MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

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Wouldn’t it be nice to be able to enjoy food and drink to one’s heart content and, once the pounds are piling up, simply swallow a pill and the weight goes down to normal? There are plenty of such pills on the market, but here I advise you to avoid them – mainly for two reasons.

The first is that they do not work. On this blog, we have discussed this before. The claims made for weight loss supplements are bogus. The manufacturers promise substantial body weight reductions not because their product is effective but because they want your money. So, unless you want to donate your cash to quacks, don’t buy such rubbish.

The second reason is probably even more compelling: weight-loss supplements endanger your health. A new paper tells us more about their risks. This investigation was aimed at identifying banned and discouraged-use ingredients, such as ephedra, 1,3-dimethylamylamine, and beta-methyl-phenylethylamine, in readily available weight loss dietary supplements within a 10-mile radius of Regis University.

A list of banned and discouraged-use ingredients was compiled with the use of the Food and Drug Administration (FDA) dietary supplement website which provides information on supplement ingredients that are no longer legal or are advised against owing to adverse event reporting. Investigators visited all retail outlet stores within a 10-mile radius of Regis University in Denver, Colorado. Retail chains were not duplicated and only one of each chain was evaluated.

A total of 51 weight loss supplement products from retail stores were found with banned or discouraged-use substances listed on their labels. At least one banned ingredient was found to be listed on the product labels in 17 of the 51 studied supplements (33%). At least one discouraged-use ingredient was found in 46 of the 51 products (90%). Retail outlet stores dedicated to supplements and sports nutrition alone were found to have the greatest number of weight loss supplements that included banned and discouraged-use ingredients.

The authors of this paper draw the following conclusions: the FDA has taken action to remove some weight loss supplements from the market that contain banned ingredients. Unfortunately, based on the findings of this study, it is evident that products containing these ingredients remain on the market today.

You might think that these findings apply only to the US, however, I am afraid, you would be mistaken. People buy such bogus supplements on the Internet where national regulations can easily be circumvented. Thus the trade in weight-loss supplements is thriving regardless of what the FDA or any other regulatory agency might do about them.

The solution is simple: avoid such products!

No, I don’t want to put you off your breakfast… but you probably have seen so many pictures of attractive athletes with cupping marks and read articles about the virtues of this ancient therapy, that I feel I have to put this into perspective:

Cupping burnsI am sure you agree that this is slightly less attractive. But, undeniably, these are also cupping marks. So, if you read somewhere that this treatment is entirely harmless, take it with a pinch of salt.

Cupping has existed for centuries in most cultures, and there are several variations of the theme. We differentiate between wet and dry cupping. The above picture is of wet cupping gone wrong. What the US Olympic athletes currently seem to be so fond of is dry cupping.

The principles of both forms are similar. In dry cupping, a vacuum cup is placed over the skin which provides enough suction to create a circular bruise. Eventually the vacuum diminishes, and the cup falls off; what is left is the mark. In wet cupping, the procedure is much the same, except that the skin is injured before the cup is placed. The suction then pulls out a small amount of blood. Obviously the superficial injury can get infected, and that is what we see on the above picture.

In the homeopathic hospital where I worked ~40 years ago, we did a lot of both types of cupping. We used it mostly for musculoskeletal pain. Our patients responded well.

But why? How does cupping work?

The answer is probably more complex than you expect. It clearly has a significant placebo effect. Athletes are obviously very focussed on their body, and they are therefore the ideal placebo-responders. Evidently, my patients 40 years ago also responded to all types of placebos, even to the homeopathic placebos which they received ‘en masse’.

But there might be other mechanisms as well. A TCM practitioner will probably tell you that cupping unblocks the energy flow in our body. This might sound very attractive to athletes or consumers, and therefore could even enhance the placebo response, but it is nevertheless nonsense.

The most plausible mode of action is ‘counter-irritation’: if you have a pain somewhere, a second pain elsewhere in your body can erase the original pain. You might have a headache, for instance, and if you accidentally hit your thumb with a hammer, the headache is gone, at least for a while. Cupping too would cause mild to moderate pain, and this is a distraction from the muscular pain the athletes aim to alleviate.

When I employed cupping 40 years ago, there was no scientific evidence testing its effects. Since a few years, however, clinical trials have started appearing. Many are from China, and I should mention that TCM studies from China almost never report a negative result. According to the Chinese, TCM (including cupping) works for everything. More recently,also some trials from other parts of the world have emerged. They have in common with the Chinese studies that they tend to report positive findings and that they are of very poor quality. (One such trial has been discussed previously on this blog.) In essence, this means that we should not rely on their conclusions.

A further problem with clinical trails of cupping is that it is difficult, if not impossible, to control for the significant placebo effects that this treatment undoubtedly generates. There is no placebo that could mimic all the features of real cupping in clinical trials; and there is no easy way to blind either the patient or the therapist.

So, we are left with an ancient treatment backed by a host of recent but flimsy studies and a growing craze for cupping fuelled by the Olympic games. What can one conclude in such a situation?

Personally, I would, whenever possible, recommend treatments that work beyond a placebo effect, because the placebo response tends to be unreliable and is usually of short duration – and I am not at all sure that cupping belongs into this category. I would also avoid wet cupping, because it can cause substantial harm. Finally, I would try to keep healthcare costs down; cupping itself is cheap but the therapist’s time might be expensive.

In a nutshell: would I recommend cupping? No, not any more than using a hammer for counter irritation! Will the Olympic athletes care a hoot about my recommendations? No, probably not!

 

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.
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