MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.

The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.

Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.

The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.

Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.

American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.

Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.

The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.

I know what my chiropractic friends will respond to this post:

  • I am alarmist,
  • I cherry-pick articles that are negative for their profession,
  • these cases are extreme rarities,
  • conventional medicine is much more dangerous.

To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.

Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?

Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?

Here is another short passage from my new book A SCIENTIST IN WONDERLAND. It describes the event where I was first publicly exposed to the weird and wonderful world of alternative medicine in the UK. It is also the scene which, in my original draft, was the very beginning of the book.

I hope that the excerpt inspires some readers to read the entire book – it currently is BOOK OF THE WEEK in the TIMES HIGHER EDUCATION!!!

… [an] aggressive and curious public challenge occurred a few weeks later during a conference hosted by the Research Council for Complementary Medicine in London. This organization had been established a few years earlier with the aim of conducting and facilitating research in all areas of alternative medicine. My impression of this institution, and indeed of the various other groups operating in this area, was that they were far too uncritical, and often proved to be hopelessly biased in favour of alternative medicine. This, I thought, was an extraordinary phenomenon: should research councils and similar bodies not have a duty to be critical and be primarily concerned about the quality of the research rather than the overall tenor of the results? Should research not be critical by nature? In this regard, alternative medicine appeared to be starkly different from any other type of health care I had encountered previously.

On short notice, I had accepted an invitation to address this meeting packed with about 100 proponents of alternative medicine. I felt that their enthusiasm and passion were charming but, no matter whom I talked to, there seemed to be little or no understanding of the role of science in all this. A strange naïvety pervaded this audience: alternative practitioners and their supporters seemed a bit like children playing “doctor and patient”. The language, the rituals and the façade were all more or less in place, but somehow they seemed strangely detached from reality. It felt a bit as though I had landed on a different planet. The delegates passionately wanted to promote alternative medicine, while I, with equal passion and conviction, wanted to conduct good science. The two aims were profoundly different. Nevertheless, I managed to convince myself that they were not irreconcilable, and that we would manage to combine our passions and create something worthwhile, perhaps even groundbreaking.

Everyone was excited about the new chair in Exeter; high hopes and expectations filled the room. The British alternative medicine scene had long felt discriminated against because they had no academic representation to speak of. I certainly did sympathize with this particular aspect and felt assured that, essentially, I was amongst friends who realized that my expertise and their enthusiasm could add up to bring about progress for the benefit of many patients.
During my short speech, I summarized my own history as a physician and a scientist and outlined what I intended to do in my new post—nothing concrete yet, merely the general gist. I stressed that my plan was to apply science to this field in order to find out what works and what doesn’t; what is safe and what isn’t. Science, I pointed out, generates progress through asking critical questions and through testing hypotheses. Alternative medicine would either be shown by good science to be of value, or it would turn out to be little more than a passing fad. The endowment of the Laing chair represented an important mile-stone on the way towards the impartial evaluation of alternative medicine, and surely this would be in the best interest of all parties concerned.

To me, all this seemed an entirely reasonable approach, particularly as it merely reiterated what I had just published in an editorial for The Lancet entitled “Scrutinizing the Alternatives”.

My audience, however, was not impressed. When I had finished, there was a stunned, embarrassed silence. Finally someone shouted angrily from the back row: “How did they dare to appoint a doctor to this chair?” I was startled by this question and did not quite understand. What had prompted this reaction? What did this audience expect? Did they think my qualifications were not good enough? Why were they upset by the appointment of a doctor? Who else, in their view, might be better equipped to conduct medical research?

It wasn’t until weeks later that it dawned on me: they had been waiting for someone with a strong commitment to the promotion of alternative medicine. Such a commitment could only come from an alternative practitioner. A doctor personified the establishment, and “alternative” foremost symbolized “anti-establishment”. My little speech had upset them because it confirmed their worst fears of being annexed by “the establishment”. These enthusiasts had hoped for a believer from their own ranks and certainly not for a doctor-scientist to be appointed to the world’s first chair of complementary medicine. They had expected that Exeter University would lend its support to their commercial and ideological interests; they had little understanding of the concept that universities should not be in the business of promoting anything other than high standards.

Even today, after having given well over 600 lectures on the topic of alternative medicine, and after coming on the receiving end of ever more hostile attacks, aggressive questions and personal insults, this particular episode is still etched deeply into my memory. In a very real way, it set the scene for the two decades to come: the endless conflicts between my agenda of testing alternative medicine scientifically and the fervent aspirations of enthusiasts to promote alternative medicine uncritically. That our positions would prove mutually incompatible had been predictable from the very start. The writing had been on the wall—but it took me a while to be able to fully understand the message.

On 1/12/2014 I published a post in which I offered to give lectures to students of alternative medicine:

Getting good and experienced lecturers for courses is not easy. Having someone who has done more research than most working in the field and who is internationally known, might therefore be a thrill for students and an image-boosting experience of colleges. In the true Christmas spirit, I am today making the offer of being of assistance to the many struggling educational institutions of alternative medicine .

A few days ago, I tweeted about my willingness to give free lectures to homeopathic colleges (so far without response). Having thought about it a bit, I would now like to extend this offer. I would be happy to give a free lecture to the students of any educational institution of alternative medicine.

I did not think that this would create much interest – and I was right: only the ANGLO-EUROPEAN COLLEGE OF CHIROPRACTIC has so far hoisted me on my own petard and, after some discussion (see comment section of the original post) hosted me for a lecture. Several people seem keen on knowing how this went; so here is a brief report.

I was received, on 14/1/2015, with the utmost kindness by my host David Newell. We has a coffee and a chat and then it was time to start the lecture. The hall was packed with ~150 students and the same number was listening in a second lecture hall to which my talk was being transmitted.

We had agreed on the title CHIROPRACTIC: FALLACIES AND FACTS. So, after telling the audience about my professional background, I elaborated on 7 fallacies:

  1. Appeal to tradition
  2. Appeal to authority
  3. Appeal to popularity
  4. Subluxation exists
  5. Spinal manipulation is effective
  6. Spinal manipulation is safe
  7. Ad hominem attack

Numbers 3, 5 and 6 were dealt with in more detail than the rest. The organisers had asked me to finish by elaborating on what I perceive as the future challenges of chiropractic; so I did:

  1. Stop happily promoting bogus treatments
  2. Denounce obsolete concepts like ‘subluxation’
  3. Clarify differences between chiros, osteos and physios
  4. Start a culture of critical thinking
  5. Take action against charlatans in your ranks
  6. Stop attacking everyone who voices criticism

I ended by pointing out that the biggest challenge, in my view, was to “demonstrate with rigorous science which chiropractic treatments demonstrably generate more good than harm for which condition”.

We had agreed that my lecture would be followed by half an hour of discussion; this period turned out to be lively and had to be extended to a full hour. Most questions initially came from the tutors rather than the students, and most were polite – I had expected much more aggression.

In his email thanking me for coming to Bournemouth, David Newell wrote about the event: The general feedback from staff and students was one of relief that you possessed only one head, :-). I hope you may have felt the same about us. You came over as someone who had strong views, a fair amount of which we disagreed with, but that presented them in a calm, informative and courteous manner as we did in listening and discussing issues after your talk. I think everyone enjoyed the questions and debate and felt that some of the points you made were indeed fair critique of what the profession may need to do, to secure a more inclusive role in the health care arena.

 
As you may have garnered from your visit here, the AECC is committed to this task as we continue to provide the highest quality of education for the 21st C representatives of such a profession. We believe centrally that it is to our society at large and our communities within which we live and work that we are accountable. It is them that we serve, not ourselves, and we need to do that as best we can, with the best tools we have or can develop and that have as much evidence as we can find or generate. In this aim, your talk was important in shining a more ‘up close and personal’ torchlight on our profession and the tasks ahead whilst also providing us with a chance to debate the veracity or otherwise of yours and ours differing positions on interpretation of the evidence.

My own impression of the day is that some of my messages were not really understood, that some of the questions, including some from the tutors, seemed like coming from a different planet, and that people were more out to teach me than to learn from my talk. One overall impression that I took home from that day is that, even in this college which prides itself of being open to scientific evidence and unimpressed by chiropractic fundamentalism, students are strangely different from other health care professionals. The most tangible aspect of this is the openly hostile attitude against drug therapies voiced during the discussion by some students.

The question I always ask myself after having invested a lot of time in preparing and delivering a lecture is: WAS IT WORTH IT? In the case of this lecture, I think the answer is YES. With 300 students present, I am fairly confident that I did manage to stimulate a tiny bit of critical thinking in a tiny percentage of them. The chiropractic profession needs this badly!

 

- Chronic low back pain (CLBP) is a condition which affects so many people that it represents a huge burden to individual patients’ suffering as well as to society in terms of loss of work time and increased economic cost. The number of therapies that have been claimed to be effective for CLBP can hardly be counted. Two of the most common treatments are spinal manipulation and exercise.

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with CLBP. Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review.

A search of the current literature was conducted using a keyword process in CINAHL, Cochrane Register of Controlled Trials Database, Medline, and Embase. The searches included studies available up to August 2014. Studies were included based on PICOS criteria 1) individuals with CLBP defined as lasting 12 weeks or longer; 2) spinal manipulation performed by a health care practitioner; 3) prescribed exercise for the treatment of CLBP and monitored by a health care practitioner; 4) measurable clinical outcomes for reducing pain, disability or improving function; 5) randomized controlled trials. The methodological quality of all included articles was determined using the criteria developed and used by the Physiotherapy Evidence Database (PEDro).

Only three RCTs met the inclusion criteria of this systematic review. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term.

The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Whenever there are uncounted treatments for a given condition, one has to ask oneself whether they are all similarly effective or equally ineffective. The present review does unfortunately not answer this question, but I fear the latter might be more true than the former.

Considering how much money we spend on treating CLBP, it is truly surprising to see that just three RCTs are available comparing two of the most commonly used treatments for this condition. Equally surprising is the fact that we simply cannot tell, on the basis of these data, which of the two therapies is more effective.

What consequences should we draw from this information. Obviously we need more high quality trials. But what should we do in the meantime?

Whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently)  is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of CLBP – and consequently consulting a chiropractor should not be the first choice for CLBP patients.

Few subjects make chiropractors more uneasy than a discussion of the safety of their spinal manipulations. Many chiropractors flatly deny that there are any risks at all. However, the evidence seems to tell a different story.

The purpose of a new review was to summarise the literature for cases of adverse events in infants and children treated by chiropractors or other manual therapists, identifying treatment type and if a preexisting pathology was present. English language, peer-reviewed journals and non-peer-reviewed case reports discussing adverse events (ranging from minor to serious) were systematically searched from inception of the relevant searchable bibliographic databases through March 2014. Articles not referring to infants or children were excluded.

Thirty-one articles met the selection criteria. A total of 12 articles reporting 15 serious adverse events were found. Three deaths occurred under the care of various providers (1 physical therapist, 1 unknown practitioner, and 1 craniosacral therapist) and 12 serious injuries were reported (7 chiropractors/doctors of chiropractic, 1 medical practitioner, 1 osteopath, 2 physical therapists, and 1 unknown practitioner). High-velocity, extension, and rotational spinal manipulation was reported in most cases, with 1 case involving forcibly applied craniosacral dural tension and another involving use of an adjusting instrument. Underlying preexisting pathology was identified in a majority of the cases.

The authors concluded that published cases of serious adverse events in infants and children receiving chiropractic, osteopathic, physiotherapy, or manual medical therapy are rare. The 3 deaths that have been reported were associated with various manual therapists; however, no deaths associated with chiropractic care were found in the literature to date. Because underlying preexisting pathology was associated in a majority of reported cases, performing a thorough history and examination to exclude anatomical or neurologic anomalies before applying any manual therapy may further reduce adverse events across all manual therapy professions.

This review is a valuable addition to our knowledge about the risks of spinal manipulations. My own review summarised 26 deaths after chiropractic manipulations. In several of these instances, the age of the patient had not been reported. Therefore the above conclusion (no deaths associated with chiropractic) seems a little odd.

The following text is a shortened version of the discussion of my review which, I think, addresses most of the pertinent issues.

 numerous deaths have been associated with chiropractic. Usually high-velocity, short-lever thrusts of the upper spine with rotation are implicated. They are believed to cause vertebral arterial dissection in predisposed individuals which, in turn, can lead to a chain of events including stroke and death. Many chiropractors claim that, because arterial dissection can also occur spontaneously, causality between the chiropractic intervention and arterial dissection is not proven. However, when carefully evaluating the known facts, one does arrive at the conclusion that causality is at least likely. Even if it were merely a remote possibility, the precautionary principle in healthcare would mean that neck manipulations should be considered unsafe until proven otherwise. Moreover, there is no good evidence for assuming that neck manipulation is an effective therapy for any medical condition. Thus, the risk-benefit balance for chiropractic neck manipulation fails to be positive.

Reliable estimates of the frequency of vascular accidents are prevented by the fact that underreporting is known to be substantial. In a survey of UK neurologists, for instance, under-reporting of serious complications was 100%. Those cases which are published often turn out to be incomplete. Of 40 case reports of serious adverse effects associated with spinal manipulation, nine failed to provide any information about the clinical outcome. Incomplete reporting of outcomes might therefore further increase the true number of fatalities.

This review is focussed on deaths after chiropractic, yet neck manipulations are, of course, used by other healthcare professionals as well. The reason for this focus is simple: chiropractors are more frequently associated with serious manipulation-related adverse effects than osteopaths, physiotherapists, doctors or other professionals. Of the 40 cases of serious adverse effects mentioned above, 28 can be traced back to a chiropractor and none to a osteopath. A review of complications after spinal manipulations by any type of healthcare professional included three deaths related to osteopaths, nine to medical practitioners, none to a physiotherapist, one to a naturopath and 17 to chiropractors. This article also summarised a total of 265 vascular accidents of which 142 were linked to chiropractors. Another review of complications after neck manipulations published by 1997 included 177 vascular accidents, 32 of which were fatal. The vast majority of these cases were associated with chiropractic and none with physiotherapy. The most obvious explanation for the dominance of chiropractic is that chiropractors routinely employ high-velocity, short-lever thrusts on the upper spine with a rotational element, while the other healthcare professionals use them much more sparingly.

[REFERENCES FOR THE ABOVE STATEMENTS CAN BE FOUND IN MY REVIEW]

Dietary supplements (DS) are heavily promoted usually with the claim that they have stood the test of time and that they are natural and hence harmless. Unsurprisingly, their use has become very wide-spread. A new study determined the use of DSs, factors associated with DS use, and reasons for use among U.S. college students.

College students (N = 1248) at 5 U.S. universities were surveyed. Survey questions included descriptive demographics, types and frequency of DS used, reasons for use and money spent on supplements. Supplements were classified using standard criteria. Logistic regression analyses examined relationships between demographic and lifestyle factors and DS use.

Sixty-six percent of college students surveyed used DS at least once a week, and 12% consumed 5 or more supplements a week. Forty-two percent used multivitamins/multiminerals, 18% vitamin C, 17% protein/amino acids and 13% calcium at least once a week. Factors associated with supplement use included dietary patterns, exercise, and tobacco use. Students used supplements to promote general health (73%), provide more energy (29%), increase muscle strength (20%), and enhance performance (19%).

The authors of this survey concluded that college students appear more likely to use DS than the general population and many use multiple types of supplements weekly. Habits established at a young age persist throughout life. Therefore, longitudinal research should be conducted to determine whether patterns of DS use established early in adulthood are maintained throughout life. Adequate scientific justification for widespread use of DS in healthy, young populations is lacking.

Another new study investigated the use of DSs in 334 dancers from 53 countries, who completed a digitally based 35-question survey detailing demographic information and the use of DSs. Supplement use was prevalent amongst this international cohort, with 48% reporting regular DSs use. Major motives for supplement use were to improve health, boost immunity, and reduce fatigue. Forty-five percent believed that dancing increased the need for supplementation, whilst 30% recognized that there were risks associated with DSs.

The most frequently consumed DSs were vitamin C (60%), multivitamins (67%), and caffeine (72%). A smaller group of participants declared the use of whey protein (21%) or creatine (14%). Supplements were mainly obtained from pharmacies, supermarkets, and health-food stores. Dancers recognized their lack of knowledge in DSs use and relied on peer recommendations instead of sound evidence-based advice from acknowledged nutrition or health care professionals.

The authors concluded that this study demonstrates that DSs use is internationally prevalent amongst dancers. Continued efforts are warranted with regard to information dissemination.

Finally, a third study investigated use of DSs in patients in Japan. This survey was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about DSs. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using DSs, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses.

The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used DSs to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using DSs concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention DSs use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with DSs.

The authors concluded that communication between patients and physicians is important to avoid health problems associated with the use of DSs.

There is little doubt, DSs are popular with all sorts of populations and have grown into a multi billion dollar industry. There is also no doubt that the use of only very few DSs are evidence-based (and if so, in only relatively rare situations). And there can be no doubt that many DSs can do harm. What follows is simple: for the vast majority of DSs the benefits do not demonstrably out-weigh the risks.

If that is true, we have to ask ourselves: Why are they so popular?

The answer, I think, is because of the very phenomenon I am constantly trying to fight on this blog – IRRESPONSIBLE CHARLATANS PULLING WOOL OVER CONSUMERS EYES.

Complementary treatments have become a popular (and ‘political correct’) option to keep desperate cancer patients happy. But how widely accepted is their use in oncology units? A brand-new article tried to find the answer to this question.

The principal aim of this survey was to map centres across Europe prioritizing those that provide public health services and operating within the national health system in integrative oncology (IO). A cross-sectional descriptive survey design was used to collect data. A questionnaire was elaborated concerning integrative oncology therapies to be administered to all the national health system oncology centres or hospitals in each European country. These institutes were identified by convenience sampling, searching on oncology websites and forums. The official websites of these structures were analysed to obtain more information about their activities and contacts.

Information was received from 123 (52.1 %) out of the 236 centres contacted until 31 December 2013. Forty-seven out of 99 responding centres meeting inclusion criteria (47.5 %) provided integrative oncology treatments, 24 from Italy and 23 from other European countries. The number of patients seen per year was on average 301.2 ± 337. Among the centres providing these kinds of therapies, 33 (70.2 %) use fixed protocols and 35 (74.5 %) use systems for the evaluation of results. Thirty-two centres (68.1 %) had research in progress or carried out until the deadline of the survey. The complementary and alternative medicines (CAMs) more frequently provided to cancer patients were acupuncture 26 (55.3 %), homeopathy 19 (40.4 %), herbal medicine 18 (38.3 %) and traditional Chinese medicine 17 (36.2 %); anthroposophic medicine 10 (21.3 %); homotoxicology 6 (12.8 %); and other therapies 30 (63.8 %). Treatments are mainly directed to reduce adverse reactions to chemo-radiotherapy (23.9 %), in particular nausea and vomiting (13.4 %) and leucopenia (5 %). The CAMs were also used to reduce pain and fatigue (10.9 %), to reduce side effects of iatrogenic menopause (8.8 %) and to improve anxiety and depression (5.9 %), gastrointestinal disorders (5 %), sleep disturbances and neuropathy (3.8 %).

As so often with surveys of this nature, the high non-response rate creates a problem: it is not unreasonable to assume that those centres that responded had an interest in IO, while those that failed to respond tended to have none. Thus the figures reported here for the usage of alternative therapies might be far higher than they actually are. One can only hope that this is the case. The idea that 40% of all cancer patients receive homeopathy, for instance, is hardly one that is in accordance with the principles of evidence-based practice.

The list of medical reasons for using largely unproven treatments is interesting, I think. I am not aware of lots of strong evidence to show that any of the treatments in question would generate more good than harm for any of the conditions in question.

What follows from all of this is worrying, in my view: thousands of desperate cancer patients are being duped into having bogus treatments paid for by their national health system. This, I think, begs the question whether these most vulnerable patients do not deserve better.

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.
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