MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

Australian researchers wanted to know whether acupuncture is effective for alleviating the symptoms of fibromyalgia, a common painful condition for which no universally accepted treatment exists. For this purpose, they conducted a Cochrane review. After extensive literature searches, they identified 9 RCTs, extracted their data and assessed risk of bias.

The results show that all studies except one were at low risk of selection bias; five were at risk of selective reporting bias; two were subject to attrition bias (favouring acupuncture); three were subject to performance bias (favouring acupuncture) and one to detection bias (favouring acupuncture).

Three studies utilised electro-acupuncture (EA) and the remainder manual acupuncture (MA) without electrical stimulation.

Low quality evidence from one study (13 participants) showed EA improved symptoms with no adverse events at one month following treatment.

Moderate quality evidence from six studies (286 participants) indicated that acupuncture (EA or MA) was no better than sham acupuncture, except for less stiffness at one month. Subgroup analysis of two studies (104 participants) indicated benefits of EA. Mean pain was 70 points on 0 to 100 point scale with sham treatment; EA reduced pain by 13% (5% to 22%).

Low-quality evidence from one study suggested that MA resulted in poorer physical function: mean function in the sham group was 28 points (100 point scale); treatment worsened function by a mean of 6 points.

Moderate quality evidence from one study (58 participants) found that, compared with standard therapy alone (antidepressants and exercise), adjunct acupuncture therapy reduced pain at one month after treatment.

Low quality evidence from one study (38 participants) showed a short-term benefit of acupuncture over antidepressants in pain relief.

Moderate-quality evidence from one study (41 participants) indicated that deep needling with or without deqi did not differ in pain, fatigue, function or adverse events.

Four studies reported no differences between acupuncture and control or other treatments described at six to seven months follow-up.

No serious adverse events were reported, but there were insufficient adverse events to be certain of the risks.

The authors draw the following conclusions: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.

What does all that mean? In my view, it means that there is no sound evidence base for acupuncture as a treatment of fibromyalgia – or as we expressed it in our own systematic review of 2007: The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia.

In a recent comment, US chiropractors stated that there is a growing recognition within the profession that the practicing chiropractor must be able to do the following: formulate a searchable clinical question, rapidly access the best evidence available, assess the quality of that evidence, determine if it is applicable to a particular patient or group of patients, and decide if and how to incorporate the evidence into the care being offered. In a word, they believe, that evidence-based chiropractic is possible, perhaps even (almost) a reality. For evidence-based practice to penetrate and transform a profession, the penetration must occur at two levels, they explain. One level is the degree to which individual practitioners possess the willingness and basic skills to search and assess the literature.

The second level, the authors explain, relates to whether the therapeutic interventions commonly employed by a particular health care discipline are supported by clinical research. The authors believe that a growing body of randomized controlled trials provides evidence of the effectiveness and safety of manual therapies. Is this really true, I wonder.

In support of these fairly bold statements, they cite a paper by Bronfort et al which, in their view, is currently the most comprehensive review of the evidence for the efficacy of manual therapies. According to these authors, the ‘Bronfort-report’ stated that evidence is inconclusive for pneumonia, stage 1 hypertension, pre-menstrual syndrome, nocturnal enuresis, and otitis media. The authors also believe that it is unlikely manipulation of the neck is causally related to stroke.

When I read this article, I could not stop myself from giggling. It seems to me that it provides pretty good evidence for the fact that the chiropractic profession is nowhere near reaching the stage where anyone could reasonably claim that chiropractors practice evidence-based medicine – not even the authors themselves seem to abide by the rules of evidence-based medicine! If they had truly been able to access the best evidence available and assess the quality of that evidence surely they would not have (mis-) quoted the ‘Bronfort-report’.

Bronfort’s overview was commissioned by the General Chiropractic Council, it was hastily compiled by ardent believers of chiropractic, published in a journal that non-chiropractors would not touch with a barge pole, and crucially it lacks some of the most important qualities of an unbiased systematic review. In my view, it is nothing short of a white-wash and not worth the paper it was printed on. Conclusions, such as the evidence regarding pneumonia, bed-wetting and otitis is inconclusive are just embarrassing; the correct conclusion is that the evidence fails to be positive for these and most other indications.

Similarly, if the authors had really studied and quoted the best evidence, how on earth could they have stated that manipulation of the neck cannot cause a stroke? The evidence for that is fairly overwhelming, and the only open question here is, how often do such complications occur? And even the biased ‘Bronfort-report’ states: Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation (specifically to the cervical spine) is vertebrobasilar artery (VBA) stroke. Less commonly reported are serious adverse events associated with lumbar spine manipulation, including lumbar disc herniation and cauda equina syndrome.

Evidence-based practice? Who are these chiropractors kidding? This article very neatly reflects the exact opposite. It ignores hundreds of peer-reviewed papers which are critical of chiropractic. The best one can do with this paper, I think, is to use it as a hilarious bit of involuntary humour or as a classic example of cherry-picking.

Come to think of it, chiropractic and evidence-based practice are contradictions in terms. Either a therapist claims to adjust mystical subluxations, in which case he/she does not practice evidence-based medicine. Or he/she practices evidence-based medicine, in which case adjusting mystical subluxations cannot be part of their therapeutic repertoire.

Towards the end of the article, we learn further fascinating things: the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article – oh, really?!?! Furthermore, we are told that this ‘research’ was funded by the ‘National Center of Complementary and Alternative Medicine’ (NCCAM) of the National Institutes of Health.

Can it be true? Does the otherwise most respectable NIH really give its name for such overt nonsense? Yes, it is true, and it is by no means the first time. In fact, our analysis shows that, when it comes to chiropractic, this organisation has sponsored almost nothing but utter rubbish, and our conclusion was blunt: the criticism repeatedly aimed at NCCAM seems justified, as far as their RCTs of chiropractic is concerned. It seems questionable whether such research is worthwhile.

The NHS tells us that our “choices include more than just which GP or hospital to use. You also have choices about your treatment decisions…”  In most other countries, similarly confusing statements about PATIENT CHOICE are being made almost on a daily basis, often by politicians who have more ambition to win votes than to understand the complex issues at hand. Consequently, patients and consumers might be forgiven to assume that PATIENT CHOICE means we are all invited to indulge in the therapy we happen to fancy, while society foots the bill. Certainly, proponents of alternative medicine are fond of the notion that the principle of PATIENT CHOICE provides a ‘carte blanche’ for everyone who wants it to have homeopathy, Reiki, Bach Flower Remedies, crystal healing, or other bogus treatments – paid for, of course, by the taxpayer.

Reality is, however, very different. Anyone who has actually tried to choose his/her hospital will know that this is far from easy. And deciding what treatment one might employ for this or that condition is even less straight forward. Choice, it turns out, is a big word, but often it is just that: a word.

Yet politicians love their new mantra of PATIENT CHOICE; it is politically correct as it might give the taxpayer the impression that he/she is firmly installed in the driving seat. Consequently PATIENT CHOICE has become a slogan that is used to score points in public debates but that, in fact, is frequently next to meaningless. More often than not, the illusion of being in control has to serve as a poor substitute for actually being in control.

To imply that patients should be able to choose their treatment has always struck me as a little naïve, particularly in the way this is often understood in the realm of alternative medicine. Imagine you have a serious condition, say cancer: after you have come over the shock of this diagnosis, you begin to read on the Internet and consider your options. Should you have surgery or faith healing, chemotherapy or homeopathy, radiotherapy or a little detox?

Clearly PATIENT CHOICE, as paid for by society, cannot be about choosing between a realistic option and an unrealistic one. It must be confined to treatments which have all been shown to be effective. Using scarce public funds for ineffective treatments is nothing short of unethical. If, for a certain condition, there happen to be 10 different, equally effective and safe options, we may indeed have a choice. Alas, this is not often the case. Often, there is just one effective treatment, and in such instances the only realistic choice is between accepting or rejecting it.

And, anyway, how would we know that 10 different treatments are equally effective and safe? After going on the Internet and reading a bit about them, we might convince ourselves that we know but, in fact, very few patients have sufficient knowledge for making complex decisions of this nature. We usually need an expert to help us. In other words, we require our doctor to guide us through this jungle of proven benefits and potential risks.

Once we accept this to be true, we have arrived at a reasonable concept of what PATIENT CHOICE really means in relation to deciding between two or more treatments: the principle of shared decision making. And this  is a  fundamentally different concept from the naïve view of those alternative medicine enthusiasts who promote the idea that PATIENT CHOICE opens the door to opting for any unproven or disproven pseudo-therapy.

To be meaningful, ethical and responsible, choice needs to be guided by sound evidence – if not, it degenerates into irresponsible arbitrariness, and health care deteriorates into some kind of Russian roulette. To claim, as some fans of alternative medicine do, that the principle of PATIENT CHOICE gives everyone the right to use unproven treatments at the expense of the taxpayer is pure nonsense. But some extreme proponents of quackery go even further; they claim that the discontinuation of payment for treatments that have been identified as ineffective amounts to a dangerous curtailment of patients’ rights. This, I think, is simply a cynical attempt to mislead the public for the selfish purpose of profit.

A cult can be defined not just in a religious context, but also as a” usually nonscientific method or regimen claimed by its originator to have exclusive or exceptional power in curing a particular disease.” After ~20 years of researching this area, I have come to suspect that much of alternative medicine resembles a cult – a bold statement, so I better explain.

One characteristic of a cult is the unquestioning commitment of its members to the bizarre ideas of their iconic leader. This, I think, chimes with several forms alternative medicine. Homeopaths, for instance, very rarely question the implausible doctrines of Hahnemann who, to them, is some sort of a semi-god. Similarly, few chiropractors doubt even the most ridiculous assumptions of their founding father, D D Palmer who, despite of having been a somewhat pathetic figure, is uncritically worshipped. By definition, a cult-leader is idealised and thus not accountable to anyone; he (yes, it is almost invariably a male person) cannot be proven wrong by logic arguments nor by scientific facts. He is quite simply immune to any form of scrutiny. Those who dare to disagree with his dogma are expelled, punished, defamed or all of the above.

Cults tend to brain-wash their members into unconditional submission and belief. Likewise, fanatics of alternative medicine tend to be brain-washed, i.e. systematically misinformed to the extend that reality becomes invisible. They unquestioningly believe in what they have been told, in what they have read in their cult-texts, and in what they have learnt from their cult-peers. The effects of this phenomenon can be dramatic: the powers of discrimination of the cult-member are reduced, critical questions are discouraged, and no amount of evidence can dissuade the cult-member from abandoning even the most indefensible concepts. Internal criticism is thus by definition non-existent.

Like religious cults, many forms of alternative medicine promote an elitist concept. Cult-members become convinced of their superiority, based not on rational considerations but on irrational beliefs. This phenomenon has a range of consequences. It leads to the isolation of the cult-member from the rest of the world. By definition, critics of the cult do not belong to the elite; they are viewed as not being able to comprehend the subtleties of the issues at hand and are thus ignored or not taken seriously. For cult-members, external criticism is thus non-existent or invalid.

Cult-members tend to be on a mission, and so are many enthusiasts of alternative medicine. They use any conceivable means to recruit new converts. For instance, they try to convince family, friends and acquaintances of their belief in their particular alternative therapy at every conceivable occasion. They also try to operate on a political level to popularize their cult. They cherry pick data, often argue emotionally rather than rationally, and ignore all arguments which contradict their belief system.

Cult-members, in their isolation from society, tend to be assume that there is little worthy of their consideration outside the cult. Similarly, enthusiasts of alternative medicine tend to think that their treatment is the only true method of healing. Therapies, concepts and facts which are not cult-approved are systematically defamed. An example is the notion of BIG PHARMA which is employed regularly in alternative medicine. No reasonable person assumes that the pharmaceutical industry smells of roses. However, the exaggerated and systematic denunciation of this industry and its achievements is a characteristic of virtually all branches of alternative medicine. Such behaviour usually tells us more about the accuser than the accused.

There are many other parallels between a  cult and alternative medicine, I am sure. In my view, the most striking one must be the fact that any spark of cognitive dissonance in the cult-victim is being extinguished by highly effective and incessant flow of misinformation which often amounts to a form of brain-washing.

A recent post of mine seems to have stimulated a lively discussion about the question IS THERE ANY GOOD EVIDENCE AT ALL FOR OSTEOPATHIC TREATMENTS? By and large, osteopaths commented that they are well aware that their signature interventions for their most frequently treated condition (back pain) lack evidential support and that more research is needed. At the same time, many osteopaths seemed to see little wrong in making unsubstantiated therapeutic claims. I thought this was remarkable and feel encouraged to write another post about a similar topic.

Most osteopaths treat children for a wide range of conditions and claim that their interventions are helpful. They believe that children are prone to structural problems which can be corrected by their interventions. Here is an example from just one of the numerous promotional websites on this topic:

STRUCTURAL  PROBLEMS, such as those affecting the proper mobility and function of the  body’s framework, can lead to a range of problems. These may include:

  • Postural – such as scoliosis
  • Respiratory  – such as asthma
  • Manifestations of brain  injury – such as cerebral palsy and spasticity
  • Developmental  – with delayed physical or intellectual progress, perhaps triggering learning  behaviour difficulties
  • Infections – such  as ear and throat infections or urinary disturbances, which may be recurrent.

OSTEOPATHY can assist in the prevention of health problems, helping children to make a smooth  transition into normal, healthy adult life.

As children cannot give informed consent, this is even more tricky than treating adults with therapies of questionable value. It is therefore important, I think, to ask whether osteopathic treatments of children is based on evidence or just on wishful thinking or the need to maximise income. As it happens, my team just published an article about these issues in one of the highest-ranking paediatrics journal.

The objective of our systematic review was to critically evaluate the effectiveness of osteopathic manipulative treatment (OMT) as a treatment of paediatric conditions. Eleven databases were searched from their respective inceptions to November 2012. Only randomized clinical trials (RCTs) were included, if they tested OMT against any type of control intervention in paediatric patients. The quality of all included RCTs was assessed using the Cochrane criteria.

Seventeen trials met our inclusion criteria. Only 5 RCTs were of high methodological quality. Of those, 1 favoured OMT, whereas 4 revealed no effect compared with various control interventions. Replications by independent researchers were available for two conditions only, and both failed to confirm the findings of the previous studies. Seven RCTs suggested that OMT leads to a significantly greater reduction in the symptoms of asthma, congenital nasolacrimal duct obstruction, daily weight gain and length of hospital stay, dysfunctional voiding, infantile colic, otitis media, or postural asymmetry compared with various control interventions. Seven RCTs indicated that OMT had no effect on the symptoms of asthma, cerebral palsy, idiopathic scoliosis, obstructive apnoea, otitis media, or temporo-mandibular disorders compared with various control interventions. Three RCTs did not report between-group comparisons. The majority of the included RCTs did not report the incidence rates of adverse-effects.

Our conclusion is likely to again dissatisfy many osteopaths: The evidence of the effectiveness of OMT for paediatric conditions remains unproven due to the paucity and low methodological quality of the primary studies.

So, what does this tell us? I am sure osteopaths will disagree, but I think it shows that for no paediatric condition do we have sufficient evidence to show that OMT is effective. The existing RCTs are mostly of low quality. There is a lack of independent replication of the few studies that suggested a positive outcome. And to make matters even worse, osteopaths seem to be violating the most basic rule of medical research by not reporting adverse-effects in their clinical trials.

I rest my case – at least for the moment.

Antioxidant vitamins include vitamin E, beta-carotene, and vitamin C. They are often recommended and widely used for preventing major cardiovascular outcomes. However, the effect of antioxidant vitamins on cardiovascular events remains unclear. There is plenty of evidence but the trouble is that it is not always of high quality and confusingly contradictory. Consequently, it is possible to cherry-pick the studies you prefer in order to come up with the answer you like. That this approach is counter-productive should be obvious to every reader of this blog. Only a rigorous systematic review can provide an answer that is as reliable as possible with the data available to date. Chinese researchers have just published such an assessment.

They searched PubMed, EmBase, the Cochrane Central Register of Controlled Trials, and the proceedings of major conferences for relevant investigations. To be eligible, studies had to be randomized, placebo-controlled trials reporting on the effects of antioxidant vitamins on cardiovascular outcomes. The primary outcome measures were major cardiovascular events, myocardial infarction, stroke, cardiac death, total death, and any adverse events.

The searches identified 293 articles of which 15 RCTs reporting data on 188209 participants met the inclusion criteria. In total, these studies reported 12749 major cardiovascular events, 6699 myocardial infarction, 3749 strokes, 14122 total death, and 5980 cardiac deaths. Overall, antioxidant vitamin supplementation, as compared to placebo, had no effect on major cardiovascular events (RR, 1.00; 95% CI, 0.96-1.03), myocardial infarction (RR, 0.98; 95% CI, 0.92-1.04), stroke (RR, 0.99; 95% CI, 0.93-1.05), total death (RR, 1.03; 95% CI, 0.98-1.07), cardiac death (RR, 1.02; 95% CI, 0.97-1.07), revascularization (RR, 1.00; 95% CI, 0.95-1.05), total CHD (RR, 0.96; 95% CI, 0.87-1.05), angina (RR, 0.98; 95% CI, 0.90-1.07), and congestive heart failure (RR, 1.07; 95% CI, 0.96 to 1.19).

The authors’ conclusion from these data could not be clearer: Antioxidant vitamin supplementation has no effect on the incidence of major cardiovascular events, myocardial infarction, stroke, total death, and cardiac death.

Few subjects in the realm of nutrition have attracted as much research during recent years as did antioxidants, and it is hard to think of a disease for which they are not recommended by this expert or another. Cardiovascular disease used to be the flag ship in this fleet of conditions; not so long ago, even the conventional medical wisdom sympathized with the notion that the regular supplementation of our diet with antioxidant vitamins might reduce the risk of cardiovascular disease and mortality.

Today, the pendulum has swung back, and it now seems to be mostly the alternative scene that still swears by antioxidants for that purpose. Nobody doubts that antioxidants have important biological functions, but this excellent meta-analysis quite clearly and fairly convincingly shows that buying antioxidant supplements is a waste of money. It does not promote cardiovascular health, it merely generates very expensive urine.

According to the UK General Osteopathic Council, osteopathy is a system of diagnosis and treatment for a wide range of medical conditions.  It works with the structure and function of the body, and is based on the principle that the well-being of an individual depends on the skeleton, muscles, ligaments and connective tissues functioning smoothly together.

To an osteopath, for your body to work well, its structure must also work well.  So osteopaths work to restore your body to a state of balance, where possible without the use of drugs or surgery.  Osteopaths use touch, physical manipulation, stretching and massage to increase the mobility of joints, to relieve muscle tension, to enhance the blood and nerve supply to tissues, and to help your body’s own healing mechanisms.  They may also provide advice on posture and exercise to aid recovery, promote health and prevent symptoms recurring.

In case this sounds a bit vague to you, and in case you wonder what this “wide range of conditions” might be, rest assured, you are not alone. So let’s try to be a little more concrete and clear up some of the confusion around this profession. There are two very different types of osteopaths: US osteopaths are virtually identical with conventionally trained physicians; their qualification is equivalent to those of medical practitioners and they can, for instance, specialise to become GPs or neurologists or surgeons etc. Elsewhere, osteopaths are non-medically qualified alternative practitioners. In the UK, they are regulated by statute, in other counties not. And as to the “wide range of conditions”, I am not aware of any disease or symptom for which the evidence is convincing.

Osteopaths most commonly treat patients suffering from Chronic Non-Specific Low Back Pain (CNSLBP) using a set of non-drug interventions, particularly manual therapies such as spinal mobilisation and manipulation. The question is how well are these techniques supported by reliable evidence. To answer it, we must not cherry-pick our evidence but we need to consider the totality of the reliable studies; in other words, we need an up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for CNSLBP was recently published by Australian experts.

A thorough search of the literature in multiple electronic databases was undertaken,  and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested  that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.

I guess, this comes as a bit of a surprise to many consumers who have been told over and over again by osteopaths and their supporters that the evidence is sound. Personally, I am not at all surprised because, two years ago, we published a similar review, albeit with a wider spectrum of conditions, namely any type of musculoskeletal pain. We managed to include a total of 16 RCTs. Five of them suggested that osteopathy leads to a significantly stronger reduction of musculoskeletal pain than a range of control interventions. However, 11 RCTs indicated that osteopathy, compared to controls, generates no change in musculoskeletal pain. At the time, we felt that these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

This lack of convincing evidence is in sharp contrast to the image of osteopaths as back pain specialists. The UK General Osteopathic council, for instance, sates that Osteopaths’ patients include the young, older people, manual workers, office professionals, pregnant women, children and sports people. Patients seek treatment for a wide variety of conditions, including back pain…In addition, thousands of websites try to convince the consumer that osteopathy is a well-proven therapy for chronic low back pain – not to mention the many other conditions for which the evidence is even less sound.

As so often in alternative medicine, these claims seem to be based more on wishful thinking than on reliable evidence. And as so often, the victims of bogus claims are the consumers who are being misled into making wrong therapeutic decisions, wasting money, and delaying recovery from illness.

Lymph oedema in the arms or legs is a frequent complication after lymph-node dissections for cancer. Treatment or prevention can be difficult, and the results  are often unsatisfactory. Consequently, the burden of suffering of cancer patients affected by this problem is immense.

Amongst several options, a little-known massage technique, called lymph-drainage (or lymphatic drainage, LD), is sometimes recommended. It consists of gentle manual movements which lightly push the lymph fluid through the lymphatic vessels that eventually enter into the blood circulation. During a session of lymph-drainage, a specially trained massage therapist lightly moves his or her hands along the lymph vessels to facilitate the lymph flow. The treatment is agreeable and relaxing, but does it really reduce the oedema?

A recent systematic review and meta-analysis of RCTs evaluated the effectiveness of LD in the prevention and treatment of breast-cancer related lymph-oedema. The primary outcome for prevention was the incidence of postoperative lymph-oedema. The outcome for management of  was a reduction in oedema volume.

In total, 10 RCTs with altogether 566 patients were identified. Two studies evaluating the preventive outcome of LD found no significant difference in the incidence of lymph-oedema between the LD and standard treatments. Seven studies assessed the reduction in arm volume, and found no significant difference between the LD and standard treatments.

The authors conclusion was negative about the value of LD: The current evidence from RCTs does not support the use of LD in preventing or treating lymph-oedema. However, clinical and statistical inconsistencies between the various studies confounded our evaluation of the effect of LD on breast-cancer-related lymph-oedema.

Perhaps a brand-new clinical trial which had not been included in the above assessment would have persuaded the authors to be a little more optimistic. This study evaluated the effectiveness of LD in the prevention of lymph-oedema after treatment of breast cancer. The study-population consisted of 67 women, who had undergone surgery for breast cancer. From the second day of surgery, 33 randomly chosen women were given LD. The control group consisted of 34 women who did not receive LD. Measurements of the volumes of both arms were taken before surgery and on days 2, 7, 14, and at 3 and 6 months after surgery.

Among the women who did not have LD, a significant increase in the arm volume on the operated side was observed after 6 month. There was no statistically significant  increase in the volume of the upper limb on the operated side in women who underwent LD.

The authors conclude that regardless of the surgery type and the number of the lymph nodes removed, LD effectively prevented lymph-oedema of the arm on the operated side. Even in high risk breast cancer treatments (operation plus irradiation), LD was demonstrated to be effective against arm volume increase. Even though confirmatory studies are needed, this study demonstrates that LD administered early after operation for breast cancer should be considered for the prevention of lymph-oedema.

So, does LD reduce oedema or not? This does not seem to be such a difficult question that it should take decades to resolve! And who would doubt that it is an important one? Lymph-oedema has the potential to seriously impede the quality of life of many patients, and it can even contribute to unnecessary mortality. The fact that the few available studies are too small and too weak to generate reliable results is disappointing and shines a dim light on the supposedly patient-centred research in oncology, in my view.

The concept of LD is plausible, at least some of the findings from clinical trials are encouraging, and the problem of lymph-oedema is both prevalent and relevant. So what is stopping us from funding a large, well-designed and definitive study?

Ignaz von Peczely (1826-1911), a Hungarian physician, got the idea for iridology (or iris-diagnosis) more than a century ago, after seeing streaks in the iris of a man he was treating for a broken leg, and similar phenomena the iris of an owl whose leg von Peczely had broken many years before. He subsequently became convinced that his method was able to distinguish between healthy organs and those that are overactive, inflamed, or distressed. Iridology became internationally known when US chiropractors began adopting this method in their clinical practice. In the United States, most insurance programs do not cover iridology but, in some European countries, they often do. In Germany, for instance, 80% of the Heilpraktiker (non-medically qualified health practitioners) practice iridology.

Iridologists claim to be able to diagnose the health status of an individual, medical conditions or predispositions to disease through abnormalities of pigmentation in the iris. The popularity of iridology renders it necessary to ask whether this method is valid.

The aim of my systematically review from 1999 was to critically evaluate all available, reliable tests of iridology as a diagnostic tool. Four case control studies were included; these are investigations where iridologists are asked to tell by looking at the iris of individuals whether that person does or does not have a certain condition. The majority of these studies suggested that iridology is not a valid diagnostic method. Back then, I concluded that “the validity of iridology as a diagnostic tool is not supported by scientific evaluations. Patients and therapists should be discouraged from using this method.”

Since the publication of my article, several further studies have emerged:

One German team conducted a study investigating the applicability of iridology as a screening method for colorectal cancer. Digital color slides were obtained from both eyes of 29 patients with histologically diagnosed colorectal cancer and from 29 age- and gender-matched healthy control subjects. The slides were presented in random order to acknowledged iridologists without knowledge of the number of patients in the two categories. The iridologists correctly detected 51.7% and 53.4%, respectively, of the patients’ slides; therefore, the likelihood was statistically no better than chance. Sensitivity was, respectively, 58.6% and 55.2%, and specificity was 44.8% and 51.7%. The authors’ conclusion was blunt: “Iridology had no validity as a diagnostic tool for detecting colorectal cancer in this study.”

A study from South Africa aimed to determine the efficacy of iridology in the identification of moderate to profound sensorineural hearing loss in adolescents. A controlled trial was conducted with an iridologist, blind to the actual hearing status of participants, analysing the irises of participants with and without hearing loss. Fifty hearing impaired and fifty normal hearing subjects, between the ages of 15 and 19 years, controlled for gender, participated in the study. An experienced iridologist analysed the randomised set of participants’ irises. A 70% correct identification of hearing status was obtained with a false negative rate of 41% compared to a 19% false positive rate. The respective sensitivity and specificity rates therefore were 59% and 81%. The authors of this investigation concluded that “iridological analysis of hearing status indicated a statistically significant relationship to actual hearing status (P < 0.05). Although statistically significant sensitivity and specificity rates for identifying hearing loss by iridology were not comparable to those of traditional audiological screening procedures.”

A further German study investigated the value of iridology as a diagnostic tool in detecting some common cancers. One hundred ten subjects were enrolled; 68 subjects had histologically proven cancers of the breast, ovary, uterus, prostate, or colorectum, and 42 were cancer-free controls. All subjects were examined by an experienced practitioner of iridology, who was unaware of their medical details. He was allowed to suggest up to five diagnoses for each subject and his results were then compared with each subject’s medical diagnosis to determine the accuracy of iridology in detecting malignancy. Iridology identified the correct diagnosis in only 3 cases (sensitivity, 0.04). The authors concluded that “iridology was of no value in diagnosing the cancers investigated in this study.”

Based on these results it is impossible, I think, to claim that iridology is a valid or useful diagnostic tool. As there is no anatomical or physiological basis for its assumptions, iridology is not biologically plausible. Furthermore, the available clinical evidence does not support its validity as a diagnostic tool. In other words, iridology is bogus. This statement is in sharp contract to the information consumers receive about the method on uncounted websites, books, articles, etc. One website picked at random provides the following information:

The iris reveals changing conditions of every part and organ of the body. Every organ and part of the body is represented in the iris in a well defined area. In addition, through various marks, signs, and discoloration in the iris, nature reveals inherited weaknesses and strengths.

By means of this art / science, an iridologist (one who studies the coloration and fiber structure of the eye) can tell an individual his/her inherited and acquired tendencies towards health and disease, his current condition in general, and the state of every organ in particular.

Iridology cannot detect a specific disease, but, can tell an individual if they have over or under activity in specific areas of the body. For example, an under-active pancreas might indicate a diabetic condition.

Another source claims:

The underlying platform of iridology is that that eyes act as a ‘window’ to a person’s health & well being. This ‘window’ enables the practitioner to see whether areas or organs within the body are healthy, inflamed or ‘over active’. It also enables them to assess a person’s past/ possible future health problems & consider if the patient has a susceptibility to certain diseases. It is important to understand that iridology is simply a method of diagnosis & analysis.

You may well think that none of this really matters. Who cares whether iridology is bogus or not! I would argue that it does matter. Bogus methods cost money that could be better spent elsewhere. More importantly, false positive and false negative diagnoses generated by bogus diagnostic methods can put lives at risk.

But there is a more general and perhaps more crucial point here: alternative medicine is an area where people far too easily get away with ignoring the published evidence and scientific consensus. In the last two decades, I have seen many alternative modalities getting scientifically dis-proven; not in a single such instance can I remember that the corresponding alternative practitioners and their professional organisations took any notice of this fact, and not once did I notice that their practice had changed.

If research is  systematically ignored, it becomes a useless appendix. More importantly, progress is then stifled to the detriment of all our best interests.

Acupuncture has remained one of the most controversial topics in the area of alternative medicine. Is it plausible? Is it safe? Is it effective? The arguments have been raging for decades and are by no means settled yet. The June issue of Anesth. Analg. is partly dedicated to this debate; the editor has invited two teams of experts to put forward their contrasting views.

The team of experts arguing in support of acupuncture conclude as follows: “clinical trials support the efficacy of acupuncture in reducing post-operative nausea and vomiting and postoperative pain; however, evidence supporting acupuncture as a treatment for chronic pain conditions is mixed. It should be noted that acupuncture trials in chronic pain have concluded that acupuncture treatment is often superior to standard of care or wait list controls and that acupuncture has minimal side effects and is cost effective. Brain imaging studies have demonstrated that there are different neural correlates between verum and sham acupuncture stimulation. Additionally, all clinical trials and many research studies have assumed that the acupuncture effect is equal to the “needle” effect, failing to recognize that factors in addition to specific effects of needling are also important contributors to the therapeutic effect of acupuncture in the setting of chronic pain.

Last, acupuncture is an ancient medical intervention first developed in an era when there were no laboratory tests, technology, or science of anatomy. The reason that the practice of acupuncture has survived for thousands of years is because it has evolved over time, with changes ranging from the number of acupuncture points to the practice techniques. Instead of criticizing this ancient art with arguments culled from modern medicine and science, physicians and scientists should try to integrate current knowledge into this ancient, yet ever-evolving practice so it may be used to treat conditions for which pharmaceutical interventions are ineffective and/or potentially dangerous. Over the last decade, there has been a growing green movement and eco-sustainability trend as well as an increased awareness that the same medication may not be effective in treating every patient with the same biomedical diagnosis. This “new age-integrative medicine in Western culture promotes a patient-oriented medical practice that complements the ancient Chinese theory behind acupuncture practice. Overall, acupuncture practice should not be seen as a placebo intervention or merely a needle therapy, but a medical option that not only treats disorders but also fosters a greater awareness of how harmonic interactions between self, family, work, and environment play a role in promoting health and restoring order”.

The two experts arguing against the usefulness of acupuncture draw the following conclusions: “It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions.  After thousands of trials of acupuncture and hundreds of systematic reviews,arguments continue unabated. In 2011, Pain published an editorial that summed up the present situation well.

“Is there really any need for more studies? Ernst et al. point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reason, including bias and low prior probability.”

Since it has proved impossible to find consistent evidence after more than 3000 trials, it is time to give up. It seems very unlikely that the money that it would cost to do another 3000 trials would be well-spent.

A small excess of positive results after thousands of trials is most consistent with an inactive intervention. The small excess is predicted by poor study design and publication bias. Furthermore, Simmons et al. demonstrated that exploitation of “undisclosed flexibility in data collection and analysis” can produce statistically positive results even from a completely nonexistent effect. They say this is “… not driven by a willingness to deceive but by the self-serving interpretation of ambiguity, which enables us to convince ourselves that whichever decisions produced the most publishable outcome must have also been the most appropriate.”

With acupuncture, in particular, there is documented profound bias among proponents. Existing studies are also contaminated by variables other than acupuncture, such as the frequent inclusion of “electroacupuncture” which is essentially transdermal electrical nerve stimulation masquerading as acupuncture.

The best controlled studies show a clear pattern, with acupuncture the outcome does not depend on needle location or even needle insertion. Since these variables are those that define acupuncture, the only sensible conclusion is that acupuncture does not work. Everything else is the expected noise of clinical trials, and this noise seems particularly high with acupuncture research. The most parsimonious conclusion is that with acupuncture there is no signal, only noise.

The interests of medicine would be best-served if we emulated the Chinese Emperor Dao Guang and issued an edict stating that acupuncture and moxibustion should no longer be used in clinical practice.

No doubt acupuncture will continue to exist on the “High Streets” where they can be tolerated as a voluntary self-imposed tax on the gullible (as long as they do not make unjustified claims).”

The readers of this blog will no doubt make up their own mind as to which arguments are stronger, more logical, more convincing, and based on more reliable evidence. I recommend reading the full articles and studying the references.

Personally, I have no hesitation in agreeing with the second, more sceptical view, and I have to admit finding the pro-acupuncture arguments weak as well as full of clichés, fallacies and errors.

I look forward to a lively discussion.

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