Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.
If we listen to acupuncturists and their supporters, we might get the impression that acupuncture is totally devoid of risk. Readers of this blog will know that this is not quite true. A recent case report is a further reminder that acupuncture can cause serious complications; in extreme cases it can even kill.
A male patient in his late forties died right after an acupuncture treatment. A medico-legal autopsy disclosed severe haemorrhaging around the right vagus nerve in the neck. All other organs were normal, and laboratory findings revealed nothing significant. Thus, the authors of this case-report concluded that the man most probably died from severe vagal bradycardia and/or arrhythmia resulting from vagus nerve stimulation following acupuncture: To the best of our knowledge, this is the first report of a death due to vagus nerve injury after acupuncture.
In total, around 100 deaths have been reported after acupuncture in the medical literature. ‘This is a negligible small figure’ claim acupuncture fans. True, it is a small number, but it could just be the tip of a much larger ice-berg: there is no reporting system that could possibly pick up severe complications, and in the absence of such a scheme, nobody can name reliable incidence rates. And even if the numbers of severe complications and deaths are small – even a single fatality would seem one too many.
The deaths that are currently on record are mostly due to bilateral pneumothorax or cardiac tamponade. The present case of vagus nerve injury seems to be ‘a first’. Perhaps we should watch out for similar events?
IF WE DON’T LOOK, WE DON’T SEE.
The discussion whether acupuncture is more than a placebo is as long as it is heated. Crucially, it is also quite tedious, tiresome and unproductive, not least because no resolution seems to be in sight. Whenever researchers develop an apparently credible placebo and the results of clinical trials are not what acupuncturists had hoped for, the therapists claim that the placebo is, after all, not inert and the negative findings must be due to the fact that both placebo and real acupuncture are effective.
Laser acupuncture (acupoint stimulation not with needle-insertion but with laser light) offers a possible way out of this dilemma. It is relatively easy to make a placebo laser that looks convincing to all parties concerned but is a pure and inert placebo. Many trials have been conducted following this concept, and it is therefore highly relevant to ask what the totality of this evidence suggests.
A recent systematic review did just that; specifically, it aimed to evaluate the effects of laser acupuncture on pain and functional outcomes when it is used to treat musculoskeletal disorders.
Extensive literature searches were used to identify all RCTs employing laser acupuncture. A meta-analysis was performed by calculating the standardized mean differences and 95% confidence intervals, to evaluate the effect of laser acupuncture on pain and functional outcomes. Included studies were assessed in terms of their methodological quality and appropriateness of laser parameters.
Forty-nine RCTs met the inclusion criteria. Two-thirds (31/49) of these studies reported positive effects. All of them were rated as being of high methodological quality and all of them included sufficient details about the lasers used. Negative or inconclusive studies mostly failed to demonstrate these features. For all diagnostic subgroups, positive effects for both pain and functional outcomes were more consistently seen at long-term follow-up rather than immediately after treatment.
The authors concluded that moderate-quality evidence supports the effectiveness of laser acupuncture in managing musculoskeletal pain when applied in an appropriate treatment dosage; however, the positive effects are seen only at long-term follow-up and not immediately after the cessation of treatment.
Surprised? Well, I am!
This is a meta-analysis I always wanted to conduct and never came round to doing. Using the ‘trick’ of laser acupuncture, it is possible to fully blind patients, clinicians and data evaluators. This eliminates the most obvious sources of bias in such studies. Those who are convinced that acupuncture is a pure placebo would therefore expect a negative overall result.
But the result is quite clearly positive! How can this be? I can see three options:
- The meta-analysis could be biased and the result might therefore be false-positive. I looked hard but could not find any significant flaws.
- The primary studies might be wrong, fraudulent etc. I did not see any obvious signs for this to be so.
- Acupuncture might be more than a placebo after all. This notion might be unacceptable to sceptics.
I invite anyone who sufficiently understands clinical trial methodology to scrutinise the data closely and tell us which of the three possibilities is the correct one.
Moxibustion is an ancient variation of acupuncture using moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.
Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.
My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.
One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.
Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.
Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.
Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.
Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.
Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.
Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.
The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.
Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.
Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.
Was all this research for nothing?
I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:
- There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
- Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
- The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
- Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
- Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
- As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.
Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.
- Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
- We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
- Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
- The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
- The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
- Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
- Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.
A special issue of Medical Care has just been published; it was sponsored by the Veterans Health Administration’s Office of Patient Centered Care and Cultural Transformation. A press release made the following statement about it:
Complementary and alternative medicine therapies are increasingly available, used, and appreciated by military patients, according to Drs Taylor and Elwy. They cite statistics showing that CAM programs are now offered at nearly 90 percent of VA medical facilities. Use CAM modalities by veterans and active military personnel is as at least as high as in the general population.
If you smell a bit of the old ad populum fallacy here, you may be right. But let’s look at the actual contents of the special issue. The most interesting article is about a study testing acupuncture for posttraumatic stress disorder (PTSD).
Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care (UPC) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone. Outcomes were assessed at baseline and 4, 8, and 12 weeks postrandomization. The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist (PCL) and the Clinician-administered PTSD Scale (CAPS) from baseline to 12-week follow-up between the two treatment groups. Secondary outcomes were depression, pain severity, and mental and physical health functioning. Mixed model regression and t test analyses were applied to the data.
The results show that the mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC. Acupuncture was also associated with significantly greater improvements in depression, pain, and physical and mental health functioning. Pre-post effect-sizes for these outcomes were large and robust.
The authors conclude from these data that acupuncture was effective for reducing PTSD symptoms. Limitations included small sample size and inability to parse specific treatment mechanisms. Larger multisite trials with longer follow-up, comparisons to standard PTSD treatments, and assessments of treatment acceptability are needed. Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment.
What shall we make of this?
I know I must sound like a broken record to some, but I have strong reservations that the interpretation provided here is correct. One does not even need to be a ‘devil’s advocate’ to point out that the observed outcomes may have nothing at all to do with acupuncture per se. A much more rational interpretation of the findings would be that the 8 times 60 minutes of TLC and attention have positive effects on the subjective symptoms of soldiers suffering from PTSD. No needles required for this to happen; and no mystical chi, meridians, life forces etc.
It would, of course, have been quite easy to design the study such that the extra attention is controlled for. But the investigators evidently did not want to do that. They seemed to have the desire to conduct a study where the outcome was clear even before the first patient had been recruited. That some if not most experts would call this poor science or even unethical may not have been their primary concern.
The question I ask myself is, why did the authors of this study fail to express the painfully obvious fact that the results are most likely unrelated to acupuncture? Is it because, in military circles, Occam’s razor is not on the curriculum? Is it because critical thinking has gone out of fashion ( – no, it is not even critical thinking to point out something that is more than obvious)? Is it then because, in the present climate, it is ‘politically’ correct to introduce a bit of ‘holistic touchy feely’ stuff into military medicine?
I would love to hear what my readers think.
Biopuncture is a therapy whereby specific locations are injected with biological products. The majority of the products are derived from plants. Most of these injections are given into the skin or into muscles. Products commonly used in Biopuncture are, for example, arnica, echinacea, nux vomica and chamomile. Arnica is used for muscle pain, nux vomica is injected for digestive problems, echinacea is used to increase the natural defense system of the body. Biopuncturists always inject cocktails of natural products. Lymphomyosot is used for lymphatic drainage, Traumeel for inflammations and sports injuries, Spascupreel for muscular cramps. Injections with antiflogistics, hyaluronic acid, blood platelets, blood, procaine, ozon, cortisone or vitamin B are not considered as Biopuncture…
How can such a small dose influence your body and stimulate healing? Scientists don’t have the final proof yet, but they postulate that these injections are working through the stimulation of the immune system (which is in fact your defense system). Let’s compare it with a vaccination. When you receive a tetanus vaccination, only small amounts of a particular product are necessary to stimulate the immune system against lockjaw. In other words, just a few injections can protect your body for years…
An important issue in Biopuncture is the detoxification of the body. It literally means “cleaning the body” from all the toxins that have accumulated: for example from the environment (air pollution, smoking), from bad nutrition, or from medication (e.g., antibiotics and steroids you’ve taken). These toxins can block your defense system. Some injections work specifically on the liver and others on the kidneys. Cleaning up the lymphatic system with Lymphomyosot is considered very important in Biopuncture. It is like taking the leaves out of the gutter. The down side of such an approach is that old symptoms (which have been suppressed earlier on) may come to the surface again. But that is sometimes part of the healing strategy of the body…
That sounds strange, to say the least. But remember: strange treatments might still work! The question is therefore: IS BIOPUNCTURE AN EFFECTIVE THERAPY? If you ask it to Dr Oz, the answer would be a resounding YES – but let’s not ask Oz, let’s try to find some reliable evidence instead. In my quest to locate such evidence, I came across claims like these.
Examples of some acute conditions we treat with biopuncture:
- Knee and ankle sprains
- Muscle sprains- quadriceps, hamstring, adductors, rotator cuff
Examples of some chronic conditions we treat with biopuncture:
- Achilles tendinitis
- Tennis elbow
- Chronic arthritis of the knee, hip, shoulder
- Back pain
- Myofascial pains
- Irritable bowel syndrome
- TMJ syndrome
Somehow I had the feeling that this was more than a little too optimistic, and I decided to conduct a rudimentary Medline search. The results were sobering indeed: not a single clinical trial seems to be available that supports any of the claims that are being made for biopuncture.
So, what should we conclude? I don’t know about you, but to me it seems that biopuncture is quackery at its purest.
Here and elsewhere, I have repeatedly written about the many things that can go wrong with acupuncture. This invariably annoys acupuncture fans who usually counter by accusing me of being alarmist. Despite their opposition, I continue to think it is important to regularly point out that acupuncture – contrary to what many acupuncturists would tell us – can result in serious injury. I will therefore carry on reporting new evidence about the harm caused by acupuncture. Here is a very brief review of new (2014) articles on this important topic.
A recent study found that the incidence of any adverse events per patient was 42.4% with traditional acupuncture, 40.7% with minimal acupuncture and 16.7% with non-invasive sham acupuncture. These figures are much higher than those around 10% previously reported.
Other authors described the case of a broken off acupuncture needle in a patient’s abdomen. A very long needle was used which happily is unusual in routine practice.
Pneumothorax has been often noted as a complication of acupuncture – it is by far the most frequently reported serious complication caused by acupuncture; well over 100 instances have been described in the medical literature which, of course, reflects only the tip of an iceberg – new cases are being reported almost on a monthly basis.
Cardiac tamponade is even more dangerous but fortunately also much rarer. A case of life-threatening cardiac tamponade due to penetration of an acupuncture needle directly into the right ventricle was recently published. Cardiac tamponade can happen when the patient is unfortunate enough to have a sternal foramen, an congenital abnormality that is not normally detected by simple inspection or palpation. An investigation found that the frequency of a sternal foramen is approximately 10.5%. The authors concluded that sternal acupuncture should be planned in the region of corpus-previous CT should be done to rule out this variation. Furthermore, we strongly recommend the acupuncture technique which prescribes a safe superficial-oblique approach to the sternum.
A review from Egypt noted that acupuncture presented a significant risks for acquiring hepatitis C infections.
Other types of infections can also be transmitted by acupuncture needles, if the therapist fails to adhere to proper procedures of sterility. One report described the diagnosis, treatment and >1 year follow-up of 30 patients presenting with acupuncture-induced primary inoculation tuberculosis.
Similarly, Chinese authors reported the case of a 54-year-old woman who presented with progressive low back pain and fever. She underwent surgical decompression, with an immediate improvement of her pain. A culture of the epidural abscess grew Serratia marcescens. One year postoperatively, magnetic resonance imaging revealed the almost complete eradication of the abscess. This case is the first case of Serratia marcescens-associated spinal epidural abscess formation secondary to acupuncture.
Other authors reported a rare case of isolated unilateral hypoglossal nerve injury following ipsilateral acupuncture for migraines in a 53-year-old lady.
Finally, Greek authors published a case of severe rhabdomyolysis and acute kidney injury after acupuncture sessions. Rhabdomyolysis is a rare condition that can be caused by muscle injury and presents with muscle weakness and pain. It is characterized by myoglobinuria which, in turn, may cause acute kidney injury.
I can hear the world of acupuncture arguing that all of these events are extreme rarities and that conventional treatments are much more dangerous. This may well be true but it also ignores the following facts:
- The frequency of such events is essentially unknown. Contrary to conventional medicine, alternative medicine has no functioning systems to monitor adverse events. Therefore the true incidence figures of acupuncture-related complications are anyone’s guess.
- Most conventional treatments in common use are backed up by good evidence for efficacy and therefore demonstrably do more good than harm, even if they regularly cause adverse effects. This is not the case for acupuncture. In the absence of solid evidence for efficacy, even relatively rare or minor adverse effects would mean that the risk/benefit profile of acupuncture is not positive.
For these reasons, it is an ethical imperative, I think, to keep a keen eye on the harm caused by acupuncture and to inform the public about the fact that it is undeniably not free of risks.
An international team of researchers wanted to determine the efficacy of laser and needle acupuncture for chronic knee pain. They conducted a Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists.
The treatments consisted of A) no acupuncture (control group, n = 71), B) needle (n = 70), C) laser (n = 71), and D) sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial.
Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data.
At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events.
The authors drew the following conclusions: In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients.
This is one of the methodologically best acupuncture studies that I have seen so far.
- its protocol has been published when the trial started thus allowing maximum transparency
- it is adequately powered
- it has a very clever study-design
- it minimizes bias in all sorts of ways
- it tests acupuncture for a condition that it is widely used for
- it even manages to blind acupuncturists by using one treatment arm with laser acupuncture
The results show quite clearly that acupuncture does have mild effects on pain and function that entirely rely on a placebo response.
Will acupuncturists learn from this study and henceforward stop treating knee-patients? Somehow I doubt it! The much more likely scenario is that they will claim the trial was, for this or that reason, not valid. Acupuncture, like most of alternative medicine, seems unable to revise its dogma.
An article with this title was published recently by a team from Israel; essentially, it reports two interesting case histories:
A 59-year-old male underwent a course of acupuncture for chronic low back pain, by a acupuncturist. During the therapy, the patient noted swelling at the point of puncture, but his therapist dismissed the claim. The region continued to swell, and three days later his family doctor diagnosed cellulitis and prescribed oral amoxicillin with clavulanic acid. The following day the patient’s condition worsened—he started to suffer from chills and more intense pain, so he went to the emergency room. At that stage, the patient had a fever of 37.9°C, a pulse of 119, and a blood pressure of 199/87. Edema was noted over the patient’s entire right flank (Figure 1A). Laboratory results were notable for a level of glucose of 298 mg/dL, sodium of 128 mmol/L, and white blood count (WBC) of 26,500 cells/μL with left shift. An emergency CT revealed an abscess of the abdominal wall involving the muscles, but no intra-abdominal pathology (Figure 1B).
Figure 1.The patient received broad-spectrum antibiotics and was taken to the operating room for debridement. Upon incision there was subcutaneous edema with no puss, gangrene of the entire external oblique muscle, and an abscess between the external and internal oblique muscles. The muscles were debrided back to healthy, bleeding tissue and the wound copiously irrigated with saline. The wound was left open, with gauze and iodine as a cover. Gram stains and cultures returned group B streptococcus (GBS) sensitive to penicillin, and antibiotic coverage was adjusted accordingly. The patient returned to the operating room for serial debridement until the wound developed healthy granulation tissue. The patient received four units of blood and required 13 days of hospitalization. To date, he suffers from a disfiguring wound of his abdominal wall.
Considering the fact that group B streptococci live primarily in the female vagina, and that the acupuncturist was a young female, it is possible to assume that the cause for this grave illness was due to improper hygiene while treating our patient with acupuncture. Although rare, this tragic consequence of acupuncture has been seen previously by other researchers.
A 27-year-old male with chronic cervical and back pain without any previous medical treatment or imaging was referred to a tertiary medical facility. To manage his pain, the patient used the services of a chiropractor who used cervical manipulation. Immediately after such a manipulation, the patient felt a severe cervical pain; 30 minutes after manipulation the patient started feeling paresthesia in his hands and legs. The patient was admitted to an emergency room with symptoms of progressive weakness in all four extremities and weakness. No additional symptoms were seen. Immediate MRI demonstrated an epidural hematoma at the C3-4 level (Figure 2).
The patient underwent immediate surgery to evacuate the hematoma via an anterior approach and C3-4 cage placement. The day after surgery the patient showed a remission of symptoms. At 6 months follow-up his remission was complete.
The literature includes several reports of SSPE immediately following a chiropractic manipulation that was considered the cause of this event. The authors of this case report concluded that chiropractic procedures can be dangerous when performed by practitioners who might be only partially trained, who might tend to perform an insufficient patient examination before the procedure, and thus endanger their patients.
On this blog, I have repeatedly warned that not all alternative treatments are free of risks. These two cases are impressive reminders of this undeniable fact.
I am sure that most proponents of alternative medicine will try to claim that
- such complications are true rarities,
- I am alarmist to keep alerting my readers to such events,
- conventional medicine is dimensions more harmful,
- the above cases are caused by poor practice.
However, I feel compelled to stress that there are no adequate post-marketing surveillance systems in alternative medicine and that the true frequencies of such events are therefore unknown. It seems therefore imperative (and not alarmist) to publicize such risks as widely as possible – in the hope that alternative practitioners, one day, might do the ethically and morally correct thing and implement proper surveillance of their practices.