MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

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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?

This article is hilarious, I think. It was written by Heike Bishop, a homeopath who works in Australia. Here she tries to advise colleagues how best to defend homeopathy and how to deal effectively with the increasingly outspoken criticism of homeopathy. Below is the decisive passage from her article; I have not changed or omitted a word, not even her grammatical or other mistakes [only the numbers in brackets were inserted by me; they refer to my comments added below]:

Getting up in the morning and hearing that all the television and radio station report that it is dangerous for people to see their homoeopath, is utterly heart breaking. Even more so because I grew up in East Germany where the government suppressed free speech and anything that was off the beaten path [1]. So what can we do in times like these?

First of all, watch out for Government inquiries. History has shown that they are usually not favourable towards homoeopathy [2] unless you live in Switzerland [3]. It is vitally important in times like these to put differences aside amongst our professional peers. Every association should be mobilised to take an active and ONGOING role to educate and advertise the benefits of homoeopathy [4]. If things have gone too far already, talk about freedom of choice [5]. Write articles and join blogs talking about what you can do specifically for certain conditions [6].  Encourage your patients to tell their success stories in blogs and other social media forums [7]. It is in most cases utterly useless to engage in any conversation [8] online with trolls [9].

Try to develop a calloused skin when it comes to criticism. Your patients don’t want to hear how difficult it is to be a homeopath [10], they want you to be in control and to be reassured that their treatment continues [11]. When someone asks you to comment on an attack on homoeopathy, put your best smile on and state how threatened the pharmaceutical industry must be to resort to such tactics [12].

Staphysagria is indeed a good remedy. Hahnemann also knew its benefits and even alternated it with Arsenicum the day his first wife died and he got a letter that the hospital built in his name allowed patients to choose their treatment between allopathy and homoeopathy [13]. That was the only time he took two remedies on the same day! [14]

Find out what you can about your country’s own internet trolls [15]. However, don’t underestimate their effectiveness in swaying popular opinion [16]. There is no denying that their methods are very effective [17]. It doesn’t matter how ludicrous their comments are, don’t go into direct explanation [18]. Learn from the enemy [19] and repeat a positive message over and over again so it can’t be contorted [20].

Our colleges should support post-graduate studies featuring marketing and media courses [21]. I once met a Homoeopath from the UK and she pointed out that part of the training in the UK is for students to hold homoeopathic first aid courses to promote homoeopathy [22]. Everyone is different – some of us are happy to stand in front of an audience others choose the pen as their sword [23]. The main thing is to do something to save the image of our healing art [24].

  1. Is she implying that facing criticism of homeopathy is akin to living in a totalitarian state? Or that criticism is a violation of free speech?
  2. I wonder why this is so – nothing to do with the evidence, I presume?
  3. Does she refer to the famous ‘Swiss Government report’ which was not by the Swiss Government at all?
  4. ‘Advertise and educate’ seems to be homeopathic speak for ‘MISLEAD’
  5. Good idea! Freedom of choice is a perfect argument (in this case, my choice would be to have a bottle of champagne at around 6 pm every day – on the NHS, of course).
  6. Certain conditions??? And I thought homeopaths do not treat conditions, only whole people.
  7. And forbid them to disclose stories where things did not work out quite so well?
  8. Very wise! Conversations are fraught with the danger of being found wrong.
  9. Critics are not critics but ‘trolls’ – makes sense.
  10. I would have thought that practising as a homeopath is not difficult at all – in most countries, they don’t even check whether you can spell the name correctly.
  11. Is it not rather the homeopath who wants the treatment to continue – after all, it is her livelihood?
  12. Ah yes, BIG PHARMA, the last resort of any quack!
  13. Did she not just praise patient choice as an important virtue?
  14. Hahnemann was famously cantankerous and argumentative all his life; does that mean that his remedies did not work?
  15. Homeopaths might need that for your ad hominem attacks.
  16. Never underestimate the power of truth!!!
  17. This might show that it is you and not the ‘trolls’ who are ludicrous.
  18. Particularly as there are no direct explanations for homeopathy.
  19. First the critics were ‘trolls’, now they have been upgraded to ‘enemy’! Is it really a war?
  20. You need to repeat it at least regularly so that eventually you believe it yourself.
  21. Are marketing and media a substitute for evidence?
  22. Really, first aid? Do homeopaths know what this is? Obviously not!
  23. But real clinicians, homeopaths call them allopaths, are quite happy simply with effective treatments that help patients to improve.
  24. And I thought the main thing was to treat patients with the most effective therapies available.

ENOUGH JOKING AND SARCASM!

There is, of course, a very serious message in all of this: when under pressure, homeopaths seem to think of all sorts of things in their (and homeopathy’s) defense – some more rational than others – but the ideas that criticism might be a good way to generate progress, and that a factual debate about the known facts might improve healthcare, do not seem to be amongst them.

Homeopathy is very popular in India – at least this is what we are being told over and over again. The notion goes as far as some sources assuming that homeopathy is quintessential Indian (see below). One Website, informs us that homeopathy is the third most popular method of treatment in India, after Allopathy and Ayurveda. It is estimated that there are about quarter million homeopaths in India. Nearly 10,000 new ones add to this number every year. The legal status of homeopathy in India is very much at par with the conventional medicine.

Another website currently advises the Indian population as well as heath tourists from abroad about homeopathy in the following terms:

Homeopathic medicines have various benefits. Some of them are as follows:

  • Such medicines can be given to infants, children, pregnant or nursing woman
  • If by chance, wrong medication is prescribed, it is not going to have any ill-effect
  • These medicines can be taken along with other medications
  • Homeopathic treatment can be used by anyone
  • The medicines work on the eradication of the symptoms so that illness never comes back
  • These medicines can be stored for a longer span of time and are inexpensive as well
  • Homeopathy has a holistic approach and deals with mind, body and emotions
  • These medicines are non-invasive and extremely effective
  • These medicines can be administered easily
  • Homeopathy useful in a number of health problems

Homeopathic Remedies, for Diseases and Conditions

  • Asthma
  • Arthritis
  • Cancer
  • Acute fevers
  • Sore throats
  • Toothache
  • Eczema
  • Mild depression
  • Fatigue
  • Anxiety
  • Cataract
  • Fractures
  • Injuries with blunt objects
  • Loss of appetite

But is it really true that so many Indian consumers swear by homeopathy, or is that just one of the many myths from the realm of quackery that stubbornly refuse to disappear ?

survey recently conducted by Indian National Sample Survey Office might provide some answers. It revealed that 90 per cent of the Indian population rely on conventional medicine. Merely 6% trusted what the investigators chose to call ‘Indian systems of medicine’, e. g. ayurveda, unani and siddha, homeopathy and yoga and naturopathy.

Odd? Not really! There are several plausible explanations for this apparent contradiction:

  1. The popularity of homeopathy in India could be a myth promoted by apologists.
  2. The figures could be correct, and many Indian patients could use homeopathy not because they believe in it but because they cannot afford effective treatments.
  3. The claim of homeopathy’s popularity could refer to the past, while the recent survey clearly relates to the present.

Whatever the true answer might be, I think this little news story is an instructive example for the fact that the ‘argumentum ad populum’ is a fallacy that easily can mislead us.

For ‘my’ journal FACT, I review all the new articles that have emerged on the subject of alternative medicine on a monthly basis. Here are a few impressions and concerns that this activity have generated:

  • The number of papers on alternative medicine has increased beyond belief: between the year 2000 and 2010, there was a slow, linear increase from 335 to 610 Medline-listed articles; thereafter, the numbers exploded to 1189 (2011), 1674 (2012) and 2236 (2013).
  • This fast growing and highly lucrative ‘market’ has been cornered mainly by one journal: ‘EVIDENCE BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE’ (EBCAM), a journal that I mentioned several times before (see here, for instance). In 2010, EBCAM published 76 papers, while these figures increased to 546, 880 and 1327 during the following three years.
  • Undeniably, this is big business, as authors have to pay tidy sums each time they get published in EBCAM.
  • The peer-review system of EBCAM is farcical: potential authors who send their submissions to EBCAM are invited to suggest their preferred reviewers who subsequently are almost invariably appointed to do the job. It goes without saying that such a system is prone to all sorts of serious failures; in fact, this is not peer-review at all, in my opinion, it is an unethical sham.
  • As a result, most (I estimate around 80%) of the articles that currently get published on alternative medicine are useless rubbish. They tend to be either pre-clinical investigations which never get followed up and are thus meaningless, or surveys of no relevance whatsoever, or pilot studies that never are succeeded by more definitive trials, or non-systematic reviews that are wide open to bias and can only mislead the reader.
  • Nowadays, very few articles on alternative medicine are good enough to get published in mainstream journals of high standing.

The consequences of these fairly recent developments are serious:

  • Conventional scientists and clinicians must get the impression that there is little research activity in alternative medicine (while, in fact, there is lots) and that the little research that does emerge is of poor quality.
  • Consequently alternative medicine will be deemed by those who are not directly involved in it as trivial, and the alternative medicine journals will be ignored or even become their laughing stock.
  • At the same time, the field of alternative medicine and its proponents (the only ones who might actually be reading the plethora of rubbish published in alternative medicine journals) will get more and more convinced that their field is supported by an ever- abundance of peer-reviewed, robust science.
  • Gradually, they will become less and less aware of the standards and requirements that need to be met for evidence to be called reliable (provided they ever had such knowledge in the first place).
  • They might thus get increasingly frustrated by the lack of acceptance of their ‘advances’ by proper scientists – an attitude which, from their perspective, must seem unfair, biased and hostile.
  • In the end, conventional and alternative medicine, rather than learning from each other, will move further and further apart.
  • Substantial amounts of money will continue to be wasted for research into alternative medicine that, whenever assessed critically, turns out to be too poor to advance healthcare in any meaningful way.
  • The ones who medicine should be all about, namely the patients who need our help and rely on the progress of research, are not well served by these developments.

In essence this suggests, I think, that alternative medicine is ill-advised and short-sighted to settle for standards that are so clearly below those generally deemed acceptable in medicine. Similarly, conventional medicine does a serious disfavour to progress and to us all, if it ignores or tolerates this process.

I am not at all sure how to reverse this trend. In the long-term, it would require a change of attitude that obviously is far from easy to bring about. In the short-term, it might help, I think, to de-list journals from Medline that are in such obvious conflict with publication ethics.

This post is dedicated to all homeopathic character assassins.

Some ardent homeopathy fans have reminded me that, some 25  years ago, I published (OH, WHAT A SCANDAL!!!) a positive trial of homeopathy; I even found a website that proudly announces this fact. Homeopaths seem jubilant about this discovery (not because they now need to revise their allegations that I never did any trials; or the other, equally popular claim, that I have always been squarely against their trade but) because the implication is that even I have to concede that homeopathic remedies are better than placebo. In their view, this seems to beg the following important and embarrassing questions:

  • Why did I change my mind?
  • Am I not contradicting myself?
  • Who has bribed me?
  • Am I in the pocket of Big Pharma?
  • Does this ‘skeleton in my closet’ discredit me for all times?

I remember the trial in question quite well. We conducted it during my time in Vienna, and I am proud of several innovative ideas that went into it. Here is the abstract in full:

The aim of this study was to test the effectiveness of a combined homeopathic medication in primary varicosity. A well-defined population of 61 patients was randomized into active medication (Poikiven®) or placebo. Both were given for 24 d. At the start of the trial, after 12 d medication and at the end of the study, objective and subjective parameters were recorded: venous filling time, leg volume, calf circumference, haemorheological measurements and patients’ symptoms such as cramps, itching, leg heaviness, pain during standing and the need to elevate the legs. The results show that venous filling time is changed by 44% towards normal in the actively-treated group. The average leg volume fell significantly more in this group, but calf circumferences did not change significantly and blood rheology was not altered in any relevant way. None of the patients reported side-effects. Subjective complaints were relieved significantly more by Poikiven than by placebo. These results suggest that the oral treatment of primary varicosity using Poikiven is feasible.

So, there we have it: a homeopathic remedy (as tested by me) is clearly better than placebo normalising important objective parameters as well as subjective symptoms of varicose veins. Is that not a contradiction of what I keep saying today, namely that homeopathy is a placebo therapy?

YES AND NO! (But much more NO than YES)

Yes, because that was clearly our result, and I never tried to deny it.

No, because our verum was far from being a homeopathic, highly diluted remedy. It contained Aesculus D1 12,5 ml, Arnica D1 2,5 ml, Carduus marianus D1 5 ml, Hamamelis D1 10 ml, Lachesis D6 5 ml, Lycopodium D4 5 ml, Melilotus officinalis D1 10 ml. Take just the first of these ingredients, Aesculus or horse chestnut. This is a herbal medicine that has been well documented (even via a Cochrane review) to be effective for the symptoms of varicose veins, and it contains Aesculus in the D1 potency. This means that it is diluted merely by a factor of 1:10. So, for all intents and purposes, our verum was herbal by nature, and there is no surprise at all that we found it to be effective.

[Here is a little ‘aside’: Aesculus is a proven treatment for varicose veins. Homeopathy must always rely on the ‘like cures like’ principle. Therefore, if Aesculus had been used in the homeopathic way, would it not, according to homeopathic dogma, had to worsen the symptoms of our patients rather than alleviating them?]

All of this would be trivial to the extreme, if it did not touch upon an important and confusing point which is often used as an ‘escape route’ by homeopaths when they find themselves between a rock and a hard place. Some trials of homeopathy are positive because they use medications which are homeopathic only by name. This regularly creates considerable confusion. In the recent BMJ debate I tried to address this issue head on by stating at the outset: ” Nobody questions, of course, that some substances used in homeopathy, such as arsenic or strychnine, can be pharmacologically active, but homeopathic medicines are typically far too dilute to have any effect.”

And that’s the point: homeopathic remedies beyond a C12 potency contain nothing, less dilute ones contain little to very little, and D1 potencies are hardy diluted at all and thus contain substantial amounts of active ingredients. Such low potencies are rarely used by homeopaths and should be called PSEUDO-HOMEOPATHIC, in my view. Homeopaths tend to use this confusing complexity to wriggle out of difficult arguments, and often they rely on systematic reviews of homeopathic trials which can generate somewhat confusing overall findings because of such PSEUDO-HOMEOPATHIC remedies.

To make it perfectly clear: the typical homeopathic remedy is far too dilute to have any effect. When scientists or the public at large speak of homeopathic remedies, we don’t mean extracts of Aesculus or potent poisons like Arsenic D1 (has anyone heard of someone claiming to have killed rats with homeopathy?); we refer to the vast majority of remedies which are highly dilute and contain no or very few active molecules – even when we do not explain this somewhat complicated and rather tedious circumstance each and every time. I therefore declare once and for all that, unless I indicate otherwise, I do NOT mean potencies below C6 when I speak of a ‘homeopathic remedy’ (sorry homeopathy fans, perhaps I should have done this when I started this blog).

What if our Vienna study all those years ago had tested not the pseudo-homeopathic ‘Poikiven’ but a highly dilute, real homeopathic remedy and had still come up with a positive finding? Would that make me inconsistent, dishonest, untrustworthy or corrupt? Certainly not!

I have always urged people to not go by the results of single trials. There are numerous reasons why a single study can produce a misleading result. We should therefore, wherever possible, rely on systematic reviews that critically evaluate the totality of the evidence (I would always mistrust even my own trial data, if it contradicted the totality of the reliable evidence) – and such analyses clearly fail to show that homeopathy is more than a placebo.

And even, if none of this had happened, and I had just changed my mind about homeopathy because

  • the evidence changed,
  • I had become wiser,
  • I had learnt how to think like a scientist,
  • I had managed to see behind the smokescreen many homeopaths put up to hide the truth?

Would that discredit me? I don’t think so! As someone once said, being able to change one’s mind is a sign of intelligence.

I am sure that the weird world of homeopathic character assassination will soon find something else to discredit me – but for now…

I REST MY CASE.

Chiropractors are back pain specialists, they say. They do not pretend to treat non-spinal conditions, they claim.

If such notions were true, why are so many of them still misleading the public? Why do many chiropractors pretend to be primary care physicians who can take care of most illnesses regardless of any connection with the spine? Why do they continue to happily promote bogus treatments? Why do chiropractors, for instance, claim they can treat gastrointestinal diseases?

This recent narrative review of the literature, for example, was aimed at summarising studies describing the management of disorders of the gastrointestinal (GI) tract using ‘chiropractic therapy’ broadly defined here as spinal manipulation therapy, mobilizations, soft tissue therapy, modalities and stretches.

Twenty-one articles were found through searching the published literature to meet the authors’ inclusion criteria. The retrieved articles included case reports to clinical trials to review articles. The majority of articles chronicling patient experiences under chiropractic care reported that they experienced mild to moderate improvements in GI symptoms. No adverse effects were reported.

From this, the authors concluded that chiropractic care can be considered as an adjunctive therapy for patients with various GI conditions providing there are no co-morbidities.

I think, we would need to look for a long time to find an article with conclusions that are more ridiculous, false and unethical than these.

The old adage applies: rubbish in, rubbish out. If we include unreliable reports such as anecdotes, our finding will be unreliable as well. If we do not make this mistake and conduct a proper systematic review, we will arrive at very different conclusions. My own systematic review, for instance, of controlled clinical trials drew the following conclusion: There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

That probably says it all. I only want to add a short question: SHOULD THIS LATEST CHIROPRACTIC ATTEMPT TO MISLEAD THE PUBLIC BE CONSIDERED ‘SCIENTIFIC MISCONDUCT’ OR ‘FRAUD’?

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