conflict of interest
On this blog, we have often noted that (almost) all TCM trials from China report positive results. Essentially, this means we might as well discard them, because we simply cannot trust their findings. While being asked to comment on a related issue, it occurred to me that this might be not so much different with Korean acupuncture studies. So, I tried to test the hypothesis by running a quick Medline search for Korean acupuncture RCTs. What I found surprised me and eventually turned into a reminder of the importance of critical thinking.
Even though I found pleanty of articles on acupuncture coming out of Korea, my search generated merely 3 RCTs. Here are their conclusions:
The results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.
The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies.
Bee venom acupuncture combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.
So yes, according to this mini-analysis, 100% of the acupuncture RCTs from Korea are positive. But the sample size is tiny and I many not have located all RCTs with my ‘rough and ready’ search.
But what are all the other Korean acupuncture articles about?
Many are protocols for RCTs which is puzzling because some of them are now so old that the RCT itself should long have emerged. Could it be that some Korean researchers publish protocols without ever publishing the trial? If so, why? But most are systematic reviews of RCTs of acupuncture. There must be about one order of magnitude more systematic reviews than RCTs!
Why so many?
Perhaps I can contribute to the answer of this question; perhaps I am even guilty of the bonanza.
In the period between 2008 and 2010, I had several Korean co-workers on my team at Exeter, and we regularly conducted systematic reviews of acupuncture for various indications. In fact, the first 6 systematic reviews include my name. This research seems to have created a trend with Korean acupuncture researchers, because ever since they seem unable to stop themselves publishing such articles.
So far so good, a plethora of systematic reviews is not necessarily a bad thing. But looking at the conclusions of these systematic reviews, I seem to notice a worrying trend: while our reviews from the 2008-2010 period arrived at adequately cautious conclusions, the new reviews are distinctly more positive in their conclusions and uncritical in their tone.
Let me explain this by citing the conclusions of the very first (includes me as senior author) and the very last review (does not include me) currently listed in Medline:
penetrating or non-penetrating sham-controlled RCTs failed to show specific effects of acupuncture for pain control in patients with rheumatoid arthritis. More rigorous research seems to be warranted.
Electroacupuncture was an effective treatment for MCI [mild cognitive impairment] patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.
Now, you might claim that the evidence for acupuncture has overall become more positive over time, and that this phenomenon is the cause for the observed shift. Yet, I don’t see that at all. I very much fear that there is something else going on, something that could be called the suspension of critical thinking.
Whenever I have asked a Chinese researcher why they only publish positive conclusions, the answer was that, in China, it would be most impolite to publish anything that contradicts the views of the researchers’ peers. Therefore, no Chinese researcher would dream of doing it, and consequently, critical thinking is dangerously thin on the ground.
I think that a similar phenomenon might be at the heart of what I observe in the Korean acupuncture literature: while I always tried to make sure that the conclusions were adequately based on the data, the systematic reviews were ok. When my influence disappeared and the reviews were done exclusively by Korean researchers, the pressure of pleasing the Korean peers (and funders) became dominant. I suggest that this is why conclusions now tend to first state that the evidence is positive and subsequently (almost as an after-thought) add that the primary trials were flimsy. The results of this phenomenon could be serious:
- progress is being stifled,
- the public is being misled,
- funds are being wasted,
- the reputation of science is being tarnished.
Of course, the only right way to express this situation goes something like this:
BECAUSE THE QUALITY OF THE PRIMARY TRIALS IS INADEQUATE, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.
It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).
Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”
But is this always interpretation correct?
I seriously doubt it.
Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.
Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).
This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”
When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?
The answer is YES and NO.
YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?
NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.
So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.
I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.
I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!
The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.
Is homeopathy an effective treatment for PMS?
No, how could it?
Previous studies have thus had mixed results:
A feasibility study of 2018 showed that, in Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03).
A case series with 23 women suggested that homeopathic treatment was well tolerated and seemed to have a positive impact on PMS symptoms. Folliculinum was the most frequent homeopathic medicine prescribed. There appears to be scope for a properly designed, randomized, placebo-controlled trial to investigate the efficacy of individual homeopathic medicines in PMS.
And a pilot study reported that homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.
The authors of this pilot include several prominent homeopath who have honoured their word by publishing their definitive study. This double-blind placebo-controlled RCT tested the efficacy of individually prescribed homeopathic medicines in women with premenstrual syndrome (PMS).
In an outpatient department of a university clinic in Jerusalem, Israel, women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat.
A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group compared to placebo.
The authors concluded that individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.
Not being able to assess the full paper – remember, I was fired from the journal’s editorial board – I am unable to scrutinise this trial properly. As I suspect that the authors were the victim of some hidden biases, I concur only with the second part of their conclusion: replication is needed before we can accept these findings – but please, make it an INDEPENDENT replication!
The journal NATURE has just published an excellent article by Andrew D. Oxman and an alliance of 24 leading scientists outlining the importance and key concepts of critical thinking in healthcare and beyond. The authors state that the Key Concepts for Informed Choices is not a checklist. It is a starting point. Although we have organized the ideas into three groups (claims, comparisons and choices), they can be used to develop learning resources that include any combination of these, presented in any order. We hope that the concepts will prove useful to people who help others to think critically about what evidence to trust and what to do, including those who teach critical thinking and those responsible for communicating research findings.
Here I take the liberty of citing a short excerpt from this paper:
Claims about effects should be supported by evidence from fair comparisons. Other claims are not necessarily wrong, but there is an insufficient basis for believing them.
Claims should not assume that interventions are safe, effective or certain.
- Interventions can cause harm as well as benefits.
- Large, dramatic effects are rare.
- We can rarely, if ever, be certain about the effects of interventions.
Seemingly logical assumptions are not a sufficient basis for claims.
- Beliefs alone about how interventions work are not reliable predictors of the presence or size of effects.
- An outcome may be associated with an intervention but not caused by it.
- More data are not necessarily better data.
- The results of one study considered in isolation can be misleading.
- Widely used interventions or those that have been used for decades are not necessarily beneficial or safe.
- Interventions that are new or technologically impressive might not be better than available alternatives.
- Increasing the amount of an intervention does not necessarily increase its benefits and might cause harm.
Trust in a source alone is not a sufficient basis for believing a claim.
- Competing interests can result in misleading claims.
- Personal experiences or anecdotes alone are an unreliable basis for most claims.
- Opinions of experts, authorities, celebrities or other respected individuals are not solely a reliable basis for claims.
- Peer review and publication by a journal do not guarantee that comparisons have been fair.
Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance).
Comparisons of interventions should be fair.
- Comparison groups and conditions should be as similar as possible.
- Indirect comparisons of interventions across different studies can be misleading.
- The people, groups or conditions being compared should be treated similarly, apart from the interventions being studied.
- Outcomes should be assessed in the same way in the groups or conditions being compared.
- Outcomes should be assessed using methods that have been shown to be reliable.
- It is important to assess outcomes in all (or nearly all) the people or subjects in a study.
- When random allocation is used, people’s or subjects’ outcomes should be counted in the group to which they were allocated.
Syntheses of studies should be reliable.
- Reviews of studies comparing interventions should use systematic methods.
- Failure to consider unpublished results of fair comparisons can bias estimates of effects.
- Comparisons of interventions might be sensitive to underlying assumptions.
Descriptions should reflect the size of effects and the risk of being misled by chance.
- Verbal descriptions of the size of effects alone can be misleading.
- Small studies might be misleading.
- Confidence intervals should be reported for estimates of effects.
- Deeming results to be ‘statistically significant’ or ‘non-significant’ can be misleading.
- Lack of evidence for a difference is not the same as evidence of no difference.
What to do depends on judgements about the problem, the relevance (applicability or transferability) of evidence available and the balance of expected benefits, harm and costs.
Problems, goals and options should be defined.
- The problem should be diagnosed or described correctly.
- The goals and options should be acceptable and feasible.
Available evidence should be relevant.
- Attention should focus on important, not surrogate, outcomes of interventions.
- There should not be important differences between the people in studies and those to whom the study results will be applied.
- The interventions compared should be similar to those of interest.
- The circumstances in which the interventions were compared should be similar to those of interest.
Expected pros should outweigh cons.
- Weigh the benefits and savings against the harm and costs of acting or not.
- Consider how these are valued, their certainty and how they are distributed.
- Important uncertainties about the effects of interventions should be reduced by further fair comparisons.
END OF QUOTE
I have nothing to add to this, except perhaps to point out how very relevant all of this, of course, is for SCAM and to warmly recommend you study the full text of this brilliant paper.
Guest post by Toby Katz
Who am I?
I’m a final-year graduate medic (also hold an Economics degree) studying at St George’s University. I founded the Integrative Medicine Society at the university, with the aim of hosting talks on evidence-based CAM. My interest in evidence-based CAM arose as many of my family members have benefitted from different CAM interventions (mostly due to chronic MSk pain), where conventional interventions (physiotherapy and chronic pain teams) have failed to resolve their issues.
When it comes to the CAM debate, I see myself as a centrist. I am both a CAM apologist and sceptic and in recent years I have looked to educate myself around this subject. I have read Ernst’s Desktop Guide to CAM and Moral Maze books, spoken to Professor Colquhoun and most recently I undertook the Foundation Course in CAM run by the College of Medicine. My review of the course follows.
Overall, there’s a lot to learn from both sides of the debate and the debate continues due to systematic issues in the UK. Ad hominem attacks don’t help anyone, but conversation can. I hope I can converse with many of you in the future.
The Foundation Course
Two days of fast-paced talks on Integrative/Complementary and Alternative Medicine. The topics included: Resilience, nutritional therapy, medical acupuncture, MSk methods for non-osteopaths, homeopathy, herbs and spices, imagery and relaxation, cancer, hypnotherapy and social prescribing.
The speakers included: Professor David Peters, Dr Catherine Zollman (Medical Director for Penny Brohn), Heather Richards (Nutritional Therapist), Dr Elizabeth Thompson (GP and homeopath), Trevor Hoskisson (Hypnotherapist), Dr Mike Cummings (BMAS), Simon Mills (Medical Herbalist) – at least two of these are already in the infamous Alt Med Hall of Fame!
My initial feelings upon hearing the talks were that most of these individuals are inherently good people, who want the best outcomes for their patients. Their aim is to operate in the areas of medicine where conventional medicine doesn’t hold the answers – chronic pain, idiopathic headache, IBS etc. But there were also people who were advocating the use of unproven alternative therapies.
These were some of my thoughts I jotted down during the two days:
Professor Peters – Constantly speaking in generalisations. Uses historic references, romantic and philosophical language to entice listeners but generally has little point to what he says. Suffers from tangential thinking. Loses track of his own point. Very Freudian-like thinking (everyone has gone through childhood trauma according to him).
Dr Catherine Zollman – Brilliant. Absolutely brilliant. The doctor I resonate most closely with out of everyone speaking. Promoting the holistic management of a cancer diagnosis; integrating (not undermining) conventional medicine with complementary ways of dealing with the stress surrounding the diagnosis and much more. Works for a non-for-profit organisation. She has many years of oncology experience and strives to create a patient-centred approach to management.
Dr Mike Cummings – promoting medical acupuncture mainly for myofascial pain syndrome. I volunteered to receive acupuncture in my shoulder (have had post-op muscular pain since April). He dry-needled one of my trigger points and it helped, for a few days – this is better than anything a physio has done for me so far. I don’t know why dry-needling isn’t taught at medical school to help with myofascial pain syndrome.
Dr Elizabeth Thompson – Very respectable but I do feel the homeopathy ship has well and truly sailed. Provided ‘evidence’ on how ‘succussion’ changes the make-up of water molecules. Though Dr Thompson is medically trained, there are many non-medical homeopaths who promote things such as homeoprophylaxis and anti-vaccine views and I’m more worried about these such homeopaths. I do respect Dr Thompson and believe her when she says she has helped many patients. Whether this is due to placebo or the get-better-anyway effect I don’t know.
What they were promoting
On reflection, it’s clear that there was a real mix in promoting evidence-based therapies and eyebrow-raising alternatives – this is often difficult for those with an untrained eye to spot the difference. There was a general air of distrust with modern science and EBM floating around the room at all times. Sure, there are things wrong with it, but I think it’s done us pretty well over the last few decades!
I irritated a few speakers when I asked about the evidence behind their claims!
What to take away
There were many GPs present, who stated they’re often in a difficult position in the current system of healthcare we have in the UK. Around half of all consultations are MSk based, many of which are associated with chronic, muscular pain. The WHO analgesic pathway does little for these patients (unless you want to knock them for six with oxycodone) and physiotherapists struggle to make a real difference in a 30-minute appointment. The truth is, we are not providing GPs with the right toolkit to cope with these “difficult” patients.
– Get a copy of Ernst et al.’s Desktop Guide for CAM
– Release more formal guidelines using this book as a base for any positive evidence
– Engage in conversation with those from both sides. We have a lot to learn from one another
– SCRAP the forms of CAM that have no plausibility
Food for thought
– If a patient’s pain improves after a session of acupuncture and not from physiotherapy, does it fit with a utilitarian ethical model to deny this person access to acupuncture if EBM shows acupuncture has rates similar to placebo?
– Chronic myofascial pain syndrome. Can we manage it better in primary care? Why not teach dry needling to healthcare professionals? (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107879/ – Desai et al suggest it works)
– What is the alternative for no CAM for many patients who suffer? If patient’s choice is reduced, does that not reduce their autonomy?
If anyone wishes to contact me, you can at firstname.lastname@example.org
Acupuncture is effective in alleviating angina when combined with traditional antianginal treatment, according to a study published today in JAMA Internal Medicine. Researchers conducted a 20-week randomized clinical trial at 5 clinical centres in China. Patients with chronic, stable angina (a serious symptom caused by coronary heart disease) were randomly assigned to 4 groups:
- acupuncture on acupoints in the disease-affected meridian,
- acupuncture on a non-affected meridian,
- sham acupuncture,
- waitlist group that did not receive acupuncture.
All participants also received recommended antianginal medications. Acupuncture was given three times each week for 4 weeks. Patients were asked to keep a diary to record angina attacks. 398 patients were included in the intention-to-treat analysis. Greater reductions in angina attacks occurred in those who received acupuncture at acupoints in the disease-affected meridian compared with those in the nonaffected meridian group, the sham acupuncture group and the wait list group.
“Acupuncture was safely administered in patients with mild to moderate angina”, Zhao et al wrote. “Compared with the [control] groups, adjunctive acupuncture showed superior benefits … Acupuncture should be considered as one option for adjunctive treatment in alleviating angina.”
This study is well-written and looks good – almost too good to be true!
Let me explain: during the last 25 years, I must have studied several thousand clinical trials of SCAM, and I think that, in the course of this work, I have developed a fine sense for detecting trials that are odd or suspect. While reading the above RCT, my alarm-bells were ringing loud and clear.
The authors claim they have no conflicts of interest. This may well be true as far as financial conflicts of interest are concerned, but I have long argued that, in SCAM, ideological conflicts are much more powerful than financial ones. If we look at some of the authors’ affiliations, we get a glimpse of this possibility:
- Acupuncture and Tuina School, Chengdu University o fTraditional Chinese Medicine, Chengdu, Sichuan, China
- Department of Acupuncture, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
- Acupuncture and Tuina School, Hunan University of Traditional Chinese Medicine, Changsha, Hunan, China
- Acupuncture and Tuina School, Guiyang University of Traditional Chinese Medicine, Guiyang, Guizhou, China
- Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China
- Acupuncture and Tuina School, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China
I have reported repeatedly that several independent analyses have shown that as good as no TCM studies from China ever report negative results. I have also reported that data falsification is said to be rife in China.
I am aware, of course, that these arguments are hardly evidence-based and therefore amount to mere suspicions. So, let me also mention a few factual points about the new trial:
- The study was concluded 4 years ago; why is it published only now?
- The primary outcome measure was entirely subjective; an objective endpoint would have been valuable.
- Patient blinding was not checked but would have been important.
- The discussion is devoid of any critical input; this is perhaps best seen when looking at the reference list. The authors cite none of the many critical analyses of acupuncture.
- The authors did actually not use normal acupuncture but electroacupuncture. One would have liked to see a discussion of effects of the electrical current versus those of acupuncture.
- The therapists were not blinded (when using electroacupuncture, this would have been achievable). Therefore, one explanation for the outcome is lies in the verbal/non-verbal communication between therapists and patients.
- Acupuncture was used as an add-on therapy, and it is conceivable that patients in the acupuncture group were more motivated to take their prescribed medications.
- The costs for 12 sessions of acupuncture would have been much higher (in the UK) than those for an additional medication.
- The practicality of consulting an acupuncturist three times a week need to be addressed.
- The long-term effects of acupuncture on angina pectoris (which is a long-term condition) are unknown.
Coming back to my initial point about the reliability of the data, I feel that it is important to not translate these findings into clinical routine without independent replications by researchers from outside China who are not promoters of acupuncture. Until such data are available, I believe that acupuncture should NOT be considered as one option for adjunctive treatment in alleviating angina.
One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:
Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.
Design Systematic review and meta-analysis.
Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.
Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.
Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).
Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.
One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?
I have to admit, I do not often read the ‘Aargauer Zeitung’. But perhaps I should? Certainly this article from yesterday’s issue is most interesting.
It reported that the University of Basel will soon have a new chair. Apparently, the move has created a fiercely controversial debate within the university. But the decision to go ahead with the plan has been made, and Carsten Gründemann has been formally invited to become the new professor for «translationale Komplementärmedizin». (I am sure in Basel they know what «translationale Komplementärmedizin» is, however, I don’t.)
As it turns out, the term seems entirely irrelevant, because the chair will be in anthroposophical medicine. In case you are not familiar with this SCAM, here is a short explanation copied from my new book:
Anthroposophic medicine is a form of healthcare developed in the 1920s by Rudolf Steiner (1861–1925) in collaboration with the physician Ita Wegman (1876–1943). It is based on Steiner’s mystical ideas of anthroposophy. Steiner had developed his ‘philosophy’ of anthroposophy from personal experiences, occult notions and mystical concepts. Ita Wegman studied medicine after having met Steiner in 1902. She pioneered an ‘alternative cancer treatment’ with a fermented mistletoe extract, according to Steiner’s ideas. Together, Wegman and Steiner wrote Steiner’s last book entitled ‘Extending Practical Medicine’ which was meant as a theoretical basis for their anthroposophical medicine. Wegman was also a co-founder of the pharmaceutical firm ‘Weleda’ which became the biggest producer of anthroposophical remedies. Proponents of anthroposophic medicine make several irrational assumptions, for instance, they claim that our past lives influence our present health, or that the course of an illness is determined by our ‘karmic’ destiny. Practitioners of anthroposophic medicine are usually medically trained; they employ a variety of treatments including massage, exercise, counselling, and a range of remedies (more than 1 300 different anthroposophic medicinal products are currently on the market). Most of the remedies are, like homeopathic remedies, highly diluted but they are not normally prescribed according to the ‘like cures like’ principle and are therefore distinct from homeopathy.
The report mentions that the creation of the new chair caused wide-spread anger amongst the science-based faculties at Basel. The head of Pharmacy, Christoph Meier, is quoted stating: «Indem die Professur in den Forschungsbetrieb eingebunden wird, bieten wir keine Hand zur Scharlatanerie.» [As the professorship will be tied into research, we offer no opportunity for quackery.]
Carsten Gründemann studied Biochemistry/Biology at the University of Tübingen and Freiburg (Germany) and received his Ph.D. in Experimental Immunology from the University of Tübingen (Germany). He was awarded the Karl und Veronica Carstens (KVC) Science Award 2018 for his research in the field of complementary medicine for multiple sclerosis (MS). He is currently based at the Center for Complementary Medicine, Institute for Environmental Health Sciences, University Medical Center Freiburg. Much of his past research seems to focus on anthroposophical medicines, including those produced by Weleda, the world’s largest manufacturer of anthroposophical preparations. Here is one of his 32 Medline-listed abstracts:
Preparations from anthroposophical medicine (AM) are clinically used to treat inflammatory disorders. We wanted to investigate effects of a selection of AM medications for parenteral use in cell-based systems in vitro.
Colchicum officinale tuber D3, Mandragora D3, Rosmarinus officinale 5% and Bryophyllum 5% were selected for the experiments. Induction of apoptosis and necrosis (human lymphocytes and dendritic cells [DCs]) and proliferation of lymphocytes as well as maturation (expression of CD14, CD83 and CD86) and cytokine secretion (IL-10, IL12p70) of DCs were analyzed. Furthermore, proliferation of allogeneic human T lymphocytes was investigated in vitro in coculture experiments using mature DCs in comparison to controls.
The respective preparations did not induce apoptosis or necrosis in lymphocytes or DCs. Lymphocyte proliferation was dose-dependently reduced by Colchicum officinale tuber D3 while the viability was unchanged. Rosmarinus officinale 5%, but not the other preparations, dose-dependently inhibited the maturation of immature DCs, reduced secretion of IL-10 and IL-12p70 and slightly inhibited proliferation of allogeneic CD4(+) T-lymphocytes in coculture experiments with DCs.
The selected preparations from AM for parenteral use are nontoxic to lymphocytes and DCs. Rosmarinus officinale 5% has immunosuppressive properties on key functions of the immune system which propose further investigation.
The new chair is contractually bound to adhere to the ‘anthroposophical model’ (which probably is a synonym for ‘Steiner cult’). It will be financed to the tune of 3 million Swiss Franks, money that comes from the ‘Software AG Stiftung‘, Weleda, Beatrice Oeri, and other anthroposophical institutions.
George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.
Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?
1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)
2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place [14–16]. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)
This factor was also ignored in most trials . At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study , where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo . (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)
3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies . Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)
4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case , the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)
5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)
In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.
First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)
Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)
Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles . (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)
Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)
Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.
I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:
- A well-designed study of homeopathy can always be recognised by its positive result.
- Any trial that fails to yield a positive finding is, by definition, wrongly designed.
In Switzerland, so-called alternative medicine (SCAM) is officially recognised within the healthcare system and mainly practised in conjunction with conventional medicine. So far no research has been published into the attitude towards, training in and offer of SCAM among paediatricians in Switzerland. This survey addresses this gap by investigating these topics with an online survey of paediatricians in Switzerland.
It employed a 19-item, self-reporting questionnaire among all ordinary and junior members of the Swiss Society of Paediatrics (SSP). A comparison of the study sample with the population of all paediatricians registered with the Swiss Medical Association (FMH) allowed an assessment of the survey’s representativeness. The data analysis was performed on the overall group level as well as for predefined subgroups (e.g. sex, age, language, workplace and professional experience).
A total of 1890 paediatricians were approached and 640, from all parts of Switzerland, responded to the survey (response rate 34%). Two thirds of respondents were female, were aged between 35 and 55 years, trained as paediatric generalist and worked in a practice. Apart from young paediatricians in training, the study sample was representative of all Swiss paediatricians.
According to the authors’ statistics, the results suggest that
- 23% had attended training in SCAM, most frequently in phytotherapy, homeopathy, acupuncture/traditional Chinese medicine (TCM) and anthroposophic medicine
- 8% had a federal certificate in one or more SCAM methods.
- 44% did not routinely ask their patients about their use of SCAM.
- 84% did not offer SCAM.
- 65% were interested in SCAM courses and training.
- 16% provided SCAM services to their patients.
- 97% were asked by patients/parents about SCAM therapies.
- More than half of the responding paediatricians use SCAM for themselves or their families.
- 42% were willing to contribute to paediatric SCAM research.
The authors concluded that in a representative sample of paediatricians in Switzerland, the overall attitude towards SCAM was positive, emphasised by great interest in SCAM training, willingness to contribute to SCAM research and, in particular, by the high rate of paediatricians using SCAM for themselves and their families. However, given the strong demand for SCAM for children, the rate of paediatricians offering SCAM is rather low, despite the official recognition of SCAM in Switzerland. Among the various reasons for this, insufficient knowledge and institutional barriers deserve special attention. The paediatricians’ great interest in SCAM training and support for SCAM research offer key elements for the future development of complementary and integrative medicine for children in Switzerland.
SCAM suffers from acute survey mania. I am anxiously waiting for a survey of SCAM use in left-handed, diabetic policemen in retirement from Devon. But every other variation of the theme has been exploited. And why not? It provides the authors with a most welcome addition to their publication list. And, of course, it lends itself very nicely to SCAM-promotion. Sadly, there is not much else that such surveys offer.
Except perhaps for an opportunity to do an alternative evaluation of their results. Here is an assessment the devil’s advocate in me proposes. Based on the reasonable assumption that those 34% of paediatricians who responded did so because they had an interest in SCAM, and the 64% who did not reply couldn’t care less, it is tempting to do an analysis of the entire population of Swiss paediatricians. Here are my findings:
- Hardly anyone had attended training in SCAM.
- Hardly anyone had a federal certificate in one or more SCAM methods.
- Very few did not routinely ask their patients about their use of SCAM.
- Hardly anyone offered SCAM.
- Very few were interested in SCAM courses and training.
- Hardly anyone provided SCAM services to their patients.
- Quite a few were asked by patients/parents about SCAM therapies.
- Very few paediatricians use SCAM for themselves or their families.
- Few were willing to contribute to paediatric SCAM research.
These results might be closer to the truth but they have one very important drawback: they do not lend themselves to drawing the SCAM-promotional conclusions formulated by the authors.
Oh Yes, reality can be a painful thing!