MD, PhD, FMedSci, FSB, FRCP, FRCPEd

acupuncture

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

I look forward to a lively discussion.

A stroke is a condition where brain cells get irreversibly damaged either by a haemorrhage in the brain or by a blood clot cutting off oxygen supply. This process leaves most patients with neurological deficits such as difficulties in moving, speaking, concentrating etc. As other parts of the brain learn to take over, these problems can partly or completely resolve themselves over time, but many patients are left with permanent handicaps. Stroke-rehabilitation can minimise these problems, and there is a long-standing debate as to which measures are most effective. Acupuncture has been discussed as a method to improve the results of stroke-rehabilitation, but the evidence is hotly disputed. This is why a new study in this area is an important contribution to our existing knowledge.

The aim of this randomised trial was to test the effectiveness of acupuncture in promoting the recovery of patients with ischaemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone. The Chinese investigators recruited 120 patients who received one of three daily treatments: 1) acupuncture, 2) physiotherapy, 3) physiotherapy combined with acupuncture. Motor function in the limbs was measured with the Fugl-Meyer assessment (FMA); the modified Barthel index (MBI) was used to rate activities of daily living; both of these measures are validated and well-established. All evaluations were performed by assessors blinded to treatment allocation.

At baseline, FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on day 28 of therapy, the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on day 56, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively. The respective MBI scores in the three groups had increased by 85.2%, 60.4%, and 63.4% at day 28 and by 108.0%, 71.2%, and 86.2% at day 56, respectively. However, FMA scores did not significantly differ between the three treatment groups on the 28th day. By the day 56, the FMA and MBI scores of the physiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group. No significant differences were seen between the combined treatment group and the other groups. The FMA subscores for the upper extremities did not show significant improvements in any group on day 56.

The authors draw the following conclusion: “Acupuncture is less effective for the outcome measures studied than is physiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these finding.”

Our own study arrived at similarly disappointing conclusions: “Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients“. Our review of all 10 sham-controlled RCTs in this area is also in line with the results of this new study: “Our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke”

I am quite sure that some acupuncture-enthusiasts will dispute this evidence. They might argue that I am too critical, the trials were not done optimally, that acupuncturists have seen plenty of good results in their clinical practice, that acupuncture is a complex intervention that does not fit into the straight jacket of an RCT, that this or that “prestigious” organisation recommends acupuncture for stroke patients, that it would be wrong not to give acupuncture a try etc. etc. I would counter that the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective and thus give false hope to severely suffering, vulnerable patients. Moreover, I would advocate using the sparse available resources to help stroke victims with treatments that demonstrably work.

I happen to be convinced that safety issues related to alternative medicine are important – very important, in fact. Therefore I will continue to report on recent publications addressing them – even at the risk of irritating a few of my readers. And here is such a recent publication:

This review, a sequel to one published 10 years ago, is an evaluation of the number and the severity of adverse events (AEs) reported after acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in 6 databases were identified and assessed by two reviewers; no Asian databases were searched and no articles were included which were in languages other than English. 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Three patients died after receiving acupuncture.

A total of 239 of infections associated with acupuncture were reported in 17 countries and regions. Korea reported 162 cases, Canada 33, Hong Kong 7, Australia 8, Japan 5, Taiwan 5, UK 4, USA 6, Spain 1, Ireland 1, France 1, Malaysia 1, Croatia 1, Scotland 1, Venezuela 1, Brazil 1, and Thailand 1. Of 38 organ or tissue injuries, 13 were pneumothoraxes; 9 were central nerve system injuries; 4 were peripheral nerve injuries; 5 were heart injuries; 7 were other injuries. These cases originated from 10 countries: 10 from South Korea, 6 from the USA, 6 from Taiwan, 5 from Japan, 3 from the UK, 2 from Germany, 2 from Hong Kong, 1 from Austria, 1 from Iran, 1 from Singapore, and 1 from New Zealand.

The authors concluded “although serious AEs associated with acupuncture are rare, acupuncture practice is not risk-free. Adequate regulation can even further minimize any risk. We recommend that not only adequate training in biomedical knowledge, such as anatomy and microbiology, but also safe and clean practice guidelines are necessary requirements and should continue to be enforced in countries such as the United States where they exist, and that countries without such guidelines should consider developing them in order to minimize acupuncture AEs.”

When I last wrote about the risks of acupuncture, I discussed a Chinese paper reporting 1038 cases of serious adverse events, including 35 fatalities. I was keen to point out that, due to under-reporting, this might just be the tip of a much bigger iceberg. Subsequently, my inbox was full with hate-mail, and comments such as this one appeared on the blog: “This is tiresome old stuff, and we have to wonder what’s wrong with Ernst that he still peddles his dubious arguments.”

I suspect that I will see similar reactions to this post. It probably does not avert the anger to point out that the authors of the new article are, in fact, proponents of acupuncture. Neither will it cool the temper of acupuncture-fans to stress that the new paper completely ignored the Chinese literature as well as articles not published in English; this means that the 1038 Chinese cases (and an unknown amount published in other languages; after all, there might be a lot of published material in Japanese, Korean or other Asian languages) would need adding to the published 308 cases summarised in the new article; and this, in turn, means that the numbers provided here are not even nearly complete. And finally, my re-publishing the conclusions from my previous post is unlikely to apease many acupuncture-enthusiasts either:

True, these are almost certainly rare events – but we have no good idea how rare they are. There is no adverse event reporting scheme in acupuncture, and the published cases are surely only the tip of the ice-berg. True, most other medical treatments carry much greater risks! And true, we need to have the right perspective in all of this!

So let’s put this in a reasonable perspective: with most other treatments, we know how effective they are. We can thus estimate whether the risks outweigh the benefit, and if we find that they do, we should (and usually do) stop using them. I am not at all sure that we can perform similar assessments in the case of acupuncture.

Having previously criticised the abundance of mostly rather meaningless surveys in alternative medicine, I now should perhaps admit to having published my fair share of such investigations. The most recent one was only just published.

The aim of this survey was to conduct a follow-up of a previous, identical investigation and to  thus ascertain changes in usage, referral rate, beliefs and attitudes towards alternative medicine during the last decade. A questionnaire was posted in 2009 to all GPs registered with the Liverpool Primary Care Trust asking them whether they treat, refer, endorse or discuss eight common alternative therapies and about their views on National Health Service (NHS) funding, effectiveness, training needs and theoretical validity of each therapy. Comparisons were made between these results and those collected 10 years ago.

The response rate was unfortunately low (32%) compared with the 1999 survey (52%). The main findings were similar as 10 years before: the most popular therapies were still acupuncture, hypnotherapy and chiropractic and the least popular were aromatherapy, reflexology and medical herbalism. GPs felt most comfortable with acupuncture and had greater belief in its theoretical validity, a stronger desire for training in acupuncture and more support for acupuncture to receive NHS funding than for the other alternative therapies. Opinions about homeopathy had become less supportive during the last 10 years. Overall, GPs were less likely to endorse alternative treatments than previously shown (38% versus 19%).

I think these findings speak for themselves. They suggest that British GPs have become more skeptical about alternative medicine in general and about homeopathy in particular. It would, of course, be interesting to know why this is so. Unfortunately we are merely able to speculate here: might it be the increasingly obvious lack of evidence and biological plausibility that matter? As a rationalist, I would hope this to be true but our data do not allow any firm conclusion.

Speaking about the data, I have to admit that they are rather soft. This was just a very small survey in one specific part of the UK. More importantly, the flaws in our investigation are fairly obvious. The most important limitation probably is the low response rate. It may be caused by a general ‘survey-fatigue’ that many GPs suffer from. Whatever the reason, it severely limits the usefulness of our paper.

So why publish the survey at all then? The answer is simple: we certainly do already have an abundance of surveys, but we have a dearth of longitudinal data. Because we employed the same methodology as 10 years ago, this investigation does provide a unique insight into what might have been happening over time – albeit with more than just a pinch of salt.

Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?

The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.

But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.

Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.

Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF

There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:

1) Acupuncture is not risk-free.

2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.

3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.

4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?

It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly  and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.

There probably is no area in health care that produces more surveys than alternative medicine. I estimate that about 500 surveys are published every year; this amounts to about two every working day which is substantially more than the number of clinical trials in this field.

I have long been critical of this ‘survey-mania’. The reason is simple: most of these articles are of such poor quality that they tell us nothing of value.

The vast majority of these surveys attempts to evaluate the prevalence of use of alternative medicine, and it is this type of investigation that I intend to discuss here.

For a typical prevalence survey, a team of enthusiastic researchers might put together a few questions and design a questionnaire to find out what percentage of a group of individuals have tried alternative medicine in the past. Subsequently, the investigators might get one or two hundred responses. They then calculate simple descriptive statistics and demonstrate that xy% (let’s assume it is 45%) use alternative medicine. This finding eventually gets published in one of the many alternative medicine journals, and everyone is happy – well, almost everybody.

How can I be such a spoil-sport and claim that this result tells us nothing of value? At the very minimum, some might argue, it shows that enthusiasts of alternative medicine are interested in and capable of conducting research. I beg to differ: this is not research, it is pseudo-research which ignores most of the principles of survey-design.

The typical alternative medicine prevalence survey has none of the features that would render it a scientific investigation:

1) It lacks an accepted definition of what is being surveyed. There is no generally accepted definition of alternative medicine, and even if the researchers address specific therapies, they run into huge problems. Take prayer, for instance – some see this as alternative medicine, while others would, of course, argue that it is a religious pursuit. Or take herbal medicine – many consumers confuse it with homeopathy, some might think that drinking tea is herbal medicine, while others would probably disagree.

2) The questionnaires used for such surveys are almost never validated. Essentially, this means that we cannot be sure they evaluate what we think they evaluate. We all know that the way we formulate a question can determine the answer. There are many potential sources of bias here, and they are rarely taken into consideration.

3) Enthusiastic researchers of alternative medicine usually use a  small convenience sample of participants for their surveys. This means they ask a few people who happen to be around to fill their questionnaire. As a consequence, there is no way the survey is representative of the population in question.

4) The typical survey has a low response rate; sometimes the response rate is not even provided or remains unknown even to the investigators. This means we do not know how the majority of patients/consumers who received but did not fill the questionnaire would have answered. Often there is good reason to suspect that those who have a certain attitude did respond, while those with a different opinion did not. This self-selection process is likely to produce misleading findings.

And why I am so sure about all of theses limitations? To my embarrassment, I know about them not least because I have made most these mistakes myself at some time in my career. You might also ask why this is important: what’s the harm in publishing a few flimsy surveys?

In my view, these investigations are regrettably counter-productive because:

they tend to grossly over-estimate the popularity of alternative medicine,

they distract money, manpower and attention from the truly important research questions in this field,

they give a false impression of a buoyant research activity,

and their results are constantly misused.

The last point is probably the most important one. The argument that is all too often spun around such survey data goes roughly as follows: a large percentage of the population uses alternative medicine; people pay out of their own pocket for these treatments; they are satisfied with them (if not, they would not pay for them). BUT THIS IS GROSSLY UNFAIR! Why should only those individuals who are rich enough to afford alternative medicine benefit from it? ALTERNATIVE MEDICINE SHOULD BE MADE AVAILABLE FOR ALL.

I rest my case.

The developed world is in the middle of a major obesity epidemic. It is predicted to cause millions of premature deaths and billions of dollars, money that would be badly needed elsewhere. The well-known method of eating less and moving more is most efficacious but sadly not very effective, that is to say people do not easily adopt and adhere to it. This is why many experts are searching for a treatment that works and is acceptable to all or at least most patients.

Entrepreneurs of alternative medicine have long jumped on this band waggon. They have learnt that the regulations are lax or non-existent, that consumers are keen to believe anything they tell them and that the opportunities to make a fast buck are thus enormous. Today, they are offering an endless array of treatments which are cleverly marketed, for instance via the Internet.

Since many years, my research team are involved in a programme of assessing the alternative slimming aids mostly through systematic reviews and occasionally also through conducting our own clinical trials. Our published analyses include the following treatments:

Phaseolus vulgaris

Supplements containing conjugated linoleic acid

Green tea

Garcinia extracts

Calcium supplements

Chromium picolinate

Guar gum

Chitosan

Acupuncture

There are, of course, many more but, for most, no evidence exist at all. The treatments listed above have all been submitted to clinical trials. The results show invariably that the outcomes were not convincingly positive: either there were too few data, or there were too many flaws in the studies, or the weight reduction achieved was too small to be clinically relevant.

Our latest systematic review is a good example; its aim was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis, for body weight reduction in obese and overweight individuals. Three RCTs were identified, and all had major methodological flaws. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. They also suggested positive effects of I. gabonensis on blood lipids. Adverse events included headache and insomnia. Despite these apparently positive findings, our conclusions had to be cautious: “Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported.”

People who want to loose weight are often extremely desperate and ready to try anything. They are thus easy victims of the irresponsible promises that are being made on the Internet and elsewhere. Despite the overwhelmingly evidence to the contrary, consumers are led to believe that alternative slimming aids are effective. What is more, they are also misled to assume they are risks-free. This latter assumption is false too: apart from the harm done to the patient’s bank account, many alternative slimming aids are associated with side-effects which, in some cases, are  serious and can even include death.

The conclusion from all this is short and simple: alternative slimming aids are bogus.

Several months ago, my co-workers and I once again re-visited the contentious issue of acupuncture’s safety. We published several articles on the topic none of which, I am afraid to say, was much appreciated by the slightly myopic world of acupuncture. The paper which created overt outrage and prompted an unprecedented amount of hate-mail was the one on deaths after acupuncture. This publication reported that around 90 fatalities associated with acupuncture had been documented in the medical literature.

The responses from acupuncturists ranged from disbelief to overt hostility. Acupuncturists the world over seemed to agree that there was something profoundly wrong with me personally and with my research; they all knew that acupuncture was entirely safe and that I was maliciously incorrect and merely out to destroy their livelihood.

So, am I alarmist or am I just doing my duty in reporting important facts? Two new articles might go some way towards answering this intriguing question.

The first is a review by Chinese acupuncturists who summarised all the adverse events published in the Chinese literature, a task which my article may have done only partially. The authors found 1038 cases of serious adverse events, including 35 fatalities. The most frequent non-fatal adverse events were syncope (468 cases), pneumothorax (307 cases), and subarachnoid hemorrhage (64 cases). To put this into context, we ought to know that the Chinese literature is hopelessly biased in favour of acupuncture. Thus the level of under-reporting can be assumed to be even larger than in English language publications.

The second new article is by a Swedish surgeon who aimed at systematically reviewing the literature specifically on vascular injuries caused by acupuncture. His literature searches found 31 such cases; the majority of these patients developed symptoms in direct connection with the acupuncture treatment. Three patients died, two from pericardial tamponade and one from an aortoduodenal fistula. There were 7 more tamponades, 8 pseudoaneurysms, two with ischemia, two with venous thrombosis, one with compartment syndrome and 7 with bleeding (5 in the central nervous system). The two patients with ischemia suffered lasting sequeleae.

The answer to the question asked above seems thus simple: the Chinese authors, the Swedish surgeon (none of whom I know personally or have collaborated with) and I are entirely correct and merely report the truth. And the truth is that acupuncture can cause severe complications through any of the following mechanisms:

1) puncturing the lungs resulting in a pneumothorax,

2) puncturing the heart causing a cardiac tamponade,

3) puncturing blood vessels causing haemorrhage,

4) injuring other vital structures in the body,

5) introducing bacteria or viruses resulting in infections.

Any of these complications can be severe and might, in dramatic cases, even lead to the death of the patient.

But we have to have the right perspective! These are extremely rare events! Most other treatments used in medicine are much much more risky! To keep banging on about such exotic events is not helpful! I can hear the acupuncture world shout in unison.

True, these are almost certainly rare events – but we have no good idea how rare they are. There is no adverse event reporting scheme in acupuncture, and the published cases are surely only the tip of the ice-berg. True, most other medical treatments carry much greater risks! And true, we need to have the right perspective in all of this!

So let’s put this in a reasonable perspective: with most other treatments, we know how effective they are. We can thus estimate whether the risks outweigh the benefit, and if we find that they do, we should (and usually do) stop using them. I am not at all sure that we can perform similar assessments in the case of acupuncture.

Clinical trials of acupuncture can be quite challenging. In particular, it is often difficult to make sure that any observed outcome is truly due to the treatment and not caused by some other factor(s). How tricky this can be, shows a recently published study.

A new RCT has all (well, almost all) the features of a rigorous study. It tested the effects of acupuncture in patients suffering from hay fever. The German investigators recruited 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. In total, 422 patients with IgE sensitization to birch and grass pollen were randomized into three groups: 1) acupuncture plus rescue medication (RM) (n= 212), 2) sham acupuncture plus RM (n= 102), or 3) RM alone (n= 108). Twelve acupuncture sessions were provided in groups 1 and 2 over 8 weeks. The outcome measures included changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMs) from baseline to weeks 7, 8 and 16 in the first year as well as week 8 in the second year after randomization.

Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score and RMS. There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over  sham were noted.

Based on these results, the authors concluded that “acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

The popular media were full of claims that this study proves the efficacy of acupuncture. However, I am not at all convinced that this conclusion is not hopelessly over-optimistic.

It might not have been the acupuncture itself that led to the observed improvements; they could well have been caused by several factors unrelated to the treatment itself. To understand my concern, we need to look closer at the actual interventions employed by the investigators.

The real acupuncture was done on acupuncture points thought to be indicated for hay fever. The needling was performed as one would normally do it, and the acupuncturists were asked to treat the patients in  group 1 in such a way that they were likely to experience the famous ‘de-qi’ feeling.

The sham acupuncture, by contrast, was performed on non-acupuncture points; acupuncturists were asked to use shallow needling only and they were instructed to try not to produce ‘de-qi’.

This means that the following factors in combination or alone could have caused [and in my view probably did cause] the observed differences in outcomes between the acupuncture and the sham group:

1) verbal or non-verbal communication between the acupuncturists and the patient [previous trials have shown this factor to be of crucial importance]

2) the visibly less deep needling in the sham-group

3) the lack of ‘de-qi’ experience in the sham-group.

Sham-treatments in clinical trials serve the purpose of a placebo. They are thus meant to be indistinguishable from the verum. If that is not the case [as in the present study], the trial cannot be accepted as being patient-blind. If a trial is not patient-blind, the expectations of patients will most certainly influence the results.

Therefore I believe that the marginal differences noted in this study were not due to the effects of acupuncture per se, but were an artifact caused through de-blinding of the patients. De facto, neither the patients nor the acupuncturists were blinded in this study.

If that is true, the effects were not just not clinically relevant, as noted by the authors, they also had nothing to do with acupuncture. In other words, acupuncture is not of proven efficacy for this condition – a verdict which is also supported by our systematic review of the subject which concluded that “the evidence for the effectiveness of acupuncture for the symptomatic treatment or prevention of allergic rhinitis is mixed. The results for seasonal allergic rhinitis failed to show specific effects of acupuncture…”

Once again, we have before us a study which looks impressive at first glance. At closer scrutiny, we find, however, that it had important design flaws which led to false positive results and conclusions. In my view, it would have been the responsibility of the authors to discuss these limitations in full detail and to draw conclusions that take them into account. Moreover, it would have been the duty of the peer-reviewers and journal editors to pick up on these points. Instead the editors even commissioned an accompanying editorial which displays an exemplary lack of critical thinking.

Having failed to do any of this, they are in my opinion all guilty of misleading the world media who reported extensively and often uncritically on this new study thus misleading us all. Sadly, the losers in this bonanza of incompetence are the many hay fever sufferers who will now be trying (and paying for) useless treatments.

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