MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

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Yesterday, a press-release reached me announcing that a Chinese herbal medicine, ‘Phynova Joint and Muscle Relief Tablets’, containing the active ingredient Sigesbeckia, is now on sale in the UK for the first time in Boots The Chemist: 

Sigesbeckia is the first traditional Chinese treatment granted a traditional herbal registration (THR) under the traditional herbal medicines product directive in the UK, by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA).  Oxford based Phynova which manufactures the product was granted the UK licence last year. 

Containing 500mg of the active ingredient, Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.  Two tablets are taken each day, one in the morning and one in the evening. They have no known side effects and are non-addictive. .. 

The product, which retails at £19.99 for one month’s supply of 60 tablets, is available in 950 UK Boots outlets and online via Click and Collect from all stores.  It will be sold both Over the Counter (OTC) by pharmacist staff and off the shelf as part of Boots’ pain relief fixture… 

END OF QUOTE

What on earth is a ‘joint and muscle relief’? Personally I do not want to be relieved of my joints and muscles!!!

Yes, I know, they probably mean ‘joint and muscle pain relief’ but were not allowed to say so because this is a medical indication.

And what about the claim of ‘no side-effects’; is it possible that a pharmacological treatment has positive effects without any risks at all? This is not what they told me during my pharmacology course, if I remember correctly. And anyway, even placebos have side-effects!

I admit, I was puzzled.

The covering letter of the press-release provided more amazement: it informed me that “Phynova joint and muscle relief contains the active ingredient Sigesbeckia which has been through clinical trials and has been used for pain relief in China for hundreds of years…” It was the remark about clinical trials (PLURAL!!!) that caught my interest most.

So, I looked up ‘Sigesbeckia’ on Medline and found as good as nothing. This is mainly because the plant is spelled correctly ‘Siegesbeckia’ in honour of the famous botanist Siegesbeck.

Looking up ‘Siegesbeckia’, I found many pre-clinical studies but no clinical trials.

Next I searched for a comment from the MHRA and discovered that their account makes it very clear that a licence has been granted to this product “exclusively upon long standing use… and not upon data from clinical trials.”

So, who is right?

Are there clinical trials of this product or not? And, if there are any, where are they?

Perhaps someone from Phynova can enlighten us?

 

Some homeopaths advise parents not to vaccinate their kids and use homeopathic vaccinations or ‘homeo-prophylaxis’ instead. Despite the fact that it has long been clear that this approach is not effective and even dangerous, some homeopathic pharmacies have been selling the remedies used for that purpose. In the UK, Helios has been at the forefront of this dubious trade. But, a few days ago, they have changed their ways.

Here is a screenshot of the results of a search for the word ‘vaccine’, with the ‘remedies’ that were subsequently removed highlighted:

Helios vaccine remedies 1

Click the image to enlarge.

This is undoubtedly a step in the right direction. The question I ask myself is WHY DID HELIOS MAKE THIS CHANGE? Was it because they had to? Or was it because they saw the light and realised that the evidence did not support the remedies in question?

If it was the latter motivation, we will soon know – because, in that case, they will surely do the same with the entire rest of their remedies.

Why?

BECAUSE THERE IS NOT GOOD EVIDENCE THAT ANY HIGHLY DILUTED HOMEOPATHIC REMEDY IS MORE THAN A PLACEBO.

AROMATHERAPY is one of the most popular alternative therapies. The experience is usually pleasant enough, but what are the risks? None!!! At least this is what the therapists would claim. But is this true? Perhaps not. According to a recent press-release, the risks might be considerable.

Officials with the Tennessee Poison Control Center (TPC) are warning that they are seeing an increasing number of toxic exposures, mostly involving children, to essential oils used in aromatherapy. The TPC says the number of essential oil exposures doubled between 2011 and 2015, and 80 percent of those cases involved children. The primary route of poisoning is by ingestion, but also occurs with excessive or inappropriate application to the skin. Children are at risk because their skin easily absorbs oils and because they may try to ingest essential oils from the container.

“Tea tree oil is commonly cited, and most of those cases are accidental ingestions by children.” said Justin Loden, PharmD, certified specialist in Poison Information (CSPI) at TPC. Most essential oils have a pleasant smell but bitter taste, so children easily choke on them and aspirate the oil to their lungs, Loden said.

Several essential oils such as camphor, clove, lavender, eucalyptus, thyme, tea tree, and wintergreen oils are highly toxic. All of the oils produce oral and throat irritation, nausea, and vomiting when ingested. Most essential oils either produce central nervous system (CNS) stimulation, which results in agitation, hallucinations, delirium, and seizures or CNS depression, which results in lethargy and coma. Other toxic effects include painless chemical burns, hypotension, acute respiratory distress syndrome, acute liver failure, severe metabolic acidosis, and cerebral edema depending on which essential oil is in question.

Tennessee Poison Center Tips for using essential oils

  • Safely using and storing essential oils is extremely important
  • Use essential oil products ONLY for their intended purpose.
  • Use only the amount stated on the label/guide.
  • Do not swallow an essential oil unless the label says to do so.
  • Do not use a product on the skin unless the label says to do so.
  • Do not leave the product out (i.e. as a pesticide) unless the label says to do so.
  • If you have bottles of essential oils at home, keep them locked up, out of sight and reach of children and pet at all times. Children act fast, so do poisons.

Many will think that this is alarmist – but I don’t. In fact, in 2012, I published a systematic review aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. No, it was not funded by ‘BIG PHARMA’ but by THE ROYAL COLLEGE OF PHYSICIANS, LONDON.

Five electronic databases were searched to identify all relevant case reports and case series. Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects.

At the time, we concluded that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.

I might add – before the therapists start making comments – that, yes, aromatherapy is still dimensions safer than many conventional treatments. But remember: the value of a therapy is not determined by its safety but by the risk/benefit balance! And what are the proven benefits of aromatherapy, I ask you.

I get comments of this nature all the time, sometimes by the dozen per day. As the argument is so very common, let me ONCE AGAIN explain what is wrong with it. Here are 10 very simple points for those who find it hard to understand the issue.

  1. My expertise is in alternative medicine and not in pharmacology. I know many pharmacologists who are competent to criticise aspects of pharmacotherapy and do so regularly. I do NOT consider myself competent to comment on pharmacotherapy.
  2. The fact that some things are not perfect in one area of health care (e. g. pharmacotherapy) does certainly not mean that one is not allowed to criticise shortcomings in other areas (e. g. homeopathy).
  3. As far as I can tell, it is not pharmaceuticals that ‘kill 100k a year’, but the issue is more complex: a sizable proportion of this tragic total is due to medical errors, for instance.
  4. The 100k figure seems to refer to the US where the vast majority of the population take pharmaceuticals but only about 2% of the population ever try homeopathy.
  5. Nobody seems to dispute that pharmaceuticals have beneficial effects beyond placebo; the general consensus regarding highly diluted homeopathics is that they have no effects beyond placebo.
  6. To judge the value of a therapy, it is naïve and dangerously misleading to consider just its risks. If we did that, aromatherapy would be preferable to surgery, reflexology would be better than chemotherapy and OF COURSE homeopathy would be better than pharmacotherapy. And if we then implemented this ‘wisdom’ into routine practice, we would hasten the deaths of millions.
  7. Any reasonable judgement of the value of any therapy must account for its documented risks in relation to its documented benefits. In other words, we must always try to weigh the two against each other and do a risk/benefit analysis.
  8. If a therapy is associated with finite risks and no benefits, its risk/benefit balance cannot possibly be positive. Where the benefit is non-existent or doubtful, even relatively small risks will inevitably tilt this balance in to the negative.
  9. This is precisely the situation that applies to homeopathy: its benefits beyond placebo are doubtful and its risks are fairly well documented.
  10. This means that homeopathy cannot be considered to be a therapy that is fit for purpose.

Cervical spine manipulation (CSM) is a popular manipulative therapy employed by chiropractors, osteopaths, physiotherapists and other healthcare professionals. It remains controversial because its benefits are in doubt and its safety is questionable. CSM carries the risk of serious neurovascular complications, primarily due to vertebral artery dissection (VAD) and subsequent vertebrobasilar stroke.

Chinese physicians recently reported a rare case of a ‘locked-in syndrome’ (LIS) due to bi-lateral VAD after CSM treated by arterial embolectomy. A 36-year-old right-handed man was admitted to our hospital with numbness and weakness of limbs after receiving treatment with CSM. Although the patient remained conscious, he could not speak but could communicate with the surrounding by blinking or moving his eyes, and turned to complete quadriplegia, complete facial and bulbar palsy, dyspnoea at 4 hours after admission. He was diagnosed with LIS. Cervical and brain computed tomography angiography revealed bi-lateral VADs. Aorto-cranial digital subtraction angiography showed a vertebro-basilar thrombosis which was blocking the left vertebral artery, and a stenosis of right vertebral artery. The patient underwent emergency arterial embolectomy; subsequently he was treated with antiplatelet therapy and supportive therapy in an intensive care unit and later in a general ward. After 27 days, the patient’s physical function gradually improved. At discharge, he still had a neurological deficit with muscle strength grade 3/5 and hyperreflexia of the limbs.

The authors concluded that CSM might have potential severe side-effect like LIS due to bilaterial VAD, and arterial embolectomy is an important treatment choice. The practitioner must be aware of this complication and should give the patients informed consent to CSM, although not all stroke cases temporally related to CSM have pre-existing craniocervical artery dissection.

Informed consent is an ethical imperative with any treatment. There is good evidence to suggest that few clinicians using CSM obtain informed consent from their patients before starting their treatment. This is undoubtedly a serious violation of medical ethics.

So, why do they not obtain informed consent?

To answer this question, we need to consider what informed consent would mean. It would mean, I think, conveying the following points to the patient in a way that he or she can understand them:

  1. the treatment I am suggesting can, in rare cases, cause very serious problems,
  2. there is little good evidence to suggest that it will ease your condition,
  3. there are other therapies that might be more effective.

Who would give his or her consent after receiving such information?

I suspect it would be very few patients indeed!

AND THAT’S THE REASON, I FEAR, WHY MANY CLINICIANS USING CSM PREFER TO BEHAVE UNETHICALLY AND FORGET ABOUT INFORMED CONSENT.

The Independent asked me yesterday to write a 500-word piece on homeopathy. I accepted with pleasure. About two hours after I had sent it, my article appeared on their website. As I had not even seen their edited version, I was surprised how much they changed without my permission.

No, I am not cross about this – I know by now how journalists function. Yet I think that some of their changes did change my meaning, and therefore I have decided to post here the original. Since I did not get paid nor sign a copyright transfer, I think I am perfectly entitled to do that.

HERE IT IS

Time to get real about homeopathy

EDZARD ERNST, EMERITUS PROFESSOR, UNIVERSITY OF EXETER

The National Health and Medical Research Council of Australia recently published what might be the most thorough evaluation of homeopathy in the 200-year long history of this therapy. They assessed a total of 57 systematic reviews summarizing 176 individual clinical trials focused on 68 different conditions. They concluded that, firstly, there is no evidence that homeopathy works better than placebo, and, secondly, that patients may harm themselves, if they nevertheless employ homeopathy instead of effective therapies. Already in 2002, on the basis of a similar but less comprehensive analysis, I concluded that “the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice” [http://www.ncbi.nlm.nih.gov/pubmed/12492603]. Yet homeopaths around the world seemed shocked by this news and are now on the war-path to rubbish or suppress it.

This reaction is as surprising as it is ridiculous. The conclusion that highly diluted homeopathic remedies are pure placebos had already been derived from the utter implausibility of Hahnemann’s theories that like cures like and that diluting a remedy would render it not weaker but stronger. Oliver Wendell Holmes, for instance, famously wrote in 1842 that homeopathy is “a mingled mass of perverse ingenuity, of tinsel erudition, of imbecile credulity, and of artful misinterpretation, too often mingled in practice…with heartless and shameless imposition.”

Homeopaths, however, claimed for the last 200 years that science was not yet able to explain how homeopathy works, in other words, that homeopaths are ahead of their time. The fact, however, is that scientists have always been perfectly able to affirm that there cannot be an explanation for homeopathy that does not fly in the face of science.

“The proof is in the pudding”, homeopaths countered, “if patients benefit from homeopathy, it works regardless what the science tells us!” This argument too has long been shown to be based on little more than the delusion of homeopaths. Patients benefit from the therapeutic encounter, from the placebo-effect and from other phenomena that are unrelated to the sugar pills dished out by homeopaths. To convey such benefits to their patients, clinicians do not need placebos. Administering truly effective treatments with compassion will make them benefit from both the specific and the non-specific effects of the therapy in question. This means that just using placebos like homeopathics is unethical and amounts to cheating the patient.

Given the overwhelming evidence against homeopathy it seems now time to act. There is no reason any longer for consumers, patients, politicians, journalists etc. to believe in homeopathy. Pretending there is room for a legitimate debate is merely misleading the public. There is also no reason to have homeopathy on the NHS, to pay for homeopathic hospitals or to invest into further research. After researching the subject for more than two decades, I am convinced that the only legitimate place for homeopathy is in the history books.

Chronic pain is a common and serious problem for many patients. Treatment often includes non-pharmacological approaches despite the mostly flimsy evidence to support them. The objective of this study was to measure the feasibility and efficacy of hypnosis (including self-hypnosis) in the management of chronic pain in older hospitalized patients.

A single center randomized controlled trial using a two arm parallel group design (hypnosis versus massage). Inclusion criteria were chronic pain for more than 3 months with impact on daily life activities, intensity of > 4; adapted analgesic treatment; no cognitive impairment. Fifty-three patients were included. Pain intensity decreased significantly in both groups after each session. Average pain measured by the brief pain index sustained a greater decrease in the hypnosis group compared to the massage group during the hospitalization. This was confirmed by the measure of intensity of the pain before each session that decreased only in the hypnosis group over time. Depression scores improved significantly over the time only in the hypnosis group. There was no effect in either group 3 months post hospitals discharge.

The authors concluded that hypnosis represents a safe and valuable tool in chronic pain management of hospitalized older patients. In hospital interventions did not provide long-term post discharge relief.

So, hypnotherapy is better than massage therapy when administered as an adjunct to conventional pain management. As it is difficult to control for placebo effects, which might be substantial in this case, we cannot be sure whether hypnotherapy per se was effective or not.

Who cares? The main thing is to make life easier for these poor patients!

There are situations where I tend to agree with this slightly unscientific but compassionate point of view. Yes, the evidence is flimsy, but we need to help these patients. Hypnotherapy has very few risks, is relatively inexpensive and might help badly suffering individuals. In this case, does it really matter whether the benefit was mediated by a specific or a non-specific mechanism?

We all hope that serious complications after chiropractic care are rare. However, this does not mean they are unimportant. Multi-vessel cervical dissection with cortical sparing is an exceptional event in clinical practice. Such a case has just been described as a result of chiropractic upper spinal manipulation.

Neurologists from Qatar published a case report of a 55-year-old man who presented with acute-onset neck pain associated with sudden onset right-sided hemiparesis and dysphasia after chiropractic manipulation for chronic neck pain.

Magnetic resonance imaging revealed bilateral internal carotid artery dissection and left extracranial vertebral artery dissection with bilateral anterior cerebral artery territory infarctions and large cortical-sparing left middle cerebral artery infarction. This suggests the presence of functionally patent and interconnecting leptomeningeal anastomoses between cerebral arteries, which may provide sufficient blood flow to salvage penumbral regions when a supplying artery is occluded.

The authors concluded that chiropractic cervical manipulation can result in catastrophic vascular lesions preventable if these practices are limited to highly specialized personnel under very specific situations.

Chiropractors will claim that they are highly specialised and that such events must be true rarities. Others might even deny a causal relationship altogether. Others again would claim that, relative to conventional treatments, chiropractic manipulations are extremely safe. You only need to search my blog using the search-term ‘chiropractic’ to find that there are considerable doubts about these assumptions:

  • Many chiropractors are not well trained and seem mostly in the business of making a tidy profit.
  • Some seem to have forgotten most of the factual knowledge they may have learnt at chiro-college.
  • There is no effective monitoring scheme to adequately record serious side-effects of chiropractic care.
  • Therefore the incidence figures of such catastrophic events are currently still anyone’s guess.
  • Publications by chiropractic interest groups seemingly denying this point are all fatally flawed.
  • It is not far-fetched to fear that under-reporting of serious complications is huge.
  • The reliable evidence fails to demonstrate that neck manipulations generate more good than harm.
  • Until sound evidence is available, the precautionary principle leads most critical thinkers to conclude that neck manipulations have no place in routine health care.

A 2016 article set out to define the minimum core competencies expected from a certified paediatric doctor of chiropractic using a Delphi consensus process. The initial set of seed statements and sub-statements was modelled on competency documents used by organizations that oversee chiropractic and medical education. The statements were then distributed to the Delphi panel, reaching consensus when 80% of the panelists approved each segment. The panel consisted of 23 specialists in chiropractic paediatrics from across the spectrum of the chiropractic profession. Sixty-one percent of panellists had postgraduate paediatric certifications or degrees, 39% had additional graduate degrees, and 74% were faculty at a chiropractic institution and/or in a postgraduate paediatrics program. The panel was initially given 10 statements with related sub-statements formulated by the study’s steering committee. On all 3 rounds of the Delphi process the panelists reached consensus; however, multiple rounds occurred to incorporate the valuable qualitative feedback received.

The results of this process reveal that the Certified Paediatric Doctor of Chiropractic requires 8 sets of skills. (S)he will …

1) Possess a working knowledge and understanding of the anatomy, physiology, neurology, psychology, and developmental stages of a child. a) Recognize known effects of the prenatal environment, length of the pregnancy, and birth process on the child’s health. b) Identify and evaluate the stages of growth and evolution of systems from birth to adulthood. c) Appraise the clinical implications of developmental stages in health and disease, including gross and fine motor, language/communication, and cognitive, social, and emotional skills. d) Recognize normal from abnormal in these areas. e) Possess an understanding of the nutritional needs of various stages of childhood.

2) Recognize common and unusual health conditions of childhood. a) Identify and differentiate clinical features of common physical and mental paediatric conditions. b) Identify and differentiate evidence-based health care options for these conditions. c) Identify and differentiate clinical features and evidence-based health care options for the paediatric special needs population.

3) Be able to perform an age-appropriate evaluation of the paediatric patient. a) Take a comprehensive history, using appropriate communication skills to address both child and parent/ guardian. b) Perform age-appropriate and case-specific physical, orthopaedic, neurological, and developmental examination protocols. c) When indicated, utilize age-appropriate laboratory, imaging, and other diagnostic studies and consultations, according to best practice guidelines. d) Appropriately apply and adapt these skills to the paediatric special needs population. e) Be able to obtain and comprehend all relevant external health records.

4) Formulate differential diagnoses based on the history, examination, and diagnostic studies.

5) Establish a plan of management for each child, including treatment, referral to, and/or co-management with other health care professionals. a) Use the scientific literature to inform the management plan. b) Adequately document the patient encounter and management plan. c) Communicate management plan clearly (written, oral, and nonverbal cues) with both the child and the child’s parent/guardian. d) Communicate appropriately and clearly with other professionals in the referral and co-management of patients.

6) Deliver skilful, competent, and safe chiropractic care, modified for the paediatric population, including but not limited to: a) Manual therapy and instrument-assisted techniques including manipulation/adjustment, mobilization, and soft tissue therapies to address articulations and/or soft tissues. b) Physical therapy modalities. c) Postural and rehabilitative exercises. d) Nutrition advice and supplementation. e) Lifestyle and public health advice. f) Adapt the delivery of chiropractic care for the paediatric special needs population.

7) Integrate and collaborate with other health care providers in the care of the paediatric patient. a) Recognize the role of various health care providers in paediatric care. b) Utilize professional inter-referral protocols. c) Interact clearly and professionally as needed with health care professionals and others involved in the care of each patient. d) Clearly explain the role of chiropractic care to professionals, parents, and children.

8) Function as a primary contact, portal of entry practitioner who will. a) Be proficient in paediatric first aid and basic emergency procedures. b) Identify and report suspected child abuse.

9) Demonstrate and utilize high professional and ethical standards in all aspects of the care of paediatric patients and professional practice. a) Monitor and properly reports of effects/adverse events. b) Recognize cultural individuality and respect the child’s and family’s wishes regarding health care decisions. c) Engage in lifelong learning to maintain and improve professional knowledge and skills. d) Contribute when possible to the knowledge base of the profession by participating in research. e) Represent and support the specialty of paediatrics within the profession and to the broader healthcare and lay communities.

I find this remarkable in many ways. Let us just consider a few items from the above list of competencies:

Identify and differentiate evidence-based health care options… such options would clearly not include chiropractic manipulations.

Identify and differentiate clinical features and evidence-based health care options for the paediatric special needs population… as above. Why is there no mention of immunisations anywhere?

Perform age-appropriate and case-specific physical, orthopaedic, neurological, and developmental examination protocols. If that is a competency requirement, patients should really see the appropriate medical specialists rather than a chiropractor.

Establish a plan of management for each child, including treatment, referral to, and/or co-management with other health care professionals. The treatment plan is either evidence-based or it includes chiropractic manipulations.

Deliver skilful, competent, and safe chiropractic care… Aren’t there contradictions in terms here?

Manual therapy and instrument-assisted techniques including manipulation/adjustment, mobilization, and soft tissue therapies to address articulations and/or soft tissues. Where is the evidence that these treatments are effective for paediatric conditions, and which conditions would these be?

Clearly explain the role of chiropractic care to professionals, parents, and children. As chiropractic is not evidence-based in paediatrics, the role is extremely limited or nil.

Function as a primary contact, portal of entry practitioner… This seems to me as a recipe for disaster.

Demonstrate and utilize high professional and ethical standards in all aspects of the care of paediatric patients… This would include obtaining informed consent which, in turn, needs to include telling the parents that chiropractic is neither safe nor effective and that better therapeutic options are available. Moreover, would it not be ethical to make clear that a paediatric ‘doctor’ of chiropractic is a very far cry from a real paediatrician?

So, what should the competencies of a chiropractor really be when it comes to treating paediatric conditions? In my view, they are much simpler than outlined by the authors of this new article: I SEE NO REASON WHATSOEVER WHY CHIROPRACTORS SHOULD TREAT CHILDREN!

The following short passage originates from the abstract of an article that I published in 1998; it is entitled TOWARDS A RISK BENEFIT EVALUATION OF PLACEBOS: the benefits of placebos are often not clearly defined. Generally speaking, the potential for benefit is considerable. The risks are similarly ill defined. Both direct and indirect risks are conceivable. On balance, the risk-benefit relation for placebo could be favourable. Under certain conditions, the clinical use of placebos might therefore be a realistic option. In the final analysis, however, our knowledge for a conclusive risk-benefit evaluation of placebo is incomplete.

Today, I would phrase my conclusion differently: the benefits of placebo therapy are uncertain, while its risks can be considerable. Therefore the use of placebos in clinical routine is rarely justified.

What brought about this change in my attitude?

Lots of things, is the answer; 18 years are a long time in research, and today we know much more about placebo. In my field of inquiry, alternative medicine, we know for instance that, because the mechanisms by which placebos operate are now better understood, some alt med enthusiasts are claiming that placebo effects are real and therefore justify the use of all sorts of placebo treatments, from homeopathy to faith healing. They say that these ineffective (i.e. no better than placebo) therapies are not really ineffective because they help many patients via the well-documented placebo response.

If you are of this opinion, please read the excellent article David Gorski recently published on this issue. Here I want to re-visit my question from above: WHAT DO WE KNOW ABOUT THE RISKS BENEFIT BALANCE OF PLACEBO?

The benefits of placebo can seem impressive on first glance: after receiving placebos, patients can feel better, have less symptoms, need less medication and improve their quality of life. Who would be against any of these outcomes, particularly considering that placebos are usually inexpensive and readily available everywhere?

However, before we get too enthusiastic about the benefits of placebos, we need to consider that they are unreliable. Nobody can predict who will respond to placebo and who won’t. Despite intensive research, it has not been possible to identify placebo-responders as a distinct group of individuals from non-responders. The usefulness of placebos in clinical routine is therefore quite limited. Furthermore, placebo effects are normally only of short duration. Therefore they are not suited for any long-term therapy.

Crucially, placebos almost never effect a cure. They may improve subjective symptoms, but they do not normally cure the disease or remove its causes. A placebo therapy will reduce pain, for instance, and thus it can ease the suffering. If a back pain is caused by a tumour, however, a placebo will not diminish its size or improve the prognosis.

The notion that placebos might cause harm seems paradoxical at first glance. A placebo pill contains no active ingredient – how can it then be harmful? As I have stressed so often before, ANY INEFFECTIVE TREATMENT BECOMES LIFE-THREATENING, IF IT IS USED AS A REPLACEMENT FOR AN EFFECTIVE THERAPY OF A SERIOUS DISEASE. And this warning also applies to placebos, of course.

Seen from this perspective, the much-praised symptomatic relief brought about by a placebo therapy can become a very mixed blessing indeed.

Let’s take the above example of the patient who has back pain. He receives a placebo and subsequently his agony becomes more bearable. Because this approach seems to work, he sticks with it for several month. Eventually the analgesic effect of the placebo wears off and the pain gets too strong to bear. Our patient finally consults a responsible doctor who diagnoses a bone cancer as the cause of his pain. The oncologist who is subsequently consulted regrets that the patient’s prolonged placebo therapy has seriously diminished his chances to cure the cancer.

This may look like an extreme example, but I don’t think it is. Exchange the term ‘placebo’ with almost any alternative treatment, or replace ‘back pain’ and ‘cancer’ with virtually any other conditions, and you will see that such events cannot be rare.

In most instances, placebos may seem helpful but, in fact, they offer little more than the illusion of a cure. They very rarely alter the natural history of a disease and usually achieve little more than a slight, short-term improvement of symptoms. In any case, they are an almost inevitable companion to any well-administered effective treatment. Prescribing pure placebos in clinical routine is therefore not responsible; in most instances, it amounts to fraud.

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