MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

evidence

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:

  1. He said that the studies unanimously show that integrating homeopathy into conventional medicine improves outcomes and saves money.
  2. 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?

OBJECTIVES:

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).

METHODS:

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).

RESULTS:

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.

CONCLUSION:

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.

  • CUCHERAT

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.’

Anybody who claims this is a proof for homeopathy’s efficacy should be sent back to school to learn how to read and understand English, in my view.
  • LINDE

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 !

  • KLEIJNEN

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.

  • MATHIE

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:

  1.  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.
  2. None of these papers provide anything near a proof for the effectiveness of homeopathy.
  3. Homeopathy has not been shown to be more than a placebo therapy.
  4. 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

9 REIKI

8 CRYSTAL HEALING

7 URINE THERAPY

6 DETOXIFYING FOOT PADS

5 WHEAT-GRASS ENEMAS

4 PSYCHIC SURGERY

3 OZONE THERAPY

2 CUPPING THERAPY

1 HOMEOPATHY

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:

…more controlled studies are required to determine the efficacy of chelation therapy in cardiovascular disease before it can be used broadly in the clinical setting.

The best available evidence does not support the therapeutic use of EDTA chelation therapy in the treatment of cardiovascular disease.

Given the potential of chelation therapy to cause severe adverse effects, this treatment should now be considered obsolete.

The available data do not support the use of chelation in cardiovascular diseases.

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 homeopathy@ftc.gov (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.

  1. Nonsensical research projects
  2. 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

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.

CONCLUSION

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.

Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:

The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).

Conclusions

Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

Let us be clear about what has happened here. I think, the events can be summarised as follows:

  • the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
  • they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
  • the question raises, what should the researchers give to the control group?
  • someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
  • the researchers are impressed and ask: but what precisely could we use?
  • let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
  • another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
  • the team is in agreement,
  • Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
  • a protocol is written,
  • ethics approval is obtained,
  • the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.

And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.

BOB’S YOUR UNCLE!

EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.

Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?

A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.

The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.

The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.

Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).

Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:

  1. Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
  2. The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
  3. The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
  4. It seems uncertain which essential oil is best suited for this indication.
  5. Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
  6. There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.

All in all, I think stronger evidence is required that aromatherapy is more that pampering.

ENOUGH SAID?

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