MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

risk

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:

  1. 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.
  2. 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.

There is much propaganda for homeopathic vaccinations or homeoprophylaxis (as homeopaths like to call it, in order to give it a veneer of respectability), and on this blog we have discussed it repeatedly. The concept is unproven and dangerous. Yet it is being promoted relentlessly. Currently, I get > 12 million websites when I google ‘homeopathic vaccination’, and there are hundreds of dangerously misleading books and newspaper articles on the subject.

One study that I therefore always wanted to conduct was a trial comparing homeopathic ‘vaccines’ to placebo in terms of immunological response in human volunteers. Somehow, I never managed to get it going. Thus, I was delighted when, a few weeks ago, I received an article for peer-review (I hope I am allowed to disclose this fact here); it was almost exactly the trial I had dreamt of doing one day: the first ever study to test whether there is an antibody response to homeopathic vaccines. Now I am even more delighted to see that it has been published.

Its aim was to compare the antibody response of homeopathic and conventional vaccines and placebo in young adults. The authors hypothesized that there would be no significant difference between homeopathic vaccines and placebo, while there would be a significant increase in antibodies in those received conventional vaccines.

A placebo-controlled, double-blind RCT was conducted where 150 university students who had received childhood vaccinations were assigned to diphtheria, pertussis, tetanus, mumps, measles homeopathic vaccine, placebo, or conventional diphtheria, pertussis, tetanus (Tdap) and mumps, measles, rubella (MMR) vaccines. The primary outcome was a ≥ two-fold increase in antibodies from baseline following vaccination as measured by ELISA. Participants, investigators, study coordinator, data blood drawers, laboratory technician, and data analyst were blinded.

None of the participants in either the homeopathic vaccine or the placebo group showed a ≥ two-fold response to any of the antigens. In contrast, of those vaccinated with Tdap, 68% (33/48) had a ≥ two-fold response to diphtheria, 83% (40/48) to pertussis toxoid, 88% (42/48) to tetanus, and 35% (17/48) of those vaccinated with MMR had a response to measles or mumps antigens (p < 0.001 for each comparison of conventional vaccine to homeopathic vaccine or to placebo). There was a significant increase in geometric mean titres of antibody from baseline for conventional vaccine antigens (p < 0.001 for each), but none for the response to homeopathic antigens or placebo.

The authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

I think this is in every respect an excellent trial. It should once and for all get rid of what is arguably the homeopathy-cult’s most dangerous idea, namely that highly diluted homeopathic remedies can protect humans against infectious diseases. On this blog, I once called it ‘a danger for both the public and the individual who might believe in it … promoting HP is unethical, irresponsible and possibly even criminal.’

I said it ‘should’ get rid of this nonsense, but will it?

As homeopaths have, for now 200 years, showed themselves utterly impervious to evidence, I for one am not holding my breath. Yet, thanks to this excellent study, we can, when confronted with the notion of homeopathic vaccinations, henceforth point out that it is not just totally implausible but that, in addition, it has also been experimentally shown to be false.

My thanks to the Canadian investigators!

This article reported the case of a woman from West Bengal who presented with generalised weakness, weight loss, intermittent diffuse pain abdomen, anorexia, nausea, off and on diarrhoea for eight months. She also noticed darkening of her complexion for six months. Since last 4 months, she had intermittent headache of varying duration, frequency and intensity with tingling and numbness of all four limbs.

Her past medical history was unremarkable except for a chronic anxiety disorder for which she was treated by homeopathy medicine. A neurological examination showed preserved higher mental function, bilateral papilledema with intact other cranial nerves. There was mild motor weakness in both lower limbs, both proximal and distal accompanied by hypotonia without any motor weakness in upper limbs. There was distal sensory deficit in the form of glove and stocking hypoesthesia with reduced deep reflexes in all 4 limbs and bilateral flexor planter response. Gastrointestinal examination revealed non-tender enlarged liver with 16 cm span, mild splenomegaly and mild ascites. Investigations showed mild microcytic hypochromic anaemia (Hb- 9.2 g/dl, MCV-78 fl, MCH-26 pg, MCHC- 31.3 g/dl), low serum iron (27.5 mcg/dl), low TIBC (84.4 mcg/ dl), high serum ferritin (808.6 ng/ml), raised transaminases (AST- 40 IU/L, ALT- 98 IU/L), low serum total protein (4.6 g/dl), low serum albumin (1.9g/dl), globulin (2.7 g/dl) and raised alkaline phosphatase (789 IU/L). Nerve conduction velocity of all four limbs was suggestive of sensorimotor neuropathy.

Unexplained, apparently unrelated multi-system involvement including chronic diarrhoea, presence of liver disease, peripheral neuropathy, idiopathic intracranial hypertension (pseudotumor cerebri ) and characteristic skin lesions suggested chronic arsenicosis. Arsenic level in hair was found to be 1.06 μg/g (N= 0.02-0.2 μg/g) and arsenic level in nail was 1.24 μg/g (N= 0.02-0.5 μg/g) with normal arsenic content (0.03 mg/l) of the drinking water of the locality.

Further questioning revealed that the patient was taking arsenicum album for her anxiety depressive disorder for last one year. The drug was discontinued. Six months later the patient had fully recovered. The authors concluded that an apparently harmless homeopathy medicine may cause multisystem involvement.

The only other case reports of homeopathic arsenic poisoning is this paper:

Case 1 presented with melanosis and keratosis following short-term use of Arsenic Bromide 1-X followed by long-term use of other arsenic-containing homeopathic preparations. Case 2 developed melanotic arsenical skin lesions after taking Arsenicum Sulfuratum Flavum-1-X (Arsenic S.F. 1-X) in an effort to treat his white skin patches. Case 3 consumed Arsenic Bromide 1-X for 6 days in an effort to treat his diabetes and developed an acute gastrointestinal illness followed by leukopenia, thrombocytopenia, and diffuse dermal melanosis with patchy desquamation. Within approximately 2 weeks, he developed a toxic polyneuropathy resulting in quadriparesis. Arsenic concentrations in all three patients were significantly elevated in integument tissue samples. In all three cases, arsenic concentrations in drinking water were normal but arsenic concentrations in samples of the homeopathic medications were elevated. CONCLUSION: Arsenic used therapeutically in homeopathic medicines can cause clinical toxicity if the medications are improperly used.

The authors of the new paper fail to mention the potency of the homeopathic arsenic preparation taken by the patient. As far as I know, in Europe, only high potencies of arsenic are prescribed and dispensed; these remedies contain no or very little arsenic and can thus be considered harmless. In India, however, the 1-X potency seems to be popular, according to the second paper cited above. It describes a dilution of 1: 10 only. It is clear that taking such a remedy would quickly lead to severe toxicity.

This begs the questions: Is it legal to prescribe and dispense such remedies in India or anywhere else? And, in case it is legal, why?

Here is the abstract of a paper that makes even the most senior assessor of quackery shudder:

Objective:

The purpose of this report is to describe the manipulation under anesthesia (MUA) treatment of 6 infants with newborn torticollis with a segmental dysfunction at C1/C2.

Clinical Features:

Six infants aged 4 1/2 to 15 months previously diagnosed with newborn torticollis were referred to a doctor of chiropractic owing to a failure to respond adequately to previous conservative therapies. Common physical findings were limited range of motion of the upper cervical spine. Radiographs demonstrated rotational malpositions and translation of atlas on axis in all 6 infants, and 1 had a subluxation of the C1/C2 articulation.

Interventions and Outcome:

Selection was based on complexity and variety of different clinical cases qualifying for MUA. Treatment consisted of 1 mobilization and was performed in the operating room of a children’s hospital by a certified chiropractic physician with the author assisting. Along with the chiropractor and his assistant, a children’s anesthesiologist, 1 to 2 operating nurses, a children’s radiologist, and in 1 case a pediatric surgeon were present. Before the mobilization, plain radiographs of the cervico-occipital area were taken. Three infants needed further investigation by a pediatric computed tomography scan of the area because of asymmetric bony conditions on the plain radiographs. Follow-up consultations at 2, 3, 5, or 6 weeks were done. Patient records were analyzed for restriction at baseline before MUA compared with after MUA treatment for active rotation, passive rotation, and passive rotation in full flexion of the upper cervical spine. All 3 measurements showed significant differences. The long-term outcome data was collected via phone calls to the parents at 6 to 72 months. The initial clinical improvements were maintained.

Conclusion:

These 6 infants with arthrogenic newborn torticollis, who did not respond to previous conservative treatment methods, responded to MUA.

___________________________________________________________________

After reading the full text, I see many very serious problems and questions with this paper; here are 14 of the most obvious ones.

1. A congenital torticollis (that’s essentially what these kids were suffering from) has a good prognosis and does not require such invasive treatments. There is thus no plausible reason to conduct a case series of this nature.

2. A retrospective case series does not allow conclusions about therapeutic effectiveness, yet in the article the author does just that.

3. The same applies to her conclusions about the safety of the interventions.

4. It is unclear how the 6 cases were selected; it seems possible or even likely that they are, in fact, 6 cases of many more treated over a long period of time.

5. If so, this paper is hardly a ‘retrospective case series’; at best it could be called a ‘best case series’.

6. The X-rays or CT scans are unnecessary and potentially harmful.

7. The anaesthesia is potentially very harmful and unjustifiable.

8. The outcome measure is unreliable, particularly if performed by the chiropractor who has a vested interest in generating a positive result.

9. The follow-up by telephone is inadequate.

10. The range of the follow-up period (6-72 months) is unacceptable.

11. The exact way in which informed consent was obtained is unclear. In particular, we would need to know whether the parents were fully informed about the futility of the treatment and its considerable risks.

12. The chiropractor who administered the treatments is not named. Why not?

13. Similarly, it is unclear why the other healthcare professionals involved in these treatments are not named as co-authors of the paper.

14. It is unclear whether ethical approval was obtained for these treatments.

The author seems inexperienced in publishing scientific articles; the present one is poorly written and badly constructed. A Medline research reveals that she has only one other publication to her name. So, perhaps one should not be too harsh in judging her. But what about her supervisors, the journal, its reviewers, its editor and the author’s institution? The author comes from the Department of Chiropractic Medicine, Medical Faculty University, Zurich, Switzerland. On their website, they state:

The Faculty of Medicine of the University of Zurich is committed to high quality teaching and continuing research-based education of students in health care professions. Excellent and internationally recognised scientists and clinically outstanding physicians are at the Faculty of Medicine devoted to patients and public health, to teaching, to the support of young researchers and to academic medicine. The interaction between research and teaching, and their connection to clinical practice play a central role for us…

The Faculty of Medicine of the University of Zurich promotes innovative research in the basic fields of medicine, in the clinical application of knowledge, in personalised medicine, in health care, and in the translational connection between all these research areas. In addition, it encourages the cooperation between primary care and specialised health care.

It seems that, with the above paper, the UZH must have made an exception. In my view, it is a clear case of scientific misconduct and child abuse.

A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.

The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.

Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.

Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.

In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.

Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.

(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)

About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.

The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:

  • SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
  • If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
  • Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
  • Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
  • Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
  • Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
  • Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
  • Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
  • The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
  • The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.

After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.

I stared my Exeter post in October 1993. It took the best part of a year to set up a research team, find rooms etc. So, our research began in earnest only mid 1994. From the very outset, it was clear to me that investigating the risks of so-called alternative medicine (SCAM) should be our priority. The reason, I felt, was simple: SCAM was being used a million times every day; therefore it was an ethical imperative to check whether these treatments were as really safe as most people seemed to believe.

In the course of this line of investigation, we did discover many surprises (and lost many friends). One of the very first revelation was that homeopathy might not be harmless. Our initial results on this topic were published in this 1995 article. In view of the still ongoing debate about homeopathy, I’d like to re-publish the short paper here:

Homoeopathic remedies are believed by doctors and patients to be almost totally safe. Is homoeopathic advice safe, for example on the subject of immunization? In order to answer this question, a questionnaire survey was undertaken in 1995 of all 45 homoeopaths listed in the Exeter ‘yellow pages’ business directory. A total of 23 replies (51%) were received, 10 from medically qualified and 13 from non-medically qualified homoeopaths.

The homoeopaths were asked to suggest which conditions they perceived as being most responsive to homoeopathy. The three most frequently cited conditions were allergies (suggested by 10 respondents), gynaecological problems (seven) and bowel problems (five).

They were then asked to estimate the proportion of patients that were referred to them by orthodox doctors and the proportion that they referred to orthodox doctors. The mean estimated percentages were 1 % and 8%, respectively. The 23 respondents estimated that they spent a mean of 73 minutes on the first consultation.

The homoeopaths were asked whether they used or recommended orthodox immunization for children and whether they only used and recommended homoeopathic immunization. Seven of the 10 homoeopaths who were medically qualified recommended orthodox immunization but none of the 13 non-medically qualified homoeopaths did. One non-medically qualified homoeopath only used and recommended homoeopathic immunization.

Homoeopaths have been reported as being against orthodox immunization’ and advocating homoeopathic immunization for which no evidence of effectiveness exists. As yet there has been no attempt in the United Kingdom to monitor homoeopaths’ attitudes in this respect. The above findings imply that there may be a problem. The British homoeopathic doctors’ organization (the Faculty of Homoeopathy) has distanced itself from the polemic of other homoeopaths against orthodox immunization, and editorials in the British Homoeopathic Journal call the abandonment of mass immunization ‘criminally irresponsible’ and ‘most unfortunate, in that it will be seen by most people as irresponsible and poorly based’.’

Homoeopathic remedies may be safe, but do all homoeopaths merit this attribute?

This tiny and seemingly insignificant piece of research triggered debate and research (my group must have published well over 100 papers in the years that followed) that continue to the present day. The debate has spread to many other countries and now involves numerous forms of SCAM other than just homeopathy. It relates to many complex issues such as the competence of SCAM practitioners, their ethical standards, education, regulation, trustworthiness and the risk of neglect.

Looking back, it feels odd that, at least for me, all this started with such a humble investigation almost a quarter of a century ago. Looking towards the future, I predict that we have so far merely seen the tip of the iceberg. The investigation of the risks of SCAM has finally started in earnest and will, I am sure, continue thus leading to a better protection of patients and consumers from charlatans and their bogus claims.

We have discussed the diagnostic methods used by practitioners of alternative medicine several times before (see for instance here, here, here, here, here and here). Now a new article has been published which sheds more light on this important issue.

The authors point out that the so-called alternative medicine (SCAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes.

  1. The paper mentions the 4 key factors for evaluation of diagnostic methods:
    Analytic validity of a test defines its ability to measure accurately and reliably the component of interest. Relevant parameters include analytical accuracy and precision, susceptibility to interferences and quality assurance.
  2. Clinical validity defines the ability to detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease. Relevant parameters include sensitivity, specificity, and an understanding of how these parameters change in different populations.
  3. Clinical utility refers to the likelihood that the test will lead to an improved outcome. What is the value of the information to the individual being tested and/or to the broader population?
  4. Ethical, legal and social implications (ELSI) of a test. Issues include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment and the cost-effectiveness of testing.

The tests used by  SCAM-practitioners range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘SCAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in SCAM testing. Some SCAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories.

In their review, the authors explore SCAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. They also review proposed changed to in-vitro diagnostic device regulations and how these might impact on SCAM testing.

The authors conclude hat the common factor in all these tests is the lack of evidence for clinical validity and utility as used in SCAM practice. This should not be surprising since this is true for SCAM practice in general. Once there is a sound evidence base for an intervention, such as a laboratory test, then it generally becomes incorporated into conventional medical practice.

The paper also discusses possible reasons why SCAM-tests are appealing:

  • Adding an element of science to the consultation. Patients know that conventional medicine relies heavily on laboratory diagnostics. If the SCAM practitioner orders laboratory tests, the patient may feel they are benefiting from a scientific approach.
  • Producing material diagnostic data to support a diagnosis. SCAM lab reports are well presented in a format that is attractive to patients adding legitimacy to a diagnosis. Tests are often ordered as large profiles of multiple analytes. It follows that this will increase the probability of getting results outside of a given reference interval purely by chance. ‘Abnormal’ results give the SCAM practitioner something to build a narrative around if clinical findings are unclear. This is particularly relevant for patients who have chronic conditions, such as CFS or fibromyalgia where a definitive cause has not been established and treatment options are limited.
  • Generating business opportunities using abnormal results. Some practitioners may use abnormal laboratory results to justify further testing, supplements or therapies that they can offer.
  • By offering tests that are not available through traditional healthcare services some SCAM practitioners may claim they are offering a unique specialist service that their doctor is unable to provide. This can be particularly appealing to patients with unexplained symptoms for which there are a limited range of evidenced-based investigations and treatments available.

Regulation of SCAM laboratory testing is clearly deficient, the authors of this paper conclude. Where SCAM testing is regulated at all, regulatory authorities primarily evaluate analytical validity of the tests a laboratory offers. Clinical validity and clinical utility are either not evaluated adequately or not evaluated at all and the ethical, legal and social implications of a test may only be considered on a reactive basis when consumers complain about how tests are advertised.

I have always thought that the issue of SCAM tests is hugely important; yet it remains much-neglected. A rubbish diagnosis is likely to result in a rubbish treatment. Unreliable diagnostic methods lead to false-positive and false-negative diagnoses. Both harm the patient. In 1995, I thus published a review that concluded with this warning “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.

Sadly, my warning has so far had no effect whatsoever.

I hope this new paper is more successful.

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