On this blog, we have repeatedly discussed the risks of acupuncture. Contrary to what we often hear, there clearly is potential for harm. Acupuncture is, of course most popular in China where it has been used for thousands of years. Therefore the Chinese literature, which is not easy to access for non-Chinese speakers and therefore often disregarded by Western researchers, might hold treasures of valuable information on the subject. It follows that a thorough review of this information might be helpful. A recent paper by Chinese scientists has tackled this issue.
The objective of this review was to determine the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers.
Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles.
The authors of this review concluded that qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.
This is a bizarrely disappointing article followed by a most strange conclusion. The authors totally fail to discuss the most important issue and they arrive at conclusions which, I think, make little sense.
The issue to discuss here is, of course, under-reporting. We know that under-reporting in the Western literature is already huge. For every complication reported there could easily be 10 or even 100 that go unreported. There is no monitoring system for adverse effects, and acupuncturists have no incentive to publish their mistakes. Accurate and realistic prevalence data are therefore anybody’s guess.
In China, under-reporting is likely to be one or two orders of magnitude bigger. I say this because close to zero % of all Chinese papers on acupuncture report negative findings. For China, TCM is a huge export business, and the interest in reporting adverse effects is close to zero.
Seen from this perspective, it seems at first glance laudable that the Chinese authors dared to address this thorny issue. In the text of the article, they even mention that the included complications resulted in a total of 25 fatalities! This seems courageous. But one only needs to read the full article to get a strong suspicion that the authors are either in denial about the real figures, or their paper is a deliberate attempt to ‘white-wash’ acupuncture from its potential to do harm.
In 2010, we published a very similar review of the Chinese literature (unsurprisingly, it was not cited by the authors of the new paper). At the time, we found almost 500 published cases of serious adverse events and stated that we suspect that underreporting of such events in the Chinese-language literature is much higher than in the English-language literature.
The truth is that nobody knows how frequent adverse events of acupuncture truly are in China – or most other countries, for that matter. I believe that, before we “further popularize acupuncture to the rest of the world”, it would be ethical and necessary to 1) state this fact openly and 2) do something about it.
Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.
The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.
Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.
Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.
Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.
The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.
The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.
These are odd conclusions, in my view, and I think I ought to add a few points:
- As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
- Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
- The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
- As the authors mention, it is hardly ever the chiropractor who reports a serious complication when it occurs.
- In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
- Therefore their true rate is anyone’s guess.
- As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
- Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
- Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.
And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.
Proponents of alternative medicine regularly stress the notion that their treatments are either risk-free or much safer than conventional medicine. This assumption may be excellent for marketing bogus treatments, however, it neglects that even a relatively harmless therapy can become dangerous, if it is ineffective. Here is yet again a tragic reminder of this undeniable fact.
Japanese doctors reported the case of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children.
She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival. Two weeks before her death, she had developed a fever of 39 degrees C, which subsided after the administration of a naturopathic herbal remedy. One week before death, she developed jaundice, and her condition worsened on the day of death.
Laboratory test results on admission to hospital showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.
With the current advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the child’s parents had opted for naturopathy instead of evidence-based medicine. They had not taken her to a hospital for a medical check-up or immunisation since she was an infant. If the child had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis of ALL.
The authors of this case-report concluded that the parents should be accused of medical neglect regardless of their motives.
Such cases are tragic and infuriating in equal measure. There is no way of knowing how often this sort of thing happens; we rely entirely on anecdotes because systematic research is hardly feasible.
While anecdotes of this nature have their obvious limitations, they are nevertheless important. They can serve as poignant reminders that alternative remedies might be relatively harmless, but this does not necessarily apply to all alternative practitioners. Moreover, they should make us redouble our efforts to inform the public responsibly about the all too often trivialized risks of alternative medicine.
If you ask a chiropractor, you will probably be told that chiropractic spinal manipulation is a safe treatment. Unfortunately this is not quite true, as regular readers of this blog will appreciate. About half of all patients suffer mild to moderate adverse effects after chiropractic treatments and, in addition, many instances of much more serious complications have been documented, including rare cases of Horner syndrome. It results from an interruption of the sympathetic nerve supply to the eye and is characterized by the classic triad of miosis (ie, constricted pupil), partial ptosis, and loss of hemifacial sweating (ie, anhidrosis).
Danish neurologists recently reported the case of a 60-year-old man with no relevant medical history who was admitted to the Department of Neurology with drooping of his right upper eyelid and an ipsilateral contracted pupil, combined with pain, weakness, and numbness in his upper right limb.
The patient had experienced thoracic back pain of moderate intensity with radiating right-sided belt-like chest pain for 7 days. When the discomfort suddenly intensified, he sought chiropractic treatment. Following manipulations of the thoracic and cervical spine, the pain intensity initially lessened. Approximately one hour after chiropractic treatment, the patient experienced the eye and upper limb symptoms described above, for which he sought medical assistance three days later.
A detailed neurologic examination revealed moderate right-sided ptosis and miosis, no facial anhidrosis, decreased strength of the intrinsic and opponens muscles of the right hand, and reduced cutaneous sensation corresponding to the T1 dermatome, with inability to discriminate pain and light touch. The remaining clinical examination, routine blood tests, and vital parameters were unremarkable.
Brain CT scan and CT angiography including the aortic arch and neck vessels were performed and ruled out cerebral stroke and carotid artery dissection, respectively. As clinical signs of Horner syndrome and a concomitant radiating pain to the medial arm were considered suggestive of either a lower brachial plexopathy, i.e., due to a Pancoast tumor, or a radiculopathy, chest X-ray and electroneurography (ENG) were performed. No apical pulmonary pathology was detected. ENG of the right medial cutaneous antebrachial nerve demonstrated a normal sensory action potential (SAP), consistent with the lesion being located proximally to the dorsal spinal root ganglion, thus suggestive of a spinal nerve root lesion. A subsequent MRI of the thoracic spine showed a para-median herniation of the T1-T2 intervertebral disc compressing the right T1 spinal nerve root.
The patient received no surgery, and follow-up examination 6 months later revealed near-complete recovery, with only mild paraesthesia in the T1 segment of his right arm and a subtle ptosis remaining.
Horner syndrome due to a herniated thoracic disc has only been reported 6 times in the English language literature, though never preceded by chiropractic manipulation.
One of the most frequent causes of Horner syndrome is carotid artery dissection, which may occur spontaneously or due to local trauma to the neck region. Chiropractic manipulation as an independent risk factor for neck artery dissection and a consequent stroke is a controversial topic, though multiple cases of Horner syndrome due to ICA dissections subsequent to chiropractic manipulation have been reported. In the patient described here, an ICA dissection was considered unlikely due to the concomitant prominent radiating medial brachialgia and was furthermore ruled out by a CT angiogram of the neck vessels.
This patient experienced the onset of a Horner syndrome and ipsilateral upper limb symptoms shortly after chiropractic treatment, suggesting the cervico-thoracic manipulation as the cause of or at least worsening factor in the T1-T2 disc herniation. Several cases of disc herniations following chiropractic treatment have been reported.
While the definite pathophysiologic mechanism to explain this patient’s Horner syndrome remains unclear, it seems, according to the authors of this case-report, evident that manipulations as a minimum altered the configuration of an already existing disc protrusion.
I have repeatedly stressed that herbal remedies can cause harm in a range of ways. Indian rheumatologists recently enforced this point by publishing a case-report of adrenal suppression caused by herbal remedies.
A 49-year-old male presented with polyarthritis from which he had suffered for more than 10 years. His serum cortisol levels were extremely low, he had vitamin D deficiency, and his rheumatoid factor was negative. He revealed symptoms of adrenal suppression, mainly muscle weakness and suicidal tendency, and few other psychiatric disturbances.
The patient eventually discontinued his herbal medicine. Then, he was put on deflazacort for 12 weeks at 12 mg twice daily and later the dose was tapered to 6 mg/day. Deflazocort, an intermediate-acting corticosteroid, was prescribed to minimize the probable withdrawal symptoms due to the probable presence of dexamethasone or betamethasone (long-acting steroids) presumably from the herbal medication.
The herbal samples of used by the patient was analysed by mass spectrometry. It showed the presence of steroidal compounds by the mass 393.81, which may be dexamethasone or betamethasone.
The authors of this paper believe that the symptoms of adrenal suppression could have precipitated or exacerbated the neuropsychiatric disturbances due to Hypothalamus-Pituitary-Adrenal (HPA) suppression. In their view, adrenal suppression following ingestion of herbal remedies is of major concern. Abrupt withdrawal of such products could precipitate adrenal failure which can be fatal.
It should be added, I think, that such illegal adulterations of herbal remedies have been reported with some regularity, particularly in Indian (and Chinese) preparations. Our systematic review showed that this problem has caused serious harm. The most severe documented adverse effects include agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema, coma, intracerebral haemorrhage, and death.
As under-reporting can be suspected to be huge, we do currently not know how frequent these events are.
There are things that cannot be said too often. In medicine, these are often related to issues that can save lives. In alternative medicine, it is worth remembering that there is nothing that can save more lives than the following rule: EVEN AN APPARENTLY HARMLESS REMEDY WILL BECOME LIFE-THREATENING, IF IT IS USED AS AN ALTERNATIVE TO AN EFFECTIVE THERAPY FOR A SERIOUS CONDITION.
Here is a publication that serves as a very sad reminder of this important axiom.
Japanese physicians recently published a case-report of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children. She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival.
Two weeks before her death, she had developed a fever of 39°C, which subsided after the administration of a naturopathic herbal remedy. Subsequently, she developed jaundice one week before death, and her condition worsened on the day of death.
Laboratory test results on admission showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.
With advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the deceased’s parents preferred alternative medicine to evidence-based medicine and had not taken her to a hospital for a medical check-up or immunisation since she was an infant. The authors state that, if she had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis. Therefore, we conclude that the parents should be accused of medical neglect regardless of their motives.
Alternative practitioners who treat their patients in this way, are in my experience often full of good intentions. They remind me of something Bert Brecht one wrote: THE OPPOSITE OF GOOD IS NOT EVIL, IT IS GOOD INTENTIONS.
A few years ago, I fell ill with shingles. When patients had consulted me for this condition, during the times when I still was a clinician, I always had to stop myself smiling; they complained bitterly but, really, this was far from serious. Now, affected myself, I did not smile a bit: this was incredibly painful!
I promptly saw my GP in Exeter who, to my utter amazement, prescribed paracetamol. She too seemed to think that this was really nothing to bother her with. As I had feared, the paracetamol did absolutely nothing to my pain. After a few sleepless nights, I went back and asked for something a little more effective. She refused, and I decided to change GP.
Meanwhile, we went on a scheduled holiday to France. I had hoped my shingles would come to a natural end, but my pain continued unabated. People could see it on my face; so our kind neighbour asked whether she could help. I explained the situation, and she instantly claimed to have just the right treatment for me: she knew a healer who lived just round the corner and had helped many of her friends when they had suffered from pain.
“A healer?” I asked, “you cannot be serious.” I explained that I had conducted studies and done other research into this particular subject. Without exception, the results had shown that healing is a pure placebo. “I prefer to carry on taking even something as useless as paracetamol!” I insisted.
But she would have none of it. The next time I saw her, she declared triumphantly that she had made an appointment for me, and there was no question: I had to go.
As it happened, the day before she announced this, I had met up with a doctor friend of mine who, seeing I was in agony, gave me a prescription for gabapentin. In fact, I was just on the way to the pharmacist to pick it up. Thus I was in hopeful that my ordeal was coming to an end. In this optimistic mood I thanked my neighbour for her effort and concern and said something non-committal like “we shall see”.
A few days later, we met again. By this time, the gabapentin had done it’s trick: a was more or less pain-free, albeit a little dazed from the powerful medication. When my neighbour saw me, she exclaimed: “I see that that you are much improved. Wonderful! Yesterday’s healing session has worked!!!”
In my daze, I had forgotten all about the healing, and I had, of course, not been to see the healer. She was so delighted with her coup, that I did not have the heart to tell her the truth. I only said “yes much better, merci”
These events happened a few years ago, but even today, my kind and slightly alternative neighbour believes that, despite having been highly sceptical, healing has cured me of my shingles. To my embarrassment, she occasionally mentions my ‘miraculous cure’.
One day, I must tell her the truth… on second thoughts, perhaps not, she might claim it was distant healing!
Yoga is a popular form of alternative medicine. Evidence for its effectiveness is scarce and generally far from convincing. But at least it is safe! At least this is what yoga enthusiasts would claim. Unfortunately, this is not entirely true; adverse events have also been reported with some regularity. Their frequency is, however, not known.
A new study was aimed at filling this gap. It was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
The subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.
Among 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.
The authors concluded that the results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.
I find these findings interesting and thought-provoking. The main question that they raise is, I think, the flowing: ARE THERE ANY CONDITIONS FOR WHICH YOGA DEMONSTRABLY GENERATES MORE GOOD THAN HARM?
If we listen to acupuncturists and their supporters, we might get the impression that acupuncture is totally devoid of risk. Readers of this blog will know that this is not quite true. A recent case report is a further reminder that acupuncture can cause serious complications; in extreme cases it can even kill.
A male patient in his late forties died right after an acupuncture treatment. A medico-legal autopsy disclosed severe haemorrhaging around the right vagus nerve in the neck. All other organs were normal, and laboratory findings revealed nothing significant. Thus, the authors of this case-report concluded that the man most probably died from severe vagal bradycardia and/or arrhythmia resulting from vagus nerve stimulation following acupuncture: To the best of our knowledge, this is the first report of a death due to vagus nerve injury after acupuncture.
In total, around 100 deaths have been reported after acupuncture in the medical literature. ‘This is a negligible small figure’ claim acupuncture fans. True, it is a small number, but it could just be the tip of a much larger ice-berg: there is no reporting system that could possibly pick up severe complications, and in the absence of such a scheme, nobody can name reliable incidence rates. And even if the numbers of severe complications and deaths are small – even a single fatality would seem one too many.
The deaths that are currently on record are mostly due to bilateral pneumothorax or cardiac tamponade. The present case of vagus nerve injury seems to be ‘a first’. Perhaps we should watch out for similar events?
IF WE DON’T LOOK, WE DON’T SEE.
Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.
The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.
Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.
The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.
Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.
American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.
Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.
The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.
I know what my chiropractic friends will respond to this post:
- I am alarmist,
- I cherry-pick articles that are negative for their profession,
- these cases are extreme rarities,
- conventional medicine is much more dangerous.
To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.
Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?
Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?