alternative medicine
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.
Even after all these years of full-time research into alternative medicine and uncounted exchanges with enthusiasts involved in this sector, I find the logic that is often applied in this field bewildering and the unproductiveness of the dialogue disturbing.
To explain what I mean, it be might best to publish a (fictitious, perhaps slightly exaggerated) debate between a critical thinker or scientist (S) and an uncritical proponent (P) of one particular form of alternative medicine.
P: Did you see this interesting study demonstrating that treatment X is now widely accepted, even by highly critical GPs at the cutting edge of health care?
S: This was a survey, not a ‘study’, and I never found the average GP “highly critical”. Surveys of this nature are fairly useless and they “demonstrate” nothing of real value.
P: Whatever, but it showed that GPs accept treatment X. This can only mean that they realise how safe and effective it is.
S: Not necessarily, GPs might just give in to consumer demand, or the sample was cleverly selected, or the question was asked in a leading manner, etc.
P: Hardly, because there is plenty of good evidence for treatment X.
S: Really? Show me.
P: There is this study here which proves that treatment X works and is risk-free.
S: The study was far too small to demonstrate safety, and it is wide open to multiple sources of bias. Therefore it does not conclusively show efficacy either.
P: You just say this because you don’t like its result! You have a closed mind!
In any case, it was merely an example! There are plenty more positive studies; do your research properly before you talk such nonsense.
S: I did do some research and I found a recent, high quality systematic review that arrived at a negative conclusion about the value of treatment X.
P: That review was done by sceptics who clearly have an axe to grind. It is based on studies which do not account for the intrinsic subtleties of treatment X. Therefore they are unfair tests of treatment X. These trials don’t really count at all. Every insider knows that! The fact that you cite it merely confirms that you do not understand what you are talking about.
S: It seems to me, that you like scientific evidence only when it confirms your belief. This, I am afraid, is what quacks tend to do!
P: I strongly object to being insulted in this way.
S: I did not insult you, I merely made a statement of fact.
P: If you like facts, you have to see that one needs to have sufficient expertise in treatment X in order to apply it properly and effectively. This important fact is neglected in all of those trials that report negative results; and that’s why they are negative. Simple! I really don’t understand why you are too stupid to understand this. Such studies do not show that treatment X is ineffective, but they demonstrate that the investigators were incompetent or hired with the remit to discredit treatment X.
S: I would have thought they are negative because they minimised bias and the danger of generating a false positive result.
P: No, by minimising bias, as you put it, these trials eliminated the factors that are important elements of treatment X.
S: Such as the placebo-effect?
P: That’s what you call it because you irrationally believe in reductionist science.
S: Science requires no belief, I think you are the believer here.
P: The fact is that scientists of your ilk negate all factors related to human interactions. Patients are no machines, you know, they need compassion; we clinicians know that because we work at the coal face of health care. Scientists in their ivory towers have no idea about patient care and just want science for science sake. This is not how you help patients. Show some compassion man!
S: I do know about the importance of compassion and care, but here we are discussing an entirely different topic, namely tests the efficacy or effectiveness of treatments, not patient-care. Let’s focus on one issue at a time.
P: You cannot separate things in this way. We have to take a holistic view. Patients are whole individuals, and you cannot do them justice by running artificial experiments. Every patient is different; clinical trials fail to account for this fact and are therefore fairly irrelevant to us and to our patients. Real life is very different from your imagined little experiments, you know.
S: These are platitudes that are nonsensical in this context and do not contribute anything meaningful to the present discussion. You do not seem to understand the methodology or purpose of a clinical trial.
P: That is typical! Whenever you run out of arguments, you try to change the subject or throw a few insults at me.
S: Not at all, I thought we were talking about clinical trials evaluating the effectiveness of treatment X.
P: That’s right; and they do show that it is effective, provided you consider those which are truly well-done by experts who know about treatment X and believe in it.
S: Not true. Only if you cherry-pick the data will you be able to produce an overall positive result for treatment X.
P: In any case, the real world results of clinical practice show very clearly that it works. It would not have survived for so long, if it didn’t. Nobody can deny that, and nobody should claim that silly little trials done in artificial circumstances are more meaningful than a wealth of experience.
S: Experience has little to do with reliable evidence.
P: To deny the value of experience is just stupid and clearly puts you in the wrong. I have shown you plenty of reliable evidence but you just ignore everything I say that does not go along with your narrow-minded notions about science; science is not the only way of knowing or comprehending things! Stop being obsessed with science.
S: No, you show me rubbish data and have little understanding of science, I am afraid.
P: Here we go again! I have had about enough of that and your blinkered arguments. We are going in circles because you are ignorant and arrogant. I have tried my best to show you the light, but your mind is closed. I offer true insight and you pay me back with insults. You and your cronies are in the pocket of BIG PHARMA. You are cynical, heartless and not interested in the wellbeing of patients. Next you will tell me to vaccinate my kids!
S: I think this is a waste of time.
P: Precisely! Everyone who has followed this debate will see very clearly that you are obsessed with reductionist science and incapable of considering the suffering of whole individuals. You want to deny patients a treatment that really helps them simply because you do not understand how treatment X works. Shame on you!!!
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.
The vexing question whether the acupuncture needle is as safe as most acupuncturists seem to believe has been raised several times before on this blog. Here is a new case-report by Japanese authors which sheds an interesting light on this issue.
A 62-year-old man was admitted to A+E complaining of dizziness and diaphoresis. He had received an acupuncture treatment in the sub-xyphoid area (lower 2 cm and left 1 cm point from the lower xyphoid process border) only about one hour ago. He had a history of cerebral infarction and atrial fibrillation, and the latter condition was treated with 2 mg warfarin per day. On admission, the acupuncture needle was still sticking in his sub-sternum.
His blood pressure was 80/50 mm Hg, and tachycardia with 110 beats/min was noted. The acupuncture-needle was duly removed, but the patient went into cardiac arrest and had to be resuscitated. Because his international normalized ratio was 1.99, 2 pints of fresh frozen plasma and 5 mg of vitamin K were administered at that stage. A transthoracic echocardiography revealed pericardial effusion with early diastolic collapse of the right ventricle. Emergency pericardiocentesis using a sub-costal approach was performed. After drainage of 500 mL of sanguineous effusion, the patient seemed to stabilize.
Two hours later, the drainage of pericardial effusion amounted to around 1000 mL, and cardiac arrest re-developed. After another resuscitation, an operation was performed under cardiopulmonary bypass (CPB). A median sternotomy allowed visualization of huge hematomas over the right atrium and ventricle. After the hematomas had been evacuated, pulsating blood loss from the marginal branch of the right coronary artery was identified. The vessel had been torn into pieces, and it was ligated which stopped the bleeding. Thereafter, the patient remained hemodynamically stable. Subsequently the patient made an uneventful recovery and, eventually, he was discharged without further complications.
The authors of this case-report conclude as follows: To our best knowledge, this appears to be the first case of an acupuncture-related coronary artery injury. The important causes of this unfortunate adverse event are a lack of anatomic knowledge and an incorrect application of the procedure. It can be avoided that acupuncture leads to cardiac tamponade like most serious complications….every acupuncturist should be aware of the possible and life-threatening adverse events and be adequately trained to prevent them.
In 2011, we published a review of all cases of cardiac tamponade after acupuncture. At the time, we found a total of 26 such incidences. In 14 patients, the complications were fatal. In most reports, there was little doubt about causality. We concluded that cardiac tamponade is a serious, often fatal complication after acupuncture. As it is theoretically avoidable, acupuncturists should be trained to minimize the risk.
Acupuncture-fans will, of course, claim (as before) that it is alarmist to go on about risks of acupuncture or alternative medicine which are so minute that they are dwarfed by those of conventional health care. And I will counter (as before) that it is never the absolute risk that counts, but that it is the risk benefit balance which defines the value of any therapeutic intervention. As long as we have no solid proof that acupuncture is more than a “theatrical placebo“, even a tiny risk weighs heavily and seems unacceptable.
But the true significance of this case-report lies elsewhere, in my view: risks of this nature can and should be avoided. The only way to achieve this aim is to train and educate acupuncturists properly. At present this does not seem to be the case, particularly in Asian countries where acupuncture is most popular. It is up to the acupuncture communities across the globe to get their act together.
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?
Alternative medicine has the image of being gentle and risk-free; it is therefore frequently used for children. German experts have just published an important article on this rather controversial topic.
They performed a systematic synthesis of all Cochrane reviews in paediatrics assessing the efficacy, clinical implications and limitations of alternative medicine use in children. The main outcome variables were: percentage of reviews concluding that a certain intervention provides a benefit, percentage of reviews concluding that a certain intervention should not be performed, and percentage of studies concluding that the current level of evidence is inconclusive. A total of 135 reviews were included – most from the United Kingdom (29), Australia (24) and China (24). Only 5 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26 (19.4%) issued a conditional positive recommendation. The 5 positive recommendations were:
1) Calcium supplements during pregnancy for prevention of hypertension and related conditions
2) Creatinine supplements for treating muscular disorders
3) Zinc supplements for prevention of pneumonia
4) Probiotics for prevention of upper respiratory infections
5) Acupuncture for prevention of post-operative nausea and vomiting
Nine (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased over time. The three most common criticisms of the quality of the primary studies included were: more research needed (82), low methodological quality (57) and small number of study participants (48).
The authors concluded: Given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.
As it happens, we published a very similar review two years ago. At the time (and using slightly different inclusion criteria), we identified a total of 17 systematic reviews. They related to acupuncture, chiropractic, herbal medicine, homeopathy, hypnotherapy, massage and yoga. Results were unconvincing for most conditions, but there was some evidence to suggest that acupuncture may be effective for postoperative nausea and vomiting, and that hypnotherapy may be effective in reducing procedure-related pain. Most of the reviews failed to mention the incidence of adverse effects of the alternative treatments in question. Our conclusions were as follows: “Although there is some encouraging evidence for hypnosis, herbal medicine and acupuncture, there is insufficient evidence to suggest that other CAMs are effective for the treatment of childhood conditions. Many of the systematic reviews included in this overview were of low quality, as were the randomised clinical trials within those reviews, further reducing the weight of that evidence. Future research in CAM for children should conform to the reporting standards outlined in the CONSORT and PRISMA guidelines.”
Treating children with unproven or dis-proven therapies is even more problematic than treating adults in this way. The main reason is that children cannot give informed consent. Thus alternative medicine for children can open difficult ethical questions, and sometimes I wonder where the line is between the application of bogus treatments and child-abuse. Examples are parents who opt for homeopathic vaccinations instead of conventional ones, or paediatric cancer patients who are being treated with bogus alternatives such as laetrile.
Why would parents not want the most effective therapy for their children? Why would anyone opt for dubious alternatives? The main reason, I think, must be misinformation. Parents who use alternative medicine are convinced they are effective and safe because they have been misinformed. We only need to google ALTERNATIVE MEDICINE to see for ourselves what utter nonsense and dangerous rubbish is being promoted under this umbrella.
Misinformation is the foremost reason why well-meaning parents (mis-) treat their children with alternative medicine. The results can be disastrous. Misinformation can kill!
A team of Swiss and UK chiropractors just published a survey to determine which management options their colleagues would choose in response to several clinical case scenarios. In order to avoid the accusations of citing out of context, or misreporting the findings in other ways, the wording of the following post is close to the original text of the article.
PART ONE
The clinical scenarios refer to treatments which appear not to be successful, not indicated, possibly harmful or where a patient might be suffering from a treatment-induced complication:
Scenario 1. A patient with non-specific low back pain has not improved at all after 4–6 treatments.
Scenario 2. A patient, who has a simple neck problem with no previous long-term problems, has now improved at least 80% and stayed at this level for a couple of weeks.
Scenario 3. A patient returns from the last treatment with a new distal pain (e.g. sciatica when treated only for localized LBP, or brachialgia when treated only for local neck pain).
Scenario 4. An elderly woman complains about immediate chest pain on inspiration after manual treatment directed to her thoracic spine.
It is worth noting that scenario 4 is the most dramatic but it is by far not the worst case scenario; this would have been the case of a patient who develops signs of a stroke after neck manipulation. It is telling, I think, that this possibility has been excluded in the survey.
The following 9 management options were provided:
• I would re-evaluate the patient with a view to establishing a better diagnosis
• I would send the patient for diagnostic imaging
• I would change my treatment approach and use another technique
• I would send the patient for a second opinion to another healthcare professional but keep on monitoring their condition
• I would try a few times more
• I would encourage the patient to continue the treatment until their spine is subluxation-free
• I would stop treatment and monitor the patient regularly
• I would stop the treatment, apologise and report the event to the chiropractic reporting and learning system
• I would stop the treatment, but tell the patient that s/he is welcome to return if they feel the need
To each of these options, the chiropractors could answer by ticking: ‘never’, ‘unlikely’, ‘likely’ and ‘most likely’.
PART TWO
In a second part of the questionnaire the researchers assessed the chiropractors’ general attitude towards safety issues by seeking the level of agreement on a five-point scale, with the responses ‘strongly disagree’, ‘disagree’, ‘neither agree nor disagree’, ‘agree’ and ‘strongly agree’, with 23 statements relating to six different safety dimensions, as follows:
• Teamwork – helping out, relationships, respect, teamwork-emphasis
• Work pressure – rushing, overwork, staff contingent, patient numbers
• Staff training – in response to new processes, on-the-job, appropriateness of tasks
• Process and standardisation – organisation, procedures, workflow, processes
• Communication openness – ideas for improvement, alternative views, asking questions, voicing disagreement
• Patient tracking/follow-up – reminders, documentation, reports, monitoring
260 Swiss and 1258 UK chiropractors were invited to complete the questionnaire. Responses were received from 76% of the Swiss and from 31% of the UK chiropractors. The dismal response rate for UK chiropractors seems to speak volumes.
The results of this survey indicate that both Swiss and UK chiropractors tend to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a serious complication might have occurred, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. The authors believe that this unlikeliness of safety incident reporting is due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.
In this context, scenario 4 is the most dramatic and therefore the most relevant scenario -but, as noted above, not a worst case scenario. It suggested a rib fracture as a result of chiropractic manipulation, with osteoporosis as a possible risk factor. The authors state that there is a strong argument for such an incident to be reported because patient injury occurred and because reflection on the detailed circumstances of the case, shared with colleagues, might serve to minimise the risk of such an occurrence happening elsewhere. However, incident reporting was found to be an unlikely option and comments revealed that this may be due to a perceived connection of reporting with guilt and error, as has been identified with other healthcare reporting initiatives, or only warranted in extreme cases.
The survey also showed that 33% of UK and 48% of Swiss chiropractors seem to work alone. In the eyes of the authors, this is limiting opportunities for fostering a safety culture through activities such as teamwork.
The authors draw the following conclusions:
• This study prompted chiropractors to reflect on aspects of clinical risk.
• Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by reevaluating their care and changing their approach
• Safety incident reporting to an online system is currently an unlikely course of action, probably due to previously recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting.
• Barriers to the use of safety incident reporting systems need to be addressed in order to encourage wider use of the existing systems.
• A significant proportion of Swiss and UK chiropractors practice in a single-handed environment. We suggest that single-handed practitioners have most to gain from participation in a national safety incident reporting and learning system.
• Female chiropractors appear to be more risk-averse than male chiropractors.
• Positivity towards key aspects of clinic safety indicate a developing safety culture within the Swiss and UK chiropractic professions.
In my view, the findings of this survey are deeply worrying and the interpretation of the authors is not far from an attempt to ‘white-wash’ the results. Like with most investigations of this nature, the results are wide open to selection bias; particularly the dismal UK response rate begs many questions. In all likelihood, reality is much worse than implied by the results of this investigation. And these results clearly show that, even with a fairly dramatic safety incident, chiropractors fail to respond adequately. There is no doubt in my mind: chiropractors put patients at risk.
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.
Indian homeopaths recently published a clinical trial aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome.
The new trial is a prospective observational study which was carried out from October 2005 to September 2009 by the Indian Central Council for Research in Homeopathy at its five Institutes. Patients suffering diabetic polyneuropathy (DPN) were screened and enrolled in the study, if they fulfilled the inclusion and exclusion criteria. The Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS), developed by the Council, served as the primary outcome measure.
A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in the 30, 200 and 1 M potencies on an individualized basis. Patients were followed up for 12 months.
Of 336 diabetics enrolled in the study, 247 patients who attended at least three follow-up appointments and baseline nerve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score was found at 12 months. Most objective measures did not show significant improvements. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the most frequently prescribed homeopathic remedies.
From these results, the authors concluded that: “homeopathic medicines may be effective in managing the symptoms of DPN patients.”
Does this study tell us anything worth knowing? The short answer to this question, I am afraid, is NO.
Its weaknesses are all too obvious:
1) There was no control group.
2) Patients who did not come back to the follow-up appointments – presumably because they were not satisfied – were excluded from the analyses. The average benefit reported is thus likely to be a cherry-picked false positive result.
3) The primary outcome measure was not validated.
4) The observed positive effect on subjective symptoms could be due to several factors which are entirely unrelated to the homeopathic treatments’ e.g. better metabolic control, regression towards the mean, or social desirability.
Anyone who had seen the protocol of this study would have predicted the result; I see no way that such a study does not generate an apparently positive outcome. In other words, conducting the investigation was superfluous, which means that the patients’ participation was in vain; and this, in turn, means that the trial was arguably unethical.
This might sound a bit harsh, but I am entirely serious: deeply flawed research should not happen. It is a waste of scarce resources and patients’ tolerance; crucially, it has a powerful potential to mislead us and to set back our efforts to improve health care. All of this is unethical.
The problem of research which is so poor that it crosses the line into being unethical is, of course, not confined to homeopathy. In my view, it is an important issue in much of alternative medicine and quite possibly in conventional medicine as well. Over the years, several mechanisms have been put in place to prevent or at least minimize the problem, for instance, ethic committees and peer-review. The present study shows, I think, that these mechanisms are fragile and that, sometimes, they fail altogether.
In their article, the authors of the new homeopathic study suggest that more investigations of homeopathy for diabetic polyneuropathy should be done. However, I suggest almost precisely the opposite: unethical research of this nature should be prevented, and the existing mechanisms to achieve this aim must be strengthened.
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.
