The safety of the manual treatments such as spinal manipulation is a frequent subject on this blog. Few experts would disagree with the argument that more good data are needed – and what could be better data than that coming from a randomised clinical trial (RCT)?
The aim of this RCT was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain.
Participants were recruited among patients seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. 767 patients were randomized to one of three treatment arms:
- manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249),
- manual therapy excluding spinal manipulation (n = 258)
- manual therapy excluding stretching (n = 260).
Treatments were provided by students in the seventh semester (of total 8). Adverse events were monitored via a questionnaire after each return visit and categorized in to five levels:
- short minor,
- long minor,
- short moderate,
- long moderate,
This was based on the duration and/or severity of the event.
The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of these adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events, and long moderate adverse events than men.
The authors conclude that adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.
What on earth is naprapathy? I hear you ask. Here is a full explanation from a naprapathy website:
Naprapathy is a form of bodywork that is focused on the manual manipulation of the spine and connective tissue. Based on the fundamental principles of osteopathy and chiropractic techniques, naprapathy is a holistic and integrative approach to restoring whole health. In fact, naprapathy often incorporates multiple, complimentary therapies, such as massage, nutritional counseling, electrical muscle stimulation and low-level laser therapy.
Naprapathy also targets vertebral subluxations, or physical abnormalities present that suggest a misalignment or injury of the spinal vertebrae. This analysis is made by a physical inspection of the musculoskeletal system, as well as visual observation. The practitioner will also conduct a lengthy interview with the client to help determine stress level and nutritional status as well. An imbalance along one or more of these lines may signal trouble within the musculoskeletal structure.
The naprapathy practitioner is particularly skilled in identifying restricted or stressed components of the fascial system, or connective tissue. It is believed that where constriction of muscles, ligaments, and tendons exists, there is impaired blood flow and nerve functioning. Naprapathy attempts to correct these blockages through hands-on manipulation and stretching of connective tissue. However, since this discipline embodies a holistic approach, the naprapathy practitioner is also concerned with their client’s emotional health. To that end, many practitioners are also trained in psychotherapy and even hypnotherapy.
So, now we know!
We also know that the manual therapies tested here cause adverse effects in about half of all patients. This figure ties in nicely with the ones we had regarding chiropractic: ~ 50% of all patients suffer mild to moderate adverse effects after chiropractic spinal manipulation which usually last 2-3 days and can be strong enough to affect their quality of life. In addition very serious complications have been noted which luckily seem to be much rarer events.
In my view, this raises the question: DO THESE TREATMENTS GENERATE MORE GOOD THAN HARM? I fail to see any good evidence to suggest that they do – but, of course, I would be more than happy to revise this verdict, provided someone shows me the evidence.
Chiropractors are notorious for their overuse and misuse of x-rays for non-specific back and neck pain as well as other conditions. A recent study from the US has shown that the rate of spine radiographs within 5 days of an initial patient visit to a chiropractor is 204 per 1000 new patient examinations. Considering that X-rays are not usually necessary for patients with non-specific back pain, such rates are far too high. Therefore, a team of US/Canadian researchers conducted a study to evaluate the impact of web-based dissemination of a diagnostic imaging guideline discouraging the use of spine x-rays among chiropractors.
They disseminated an imaging guideline online in April 2008. Administrative claims data were extracted between January 2006 and December 2010. Segmented regression analysis with autoregressive error was used to estimate the impact of guideline recommendations on the rate of spine x-rays. Sensitivity analysis considered the effect of two additional quality improvement strategies, a policy change and an education intervention.
The results show a significant change in the level of spine x-ray ordering weeks after introduction of the guidelines (-0.01; 95% confidence interval=-0.01, -0.002; p=.01), but no change in trend of the regression lines. The monthly mean rate of spine x-rays within 5 days of initial visit per new patient exams decreased by 10 per 1000, a 5.26% relative decrease after guideline dissemination.
The authors concluded that Web-based guideline dissemination was associated with an immediate reduction in spine x-ray claims. Sensitivity analysis suggests our results are robust. This passive strategy is likely cost-effective in a chiropractic network setting.
These findings are encouraging because they suggest that at least some chiropractors are capable of learning, even if this means altering their practice against their financial interests – after all, there is money to be earned with x-ray investigations! At the same time, the results indicate that, despite sound evidence, chiropractors still order far too many x-rays for non-specific back pain. I am not aware of any recent UK data on chiropractic x-ray usage, but judging from old evidence, it might be very high.
It would be interesting to know why chiropractors order spinal x-rays for patients with non-specific back pain or other conditions. A likely answer is that they need them for the diagnosis of spinal ‘subluxations’. To cite just one of thousands of chiropractors with the same opinion: spinography is a necessary part of the chiropractic examination. Detailed analysis of spinographic film and motion x-ray studies helps facilitate a specific and timely correction of vertebral subluxation by the Doctor of Chiropractic. The correction of a vertebral subluxation is called: Adjustment.
This, of course, merely highlights the futility of this practice: despite the fact that the concept is still deeply engrained in the teaching of chiropractic, ‘subluxation’ is a mystical entity or dogma which “is similar to the Santa Claus construct”, characterised by a “significant lack of evidence to fulfil the basic criteria of causation”. But even if chiropractic ‘subluxation’ were real, it would not be diagnosable with spinal x-ray investigations.
The inescapable conclusion from all this, I believe, is that the sooner chiropractors abandon their over-use of x-ray studies, the better for us all.
Even relatively well-informed people tend to think that homeopathy might be quirky and useless but, so what, it cannot do any harm. This is perhaps true for the homeopathic remedies but it does certainly not apply to the homeopaths. As soon as there is a public health problem, homeopaths claim that their approach offers a solution – never mind the evidence to the contrary. Just look at what they presently try to sell us in terms of cold and flu treatments!
The often criminal fight of homeopaths against public health is nowhere clearer than with their never-ending propaganda against the most successful public health measure in the history of medicine, immunisation. Some professional organisations of homeopathy have issued politically correct statements about this and thus feel they are out of the firing line. But, as far as I can see, most homeopaths are against vaccinations. Their arguments are wilfully misguided; here are just a few examples:
- It is well known that measles is an important development milestone in the life and maturing processes in children. Why would anybody want to stop or delay the maturation processes of children and of their immune systems?
- Homoeopathy offers an option for disease prevention and cure. There is scientific evidence in favour of homoeopathy for prevention of diseases.
- Seek out homeopathic, osteopathic, naturopathic, or Chinese medical constitutional treatment to boost your child’s immune system and help them be as healthy as they can be.
- If your children do get sick, use homeopathy to help their immune system get over it. Homeopathy is very effective in epidemics of acute illness. Either see a homeopath, buy a book on homeopathic acute care, or take a class on acute homeopathic prescribing.
- It is possible to prevent post-vaccination damage by giving the homeopathic dilution of the vaccine shortly before and after the vaccination in the C200 dilution.
- there are many recorded cases of people making dramatic recoveries with homeopathic medicines following a bad reaction to a vaccination. Expert advice from a registered homeopath is usually required.
- As you would keep your children away from toxic chemicals in the environment as much as possible, inform yourself about the toxicity of the solutions that are being injected into their bloodstream. It’s up to you to find the information: no one loves your children the way you do.
If you think I cherry-picked these quotes, you are mistaken. I simply used the citations as they appeared on my computer screen after a simple Google search. You might try this yourself because there are hundreds, if not thousands more to be discovered.
A typical and interesting example of a homeopathic anti-vaccinationist is Oksana Frolov, D.Hom. graduate of Saint Petersburg, Russia, I.P.Pavlov State Medical University, General Medicine, and graduate of Los Angeles School of Homeopathy. She states that, although I do hold a medical degree, I am not a licensed medical health provider in the United States. As a homeopathic practitioner, I will provide you with the treatment which is alternative or complementary to healing arts that are licensed by the State of California. On her blog, she provides detailed advice for people who might be uncertain whether to vaccinate their children: immunisation… can cause some very serious side effects including permanent brain damage, epilepsy, autism, and mental retardation. With so many vaccinations being required, doctors often have to administer several shots at a time, which can often result in a disaster. Vaccines, along with the elements that are supposed to create the antibodies, also contain mercury, aluminum, formaldehyde, animal tissue, animal blood, human cell from aborted babies, potatoes, yeast, lactose, phenol, antibiotics and unrelated species of germs that inadvertently get into the vaccines. Do you really want all this to be injected into your child just to prevent him or her from having a chicken pox? Vaccines are said to work by stimulating the body to produce antibodies, which are supposed to protect us from an invasion of harmful germs. Childhood diseases, such as measles, mumps, rubella and chicken pox, affect the immune system in a way that makes most people immune to them for the rest of their lives. Vaccinations, on the other hand, create an artificial immunity that wears off and allows the person to catch the disease later in life….
Homeopathy has proved to be very effective in treatment of childhood diseases, as well as other infections. From its earliest days, homeopathy has been able to treat epidemic disease, such as cholera, typhus, yellow fever, and diphtheria, with a substantial rate of success, when compared to conventional treatments.
Doctors who practice homeopathy usually claim that only non-medically qualified homeopaths hold such deranged views. Dr Frolov shows us that this assumption is clearly not true. In my experience, most homeopaths, medical or not, advise their patients against immunizations or are at least very cagey about this subject in order to raise doubts in concerned parents. Professional organisations of homeopaths usually hide behind some powerless statement in favour of informed choice; yet they must be well-aware that many of their members fail to abide by it. And what do they do about it? Nothing!
Yes, I am afraid the fight of many homeopaths against public health is active, incessant and often criminal. Of course, they do not for one second believe that they are doing anything wrong; on the contrary, they are convinced of their good intentions. As Bert Brecht once wrote, THE OPPOSITE OF GOOD IS NOT EVIL, BUT GOOD INTENTIONS.
Having disclosed in my previous post that, on 1 October, I have been in full-time alternative medicine research for exactly 20 years, I thought it might be interesting to briefly reflect on these two decades. One thing I ought to make clear from the beginning: I truly enjoy my work (well, ~90% of it anyway). When I came to Exeter, I never expected it to get so fascinating, and I am surprised to see how it gripped me.
A PERIOD OF TWO HALVES
One could divide these two decades in two periods of roughly equal length. The first half was characterised by defining my aims, assembling a team, getting the infrastructure sorted and doing plenty of research. I had made it very clear from the beginning that I was not going to promote alternative medicine; my aim was to critically evaluate it. Once I realised how controversial and high profile some of our work could become, I made a conscious effort to keep out of any disputes and tried to avoid the limelight. I wanted to first do my ‘homework’, analyse the evidence, produce own results and be quite sure of my own position before I entered into any public controversies. During this time, we therefore almost exclusively published in medical journals, lectured to medical audiences and generally kept as low a public profile as possible.
The second half was characterised by much more research and my increasing willingness to stick my head out and stand up publicly for the findings I had reasons to be confident about. The evidence had reached a point where it was simply no longer possible nor ethical to keep silent. I felt we had a moral duty to speak up and present the evidence clearly; and that often meant going public: after all, alternative medicine is an area where the public often make the therapeutic decisions without consulting a health care professional – so they need accurate and reliable information. Therefore, I began publishing in the daily papers, lecturing to lay audiences more regularly and addressing the public in many other ways.
THE PLEASURE OF SUPPORTING YOUNG SCIENTISTS
One of the most gratifying aspects of directing a research team is to meet and befriend scientists from all over the world. When several independent analyses had shown that our team had grown into the most productive research unit in alternative medicine worldwide, we started receiving numerous requests from young scientists across the globe to join us. Many of those individuals later went back to their home countries to occupy key positions in research. Our concept of critical evaluation thus spread around the world – at least this is what I hope when I feel optimistic about our achievements.
Amongst the ~90 staff who have worked with me during the last 20 years, we had many enthusiastic and gifted scientists. I owe thanks to all of those who advanced our research and helped us to make progress through critical evaluation. Unfortunately, we also had a few co-workers who, despite of our best efforts, proved to be unable of critical thinking, and more than once this created unrest, tension and trouble. When I analyse these cases in retrospect, I realise how quasi-religious belief must inevitably get in the way of good science. If a person is deeply convinced about the value of his/her particular alternative therapy and thus decides to become a researcher in order to prove his/her point, serious problems are unavoidable.
THE THREE MOST IMPORTANT MESSAGES
But generally speaking, my team worked both very well and extremely hard. Perhaps the best evidence for that statement is the fact that we published more than 1000 articles in the peer review literature, including ~30 clinical trials and 300 systematic reviews/meta-analyses. If I had to extract what I consider to be the three the most important messages from these papers, I might make the following points:
- The concepts that underpin alternative treatments are often not plausible and must be assessed critically.
- Most claims made for alternative medicine are unproven and quite a few should be regarded as disproven.
- Very few alternative therapies demonstrably generate more good than harm.
Looking back to those 20 years, I am struck by the frequency with which I encountered intellectual dishonesty and denial of facts and evidence. Medical research, I had previously assumed is a rather dry and unemotional business – not so when it comes to research into alternative medicine! Here it is dominated by people who carry so much emotional baggage that rational analysis becomes the exception rather than the rule.
The disappointment of alternative medicine apologists had been noticeable virtually from the start; they had quickly realised that I was not in the business of promoting quackery. My remit was to test hypotheses, and when you do that, you have to try to falsify them. To those who fail to understand the rules of science – and that is the vast majority of alternative medicine fans – this process can appear like a negative, perhaps even destructive activity. Consequently, some people began to suspect that I was working against their interests. In fact, as a researcher, I had little patience with such people’s petty interests; all I wanted is to do good science, hopefully for the benefit of the patient.
These sentiments grew dramatically during the second decade when I began to go public with the evidence which often failed to confirm the expectations of alternative medicine enthusiasts. To see the truth published in relatively obscure medical journals might have already been tough for them; to see it in the daily papers or hear it on the radio from someone whom they could not easily accuse of incompetence was obviously more than the evangelic believers could take. Their relatively cautious attitude towards our work soon changed into overt aggression, particularly after our book ‘TRICK OR TREATMENT…‘. The second decade was therefore also characterised by numerous attacks, challenges, defamations and conflicts, not least the ‘run ins’ with Prince Charles and his sycophants. Unfortunately, my own University as well as my newly formed Medical School had no stomach for such battles; the top officials of both institutions seemed more concerned about their knighthoods than about defending me against obviously malicious attacks which could only have one aim: to silence me.
But silence they did me not! It is simply not in my character to give up when I know that I have done nothing wrong and fighting ‘the good fight’. On the contrary, each attack merely strengthened my resolve to fight harder for what I knew was right, ethical and necessary. Eventually, my peers became so frustrated with my resilience that they pulled the plug: they stopped all support. This meant my team had to be dismissed and I had to go into early retirement.
Since about a year, I am ‘Emeritus Professor’, a status which has disadvantages (no co-workers to help with the research, no salary) but also important advantages. I can finally speak the truth without fearing that some administrator suffering from acute ‘knighthood starvation syndrome’ is going to try to discipline me for my actions.
This blog, I think, is pretty good evidence for the fact that I continue to enjoy my work in alternative medicine. I cannot promise to do another 20 years but, for the time being, I continue to be research-active and am involved in numerous other activities. Currently I am also writing a book which will provide a full account of those remarkable last 20 years (almost finished but I have no publisher yet) and I am working on the concept of another book that deals with alternative medicine in more general terms. They did not silence me yet, and I do not assume they will soon.
Colonic irrigation is the alternative therapy of celebrities (and those who like to imitate them): they tend to use it for all sorts of ailments, predominantly for loosing weight. And it works! When they have paid for the session, they are relieved of some cash as well as of about half a kilo of body weight. By the time they wake up the next morning, the money is still gone, but the weight is back. This is a most effective method for getting rid of some £s, but NOT an effective way for shedding a few pounds.
Numerous synonyms for colonic irrigation exist, e.g. colonic treatment, colon cleansing, rectal irrigation, colon therapy, colon hydrotherapy, colonic. The treatment is based on the ancient but obsolete theory of ‘autointoxication’, i.e. the body is assumed to poison itself with, ‘autotoxins’ which, in turn, cause various illnesses. So, it is implausible and there is also no evidence to suggest it is effective. But this does not stop professional organisations to make claims which are good for business.
My analysis of the claims made by professional organisations of practitioners of colonic irrigation across the globe aimed at assessing the therapeutic claims made by these institutions. Six such organisations were identified, and the contents of their websites were studied. The results showed that all of the six organisations make therapeutic claims on their websites. Frequently mentioned themes are ‘detoxification’, normalisation of intestinal functions, treatment of inflammatory bowel diseases and body weight reduction. The claims are mostly confined to symptomatic improvements – but there are exceptions, e.g. prevention of bowel cancer or sorting out Irritable Bowel Syndrome ‘once and for all’ . Other therapeutic claims pertain to asthma, menstrual irregularities, circulatory disorders, skin problems, improvement in energy levels and no longer requiring pharmacotherapy. All these claims represent testable hypotheses.
The question therefore arises whether these hypotheses have been tested and, if so, what the results of such investigations suggest? The use of colonic irrigation by alternative practitioners for any indications is not supported by any sound evidence at all. There are simply no trials to show effectiveness. Even worse is the fact that, although touted as safe, colonic irrigation can lead to serious complications.
The conclusion is therefore simple: colonic irrigation is neither demonstrably effective nor safe, and the information supplied by its professional organisations is therefore a significant contributor to the sea of misinformation in the realm of alternative medicine.
One of the most gratifying aspect of my work in Exeter was being able to offer posts to visiting researchers from across the world. Some of these co-workers, after returning to their home countries, became prominent scientists in their own right, and quite a few remained in contact and continued to collaborate with me or with members of my team. In one of these collaborative projects, we wanted to investigate adverse events attributed to traditional medical treatments in the Republic of Korea.
For this purpose, we reviewed adverse events recorded in the Republic of Korea, between 1999 and 2010, by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers’ complaints, were evaluated.
Overall, 9624 records of adverse events were identified. Liver problems after the administration of herbal medicines were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 – mostly infections, cases of pneumothorax and burns – were linked to physical therapies (n = 285) or acupuncture/moxibustion (n = 1104).
We concluded that traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system.
The assumption that alternative treatments are entirely harmless is widespread, not least because it is incessantly promoted via millions of web-site, thousands of books, newspaper articles, VIPs like Prince Charles etc. etc. Consumers are incessantly being told that NATURAL = SAFE. Yet, if we look closely, most alternative treatments are not natural and, as this investigation demonstrates, they are certainly not devoid of risks.
I already see the apologists preparing to comment that, compared to conventional therapies, alternative treatments are very safe. So let me pre-empt this fallacy by pointing out (yet again) that 1) in the absence of adequate surveillance systems, nobody can say how frequent adverse-effects of alternative treatments really are, and that 2) even severe adverse effects can normally be tolerated, if the treatment in question has been shown to be efficacious.
So, instead of commenting on my repeated reports about the risks of alternative medicine, I invite, in fact, I challenge my critics to answer this simple question: For how many alternative therapies is there a well-documented positive risk/benefit balance?
I happen to be convinced that safety issues related to alternative medicine are important - very important, in fact. Therefore I will continue to report on recent publications addressing them – even at the risk of irritating a few of my readers. And here is such a recent publication:
This review, a sequel to one published 10 years ago, is an evaluation of the number and the severity of adverse events (AEs) reported after acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in 6 databases were identified and assessed by two reviewers; no Asian databases were searched and no articles were included which were in languages other than English. 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Three patients died after receiving acupuncture.
A total of 239 of infections associated with acupuncture were reported in 17 countries and regions. Korea reported 162 cases, Canada 33, Hong Kong 7, Australia 8, Japan 5, Taiwan 5, UK 4, USA 6, Spain 1, Ireland 1, France 1, Malaysia 1, Croatia 1, Scotland 1, Venezuela 1, Brazil 1, and Thailand 1. Of 38 organ or tissue injuries, 13 were pneumothoraxes; 9 were central nerve system injuries; 4 were peripheral nerve injuries; 5 were heart injuries; 7 were other injuries. These cases originated from 10 countries: 10 from South Korea, 6 from the USA, 6 from Taiwan, 5 from Japan, 3 from the UK, 2 from Germany, 2 from Hong Kong, 1 from Austria, 1 from Iran, 1 from Singapore, and 1 from New Zealand.
The authors concluded “although serious AEs associated with acupuncture are rare, acupuncture practice is not risk-free. Adequate regulation can even further minimize any risk. We recommend that not only adequate training in biomedical knowledge, such as anatomy and microbiology, but also safe and clean practice guidelines are necessary requirements and should continue to be enforced in countries such as the United States where they exist, and that countries without such guidelines should consider developing them in order to minimize acupuncture AEs.”
When I last wrote about the risks of acupuncture, I discussed a Chinese paper reporting 1038 cases of serious adverse events, including 35 fatalities. I was keen to point out that, due to under-reporting, this might just be the tip of a much bigger iceberg. Subsequently, my inbox was full with hate-mail, and comments such as this one appeared on the blog: “This is tiresome old stuff, and we have to wonder what’s wrong with Ernst that he still peddles his dubious arguments.”
I suspect that I will see similar reactions to this post. It probably does not avert the anger to point out that the authors of the new article are, in fact, proponents of acupuncture. Neither will it cool the temper of acupuncture-fans to stress that the new paper completely ignored the Chinese literature as well as articles not published in English; this means that the 1038 Chinese cases (and an unknown amount published in other languages; after all, there might be a lot of published material in Japanese, Korean or other Asian languages) would need adding to the published 308 cases summarised in the new article; and this, in turn, means that the numbers provided here are not even nearly complete. And finally, my re-publishing the conclusions from my previous post is unlikely to apease many acupuncture-enthusiasts either:
True, these are almost certainly rare events – but we have no good idea how rare they are. There is no adverse event reporting scheme in acupuncture, and the published cases are surely only the tip of the ice-berg. True, most other medical treatments carry much greater risks! And true, we need to have the right perspective in all of this!
So let’s put this in a reasonable perspective: with most other treatments, we know how effective they are. We can thus estimate whether the risks outweigh the benefit, and if we find that they do, we should (and usually do) stop using them. I am not at all sure that we can perform similar assessments in the case of acupuncture.
Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.
Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus inert interventions, sham SMT, other interventions, and for SMT as an adjunct to other forms of treatment.
The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.
The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”
In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”
This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.
Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.
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.
As I have mentioned before, I like positive news as much as the next person. Therefore, I am constantly on the look-out for recently published, sound evidence suggesting that some form of alternative medicine is effective and safe for this or that condition. This new systematic review fits that description, I am pleased to report.
Its authors evaluated the effectiveness of massage therapy (MT) for neck and shoulder pain. Their extensive literature searches identified 12 high-quality studies. The meta-analyses showed significant effects of MT for neck pain and shoulder pain compared to inactive therapies. MT did not yield better effects for neck pain or shoulder pain than other active therapies administered to the control groups. Shoulder function was not significantly affected by MT. The authors concluded that “MT may provide immediate effects for neck and shoulder pain. However, MT does not show better effects on pain than other active therapies. No evidence suggests that MT is effective in functional status”.
Massage therapy is thus a promising treatment, particularly as this systematic review is by no means the only piece of encouraging evidence. It is not better than other effective treatments, but it is not associated with frequent or serious adverse effects. This means that the demonstrable benefits are likely to outweigh its risks; in other words, the risk benefit balance is positive. Regular readers of this blog will appreciate the importance of this point.
Massage is practiced by several professions: mostly, of course, by massage therapists, but occasionally also by nurses, osteopath, chiropractors etc. Chiropractors, in particular, have recently tried to make much - I think too much - of this fact. They tend to claim that, as they use treatments which are evidence-based, such as massage, chiropractic is an evidence-based profession. I think this is akin to surgeons claiming that all of surgery is evidence-based because surgeons use medications which effectively reduce post-operative pain. Chiropractors foremost employ spinal manipulation and surgeons foremost use surgery; if they want us to believe that their practice is evidence-based, they need to show us the evidence for their hall-mark interventions. In the case of surgery, the evidence is mostly established; in the case of chiropractic, it is mostly not.
Massage is backed by reasonably sound evidence not just for neck and shoulder pain but for a range of other conditions as well. WHAT DO WE CALL AN ALTERNATIVE MEDICINE THAT WORKS? WE CALL IT MEDICINE!
So why is massage not a mainstream therapy? The answer is simple: in many countries, massage therapy has long been considered to be entirely conventional. Twenty years ago, I was chair of rehabilitation medicine at the university of Vienna. Amongst my staff, there always were about 5-8 full time massage therapists and nobody thought this to be unusual in any way. Similarly, in Germany, massage is entirely conventional.
Perhaps it is time that the English-speaking countries catch up with Europe when it comes to massage therapy and the evidence that supports it?