Spinal manipulation has been associated with a wide range of serious complications. Usually, they occur after neck manipulations. Neurologists from Morocco just published a case-report of a patient suffering a subdural haematoma after lumbar spinal manipulation.
A previously healthy 23 years-old man was receiving spinal manipulation for chronic back pain by a physiotherapist when he experienced a knife-like low back pain and lower limbs radiculalgia. The manipulation consisted on high velocity pression in the lumbar region while the patient was in prone position. He woke up the next morning with a weakness of both lower limbs and sensation of bladder fullness.
On presentation to the emergency department, 24 hours after the manipulation, the neurological examination found a cauda equina syndrome with motor strength between 2/5 and 3/5 in the left lower limb, 4/5 in the right lower limb, an abolition of the patellar and Achilles reflexes, a saddle hypoesthesia and a tender bladder. The general examination was normal. Magnetic resonance imaging (MRI) of the lumbar spine was performed promptly and showed intradural collection extending from L2 to L3 level with signal intensity consistent with blood. There were no adjacent fractures, disc or ligament injuries. Routine blood investigations were normal.
The patient underwent an emergency operation via L2-L3 laminectomy. The epidural space had no obvious abnormalities but the dura mater was tense and bluish. After opening the dura, a compressive blood clot was removed completely. The origin of the bleeding could not be determined. At the end of the intervention, nerve roots appeared free with normal courses. Subsequently, the patient’s the motor function of lower limbs gradually returned. He was discharged without neurological deficits 6 days postoperatively. At 6-months’ follow-up, the neurological examination was totally normal.
Subdural haematoma is a rare occurrence. As a complication after spinal manipulation, it seems to be ever rarer. Our case-series of serious adverse effects after chiropractic manipulation did include such a case, albeit not at the lumbar level (as far as I remember):
To obtain preliminary data on neurological complications of spinal manipulation in the UK all members of the Association of British Neurologists were asked to report cases referred to them of neurological complications occurring within 24 hours of cervical spine manipulation over a 12-month period. The response rate was 74%. 24 respondents reported at least one case each, contributing to a total of about 35 cases. These included 7 cases of stroke in brainstem territory (4 with confirmation of vertebral artery dissection), 2 cases of stroke in carotid territory and 1 case of acute subdural haematoma. There were 3 cases of myelopathy and 3 of cervical radiculopathy. Concern about neurological complications following cervical spine manipulation appears to be justified. A large long-term prospective study is required to determine the scale of the hazard.
The big problem with adverse events of this nature is that their true incidence is essentially unknown. The two cases of subdural haematoma mentioned above seem to be the only two reported in the medical literature. But, as there is no monitoring system, the true figure is anybody’s guess.
Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.
But is it effective?
The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.
Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).
The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.
I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:
- Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
- The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
- There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
- There seemed to be a sizable publication bias hidden in the data.
- All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
- Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.
I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.
The U.S. Food and Drug Administration posted warning letters to 4 US companies producing homeopathic products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products produced by King Bio.
Please allow me to copy the FDA’s announcement unaltered and without comment:
“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as homeopathic are being marketed for serious diseases and/or conditions where the products haven’t been shown to offer clinical benefits. We’re committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues. One company that continues to concern us because of the low quality of their operation and the threat their products pose to consumers is King Bio. Despite previous actions we’ve taken, our concerns remain. The warning letter we’re sending is a formal notice to King Bio outlining a number of ongoing, serious violations with their manufacturing operations that must be corrected,” said FDA Commissioner Scott Gottlieb, M.D. “Today we’ve also posted warnings letters to three other homeopathic drug manufacturers for additional concerns we’ve observed – from the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit, to other firms whose products we’ve found to be contaminated. These actions build on similar steps we’ve taken over the past year, as we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer. In addition to our concerns with contamination, some products labeled as homeopathic may not deliver any benefit and may have the potential to cause harm. That’s why we’ve proposed a new regulatory approach to prioritize additional enforcement and regulatory actions against certain products labeled as homeopathic. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. The actions we’ve taken recently, and over the course of the past year are further warning to all companies that these types of products must be manufactured and labeled appropriately. We’re working to finalize our draft guidance in the coming months to help ensure that products that reach consumers are not harmful to their health.”
Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.
The warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality assurance systems found during a July 2018 FDA inspection of the facility. Beyond the violations found during the inspection, the FDA collected and tested samples of finished homeopathic drug products; results revealed inordinately high microbiological contamination. Additionally, evidence collected during the FDA’s inspection indicated recurring microbial contamination associated with the water system used to manufacture drugs. The microbiological contamination of the water system led, in part, to a voluntary recall of more than 900 potentially homeopathic drug products manufactured by King Bio. Following the July 2018 inspection, the FDA alerted consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to the high levels of microbial contamination identified at the manufacturing site. The company recalled all drug products made with water marketed for humans and animals.
King Bio manufactures a range of products including those for children, adults and pets. Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labeled as Aquaflora, Canada, Dr. King’s Natural Medicine(s), Natural Pet, People’s Best and SafeCare. Additionally, other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include products sold under the brand names Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories.
Today, the FDA also posted warning letters to additional companies for products labeled as homeopathic due to various quality and misbranding violations.
- Red Mountain Incorporated, Oakland Park, Fla. — warning letter for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
- Tec Laboratories Incorporated, Albany, Ore. — warning letter for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system
- B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India — warning letter after FDA investigators observed insects in the facility and in ingredients used to make its products.
The FDA has taken similar actions this year, including a warning letter to Nutra Pharma Corp., Boca Raton, Fla.; as announced earlier this month, the FDA issued a warning letter regarding the company illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain; the agency also alerted consumers to this health fraud scam. In February, the FDA issued a warning letter to Pure Source LLC, Doral, Fla. for distributing drugs made with contaminated raw materials.
In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA stated when it issued the draft guidance that it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public. We expect to finalize this guidance soon.
The FDA encourages healthcare professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program.
Spinal manipulation has regularly been associated with serious complications, most commonly strokes due to arterial dissections. But there are several other possibilities as well.
A new and unusual case report a serious complication after spinal manipulation has just been published:
A 54-year-old Indian gentleman, presented to hospital with exertional dyspnoea and chest heaviness for the past 6 months which had increased in the last 6 days. Dyspnoea increased on lying down. He was diagnosed as pneumonia on the basis of X-ray and chest CT scan, received treatment for the same and responded to the therapy.
However, breathlessness and hypercapnia persisted. He had unexplained hypercapnia for which extensive investigations were carried out. Neurological and cardiac assessments were essentially normal. On revisit clinical examination, he was found to have paradoxical diaphragmatic movement with respiration. Ultrasound of chest detected no diaphragmatic movement. Detailed history elicited that patient was fond of neck massage and neck cracking wherein his barber would bend his neck with jerk to either side after a haircut.
After considering all possible aetiologies, the authors concluded that this was a case of diaphragm palsy induced by barber neck manipulation, leading to Type-2 respiratory failure. The fact that the vital clues to the diagnosis were elicited by detailed history and thorough examination reinforces that history and clinical examination for doctors shall remain a very important tool for clinical diagnosis.
My chiropractor friends will be relieved, no doubt, to read that, in this incident, a barber rather than a chiropractor caused this unusual incident. Putting my tongue slightly in the direction of my cheek, the story shows me one thing: one does not necessarily have to be a graduate of a chiro-school to cause severe complications with neck manipulations. Occasionally, osteopaths, physiotherapists, doctors and even barbers are capable of the same feast.
Bleach can be a useful product – but not as a medicine taken by mouth or for injection.
A 39-year-old man with a fracture of the right acetabulum underwent open reduction and internal fixation with a plate under general anaesthesia. At closure, the surgeons injected 0.75% ropivacaine into the subcutaneous tissue of the incision wound for postoperative analgesia. Soon after injection, subcutaneous emphysema at the injection site and a sudden decrease in end-tidal CO2 tension with crude oscillatory ripples during the alveolar plateau phase were observed. Shortly thereafter, it was found that the surgeons had mistakenly injected hydrogen peroxide instead of ropivacaine. Fortunately, the patient recovered to normal status after 10 minutes. After the surgery, the patient was carefully observed for suspected pulmonary embolism and discharged without complications.
A team from Morocco reported the case of a massive embolism after hydrogen peroxide use in the cleaning of infected wound with osteosynthesis material left femoral done under spinal anaesthesia in a young girl of 17 years admitted after to the ICU intubated ventilated. She was placed under mechanical ventilation with vasoactive drugs for ten hours and then extubated without neurological sequelae.
Tunisian doctors reported 2 cases of embolic events with neurological signs. The first, during a pleural cleaning with hydrogen peroxide after cystectomy of a pulmonary hydatic cyst at the right upper lobe. The second case, after a pleural washing during the treatment of hepatitic hydatidosis complicated by a ruptured cyst in the thorax.
Canadian anaesthetists reported a case of suspected oxygen venous embolism during lumbar discectomy in the knee-prone position after use of H2O2. Immediately after irrigation of a discectomy wound with H2O2, a dramatic decrease of the PETCO2, blood pressure and oxygen saturation coincident with ST segment elevation occurred suggesting a coronary gas embolism. Symptomatic treatment was initiated immediately and the patient recovered without any sequelae.
Indian nephrologists reported a case of chlorine dioxide poisoning presenting with acute kidney injury.
A 1-year-old boy presented to the emergency department with vomiting and poor complexion after accidentally ingesting a ClO2-based household product. The patient had profound hypoxia that did not respond to oxygen therapy and required endotracheal intubation to maintain a normal oxygen level. Methemoglobinemia was suspected based on the gap between SpO2 and PaO2, and subsequently increased methemoglobin at 8.0% was detected. The patient was admitted to the paediatric intensive care unit for further management. After supportive treatment, he was discharged without any complications. He had no cognitive or motor dysfunction on follow up 3 months later.
The medical literature is littered with such case-reports. They give us a fairly good idea that the internal use of bleach is not a good idea. In fact, it has caused several deaths. Yet, this is precisely what some SCAM practitioners are advocating.
Now one of them is in court for manslaughter. “If I am such a clear and present danger and a murderer, I should be in jail by now,” said doctor Shortt, who despite a criminal investigation, is still treating patients in his office on the outskirts of Columbia, S.C. Shortt got his medical degree 13 years ago on the Caribbean island of Montserrat. Being a “longevity physician” didn’t seem to bother anyone until one of his patients wound up dead. Shortt gave her an infusion of hydrogen peroxide. Katherine Bibeau, a medical technologist and a mother of two, had been battling multiple sclerosis for two years, and was looking for any treatment that might keep her out of a wheelchair. According to her husband, doctor Shortt said hydrogen peroxide was just the thing. “He had said that there was other people who had been in wheelchairs, and had actually gone through treatment and were now walking again.” It didn’t worry the Bibeaus that Shortt wasn’t affiliated with any hospital or university – and that insurance didn’t cover most of his treatments. “He was a licensed medical doctor in Carolina,” says Bibeau. “So I put my faith in those credentials.” According to Shortt’s own records, the patient subsequently complained of “nausea,” “leg pain,” and later “bruises” with no clear cause. “She went Tuesday, she went Thursday. And by 11 o’clock on Sunday, she died,” says Mr Bibeau. Shortt never told him or his wife about any serious risks. “Even if it wasn’t effective, it should not have been harmful.”
Shortt has been putting hydrogen peroxide in several of his patients’ veins, because he believes it can effectively treat illnesses from AIDS to the common cold. “I think it’s an effective treatment for the flu,” says Shortt, who also believes that it’s effective for multiple sclerosis, Lyme disease, and “as adjunctive therapy” for heart disease. “Things that involve the immune system, viruses, bacteria, sometimes parasites.”
He’s not the only physician using this treatment. Intravenous hydrogen peroxide is a SCAM touted as a cure the medical establishment doesn’t want you to know about. There even is an association that claims to have trained hundreds of doctors how to administer it. The theory is that hydrogen peroxide releases extra oxygen inside the body, killing viruses and bacteria.
Natural News, for instance, tells us that cancer has a rival that destroys it like an M-60 leveling a field of enemy soldiers. It’s called “hydrogen peroxide,” and the “lame-stream,” mainstream media will tell you how “dangerous” it is at 35%, but they won’t tell you that you can drip a couple drops in a glass of water each day and end cancer. Yes, it’s true.
And hydrogen peroxide is not the only bleach that found its way into the realm of SCAM.
Perhaps even worse (if that is possible), the Genesis II Church of Health and Healing promote MMS as a miracle cure. It consists of chlorine dioxide, a powerful bleach that has been banned in several countries around the world for use as a medical treatment. The ‘Church’ claim that MMS cures 95% of all diseases in the world by making adults and children, including infants, drink industrial bleach. The group is inviting members to attend what they call their “effective alternative healing”.
The organizer of the event, Tom Merry, has publicized it by telling people that learning how to consume the bleach “could save your life, or the life of a loved one sent home to die”. The “church” is asking attendants of the meeting to “donate” $450 each, or $800 per couple, in exchange for receiving membership to the organization as well as packages of the bleach, which they call “sacraments”. The chemical is referred to as MMS, or “miracle mineral solution or supplement”, and participants are promised they will acquire “the knowledge to help heal many people of this world’s terrible diseases”.
Fiona O’Leary, a tireless and courageous campaigner for putting an end to a wide variety of mistreatments of children and adults, whose work helped to get MMS banned in Ireland, said she was horrified that the Genesis II Church, which she called a “bleach cult”, was hosting a public event in Washington.
In Fiona’s words: “ Its experimentation and abuse”. I do agree and might just add this: selling bleach for oral or intravenous application, while pretending it is an effective medicine, seems criminal as well.
Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.
This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.
Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:
- vitamins and minerals (89 practitioners, 127 recommendations),
- probiotics (110 practitioners, 110 recommendations),
- essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
- homeopathics (56 practitioners, 66 recommendations),
- botanicals (29 practitioners, 31 recommendations),
- other NHPs (33 practitioners, 34 recommendations).
Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:
- 596 total indications for probiotics,
- 318 indications for essential fatty acids,
- 138 indications for vitamin D,
- 71 indications for multi-vitamins.
Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless and potentially harmful children.
In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.
Is this a Canadian phenomenon? If you think so, read this abstract:
This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).
AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.
Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.
Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.
This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and who prescribe or recommend treatments of unknown value, usually without the children needing them.
Why are regulators not more concerned about this obvious abuse?
The purpose of this recently published survey was to obtain the demographic profile and educational background of chiropractors with paediatric patients on a multinational scale.
A multinational online cross-sectional demographic survey was conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis.
The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted paediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor’s degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in paediatric chiropractic.
The authors from the Anglo-European College of Chiropractic (AECC), Bournemouth University, United Kingdom, drew the following conclusion: this is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.
A survey with a response rate of 10%?
An investigation published 9 years after it has been conducted?
Who at the AECC is responsible for controlling the quality of the research output?
Or is this paper perhaps an attempt to get the AECC into the ‘Guinness Book of Records’ for outstanding research incompetence?
But let’s just for a minute pretend that this paper is of acceptable quality. If the finding that ~90% of chiropractors tread kids is approximately correct, one has to be very concerned indeed.
I am not aware of any good evidence that chiropractic care is effective for paediatric conditions. On the contrary, it can do quite a bit of direct harm! To this, we sadly also have to add the indirect harm many chiropractors cause, for instance, by advising parents against vaccinating their kids.
This clearly begs the question: is it not time to stop these charlatans?
What do you think?
Spinal manipulative therapy (SMT), especially hyperextension and rotation. have often been associated with cervical artery dissection (CAD), a tear in the internal carotid or the vertebral artery resulting in an intramural haematoma and/or an aneurysmal dilatation. But is the association causal? This question is often the subject of fierce discussions between chiropractors and the real doctors.
The lack of established causality relates to the chicken and egg discussion, i.e., whether the CAD symptoms lead the patient to seek cervical SMT or whether the cervical SMT provokes CAD along with the non-CAD presenting headache and/or neck complaint.
The aim of a new review was to provide an updated step-by-step risk-benefit assessment strategy regarding manual therapy and to provide tools for clinicians to exclude cervical artery dissection.
In light of the evidence provided, the reality, according to the review-authors, is:
- a) that there is no firm scientific basis for direct causality between cervical SMT and CAD;
- b) that the internal carotid artery (ICA) moves freely within the cervical pathway, while 74% of cervical SMTs are conducted in the lower cervical spine where the vertebral artery (VA) also moves freely;
- c) that active daily life consists of multiple cervical movements including rotations that do not trigger CAD, as is true for a range of physical activities;
- d) that a cervical manipulation and/or grade C cervical mobilization goes beyond the physiological limit but remains within the anatomical range, which theoretically means that the artery should not exceed failure strain.
These factors underscore the fact that no serious adverse event (AE) was reported in a large prospective national survey conducted in the UK that assessed all AEs in 28,807 chiropractic treatment consultations, which included 50,276 cervical spine manipulations.
The figure outlines a risk-benefit assessment strategy that should provide additional knowledge and improve the vigilance of all clinicians to enable them to exclude CAD, refer patients with suspected CAD to appropriate care, and consequently prevent CAD from progressing.
It has been argued that most patients present with at least two physical symptoms. The clinical characteristics and recommendations in the figure follow this assumption. This figure is intended to function as a knowledge base that should be implemented in preliminary screening and be part of good clinical practice. This knowledge base will likely contribute to sharpening the attention of the clinicians and alert them as to whether the presenting complaint, combined with a collection of warning signs listed in the figure, deviates from what he or she considers to be a usual musculoskeletal presentation.
Even though this is a seemingly thoughtful analysis, I think it omits at least two important points:
- The large prospective UK survey which included 50,276 cervical spine manipulations might be less convincing that it seems. It recorded about one order of magnitude less minor adverse effects of spinal manipulation than a multitude of previously published prospective surveys. The self-selected, relatively small group of participating chiropractors (32% of the total sample) were both experienced (67% been in practice for 5 or more years) and may not always have adhered to the protocol of the survey. Thus they may have employed their experience to intuitively select low-risk patients rather than including all consecutive cases, as the protocol prescribed. This hypothesis would ﬁrstly account for the unusually low rate of minor adverse effects, and secondly, it would explain why no serious complications occurred at all. Given that about 700 such complications are on record, the low incidence of serious adverse events could well be a gross underestimate.
- The effect of chiropractic spinal manipulative therapy is probably due to a placebo response. This means that it should probably not be done in the first place.
Fructus Psoraleae is the seed of Psoralea corylifolia Linn. It is the main ingredient of the herbal mixtures such as Qubaibabuqi, popular in China, India and other countries. It has been used for medicinal purposes for millennia. Thus many proponents would claim that it must be risk-free.
A recent case-report suggests that it might not be as safe as often assumed.
A 53-year-old woman was diagnosed with vitiligo in September 2017 and was treated with oral Qubaibabuqi tablets (15 tablets three times daily; Xinjiang Yinduolan Uyghur Pharmaceutical Company Limited, Urumqi, China), 10 mg of prednisone acetate tablets (Xinhua Pharmaceutical Company Limited, Zibo, China) once daily, and narrowband-ultraviolet B (NB-UVB) phototherapy (Sigma household narrowband-ultraviolet phototherapy instrument [SS-01B] pocket portable; Shanghai Sigma High Technology Co., Ltd. Shanghai, China) every other day. The prednisone acetate tablets were self-discontinued 3 months later; however, she continued to take Qubaibabuqi tablets orally and NB-UVB phototherapy was undertaken at home.
After approximately 7 months of treatment, the patient developed a severe, diffuse yellow staining of the skin and sclera in March 2018. On admission, she was diagnosed with acute cholestatic hepatitis associated with Fructus Psoraleae. Despite receiving active treatment, her condition rapidly deteriorated and she died 5 days later due to acute liver failure and multiple organ dysfunction. There are 6 further reported cases of liver injury associated with Fructus Psoraleae described in the English language literature. Cases of acute liver failure associated with the use of Fructus Psoraleae have not been previously described.
The authors of the case-report concluded that as a main ingredient in the Qubaibabuqi tablet formula, Fructus Psoraleae has potential hepatotoxicity. This potentially fatal adverse effect should be considered when physicians prescribe Qubaibabuqi tablets.
Psoralea corylifolia Linn (also known as Bu-gu-zh, Bu Ku Zi, Bol-gol-zhee, Boh-Gol-Zhee, Babchi, and Bakuchi) is a plant grown in China, India, Sri Lanka, Burma, and other countries, which is considered an important herbal medicine. It is used in TCM to tonify the kidneys, particularly kidney yang and essence. It is used for helping the healing of bone fractures, for lower back and knee pain, impotence, bed wetting, hair loss, and vitiligo. A recent review named it as one of the main herbs causing liver problems (other herbs included Polygonum multiflorum, Corydalis yanhusuo, and Rheum officinale).
Another review found that Psoralea corylifolia has cardiotonic, vasodilator, pigmentor, antitumor, antibacterial, cytotoxic, and anti-helminthic properties. About one hundred bioactive compounds have been isolated from seeds and fruits; the most important ones belong to coumarins, flavonoids, and meroterpenes groups. Psoralea corylifolia is part of many Ayurvedic and Chinese herbal mixtures.
Despite of the popularity of Psoralea corylifolia in the treatment of a very wide range of conditions, and despite the pharmacological studies into its potential therapeutic uses, there is an almost complete void as to clinical trials testing its clinical effectiveness.
The case-report is a poignant and tragic reminder of the often-neglected fact that neither a long history of usage nor popularity of a (herbal) treatment are reliable indicators for safety.
The most regularly reported serious complication of chiropractic neck manipulation is a stroke due to arterial dissection. Atlantoaxial dislocation (a dislocations of the first and second vertebrae which means that the spinal cord is in danger of being compressed which, in turn, would have devastating consequences) has not been previously reported, but is just as serious.
This new case-report described an 83-year-old man with a history of old cerebellar infarction who presented to the emergency department with acute left hemiplegia after a chiropractic manipulation of the neck and back several hours before symptom onset. Mild hypoesthesia was observed on his left limbs. No speech disturbance, facial palsy, or neck or shoulder pain was observed.
Intravenous thrombolytic treatment was given 238 min after symptom onset. Brown-Sequard syndrome (damage to one side of the spinal cord causing paralysis and loss of feeling on one side) subsequently developed 6 h after thrombolysis with a hypo-aesthetic sensory level below the right C5 dermatome. An emergent brain magnetic resonance angiography did not reveal an acute cerebral infarct but rather an atlantoaxial dislocation causing upper cervical spinal cord compression.
Clinical symptoms did not deteriorate after thrombolysis. He received successful decompressive surgery 1 week later, and his muscle power gradually improved, with partial dependency when performing daily living activities two months later.
A literature review revealed that only 15 patients (including the patient mentioned here) with spinal disorder mimicking acute stroke who received thrombolytic therapy have been reported. Atlantoaxial dislocation may present as acute hemiplegia mimicking acute stroke, followed by Brown-Sequard syndrome. Inadvertent thrombolytic therapy is likely not harmful for patients with atlantoaxial dislocation-induced cervical myelopathy. The neurological deficits of patients should be carefully and continuously evaluated to differentiate between stroke and myelopathy.
The authors of this case report provide no detail about the exact treatment that caused this complication, nor do they elaborate on the type of healthcare professional who administered the cervical manipulation (they focus on the issue of non-indicated thrombolytic therapy). We also do not learn why the patient had neck manipulations in the first place. However, the authors seem confident that the ‘chiropractic manipulation’ was the cause of this atlantoaxial dislocation causing severe upper cervical spinal cord compression.
The patient was treated surgically, with corticosteroids and subsequent rehabilitation. Two months later, his neurological deficits were much improved.