A case report was published of a 35-year-old Chinese man with no risk factors for stroke. He presented with a 2-day history of expressive dysphasia and a 1-day history of right-sided weakness. The symptoms were preceded by multiple sessions of the neck, shoulder girdle, and upper back massage for pain relief in the prior 2 weeks. A CT-scan of the brain demonstrated an acute left middle cerebral artery infarct and left internal carotid artery dissection. The MRI cerebral angiogram confirmed left carotid arterial dissection and intimal oedema of bilateral vertebral arteries. In the absence of other vascular comorbidities and risk factors, massage-induced internal carotid arterial dissection was deemed to be the most likely cause of the near-fatal cerebrovascular event.
INSIDER reported further details of the case: the patient told the doctors who treated him that he had seen the chiropractor for two weeks before he experienced trouble reading, writing and talking. After experiencing those symptoms for two days and one day of pain on his right side, a friend convinced the patient to consult a neurologist. This led to the hospital admission, the above-named tests, and diagnosis. After three months of therapy and rehab, the patient showed “significant improvement,” according to the doctors.
What remains unclear is the exact nature of the neck treatment that is believed to have caused the arterial dissection. A massage is mentioned but massages have rarely been associated with such problems. Neck manipulations, on the other hand, are the hallmark therapy of chiropractors and have, as I have pointed out regularly, often been reported to cause arterial dissections.
Chiropractors usually deny this fact; alternatively, they claim that only poorly trained practitioners cause these adverse events or that their frequency is exceedingly small. However, without a proper post-marketing surveillance system, this argument is hardly convincing.
Former chiropractor Malcolm Hooper, 61, and hyperbaric oxygen therapy provider Oxymed Pty Ltd have been fined following the death of a customer in 2016. They were each convicted of three work safety-related charges, all of failing to ensure a workplace is safe and without risks to health. Hooper was fined $176,750, while the company was fined $550,000. Oxymed was trading as HyperMed at its South Yarra premises in April 2016 when a long-term client with multiple sclerosis and a history of life-threatening seizures came in for treatment. He was later found unconscious in a single-person hyperbaric chamber, taken to hospital, and placed on life support, but died five days later.
The County Court heard that both the company and Hooper had an inadequate system in place for assessing the risks oxygen therapy could pose to clients, and an inadequate system too for developing plans to eliminate or reduce those risks. In her judgment, County Court judge Amanda Fox said HyperMed wasn’t a hospital nor a medical practice and had been described as an “alternative health facility”. Hooper had already been deregistered in 2013 by the national board for chiropractors for misleading and deceptive advertising about the benefits of hyperbaric treatment.
Hyperbaric oxygen therapy involves administering pure oxygen in a pressurised environment, with the heightened air pressure allowing a patients’ lungs to gather much more oxygen than would be possible under normal conditions. The therapy is not based on strong data. A systematic review failed to find good evidence for hyperbaric oxygen therapy as a treatment of multiple sclerosis:
Multiple sclerosis (MS) is a chronic, inflammatory, and degenerative neurological illness with no cure. It has been suggested that Hyperbaric Oxygen Therapy (HBO(2)T) may slow or reverse the progress of the disease. This article summarizes the clinical evidence for the use of HBO(2)T in the treatment of MS. We conducted a literature review focused on the interaction of hyperbaric oxygenation and MS. In particular, we appraised the clinical data regarding treatment and performed a meta-analysis of the randomized evidence using the methodology of the Cochrane Collaboration. We found 12 randomized studies in the area, all of which were performed between 1983 and 1987. A meta-analysis of this evidence suggests there is no clinically significant benefit from the administration of HBO(2)T. The great majority of randomized trials investigated a course of 20 treatments at pressures between 1.75ATA and 2.5ATA daily for 60-120 min over 4 weeks against a placebo regimen. None have tested the efficacy of HBO(2)T against alternative current best practice. No plausible benefit of HBO(2)T on the clinical course of MS was identified in this review. It remains possible that HBO(2)T is effective in a subgroup of individuals not clearly identified in the trials to date, but any benefit is unlikely to be of great clinical significance. There is some case for further human trials in selected subgroups and for prolonged courses of HBO(2)T at modest pressures, but the case is not strong. At this time, the routine treatment of MS with HBO(2)T is not recommended.
The case reminds me of that of John Lawler. Mr. Lawlwer’s chiropractor also used a therapy that was not indicated, broke his neck (to put it crudely), and subsequently proved herself more than inept in saving his life. It suggests to me that some chiros may not be trained adequately to deal with emergencies. If that is true, they should perhaps focus less on practice-building courses and more on first aid instructions.
This retrospective electronic medical record data analysis compared the characteristics and outcomes of drug-induced liver injury (DILI) caused by paracetamol and non-paracetamol medications, particularly herbal and dietary supplements. Adults admitted with DILI to the Gastroenterology and Liver Centre at the Royal Prince Alfred Hospital, Sydney (a quaternary referral liver transplantation centre), 2009-2020 were included. The 90-day transplant-free survival and the drugs implicated as causal agents in DILI were extracted from the records.
A total of 115 patients with paracetamol-related DILI and 69 with non-paracetamol DILI were admitted to our centre. The most frequently implicated non-paracetamol medications were:
- antibiotics (19, 28%),
- herbal and dietary supplements (15, 22%),
- anti-tuberculosis medications (6, 9%),
- anti-cancer medications (5, 7%).
The number of non-paracetamol DILI admissions was similar across the study period, but the proportion linked with herbal and dietary supplements increased from 2 of 11 (15%) during 2009-11 to 10 of 19 (47%) during 2018-20 (linear trend: P = 0.011). Despite higher median baseline model for end-stage liver disease (MELD) scores, 90-day transplant-free survival for patients with paracetamol-related DILI was higher than for patients with non-paracetamol DILI (86%; 95% CI, 79-93% v 71%; 95% CI, 60-82%) and herbal and dietary supplement-related cases (59%; 95% CI, 34-85%). MELD score was an independent predictor of poorer 90-day transplant-free survival in both paracetamol-related (per point increase: adjusted hazard ratio [aHR], 1.19; 95% CI, 1.09-3.74) and non-paracetamol DILI (aHR, 1.24; 95% CI, 1.14-1.36).
The authors concluded that, in our single centre study, the proportion of cases of people hospitalised with DILI linked with herbal and dietary supplements has increased since 2009. Ninety-day transplant-free survival for patients with non-paracetamol DILI, especially those with supplement-related DILI, is poorer than for those with paracetamol-related DILI.
A co-author of the paper, specialist transplant hepatologist Dr Ken Liu, was quoted in the Guardian saying he felt compelled to conduct the study because he was noticing more patients with liver injuries from drugs not typically associated with liver harm. “I was starting to see injury in patients admitted with liver injury after using bodybuilding supplements for males or weight loss supplements in females,” he said. “I just decided I better do a study on it to see if my hunch that more of these substances were causing these injuries was true.”
Liu and his colleagues said there needed to be more rigorous regulatory oversight for supplements and other alternative and natural therapies. They also noticed almost half the patients with supplement-induced severe liver injury had non-European ethnic backgrounds. Liu said more culturally appropriate community education about the risks of supplements was needed.
Dr Ken Harvey, public health physician and president of Friends of Science in Medicine, said it was important to note that Liu’s study only examined the most severe cases of supplement-induced liver harm and that the actual rate of harm was likely much higher. “The study only examines severe cases admitted to a specialised liver unit; they cannot be extrapolated to the overall incidence of complementary medicine associated liver injury in Australia,” Harvey said.
The Royal Australian College of General Practitioners, Choice, Friends of Science in Medicine and others have called for an educational statement on the pack and promotional material of medicines making traditional claims, for example saying “This product is based on traditional beliefs and not modern scientific evidence”.
“This was opposed by industry and the TGA,” Harvey said. “But is still needed.”
Tinospora cordifolia, a plant used in Ayurvedic medicine, is a widely grown glabrous, deciduous climbing shrub which has been described in traditional medicine texts to have a long list of health benefits. It contains diverse phytochemicals, including alkaloids, phytosterols, glycosides. Preparations utilize the stem and root of the plant which is consumed in the form of capsules, powder, or juice or in an unprocessed form. Its benefits are said to include anti-inflammatory, anti-pyretic properties, anti-viral and anti-cancer, and immune-boosting properties. The latter alleged activity made it popular during the pandemic. Indian researchers recently reported 6 patients who presented with liver injuries after taking Tinospora cordifolia.
A previously healthy 40- year-old male without comorbidities, presented with jaundice of 15 days duration. On persistent probing, he gave a history of consumption of TC plant twigs (10 to 12 pieces) boiled with cinnamon and cloves in half a glass of water, once in two days for 3 months prior to presentation. USG of the abdomen was unremarkable. He underwent a percutaneous liver biopsy which showed features of the hepatocellular pattern of liver injury – with lymphoplasmacytic cell infiltrate, interface hepatitis, and foci of necrosis – suggesting the diagnosis of DILI with autoimmune features. He was managed with standard medical treatment (SMT) which included multivitamins and ondansetron for associated nausea. He was followed up for 5 months till the complete resolution of symptoms and normalization of liver function.
A 54- year -old female, with type 2 diabetes mellitus, presented with jaundice for 1 week. A 7-month history of unsupervised consumption of TC plant (1 twig per day), which was boiled and extract consumed – was obtained. Evaluation for cause revealed a positive ANA (1:100), negative ASMA, negative viral markers, and normal IgG. USG features showing a liver with coarse echotexture, spleen of 13.4 cm, and minimal free fluid in the abdomen. A percutaneous liver biopsy showed a mixed pattern of liver injury (hepatocellular and cholestatic) with features of lymphocytic, neutrophilic and eosinophilic infiltrate, prominent interface hepatitis, intracytoplasmic and canalicular cholestasis, and altered architecture. She was managed with SMT. In view of chronicity, she was started on oral prednisolone in a dose of 40 mg which was tapered over a period of 10 weeks following which there was the resolution of her symptoms, improvement in LFTs and she was advised regular follow up.
A 38- year-male with Beta-thalassemia minor presented with jaundice of 1-week duration. He gave a history of consumption of 3-4 TC plant twigs – boiled and extract consumed 15 ml/day for 6 months prior to presentation. Work up for the etiology showed a positive ANA (1:100). USG showed hepatomegaly (16 cm) with diffuse fatty infiltration and splenomegaly (17.3 cm). A percutaneous liver biopsy suggested the diagnosis of drug-induced hepatitis with a hepatocellular pattern of liver injury along with moderate lymphocytic infiltrate admixed with plenty of eosinophils and few plasma cells, mild interface hepatitis. He was managed with SMT and followed up until complete resolution of symptoms and LFTs.
A 62- year-old female with type 2 diabetes mellitus, presented with complaints of malaise, reduced appetite and yellowish discoloration of urine, eyes, and skin with abdominal distension for 15 days. She confirmed consumption of commercially available syrup containing TC plant – 15 ml/day, every alternate day for a month, prior to the onset of her symptoms. Investigations revealed a positive ANA (1:320) and ASMA. Imaging showed hepatomegaly and ascites. A trans-jugular liver biopsy suggested a diagnosis of autoimmune hepatitis suggested by lymphoplasmacytic infiltrate with eosinophils and neutrophils, as well as interface hepatitis. There was also cirrhosis suggested by marked lobular disarray, pseudo-glandular transformation, and bridging hepatic fibrosis. She was treated with standard medical therapy including a low salt diet and diuretics for ascites and started on oral prednisolone 40 mg per day. She initially showed clinical improvement and improving trends of LFTs. However, on tapering of steroids, she came back with increasing ascites and oliguria and succumbed to hepato-renal syndrome around 120 days from the first presentation.
A 56- year-old female with hypothyroidism presented with yellowish discoloration of urine and eyes. A short, 3-week history of consumption of TC plant boiled extract of 1 twig, 2 to 3 days/week was obtained. Standard investigations for etiology were negative except for a high serum IgG of 2570 mg/dl. The auto-immune markers were negative. USG showed mild ascites, nodular liver, and spleen of 12.3 cm. A trans-jugular liver biopsy showed lymphoplasmacytic infiltrate admixed with plasma cells and eosinophils, moderate interface hepatitis, fibrosis, and altered architecture suggestive of auto-immune cirrhosis. SMT and tapering doses of prednisolone starting with 40 mg orally over 6 weeks led to the resolution of symptoms with the improvement of LFT. She was continued on a maintenance dose of steroids and advised to close follow-up.
A 56- year-old female, with hypothyroidism presented with jaundice of 20 days duration. History of TC plant formulation in the form of commercially available tablets – 1 pill a day, for 3 months prior to presentation was obtained. Routine evaluation for the cause of liver injury showed a weakly positive ASMA and a high serum IgG (2045 mg/dl). ANA was negative. USG showed diffuse heterogeneous echotexture of liver and normal-sized spleen. A percutaneous liver biopsy showed chronic hepatitis with lymphoplasmacytic infiltrate, interface hepatitis with significant bridging fibrosis suggesting the possibility of autoimmune hepatitis. She was managed with SMT, leading to complete symptomatic and biochemical resolution. There was no relapse of hepatitis after stopping TC and a follow-up of 2 months.
The authors believe that the liver injury seen in these patients was caused by autoimmune-like hepatitis due to consumption of TC, or the unmasking of latent chronic auto-immune liver disease. Most drug-induced autoimmune liver injuries are an acute idiosyncratic reaction which was also supported by the fact that one patient taking the drug for only 3 weeks on alternate days.
“Working well for him…” That was the response to my tweet yesterday about cupping for Olympic swimmers. I had tweeted this picture showing one swimmer’s cupping marks (similar signs currently are currently being displayed by several competitors in Tokyo).
I had added to the tweet my post from 2018 which failed to show that cupping is an effective means of improving athletic performance.
The response ‘WORKING WELL FOR HIM..’ irritated me (not that it has the slightest importance) and made me think how prone we all are to find causal relationships where there are, in fact, none (which might have more importance). I feel that we must, as intelligent humans, do more to fight this reflex.
In 2008, just before Simon Singh and I published ‘TRICK OT TREATMENT?‘, I broke my left shoulder. It was stupid, painful, unpleasant, and most annoying. Yet, it coincided with a very nice publishing success: our book received plenty of praise and was translated into about 20 languages.
So, should we recommend to all authors who are about to publish a book that they break their left shoulder? I think we can probably agree that this would be absurd.
But why do many people who see the cupping-marked Olympic athletes think that cupping is WORKING WELL FOR THEM? I know, it is tempting to think that they know best, and they must have tested it, etc. But why not rather consult the evidence? Why not rather question the plausibility of cupping as a means to improve performance? Why not rather consider that athletes do all sorts of weird, irrational things that make them feel a little more secure?
Frankly, the evidence that breaking your arm makes you publish a decent book is just as sound as the evidence that cupping improves the speed of swimmers. My advice, therefore, is to resist quick thinking where slow thinking including asking probing questions and consulting the evidence is indicated.
Spinal manipulation therapy (SMT) is widely used worldwide to treat musculoskeletal and many other conditions. The evidence that it works for any of them is weak, non-existent, or negative. What is worse, SMT can – as we have discussed so often on this blog – cause adverse events some of which are serious, even fatal.
Spinal epidural hematoma (SEH) caused by SMT is a rare emergency that can cause neurological dysfunction. Chinese researchers recently reported three cases of SEH after SMT.
- The first case was a 30-year-old woman who experienced neck pain and numbness in both upper limbs immediately after SMT. Her symptoms persisted after 3 d of conservative treatment, and she was admitted to our hospital. Magnetic resonance imaging (MRI) demonstrated an SEH, extending from C6 to C7.
- The second case was a 55-year-old man with sudden back pain 1 d after SMT, numbness in both lower limbs, an inability to stand or walk, and difficulty urinating. MRI revealed an SEH, extending from T1 to T3.
- The third case was a 28-year-old man who suddenly developed symptoms of numbness in both lower limbs 4 h after SMT. He was unable to stand or walk and experienced mild back pain. MRI revealed an SEH, extending from T1 to T2.
All three patients underwent surgery after failed conservative treatment and all recovered to ASIA grade E on day 5, 1 wk, and day 10 after surgery, respectively. All patients returned to normal after 3 mo of follow-up.
The authors concluded that SEH caused by SMT is very rare, and the condition of each patient should be evaluated in full detail before operation. SEH should be diagnosed immediately and actively treated by surgery.
These cases might serve as an apt reminder of the fact that SMT (particularly SMT of the neck) is not without its dangers. The authors’ assurance that SEH is VERY RARE is a little puzzling, in my view (the paper includes a table with all 17 previously published cases). There is, as we often have mentioned, no post-marketing surveillance, surgeons only see those patients who survive such complications long enough to come to the hospital, and they publish such cases only if they feel like it. Consequently, the true incidence is anyone’s guess.
As pointed out earlier, the evidence that SMT might be effective is shaky for most indications. In view of the potential for harm, this can mean only one thing:
The risk/benefit balance for SMT is not demonstrably positive.
In turn, this leads to the conclusion that patients should think twice before having SMT and should inquire about other therapeutic options that have a more positive risk/benefit balance. Similarly, the therapists proposing SMT to a patient have the ethical and moral duty to obtain fully informed consent which includes information about the risk/benefit balance of SMT and other options.
I have often warned that, even if chiropractic manipulations were harmless (which they are clearly not), this would not necessarily apply to those who administer them, the chiropractors. They can do harm via interfering or advising against conventional interventions (the best-research example is immunization) or by treating conditions that they are not competent to tackle (like ear infections), or giving advice that endangers the health of the patient.
Italian authors reported the case of a 67-year-old woman, who had been suffering from low back pain due to herniated discs, decided to undergo chiropractic treatment. According to the chiropractor’s prescription, the patient drank about 8 liters of water in a day. During the afternoon, she developed headaches, nausea, vomiting, and fatigue, for which reason she consulted the chiropractor, who reassured the patient and suggested continuing the treatment in order to purify the body. The next day, following the intake of another 6 liters of water, the patient developed sudden water retention, loss of consciousness, and tonic-clonic seizures; for this reason, she was admitted to the Intensive Care Unit with a coma from electrolyte alterations.
The diagnosis of water intoxication was stated based on the history reported by the family members; according to the clinical findings, the hydro-electrolytic alterations were adequately corrected, allowing the disease resolution. Once resolved the intoxication, the patient underwent surgery to treat a shoulder dislocation and a humerus fracture which occurred due to a fall consequent to the tonic-clonic seizures.
The Judicial Authority thus ordered a medico-legal evaluation of the chiropractor’s behavior in order to identify any professional liability issue.
The Italian authors commented that this case is peculiar since it shows the dangerous implications for the patients’ health and safety deriving from the prescription of a large quantity of water intake, without any control by the chiropractor, and thus underestimating the risks of such a practice, as evidenced by the suggestion to continue the water intake aiming to detoxify the body from pharmacological substances. As a consequence, the patient developed a severe form of hyponatremia, leading to life-threatening complications that could have been otherwise avoided.
The medico-legal evaluation of the case led to the admission of professional liability of the chiropractor, who
thus had to pay the damages to the patient.
It is, of course, tempting to argue that the patient was not very clever to follow this ridiculous advice (and that the chiropractor was outright stupid to give it). One might even go further and argue that most patients trusting chiros are not all that smart … one could … but it is far from me to do so.
Some time ago, we published a systematic review of adverse effects of homeopathic remedies. It prompted a spade of angry letters to the editor essentially claiming that homeopathic are so dilute that they cannot possibly cause problems. But they can! And here is another case in point.
It has been reported that, in Germany, several patients suffered from adverse effects such as visual disturbances and dry mouth after taking a homeopathic atropine remedy purchased from a pharmacy.
A 56-year-old man experienced taste and visual disturbances and drowsiness about 15 minutes after taking 30 drops of a homeopathic solution prepared at the pharmacy. Two further patients also experienced increased symptoms of malaise, slurred speech, dry mouth, hypertension, and dizziness after taking the homeopathic product. In each case, the symptoms improved one to two days after discontinuation of intake. In one case, the effects were observed again after repeated intake.
The pharmacy prepared the homeopathic prescriptions on the prescription of a Heilpraktiker. For this purpose, the pharmacy first diluted an Atropinum sulfuricum D4 dilution in a ratio of 1:10. The diluted solution was then added to three other OTC homeopathics. The proportion of the diluted solution was 50 percent (M/M) in each case.
Laboratory analyses found an increased atropine content of up to a factor of 800 in all the solutions tested. It was determined that the pharmacy’s manufacturing process was not the cause of the problem. The steps taken to produce the homeopathic remedy were demonstrably correct.
Eventually, the company that supplied the atropine solution discovered a mix-up: what was declared to be a D4 dilution was in fact the mother tincture of atropine, i.e. undiluted substance. The pharmacist had therefore used the mother tincture instead of the D4 dilution to prepare the formulations.
The story shows that, unsurprisingly, the quality control of homeopathic remedies can be deficient. When this happens, remedies that should contain nothing suddenly contain something. It is, I think, indisputable that this has the potential to harm patients. And this leads me to the conclusions that:
- homeopathic remedies are dangerous when they contain nothing because they leave illness untreated;
- homeopathic remedies are dangerous when they contain something because they may poison patients.
An article in the Daily Mail (I know, not my favorite newspaper either) reported about a UK court case against the father of an 11-year-old daughter who objected to her being given conventional life-saving treatments for her leukemia. The man was said to be worried about possible side effects and wanted to explore homeopathic and natural therapies, while his estranged wife favored the conventional approach.
Mr Justice Hayden decided that there is ‘no basis’ for the man’s homeopathic option and that specialists can lawfully carry out the conventional treatments. But the father said he believed that previous chemotherapy had already weakened his daughter’s immune system and that the conventional treatment proposed has further side effects. He, therefore, wanted to try homeopathic and natural therapies, including ozone therapy. ‘I am not waiting for her to deteriorate and get worse,’ he told the judge. ‘Chemotherapy is not the only way. There are so many other different therapies I am hoping to try – anything as long as it doesn’t really affect her.’
A specialist treating the girl told the judge that the treatments proposed are the best option and that they know of no homeopathic options which would help. Mr Justice Hayden approved Great Ormond Street’s plan and said doctors should start the treatments as soon as possible. ‘If she receives no treatment then her life expectancy is weeks,’ he said. ‘There is no basis for the father’s homeopathic option.’
This case highlights the indirect risks of homeopathy and similar treatments in an exemplary fashion. The therapies per se might be harmless but the therapists are clearly not. There are enough homeopaths who are deluded enough to persuade their patients that homeopathy can alter the natural history of even serious conditions such as cancer. And, as we have discussed recently, these irresponsible fools are not just from the ranks of the lay-homeopaths (homeopaths who have not been to medical school) who might not know better; they also include medically trained homeopaths and even professors at leading medical schools.
The Higher Administrative Court of Bremen has rejected as inadmissible the application for a judicial review by a Bremen physician against the deletion of the ‘HOMEOPATHY’-title from the further training regulations of the Bremen Medical Association (decision of June 2, 2021). Thus, the new regulation for postgraduate training of the Bremen Medical Association without the additional designation of homeopathy has been upheld.
“We are very pleased that the Court shares our legal opinion and has rejected the plaintiff’s application,” said Heike Delbanco, Chief Executive Officer of the Bremen Medical Association. “This is also a clear signal for other German medical associations where comparable lawsuits against the removal of homeopathy from the canon of additional designations are pending.”
The Assembly of Delegates of the Medical Association had decided in September 2019 on a new training regulation, which – unlike the previous regulation – no longer provided for the postgraduate training in homeopathy. After the expiry of a transitional period, the qualification of homeopathy can therefore no longer be acquired at the Bremen Medical Association; however, titles already acquired can continue to be held.
A physician from Bremen, who holds the title of homeopathy, brought an action before the Higher Administrative Court against the cancellation of the additional title. He claimed that the removal of the additional designation from the continuing education regulations interfered with his fundamental right to freedom of profession and his fundamental right to property and complained of a violation of the general principle of equality. The medical association considered the action inadmissible.
The Higher Administrative Court now rejected the application, since a violation of the plaintiff’s rights could not be recognized. The plaintiff can continue to use his title HOMEOPATHY also under the new regulations.
The expectations presented by him – in particular, the expectation to find suitable practice representatives and to be able to sell his practice on retirement at a profit – do not justify any legal positions protected by fundamental rights and consequently also no obligation of the Bremen Medical Association to enable physicians to obtain the additional title of homeopathy in future.
As several further medical associations in Germany have banned homeopathy in the same way as Bremen and were consequently also taken to court by homeopathy enthusiasts, one can be optimistic that these cases will also go against homeopathy.