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

test of time

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

Guest post by Christian Lehmann

It’s the end of February. We see the first death, in the Oise department, near Paris, of a French citizen who has not recently travelled abroad. For doctors concerned about what is happening in China, this is the red alert. In spite of of the little notices posted by the health minister, Agnes Buzyn, at airports, the coronavirus has made it onto French soil. Nobody knows at that point how it will spread. Almost nobody, apart from those responsible for it, yet knows that France has completely run down its stocks of masks. Doctors themselves do know that the health service has only held out, for as long as it has, on the backs of its care personnel. Some are assessing the scale of what is to come.

The announcement by Didier Raoult about the spectacular effectiveness of a synthetic antimalarial, chloroquine, has brought enormous relief, followed immediately for many of us health professionals by growing doubts about an accumulation of errors: Raoult denies any toxicity, urges people to “fall upon” a medication requiring sensitive handling. When we locate the Chinese article on which Didier Raoult is basing his crisis communication, we are stupefied. No need for specialised knowledge in statistical methodology to understand that there is something seriously wrong. No numerical data. Nobody knows what dosage has been given, to what type of patient, nor how many have been treated. The article has not been “peer reviewed”, that is to say reviewed by professional equals; decoded, it has the effect of a simple announcement. So of course at this chaotic time we tell ourselves that, given a revelation of such importance, the Chinese wanted to act as quickly as possible, to inform the whole world. And Didier Raoult, who routinely advises, as he explains with delicious modesty, the Chinese, « the world’s best virologists », has probably been entitled to the first fruits of this revelation.

On Youtube, on 28 February, he posts a weird interview, “Why would the Chinese be mistaken?”, in which he repeatedly takes up his interviewer with obvious irritation. “No, that’s not the question that you should be asking me. You should be asking me….” An informal group of doctors and tweeters pass around the link. We are rubbing our eyes in disbelief. What Didier Raoult is passing off as an interview is nothing more then an audience accorded to one of his media aides. We advise him, sarcastically, to make a professional cut of the video before broadcasting it. An hour later the video disappears and returns in a more professional form which could create the illusion of a genuine interview. And rapidly, in the Press which is beginning to turn its microphones towards the Professor from Marseille, he modifies his stance, without ever acknowledging the radical changes.

Chloroquine, spectacular and miraculous only yesterday, disappears as if by magic, replaced from one day to the next by hydroxychloroquine (Plaquenil), a different medicine, less common. Though its chemical structure is close to that of the antimalarial medication, hydroxychloroquine is used primarily in rheumatic conditions such as rheumatoid polyarthritis, or immune conditions such as lupus. So at least it isn’t lying around in large quantities in medicine cabinets. And its cardiac toxicity, very real, is slightly lower then that of chloroquine. Didier Raoult puts forward HCQ as an immense discovery, continuing in his usual manner to ridicule his detractors. “The doctors who criticise me are neither in my field nor up to my weight”. He flays the inaction of embittered petty health officials, only fit to follow the diktats of the authorities, who, bogged down in their catastrophic crisis management, dare not intervene. And his posturing as a refractory Gaul, a loudmouth taking on the system, gains sympathy, from those to whom he gives hope, from those who understand that the State does not tell them everything, and from those looking for a hero to fit in with their stereotypes: the man on his own against the establishment, the White Knight taking on Big Pharma, the Hippocratic colossus besieged by hordes of soulless ants.

No one among those who hold out their microphones to him, not one asks him the question which we are all asking, GPs, cardiologists, pharmaceutical specialists, emergency specialists, resuscitation specialists – by what sleight of hand has Didier Raoult exchanged his miracle medicine, in 48 hours, openly and publicly? And how is it that no one has noticed the sleight-of-hand? Has this man who makes such a big deal of his image on social networks suddenly become aware of the risk of being confronted about chloroquine with a justifiable public outcry and with deaths by self-medication?

While the World Health Organisation is sounding alarm bells, in the context of overall mistrust with regard to scientific opinion, of confrontation with regard to government, of growing awareness ( belated and sometimes disproportionate) of the influence of Big Pharma, and as the initial fear gives way to real panic for some with the registration of each new case, Didier Raoult piles up Facebook likes, fans, sites to his glory. And for us, fearful, begins the long registration of flagrant mistruths delivered as revealed truths, which this professor will never have the honestly to set right.

For Didier Raoult, a minimum of intellectual integrity would demand that he admits having changed horses in midstream. That he admits that the concern of his despised detractors was well founded, with respect to chloroquine to which many have access without knowing its dangers ( Nivaquine is very often used in suicides). And, because Didier Raoult withdraws nothing, he continues to stash away all the profits of his media coverage. Every supporter of the Wise Man of Marseille piles in with testimony. Their brother, sister, uncle, the father-in-law of their hairdresser has been taking the Professor’s medicine ( Which one? ) for eight years in Africa and has never had a problem, so that’s the real proof that his detractors are just jealous, or, even worse, backed by “the lobbies”.

And untiringly we repeat the fundamental truths:

  • Yes chloroquine has existed for years
  • Yes it is widely used
  • But for a different treatment, the prevention of malaria
  • And in dosages 5 to 10 times smaller
  • And in large dosages it causes cardiac arrest
  • And it has never been effective in fighting a virus
  • Not this virus nor any other
  • And the same is true for hydroxychloroquine
  • In fact it’s rather the opposite

In fact what is being patiently stated by the upholders of the scientific method is very counter-intuitive, almost inaudible, because they are telling worried and disorientated people, who have put their trust and their hope in one man, that in his assertions………nothing makes sense.

While many of us are wondering what SCAM will be promoted next for the corona pandemic, the editor of the infamous JCAM thought it wise to publish this note along with an article advertising the wonders of Ayurvedic medicine and yoga for the corona-virus entitled: ‘Public Health Approach of Ayurveda and Yoga for COVID-19 Prophylaxis‘.

Here are John Weeks’ remarks:

National governments are deeply divided over whether traditional, complementary and integrative practices have value for human beings relative to COVID-19. We witness a double standard. Medical doctors explore off-label uses of pharmaceutical agents that may have some suggestive research while evidence that indicates potential utility of natural products, practices and practitioners is often dismissed. In this Invited Commentary, a long-time JACM Editorial Board member Bhushan Patwardhan, PhD, from the AYUSH Center of Excellence, Center for Complementary and Integrative Health at the Savitribai Phule Pune University, India and colleagues from multiple institutions make a case for the potential roles of Ayurvedic medicine and Yoga as supportive measures in self-care and treatment. Patwardhan is a warrior for enhancing scientific standards in traditional medicine in India. Patwardhan was recently appointed by the Ministry of AYUSH, Government of India, as Chairman of an 18 member expert group known as “Interdisciplinary AYUSH Research and Development Taskforce” for initiating, coordinating and monitoring efforts against COVID-19. He was last seen here in an invited commentary entitled “Contesting Predators: Cleaning Up Trash in Science” (JACM, October 2019). We are pleased to have this opportunity to share the recommended approaches, the science, and the historic references as part of the global effort to leave no stone unturned in best preparing our populations to withstand COVID-19 and future viral threats. – John Weeks, Editor-in-Chief, JACM

His remarks are, I think, worthy of four very brief comments:

  1. As far as I can see, national governments and their advisors struggle to make sense of the rapidly changing situation. In all the confusion, they are, however, very clear about one thing: traditional, complementary and integrative practices have no real value for human beings relative to COVID-19.
  2. The double standards Weeks bemoans do not exist. There are dozens of studies currently on their way testing virtually any therapeutic option that shows even the smallest shimmer of hope. Testing implausible options only because some quacks feel neglected would be the last thing the world needs in the present situation.
  3. Weeks claims that ‘evidence that indicates potential utility of natural products, practices and practitioners is often dismissed’. What evidence? The article published alongside his remarks is free of what anyone with a thinking brain might call ‘evidence’. If there is evidence, Weeks or anyone else should approach the experts responsible for conducting the current trials; I am sure that they would listen and be only too happy to consider any reasonable option.
  4. The Indian Ministry of AYUSH has indeed been promoting all sorts of quackery for the corona-virus. This behaviour is likely to cause many fatalities in India. It should be squarely condemned and not promoted as Weeks seem to think.

The ‘Corona-Virus Quackery Club’ (CVQC) is getting positively crowded. You may remember, its members include:

Today we are admitting the herbalists. The reason is obvious: many of them have jumped on the corona band-wagon by trying to improve their cash-flow on the back of the pandemic-related anxiety of consumers. If you go on the Internet you will find many examples, I am sure. I have chosen this website for explaining the situation.

Herbs That Can Stop Coronavirus Reproduction

CoV multiplies fast in the lungs and the stomach and intestines. The more virus, the sicker you get. The herbs are in their scientific names and common names.

    1. Cibotium barometz – golden chicken fern or woolly fern grows in China and Southeast Asia.

      Cibotium Barometz

    2. Gentiana scabra – known as Korean gentian or Japanese gentian seen in the United States and Japan.

      Japanese Gentian

    3. Dioscorea batatas or Chinese Yam grows in China and East Asia

      Chinese Yam

    4. Cassia tora or Foetid cassia, The Sickle Senna, Wild Senna – grows in India and Central America

      Cassia Tora

    5. Taxillus Chinensis – Mulberry Mistletoe

Lectin Plants that Have Anti Coronavirus Properties

Plant Lectins with Antiviral activity Against Coronavirus

From the table above, all have anti coronavirus activity except for garlic. One plant that is effective but not listed is Stinging nettle.

Yes, very nice pictures – but sadly utterly unreliable messages. My advice is that, in case you have concerns about corona (or any other health problem for that matter), please do not ask a herbalist.

WELCOME TO THE CVQC, HERBALISTS!

I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.

The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis.  It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.

The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.

Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.

Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.

But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public.  He said it is ‘almost impossible to satisfy the licensing conditions’.  He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.

How exciting!

Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).

Frustrated I looked at the website of the manufacturer. Here I found this:

Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.

Benefits

– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food

And this:

What can Sigesbeckia be used to treat?

Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;

Backache

Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.

Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.

Minor sports injuries

Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.

Rheumatic and muscular pain

Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.

General aches and pains in muscles and joints

Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.

The Benefit of Sigesbeckia extract

One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.

In summary: Look after your joints and muscles with Sigesbeckia

Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.

Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?

But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.

I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.

Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?

Realgar, α-As4S4, is an arsenic sulfide mineral, also known as “ruby sulphur” or “ruby of arsenic”. It is a soft, sectile mineral occurring in monoclinic crystals, or in granular, compact, or powdery form, often in association with the related mineral, orpiment (As2S3).

In Traditional Chinese Medicine (TCM), realgar is often used in combination with herbs. An investigation found a total of 191 different, realgar-containing traditional Chinese patent medicines, and about 87% of them were for oral application. Realgar is said to: 

counteract toxic pathogen both externally and internally. For abscess swelling and sores, it can be used singly or in compound prescription for external application mostly. When taken internally, it is combined with blood-activating and abscess-curing herbs to obtain the action of activating blood to relieve swelling, removing toxicity to cure sores. For example, it is combined with Ru Xiang, Mo Yao and She Xiang in Xing Xiao Wan from Wai Ke Quan Sheng Ji. For itching of skin due to scabies and ringworm, it is often combined with dampness-astringing and itching-relieving herbs to obtain actions of killing parasites and curing ringworm, astringing dampness and relieving itching. For instance, it is combined with the same dose of Bai Fan in powder mixed with clear tea for external application in Er Wei Ba Du San from Yi Zong Jin Jian. For poisonous insect bite, it is mixed with sesame oil and then applied on the afflicted sites.

This herb can kill parasites so it is indicated for intestine track parasites. For roundworm induced abdominal pain, it is often combined with other roundworm-killing herbs to reinforce action. For instance, it is combined with Qian Niu Zi and Bing Lang, etc. in Qian Niu Wan from Shen Shi Zun Sheng Shu. For anus pruritus caused by pinworm, it can be made into gauze strip by mixing with vaseline, and then inserted into the anus.

In addition, according to some ancient formulas, this herb can dispel phlegm and check malaria for internal application, so it can also be indicated for epilepsy, asthma and malaria.

Longtime topical over-dose or oral intake of realgar can cause chronic arsenic poisoning and even death. Chinese authors recently published the case of a 35-year-old Chinese man, who was diagnosed with severe psoriasis and died of fatal acute arsenic poisoning after he applied a local folk prescription ointment containing mainly realgar to the affected skin for about 4 days. The autopsy showed multiple punctate haemorrhages over the limbs, pleural effusion, oedematous lungs with consolidation, mild myocardial hypertrophy and normal-looking kidneys. The histopathological examination of renal tissue showed severe degeneration, necrosis and desquamation of renal tubular epithelial cells, presence of protein cast and a widened oedematous interstitium with interstitial fibrosis. The presence of arsenic in large amount in the ointment (about 6%), in blood (1.76 μg/mL), and in skin (4.71 μg/g), were confirmed analytically. The authors also review 7 similar cases in literature.

My advice is that, when you see recommendations by TCM practitioners like this one

the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically

you think again and consider that TCM really is not a form of healthcare that can be trusted to be safe.

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.

 

 

Pertussis (whooping-cough) is a serious condition. Today, we have vaccinations and antibiotics against it and therefore it is rarely a fatal disease. A century or so, the situation was different. Then all sorts of quacks claimed to be able to treat pertussis and many patients, particularly children, died.

This article starts with this amazing introduction: Osteopathic physicians may want to consider using osteopathic manipulative treatment (OMT) as an adjunctive treatment modality for pertussis; however, suitable OMT techniques are not specified in the research literature.

For the paper, the author then searched the historical osteopathic literature to identify OMT techniques that were used in the management of pertussis in the pre-antibiotic era. The 24 identified sources included 8 articles and 16 book contributions from the years 1886 to 1958. Most sources were published within the first quarter of the 20th century. Commonly identified OMT techniques included mobilization techniques, lymphatic pump techniques, and other manipulative techniques predominantly in the cervical and thoracic regions.

The author concluded that the wealth of OMT techniques for patients with pertussis that were identified suggests that pertussis was commonly treated by early osteopaths. Further research is necessary to identify or establish the evidence base for these techniques so that in case of favorable outcomes, their use by osteopathic physicians is justified as adjunctive modalities when encountering a patient with pertussis.

I found it hard to decide whether to laugh or to cry after reading this. One could easily have a good giggle about the silliness of the idea to revive obsolete techniques for treating a potentially serious infection. One the other hand, I cannot help but ask myself:

  • Is there any suggestion at all that OMT was successful in treating pertussis?
  • If the answer is negative (and I fear it is), why would anyone spend considerable resources to establish the evidence base for these techniques?
  • Do osteopaths believe in progress at all?
  • Do they really think that there is even a remote chance that mobilization techniques, lymphatic pump techniques, and other manipulative techniques will, one day, come back as adjunctive therapies for pertussis?
  • Do they not believe in a rational approach to prioritising medical research such that scarce resources are spent ethically and wisely?

You may think that none of this really matters. The author of this paper is just a lone loon! That may well be so, but even lone loons can do a lot of harm, if they convince consumers of their bizarre ideas.

But surely, the profession of osteopathy would not tolerate this, you say. I am not convinced. The article was published in the Journal of the American Osteopathic Association. This seems significant to me. It is comparable to the JAMA or the BMJ publishing an article calling for a programme of research into the possible benefits of blood-letting as a treatment of pneumonia!

 

 

We all know Epsom salt, don’t we? This paper provides an interesting history of it: The purgative effect of the waters of Epsom, in southern England, was first discovered in the early seventeenth century. Epsom subsequently developed as one of the great English spas where high society flocked to take the medicinal waters. The extraction of the Epsom Salts from the spa waters and their chemical analysis, the essential feature of which was magnesium sulphate, were first successfully carried out by Doctor Nehemiah Grew, distinguished as a physician, botanist and an early Fellow of the Royal Society. His attempt to patent the production and sale of the Epsom Salts precipitated a dispute with two unscrupulous apothecaries, the Moult brothers. This controversy must be set against the backcloth of the long-standing struggle over the monopoly of dispensing of medicines between the Royal College of Physicians and the Worshipful Society of Apothecaries of London.

Epsom salt has the reputation of being very safe. But unfortunately, even something as seemingly harmless as Epsom salt can become dangerous in the hand of people who have little understanding of physiology and medicine. Indian doctors have just published a paper in (‘BMJ Case Reports’) with the details of a 38-year-old non-alcoholic, non-diabetic man suffering from gallstones. The patient was prescribed three tablespoons of Epsom salt to be taken with lukewarm water for 15 days for ‘stone dissolution’ by a ‘naturopathy practitioner’. He subsequently developed loss of appetite and darkening of urine from the 12th day of treatment and jaundice from the second day after treatment completion. The patient denied fevers, skin rash, joint pains, myalgia, abdominal pain, abdominal distension and cholestatic symptoms.

Examination revealed a deeply icteric patient oriented to time, place and person without an enlarged liver or stigmata of chronic liver disease. Liver function tests were abnormal, and a  liver biopsy revealed sub-massive necrosis with dense portal-based fibrosis, mixed portal inflammation, extensive peri-venular canalicular and hepatocellular cholestasis with macro-vesicular steatosis and peri-sinusoidal fibrosis (suggestive of steato-hepatitis) without evidence of granulomas, inclusion bodies or vascular changes suggestive of acute drug-induced liver injury.

After discontinuation of Epsom salt and adequate hydration, the patient had an uneventful recovery with normalisation of liver function tests after 38 days.  The Roussel Uclaf Causality Assessment score was strongly suggestive of Epsom salt-induced liver injury.

I was invited to provide a comment and stated that, in my view, this case reminds us:

1) that naturopaths prescribe a lot of nonsense,

2) that not everything which is promoted as natural is safe,

3) that treatments which apparently have ‘stood the test of time’ can still be rubbish, and

4) that even a relatively harmless remedy can become life-threatening, if one takes it at a high dose for a prolonged period of time.

Naturopaths have advocated Epsom salt for gall-bladder problems since centuries, yet there is no good evidence that it works. It is time that alternative practitioners abide by the rules of evidence-based medicine.

A quick Medline search reveals that there is only one further report of a serious adverse effect after Epsom salt intake: a case of fatal hypermagnesemia caused by an Epsom salt enema. A 7-year-old male presented with cardiac arrest and was found to have a serum magnesium level of 41.2 mg/dL (33.9 mEq/L) after having received an Epsom salt enema earlier that day. The medical history of Epsom salt, the common causes and symptoms of hypermagnesemia, and the treatment of hypermagnesemia are reviewed. The easy availability of magnesium, the subtle initial symptoms of hypermagnesemia, and the need for education about the toxicity of magnesium should be of interest to physicians.

… and to alternative practitioners, I hasten to add.

Guest post by Richard Rawlins MB BS MBA FRCS

Doctors who are registered medical practitioners (RMPs) must comply with the standards of practice set down by the General Medical Council. ‘Homeopathy’ is a specific system of medical care, devised by Dr Samuel Hahnemann in the nineteenth century, and comprises two distinct dimensions: (i) the establishment of a constructive therapeutic relationship between an empathic homeopath and a patient. This may provide benefit due to the non-specific effects of condolence, counselling, and care – and should be a component of the practice of all doctors in any event; (ii) the homeopathically prepared (HP) remedies that are generally prescribed. To avoid confusion, these two dimensions should not be conflated.

HP remedies may be obtained over the counter, prescribed by lay homeopaths and even given out by dentists and nurses on the grounds that “30C homeopathic arnica helps bruising”. The US Federal Trades Commission has stated that “The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted…accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.” (FTC Policy statement 2017).

Special focus should be brought to bear on the ethical, intellectual and professional obligations of those doctors registered as medical practitioners by the GMC and practicing homeopathy in the UK. Some homeopaths may intend taking advantage of gullible and vulnerable patients. Here I take it that those practitioners who prescribe homeopathic remedies sincerely do believe they have worthwhile effects, but I contend such practice generally fails to comply with ethical and professional standards as set down by the GMC. That is to be deprecated.

Systems to regulate medical practice in the British Isles have been devised since the middle ages. In 1518, Thomas Linacre founded the College of Physicians – based on systems he had seen in Europe. From 1704, the Society of Apothecaries licensed its members to prescribe and dispense medicines, and developed the profession of general practice. In order to protect the public from charlatans, quacks and fraudsters more effectively, the Medical Act of 1858 established formal statutory regulation of doctors by the General Medical Council. Registrants who are not deemed fit to practice may be struck off the register. They can still practice, but not as registered medical practitioners. They can still use the title ‘doctor’ (as can anyone), but not for fraudulent purposes.

Dr Samuel Hahnemann qualified in Saxony in 1781 and was a good doctor, but he became disillusioned with many of the practices and practitioners of his day. He wrote about his fellow doctors: “Precious and fragile human life, so easily destroyed, was frequently placed in jeopardy at the hands of these perverted people, especially since bleedings, emetics, purges, blistering plaster, fontanels, setons, caustics and cauterisations were used.” In 1796 he wrote to a friend, “I renounced the practice of medicine that I might no longer incur the risk of doing injury, and I engaged in chemistry exclusively and in literary occupations.”

Hahnemann went on to develop his own alternative system of health care, which he styled ‘Homoeopathy’. Published as the Organon of the Healing Arts in 1810, Hahnemann set out an idiosyncratic medical system based on identifying ‘remedies’ which in large doses, could produce symptoms comparable to those suffered by the patient. The remedies he prescribed were prepared with serial dilutions so that no active principle remained. Today’s homeopaths hold that a remedy’s ‘vital force’, ‘healing energy’ or ‘memory’ provides therapeutic benefit. That may be the case, but the consensus of informed scientific and medical opinion is that any effects of ‘homeopathy’ are as a result of contextual placebo effects. The remedies themselves cannot and do not have any effect. England’s Chief Medical Officer has described homeopathy’s principles as ‘rubbish’. The government’s Chief Scientific Adviser, Sir Mark Walport has said he would tell ministers, “My view, scientifically, is absolutely clear: homeopathy is nonsense. The most it can have is a placebo effect.” Simon Stevens, CEO of the NHS, when interviewed on Radio 4 said he agrees with Sir Mark – yet failed to explain why he had not included homeopathic remedies in the 2017 list of NHS proscribed medicines. That stance is being reviewed.

The GMC states, “Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected.” Those standards are set down in the GMC’s Good Medical Practice which advises, “Serious or persistent failure to follow this guidance will put your registration at risk.” The GMC standards are coherent with those of the American Medical Association’s Principles of Medical Ethics (2016).

In précis, the most relevant and important GMC standards are:

  • Make the care of your patient your first concern.
  • Give patients the information they want or need in a way they can understand.
  • Be honest and open and act with integrity.
  • Never abuse your patients’ trust in you or the public’s trust in the profession.
  • You are personally accountable for your professional practice and must always be prepared to justify your decisions and actions.
  • You must  prescribe drugs or treatment only when you are satisfied that the drugs or treatment serve the patient’s needs.                                                                                                                                             
  • You must provide effective treatments based on the best available evidence.
  • You must be satisfied that you have consent or other valid authority before you carry out any examination, investigation or provide treatment.
  • You must make good use of the resources available to you.

I contend that medical practitioners who prescribe homeopathic remedies regularly fail to meet these standards. They know perfectly well that the best available evidence indicates no support for the assertion that homeopathic remedies ‘serve the patient’s needs’, except as placebos; that the treatments have no specific effects; that the remedies are placebos; and that resources are wasted by expenditure on these ineffective remedies. Medical homeopaths invariably do not give patients this information; they fail to obtain properly informed consent; they do not justify their decisions and actions rationally; and they may be obtaining financial advantage by misrepresentation to insurance companies or the NHS. This is an abuse of the public’s trust in the medical profession.

The issue of informed consent is particularly important. GMC guidance states that, “The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. …Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.”

The GMC states that, “in order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options… risks can take a number of forms, but will usually be: side effects; complications; failure of an intervention to achieve the desired aim.” The risk of wasting money on ineffective remedies, whether NHS or private, and of delaying treatment known to be effective should also be discussed.

Homeopaths acknowledge that after ministration of remedies, some patients experience ‘aggravations’ – a worsening of symptoms, but they advise this is evidence that the remedy is ‘working’. Medical consensus is more likely to suggest ‘aggravations’ are evidence of an underlying psychological component to the patient’s condition. Suggestions that remedies themselves have any effect, good or bad, is misrepresentation and may be fraud. Offering patients sugar pills with a claim the pills have therapeutic effects means lying to them, and is an abuse of trust.

Homeopaths’ system of diagnosis and prescription of remedies requires them to have beliefs for which there is no plausible evidence base. The Oxford Dictionary defines ‘belief’ as “assent to a proposition, statement or fact, especially on the grounds of testimony or authority, or in the absence of proof or conclusive evidence.” It might be acceptable to practice ‘homeopathy’ as a counselling modality, providing the practitioner complies with the GMC standard that, “You must not express your personal beliefs to patients in ways that exploit their vulnerability or are likely to cause them distress.”

Homeopaths are invariably non-compliant in obtaining fully informed consent. Such a failing is an abuse of patients’ trust in the medical profession. Doctors might be determined to be unfit to practice unless they clearly justify their prescriptions, and identify the evidence that supports them. All these issues should also be explored during the doctor’s annual appraisal, without which a registered medical practitioner will not be licensed to practice. Even registration without a licence requires compliance with the standards. Appraisal can be carried out by non-homeopaths, as the issue is not the assessment of the standard of ‘homeopathic practice’, but compliance with GMC standards of good medical practice.

If a medical homeopath wishes to be GMC compliant, they must properly inform patients about contentious issues. I suggest that consent should be obtained along the lines: “I propose prescribing you a remedy comprising sugar pills impregnated with a solution which has been diluted to such an extent that a sphere of water the size of the Earth’s average radius to the Sun would probably contain no more than one molecule of the original substance. Nevertheless, my clinical experience suggests to me that this remedy will improve your condition. You need to understand that colleagues who practise conventional evidence-based scientific medicine regard my belief as implausible and the methods I use as ‘alternative.’ I believe the remedy will help you, but I have no evidence accepted by the majority of doctors that the intervention I propose will achieve the desired effects. I do not believe that taking a homeopathic remedy will delay any other treatment which might reasonably help your condition and I invite you to take this remedy with understanding of the issues I have outlined.” A copy of the consent should be placed in the patient’s records.

Those who defend the right of registered medical practitioners to prescribe HP remedies do so with arguments fatally holed by a myriad of logical fallacies. Some arguments are (with fallacies in parenthesis):

  • “Homeopathy has been used for over two hundred years” (appeal to tradition and argument from ignorance);
  • “It has become very popular and is what patients want (appeal to popularity);
  • “Homeopathy has the capacity to help patients” (red herring, because present consideration is about the value of HP remedies, not relationships);
  • “Remedies are cheap” (red herring);
  • “Homeopathy does not do any harm” (irrelevant and a red herring);
  • “Pharmaceuticals have side effects” (tu quoque and red herring);
  • “The Royal Family use it” (appeal to irrelevant authority);
  • “The remedies enhance the doctor/patient relationship (straw man);
  • “Science does not know everything” (red herring and false dichotomy);
  • “Those who oppose us don’t understand homeopathy” (argumentum ad hominem and ‘poisoning the well’);
  • “I have the evidence of patients’ anecdotes and testimonials” (pseudoscience, confirmation bias and cherry picking);
  • “Homeopathic doctors are caring people” (red herring and straw man);
  • “I’ve got much evidence of  patients taking remedies and getting better” (post hoc ergo propter hoc – ‘after this, therefore because of this’ – confusion of coincidence with causation).

The latter most perverse fallacy is the foundation of homeopathic practice, based on identifying a remedy whereby ‘like cures like’ – a principle based on post hoc fallacy for which there is no scientifically credible evidence.

Unless and until medical homeopaths understand the intellectual environment in which they practice, are prepared to properly inform their patients, and obtain consent for treatment having done so, they should not prescribe homeopathic remedies. Fortunately, there is no evidence that patients who are prescribed HP remedies by empathic GMC registered homeopaths have any different outcomes from those prescribed pure sugar pills – even if they are told they are placebos. However, trust in the medical profession can only be maintained if deceptive practices are set aside and full explanations for proposed interventions are offered. Given the scientific consensus, patients have to face up to the fact that to the highest degree of probability, HP remedies have no value. Regrettably, too many patients and even homeopaths are in denial. Medical homeopaths should continue to serve their patients with care, compassion and intellectual honesty, but if they are to comply with the standards required for GMC registration, they should not prescribe homeopathically prepared remedies.

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