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

conflict of interest

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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!

  1. Experience based medicine
  2. Eminence based medicine
  3. 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.

  1. JOURNAL OF CHIROPRACTIC MEDICINE (JCM)
  2. CHIROPRACTIC AND MANUAL THERAPY (CMT)

I evaluated them according to

  1. TYPE OF ARTICLE
  2. DIRECTION OF CONCLUSION

The results of my analysis are as follows:

  1. The JCM published 39 Medline-listed papers in 2018.
  2. The CMT published 50 such papers in 2018.
  3. 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.

Some of you might have followed my recent discussion with a homeopath. It followed a typical path, and I decided therefore to try and analyse this exchange here. Perhaps others can learn from this example when debating with homeopaths or other providers of so-called alternative medicine (SCAM).

THE START

These conversations often start ‘out of the blue’ by some falsehood being trumpeted on social media. In the present case, the encounter commenced by someone tweeting this message to me: “…remember that asthma trial whose results you faked?” As I did not even remember having ever met the man, I was perplexed. And as I have not faked the study in question nor any other results, I did not think his remark was credible or funny. My mention of the fact that the aggressor was being libellous seemed to bring an end to this unhappy dialogue.

But not for very long. When the man insulted me again – this time very publicly in a UK newspaper – I decided to look into it a bit closer. The aggressor turned out to be in charge of the well-known UK homeopathic pharmacy, Ainsworth, and thus had an overt conflict of interest in defaming my often critical stance on homeopathy. Intriguingly, he had also published his own study of homeopathy. When I assessed this research, it turned out to be both incompetent and unethical. I had hoped that he would defend his work and discuss its limitations with me in a rational fashion. Yet, at this stage, he remained silent.

I then decided to write a further post in the hope of getting some sort of response from him. Alas, my hope was disappointed again. Even when I challenged him and his ROYAL WARRANT directly, he remained silent.

THE BUILD-UP

It needed a seemingly unrelated post of mine for him to find his voice:

Dear Ezard
We can all go round in endless circles arguing whether the Earth is Flat, but eventually someone has to venture out in a boat to the horizon to determine the fact. A cursory reading of Hahnemann encourages every student of homoeopathy to gain their own experience empirically. We all know you and your friends on this blog are standing on the shore proclaiming the Earth to be flat, but when are you going to pedal out,to bravely cite actual cases you have treated with homoeopathy as evidence of your position? What the audience reading this wants to know is what experience and knowledge any of you actually have of the subject you spend so much time criticising?

At this stage a had grown a little weary of Mr Pinkus and his innuendos. My response was thus a little impatient:

Dear Tony
I don’t think highly of people who
1) are too daft to spell my name correctly,
2) imply I have no experience in homeopathy,
3) pretend that I make a secret of it, while, in fact, I published this multiple times (i.e. https://www.amazon.co.uk/Scientist-Wonderland-Searching-Finding-Trouble/dp/1845407776),
4) accuse others of being flat earthers, while evidently being one themselves,
5) do all this without declaring their massive conflict of interest.
Best regards
Edzard

What followed was Pinkus’ increasingly irrational attempts to defame me by revealing to the world that I (and other critics of homeopathy) lacked sufficient clinical experience with homeopathy and therefore were not competent to discuss the subject. Explanations by myself and others that,

  • firstly I did have knowledge and experience of homeopathy,
  • and secondly no experience is required for a critical evaluation of any treatment,

all fell on deaf ears.

THE END

The conclusion of this odd discussion was Pinkus’ triumphant declaration of victory:

I came to this blog to see if anyone in the discussion had any serious intention to discuss the subject of homoeopathy. In order to do this there are certain prerequisites for a sensible debate and one of these is actual knowledge and experience of the subject matter under discussion. To this end I asked if anyone has case they treated in order to discuss the merits and demerits of the experience. No one offered one. I repeated the request and the silence changed to attacks on me even asking.

Any scientist worthy of the challenge, and certainly someone who proudly styles himself as a Professor of CAM with experience and knowledge, would be only too glad to share this with others. Sadly though I have met with rebuke and insult but no evidence to support the opposition to homoeopathy saving some incoherent rant about the needlessness of empirical experience. The cornerstone of Hahnemann’s work on homoeopathy and the one thing he advocated to other doctors. “Don’t take my word for it, prove it to yourself”

When you find the need to attack me to defend your incessant argument that homoeopathy is implausible I really cannot take you seriously.

Here we have a blog hosted by a chap who claims to be an expert on the subject but now claims he hasn’t practiced it for over 40 years. Won’t say what he did when he practised, what he learned and when asked to give at least once case he treated, refuses and creates some diversion to cover his ignorance of the question. Now that’s what I call a charlatan.

I understand you have made a living out of this but it must be a miserable existence old chap

______________________________________________________________________

I find this exchange rather typical for an argument with  SCAM-fanatics. It follows a fairly standard strategy:

  • aggression form a complete stranger,
  • attempt of a rational defence,
  • more aggression and insults
  • attempts to debate the published evidence,
  • silence from the aggressor who seems unable to defend his evidence,
  • more aggression at an unexpected opportunity,
  • further attempts to rationalise and discuss the facts,
  • the aggressor questions his opponent’s competence,
  • more attempts to rationalise and provide valid explanations,
  • conclusion of the discussion with aggressor trying to occupy the moral high ground.

Of course, this is eerily similar to playing chess with a pigeon.

So, what, if anything, can we learn from this?

Mainly three things, I think:

  1. Either you don’t argue with fanatics at all,
  2. or you realise from the beginning what is about to happen; in this case, have fun exposing irrationality in the hope that others might profit from your experience.
  3. In any case, do not expect that your aggressor will be able to learn anything.

I wish people would think a bit before naming things! What is ‘natural health’? Is it the opposite of ‘unnatural health’ or of ‘natural illness’? But who am I to question the terminology of the NHS? I am not even a native English speaker!

Therefore, let me rather look at what this oddly-named school does. Here is how the ‘NHS Natural Health School‘ explain their work:

The NHS Natural Health School has been developed to meet the standards of practice, and experience that are essential for complementary therapists wishing to treat patients within an NHS healthcare setting. The school offers a wide range of approved and accredited courses, taught by highly qualified and clinically skilled lecturers who are experienced in working clinically within NHS Healthcare settings and providing complementary therapy treatments for patients with a range of complex needs including cancer diagnosis. By welcoming you into the multi-disciplinary care team, we not only prepare you as a confident, competent practitioner ready to meet the needs of a demanding industry, but we are able to support the provision of specialist care for a wide range of patients and clients who otherwise would miss out on beneficial treatments.

Courses include supervised clinical placements across hospital and community healthcare settings. All proceeds raised from the courses are reinvested into the Harrogate Hospital and Community Charity’s SROMC Complementary Therapy Fund to ensure the financial sustainability of the HDFT NHS Trust Complementary Therapy Service. For more information on the courses and education available please click the courses link above.

Naturally, I am intrigued and have a look at their courses. They include shiatsu, holistic massage and reflexology. Having published several papers on the latter, it is of particular interest to me. Reflexologists have maps of the sole of the foot where all the body’s organs are depicted. Numerous such maps have been published and, embarrassingly, they do not all agree with each other as to the location of the organs on the sole of the feet. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs.  Here is what the NHS Natural Health School advertise about their reflexology course:

A combination of theory and practical modules designed to equip the learner with the skills required to provide Reflexology treatments for a wide range of clients. On successful completion of the course you will be able to register with the relevant regulatory and professional associations and gain full insurance to practice.

Course content includes;

  • Explore the history and origins of Reflexology
  • Explore the use of various mediums used in treatment including waxes, balms, powders and oils
  • Explore the philosophy of holism and its role within western bio medicine
  • Reading the feet/hands and mapping the reflex points
  • Relevant anatomy, physiology and pathology
  • Managing a wide range of conditions
  • Legal implications
  • Cautions and contraindications
  • Assessment and client care
  • Practical reflexology skills and routines
  • Treatment planning

Assessment: You will produce evidence of 30 reflexology treatments. An additional assessment of your competence will determine your readiness to undertake 72 in-depth case studies and complete a practical assessment.

Course Duration: Attendance is required at 8 Reflexology technical days over 12 months, during which time you will demonstrate a minimum of 100 practical hours.

Special Notes: The core modules; Anatomy, Physiology and Pathology, Business Practice and Principles and Practice of Complementary Therapy are normally completed concurrently as part of the diploma.

Learners who already have a Level 3 diploma in a complementary therapy may be exempt from the core modules.

A first aid certificate is required prior to completion of the diploma.

Fascinating! Personally I am most intrigued about the module on anatomy, physiology and pathology, because all of the three squarely contradict what reflexologists believe. But I wonder even more why there is no mention of the evidence. Have they forgotten to mention it? Unlikely; their other courses on SCAMs such as aromatherapy, holistic massage or shiatsu have similar omissions. Or does the ‘NHS Natural Health School’ not think that evidence matters to ‘competent practitioners’ of the NHS? Or perhaps this is where ‘natural health’ is different from unnatural health?

No, silly me! The reason clearly lies elsewhere: the evidence fails to show that reflexology generates more good than harm. So, the clever people from the ‘NHS Natural Health School’ decided to hide it discretely. Shrewd move! Albeit slightly embarrassing as well as just a little unethical, particularly for the NHS Harrogate, I’d say.

Just in case some readers do wonder nonetheless what the evidence does tell us about reflexology, here is the summary table from my recent book:

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Debatable
RISK/BENEFIT BALANCE negative

I cannot help but being reminded of something I stated many times before: EVEN THE MOST PROPER TEACHING OF NONSENSE CAN ONLY RESULT IN NONSENSE.

These days, I am often not sure what puzzles me more, Boris Johnson or homeopathy. Come to think of it, our PM seems, in fact, to have a lot in common with homeopathy/homeopaths. With my tongue lodged firmly in my cheek, I can see some communalities:

  • They are both popular in the UK but have their origins elsewhere.
  • They were both laughed at by people who are serious.
  • They have both been around for far too long.
  • They both are useless.
  • They both have plenty of charisma.
  • They both, however, have little more than that.
  • They have a long history of misleading the public.
  • They have both been taken to court.
  • They both failed to accept the judgement when it went against them.
  • They are both particularly successful with the female section of the population.
  • They both thrive on personal attacks.
  • They both make far-reaching claims which turn out to be false.
  • They both claim to want only the best for the public.
  • They both consider themselves as progressive.
  • In truth, however, they are both deeply regressive.
  • They both do not to think that ethics are all that important.
  • They both irritate people who are rational thinkers.
  • They both negate the evidence and act in overt contradiction to the evidence.
  • They both tend to think that popularity is a measure of efficacy.
  • They both managed to mislead even the Queen.
  • Nevertheless, they both enjoy royal support (at least for the time being).
  • They both seem to think that the laws (of the land/of nature) do not apply to them.
  • They are both only bearable when highly diluted.
  • They are both a complete waste of money.
  • They are both dangerous when the public follow their advice.

Have I forgotten anything?

Do tell me, please.

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:

RCT No1

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.

RCT No2

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.

RCT No3

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:

1st review

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.

Last review

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:

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.

COMPARISONS:

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.

CHOICES:

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!

Initial feelings

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.

Going forward

– 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 tkatz@live.co.uk

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