MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

Adults using unproven treatments is one thing; if kids do it because they are told to, that is quite another thing. Children are in many ways more vulnerable than grown-ups and they usually cannot give fully informed consent. It follows that the use of such treatments for kids can be a delicate and complex matter.

A recent systematic review was aimed at summarizes the international findings for prevalence and predictors of complementary and alternative medicine (CAM) use among children/adolescents. The authors systematically searched 4 electronic databases (PubMed, Embase, PsycINFO, AMED; last update in 07/2013) and reference lists of existing reviews and all included studies. Publications without language restriction reporting patterns of CAM utilization among children/adolescents without chronic conditions were selected for inclusion. The prevalence rates for overall CAM use, homeopathy, and herbal drug use were extracted with a focus on country and recall period (lifetime, 1 year, current use). As predictors, the authors extracted socioeconomic factors, child‘s age, and gender.

Fifty-eight studies from 19 countries could be included in the review. There were strong variations regarding study quality. Prevalence rates for overall CAM use ranged from 10.9 – 87.6 % for lifetime use, and from 8 – 48.5 % for current use. The respective percentages for homeopathy (highest in Germany, United Kingdom, and Canada) ranged from 0.8 – 39 % (lifetime) and from 1 – 14.3 % (current). Herbal drug use (highest in Germany, Turkey, and Brazil) was reported for 0.8 – 85.5 % (lifetime) and 2.2 – 8.9 % (current) of the children/adolescents. Studies provided a relatively uniform picture of the predictors of overall CAM use: higher parental income and education, older children. But only a few studies analyzed predictors for single CAM modalities.

The authors drew the following conclusion: CAM use is widespread among children/adolescents. Prevalence rates vary widely regarding CAM modality, country, and reported recall period.

In 1999, I published a very similar review; at the time, I found just 10 studies. Their results suggested that the prevalence of CAM use by kids was variable but generally high. CAM was often perceived as helpful. Insufficient data existed about safety and cost. Today, the body of surveys monitoring CAM use by children seems to have grown almost six-fold, and the conclusions are still more or less the same – but have we made progress in answering the most pressing questions? Do we know whether all these CAM treatments generate more good than harm for children?

Swiss authors recently published a review of Cochrane reviews which might help answering these important questions. They performed a synthesis of all Cochrane reviews published between 1995 and 2012 in paediatrics that assessed the efficacy, and clinical implications and limitations of CAM use in children. Main outcome variables were: percentage of reviews that concluded that a certain intervention provides a benefit, percentage of reviews that concluded that a certain intervention should not be performed, and percentage of studies that concluded that the current level of evidence is inconclusive.

A total of 135 reviews were included – most from the United Kingdom (29/135), Australia (24/135) and China (24/135). Only 5/135 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26/135 (19.4%) issued a conditional positive recommendation, and 9/135 (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased during three, a priori-defined, time intervals (1995-2000: 15/27 [55.6%]; 2001-2006: 33/44 [75%]; and 2007-2012: 47/64 [73.4%]). The three most common criticisms of the quality of the studies included were: more research needed (82/135), low methodological quality (57/135) and small number of study participants (48/135).

The Swiss authors concluded that given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.

And what about the risks?

To determine the types of adverse events associated with the use of CAM that come to the attention of Australian paediatricians. Australian researchers conducted a monthly active surveillance study of CAM-associated adverse events as reported to the Australian Paediatric Surveillance Unit between January 2001 and December 2003. They found 39 reports of adverse events associated with CAM use, including four reported deaths. Reports highlighted several areas of concern, including the risks associated with failure to use conventional medicine, the risks related to medication changes made by CAM practitioners and the significant dangers of dietary restriction. The reported deaths were associated with a failure to use conventional medicine in favour of a CAM therapy.

These authors concluded that CAM use has the potential to cause significant morbidity and fatal adverse outcomes. The diversity of CAM therapies and their associated adverse events demonstrate the difficulty addressing this area and the importance of establishing mechanisms by which adverse effects may be reported or monitored.

So, we know that lots of children are using CAMs because their parents want them to. We also know that most of the CAMs used for childhood conditions are not based on sound evidence. The crucial question is: can we be sure that CAM for kids generates more good than harm? I fear the answer is a clear and worrying NO.

Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.

  1. Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
  2. We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
  3. Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
  4. The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
  5. The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
  6. Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
  7. Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.

While the previous post was about seeing a traditional herbalist (who prescribe their own herbal mixtures, tailor-made for each individual patient), this post provides essential information for those consumers who are tempted to take a commercially available herbal remedy available in pharmacies, health food shops, over the Internet etc. These remedies are usually bought by consumers and then be self-administered, or (less frequently) they might be prescribed/recommended/sold by a clinician such as a doctor, naturopath, chiropractor etc. Typically, they contain just one (or relatively few) herbal extracts and are used under similar assumptions as conventional medicines: one (hopefully well-tested) remedy is employed for treating a defined condition, diagnosed according to validated and generally accepted criteria (for instance, St John’s Wort for depression or Devil’s claw for back pain). This approach is sometimes referred to as ‘rational phytotherapy’ – it is certainly more rational than the traditional herbalism referred to in my previous post. The manufacture, promotion and sale of commercial herbal remedies (in many countries marketed as ‘dietary supplements’) has grown into a multi-billion dollar industry.

Here are a few essentials you ought to know before you decide to take such an herbal remedy:

  1. Many people claim that herbal medicine is effective because many of our modern drugs are based on plants. The latter part of this claim is true, of course, but this does not necessarily mean that herbal remedies are effective. The drugs derived from plants contain one single, well-defined, extensively researched molecule (by definition, this makes them conventional drugs and not herbal remedies), while herbal remedies are based on entire (parts of) plants; thus they contain many pharmacologically active molecules. This often means that it is difficult or impossible to tell what dose of which ingredient is being administered and what pharmacological actions can be expected.
  2. Even though national regulations differ greatly, herbal remedies generally do not have to be supported by evidence for efficacy in order to be legally available. This means that a given remedy might or might not have been tested in clinical trials to determine whether it works for the condition advertised. In fact, only very few (less than 30, I estimate) herbal remedies are supported by sound evidence for efficacy; thousands do not meet this criterion.
  3. The extremely wide-spread notion that herbal remedies are by definition natural and therefore safe is nothing but a promotional myth. Plants contain many chemicals which can have pharmacological activity. This means they might be therapeutic, but it also means that they might be toxic (traditionally the most powerful poisons originated from the plant kingdom). If anyone uses the ‘natural = safe fallacy’ remind him/her of hemlock, poison ivy etc.
  4. In addition to potential toxicity of an herbal ingredient, there are other important safety issues to be considered. Most importantly, herbal remedies can interact with prescribed medicines. For instance, St John’s Wort (one of the best-studied herbal remedies in this respect) powerfully interacts with about 50% of all prescription drugs – in fact, it lowers their level in the blood which means that a patient on anti-coagulants would lose her anti-coagulant protection and might suffer from a (potentially fatal) blood clot.
  5. In many countries, including the US, the regulation of herbal remedies is so lax, that there is no guarantee that an herbal remedy which is being legally sold is safe. The regulators are only allowed to intervene once there are reports of adverse effects. This means that the burden of proof of safety is effectively reversed which obviously exposes consumers to incalculable risks.
  6. The quality of the herbal product is equally poorly regulated in most countries. A plethora of investigations in the US, for instance, has shown that the dose of the herbal ingredient printed on the label of a commercial product can range virtually from 0 – 100%. Similarly there is little safe-guard that the ingredients listed on the label correspond to the ones in the preparation. This means that it is worth purchasing not just well-researched herbal remedies but also those marketed by high quality manufacturers via respectable outlets.
  7. Any regulation of herbal remedies, even the European one that is often praised as protecting consumers adequately, is null and void once consumers go on the Internet and purchase their herbal remedies from one of the many dubious sources found there in truly alarming profusion. Bogus claims, inferior quality and even outright dangerous products abound, and it is often impossible to tell the acceptable from the fraudulent product.

Here I am not writing about herbal medicine in general – parts of which are supported by some encouraging evidence (I will therefore post more than one ‘seven things to remember…’ article on this subject) – here I am writing about the risks and benefits of consulting a traditional herbal practitioner. Herbalists come in numerous guises depending what tradition they belong to: Chinese herbalist, traditional European herbalist, Ayurvedic practitioner, Kampo practitioner etc. If you consult such a therapist, you should be aware of the following issues.

  1. Worldwide, the treatment by traditional herbal practitioners is by far the most common form of herbal medicine; it is more common than to use specific, well-tested herbs to treat specific conventionally diagnosed conditions (an approach that might best be called ‘rational phytotherapy’).
  2. Herbalists often use their very own diagnostic methods (think, for instance, of ‘tongue and pulse diagnoses’ used by Chinese herbalists) and reject (or are untrained to use) conventional diagnostic methods. The traditional diagnostic techniques of herbalists have either not been validated at all or they have been tested and found to be not valid.
  3. Herbalists usually do not recognise conventional disease categories. Instead they arrive at a diagnosis according to their specific philosophy which has no grounding in reality (for instance, energy imbalance in traditional Chinese herbalism).
  4. Herbalists individualise their treatments, meaning that 10 patients suffering from depression, for instance, might receive 10 different, tailor-made prescriptions according to their individual characteristics (and none of the 10 patients might receive St John’s Wort, the only herbal remedy that actually is proven to work for depression).
  5. Typically, such prescriptions contain not one herbal ingredient, but are mixtures of many – up to 10 or 20 – herbs or herbal extracts.
  6. Even though the efficacy of the individualised herbal approach can, of course, be tested in rigorous trials, and even though about a dozen such studies are available today, there is currently no good evidence to show that it is effective.
  7. The risk of harm through these individualised herbal mixtures can be considerable: the more ingredients, the higher the likelihood that one of them has toxic effects or that one interacts with a prescription medicine. Essentially, this means that there is no good evidence that individualised herbal treatments as used by so many herbal practitioners across the globe generates more good than harm.

THIS POST IS DEDICATED TO HRH, THE PRINCE OF WALES WHO CELEBRATES HIS 66TH BIRTHDAY TODAY AND HAS SUPPORTED HOMEOPATHY ALL HIS LIFE

Like Charles, many people are fond of homeopathy; it is particularly popular in India, Germany, France and parts of South America. With all types of health care, it is important to make therapeutic decisions in the knowledge of the crucial facts. In order to aid evidence-based decision-making, I will summarise a few things you might want to consider before you try homeopathy – either by buying homeopathic remedies over the counter, or by consulting a homeopath.

  1. Homeopathy was invented by Samuel Hahnemann, a charismatic German doctor, about 200 years ago. At the time, our understanding of the laws of nature was woefully incomplete, and therefore Hahnemann’s ideas seemed far less implausible than they actually are. Moreover, the conventional treatments of this period were often more dangerous than the disease they were supposed to cure; consequently homeopathy was repeatedly shown to be better than ‘allopathy’ (a term coined by Hahnemann to insult conventional medicine). Thus Hahnemann’s treatments were an almost instant worldwide success. When, about 100 years later, more and more effective conventional therapies were discovered, homeopathy all but disappeared, only to be re-discovered in developed countries as the baby-boomers started their recent love-affair with alternative medicine.
  2. Many consumers confuse homeopathy with herbal medicine; yet the two are fundamentally different. Herbal medicines are plant extracts with potentially active ingredients. Homeopathic remedies may be based on plants (or any other material as well) but are typically so dilute that they contain absolutely nothing. The most frequently used dilution (homeopaths call them ‘potencies’) is a ‘C30’; a C30-potency has been diluted 30 times at a ratio of 1:100. This means that one drop of the staring material is dissolved in 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 drops of diluent – and that equates to one molecule of the original substance per all the molecules of many thousand universes.
  3. Homeopaths know all of this, of course, and they thus claim that their remedies do not work via pharmacological effects but via some ‘energy’ or ‘vital force’. They are convinced that the process of preparing the homeopathic dilutions (they shake the mixtures at each dilution step) transfers some ‘vital energy’ from one to the next dilution. They cite all sorts of fancy theories to explain how this ‘energy transfer’ might come about, however, none of them has ever been accepted by mainstream scientists.
  4. Homeopathic remedies are usually prescribed according to the ‘like cures like’ principle. For instance, if you suffer from runny eyes, a homeopath might prescribe a remedy made of onion, because onion make our eyes water. This and all other basic assumptions of homeopathy contradict the known laws of nature. In other words, we do not just fail to understand how homeopathy works, but we understand that it cannot work unless the known laws of nature are wrong.
  5. The clinical trials of homeopathy are broadly in agreement with these insights from basic science. Today, more than 200 such studies have been published; if we look at the totality of this evidence, we have to conclude that it fails to show that homeopathic remedies are anything other than placebos.
  6. This is, of course, in stark contrast to what many enthusiasts of homeopathy insist upon; they swear by homeopathy and claim that it has helped them (or their pet, aunt, child etc.) repeatedly. Nobody doubts their accounts; in fact, it is indisputable that many patients do get better after taking homeopathic remedies. The best evidence available today clearly shows, however, that this improvement is unrelated to the homeopathic remedy per se. It is the result of an empathetic, compassionate encounter with a homeopath, a placebo-response or other factors which experts often call ‘context effects’.
  7. The wide-spread notion that homeopathy is completely free of risks is not correct. The remedy itself might be harmless (except, of course, for the damage it creates to your finances, and the fact that irrational nonsense about ‘vital energy’ etc. undermines rationality in general) but this does not necessarily apply to the homeopath. Whenever homeopaths advise their patients, as they often do, to forgo effective conventional treatments for a serious condition, they endanger lives. This phenomenon is documented, for instance, in relation to the advice of many homeopaths against immunisations. Any treatment that has no proven benefit, while carrying a finite risk, cannot generate more good than harm.

In many countries, consumers seem to be fond of consulting chiropractors – mostly for back pain, but also for other conditions. I therefore think it is might be a good and productive idea to give anyone who is tempted to see a chiropractor some simple, easy to follow advice. Here we go:

  1. Ask your chiropractor what he/she thinks about the chiropractic concept of subluxation. This is the chiropractors’ term (real doctors use the word too but understand something entirely different by it) for an imagined problem with your spine. Once they have diagnosed you to suffer from subluxation, they will persuade you that it needs correcting which is done by spinal manipulation which they tend to call ‘adjustments’. There are several important issues here: firstly subluxations do not exist outside the fantasy world of chiropractic; secondly chiropractors who believe in subluxation would diagnose subluxation in about 100% of the population – also in individuals who are completely healthy. My advice is to return straight back home as soon as the chiropractor admits he believes in the mystical concept of subluxation.
  2. Ask your chiropractor what he/she thinks of ‘maintenance care’. This is the term many chiropractors use for indefinite treatments which do little more than transfer lots of cash from your account to that of your chiropractor. There is no good evidence to show that maintenance care does, as chiropractors claim, prevent healthy individuals from falling ill. So, unless you have the irresistible urge to burn money, don’t fall for this nonsense. You should ask your chiropractor how long and frequent your treatment will be, what it will cost, and then ask yourself whether it is worth it.
  3. Run a mile, if the chiropractor wants to manipulate your neck (which most will do regardless of whether you have neck-pain, some even without informed consent). Neck manipulation is associated with very serious complications; they are usually caused by an injury to an artery that supplies parts of your brain. This can cause a stroke and even death. Several hundred such cases have been documented in the medical literature – but the true figure is almost certainly much larger (there is still no system in place to monitor such events).
  4. Run even faster, if the chiropractor wants to treat your children for common paediatric conditions. Many chiropractors believe that their manipulations are effective for a wide range of health problems that kids frequently suffer from. However, there is not a jot of evidence that these claims are true.
  5. Be aware that about 50% of all patients having chiropractic treatments will suffer from side effects like pain and stiffness. These symptoms usually last for 2-3 days and can be severe enough to impede your quality of life. Ask yourself whether the risk is outweighed by the benefit of chiropractic.
  6. Remember that there is no good evidence that chiropractors can treat any condition effectively other than lower back pain (and even for that condition the evidence is far from strong). Many chiropractors claim to be able to treat a plethora of non-spinal conditions like asthma, ear infection, gastrointestinal complaints, autism etc. etc. There is no good evidence that these claims are correct.
  7. Distrust the advice given by many chiropractors regarding prescribed medications, vaccinations or surgery. Chiropractic has a long history of warning their patients against all sorts of conventional treatments. Depending on the clinical situation, following such advice can cause very serious harm.

I am minded to write similar posts for all major alternative therapies (this will not make me more popular with alternative therapists, but I don’t mind all that much) – provided, of course, that my readers find this sort of article useful. So, please do give me some feedback.

Here and elsewhere, I have repeatedly written about the many things that can go wrong with acupuncture. This invariably annoys acupuncture fans who usually counter by accusing me of being alarmist. Despite their opposition, I continue to think it is important to regularly point out that acupuncture – contrary to what many acupuncturists would tell us – can result in serious injury. I will therefore carry on reporting new evidence about the harm caused by acupuncture. Here is a very brief review of new (2014) articles on this important topic.

A recent study found that the incidence of any adverse events per patient was 42.4% with traditional acupuncture, 40.7% with minimal acupuncture and 16.7% with non-invasive sham acupuncture. These figures are much higher than those around 10% previously reported.

Other authors described the case of a broken off acupuncture needle in a patient’s abdomen. A very long needle was used which happily is unusual in routine practice.

Pneumothorax has been often noted as a complication of acupuncture – it is by far the most frequently reported serious complication caused by acupuncture; well over 100 instances have been described in the medical literature which, of course, reflects only the tip of an iceberg – new cases are being reported almost on a monthly basis.

Cardiac tamponade is even more dangerous but fortunately also much rarer. A case of life-threatening cardiac tamponade due to penetration of an acupuncture needle directly into the right ventricle was recently published. Cardiac tamponade can happen when the patient is unfortunate enough to have a sternal foramen, an congenital abnormality that is not normally detected by simple inspection or palpation. An investigation found that the frequency of a sternal foramen is approximately 10.5%. The authors concluded that sternal acupuncture should be planned in the region of corpus-previous CT should be done to rule out this variation. Furthermore, we strongly recommend the acupuncture technique which prescribes a safe superficial-oblique approach to the sternum.

A review from Egypt noted that acupuncture presented a significant risks for acquiring hepatitis C infections.

Other types of infections can also be transmitted by acupuncture needles, if the therapist fails to adhere to proper procedures of sterility. One report described the diagnosis, treatment and >1 year follow-up of 30 patients presenting with acupuncture-induced primary inoculation tuberculosis.

Similarly, Chinese authors reported the case of a 54-year-old woman who presented with progressive low back pain and fever. She underwent surgical decompression, with an immediate improvement of her pain. A culture of the epidural abscess grew Serratia marcescens. One year postoperatively, magnetic resonance imaging revealed the almost complete eradication of the abscess. This case is the first case of Serratia marcescens-associated spinal epidural abscess formation secondary to acupuncture.

Other authors reported a rare case of isolated unilateral hypoglossal nerve injury following ipsilateral acupuncture for migraines in a 53-year-old lady.

Finally, Greek authors published a case of severe rhabdomyolysis and acute kidney injury after acupuncture sessions. Rhabdomyolysis is a rare condition that can be caused by muscle injury and presents with muscle weakness and pain. It is characterized by myoglobinuria which, in turn, may cause acute kidney injury.

I can hear the world of acupuncture arguing that all of these events are extreme rarities and that conventional treatments are much more dangerous. This may well be true but it also ignores the following facts:

  • The frequency of such events is essentially unknown. Contrary to conventional medicine, alternative medicine has no functioning systems to monitor adverse events. Therefore the true incidence figures of acupuncture-related complications are anyone’s guess.
  • Most conventional treatments in common use are backed up by good evidence for efficacy and therefore demonstrably do more good than harm, even if they regularly cause adverse effects. This is not the case for acupuncture. In the absence of solid evidence for efficacy, even relatively rare or minor adverse effects would mean that the risk/benefit profile of acupuncture is not positive.

For these reasons, it is an ethical imperative, I think, to keep a keen eye on the harm caused by acupuncture and to inform the public about the fact that it is undeniably not free of risks.

In 2004, I published an article rather boldly entitled ‘Ear candles: a triumph of ignorance over science’. Here is its summary:

Ear candles are hollow tubes coated in wax which are inserted into patients’ ears and then lit at the far end. The procedure is used as a complementary therapy for a wide range of conditions. A critical assessment of the evidence shows that its mode of action is implausible and demonstrably wrong. There are no data to suggest that it is effective for any condition. Furthermore, ear candles have been associated with ear injuries. The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.

Sadly, since the publication of this paper, ear candles have not become less but more popular. There are about 3 000 000 websites on the subject; most are trying to sell products and make claims which are almost comically misguided; three examples have to suffice:

I said ALMOST comical because such nonsense has, of course a downside. Not only are consumers separated from their cash for no benefit whatsoever, but they are also exposed to danger; again, three examples from the medical literature might explain:

  • Otolaryngologists from London described a case of ear candling presenting as hearing loss, and they concluded that this useless therapy can actually cause damage to the ears.
  • A 50-year-old woman presented to her GP following an episode of ear candling. After 15 minutes, the person performing the candling burned herself while attempting to remove the candle and spilled candle wax into the patient’s right ear canal. On examination, a piece of candle wax was found in the patient’s ear, and she was referred to the local ear, nose, and throat department. Under general aesthetic, a large mass of solidified yellow candle wax was removed from the deep meatus of the ear. The patient had a small perforation in her right tympanic membrane. Results of a pure tone audiogram showed a mild conductive hearing loss on the right side. At a follow-up appointment 1 month later, the perforation was still there, and the patient’s hearing had not improved.
  • case report of a 4-year-old girl from New Zealand was published. The patient was diagnosed to suffer from otitis media. During the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.

I should stress that we do not know how often such events happen; there is no monitoring system, and one might expect that the vast majority of cases do not get published. Most consumers who experience such problems, I would guess, are far to embarrassed to admit that they have been taken in by this sort of quackery.

It was true 10 yeas ago and it is true today: ear candles are a triumph of ignorance over science. But also they are a victory of gullibility over common sense and the unethical exploitation of naive hope by greedy frauds.

If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:

  • one or more ingredients of a plant are toxic,
  • they interact with prescribed drugs,
  • they are contaminated, for instance, with heavy metals,
  • they are adulterated with prescription drugs.

There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:

German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.

A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs

US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.

Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.

Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.

So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.

We all know, I think, that chronic low back pain (CLBP) is common and causes significant suffering in individuals as well as cost to society. Many treatments are on offer but, as we have seen repeatedly on this blog, not one is convincingly effective and some, like chiropractic, is associated with considerable risks.

Enthusiasts claim that hypnotherapy works well, but too little is known about the minimum dose needed to produce meaningful benefits, the roles of home practice and hypnotizability on outcome, or the maintenance of treatment benefits beyond 3 months. A new trial was aimed at addressing these issues.

One hundred veterans with CLBP participated in a randomized, four parallel group study. The groups were (1) an eight-session self-hypnosis training intervention without audio recordings for home practice; (2) an eight-session self-hypnosis training intervention with recordings; (3) a two-session self-hypnosis training intervention with recordings and brief weekly reminder telephone calls; and (4) an eight-session active (biofeedback) control intervention.

Participants in all four groups reported significant pre- to post-treatment improvements in pain intensity, pain interference and sleep quality. The three hypnotherapy groups combined reported significantly more pain intensity reduction than the control group. There was no significant difference among the three hypnotherapy groups. Over half of the participants who received hypnotherapy reported clinically meaningful (≥30%) reductions in pain intensity, and they maintained these benefits for at least 6 months after treatment. Neither hypnotizability nor amount of home practice was associated significantly with treatment outcome.

The authors conclude that two sessions of self-hypnosis training with audio recordings for home practice may be as effective as eight sessions of hypnosis treatment. If replicated in other patient samples, the findings have important implications for the application of hypnosis treatment for chronic pain management.

Even though this trial has several important limitations, I do agree with the authors: these results would be worth an independent replication – not least because self-hypnosis is cheap and does not carry great risks. What would be interesting, in my view, are studies that compare several alternative LBP therapies (e.g. chiropractic, osteopathy, acupuncture, massage, various form of exercise and hypnotherapy) in terms of cost, risks, long-term effectiveness and patients’ preference. I somehow feel that the results of such comparative trials might overturn the often issued recommendations for spinal manipulation, i.e. chiropractic or osteopathy.

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