MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

commercial interests

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!

This seems to be the question that occupies the minds of several homeopaths.

Amazed?

So was I!

Let me explain.

In 1997, Linde et al published their now famous meta-analysis of clinical trials of homeopathy which concluded that “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.”

This paper had several limitations which Linde was only too happy to admit. The authors therefore conducted a re-analysis which, even though published in an excellent journal, is rarely cited by homeopaths. Linde et al stated in their re-analysis of 2000: “there was clear evidence that studies with better methodological quality tended to yield less positive results.” It was this phenomenon that prompted me and my colleague Max Pittler to publish a ‘letter to the editor’ which now – 15 years later – seems the stone of homeopathic contention.

A blog-post by a believer in homeopathy even asks the interesting question: Did Professor Ernst Sell His Soul to Big Pharma? It continues as follows:

Edzard Ernst is an anti-homeopath who spent his career attacking traditional medicine. In 1993 he became Professor of Complementary Medicine at the University of Exeter. He is often described as the first professor of complementary medicine, but the title he assumed should have fooled no-one. His aim was to discredit medical therapies, notably homeopathy, and he then published some 700 papers in ‘scientific’ journals to do so.

Now, Professor Robert Hahn, in his blog, has made an assessment of the quality of his work… In the interests of the honesty and integrity in science, it is an important assessment. It shows, in his view, how science has been taken over by ideology (or as I would suggest, more accurately, the financial interests of Big Corporations, in this case, Big Pharma). The blog indicates that in order to demonstrate that homeopathy is ineffective, over 95% of scientific research into homeopathy has to be discarded or removed! 

So for those people who, like myself, cannot read the original German, here is an English translation of the blog…

“I have never seen a science writer so blatantly biased as Edzard Ernst: his work should not be considered of any worth at all, and discarded” finds Sweden’s Professor Robert Hahn, a leading medical scientist, physician, and Professor of Anaesthesia and Intensive Care at the University of Linköping, Sweden.

Hahn determined therefore to analyze for himself the ‘research’ which supposedly demonstrated homeopathy to be ineffective, and reached the shocking conclusion that:

“only by discarding 98% of homeopathy trials and carrying out a statistical meta-analysis on the remaining 2% negative studies, can one ‘prove’ that homeopathy is ineffective”.

In other words, all supposedly negative homeopathic meta-analyses which opponents of homeopathy have relied on, are scientifically bogus…
 
 Who can you trust? We can begin by disregarding Edzard Ernst. I have read several other studies that he has published, and they are all untrustworthy. His work should be discarded… 

In the case of homeopathy, one should stick with what the evidence reveals. And the evidence is that only by removing 95-98% of all studies is the effectiveness of homeopathy not demonstrable…

So, now you are wondering, I am sure: HOW MUCH DID HE GET FOR SELLING HIS SOUL TO BIG PHARMA?

No? You are wondering 1) who this brilliant Swedish scientist, Prof Hahn, is and 2) what article of mine he is criticising? Alright, I will try to enlighten you.

PROFESSOR HAHN

Here I can rely on a comment posted on my blog some time ago by someone who can read Swedish (thank you Bjorn). He commented about Hahn as follows:

A renowned director of medical research with well over 300 publications on anesthesia and intensive care and 16 graduated PhD students under his mentorship, who has been leading a life on the side, blogging and writing about spiritualism, and alternative medicine and now ventures on a public crusade for resurrecting the failing realm of homeopathy!?! Unbelievable!

I was unaware of this person before, even if I have lived and worked in Sweden for decades.

I have spent the evening looking up his net-track and at his blog at roberthahn.nu (in Swedish).

I will try to summarise some first impressions:

Hahn is evidently deeply religious and there is the usual, unmistakably narcissistic aura over his writings and sayings. He is religiously confident that there is more to this world than what can be measured and sensed. In effect, he seems to believe that homeopathy (as well as alternative medical methods in general) must work because there are people who say they have experienced it and denying the possibility is akin to heresy (not his wording but the essence of his writing).

He has, along with his wife, authored at least three books on spiritual matters with titles such as (my translations) “Clear replies from the spiritual world” and “Connections of souls”.

He has a serious issue with skeptics and goes on at length about how they are dishonest bluffers[sic] who willfully cherry-pick and misinterpret evidence to fit their preconceived beliefs.

He feels that desperate patients should generally be allowed the chance that alternative methods may offer.

He believes firmly in former-life memories, including his own, which he claims he has found verification for in an ancient Italian parchment.

His main arguments for homeopathy are Claus Linde’s meta analyses and the sheer number of homeopathic research that he firmly believes shows it being superior to placebo, a fact that (in his opinion) shows it has a biological effect. Shang’s work from 2005 he dismisses as seriously flawed.

He also points to individual research like this as credible proof of the biologic effect of remedies.

He somewhat surprisingly denies recommending homeopathy despite being convinced of its effect and maintains that he wants better, more problem oriented and disease specific studies to clarify its applicability. (my interpretation)

If it weren’t for his track record of genuine, acknowledged medical research and him being a renowned authority in a genuine, scientific medical field, this man would be an ordinary, religiously devout quack.

What strikes me as perhaps telling of a consequence of his “exoscientific” activity, is that Hahn, who holds the position of research director at a large city trauma and emergency hospital is an “adjungerad professor”, which is (usually) a part time, time limited, externally financed professorial position, while any Swedish medical doctor with his very extensive formal merits would very likely hold a full professorship at an academic institution.

END OF QUOTE

MY 2000 PAPER THAT SEEMS TO IRRITATE HAHN

This was a short ‘letter to the editor’ by Ernst and Pittler published in the J Clin Epidemiol commenting on the above-mentioned re-analysis by Linde et al which was published in the same journal. As its text is not available on-line, I re-type parts of it here:

In an interesting re-analysis of their meta-analysis of clinical trials of homeopathy, Linde et al conclude that there is no linear relationship between quality scores and study outcome. We have simply re-plotted their data and arrive at a different conclusion. There is an almost perfect correlation between the odds ratio and the Jadad score between the range of 1-4… [some technical explanations follow which I omit]…Linde et al can be seen as the ultimate epidemiological proof that homeopathy is, in fact, a placebo.

And that is, as far as I can see, the whole mysterious story. I cannot even draw a conclusion – all I can do is to ask a question:

DOES ANYONE UNDERSTAND WHAT THEY ARE GOING ON ABOUT?

On this blog, we have repeatedly discussed the risks of acupuncture. Contrary to what we often hear, there clearly is potential for harm. Acupuncture is, of course most popular in China where it has been used for thousands of years. Therefore the Chinese literature, which is not easy to access for non-Chinese speakers and therefore often disregarded by Western researchers, might hold treasures of valuable information on the subject. It follows that a thorough review of this information might be helpful. A recent paper by Chinese scientists has tackled this issue.

The objective of this review was to determine the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers.

Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles.

The authors of this review concluded that qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.

This is a bizarrely disappointing article followed by a most strange conclusion. The authors totally fail to discuss the most important issue and they arrive at conclusions which, I think, make little sense.

The issue to discuss here is, of course, under-reporting. We know that under-reporting in the Western literature is already huge. For every complication reported there could easily be 10 or even 100 that go unreported. There is no monitoring system for adverse effects, and acupuncturists have no incentive to publish their mistakes. Accurate and realistic prevalence data are therefore anybody’s guess.

In China, under-reporting is likely to be one or two orders of magnitude bigger. I say this because close to zero % of all Chinese papers on acupuncture report negative findings. For China, TCM is a huge export business, and the interest in reporting adverse effects is close to zero.

Seen from this perspective, it seems at first glance laudable that the Chinese authors dared to address this thorny issue. In the text of the article, they even mention that the included complications resulted in a total of 25 fatalities! This seems courageous. But one only needs to read the full article to get a strong suspicion that the authors are either in denial about the real figures, or their paper is a deliberate attempt to ‘white-wash’ acupuncture from its potential to do harm.

In 2010, we published a very similar review of the Chinese literature (unsurprisingly, it was not cited by the authors of the new paper). At the time, we found almost 500 published cases of serious adverse events and stated that we suspect that underreporting of such events in the Chinese-language literature is much higher than in the English-language literature.

The truth is that nobody knows how frequent adverse events of acupuncture truly are in China – or most other countries, for that matter. I believe that, before we “further popularize acupuncture to the rest of the world”, it would be ethical and necessary to 1) state this fact openly and 2) do something about it.

Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.

The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.

Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.

Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.

Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.

The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.

The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.

These are odd conclusions, in my view, and I think I ought to add a few points:

  • As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
  • Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
  • The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
  • As the authors mention, it is  hardly ever the chiropractor who reports a serious complication when it occurs.
  • In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
  • Therefore their true rate is anyone’s guess.
  • As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
  • Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
  • Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.

And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.

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.

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.

While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.

This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.

In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.

Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.

The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.

This sounds like good news for naturopathy! However, there are several important caveats:

  • the authors seem to have only looked at US studies (naturopathy is a European tradition!),
  • the searches were done three years ago, and more recent data were thus omitted,
  • the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
  • rigorous trials were very scarce; and for each condition, they were even more so,
  • the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.

My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.

Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.

I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.

The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.

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.

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