solution are potent inhibitors of H. pylori induced gene expression.
Most of these clinical studies have been deemed to be high quality trials, according to the three most commonly referenced meta-analyses of homeopathic research. Basic in vitro experimental studies also provide evidence that the effects of homeopathy differ from placebo.
This study is based on 25 well documented reports of cases which responded well to treatment with Petroleum.
Animals treated with the standard test solution thyroxine 10(-30) metamorphosed more slowly than the control animals, ie the effect of the homeopathically prepared thyroxine was opposed to the usual physiological effect of molecular thyroxine.
Our report suggests that homeopathy may be applicable even for critically ill patients.
Our data suggest that homeopathic treatment may be a useful additional therapeutic measure with a long-term benefit for severely septic patients admitted to the intensive care unit. A constraint to wider application of this method is the limited number of trained homeopaths.
These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.
These animals reacted to the homeopathically prepared thyroxine with a slowing down of metamorphosis, even when they had not been prestimulated with a molecular dose of the hormone. This effect was observed in all 3 laboratories and is consistent with the results of previous studies.
So am I!
How can homeopathy produce nothing but positive results in the hands of this researcher? How can it work in so many entirely different conditions? How is it possible that homeopathic remedies are better than placebo regardless of the methodology used? Why does homeopathy, in the hands of Prof Frass, not even once produce a result that disappoints the aspirations of homeopaths and its advocates? Why are these sensational results almost invariably published in very minor journals? Crucially, why has not one of the findings (as far as I can see) ever been independently reproduced?
I do not know the answers to these questions.
If anyone does, I would like to hear them.
We could have expected it, couldn’t we? With so much homeopathy in the press lately, Dr Dixon (we have seen him on this blog before, for instance here, here and here) had to comment. His article in yesterday’s NURSING IN PRACTICE is far too perfect to abbreviate it; I just have to cite it in full (only the reference numbers are mine and refer to my comments below).
HERE WE GO
Should homeopathy be blacklisted in general practice?
I have not prescribed them myself but I know of many GPs and patients who find homeopathic preparations helpful, especially in clinical areas where there is no satisfactory conventional treatment . They are cheap and entirely safe , which cannot always be said of conventional treatment . Is the concern about cost? That is implausible as GP prescriptions cost a mere £100,000 per annum, approximately £10 per UK General Practice but effectively less as some patients will be paying for them and they may reduce other prescriptions or medical costs . Is it about evidence?  Possibly, and that is because the necessary pragmatic trials on comparative cost effectiveness have never been done . Homeopathy thus joins the frequently quoted 25% of general practice activity that has an insufficient evidence base… So, why not do the research rather than single out homeopathy for blacklisting ? Apparently, because it irritates a powerful fraternity of “scientists”  with a narrow biomedical perspective on health and healing, who feel the need to impose their atheism  on others. They seem opposed to “patient-centred medicine” which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them . Led by the World Health Organization, many countries are examining the appropriate role of complementary and traditional medicine (CAM). Indian Prime Minister Modi has created the first minister for medicine in this area (called AYUSH with the “H” standing for homeopathy). Australia, whose government and medical deans (unlike the UK ) are not intimidated by this breed of scientific fundamentalism, has invested money in research, regulated its herbal  practitioners and created important trade links with China in this area . Meanwhile the UK invests 0% of its research budget on CAM and appears to have a closed mind . General practice is at its best a subtle and complex blend of science and art combined in a heady mixture, which recognises personal belief and perspective and respects differences . Blacklisting homeopathy would be the thin edge of the wedge. It would be a mean-minded act of outside interference by many who do not treat patients themselves, denying patient choice and signifying a new age of intolerance and interference . It is a threat to the autonomy of general practice that should concern every GP and patient whatever their views on homeopathy .
About the Author
Chairman of the NHS Alliance and a GP
Mike Dixon, chairman of the NHS Alliance and a GP at College Surgery in Cullompton, Devon and a Royal College of General Practitioners presidential candidate.
END OF QUOTE AND BEGINNING OF MY DELIBERATELY BRIEF COMMENTS
- Whenever this argument comes up, people fail to cite an example. Are they afraid that we would point out what can be done for such a patient other than prescribing placebos?
- Actually, they are extremely expensive considering that they are just lactose or water. And the claim that homeopathy is safe merely displays an embarrassing lack of knowledge; see the many posts on this blog that deal with this issue.
- Classical ‘tu quoque’ fallacy; display of the ignorance of the risk/benefit concept for judging the value of medical interventions.
- Display of ignorance regarding the actual evidence, see here, for instance.
- Yes, it’s the evidence but also it’s the biological implausibility and the fact that disregarding it undermines rationality in general.
- Pure ignorance again, see my point 4.
- Are ~ 300 clinical trials and about 100 systematic reviews not enough? How much more money needs to be wasted?
- It seems that Dixon has a problem with science and those who pursue it to improve future health care for the benefit of patients.
- Does Dixon admit that homeopathy is a religion?
- Patient-centred medicine which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them – does Dixon not know that all good medicine fits this description, but homeopathy certainly does not?
- Every one with an IQ above 50 knows by now that herbal is not homeopathic; is Dixon the exception?
- What about the Australian report which concluded that “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.”
- This is simply not true, and Dixon should know it.
- No reason to include disproven nonsense like homeopathy.
- Intolerance is on Dixon’s side, I think. Improving health care by abandoning disproven therapies in favour of evidence-based treatments is no interference, it’s progress.
- This can only be true, if we misunderstand autonomy as arbitrariness without rules, checks, ethics and controls. Good general practice has, like all medicine, be in the best interest of patients. An obsolete, expensive, unsafe, ineffective and implausible treatment is clearly not.
Not long ago, Peter Fisher fired me from the editorial board of ‘his’ journal ‘HOMEOPATHY’. I thought that this was a surprisingly daft move, particularly as we used to have respect for each other and even published together as co-authors (for instance here). But perhaps I should not have been surprised because, already in 2007, he published an important, potentially libellous falsehood about me.
In this article which he published as Dr. Peter Fisher, Homeopath to Her Majesty, the Queen, he wrote: There is a serious threat to the future of the Royal London Homoeopathic Hospital (RLHH), and we need your help…Lurking behind all this is an orchestrated campaign, including the ’13 doctors letter’, the front page lead in The Times of 23 May 2006, Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), and the deeply flawed, but much publicised Lancet meta-analysis of Shang et al…
If you have read my memoir, you will know that even the hostile 13-months investigation by my own university did not find me guilty of the ‘leak’. The Times journalist who interviewed me about the Smallwood report already had the document on his desk when we spoke, and I did not disclose any contents of the report to him. But the truth in homeopathy seems often highly diluted.
More recently, Peter Fisher could be heard on UK radio and TV (for instance here) making further claims which, in my view, are false. Specifically, I am thinking of two of his statements which would mislead the public, if they stood uncorrected:
- He said that the studies unanimously show that integrating homeopathy into conventional medicine improves outcomes and saves money.
- He also claimed that most of the homeopathic remedies available in the high street still contain small amounts of active ingredients.
POINT NUMBER 1
It seems obvious that adding homeopathy with its lengthy, compassionate encounters to conventional care can easily generate positive outcomes. But costs? I don’t see unanimously positive evidence here at all.
Dr Fisher must know the literature on homeopathy very well. Therefore I assume that he is aware of the most up-to-date systematic review of economic evaluations of this subject. Its authors from the ‘School of Health and Related Research’, University of Sheffield concluded that “it is… not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Fisher knows and likes to quote Claudia Witt’s work on homeopathy. Why does he not cite this recent paper then?
The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group).
Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache).
Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14-7,414.29]) than in the control group (EUR 5,857.56 [5,650.98-6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48-3,809.53] vs. control EUR 3,092.84 [2,981.31-3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90-1,102.59] vs. control EUR 867.87 [853.52-882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant.
Compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system.
To speak about unanimously positive evidence is simply not true! And Fisher, I suspect, must know it.
POINT NUMBER 2
This point is even clearer, I think. The most commonly used homeopathic potency is surely a ’30C’ – it was already Hahnemann’s favourite. A small statistic proves my point: of the 24 products listed on the Nelson site, 21 are ’30C’ and just three are ‘6C’. For Ainsworths, all 33 of their listed standard products are ’30C’. Helios have 70 ’30C’ products and 27 ‘200C’ products
The likelihood that a ’30C’ contains a single molecule of what it says on the bottle is precisely zero. In fact, this applies already to all remedies beyond ’12C’. Fisher knows that, of course, I assume; if not he should not be a homeopath.
MY CONCLUSION OF ALL THIS
I do not take any pleasure in calling anyone a liar – and it is, of course, far from me to use this word in connection with the Queen’s homeopath. Therefore, in the interest of the scientific truth, medical ethics and honesty, I would like to give Dr Fisher the opportunity to comment on the above issues and herewith invite him to correct the three errors/falsehoods/inaccuracies/misunderstandings mentioned above by supplying the evidence for his statements or by withdrawing them. Then we won’t have to call him names which he might feel are hurtful.
Recently an interesting article caught my eye. It was published in the official journal of the ‘Deutscher Zentralverein Homoeopathischer Aerzte’ (the professional body of German doctor homeopath which mostly acts as a lobby group). Unfortunately it is in German – but I will try to take you through what I believe to be the most important issue.
The article seems to have the aim to defame Natalie Grams, the homeopath who had the courage to change her mind about homeopathy and to even write a book about her transformation. This book impressed me so much that I wrote a post about it when it was first published. The book did, however, not impress her ex-colleagues. Consequently the book review by the German lobbyists is full of personal attacks and almost devoid of credible facts.
A central claim of the defamatory piece is that, contrary to what she claims in her book, homeopathy is supported by sound evidence. Here is the crucial quote: Meta-Analysen von Kleijnen (1991), Linde (1997), Cucherat (2000) und Mathie (2014) [liefern] allesamt positive Ergebnisse zur Wirksamkeit der Homöopathie… This translates as follows: meta-analyses of Kleijnen, Linde, Cucherat and Matie all provide positive results regarding the effectiveness of homeopathy. As this is a claim, we hear ad nauseam whenever we discuss the issue with homeopathy (in the UK, most homeopathic bodies and even the Queen’s homeopath, P Fisher, have issued very similar statements), it may be worth addressing it once and for all.
This paper was the result of an EU-funded project in which I was involved as well; I therefore know about it first hand. The meta-analysis itself is quite odd in that it simply averages the p-values of all the included studies and thus provides a new overall p-value across all trials. As far as I know, this is not an accepted meta-analytic method and seems rather a lazy way of doing the job. The man on our EU committee was its senior author, professor Boissel, who did certainly not present it to us as a positive result for homeopathy (even Peter Fisher who also was a panel member should be able to confirm this). What is more, the published conclusions are not nearly as positive as out lobbyists seem to think: ‘There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.’
The meta-analysis by Linde et al seems to be the flag-ship in the homeopathic fleet. For those who don’t know it, here is its abstract in full:
BACKGROUND: Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo.
METHODS: We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, “remedy”, population, and outcomes.
FINDINGS: The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05).
INTERPRETATION: The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
Again, the conclusions are not nearly as strongly in favour of homeopaths as the German lobby group assumes. Moreover, this paper has been extensively criticised for a wide range of reasons which I shall not have to repeat here. However, one point is often over-looked: this is not an assessment of RCTs, it is an analysis of studies which were double-blind and/or randomised and placebo-controlled. This means that it includes trials that were not randomised and studies that were not double-blind.
But this is just by the way. What seems much more important is the fact that, in response to the plethora of criticism to their article, the same authors published a re-analysis of exactly the same data-set two years later. Having considered the caveats and limitations more carefully, they now concluded that ‘in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results.’
It is most intriguing to see how homeopaths cite their ‘flagship’ on virtually every possible occasion, while forgetting that a quasi correction has been published which puts the prior conclusions in a very different light !
The much-cited article by Kleijnen is now far too old to be truly relevant. It includes not even half of the trials available today. But, for what it’s worth, here are Kleijnen’s conclusions: At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials.
If the homeopathy lobby today proclaims that this paper constitutes proof of efficacy, they are in my view deliberately misleading the public.
The Mathie meta-analysis has been extensively discussed on this blog (see here and here). It is not an overall meta-analysis but merely evaluates the subset of those trials that employed individualised homeopathy. Crucially, it omits the two most rigorous studies which happen to be negative. Its conclusions are as follows: ‘Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.’
Again, I would suggest that anyone who interprets this as stating that this provides ‘positive results regarding the effectiveness of homeopathy’ is not telling the truth.
MY CONCLUSIONS FROM ALL THIS:
- Some systematic reviews and meta-analyses do indeed suggest that the trial data are positive. However, they all caution that such a result might be false-positive.
- None of these papers provide anything near a proof for the effectiveness of homeopathy.
- Homeopathy has not been shown to be more than a placebo therapy.
- To issue statements to the contrary is dishonest.
When it comes to alternative medicine, the public relies heavily on the writings of health journalists. We therefore have to count ourselves lucky to have some that are outstanding in their ability to inform the public honestly, objectively and responsibly. Here is an excerpt of what one particularly gifted and ethical heath journalist (and consultant!!!) just published regarding the treatment of babies and kids on a highly visible, popular website:
Homeopathy, or homeopathic medicine, is based on the principle that “like cures like.” Instead of treating an individual’s illness, homeopathy treats individual symptoms with substances from plants and minerals that are highly diluted and “succussed,” or shaken to release energy, said Sara Chana Silverstein, a homeopath, master herbalist and an international board-certified lactation consultant…Although homeopathy isn’t meant to replace Western medicine, it can be a complementary or alternative approach for ailments like colds, the stomach flu and teething. For example, if your pediatrician has diagnosed your baby with an upper respiratory infection, there’s not much you can do other than offer lots of fluids, rest and possibly acetaminophen or ibuprofen. In this case, a homeopathic remedy might help. Plus, since antibiotic overuse and antimicrobial resistance remain a major concern in the U.S., and antibiotics often have side effects, homeopathy could help heal without the need for a prescription. In fact, a study in the journal Homeopathy found that homeopathy for ear infections was just as effective as conventional treatment but patients in the homeopathic group had a faster improvement in symptoms. Although some studies show promising results, more research is needed to determine who homeopathic remedies work best for and in what situations, said Dr. Hilary McClafferty, chair of the American Academy of Pediatrics’ Section on Complementary and Integrative Medicine…
“In the United, States, the homeopathic products that carry the label, HPUS—
Homeopathic Pharmacopeia of the United States— are prepared with a very standardized, procedural monograph. So there is a map and regulations that ensure what’s on the label is what’s in the bottle,” McClafferty said…The only adverse effect of homeopathy, according to Silverstein, is that if a baby consumed a remedy too frequently, such as every hour for 10 hours, they would “prove” the remedy, or create the symptoms the remedy was trying to heal. “But if you gave it to a child 3 times a day at a low dose, personally I do not believe it could injure a child in anyway whatsoever,” she said…Your best bet is to see a trained homeopath who will target individual symptoms and give you pellets in the size that’s appropriate for your child’s age, Silverstein said. The bottom line when it comes to deciding between homeopathy, a medication or another remedy? “You want to be well educated, conservative and in touch with your pediatrician,” McClafferty said.
Julie Revelant is a health journalist and a consultant who provides content marketing and copywriting services for the healthcare industry. She’s also a mom of two. Learn more about Julie at revelantwriting.com.
As I said: outstanding!
With so much sound information about homeopathy and its merits in the treatment of childhood conditions, we are inclined to forgive the few tiny errors and marginally misleading statements that might require corrections such as:
- homeopathy is very much meant as a replacement of conventional medicine by its inventor Hahnemann who was adamant that it must not be combined with other treatments because it is the only true healing art;
- there is no good evidence that homeopathy is anything else than a placebo for children or, indeed, for anyone else;
- the study in the journal ‘Homeopathy’ was lousy and does not allow any conclusions whatsoever about the effectiveness of homeopathy;
- to state “some studies show promising results” is very misleading; the totality of the reliable evidence is negative;
- more research is not needed to determine who benefits from homeopathy; there is no longer a debate about homeopathy within science;
- the label of a typical homeopathic preparation does not tell you what’s in the bottle, at best it tells you what used to be there;
- the main risk of homeopathy is that diseases are not treated effectively; in this way, homeopathy can kill.
Yes, these are but very minor flaws, I know. They should not distract from this journalist’s great achievement of getting her brilliantly informative article read by the widest possible audience. If Prince Charles offered an award for the best science writer of the year (why has he not yet thought of this publicity stunt?), she would certainly be a candidate.
An article in the Australian Journal of Pharmacy seems well worth mentioning on this blog. It throws some light on what is happening in Australia regarding an issue that I have repeatedly written about: the sale of homeopathic remedies by pharmacists.
Pharmaceutical Society of Australia have apparently published a ‘Complementary Medicines Position Paper’ which states that complementary medicines may be used as an adjunctive therapy with conventional medicines, provided there is evidence to support their use. The president of the PSA, Joe Demarte, says that the PSA is committed to supporting pharmacists help consumers make informed decisions regarding complementary medicines and continued to advocate strongly for a partnership approach with consumers to promote the Quality Use of Medicines and responsible self-medication. “This is a partnership between the pharmacist and the consumer where the pharmacist as the medicines expert can advise on the appropriate use of complementary medicines the consumer may be considering,” Demarte is quoted saying. He continues: “There is a wealth of information available about complementary medicines which can be confusing and the pharmacist can assist in ensuring that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm. In the event that a consumer chooses to use a product with limited evidence, the pharmacist must advise the consumer on the risks of rejecting or delaying treatments for which there is good evidence for safety and effectiveness. PSA strongly encourages all consumers considering taking complementary medicines to first consult their pharmacist for sound, evidence-based advice.”
So far so good – but what about disproven treatments such as homeopathy, I wonder.
Demarte says the PSA endorses the NHMRC report, released in March 2015, which found there were no health conditions for which there was reliable evidence that homeopathy was effective. And he states that the PSA does not support the sale of homeopathy products in pharmacies: “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect.”
This surely is good news for all who stand up for evidence-based medicine and foremost for patients. It comes only a few months after the RPS Chief Scientist of the UK Royal Pharmaceutical Society, Professor Jayne Lawrence stated very similar things: “The public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”
Now that we are (almost) all in perfect agreement, we only need one thing: adequate action by pharmacists!
A recent article promised to provide details of the ’10 most mind-numbingly stupid alternative therapies’. Naturally I was interested what these might be. In descending order they are, according to the author of the most enjoyable piece:
10 VEGA TESTING
8 CRYSTAL HEALING
7 URINE THERAPY
6 DETOXIFYING FOOT PADS
5 WHEAT-GRASS ENEMAS
4 PSYCHIC SURGERY
3 OZONE THERAPY
2 CUPPING THERAPY
This is quite a list, I have to admit. Despite some excellent choices, I might disagree with a few of them. Detoxifying foot pads will take care of a common and most annoying problem: smelly feet; therefore it cannot be all bad. And drinking your own urine can even be a life-saver! Lets assume someone has a kidney or bladder cancer. Her urine might, at one stage, be bright red with blood. The urine therapy enthusiast would realise early that something is wrong with her, go and see a specialist, get early treatment and save her life. No, no no, I cannot fully condemn urine therapy!
The other thing with the list is that one treatment which is surely mind-bogglingly stupid is missing: CHELATION THERAPY.
I have previously written about this form of treatment and pointed out that some practitioners of alternative medicine (doctors, naturopaths, chiropractors and others) earn a lot of money claiming that chelation therapy (a well-established mainstream treatment for acute heavy metal poisoning) is an effective therapy for cardiovascular and many other diseases. However, this claim is both implausible and not evidence-based. Several systematic reviews of the best evidence concluded less than optimistically:
Despite all this, the promotion of chelation continues unabated. An Australian website, ironically entitled ‘LEADERS IN INTEGRATIVE MEDICINE’, might stand for many others when it informs its readers about chelation therapy. Here is a short passage:
Chelation therapy has the ability to remove the calcium from artery plaques as well as remove toxic ions, reduce free radical damage and restore circulation to all tissues of the body. A growing number of physicians use chelation therapy to reverse the process of atherosclerosis (hardening of the arteries) and as an alternative to angioplasty and bypass surgery.
Chelation therapy is a treatment to be considered for all conditions of reduced blood flow (coronary artery disease, cerebral vascular disease, peripheral vascular disease, angina, vertigo, tinnitus, senility), any situations of heavy metal toxicity or tissue overload and various chronic immune system disorders such as rheumatoid arthritis. Intravenous vitamin C is useful for the treatment of chronic and acute infections, fatigue, pre- and post-surgery and to boost the immune system while undergoing cancer therapies.
Not bad, isn’t it. How come such mind-numbing stupidity escaped the author of the above article? Was it an oversight? Was the choice just too overwhelming? Or did he not think chelation was all that funny? I ought to mention that it is not at all harmless like sampling your own urine or having a Reiki healer sending some ‘healing energy’.
Whatever the reason, I hope for an up-date of the list, he will consider chelation as a seriously mind-numbing contender.
A short report about a Scottish legal case is worth a mention, I think.
Honor Watt, 73 had sued Lothian Health Board after the authority stopped in June 2013 to provide homeopathic treatments to patients. Ms Watt, an arthritis sufferer, had previously received homeopathic medicine for this condition. There is, of course, no good evidence that homeopathic remedies are better than placebos for this (or any other) disease.
Ms Watt’s lawyers decided to challenge the board’s decision in the Court of Session claiming the health board acted illegally. There is reason to believe that Ms Watt was assisted by a professional organisation of homeopathy ( the judgement mentions that the Board’s submission stated that ‘the real force behind the petition was a charity, not the petitioner’).
In any case, Watt’s legal team claimed the Equality Act 2010 placed an obligation on the health board to ask their patients for their views on whether homeopathy should be continued to be funded. The legislation states that public sector organisations have an obligation to consider their decisions on the terms of what is called a public sector equality duty.
The case went to court and the judge, Lord Uist, recently ruled that the health board had acted legally. He therefore refused to overturn the board’s original decision. In a written judgement issued on Friday, Lord Uist confirmed that the health board acted correctly: “It is clear to me from an examination of the relevant documents that the board was from the outset consciously focusing on its PSED.”
The judgement explains that Ms Watt was first referred to the homeopathic service in 2003 when she was suffering from anxiety. Later, she was given a homeopathic medicine for her arthritis after telling her doctor that conventional medicine wasn’t controlling her problems with this condition. In January 2014, she had a final appointment with the homeopathic service and told that she was no longer entitled to homeopathic treatment. However, the judgement states that Ms Watt still receives a prescription of homeopathic medicine.
Lothian Health Board decided to end homeopathic provision after concluding the money would be better spent on conventional treatments. The board made the decision after holding a consultation exercise and concluding that only few NHS users would be affected by their decision. In a report, the reasons for why the board should stop spending money on homeopthy were set out.
Judge Uist confirmed that this report “stated that the withdrawal of funding for homeopathic services would have a limited negative impact on patients and staff, the majority of patients were from more affluent areas and it was felt that they could perhaps afford to self fund alternative provision.”
Ms Watt’s lawyers claimed that the board didn’t do enough to seek the views of those who used the service. They argued that the board broke the terms of the 2010 Equality Act. After examining the evidence, Judge Uist concluded, however, that the health board had done everything in its power and had made the correct decision: “I am satisfied that reduction of the board’s decision of June 26 2013 would result only in a waste of time and public funds as it would inevitably result in exactly the same decision being taken by the board.”
From my perspective, this is an important decision. As a physician, I naturally dislike not giving patients what they want. However, I dislike it even more when there is not enough money for other patients to have essential treatments. Thus it is obvious that harsh decisions have to be made in order to spend the available funds as rationally as possible – and that, of course, means that treatments for which there is no good evidence must not be funded from public money. Homeopathy clearly falls in that category.
As I am not a lawyer, I see this case with the eyes of a medic and researcher. For me, it is about the age-old question: should patients get the treatment they want or the treatment they need? For me, health care is not a supermarket where people can their trolleys with everything they happen to fancy. For me, health care is not about satisfying the ‘wants’; it is about coping with the needs of people. For me, this is a question of medical ethics. For me, the Scottish judgement is spot on.
I just came across an announcement which could be important. Here are what I consider the important passages:
The Federal Trade Commission will host a public workshop on Monday, September 21, 2015 in Washington, DC, to examine advertising for over-the-counter (OTC) homeopathic products…
Because of rapid growth in the marketing and consumer use of homeopathic products, the FTC is hosting a workshop to evaluate the advertising for such products. The workshop will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.
The FTC invites the public to submit research, recommendations for topics of discussion, and requests to participate as panelists. The workshop will cover topics including:
- A look at changes in the homeopathic market, its advertising, and what consumers know;
- The science behind homeopathy and its effectiveness;
- The effects of recent class actions against homeopathic product companies;
- The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
- Public policy concerns about the current regulation of homeopathic products.
Public comments can be submitted electronically. Paper submissions should be sent to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex B), Washington, DC 20580, or delivered to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024. Paper submissions should reference the Homeopathic Medicine & Advertising Workshop both in the text and on the envelope. The deadline for submitting public comments is Friday, November 20, 2015.
The FTC also has set up an email box for anyone interested in being a panelist at the event or suggesting additional topics for discussion. It is firstname.lastname@example.org (link sends e-mail), and will be open until August 1, 2015.
The workshop is free and open to the public. It will be held at the Constitution Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date…
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad…
In my view, this is a long overdue initiative. Consumers are constantly and outrageously misled by the advertising of homeopathic products. This has the potential to impact negatively on public health.
It would not surprise me, if homeopathy advocates were to try to swamp this event with their promotion of homeopathy. Therefore, I thought it was important to post the announcement on my blog, in the hope that as many scientifically minded people as possible might file their evidence and objections.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.