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.
A new condition, the Knighthood Starvation Syndrome (KSS), might soon be included in our systems of disease classification. Sporadic cases have been noted as far back as the 1950s, but recent decades have seen an alarming proliferation of incidents. The epidemiology of the KSS is most peculiar: it is endemic in the British Isles, particularly in large centres and seems to affect almost exclusively alpha males in their 60ies who have climbed up to dizzy heights on the career ladder and who think of themselves very highly.
The KSS tends to remain unrecognised for many years; early signs of dormant KSS include name dropping, pomposity, and a general alignment with the views of the establishment. Later stages are characterised by a sudden and often surprising change of opinion on several professional matters, an abnormal need for political correctness, an insatiable hunger for favourable mentions in the national press, a phobia related to rocking boats or blowing whistles, an urge to get involved in charitable work and/or high-profile committees of any type, and an increasing ruthlessness in pursuing ones personal goals under the guise of a professional purpose. Some of the features of the KSS are reminiscent of a classical degenerative disease, say experts who have studied the syndrome in much detail.
Opinions are divided as to the root causes of the KSS. Some psychiatrists claim it is due to early childhood mal-adaptation or bad potty-training, while sexologist are convinced that it caused by a chronically unfulfilled sex-life, and psychologists tend to believe it is a delayed mid-life crisis that was not allowed to blossom in a timely fashion. Endocrinologists have identifies various abnormalities regarding the levels of stress and sex hormones, nutritionists are discussing a lack of vitamin D in combination with an excess of red meat and fast food, and ENT surgeons speculate that it is caused by the absence of tonsillectomy during adolescence.
Unsurprisingly, alternative practitioners have developed their own theories most of which are, however, frowned upon by mainstream medics. Chiropractors view the KSS as the result of subluxation at the atlas level and advocate spinal adjustments followed by life-long maintenance therapy. TCM-practitioners are suggesting that a blocked kidney-chi has led to a pathological dominance of yin-energy, a minor aberration which could easily be corrected by acupuncture along the appropriate meridian. Bach Flower enthusiasts speak of vibrations being out of tune and recommend an intensive cure with Rescue Remedy. And finally, homeopaths see the KSS as the final poof of their theory of miasma where the bad air of the executive floor and caused serious damage which can only be neutralised by an in-depth homeopathic history and prolonged, individualised treatment.
Despite these and other attempts of altering the natural history of the syndrome, it tends to progress gradually in predisposed individuals, and symptoms are likely to worsen significantly over time, often to the point that the poor victim becomes a public menace. So far, the only known, evidence-based remedy is rather heroic and sadly not often available: the award of a knighthood. This intervention usually leads to a swift and uneventful recovery. In some tragic cases, however, the KSS subsequently degenerates into the HoLS-Syndrome, the even more vicious House of Lords Starvation Syndrome.
The main aim of our systematic review was to estimate the prevalence of use of alternative medicine (AM) in the UK. Five databases were searched for peer-reviewed surveys published between 1 January 2000 and 7 October 2011. In addition, relevant book chapters and files from our own departmental records were searched by hand. Eighty-nine surveys were included, with a total of 97,222 participants. Surely, fact that this large amount of UK surveys had emerged in only about one decade, speaks for itself.
Most studies turned out to be of poor methodological quality. Across all surveys, the average one-year prevalence of AM-use was 41.1%, and the average lifetime prevalence was 51.8%. However, many of these investigations were flimsy. According to methodologically sound surveys, the equivalent rates were 26.3% and 44%, respectively. In surveys with response rates >70%, the average one-year prevalence was nearly threefold lower than in surveys with response rates below 50%. Herbal medicine was the most popular CAM, followed by homeopathy, aromatherapy, massage and reflexology.
To the best of my knowledge, this is the first time that four crucial points about such surveys have been clearly documented:
1) The amount of surveys in AM is staggering.
2) They contribute very little worthwhile knowledge and mostly seem to be exercises in AM-promotion.
3) Their methodological quality is usually low.
4) The poor quality surveys systematically over-estimate the prevalence of AM-use.
I think it is time that AM investigators focus on real research answering important questions which advance out knowledge, that AM-journal editors stop publishing meaningless nonsense, and that decision-makers understand the difference between promotion dressed up as science and real research.
Tai Chi, as we know it in the West, is said to promote the smooth flow of “energy” throughout the body by performing postures, slow meditative movements and controlled breathing. Tai Chi is also supposed to help increasing flexibility, suppleness, balance and coordination. According to enthusiasts, the smooth, gentle movements of Tai Chi aid relaxation and help to keep the mind calm and focused.
Tai Chi has become popular in Western countries and is being considered for a surprisingly wide range of conditions. The patient/consumer is taught to perform postures, slow meditative movements and controlled breathing. The concepts underlying Tai Chi are strange, but that does not necessarily mean that the treatment is not effective for certain illnesses or symptoms.
There has been a surprising amount of research in this area, and some studies have generated encouraging results. A recent study which is unfortunately not available electronically ( Wu, WF; Muheremu, A; Chen, CH; Liu, WG; Sun, L. Effectiveness of Tai Chi Practice for Non-Specific Chronic Low Back Pain on Retired Athletes: A Randomized Controlled Study. JOURNAL OF MUSCULOSKELETAL PAIN 2013, 21:1, p.37-45) tested the effectiveness of Tai Chi for chronic back pain. Specifically, the researchers wanted to determine whether regular Tai Chi practice is superior to other means of sports rehabilitation in relieving non-specific chronic low back pain [LBP] in a younger population. They randomized 320 former athletes suffering from chronic LBP into a treatment [tai chi practice] and several control groups [regular sessions with swimming, backward walking or jogging, or no such interventions]. At the beginning, middle, and end of a six-month intervention, patients from all groups completed questionnaires assessing the intensity of LBP; in addition, a physical examination was conducted.
After 3 and 6 months, no statistically significant difference in the intensity of LBP was demonstrated between the Tai Chi and swimming. However, significant differences were demonstrated between the Tai Chi and backward walking, jogging, and no exercise groups.
The authors’ concluded that “Tai chi has better efficacy than certain other sports on the treatment of non-specific chronic LBP.”
This is only the second RCT of Tai chi for back pain. The first such study consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The experimental group (n = 80) had 18 Tai Chi sessions over a 10-week period. The waitlist control group continued with their usual health care. Bothersomeness of symptoms was the primary outcome, and secondary outcomes included pain intensity and pain-related disability. Tai Chi reduced bothersomeness of back symptoms by 1.7 points on a 0-10 scale, reduced pain intensity by 1.3 points on a 0-10 scale, and improved self-report disability by 2.6 points on the 0-24 Roland-Morris Disability Questionnaire scale. The authors of this RCT concluded that a 10-week Tai Chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.
My own team have conducted their fair share of Tai Chi research. Specifically,we have published several systematic reviews of Tai Chi as an adjunctive or supportive treatment of various conditions, and the conclusions (in italics) have been mixed.
DIABETES: The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes.
HYPERTENSION: The evidence for tai chi in reducing blood pressure in the elderly individuals is limited.
BREAST CANCER: the existing trial evidence does not show convincingly that tai chi is effective for supportive breast cancer care.
IMPROVEMENT OF AEROBIC EXCERCISE CAPACITY: the existing evidence does not suggest that regular tai chi is an effective way of increasing aerobic capacity.
PARKINSON’S DISEASE: the evidence is insufficient to suggest tai chi is an effective intervention for Parkinson’s Disease.
OSTEOPOROSIS: The evidence for tai chi in the prevention or treatment of osteoporosis is not convincing.
OSTEOARTHRITIS: there is some encouraging evidence suggesting that tai chi may be effective for pain control in patients with knee OA.
RHEUMATOID ARTHRITIS: Collectively this evidence is not convincing enough to suggest that tai chi is an effective treatment for RA.
Finally, an overview over all systematic reviews of Tai Chi suggested that the only area where the evidence is convincing is the prevention of falls in the elderly.
I think, this indicates that we should not pin our hopes too high as to the therapeutic value of Tai Chi. In particular, for back pain, the evidence might be optimistically judged as encouraging, but it is by no means convincing; the effect size seems to be small and two studies are not enough to issue general recommendations. On the other hand, considering that there is so little to offer to back pain patients, I concede that this is an area that should be studied further. Meanwhile, one could argue that Tai Chi can be fun and is devoid of risks – so, why not give it a try?
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!