The vexing question whether the acupuncture needle is as safe as most acupuncturists seem to believe has been raised several times before on this blog. Here is a new case-report by Japanese authors which sheds an interesting light on this issue.
A 62-year-old man was admitted to A+E complaining of dizziness and diaphoresis. He had received an acupuncture treatment in the sub-xyphoid area (lower 2 cm and left 1 cm point from the lower xyphoid process border) only about one hour ago. He had a history of cerebral infarction and atrial fibrillation, and the latter condition was treated with 2 mg warfarin per day. On admission, the acupuncture needle was still sticking in his sub-sternum.
His blood pressure was 80/50 mm Hg, and tachycardia with 110 beats/min was noted. The acupuncture-needle was duly removed, but the patient went into cardiac arrest and had to be resuscitated. Because his international normalized ratio was 1.99, 2 pints of fresh frozen plasma and 5 mg of vitamin K were administered at that stage. A transthoracic echocardiography revealed pericardial effusion with early diastolic collapse of the right ventricle. Emergency pericardiocentesis using a sub-costal approach was performed. After drainage of 500 mL of sanguineous effusion, the patient seemed to stabilize.
Two hours later, the drainage of pericardial effusion amounted to around 1000 mL, and cardiac arrest re-developed. After another resuscitation, an operation was performed under cardiopulmonary bypass (CPB). A median sternotomy allowed visualization of huge hematomas over the right atrium and ventricle. After the hematomas had been evacuated, pulsating blood loss from the marginal branch of the right coronary artery was identified. The vessel had been torn into pieces, and it was ligated which stopped the bleeding. Thereafter, the patient remained hemodynamically stable. Subsequently the patient made an uneventful recovery and, eventually, he was discharged without further complications.
The authors of this case-report conclude as follows: To our best knowledge, this appears to be the first case of an acupuncture-related coronary artery injury. The important causes of this unfortunate adverse event are a lack of anatomic knowledge and an incorrect application of the procedure. It can be avoided that acupuncture leads to cardiac tamponade like most serious complications….every acupuncturist should be aware of the possible and life-threatening adverse events and be adequately trained to prevent them.
In 2011, we published a review of all cases of cardiac tamponade after acupuncture. At the time, we found a total of 26 such incidences. In 14 patients, the complications were fatal. In most reports, there was little doubt about causality. We concluded that cardiac tamponade is a serious, often fatal complication after acupuncture. As it is theoretically avoidable, acupuncturists should be trained to minimize the risk.
Acupuncture-fans will, of course, claim (as before) that it is alarmist to go on about risks of acupuncture or alternative medicine which are so minute that they are dwarfed by those of conventional health care. And I will counter (as before) that it is never the absolute risk that counts, but that it is the risk benefit balance which defines the value of any therapeutic intervention. As long as we have no solid proof that acupuncture is more than a “theatrical placebo“, even a tiny risk weighs heavily and seems unacceptable.
But the true significance of this case-report lies elsewhere, in my view: risks of this nature can and should be avoided. The only way to achieve this aim is to train and educate acupuncturists properly. At present this does not seem to be the case, particularly in Asian countries where acupuncture is most popular. It is up to the acupuncture communities across the globe to get their act together.
A stroke is a condition where brain cells get irreversibly damaged either by a haemorrhage in the brain or by a blood clot cutting off oxygen supply. This process leaves most patients with neurological deficits such as difficulties in moving, speaking, concentrating etc. As other parts of the brain learn to take over, these problems can partly or completely resolve themselves over time, but many patients are left with permanent handicaps. Stroke-rehabilitation can minimise these problems, and there is a long-standing debate as to which measures are most effective. Acupuncture has been discussed as a method to improve the results of stroke-rehabilitation, but the evidence is hotly disputed. This is why a new study in this area is an important contribution to our existing knowledge.
The aim of this randomised trial was to test the effectiveness of acupuncture in promoting the recovery of patients with ischaemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone. The Chinese investigators recruited 120 patients who received one of three daily treatments: 1) acupuncture, 2) physiotherapy, 3) physiotherapy combined with acupuncture. Motor function in the limbs was measured with the Fugl-Meyer assessment (FMA); the modified Barthel index (MBI) was used to rate activities of daily living; both of these measures are validated and well-established. All evaluations were performed by assessors blinded to treatment allocation.
At baseline, FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on day 28 of therapy, the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on day 56, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively. The respective MBI scores in the three groups had increased by 85.2%, 60.4%, and 63.4% at day 28 and by 108.0%, 71.2%, and 86.2% at day 56, respectively. However, FMA scores did not significantly differ between the three treatment groups on the 28th day. By the day 56, the FMA and MBI scores of the physiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group. No significant differences were seen between the combined treatment group and the other groups. The FMA subscores for the upper extremities did not show significant improvements in any group on day 56.
The authors draw the following conclusion: “Acupuncture is less effective for the outcome measures studied than is physiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these finding.”
Our own study arrived at similarly disappointing conclusions: “Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients“. Our review of all 10 sham-controlled RCTs in this area is also in line with the results of this new study: “Our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke”
I am quite sure that some acupuncture-enthusiasts will dispute this evidence. They might argue that I am too critical, the trials were not done optimally, that acupuncturists have seen plenty of good results in their clinical practice, that acupuncture is a complex intervention that does not fit into the straight jacket of an RCT, that this or that “prestigious” organisation recommends acupuncture for stroke patients, that it would be wrong not to give acupuncture a try etc. etc. I would counter that the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective and thus give false hope to severely suffering, vulnerable patients. Moreover, I would advocate using the sparse available resources to help stroke victims with treatments that demonstrably work.
Many people who have arrived at a certain age have knee osteoarthritis and most of them suffer pain, lack of mobility etc. because of it. There are many effective treatments for this condition, of course, but some have serious side-effects, others are tedious to follow and therefore not popular, and none of the existing options totally cure the problem. In many cases, surgery is the best solution; a knee-endoprosthesis can restore everything almost back to normal. But surgery carries risks and will cause considerable pain and rehabilitation-effort. This is perhaps why we are still looking for a treatment that is both effective and risk-free. Personally, I doubt that such a therapy will ever be found, but that does, of course, not stop alternative medicine enthusiasts from claiming that this or that treatment is what the world has been waiting for. The newest kid on this block is leech therapy. Did I just write “newest”? Leeches are not new at all; they are a treatment from the dark ages of medicine – but are they about to experience a come-back?
A recent systematic review and meta-analysis evaluated the effectiveness of medical leech therapy for osteoarthritis of the knee. Five electronic databases were screened to identify randomized (RCTs) and non randomized controlled clinical trials (CCTs) comparing leech therapy to any type of control condition. The main outcome measures were pain, functional impairment, and joint stiffness. Three RCTs and 1 CCT with a total of 237 patients with osteoarthritis were included. Three trials had, according to the review-authors, a low risk of bias. They claimed to have found strong evidence for immediate and short-term pain reduction, immediate improvement in patients’ physical function, and both immediate and long-term improvement in their joint stiffness. Moderate evidence was found for leech therapy’s short-term effects on physical function and long-term effects on pain. Leech therapy was not associated with any serious adverse events. The authors reached the following conclusion: ” Given the low number of reported adverse events, leech therapy may be a useful approach in treating this condition. Further high-quality RCTs are required for the conclusive judgment of its effectiveness and safety.”
When, about 35 years ago, I worked as a young doctor in the homeopathic hospital in Munich, I was taught how to apply leeches to my patients. We got the animals from a specialised supplier, put them on the patient’s skin and waited until they had bitten a little hole and started sucking the patient’s blood. Once they were full they spontaneously fell off and were then disposed off. Many patients were too disgusted with the prospect of leech therapy to agree to this intervention. Those who did were very impressed with the procedure; it occurred to me then that this therapy must be associated with an enormous placebo-effect simply because it is exotic, impressive and a treatment that no patient will ever forget.
The bite of the leech is not normally painful because the leech has a local anaesthetic which it applies in order to suck blood without being noticed. The leech furthermore injects a powerful anticoagulant into its victim’s body which is necessary for preventing the blood from clotting. Through the injection of these pharmacologically active substances, leeches can clearly be therapeutic and they are thus not entirely unknown in conventional medicine; in plastic surgery, for instance, they are sometimes being used to generate optimal results for micro surgical wounds. Their anticoagulant has long been identified and is sometimes being used therapeutically. The use of leeches for the management of osteoarthritis, however, is not a conventional concept. So, how convincing are the above data? Should we agree with the authors’ conclusion that “leech therapy may be a useful approach in treating this condition“? I think not, and here is why:
1) The collective evidence for efficacy is far from convincing. The few studies which were summarised in this systematic review are mostly those of the research group that also authored the review. Critical thinkers would insist on an independent assessment of those trials. Moreover, none of the trials was patient-blind (which would not be all that difficult to do), and thus the enormous placebo-effect of applying a leech might be the cause of all or most of the observed effect.
2) The authors claim that the treatment is safe. On the basis of just 250 patients treated under highly controlled conditions, this claim has almost no evidential basis.
3) As already mentioned above, there are many treatments which are more effective for improving pain and function than leeches.
4) Leech therapy is time-consuming, relatively expensive and quite unpractical as a regular, long-term therapy.
5) In my experience, patients will run a mile to avoid having something as ‘disgusting’ as leeches sucking blood from their body.
6) The animals need to be destroyed after the treatment to avoid infections.
7) As multiple leeches applied regularly will suck a significant volume of blood, the treatment might lead to anaemia and would be contra-indicated in patients with low haemoglobin levels.
8) Like most other treatments for osteoarthritis, leech therapy would not be curative but might just alleviate the symptoms temporarily.
On balance therefore, I very much doubt that the leech will have a come-back in the realm of osteoarthritis therapy. In fact, I think that, in this particular context, leeches are just a chapter from the dark ages of medicine. Their re-introduction into osteoarthritis care seems like a significant step into the wrong direction.
Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?
The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.
But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.
Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.
Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF”
There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:
2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.
3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.
4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?
It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.
Five years ago to the day, Simon Singh and I published an article in The Daily Mail to promote our book TRICK OR TREATMENT… which was then about to be launched. We recently learnt that our short article prompted a “confidential” message by the BRITISH CHIROPRACTIC ASSOCIATION to all its members. “Confidential” needs to be put in inverted commas because it is readily available on the Internet. I find it fascinating and of sufficient public interest to reproduce it here in full. I have not altered a thing in the following text, except putting it in italics and putting the section where the BCA quote our text in bold for clarity.
CONFIDENTIAL FOR BCA MEMBERS ONLY
Information for BCA members regarding an article in the Daily Mail – April 8th 2008
A double page spread appeared in the edition of the Daily Mail April 8th 2008 on page 46 and 47 and titled ‘Alternative Medicine The Verdict’.
The article was written by Simon Singh and Edzard Ernst and is a publicity prelude to a book they have written called ‘Trick or Treatment? Alternative Medicine on Trial’, which will be published later this month.
The article covers Alexander Technique, Aromatherapy, Flower Remedy, Chiropractic, Hypnotherapy, Magnet Therapy and Osteopathy.
The coverage of Chiropractic follows a familiar pattern for E Ernst. The treatment is oversimplified in explanation, with a heavy emphasis on words like thrust, strong and aggressive. There is tacit acknowledgement that chiropractic works for back pain, but then there is a long section about caution regarding neck manipulation. The article concludes by advising people not to have their neck manipulated and not to allow children to be treated.
WHAT IS IT? Chiropractors use spinal manipulation to realign the spine to restore mobility. Initial examination often includes X-ray images or MRI scans.
Spinal manipulation can be a fairly aggressive technique, which pushes the spinal joint slightly beyond what it is ordinarily capable of achieving, using a technique called high-velocity, low-amplitude thrust – exerting a relatively strong force in order to move the joint at speed, but the extent of the motion needs to be limited to prevent damage to the joint and its surrounding structures.
Although spinal manipulation is often associated with a cracking sound, this is not a result of the bones crunching or a sign that bones are being put back; the noise is caused by the release and popping of gas bubbles, generated when the fluid in the joint space is put under severe stress.
Some chiropractors claim to treat everything from digestive disorders to ear infections, others will treat only back problems.
DOES IT WORK? There is no evidence to suggest that spinal manipulation is effective for anything but back pain and even then conventional approaches (such as regular exercise and ibuprofen) are just as likely to be effective and are cheaper.
Neck manipulation has been linked to neurological complications such as strokes – in 1998, a 20-year-old Canadian woman died after neck manipulation caused a blood clot which led to stroke. We would strongly recommend physiotherapy exercises and osteopathy ahead of chiropractic therapy because they are at least effective and much safer.
If you do decide to visit a chiropractor despite our concerns and warnings, we very strongly recommend you confirm your chiropractor won’t manipulate your neck. The dangers of chiropractic therapy to children are particularly worrying because a chiropractor would be manipulating an immature spine.
Daily Mail 2008 April 8th.
As we are aware that patients or potential patients of our members will be confronted with questions regarding this article, we have put together some comment and Q&As to assist you.
• Please consider this information as strictly confidential and for your use only.
• Only use this if a patient asks about these specific issues; there is nothing to be gained from releasing any information not asked for.
• Do not duplicate these patient notes and hand out direct to the patient or the media; these are designed for you to use when in direct conversation with a patient.
The BCA will be very carefully considering any questions or approaches we may receive from the press and will respond to them using specially briefed spokespeople. We would strongly advise our members not to speak directly to the press on any of the issues raised as a result of this coverage.
Please note that In the event of you receiving queries from the media, please refer these direct to BCA (0118 950 5950 – Anne Barlow or Sue Wakefield) or Publicasity (0207 632 2400 – Julie Doyle or Sara Bailey).
The following points should assist you in answering questions that patients may ask with regard to the safety and effectiveness of chiropractic care. Potential questions are detailed along with the desired ‘BCA response’:
o “The Daily Mail article seems to suggest chiropractic treatment is not that effective”
Nothing could be further from the truth. The authors have had to concede that chiropractic treatment works for back pain as there is overwhelming evidence to support this. The authors also contest that pain killers and exercises can do the job just as well. What they fail to mention is that research has shown that this might be the case for some patients, but the amount of time it may take to recover is a lot longer and the chance of re-occurrence of the problem is higher. This means that chiropractic treatment works, gets results more quickly and helps prevent re-occurrence of the problem. Chiropractic is the third largest healthcare profession in the world and in the UK is recognised and regulated by the UK Government.
o “The treatment is described as aggressive, can you explain?”
It is important to say that the authors of the article clearly have no direct experience of chiropractic treatment, nor have they bothered to properly research the training and techniques. Chiropractic treatment can take many forms, depending on the nature of the problem, the particular patient’s age and medical history and other factors. The training chiropractors receive is overseen by the government appointed regulator and the content of training is absolutely designed to ensure that an individual chiropractor understands exactly which treatment types are required in each individual patient scenario. Gentle technique, massage and exercise are just some of the techniques available in the chiropractor’s ‘toolkit’. It is a gross generalisation and a demonstration of lack of knowledge of chiropractic to characterise it the way it appeared in the article.
o “The article talked about ‘claims’ of success with other problems”
There is a large and undeniable body of evidence regarding the effectiveness of chiropractic treatment for musculoskeletal problems such as back pain. There is also growing evidence that chiropractic treatment can help many patients with other problems; persistent headaches for example. There is also anecdotal evidence and positive patient experience to show that other kinds of problems have been helped by chiropractic treatment. For many of these kinds of problems, the formal research is just beginning and a chiropractor would never propose their treatment as a substitute for other, ongoing treatments.
o “Am I at risk of having a stroke if I have a chiropractic treatment?”
What is important to understand is that any association between neck manipulation and stroke is extremely rare. Chiropractic is a very safe form of treatment.
Another important point to understand is that the treatments employed by chiropractors are statistically safer than many other conservative treatment options (such as ibuprofen and other pain killers with side effects such as gastric bleeding) for mechanical low back or neck pain conditions.
A research study in the UK, published just last year studied the neck manipulations received by nearly 20,000 chiropractic patients. NO SERIOUS ADVERSE SIDE EFFECTS WERE IDENTIFIED AT ALL. In another piece of research, published in February this year, stroke was found to be a very rare event and the risk associated with a visit to a chiropractor appeared to be no different from the risk of a stroke following a visit to a GP.
Other recent research shows that such an association with stroke may occur once in every 5.85 million adjustments.
To put this in context, a ‘significant risk’ for any therapeutic intervention (such as pain medication) is defined as 1 in 10,000.
Additional info: Stroke is a natural occurring phenomenon, and evidence dictates that a number of key risk factors increase the likelihood of an individual suffering a stroke. Smoking, high blood pressure, high cholesterol and family medical histories can all contribute; rarely does a stroke occur in isolation from these factors. Also, stroke symptoms can be similar to that of upper neck pains, stiffness or headaches, conditions for which patients may seek chiropractic treatment. BCA chiropractors are trained to recognise and diagnose these symptoms and advise appropriate mainstream medical care.
o “Can you tell if I am at risk from stroke?”
As a BCA chiropractor I am trained to identify risk factors and would not proceed with treatment if there was any doubt as to the patient’s suitability. Potential risks may come to light during the taking of a case history, which may include: smoking, high cholesterol, contraceptive pill, Blood clotting problems/blood thinning meds, heart problems, trauma to the head etc and on physical examination e.g. high blood pressure, severe osteoarthritis of the neck, history of rheumatoid arthritis
o “Do you ever tell patients if they are at risk?”
Yes, I would always discuss risks with patients and treatment will not proceed without informed consent.
o “Is it safe for my child to be treated by a chiropractor”
It is a shame that the article so generalises the treatment provided by a chiropractor, that it makes such outrageous claims. My training in anatomy, physiology and diagnosis means that I absolutely understand the demands and needs of spines from the newborn baby to the very elderly patient. The techniques and treatments I might use on a 25 year old are not the same as those I would employ on a 5 year old. I see a lot of children as patients at this clinic and am able to offer help with a variety of problems with the back, joints and muscles. I examine every patient very thoroughly, understand their medical history and discuss my findings with them and their parents before undertaking any treatment.
– Chiropractic is a mature profession and numerous studies clearly demonstrate that chiropractic treatment, including manipulative and spinal adjustment, is both safe and effective.
– Thousands of patients are treated by me and my fellow chiropractors every day in the UK. Chiropractic is a healthcare profession that is growing purely because our patients see the results and GPs refer patients to us because they know we get results!
This article is to promote a book and a controversial one at that. Certainly, in the case of the comments about chiropractic, there is much evidence and research that has formed part of guidelines developed by the Royal Society of General Practitioners, NICE and other NHS/Government agencies, has been conveniently ignored. The statements about chiropractic treatment and technique demonstrate that there has clearly been no research into the actual education that chiropractors in the UK receive – in my case a four year full-time degree course that meets stringent educational standards set down by the government appointed regulator.
Shortly after the article in The Daily Mail, our book was published and turned out to be much appreciated by critical thinkers across the globe — not, however, by chiropractors.
At the time, I did, of course, not know about the above “strictly confidential” message to BCA members, yet I strongly suspected that chiropractors would do everything in their power to dispute our central argument, namely that most of the therapeutic claims by chiropractors were not supported by sufficient evidence. I also knew that our evidence for it was rock solid; after all, I had researched the evidence for or against chiropractic in full depth and minute detail and published dozens of articles on the subject in the medical literature.
When, one and a half weeks after our piece in the Mail, Simon published his now famous Guardian comment stating that the BCA “happily promote bogus treatments”, he was sued for libel by the BCA. I think the above “strictly confidential” message already reveals the BCA’s determination and their conviction to be on firm ground. As it turned out, they were wrong. Not only did they lose their libel suit, but they also dragged chiropractic into a deep crisis.
The “strictly confidential” message is intriguing in several more ways – I will leave it to my readers to pick out some of the many gems hidden in this text. Personally, I find the most remarkable aspect that the BCA seems to attempt to silence its own members regarding the controversy about the value of their treatments. Instead they proscribe answers (should I say doctrines?) of highly debatable accuracy for them, almost as though chiropractors were unable to speak for themselves. To me, this smells of cult-like behaviour, and is by no means indicative of a mature profession – despite their affirmations to the contrary.
My aim with this blog is to eventually cover most of the 400 or so different alternative therapies and diagnostic techniques. So far, I have focused on some of the most popular modalities; and this means, I have neglected many others. Today, it is time, I think, to discuss aromatherapy, after all, it is one of the most popular forms of alternative medicine in the UK.
Aromatherapists use essential oils, and this is where the confusion starts. They are called “essential” not because humans cannot do without them, like essential nutrients, for instance; they are called “essential” because they are made of flower ESSENCES. The man who ‘discovered’ aromatherapy was a chemist who accidentally had burnt his hand and put some lavender essence on the burn. It healed very quickly, and he thus concluded that essential oils can be useful therapeutics.
Today’s aromatherapists would rarely use the pure essential oil; they dilute it in an inert carrier oil and usually apply it via a very gentle massage to the skin. They believe that specific oils have specific effects for specific conditions. As these oils contain pharmacologically active ingredients, some of these assumptions might even be correct. The question, however, is one of concentration. Do these ingredients reach the target organ in sufficient quantities? Are they absorbed through the skin at all? Does smelling them have a sufficiently large effect to produce the claimed benefit?
The ‘acid test’ for any therapeutic claim is, as always, the clinical trial. As it happens a new paper has just become available. The aim of this randomised study was to determine the effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content were selected and among these the one preferred by the participant was used. Thirteen pregnant women in week 28 of a single pregnancy were randomly assigned into an aromatherapy and a control group. The main outcome measures were several validated scores to assess mood and the heart-rate variability. The results showed significant differences in the Tension-Anxiety score and the Anger-Hostility score after aromatherapy. Heart rate variability changes indicated that the parasympathetic nerve activity increased significantly in the verum group. The authors concluded that aromatherapy inhalation was effective and suggest that more research is warranted.
I have several reasons for mentioning this study here.
1st research into aromatherapy is rare and therefore any new trial of this popular treatment might be important.
2nd aromatherapy is mostly (but not in this study) used in conjunction with a gentle, soothing massage; any outcome of such an intervention is difficult to interpret: we cannot then know whether it was the massage or the oil that produced the observed effect. The present trial is different and might allow conclusions specifically about the effects of the essential oils.
3rd the study displays several classic methodological mistakes which are common in trials of alternative medicine. By exposing them, I hope that they might become less frequent in future.
The most obvious flaw is its tiny sample size. What is an adequate size, people often ask. This question is unfortunately unanswerable. To determine the adequate sample size, it is best to conduct a pilot study or use published data to calculate the required number of patients needed for the specific trial you are planning. Any statistician will be able to help you with this.
The second equally obvious flaw relates to the fact that the results and the conclusions of this study were based on comparing the outcome measures before with those after the interventions within one intervention group. The main reason for taking the trouble of running a control group in a clinical trial is that the findings from the experimental group are compared to those of the control group. Only such inter-group comparisons can tell us whether the results were actually caused by the intervention and not by other factors such as the passage of time, a placebo-effect etc.
In the present study, the authors seem to be aware of their mistake and mention that there were no significant differences in outcomes when the two groups were compared. Yet they fail to draw the right conclusion from this fact. It means that their study demonstrated that aromatherapy inhalation had no effect on the outcomes studied.
So, what does the reliable trial evidence on aromatherapy tell us?
A clinical trial in which I was involved failed to show that it improves the mood or quality of life of cancer patients. But one swallow does not make a summer; what do systematic reviews of all available trials indicate?
The first systematic review was probably the one we published in 2000. We then located 12 randomised clinical trials: six of them had no independent replication; six related to the relaxing effects of aromatherapy combined with massage. These 6 studies collectively suggested that aromatherapy massage has a mild but short-lasting anxiolytic effect. These effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. We concluded that the hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
Since then several other systematic reviews have emerged. We therefore decided to summarise their findings in an overview of all available reviews. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Our conclusions therefore had to be cautious: due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
Finally, we also investigated the safety of aromatherapy by assessing all published data regarding adverse effects. Forty two primary reports met our inclusion criteria. In total, 71 patients had experienced adverse effects after aromatherapy which 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. We concluded that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown.
And what is the conclusion of all this? To me, it seems fairly straight forward: Aromatherapy is not demonstrably effective for any condition. It also is not entirely free of risks. Its risk/benefit profile is thus not positive which can only mean that it is not a useful or recommendable treatment for anybody who is ill.
Believe it or not, but my decision – all those years ago – to study medicine was to a significant degree influenced by a somewhat naive desire to, one day, be able to save lives. In my experience, most medical students are motivated by this wish – “to save lives” in this context stands not just for the dramatic act of administering a life-saving treatment to a moribund patient but it is meant as a synonym for helping patients in a much more general sense.
I am not sure whether, as a young clinician, I ever did manage to save many lives. Later, I had a career-change and became a researcher. The general view about researchers seems to be that they are detached from real life, sit in ivory towers and write clever papers which hardly anyone understands and few people will ever read. Researchers therefore cannot save lives, can they?
So, what happened to those laudable ambitions of the young Dr Ernst? Why did I decide to go into research, and why alternative medicine; why did I not conduct research in more the promotional way of so many of my colleagues (my life would have been so much more hassle-free, and I even might have a knighthood by now); why did I feel the need to insist on rigorous assessments and critical thinking, often at high cost? For my many detractors, the answers to these questions seem to be more than obvious: I was corrupted by BIG PHARMA, I have an axe to grind against all things alternative, I have an insatiable desire to be in the lime-light, I defend my profession against the concurrence from alternative practitioners etc. However, for me, the issues are a little less obvious (today, I will, for the first time, disclose the bribe I received from BIG PHARMA for criticising alternative medicine: the precise sum was zero £ and the same amount again in $).
As I am retiring from academic life and doing less original research, I do have the time and the inclination to brood over such questions. What precisely motivated my research agenda in alternative medicine, and why did I remain unimpressed by the number of powerful enemies I made pursuing it?
If I am honest – and I know this will sound strange to many, particularly to those who are convinced that I merely rejoice in being alarmist – I am still inspired by this hope to save lives. Sure, the youthful naivety of the early days has all but disappeared, yet the core motivation has remained unchanged.
But how can research into alternative medicine ever save a single life?
Since about 20 years, I am regularly pointing out that the most important research questions in my field relate to the risks of alternative medicine. I have continually published articles about these issues in the medical literature and, more recently, I have also made a conscious effort to step out of the ivory towers of academia and started writing for a much wider lay-audience (hence also this blog). Important landmarks on this journey include:
Alternative medicine is cleverly, heavily and incessantly promoted as being natural and hence harmless. Several of my previous posts and the ensuing discussions on this blog strongly suggest that some chiropractors deny that their neck manipulations can cause a stroke. Similarly, some homeopaths are convinced that they can do no harm; some acupuncturists insist that their needles are entirely safe; some herbalists think that their medicines are risk-free, etc. All of them tend to agree that the risks are non-existent or so small that they are dwarfed by those of conventional medicine, thus ignoring that the potential risks of any treatment must be seen in relation to their proven benefit.
For 20 years, I have tried my best to dispel these dangerous myths and fallacies. In doing so, I had to fight many tough battles (sometimes even with the people who should have protected me, e.g. my peers at Exeter university), and I have the scars to prove it. If, however, I did save just one life by conducting my research into the risks of alternative medicine and by writing about it, the effort was well worth it.
When I retired a few months ago, I began to sort out hundreds of old files and, in the course of doing so, I stumbled across my inauguration lecture given at Exeter in late 1993. Because so many people have been puzzled, bewildered or annoyed by my post, my attitude, my remit, my writings, my errors, my perceived lack of support for CM or my alleged inconsistencies, I have now decided to reproduce the most important sections of this publication here (unfortunately, the article is not available on line but I will send a PDF to anyone who asks for it). For clarity, the original text is in italics; where i needed to add something, I put it in square brackets so that there can be no misunderstandings.
… there are some common denominators [for all different types of CM]: an all encompassing theory (sometimes more a philosophy than a theory) the view of health as a balance of forces within the body and healing as the restoration of this balance, the holistic approach, and the emphasis on each individual’s own responsibility for health. It is noteworthy that the latter two characteristics are, of course, an integral part of (good) orthodox medicine.
…[CM] often lacks an adequate theoretical basis, its diagnoses are usually not in line with science, and it has failed to demonstrate clinical effectiveness convincingly. CM may thus be defined as those branches of the art and science of health care that are not in accordance with current medical thought, scientific knowledge or university teaching…
… no one doubts that today’s modern, orthodox medicine is more successful than any of its predecessors in diagnosing, treating and preventing disease. Yet the public chooses complementary medicine in vast numbers. Why? There must be many reasons, ranging from dissatisfaction with high-tech medicine to a fascination with mysticism, from grabbing ‘the last straw’ to looking for more empathy, to falling victim to the Barnum-Effect or the Health Information Fatigue Phenomenon. Whatever the reasons are (and no doubt they need to be researched in much more detail), they represent a severe criticism to the content and style of today’s medicine. Orthodoxy might be well advised to try and learn a lesson from the apparent success and obvious popularity of CM…
CM also accepts more and more its own limitations, the fact that it may also do harm and the urgent need for much more scientific proof – a remarkable change considering that the scientific method was formerly said to be nothing short of naive reductionism representing an over-simplified mechanistic philosophy, which does injustice to the complexities of the human being.
… the medical establishment is gradually becoming more open-minded and prepared to look into the matter seriously. It realises that it must abandon old prejudice and differentiate between various approaches – maybe not everything in CM is bad after all! A wry and useful classification is the schematic listing of CM in 3 categories: the frankly fraudulent, the foolishly harmless, and the possibly useful. It is clear that only rigorous research will be able to differentiate one from the other.
…why do we need controlled trials, some proponents of CM would argue, when everyday experience shows us that our treatments work? The answer is disarmingly simple: clinical experience can be totally and repeatedly misleading. Medical history abounds with examples. Blood-letting, the panacea of the middle-ages, killed probably more people than it ever helped. Yet clinicians thought to witness its benefit for centuries. Every time in the past, present and future, when a patient’s cure is solely attributed to a treatment, two important factors are neglected: the natural history of the disease, and the placebo effect. There is only one way to be sure, and that is to conduct randomised controlled trials. The notion that they are not feasible, desirable or conclusive is blatantly wrong; not to believe in controlled trials is not to care about the effectiveness of one’s doings and to adopt a quasi-religious attitude towards medicine.
I find some of the points I made back in 1993 remarkable. To be honest, I could not stop smiling when I re-read my text after almost 20 years. Rather than discussing the messages of my own lecture, I will leave the critical assessment of these points to the probably lively comment section that will follow this post. In closing, I do, however, want to briefly highlight two aspects.
1) Many CM proponents have attacked me because they feel that I am too critical and some even assume that I am in the pockets of BIG PHARMA and got the Exeter job under false pretences. The University of Exeter should have employed an outspoken champion of CM, they argue. I think my inaugural lecture shows beyond any doubt that they always knew who they were getting and it suggests that, at least initially (before Prince Charles intervened), they wanted me because universities need scientists, not promoters.
2) Since 1993, about 10 000 articles have been published on the subject of CM (my estimate), and yet we do not seem to have advanced all that much. The title “changing attitudes” might thus have been more than a little optimistic on my part!
A few weeks ago, The College of Chiropractors, a Company Limited by guarantee, was given a royal charter. A royal charter is a formal document issued by a monarch, granting a right or power to an individual or an corporate body. They are used to establish significant organisations such as cities or universities.
This is how the event was protrayed by chiropractors [link disabled by admin due to possible malware]:
Rarely granted, a Royal Charter signals permanence and stability and, in the College of Chiropractors’ case, a clear indication to others of the leadership value and innovative approach the College brings to the development of the chiropractic profession. The Royal Charter essentially formalises the College’s position as a unique, apolitical, consultative body, recognising its role in promoting high practice standards and certifying quality and thus securing public confidence.
For those of us who are not familiar with the College, here is how they describe themselves and their history:
On the advice of a senior medical figure, an organisational model similar to that of a Medical Royal College was devised. Thus, the College of Chiropractors was conceived during 1997 and incorporated in 1998 as an independent body to develop, encourage and maintain the highest possible standards of chiropractic practice for the benefit of patients.
Over the next couple of years the embryonic ‘College’ grew with a regional faculty infrastructure, the mainstay of the organisation, becoming firmly established in order to foster education locally. As an independent body, separate from any of the political groups, members were able to share information and expertise from all areas of the profession. Following its incorporation in October 1998, the College of Chiropractors was formally launched on 28th April 1999 at the King’s Fund.
The College is now an academic membership organisation with almost 3000 members worldwide, and the following objectives:
- to promote the art, science and practice of chiropractic;
- to improve and maintain standards in the practice of chiropractic for the benefit of the public;
- to promote awareness and understanding of chiropractic amongst medical practitioners and other healthcare professionals and the public;
- to educate and train practitioners in the art, science and practice of chiropractic;
- to advance the study of and research in chiropractic.
From my perspective, this begs numerous questions; here are just some of them:
1) Have UK chiropractors truly been promoting “high practice standards and certifying quality and thus securing public confidence”?
I would argue that they have been doing the opposite. They made bogus therapeutic claims by the hundreds on their websites, and when Simon Singh had the courage to make this public, they sued him for libel. Call me old-fashioned, but I fail to see how this maintains “the highest possible standards of chiropractic practice for the benefit of patients” nor how this might “promote the art, science and practice of chiropractic.”
I would have thought that this is a serious disservice to the people and the health of the nation and believe it reflects an irresponsible disregard of the precautionary principle in health care.
3) How can we accord the high aims of the College with the fact that UK chiropractors demonstrably violate fundamental rules of medical ethics, e.g. informed consent, and that their professional bodies must be aware of this fact, yet have so far failed to do anything about it?
I think there is a discrepancy here that needs explaining.
4) Does the College truly “advance the study of and research in chiropractic?”
We have shown that UK research into chiropractic has not increased but decreased since statutory regulation. This leads me to suspect that regulation is being abused as a means of gaining recognition and not as a mechanism to protect the public.
Considering all this, I find that the status of the other Royal Colleges has been de-valued by the ascent of this organisation. And I ask myself WHAT NEXT? A COLLEGE OF WINDOW SALES-MEN, perhaps? Or would this giving a bad name to the poor window-salesmen?
If I had a pint of beer for every time I have been accused of bias against chiropractic, I would rarely be sober. The thing is that I do like to report about decent research in this field and I am almost every day looking out for new articles which might be worth writing about – but they are like gold dust!
“Huuuuuuuuh, that just shows how very biased he is” I hear the chiro community shout. Well let’s put my hypothesis to the test. Here is a complete list of recent (2013)Medline-listed articles on chiropractic; no omission, no bias, just facts (for clarity, the Pubmed-link is listed first, then the title in bold followed by a short comment in italics):
Towards establishing an occupational threshold for cumulative shear force in the vertebral joint – An in vitro evaluation of a risk factor for spondylolytic fractures using porcine specimens.
This is an interesting study of the shear forces observed in porcine vertebral specimen during maneuvers which might resemble spinal manipulation in humans. The authors conclude that “Our investigation suggested that pars interarticularis damage may begin non-linearly accumulating with shear forces between 20% and 40% of failure tolerance (approximately 430 to 860N”
Development of an equation for calculating vertebral shear failure tolerance without destructive mechanical testing using iterative linear regression.
This is a mathematical modelling of the forces that might act on the spine during manipulation. The authors draw no conclusions.
Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial.
This is merely the publication of a trial that is about to commence.
Military Report More Complementary and Alternative Medicine Use than Civilians.
This is a survey which suggests that ~45% of all military personnel use some form of alternative medicine.
Complementary and Alternative Medicine Use by Pediatric Specialty Outpatients
This is another survey; it concludes that ” that CAM use is high among pediatric specialty clinic outpatients”
Extending ICPC-2 PLUS terminology to develop a classification system specific for the study of chiropractic encounters
This is an article on chiropractic terminology which concludes that “existing ICPC-2 PLUS terminology could not fully represent chiropractic practice, adding terms specific to chiropractic enabled coding of a large number of chiropractic encounters at the desired level. Further, the new system attempted to record the diversity among chiropractic encounters while enabling generalisation for reporting where required. COAST is ongoing, and as such, any further encounters received from chiropractors will enable addition and refinement of ICPC-2 PLUS (Chiro)”.
US Spending On Complementary And Alternative Medicine During 2002-08 Plateaued, Suggesting Role In Reformed Health System
This is a study of the money spent on alternative medicine concluding as follows “Should some forms of complementary and alternative medicine-for example, chiropractic care for back pain-be proven more efficient than allopathic and specialty medicine, the inclusion of complementary and alternative medicine providers in new delivery systems such as accountable care organizations could help slow growth in national health care spending”
A Royal Chartered College joins Chiropractic & Manual Therapies.
This is a short comment on the fact that a chiro institution received a Royal Charter.
Exposure-adjusted incidence rates and severity of competition injuries in Australian amateur taekwondo athletes: a 2-year prospective study.
This is a study by chiros to determine the frequency of injuries in taekwondo athletes.
The first thing that strikes me is the paucity of articles; ok, we are talking of just january 2013 but by comparison most medical fields like neurology, rheumatology have produced hundreds of articles during this period and even the field of acupuncture research has generated about three times more.
The second and much more important point is that I fail to see much chiropractic research that is truly meaningful or tells us anything about what I consider the most urgent questions in this area, e.g. do chiropractic interventions work? are they safe?
My last point is equally critical. After reading the 9 papers, I have to honestly say that none of them impressed me in terms of its scientific rigor.
So, what does this tiny investigation suggest? Not a lot, I have to admit, but I think it supports the hypothesis that research into chiropractic is not very active, nor high quality, nor does it address the most urgent questions.