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.
A reader of this blog recently sent me the following message: “Looks like this group followed you recent post about how to perform a CAM RCT!” A link directed me to a new trial of ear-acupressure. Today is ‘national acupuncture and oriental medicine day’ in the US, a good occasion perhaps to have a critical look at it.
The aim of this study was to assess the effectiveness of ear acupressure and massage vs. control in the improvement of pain, anxiety and depression in persons diagnosed with dementia.
For this purpose, the researchers recruited a total of 120 elderly dementia patients institutionalized in residential homes. The participants were randomly allocated, to three groups:
- Control group – they continued with their routine activities;
- Ear acupressure intervention group – they received ear acupressure treatment (pressure was applied to acupressure points on the ear);
- Massage therapy intervention group – they received relaxing massage therapy.
Pain, anxiety and depression were assessed with the Doloplus2, Cornell and Campbell scales. The study was carried out during 5 months; three months of experimental treatment and two months with no treatment. The assessments were done at baseline, each month during the treatment and at one and two months of follow-up.
A total of 111 participants completed the study. The ear acupressure intervention group showed better improvements than the two other groups in relation to pain and depression during the treatment period and at one month of follow-up. The best improvement in pain was achieved in the last (3rd) month of ear acupressure treatment. The best results regarding anxiety were also observed in the last month of treatment.
The authors concluded that ear acupressure and massage therapy showed better results than the control group in relation to pain, anxiety and depression. However, ear acupressure achieved more improvements.
The question is: IS THIS A RIGOROUS TRIAL?
My answer would be NO.
Now I better explain why, don’t I?
If we look at them critically, the results of this trial might merely prove that spending some time with a patient, being nice to her, administering a treatment that involves time and touch, etc. yields positive changes in subjective experiences of pain, anxiety and depression. Thus the results of this study might have nothing to do with the therapies per se.
And why would acupressure be more successful than massage therapy? Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc. Features like that have the potential to maximise the placebo-response. Therefore it is conceivable that they have contributed to the superiority of acupressure over massage.
What I am saying is that the results of this trial can be interpreted in not just one but several ways. The main reason for that is the fact that the control group were not given an acceptable placebo, one that was indistinguishable from the real treatment. Patients were fully aware of what type of intervention they were getting. Therefore their expectations, possibly heightened by the therapists, determined the outcomes. Consequently there were factors at work which were totally beyond the control of the researchers and a clear causal link between the therapy and the outcome cannot be established.
An RCT that is aimed to test the effectiveness of a therapy but fails to establish such a causal link beyond reasonable doubt cannot be characterised as a rigorous study, I am afraid.
Sorry! Did I spoil your ‘national acupuncture and oriental medicine day’?
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.
For every condition which is not curable by conventional medicine there are dozens of alternative treatments that offer a cure or at least symptomatic relief. Multiple sclerosis (MS) is such a disease. It is hard to find an alternative therapy that is not being promoted for MS.
Acupuncture is, of course, no exception. It is widely promoted for treating MS symptoms and many MS patients spend lots of money hoping that it does. The US ‘National MS Society’, For instance claim that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression. There is no evidence, however, that acupuncture can reduce the frequency of MS exacerbations or slow the progression of disability. And the ‘British Acupuncture Council’ state that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression.
Such claims seem a little over-optimistic; let’s have a look what the evidence really tells us.
The purpose of this brand-new review was to assess the literature on the effectiveness of acupuncture for treating MS. A literature search resulted in 12 peer-reviewed articles on the subject that examined the use of acupuncture to treat MS related quality of life, fatigue, spasticity, and pain. The majority of the studies were poorly designed-without control, randomization, or blinding. Description of the subjects, interventions, and outcome measures as well as statistical analysis were often lacking or minimal.
The authors concluded that although many of the studies suggested that acupuncture was successful in improving MS related symptoms, lack of statistical rigor and poor study design make it difficult to draw any conclusions about the true effectiveness of this intervention in the MS population. Further studies with more rigorous designs and analysis are needed before accurate claims can be made as to the effectiveness of acupuncture in this population.
And what about other alternative therapies? Our own systematic review of the subject included 12 randomized controlled trials: nutritional therapy (4), massage (1), Feldenkrais bodywork (1), reflexology (1), magnetic field therapy (2), neural therapy (1) and psychological counselling (2). But the evidence was not compelling for any of these therapies, with many trials suffering from significant methodological flaws. There is evidence to suggest some benefit of nutritional therapy for the physical symptoms of MS. Magnetic field therapy and neural therapy appear to have a short-term beneficial effect on the physical symptoms of MS. Massage/bodywork and psychological counselling seem to improve depression, anxiety and self-esteem.
That was some time ago, and it is therefore reasonable to ask: has the evidence changed? Thankfully, the ‘American Academy of Neurology’ has just published the following guidelines entitles complementary and alternative medicine in multiple sclerosis:
Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.
Interestingly, on yesterday it was announced that the NHS in Wales has just made available a cannabis-based spray for MS-sufferers (I should mention that most cannabis-based preparations are not full plant extracts and thus by definition not herbal but conventional medicines).
It would be wonderful, if other alternative therapies were of proven benefit to MS-sufferers. But sadly, this does not seem to be the case. I think it is better to be truthful about this than to raise false hopes of desperate patients.
Blinding patients in clinical trials is a key methodological procedure for minimizing bias and thus making sure that the results are reliable. In alternative medicine, blinding is not always straight forward, and many studies are therefore not patient-blinded. We all know that this can introduce bias into a trial, but how large is its effect on study outcomes?
This was the research question addressed by a recent systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control) involving blinded patients and another, otherwise identical, sub-study involving non-blinded patients. Within each trial, the researchers compared the difference in effect sizes (i.e. standardized mean differences) between the two sub-studies. A difference <0 indicates that non-blinded patients generated a more optimistic effect estimate. The researchers then pooled the differences with random-effects inverse variance meta-analysis, and explored reasons for heterogeneity.
The main analysis included 12 trials with a total of 3869 patients. Ten of these RCTs were studies of acupuncture. The average difference in effect size for patient-reported outcomes was -0.56 (95% confidence interval -0.71 to -0.41), (I(2 )= 60%, P = 0.004), indicating that non-blinded patients exaggerated the effect size by an average of 0.56 standard deviation, but with considerable variation. Two of the 12 trials also used observer-reported outcomes, showing no indication of exaggerated effects due lack of patient blinding.
There was an even larger effect size difference in the 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding was also associated with increased attrition rates and the use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control group co-intervention risk 1.55 (0.99 to 2.43).
The authors conclude that this study provides empirical evidence of pronounced bias due to lack of patient blinding in complementary/alternative randomized clinical trials with patient-reported outcomes.
This is a timely, rigorous and important analysis. In alternative medicine, we currently see a proliferation of trials that are not patient-blinded. We always suspected that they are at a high risk of generating false-positive results – now we know that this is, in fact, the case.
What should we do with this insight? In my view, the following steps would be wise:
- Take the findings from the existing trials that are devoid of patient-blinding with more than just a pinch of salt.
- Discourage the funding of future studies that fail to include patient-blinding.
- If patient-blinding is truly and demonstrably impossible – which is not often the case – make sure that the trialists at least include blinding of the assessors of the primary outcome measures.
There must be well over 10 000 clinical trials of acupuncture; Medline lists ~5 000, and many more are hidden in the non-Medline listed literature. That should be good news! Sadly, it isn’t.
It should mean that we now have a pretty good idea for what conditions acupuncture is effective and for which illnesses it does not work. But we don’t! Sceptics say it works for nothing, while acupuncturists claim it is a panacea. The main reason for this continued controversy is that the quality of the vast majority of these 10 000 studies is not just poor, it is lousy.
“Where is the evidence for this outraging statement???” – I hear the acupuncture-enthusiasts shout. Well, how about my own experience as editor-in-chief of FACT? No? Far too anecdotal?
How about looking at Cochrane reviews then; they are considered to be the most independent and reliable evidence in existence? There are many such reviews (most, if not all [co-]authored by acupuncturists) and they all agree that the scientific rigor of the primary studies is fairly awful. Here are the crucial bits of just the last three; feel free to look for more:
Or how about providing an example? Good idea! Here is a new trial which could stand for numerous others:
This study was performed to compare the efficacy of acupuncture versus corticosteroid injection for the treatment of Quervain’s tendosynovitis (no, you do not need to look up what condition this is for understanding this post). Thirty patients were treated in two groups. The acupuncture group received 5 acupuncture sessions of 30 minutes duration. The injection group received one methylprednisolone acetate injection in the first dorsal compartment of the wrist. The degree of disability and pain was evaluated by using the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) scale and the Visual Analogue Scale (VAS) at baseline and at 2 weeks and 6 weeks after the start of treatment. The baseline means of the Q-DASH and the VAS scores were 62.8 and 6.9, respectively. At the last follow-up, the mean Q-DASH scores were 9.8 versus 6.2 in the acupuncture and injection groups, respectively, and the mean VAS scores were 2 versus 1.2. Thus there were short-term improvements of pain and function in both groups.
The authors drew the following conclusions: Although the success rate was somewhat higher with corticosteroid injection, acupuncture can be considered as an alternative option for treatment of De Quervain’s tenosynovitis.
The flaws of this study are exemplary and numerous:
- This should have been a study that compares two treatments – the technical term is ‘equivalence trial – and such studies need to be much larger to produce a meaningful result. Small sample sizes in equivalent trials will always make the two treatments look similarly effective, even if one is a pure placebo.
- There is no gold standard treatment for this condition. This means that a comparative trial makes no sense at all. In such a situation, one ought to conduct a placebo-controlled trial.
- There was no blinding of patients; therefore their expectation might have distorted the results.
- The acupuncture group received more treatments than the injection group; therefore the additional attention might have distorted the findings.
- Even if the results were entirely correct, one cannot conclude from them that acupuncture was effective; the notion that it was similarly ineffective as the injections is just as warranted.
These are just some of the most fatal flaws of this study. The sad thing is that similar criticisms can be made for most of the 10 000 trials of acupuncture. But the point here is not to nit-pick nor to quack-bust. My point is a different and more serious one: fatally flawed research is not just a ‘poor show’, it is unethical because it is a waste of scarce resources and, even more importantly, an abuse of patients for meaningless pseudo-science. All it does is it misleads the public into believing that acupuncture might be good for this or that condition and consequently make wrong therapeutic decisions.
In acupuncture (and indeed in most alternative medicine) research, the problem is so extremely wide-spread that it is high time to do something about it. Journal editors, peer-reviewers, ethics committees, universities, funding agencies and all others concerned with such research have to work together so that such flagrant abuse is stopped once and for all.