conflict of interest
The Society of Homeopaths (SoH) is the UK’s professional organisation of lay-homeopaths, therapists who treat patients without having studies medicine. This is what they say about themselves:
Everyone needs a healthcare professional they can trust – one who’s trained to rigorous standards, bound by a strict code of ethics, and subject to independent regulation. That’s what the Society of Homeopaths stands for. We’re the UK’s largest group of professional homeopaths, and the only dedicated register accredited by the Professional Standards Authority, an independent body set up by the government to protect the public.
We work to uphold standards of homeopathic care, support our members in their practices, and help their patients back to good health. We ensure that the letters RSHom are your guarantee of a well-trained, registered and insured professional homeopath.
This sounds fine, but is any of this true? Because of their dubious activities endangering public health, the SoH has attracted my attention many times before (for instance here, here and here). Today, they made national headlines.
It has been reported that Linda Wicks, chair of the Society of Homeopaths (S0H), has shared a series of bizarre petitions claiming that childhood immunisations are unsafe, and calling for The Medicines and Healthcare products Regulatory Agency (MHRH) to be disbanded. Mrs Wicks also posted a petition supporting Andrew Wakefield, the disgraced former doctor who falsely linked the MMR vaccine to autism. It claimed that the scientific establishment’s rejection of his flawed research was ‘the greatest lie ever told’.
Mrs Wicks, a Cornwall-based lay-homeopath and owner of the Linda Wicks Homeopathy Clinic in Truro, has been an adviser to the society for 16 years. She was appointed to the SoH chair in April. She has used her Facebook account to spread ‘anti-vaxx’ propaganda for years. Mrs Wicks must now consider whether such to resign.
Two other members of the board of directors of the SoH are also under pressure to quit. One of them, Francis Treuherz, used his Facebook feed to share a petition describing Mr Wakefield as a ‘hero’ who ought to be ‘honoured’ with the Nobel Peace Prize. In 2016 Treuherz endorsed a campaign urging the then education secretary Justine Greening to ‘STOP vaccination’ of schoolchildren against flu.
The flu petition was shared on Facebook by a third member of the SoH’s board, Maggie Dixon, who owns a homeopathic clinic in Bath. Mrs Dixon works as a member of the ‘team of practitioners’ at Ainsworths, the homeopathic pharmacy boasting of royal warrants from the Queen as well as Prince Charles.
It seems clear to me that the behaviour of Wicks, Treuherz and Dixon endangers public health and is deeply unethical. Considering what the SoH say about themselves (see above), it looks like a bad joke. In my view, it is incompatible with holding an office in a professional organisation of healthcare professionals.
Homeopathy does not have a good name when it comes to advising the public responsibly. Such behaviour is hardly going to improve this situation. The recent call of NHS leaders to stop the accreditation of homeopaths in the UK seems therefore well-justified.
Mrs Wicks meekly apologised yesterday, saying: ‘I regret my association with these petitions and any confusion this may have caused, and I have removed the page which allegedly showed this historic material.’ Confusion? At this stage, I must conclude that she is joking!
The SoH said it was working to improve communication standards ‘with clearer guidelines’. Improve communication standards. Yes, definitely, they are taking the Mikey!
Mr Treuherz and Mrs Dixon did not comment.
So, should they resign?
Would that save the reputation of the SoH?
Is there any reputation to save?
WHAT DO YOU THINK?
The aim of this update of a Cochrane review was to assess the effectiveness and safety of homeopathic treatment for irritable bowel syndrome (IBS). Hold on, the bit about safety is odd here and does not bode well: one cannot possibly assess the safety of an intervention on the basis of just a few trials.
Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. The Cochrane risk of bias tool was used to assess risk of bias.
Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care.
The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).
A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence).
In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence).
In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence).
The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence). In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence). None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.
The authors concluded that the results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
[The previous version of this review was published in 2013 and concluded: A pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.]
This is a thorough review that is technically well-done (no wonder, as it had to comply with Cochrane standards!). However, as with some other Cochrane reviews of homeopathy, acupuncture and other SCAMs, one might object to the phraseology used in the conclusions (the part that most people would focus on). Don’t get me wrong, the conclusions are technically correct; however, they are not as clear as they should be and hide the essence of the evidence, in my view.
Systematic reviews have one main purpose: they need to inform the reader whether there is or is not good evidence that the treatment in question works for the condition in question. This question is not well addressed by stating THE RESULTS ARE UNCERTAIN. The truth is that a firm conclusion can very well be drawn: THERE IS NO GOOD EVIDENCE THAT ANY FORM OF HOMEOPATHY IS EFFECTIVE FOR IBS!
Surely that’s correct and firm enough!!!
Why do the authors not dare to put this clearly?
Probably because some of them are well-known, long-term proponents of homeopathy.
Why does the Cochrane Collaboration allow them to get away with their petty attempt of obfuscation?
Hirudotherapy, also known as leech therapy, has been used to treat a wide range of disorders for thousands of years. It is also mentioned as a minimal invasive technique called Jalaukavacharana in the Sushruta Samhita, an ancient Sanskrit text of Ayurvedic medicine.
But a long history is a fallacious argument (appeal to tradition) when used to imply efficacy. So, does this treatment work?
A review located a total of 834 articles were found of which 89.8% were original articles. USA was the leading country with 280 publications, followed by UK, Germany and France (128, 101 and 41 items, respectively). The most productive countries regarding hirudotherapy were the UK (1.93), Slovenia (1.44), and Israel (1.32). The peak publication year for hirudotherapy literature was 2011 with 41 papers.
What does that tell us about the efficacy of leech therapy?
The authors of another review concluded that reached the following conclusion: ” Given the low number of reported adverse events, leech therapy may be a useful approach in treating this condition. Further high-quality RCTs are required for the conclusive judgment of its effectiveness and safety.”
The few clinical trials that were reviewed are mostly by one research group – and yes, you guessed it: it was also this group who published the review.
And anyway: why do they conclude that there is a low number of adverse events? Firstly, there is no reporting system for such events; so, a low number is next to meaningless. Secondly, there are several reports of adverse events. Here are three recent cases:
A 59-year-old woman was admitted to the emergency department with complaints of redness and swelling in both eyes and face. She had a long history of headache, therefore applied leech treatment occasionally. Swelling began on the face after the treatment of leech therapy. Vital signs were as follows; fever: 36.5°C, BP: 126/81 mmHg, heart rate: 84/min and sO2: 98%; respiratory rate: 12/min. In physical examination, GCS was 15, conscious, oriented cooperative. There was no lymphadenopathy in the palpation of the head and neck examination. Oropharynx was in natural appearance and no uvula edema. Facial palpation revealed redness, pain and heat rise. Other systemic findings were normal. Laboratory tests showed leukocytes: 11,000/mm3 (4,000-10,000/mm3), haemoglobin: 12.8 g/dL (12,00-14,00 g/dL) platelet: 271,000 (100,000-400,000/mm3) CRP: 3.45 mg/L (0-0.5mg/L). Other parameters were within normal limits. Computed tomography (CT) showed bilateral periorbital, frontal subcutaneous soft tissue oedema and lymphatic dilatations. She was hospitalized with the diagnosis of orbital cellulite due to leech therapy.
Anorectal sepsis usually presents with anal abscesses, which may evolve to become anorectal fistulas. Most of these cases are either of cryptoglandular origin, or they develop secondary to inflammatory bowel diseases. A 32-year-old male patient applied to our Proctology Unit with severe anal pain and swelling. Three days before admission, leeches were applied to the hemorrhoidal swellings in a medical center. The abscess was drained with appropriate unroofing and search for any compartments. The patient recovered rapidly. The abscess culture and microscopy revealed mix flora with predominant Escherichia coli. After 6 months, he has been symptom-free with perfect healing of the surgical site. We need to check up on possible handicaps in our modern patient care policies that divert people to such methods. Nevertheless, such alternative methods should be regarded as nonscientific and out of context unless their efficacy and safety are documented.
Pseudolymphoma, also known as Jessner’s lymphocytic infiltration, is a benign but usually chronic, T-cell infiltrating disease with erythematous papules and plaques usually seen on the skin of the face, neck, and back. The use of leech therapy also known as hirudotherapy has increased in recent years. Here, we report a 52-year-old male patient who had undergone hirudotherapy in his neck and developed infiltrating plaques after four months. A skin biopsy confirmed the diagnosis of Jessner’s lymphocytic infiltration. In parallel with the increasing use of hirudotherapy in recent years, the side-effect reports will likely to increase. Indications and contraindications of hirudotherapy, which is being used officially in hospitals, should be taken into consideration.
So, what do we make of this evidence?
I don’t know about you, but I am not likely to try or recommend leech therapy in a hurry.
Burning mouth syndrome (BMS) is a rare but potentially debilitating condition. So far, individualised homeopathy (iHOM) has not been evaluated or reported in any peer-reviewed journal as a treatment option. Here is a recently published case-report of iHOM for BMS.
At the Centre of Complementary Medicine in Bern, Switzerland, a 38-year-old patient with BMS and various co-morbidities was treated with iHOM between July 2014 and August 2018. The treatment involved prescription of individually selected homeopathic single remedies. During follow-up visits, outcome was assessed with two validated questionnaires concerning patient-reported outcomes. To assess whether the documented changes were likely to be associated with the homeopathic intervention, an assessment using the modified Naranjo criteria was performed.
Over an observation period of 4 years, an increasingly beneficial result from iHOM was noted for oral dysaesthesia and pains as well as for the concomitant symptoms.
The authors concluded that considering the multi-factorial aetiology of BMS, a therapeutic approach such as iHOM that integrates the totality of symptoms and complaints of a patient might be of value in cases where an association of psychological factors and the neuralgic complaints is likely.
BMS can have many causes. Some of the possible underlying conditions that can cause BMS include:
- hormonal imbalances
- acid reflux
- infections in the mouth
- various medications
- nutritional deficiencies in iron or zinc
Threatemnt of BMS consists of identifying and eliminating the underlying cause. If no cause of BMS can be found, we speak of primary BMS. This condition can be difficult to treat; the following approaches to reduce the severity of the symptoms are being recommended:
- avoiding acidic or spicy foods
- reducing stress
- avoiding any other known food triggers
- exercising regularly
- changing toothpaste
- avoiding mouthwashes containing alcohol
- sucking on ice chips
- avoiding alcohol if it triggers symptoms
- drinking cool liquids throughout the day
- smoking cessation
- eating a balanced diet
- checking medications for potential triggers
The authors of the above case-report state that no efficient treatment of BMS is known. This does not seem to be entirely true. They also seem to think that iHOM benefitted their patient (the post hoc ergo propter hoc fallacy!). This too is more than doubtful. The natural history of BMS is such that, even if no effective therapy can be found, the condition often disappears after weeks or months.
The authors of the above case-report treated their patient for about 4 years. The devil’s advocate might assume that not only did iHOM contribute nothing to the patient’s improvement, but that it had a detrimental effect on BMS. The data provided are in full agreement with the notion that, without iHOM, the patient would have been symptom-free much quicker.
Traditional Chinese Medicine (TCM) is a term created by Mao lumping together various modalities in an attempt to pretend that healthcare in the People’s Republic of China (PRC) was being provided despite the most severe shortages of conventional doctors, drugs and facilities. Since then, TCM seems to have conquered the West, and, in the PRC, the supply of conventional medicine has hugely increased. Today therefore, TCM and conventional medicine peacefully co-exist side by side in the PRC on an equal footing.
At least this is what we are being told – but is it true?
I have visited the PRC twice. The first time, in 1980, I was the doctor of a university football team playing several games in the PRC, including one against their national team. The second time, in 1991, I co-chaired a scientific meeting in Shanghai. On both occasions, I was invited to visit TCM facilities and discuss with colleagues issues related to TCM in the PRC. All the official discussions were monitored by official ‘minders’, and therefore fee speech and an uninhibited exchange of ideas are not truly how I would describe them. Yet, on both visits, there were occasions when the ‘minders’ were absent and a more liberal discussion could ensue. Whenever this was the case, I did not at all get the impression that TCM and conventional medicine were peacefully co-existing. The impression that I did get was that their co-existence resembled more a ‘shot-gun marriage’.
During my time running the SCAM research unit at Exeter, I had the opportunity to welcome several visiting researchers from the PRC. This experience seemed to confirm my impression that TCM in the PRC was less than free. As an example, I might cite one acupuncture project I was once working on with a scientist from the PRC. When it was nearing its conclusion and I mentioned that we should now think about writing it up to publish the findings, my Chinese colleague said that being a co-author was unfortunately not an option. Knowing how important publications in Western journals are for researchers from the PRC, I was most surprised by this revelation. The reason, it turned out, was that our findings failed to be favourable for TCM. My friend explained that such a paper would not advance but hinder an academic career, once back in the PRC.
Suspecting that the notion of a peaceful co-existence of TCM and conventional medicine in the PRC was far from true, I have always been puzzled how the myth could survive for so many years. Now, finally, it seems to crumble. This is from a recent journalistic article entitled ‘Chinese Activists Protest the Use of Traditional Treatments – They Want Medical Science’ which states that thousands of science activists in the PRC protest that the state neglects its duty to treat its citizens with evidence-based medicine (here is the scientific article this is based on):
Over a number of years, Chinese researcher Qiaoyan Zhu, who has been affiliated with the University of Copenhagen’s Department of Communication, has collected data on the many thousand science activists in China through observations in Internet forums, on social media and during physical meetings. She has also interviewed hundreds of activists. Together with Professor Maja Horst, who has specialized in research communication, she has analyzed the many data on the activists and their protests in an article that has just been published in the journal Public Understanding of Science:
“The activists are better educated and wealthier than the average Chinese population, and a large majority of them keep up-to-date with scientific developments. The protests do not reflect a broad popular movement, but the activists make an impact with their communication at several different levels,” Maja Horst explained and added: “Many of them are protesting individually by writing directly to family, friends and colleagues who have been treated with – and in some cases taken ill from – Traditional Chinese Medicine. Some have also hung posters in hospitals and other official institutions to draw attention to the dangers of traditional treatments. But most of the activism takes place online, on social media and blogs.
Activists operating in a regime like the Chinese are obviously not given the same leeway as activists in an open democratic society — there are limits to what the authorities are willing to accept in the public sphere in particular. However, there is still ample opportunity to organize and plan actions online.
“In addition to smaller groups and individual activists that have profiles on social media, larger online groups are also being formed, in some cases gaining a high degree of visibility. The card game with 52 criticisms about Traditional Chinese Medicine that a group of activists produced in 37,000 copies and distributed to family, friends and local poker clubs is a good example. Poker is a highly popular pastime in rural China so the critical deck of cards is a creative way of reaching a large audience,” Maja Horst said.
Maja Horst and Qiaoyan Zhu have also found examples of more direct action methods, where local activist groups contact school authorities to complain that traditional Chinese medicine is part of the syllabus in schools. Or that activists help patients refuse treatment if they are offered treatment with Traditional Chinese Medicine.
I am relieved to see that, even in a system like the PRC, sound science and compelling evidence cannot be suppressed forever. It has taken a mighty long time, and the process may only be in its infancy. But there is hope – perhaps even hope that the TCM enthusiasts outside the PRC might realise that much of what came out of China has led them up the garden path!?
A systematic review of the evidence for effectiveness and harms of specific spinal manipulation therapy (SMT) techniques for infants, children and adolescents has been published by Dutch researchers. I find it important to stress from the outset that the authors are not affiliated with chiropractic institutions and thus free from such conflicts of interest.
They searched electronic databases up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1–18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed risk of bias of included studies and quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, random-effects meta-analysis was performed.
Of the 1,236 identified studies, 26 studies were eligible. In all but 3 studies, the therapists were chiropractors. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.
The authors concluded that, based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.
We have often noted that, in chiropractic trials, harms are often not mentioned (a fact that constitutes a violation of research ethics). This was again confirmed in the present review; only 4 of the controlled clinical trials reported such information. This means harms cannot be evaluated by reviewing such studies. One important strength of this review is that the authors realised this problem and thus included other research papers for assessing the risks of SMT. Consequently, they found considerable potential for harm and stress that under-reporting remains a serious issue.
Another problem with SMT papers is their often very poor methodological quality. The authors of the new review make this point very clearly and call for more rigorous research. On this blog, I have repeatedly shown that research by chiropractors resembles more a promotional exercise than science. If this field wants to ever go anywhere, if needs to adopt rigorous science and forget about its determination to advance the business of chiropractors.
I feel it is important to point out that all of this has been known for at least one decade (even though it has never been documented so scholarly as in this new review). In fact, when in 2008, my friend and co-author Simon Singh, published that chiropractors ‘happily promote bogus treatments’ for children, he was sued for libel. Since then, I have been legally challenged twice by chiropractors for my continued critical stance on chiropractic. So, essentially nothing has changed; I certainly do not see the will of leading chiropractic bodies to bring their house in order.
May I therefore once again suggest that chiropractors (and other spinal manipulators) across the world, instead of aggressing their critics, finally get their act together. Until we have conclusive data showing that SMT does more good than harm to kids, the right thing to do is this: BEHAVE LIKE ETHICAL HEALTHCARE PROFESSIONALS: BE HONEST ABOUT THE EVIDENCE, STOP MISLEADING PARENTS AND STOP TREATING THEIR CHILDREN!
I live (most of my time) in the UK, a country where the media interest in so-called alternative medicine (SCAM) is considerable. Years ago, the UK press used to be very much in favour of SCAM. In 2000, we showed that the level of interest was huge and the reporting was biased. Here is our short BMJ paper on the subject:
The media strongly influences the public’s view of medical matters.1 Thus, we sought to determine the frequency and tone of reporting on medical topics in daily newspapers in the United Kingdom and Germany. The following eight newspapers were scanned for medical articles on eight randomly chosen working days in the summer of 1999: the Times, the Independent, the Daily Telegraph, and the Guardian in the United Kingdom, and Frankfurter Allgemeine Zeitung, Süddeutsche Zeitung, Frankfurter Rundschau, and Die Welt in Germany. All articles relating to medical topics were extracted and categorised according to subject, length, and tone of article (critical, positive, or neutral).
A total of 256 newspaper articles were evaluated. The results of our analysis are summarised in the table. We identified 80 articles in the German newspapers and 176 in the British; thus, British newspapers seem to report on medical topics more than twice as often as German broadsheets. Articles in German papers are on average considerably longer and take a positive attitude more often than British ones. Drug treatment was the medical topic most frequently discussed in both countries (51 articles (64%) in German newspapers and 97 (55%) in British). Surgery was the second most commonly discussed medical topic in the UK newspapers (32 articles; 18%). In Germany professional politics was the second most commonly discussed topic (11 articles; 14%); this category included articles about the standing of the medical profession, health care, and social and economic systems—that is, issues not strictly about treating patients.
Because our particular interest is in complementary medicine, we also calculated the number of articles on this subject. We identified four articles in the German newspapers and 26 in the UK newspapers. In the United Kingdom the tone of these articles was unanimously positive (100%) whereas most (3; 75%) of the German articles on complementary medicine were critical.
This analysis is, of course, limited by its small sample size, the short observation period, and the subjectivity of some of the end points. Yet it does suggest that, compared with German newspapers, British newspapers report more frequently on medical matters and generally have a more critical attitude (table). German newspapers frequently discuss medical professional politics, a subject that is almost totally absent from newspapers in the United Kingdom.
The proportion of articles about complementary medicine seems to be considerably larger in the United Kingdom (15% v 5%), and, in contrast to articles on medical matters in general, reporting on complementary medicine in the United Kingdom is overwhelmingly positive. In view of the fact that both healthcare professionals and the general public gain their knowledge of complementary medicine predominantly from the media, these findings may be important.2,3
Reporting on medical topics by daily newspapers in the United Kingdom and Germany, 1999
|United Kingdom (n=176)||Germany (n=80)|
|Mean No articles/day||5.5||2.5|
|Mean (SD) No words/article||130 (26)||325 (41)|
|Ratio of positive articles to critical articles*||1.0||3.2|
Even though I have no new data on this, my impression is that things have since changed. It seems that the UK press has become more objective and are now reporting more critical comments on SCAM. While this is most welcome, of course, one feature is still deplorable, in my view: journalists’ obsession with ‘balance’.
A recent example might explain this best. The ‘i’ newspaper published an article about homeopathy which was well-written and thoroughly researched. It explained the current best evidence on the subject and made it quite clear why homeopathy is not a reasonable therapy for any condition. But then, towards the end of the article, the journalist added this section:
Dr Lise Hansen, a veterinary homeopath based in London and author of a forthcoming book, The Complete Book of Cat and Dog Health, argues that scientists have shown how homeopathy works. She cites a paper by Luc Montagnier, the French virologist who won a Nobel Prize in 2008 for his role in discovering HIV. The following year, he published evidence of his discovery of “electromagnet signals that are produced by nanostructures derived from bacterial DNA at high aqueous dilutions”. “Mainstream medicine is about chemistry, homeopathy is physics and scientists have only recently begun to study these nanostructures,” Hansen says.
Basically, the reader is left with the impression that homeopathy might be fine after all, and that science will soon be able to catch up with it. In the interest of balance, the journalist thus confused her readers and misled the public.
Journalists are obviously taught to always cover ‘both sides’ of their stories, and they adhere to this dogma no matter what. In most instances, this works out well, because in most cases there are two sides.
But not always!
When there is a strong consensus supported by facts, science and reproducible findings, the other side ceases to have a reasonable point. There simply is no reasonable ‘other side’ when we consider global warming, evolution, the Holocaust, and many other subjects. Of course, one can always find some loon who claims the earth is flat, or that cancer is a Jewish plot against public health. But these arguments lack reason and integrity – to dish them out without anything remotely resembling a ‘fact check’ is not just annoying but harmful.
Journalists should, in my view, be more responsible, check the facts, and avoid false balance. I know this will often entail much more work, but they owe it to their readers and to the reputation of their profession.
Controlled clinical trials are methods for testing whether a treatment works better than whatever the control group is treated with (placebo, a standard therapy, or nothing at all). In order to minimise bias, they ought to be randomised. This means that the allocation of patients to the experimental and the control group must not be by choice but by chance. In the simplest case, a coin might be thrown – heads would signal one, tails the other group.
In so-called alternative medicine (SCAM) where preferences and expectations tend to be powerful, randomisation is particularly important. Without randomisation, the preference of patients for one or the other group would have considerable influence on the result. An ineffective therapy might thus appear to be effective in a biased study. The randomised clinical trial (RCT) is therefore seen as a ‘gold standard’ test of effectiveness, and most researchers of SCAM have realised that they ought to produce such evidence, if they want to be taken seriously.
But, knowingly or not, they often fool the system. There are many ways to conduct RCTs that are only seemingly rigorous but, in fact, are mere tricks to make an ineffective SCAM look effective. On this blog, I have often mentioned the A+B versus B study design which can achieve exactly that. Today, I want to discuss another way in which SCAM researchers can fool us (and even themselves) with seemingly rigorous studies: the de-randomised clinical trial (dRCT).
The trick is to use random allocation to the two study groups as described above; this means the researcher can proudly and honestly present his study as an RCT with all the kudos these three letters seem to afford. And subsequent to this randomisation process, the SCAM researcher simply de-randomises the two groups.
To understand how this is done, we need first to be clear about the purpose of randomisation. If done well, it generates two groups of patients that are similar in all factors that might impact on the results of the study. Perhaps the most obvious factor is disease severity; one could easily use other methods to make sure that both groups of an RCT are equally severely ill. But there are many other factors which we cannot always quantify or even know about. By using randomisation, we make sure that there is an similar distribution of ALL of them in the two study groups, even those factors we are not even aware of.
De-randomisation is thus a process whereby the two previously similar groups are made to differ in terms of any factor that impacts on the results of the trial. In SCAM, this is often surprisingly simple.
Let’s use a concrete example. For our study of spiritual healing, the 5 healers had opted during the planning period of the study to treat both the experimental group and the control group. In the experimental group, they wanted to use their full healing power, while in the control group they would not employ it (switch it off, so to speak). It was clear to me that this was likely to lead to de-randomisation: the healers would have (inadvertently or deliberately) behaved differently towards the two groups of patients. Before and during the therapy, they would have raised the expectation of the verum group (via verbal and non-verbal communication), while sending out the opposite signals to the control group. Thus the two previously equal groups would have become unequal in terms of their expectation. And who can deny that expectation is a major determinant of the outcome? Or who can deny that experienced clinicians can manipulate their patients’ expectation?
For our healing study, we therefore chose a different design and did all we could to keep the two groups comparable. Its findings thus turned out to show that healing is not more effective than placebo (It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.). Had we not taken these precautions, I am sure the results would have been very different.
In RCTs of some SCAMs, this de-randomisation is difficult to avoid. Think of acupuncture, for instance. Even when using sham needles that do not penetrate the skin, the therapist is aware of the group allocation. Hoping to prove that his beloved acupuncture can be proven to work, acupuncturists will almost automatically de-randomise their patients before and during the therapy in the way described above. This is, I think, the main reason why some of the acupuncture RCTs using non-penetrating sham devices or similar sham-acupuncture methods suggest that acupuncture is more than a placebo therapy. Similar arguments also apply to many other SCAMs, including for instance chiropractic.
There are several ways of minimising this de-randomisation phenomenon. But the only sure way to avoid this de-randomisation is to blind not just the patient but also the therapists (and to check whether both remained blind throughout the study). And that is often not possible or exceedingly difficult in trials of SCAM. Therefore, I suggest we should always keep de-randomisation in mind. Whenever we are confronted with an RCT that suggest a result that is less than plausible, de-randomisation might be a possible explanation.
I recently saw a tweet by a German homeopath stating that ‘homeopathy is 100% experienced based medicine’. It made me think and realise that there is not just one EBM, there are, in fact, at least three EBMs!
- Experience based medicine
- Eminence based medicine
- Evidence based medicine
I will start with the type which I encountered first when studying medicine all those years ago.
EMINENCE BASED MEDICINE
German healthcare was at the time – 1970s – deeply steeped in this variety of EBM. What the professor said was right, and there was no discussion about it. I don’t even know how my teachers would have reacted, if we had challenged their wisdom, because nobody ever did; it just did not occur to us.
Personally, I never got along too well with this type of EBM. I found it stifling, and this feeling might have contributed to my first ‘escape’ to England in 1979. In the UK, I felt, things were refreshingly different (see also my recent obituary of my former boss).
EXPERIENCE BASED MEDICINE
So-called alternative medicine (SCAM) is almost entirely based on this type of EBM. Practitioners of SCAM pride themselves of their experience and are convinced that it outweighs evidence any time. They rarely miss an occasion to stress that their treatment as stood the test of time. And as such it does not require evidence; if SCAM did not work, it would not have survived all these years.
Little do they know that the appeal to tradition is a logical fallacy. And little do they care that the long tradition of their SCAMs might just signal how obsolete their treatments truly are. Hundreds (homeopathy) or thousands (acupuncture) of years ago, we had little knowledge about physiology, pathology, etc., and clinicians had to make do with the little that got. Seen in this light, experience based medicine is a negative label that indicates the fact that the treatments are likely to be obsolete and out-dated.
EVIDENCE BASED MEDICINE
Providers of SCAM have a deeply rooted dislike for the word evidence. The reason is simple: their SCAMs are usually very shy on evidence; little wonder that they like to focus on experience instead. Yet, try to explain the concept of evidence to someone neutral like a barman, for instance – whenever I made this attempt, I was interrupted by him saying: ‘Hold on, are you saying that before EBM you did not depend on evidence? This is frightening! What on earth did you rely on then?’
It is indeed not logical to rely on eminence or on experience, in my view. And therefore, I have stopped explaining EBM to people who have common sense, like my barman. Let’s try something else instead: imagine you are seriously ill and are able to chose between three clinician who are each the leading head in their type of EMB.
THE EMINENCE IS A PROFESSOR MANY TIMES OVER AND SIMPLY KNOWS THAT HE IS ALWAYS RIGHT
Personally, I would run a mile. I have seen too many of those blundering through the wards of university hospitals. He never makes a mistake, except that things do go wrong quite often; and when they do, it is the fault of some underling, of course.
THE EXPERIENCED CLINICIAN WITH YEARS OF PRACTICE WHO HAS SEEN IT ALL AND HAS ALL THE ANSWERS
With a bit of bad luck, he might be a homeopath. He will tell you endlessly of cases that were similar to yours. Occasionally, there was an aggravation (which, of course, is a good sign in his view), but in the end he cured them all with his treatments that had stood the test of time. He has excellent bedside manners, a lot of charisma, and is a good listener. Who was it that said: “the three most dangerous words in medicine are IN MY EXPERIENCE”?
Yes, you guessed it: run and don’t turn back!
THE CLINICIAN WHO KNOWS WHAT THE CURRENT BEST EVIDENCE HAS TO OFFER
He might not be all that charismatic, perhaps he even is a bit abrupt. But he will know the latest developments and weigh the risks of all therapeutic options against their benefits.
But hold on, my barman would interrupt at this point, this is not either or. One can have both experience and evidence!
I told you my barman was clever. The definition of evidence based medicine is not healthcare based on up-to date knowledge, it is the integration of best research evidence with clinical expertise and patient values. It thus rests on three pillars: external evidence, ideally from systematic reviews, the clinician’s experience, and the patient’s preferences.
Therefore, my barman and I agree that eminence based medicine is highly questionable, experience based medicine can be outright dangerous, and evidence based medicine is the only EBM version that does make sense.
“There is a ton of chiropractor journals. If you want evidence then read some.”
This was the comment by a defender of chiropractic to a recent post of mine. And it’s true, of course: there are quite a few chiro journals, but are they a reliable source of information?
One way of quantifying the reliability of medical journals is to calculate what percentage of its published articles arrive at negative conclusion. In the extreme instance of a journal publishing nothing but positive results, we cannot assume that it is a credible publication. In this case, it would be not a scientific journal at all, but it would be akin to a promotional rag.
Back in 1997, we published our first analysis of journals of so-called alternative medicine (SCAM). It showed that just 1% of the papers published in SCAM journals reported findings that were not positive. In the years that followed, we confirmed this deplorable state of affairs repeatedly, and on this blog I have shown that the relatively new EBCAM journal is similarly dubious.
But these were not journals focussing specifically on chiropractic. Therefore, the question whether chiro journals are any different from the rest of SCAM is as yet unanswered. Enough reason for me to bite the bullet and test this hypothesis. I thus went on Medline and assessed all the articles published in 2018 in two of the leading chiro journals.
- JOURNAL OF CHIROPRACTIC MEDICINE (JCM)
- CHIROPRACTIC AND MANUAL THERAPY (CMT)
I evaluated them according to
- TYPE OF ARTICLE
- DIRECTION OF CONCLUSION
The results of my analysis are as follows:
- The JCM published 39 Medline-listed papers in 2018.
- The CMT published 50 such papers in 2018.
- Together, the 2 journals published:
- 18 surveys,
- 17 case reports,
- 10 reviews,
- 8 diagnostic papers,
- 7 pilot studies,
- 4 protocols,
- 2 RCTs,
- 2 non-randomised trials,
- 2 case-series,
- the rest are miscellaneous types of articles.
4. None of these papers arrived at a conclusion that is negative or contrary to chiropractors’ current belief in chiropractic care. The percentage of publishing negative findings is thus exactly 0%, a figure that is almost identical to the 1% we found for SCAM journals in 1997.
I conclude: these results suggest that the hypothesis of chiro journals publishing reliable information is not based on sound evidence.