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.
Many cancer patients use some form of complementary and alternative medicine (CAM), mostly as an adjunct to conventional cancer therapies to improve the symptoms of the disease or to alleviate the side-effects of the often harsh cancer-therapy. The hope is that this approach leads to less suffering and perhaps even longer survival – but is this really so?
In a recently published study, Korean researchers evaluated whether CAM-use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. From July 2005 to October 2006, they prospectively studied a cohort study of 481 cancer patients. During a follow-up of 163.8 person-years, they identified 466 deceased patients. Their multivariate analyses of these data showed that, compared with non-users, CAM-users did not have better survival. Using mind-body interventions or prayer was even associated with significantly worse survival. CAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that “CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.”
Most proponents of CAM would find this result counter-intuitive and might think it is a one-off coincidental result or a fluke. But, in fact, it is not; similar data have been reported before. For instance, a Norwegian study from 2003 examined the association between CAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients used CAM. During the follow-up period, 350 patients died. Death rates were higher in CAM-users (79%) than in those who did not use CAM (65%). The hazard ratio of death for CAM-use compared with no use was 1.30. The authors of this paper concluded that “use of CAM seems to predict a shorter survival from cancer.”
I imagine that, had the results been the opposite (i.e. showing that CAM-users live longer and have a better quality of life), most CAM-enthusiasts would not have hesitated in claiming a cause effect relationship (i.e. that the result was due to the use of alternative medicine). Critical thinkers, however, are more careful, after all, correlation is not causation! So, how can these findings be explained?
There are, of course, several possibilities, for example:
1) Some patients might use ineffective alternative therapies instead of effective cancer treatments thus shortening their life and reducing their quality of life.
2) Other patients might employ alternative treatments which cause direct harm; for this, there are numerous options; for instance, if they self-medicate St John’s Wort, they would decrease the effectiveness of many mainstream medications, including some cancer drugs.
3) Patients who elect to use alternative medicine as an adjunct to their conventional cancer treatment might, on average, be more sick than those who stay clear of alternative medicine.
The available data do not allow us to say which explanation applies. But things are rarely black or white, and I would not be surprised, if a complex combination of all three possibilities came closest to the truth.
Chiropractors have become (in)famous for making claims which contradict the known facts. One claim that we find with unfailing regularity is that “regular chiropractic treatments will improve your quality of life“. There are uncounted websites advertising this notion, and most books on the subject promote it as well, some are even entirely dedicated to the theme. Here is a quote from a typical quote from one site chosen at random: “Quality of life chiropractic care is the pinnacle of chiropractic care within the chiropractic paradigm. It does not solely rely on pain or postural findings, but rather on how a persons life can be positively influenced through regular adjustments… A series of regular adjustments is programmed and continual advice on life improvement is given. It is designed as a long term approach and gains its strength from the regularity of its delivery.”
Given the ubiquitous nature of such claims, and given the fact that many chiropractic clients have back problems which reduce their quality of life, and given that back pain is just about the only condition for which chiropractors might have something to offer, it seems relevant to ask the following question: what is the evidence that chiropractic interventions affect the quality of life of back pain sufferers?
Some time ago, an Italian randomised clinical trial compared chiropractic spinal manipulations with sham-manipulations in patients affected by back pain and sciatica. Its results were disappointing and showed “no significant differences in quality of life and psychosocial scores.” But this is just one (potentially cherry-picked) study, I hear my chiropractic friends object. What we quite clearly need, is someone who takes the trouble to evaluate the totality of the available evidence.
Recently, Australian researchers published a review which did just that. Its authors conducted thorough literature searches to find all relevant studies on the subject. Of the 1,165 articles they located, 12 investigations of varying quality were retained, representing 6 studies, 4 randomised clinical trial and two observational studies. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of additional treatments as a positive outcome; two studies reported a positive effect of chiropractic interventions on pain, and two studies reported a positive effect on disability. The 6 studies reviewed concentrated on the impact of chiropractic care on physical health and disability, rather than the wider holistic view which was the focus of the review. On the basis of this evidence, the authors conclude that “it is difficult… to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.”
What should we make of all this? I don’t know about you, but I fear the notion that chiropractic improves the quality of life of back pain patients is just another of these many bogus assumptions which chiropractors across the globe seem to promote, advertise and make a living from.
Reiki is a form of healing which rests on the assumption that some form ”energy” determines our health. In this context, I tend to put energy in inverted commas because it is not the energy a physicist might have in mind. It is a much more mystical entity, a form of vitality that is supposed to be essential for life and keep us going. Nobody has been able to define or quantify this “energy”, it defies scientific measurement and is biologically implausible. These circumstances render Reiki one of the least plausible therapies in the tool kit of alternative medicine.
Reiki-healers (they prefer to be called “masters”) would channel “energy” into his or her patient which, in turn, is thought to stimulate the healing process of whatever condition is being treated. In the eyes of those who believe in this sort of thing, Reiki is therefore a true panacea: it can heal everything.
The clinical evidence for or against Reiki is fairly clear – as one would expect after realising how ‘far out’ its underlying concepts are. Numerous studies are available, but most are of very poor quality. Their results tend to suggest that patients experience benefit after having Reiki but they rarely exclude the possibility that this is due to placebo or other non-specific effects. Those that are rigorous show quite clearly that Reiki is a placebo. Our own review therefore concluded that “the evidence is insufficient to suggest that Reiki is an effective treatment for any condition… the value of Reiki remains unproven.”
Since the publication of our article, a number of new investigations have become available. In a brand-new study, for instance, the researchers wanted to explore a Reiki therapy-training program for the care-givers of paediatric patients. A series of Reiki training classes were offered by a Reiki-master. At the completion of the program, interviews were conducted to elicit participant’s feedback regarding its effectiveness.
Seventeen families agreed to participate and 65% of them attended three Reiki training sessions. They reported that Reiki had benefited their child by improving their comfort (76%), providing relaxation (88%) and pain relief (41%). All caregivers thought that becoming an active participant in their child’s care was a major gain. The authors of this investigation conclude that “a hospital-based Reiki training program for caregivers of hospitalized pediatric patients is feasible and can positively impact patients and their families. More rigorous research regarding the benefits of Reiki in the pediatric population is needed.”
Trials like this one abound in the parallel world of “energy” medicine. In my view, such investigations do untold damage: they convince uncritical thinkers that “energy” healing is a rational and effective approach – so much so that even the military is beginning to use it.
The flaws in trials as the one above are too obvious to mention. Like most studies in this area, this new investigation proves nothing except the fact that poor quality research will mislead those who believe in its findings.
Some might say, so what? If a patient experiences benefit from a bogus yet harmless therapy, why not? I would strongly disagree with this increasingly popular view. Reiki and similarly bizarre forms of ”energy” healing are well capable of causing harm.
Some fanatics might use these placebo-treatments as a true alternative to effective therapies. This would mean that the condition at hand remains untreated which, in a worst case scenario, might even lead to the death of patients. More important, in my view, is an entirely different risk: making people believe in mystic “energies” undermines rationality in a much more general sense. If this happens, the harm to society would be incalculable and extends far beyond health care.
Today, one day after a homeopathic retailer made headlines for advocating homeopathy as a treatment of measles, is the start of WORLD HOMEOPATHY AWARENESS WEEK. This is an ideal occasion, I think, for raising awareness of the often lamentably poor research that is being conducted in this area.
We have already on this blog discussed some rather meaningless research by Boiron, the world’s largest manufacturer of homeopathic preparations. I concluded my post by asking: “what can possibly be concluded from this article that is relevant to anyone? I did think hard about this question, and here is my considered answer: nothing (other than perhaps the suspicion that homeopathy-research is in a dire state)”. Now a new article has become available which sheds more light on those issues.
With this prospective observational study, the Boiron researchers wanted to determine the ”characteristics and management of patients in France consulting allopathic general practitioners (AGPs) and homeopathic general practitioners (HGPs) for influenza-like illness (ILI)”. The investigation was conducted in Paris during the 2009-2010 influenza season. Sixty-five HGPs and 124 AGPs recruited a total of 461 patients with ILI. All the physicians and patients completed questionnaires recording demographic characteristics as well as patients’ symptoms.
Most AGPs (86%), and most patients consulting them (58%) were men; whereas most HGPs (57%), and most patients visiting them (56%) were women. Patients consulting AGPs were seen sooner after the onset of symptoms, and they self-treated more frequently with cough suppressants or expectorants. Patients visiting HGPs were seen later after the onset of symptoms and they self-treated with homeopathic medications more frequently.
At enrollment, headaches, cough, muscle/joint pain, chills/shivering, and nasal discharge/congestion were more common in patients visiting AGPs. 37.1% of all patients consulting AGPs were prescribed at least one homeopathic remedy, and 59.6% of patients visiting HGPs were prescribed at least one conventional medication. Patients’ satisfaction with their treatments did not differ between AGPs and HGPs; it was highest for the sub-group of patients who had been treated exclusively with homeopathy.
The authors draw the following conclusions from these data: In France, homeopathy is widely accepted for the treatment of ILI and does not preclude the use of allopathic medications. However, patients treated with homeopathic medications only are more satisfied with their treatment than other patients.
This type of article, I think, falls into the category of promotion rather than science; it seems to me as though the investigation was designed not by scientists but by Boiron’s marketing team. The stated aim was to determine the “characteristics and management of patients…“, yet the thinly disguised true purpose is, I fear, to show that patients who receive homeopathic treatment are satisfied with this approach. I have previously pointed out that such findings are akin to demonstrating that people who elect to frequent a vegetarian restaurant tend to not like eating meat. Patients who want to consult a homeopath also want homeopathy; consequently they are happy when they get what they wanted. This is not rocket science, in fact, it is not science at all.
But what about the impressive acceptance of homeopathic remedies by French non-homeopathic doctors? It would, of course, be an ’argumentum ad populum’ fallacy [which implies that 'generally accepted' equals 'effective'] to assume that this proves the value of homeopathy. Yet this finding nevertheless requires an explanation: why did these doctors chose to employ homeopathy? Was it because they knew it worked? I doubt it! In my view, there are other, more plausible reasons: perhaps their patients asked for or even insisted on it; perhaps they felt that this is better than causing bacterial resistance by prescribing an antibiotic for a viral infection?
While I find this study as useless as the one I previously discussed on this blog, and while I fear that it confirms the all too often doubtful quality of research in this area, it might nevertheless contain a tiny item of interest. The authors report that “at enrollment, headaches, cough, muscle/joint pain, chills/shivering, and nasal discharge/congestion were more common in patients visiting AGPs”. In plain English, this strongly suggests that patients who decide to consult a homeopath are less ill than those who go to see a conventional doctor.
Does that mean that a certain group of individuals frequent homeopaths only when they are not really very sick? Does that indicate that even enthusiasts do not trust homeopathy all that far? Is that perhaps similar to out Royal family who seem to consult real doctors and surgeons when they are truly ill, while keeping a homeopath on stand-by for the rest of the time? These might be relevant research questions for the future; somehow I doubt, however, that the guys in charge of Boiron will ever address them.
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.
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?
Reflexology is one of the most popular of all alternative therapies. Anyone who has ever had a session knows why: it is a strangely pleasant and oddly agreeable experience. Reflexologists massage your feet which can be mildly painful but usually is quite relaxing. They look for and subsequently focus on areas of tenderness believing they correspond to specific organs or whole organ systems. Even though few reflexologists would admit to it, they tend to make vague and unreliable diagnoses: if they feel something unusual at a certain point of the sole of your foot, they assume that a certain inner organ is in trouble. Reflexologists even have maps where the sole of a foot is depicted showing which area corresponds to which organ.
The treatment might be enjoyable but the assumptions that underpin it are nonsensical for at least two reasons: firstly, there are no nerve or other connections between a specific area on the sole of a foot and a certain organ. Secondly, the maps which reflexologists employ differ and fail to agree which area corresponds to which organ. Thus there are inconsistencies within the realm of reflexology and there are inconsistencies in relation to the known facts regarding physiology, anatomy etc.
Proponents of reflexology are quite undisturbed by these problems and seem to believe that not their assumptions but science must be wrong. After all, reflexology does work! That is to say that patients perceive benefit from it, pay out of their own pocket for the experience and tend to come back for more.
Several years ago, we asked 8 UK professional organisations of reflexology which conditions they thought could be treated effectively with reflexology. We gave them a list of 25 conditions to chose from, many of which were serious, e.g. cancer and AIDS. Collectively, the organisations felt that 22 of these illnesses would respond to reflexology.
But this is opinion, not evidence! What do the trial data tell us? Is reflexology more than a placebo?
As with many other areas of alternative medicine, controlled clinical trials are scarce; but this is not to say that none at all are available. Our own trial of reflexology for menopausal symptoms failed to show that this therapy has any effects beyond placebo. More recently, we published a systematic review to evaluate all of the 23 studies that had been published at that stage. They related to a wide range of medical conditions and their methodological quality was often poor. Nine high quality randomised clinical trials (RCTs) generated negative findings. Eight RCTs suggested that reflexology is effective for the following conditions: diabetes, premenstrual syndrome, cancer patients, multiple sclerosis, symptomatic idiopathic detrusor over-activity and dementia. These studies, however, were wide open to bias. Therefore, our conclusions had to be cautious: the best clinical evidence does not demonstrate convincingly reflexology to be an effective treatment for any medical condition.
For you and me, this simply means that there is currently no good evidence to suggest that reflexology works. But the story does not end here. There will be more studies and enthusiasts are most likely to concede that our conclusions were incorrect. In fact, a further trial has just become available.
This new single-blind, randomized and placebo controlled study included 20 moderately to severely affected multiple sclerosis patients. Each participant received for 8 weeks, 1 hour per week of either reflexology or sham reflexology. The primary outcome measure was the Multiple Sclerosis Impact Scale at baseline, 8 weeks and 16 weeks. The results revealed improvements in both groups but no statistically significant differences between the two groups at either 8 or 16 weeks. The conclusions of the investigators were clear: The results do not support the use of reflexology for symptom relief in a more disabled multiple sclerosis population and are strongly suggestive of a placebo response.
There is, of course, nothing wrong with a relaxing foot-massage; it is agreeable, no doubt, and if someone wants to pay for the luxury, why not? By contrast, there is a lot wrong with reflexology, I think. A foot-massage is not administered under the pretence of generating any specific therapeutic effects. Reflexologists, however, claim they can exert highly specific effects on inner organs, influence the natural history of a wide range of diseases, and provide reliable diagnoses. They thus mislead their clients. This is not just wrong, it also has the potential to do serious harm. I believe it is time to end this nonsense.
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.