MD, PhD, FMedSci, FSB, FRCP, FRCPEd

case report

Upper spinal manipulation, the signature-treatment of many chiropractors is by no means free of serious risks. Most chiropractors negate this, but can any reasonable person deny it? Neurosurgeons from New York have just published an interesting case-report in this context:

A 45 year old male with presented to his internist with a two-week history of right sided neck pain and tenderness, accompanied by tingling in the hand. The internists’ neurological examination revealed nothing abnormal, except for a decreased range of motion of the right arm. He referred the patient to a chiropractor who performed plain X-rays which apparently showed “mild spasm” (how anyone can see spasm on an X-ray is beyond me!). No magnetic resonance imaging study was done.

The chiropractor proceeded manipulating the patient’s neck on two successive days. By the morning of the third visit, the patient reported extreme pain and difficulty walking. Without performing a new neurological examination or obtaining a magnetic resonance study, the chiropractor manipulated the patient’s neck for a third time.

Thereafter, the patient immediately became quadriplegic. Despite undergoing an emergency C5 C6 anterior cervical diskectomy/fusion to address a massive disc found on the magnetic resonance scan, the patient remained quadriplegic. There seemed to be very little doubt that the quadriplegia was caused by the chiropractic spinal manipulation.

The authors of this report also argue that a major point of negligence in this case was the failure of both the referring internist and chiropractor to order a magnetic resonance study of the cervical spine prior to the chiropractic manipulations. In his defence, the internist claimed that there was no known report of permanent quadriplegia resulting from neck manipulation in any medical journal, article or book, or in any literature of any kind or on the internet. Even the quickest of literature searches discloses this assumption to be wrong. The first such case seems to have been published as early as 1957. Since then, numerous similar reports have been documented in the medical literature.

The internist furthermore claimed that the risk of this injury must be vanishingly small given the large numbers of manipulations performed annually. As we have pointed out repeatedly, this argument is pure speculation; under-reporting of such cases is huge, and therefore exact incidence figures are anybody’s guess.

The patient sued both the internist and the chiropractor, and the total amount of the verdict was $14,596,000.00 the internist’s liability was 5% ($759,181.65).

On this blog, we have repeatedly discussed the serious adverse effects of Spinal Manipulative Therapies (SMT) as frequently administered by chiropractors, osteopaths and physiotherapists. These events mostly relate to vascular accidents involving vertebral or carotid arterial dissections after SMT of the upper spine. Lower down, the spine is anatomically far less vulnerable which, however, does not mean that injuries in this region after SMT are impossible. They have been reported repeatedly but, to the best of my knowledge, there is no up-to-date review of such events – that is until recently.

Australian researchers have just filled this gap by publishing a systematic review aimed at systematically reviewing all reports of serious adverse events following lumbo-pelvic SMT. They conducted electronic searches in MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012. Article-selection was performed by two independent reviewers using predefined criteria. Cases were included involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that resulted in death or was life threatening, required hospital admission, or resulted in significant or permanent disability. Reports published in English, German, Dutch, and Swedish were included.

The searches identified a total of 2046 papers, and 41 articles reporting a total of 77 cases were included in the review. Important case details were frequently missing in these reports, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome.

The 77 adverse events consisted of cauda equina syndrome (29 cases); lumbar disk herniation (23 cases); fracture (7 cases); haematoma or haemorrhagic cyst (6 cases); and12 cases of neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and oesophageal rupture.

The authors’ conclusion was that this systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbo-pelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review.

This review is timely and sound. Yet several factors need consideration:

1) The search strategy was thorough but it is unlikely that all relevant articles were retrieved because these papers are often well-hidden in obscure and not electronically listed journals.

2) It is laudable that the authors included languages other than English but it would have been preferable to impose no language restrictions at all.

3) Under-reporting of adverse events is a huge problem, and it is anyone’s guess how large it really is [we have shown that, in our research it was precisely 100%]

4) This means that the 77 cases, which seem like a minute number, could in reality be 770 or 7700 or 77000; nobody can tell.

Cauda equina (horse tail) syndrome was the most frequent and most serious adverse event reported. This condition is caused by nerve injury at the lower end of the spinal canal. Symptoms can include leg pain along the sciatic nerve, severe back pain, altered or loss of sensation over the area around the genitals, anus and inner thighs as well as urine retention or incontinence and faecal incontinence. The condition must be treated as an emergency and usually requires surgical decompression of the injured nerves.

Disk herniation, the second most frequent adverse event, is an interesting complication of SMT. Most therapists using SMT would probably claim (no, I have no reference for that speculation!) that they can effectively treat herniated disks with SMT. The evidence for this claim is, as far as I know, non-existent. In view of the fact that SMT can actually cause a disk to herniate, I wonder whether SMT should not be contra-indicated for this condition. I am sure there will be some discussion about this question following this post.

The authors make a strong point about the fact that case reports never allow causal inference. One can only agree with this notion. However, the precautionary principle in medicine also means that, if case reports provide reasonable suspicion that an intervention might led to adverse-effects, we need to be careful and should warn patients of this possibility. It also means that it is up to the users of SMT to demonstrate beyond reasonable doubt that SMT is safe.

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.

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.

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.

In 2010, I have reviewed the deaths which have been reported after chiropractic treatments. My article suggested that 26 fatalities had been published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery. Whenever I write about the risks of spinal manipulation, chiropractors say that I am irresponsible and alarmist. Yet I believe I am merely doing my duty in alerting health care professionals and the public to the possibility that this intervention is associated with harm and that caution is therefore recommended.

Fortunately, I am not alone, as a new report from China shows.This review summarised published cases of injuries associated with cervical manipulation in China, and to describe the risks and benefits of the therapy.

A total of 156 cases met the inclusion criteria. They included the following problems: syncope = 45 cases , mild spinal cord injury or compression = 34 cases, nerve root injury = 24 cases, ineffective treatment or symptom increased = 11 cases ; cervical spine fracture = 11 cases, dislocation or semiluxation = 6 cases, soft tissue injury = 3 cases, serious accident = 22 cases including paralysis, death and cerebrovascular accident. Manipulation including rotation was involved in 42.00%, 63 cases). 5 patients died.

The authors conclude that “it is imperative for practitioners to complete the patients’ management and assessment before manipulation. That the practitioners conduct a detailed physical examination and make a correct diagnosis would be a pivot method of avoiding accidents. Excluding contraindications and potential risks, standardizing evaluation criteria and practitioners’ qualification, increasing safety awareness and risk assessment and strengthening the monitoring of the accidents could decrease the incidence of accidents” (I do apologize for the authors’ poor English).

It is probable that someone will now calculate that the risk of harm is minute. Chinese traditional healers seem to use spinal manipulation fairly regularly, so the incidence of complications would be one in several millions.

Such calculations are frequently made by chiropractors in an attempt to define the incidence rates of risks associated with chiropractic in the West. They look convincing but, in fact, they are complete nonsense.

The reason is that under-reporting can be huge. Clinical trials of chiropractic often omit any mention of adverse effects (thus violating publication ethics) and, in our case-series, under-reporting was precisely 100% (none of the cases we discovered had been recorded anywhere). This means that these estimates are entirely worthless.

I sincerely hope that the risk turns out to be extremely low – but without a functioning reporting system for such events, we might as well read tea-leaves.

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