Multivitamins are widely used, mainly for disease prevention, and particularly cardiovascular disease (CVD). But there are only few prospective studies investigating their association with both long- and short-term risk. In view of these facts, new evidence is more than welcome.
The objective of this study was to investigate how multivitamin use is associated with the long- and short-term risk of CVD. A prospective cohort study was conducted of 37,193 women from the Women’s Health Study aged ≥45 y and free of CVD and cancer at baseline who were followed for an average of 16.2 y. At baseline, women self-reported a wide range of lifestyle, clinical, and dietary factors. Women were categorized into 1) no current use and 2) current use of multivitamins. Duration and updated measures over the course of the follow-up to address short-term effects were also considered. Women were followed for major CVD events, including myocardial infarction (MI), stroke, and CVD death.
During the follow-up, 1493 incident cases of CVD [defined as myocardial infarction (MI), stroke, and CVD death] occurred. In multivariable analyses, multivitamin use compared with no use was not associated with major CVD event, stroke, or CVD death. A non-significant inverse association was observed between baseline multivitamin use and major CVD events among women aged ≥70 y (P-interaction = 0.04) and those consuming <3 servings/d of fruit and vegetables (P-interaction = 0.01). When updating information on multivitamin use during the course of follow-up, no associations were observed for major CVD events, MI, stroke, and CVD death.
The authors concluded that, in this study of middle-aged and elderly women, neither baseline nor time-varying multivitamin use was associated with the long-term risk of major CVD events, MI, stroke, cardiac revascularizations, or CVD death. Additional studies are needed to clarify the role of multivitamins on CVD.
Even the most enthusiastic vitamin fan will find it hard to argue with these findings; they seem rock solid. Vitamins have their name from the fact that they are vital for our survival – we all need them. But, in developed countries, we all get them through our daily food. Any excess of water-soluble vitamins is swiftly excreted via the urine. Any excess of fat-soluble vitamins is stored in the body and may, in some cases, even represent a health risk.
Exceptions are vulnerable groups such as children, the elderly, pregnant women and patients with certain diseases. These individuals can suffer from hypovitaminoses, the only reason for regularly using vitamin supplements. But for the vast majority of the population, the only effects of regular vitamin supplementation are that we enrich the manufacturers and render our urine expensive.
In the past, I have been involved in several court cases where patients had complained about mistreatment by charlatans. Similarly I have acted as an expert witness for the General Medical Council in similar circumstances.
So, it is true, quacks are sometimes being held to account by their victims. But, generally speaking, patients seem to complain very rarely when they fall in the hands of even the most incompetent of quacks.
Here is one telling reminder showing how long it can take until a complaint is finally filed.
Dr Julian Kenyon is, according to his website, an integrated medicine physician and Medical Director of the Dove Clinic for Integrated Medicine, Winchester and London. Dr Julian Kenyon is Founder-Chairman of the British Medical Acupuncture Society in 1980 and Co-Founder of the Centre for the Study of Complementary Medicine in Southampton and London where he worked for many years before starting The Dove Clinic in 2000. He is also Founder/President of the British Society for Integrated Medicine and is an established authority in the field of complementary treatment approaches for a wide range of medical conditions. He has written approximately 20 books and has had many academic papers published in peer review journals* and has several patents to his name. He graduated from the University of Liverpool with a Bachelor of Medicine and Surgery and subsequently with a research degree, Doctor of Medicine. In 1972, he was appointed a Primary Fellow of the Royal College of Surgeons, Edinburgh.
*[I found only 4 on Medline]
Kenyon has been on sceptics’ radar for a very long time. For instance, he is one of the few UK doctors who use ‘LIVE BLOOD ANALYSIS’, a bogus diagnostic method that can harm patients through false-negative or false-positive diagnoses. A 2003 undercover investigation for BBC 1 South’s ‘Inside Out’ accused Dr Julian Kenyon of using yet another spurious diagnostic test at his clinic near Winchester. Kenyon has, for many years, been working together with George Lewith, another of the country’s ‘leading’ complementary doctors. In 1994, the two published an article about their co-operation; here is its abstract:
This paper outlines the main research effort that has taken place within the Centre for the Study of Complementary Medicine over the last 10 years. It demonstrates the Centre’s expertise and interest in a whole variety of areas, including the social implications and development of complementary medicine, clinical trial methodology, the evaluation of complementary medical machinery, the effects of electromagnetic fields on health and the investigation of the subtle energetic processes involved in complementary medicine. Our future plans are outlined.
Lewith and Kenyon have been using a technique called electrodermal testing for more than 20 years. Considering the fact that the two doctors authored a BMJ paper which concluded that electrodermal machines couldn’t detect environmental allergies, this seems more than a little surprising.
Using secret filming, ‘Inside Out’ showed Dr Kenyon testing a six-year-old boy and then deciding that he is sensitive to dust mites. Later, Dr Kenyon insists that he made his diagnosis purely on the boy’s symptoms and that he didn’t use the machine to test for dust mites. The BBC then took the boy for a conventional skin prick test, which suggested he didn’t have any allergies at all. But Dr Kenyon then says the conventional test may not be accurate: “He may be one of the 10% who actually are negative to the skin tests but benefit from measures to reduce dust mite exposure.”
Despite this very public disclosure, Kenyon was able to practice unrestrictedly for many years.
In December 2014, it was reported in the Hampshire Chronicle that Dr Kenyon eventually did, after a complaint from a patient, end up in front of the General Medical Council’s conduct tribunal. The panel heard that, after a 20-minute consultation, which cost £300, Dr Kenyon told one terminally-ill man with late-stage cancer: “I am not claiming we can cure you, but there is a strong possibility that we would be able to increase your median survival time with the relatively low-risk approaches described here.” He also made bold statements about the treatment’s supposed benefits to an undercover reporter who posed as the husband of a woman with breast cancer.
After considering the full details of the case, Ben Fitzgerald, for the General Medical Council, had called for Dr Kenyon to be suspended, but the panel’s chairman Dr Surendra Kumar said Dr Kenyon’s misconduct was not serious enough to warrant a ban. The panel eventually imposed restrictions on Kenyon’s licence lasting for 12 months.
I estimate that patients are exposed to quackery from doctors and alternative practitioners thousands of times every day. Why then, I ask myself, do so few of them complain? Here are some of the possible answers to this important question:
- They do not dare to.
- They feel embarrassed.
- They don’t know how to.
- They cannot be bothered and fear the agro.
- They fail to identify quackery and fall for the nonsense they are being told.
- They even might perceive benefit from treatments which, in fact, are pure quackery.
Whatever the reasons, I think it is regrettable that not far more quacks are held to account – regardless of whether the charlatan in question as studied medicine or not. If you disagree, consider this: not filing a complaint means that many more patients will be put at risk.
Much has been written on this blog about progress in the area of chiropractic practice and research. But where is the evidence for progress? I did a little search and one of the first sites I stumbled across was this one which is full to bursting with bogus claims. This cannot be what chiropractors call ‘progress’, I thought.
Determined to find real progress, I continued searching and found THE FOUNDATION FOR CHIROPRACTIC PROGRESS. Great, I thought, an organisation and a website entirely devoted to the very subject I was looking for. Consequently, I studied the information provided here in some detail. What follows are excerpts from the site:
Chiropractic care is a health option that has proven beneficial for a multitude of health conditions, along with in the practice of achieving optimal wellness. It is essential for those unaware of chiropractic care to be adequately informed, so they too can experience the benefits that over 60,000 practicing doctors of chiropractic in the U.S. provide to their patients daily. Established in 2003, the not-for-profit Foundation for Chiropractic Progress (F4CP) aims to educate the public about the many benefits associated with chiropractic care.On behalf of the F4CP, I invite you to tour this site and learn more about this effective form of treatment.
Chairman | Foundation for Chiropractic Progress
THIS WAS A STRANGE INTRODUCTION, I THOUGHT; BUT UNDETERRED I READ ON:
Parents of Colicky Infants Turn to Chiropractic Care
For those parents who never imagined their ailing babies and toddlers could be helped by chiropractic care, it may be time for some rethinking.New mom Jean, a 31-year-old speech therapist from New Jersey, became an advocate after enlisting the help of her own chiropractor to treat her colicky infant girl, Emma. After having had what she says was “no luck” with the usual ways of alleviating colic symptoms – including giving Emma children’s probiotics daily – one appointment with board-certified in chiropractic pediatrics Dr. Lora Tanis produced an immediate difference.
Concussions Among Athletes
A concussion is a type of traumatic brain injury caused by a bump, blow or jolt to the head that can change the way the brain functions. Symptoms include dizziness, instability and confusion.
Using methods that rely on brain-based, non-invasive, drugfree approaches — like chiropractic
care and physical rehab — can help re-establish balance and maximal brain and nervous system functionality.
News of Health – Improving Military Health Care
Retired U.S. Army Brigadier General Becky Halstead—the first woman in U.S. history to command in combat at the strategic level—is speaking out on the value of chiropractic care for the nation’s military men and women.
With the epidemic now estimated to be costing the nation $147 billion annually, it’s a question that’s very much on the minds of health experts. And many, including lifestyle guru Shea Vaughn, are citing chiropractic care as a crucial part of overall wellness programs.
FEELING A LITTLE DISAPPOINTED, I STOPPED READING AND THOUGHT
PROGRESS INDEED !!!
Homeopathy has many critics who claim that there is no good evidence for this type of therapy. Homeopaths invariably find this most unfair and point to a plethora of studies that show an effect. They are, of course, correct! There are plenty of trials that suggest that homeopathic remedies do work. The question, however, is HOW RELIABLE ARE THESE STUDIES?
Here is a brand new one which might stand for dozens of others.
In this study, homeopaths treated 50 multimorbid patients with homeopathic remedies identifies by a method called ‘polarity analysis’ (PA) and prospectively followed them over one year (PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen’s grading of polar symptoms).
The 43 patients (86%) who completed the observation period experienced an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment.
Good news then for enthusiasts of homeopathy? 91% improvement!
Yet, I am afraid that critics might not be bowled over. They might smell a whiff of selection bias, lament the lack of a control group or regret the absence of objective outcome measures. But I was prepared to go as far as stating that such results might be quite interesting… until I read the authors’ conclusions that is:
Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine.
Virtually nothing in these conclusions is based on the data provided. They are pure extrapolation and wild assumptions. Two questions seem to emerge from this:
- How on earth can we take this and so many other articles on homeopathy seriously?
- When does this sort of article cross the line between wishful thinking and scientific misconduct?
According to the ‘General Osteopathic Council’ (GOC), osteopathy is a primary care profession, focusing on the diagnosis, treatment, prevention and rehabilitation of musculoskeletal disorders, and the effects of these conditions on patients’ general health.
Using many of the diagnostic procedures applied in conventional medical assessment, osteopaths seek to restore the optimal functioning of the body, where possible without the use of drugs or surgery. Osteopathy is based on the principle that the body has the ability to heal, and osteopathic care focuses on strengthening the musculoskeletal systems to treat existing conditions and to prevent illness.
Osteopaths’ patient-centred approach to health and well-being means they consider symptoms in the context of the patient’s full medical history, as well as their lifestyle and personal circumstances. This holistic approach ensures that all treatment is tailored to the individual patient.
On a good day, such definitions make me smile; on a bad day, they make me angry. I can think of quite a few professions which would fit this definition just as well or better than osteopathy. What are we supposed to think about a profession that is not even able to provide an adequate definition of itself?
Perhaps I try a different angle: what conditions do osteopaths treat? The GOC informs us that commonly treated conditions include back and neck pain, postural problems, sporting injuries, muscle and joint deterioration, restricted mobility and occupational ill-health.
This statement seems not much better than the previous one. What on earth is ‘muscle and joint deterioration’? It is not a condition that I find in any medical dictionary or textbook. Can anyone think of a broader term than ‘occupational ill health’? This could be anything from tennis elbow to allergies or depression. Do osteopaths treat all of those?
One gets the impression that osteopaths and their GOC are deliberately vague – perhaps because this would diminish the risk of being held to account on any specific issue?
The more one looks into the subject of osteopathy, the more confused one gets. The profession goes back to Andrew Still ((August 6, 1828 – December 12, 1917) Palmer, the founder of chiropractic is said to have been one of Still’s pupils and seems to have ‘borrowed’ most of his concepts from him – even though he always denied this) who defined osteopathy as a science which consists of such exact exhaustive and verifiable knowledge of the structure and functions of the human mechanism, anatomy and physiology & psychology including the chemistry and physics of its known elements as is made discernable certain organic laws and resources within the body itself by which nature under scientific treatment peculiar to osteopathic practice apart from all ordinary methods of extraneous, artificial & medicinal stimulation and in harmonious accord with its own mechanical principles, molecular activities and metabolic processes may recover from displacements, derangements, disorganizations and consequent diseases and regain its normal equilibrium of form and function in health and strength.
This and many other of his statements seem to indicate that the art of using language for obfuscation has a long tradition in osteopathy and goes back directly to its founding father.
What makes the subject of osteopathy particularly confusing is not just the oddity that, in conventional medicine, the term means ‘disease of the bone’ (which renders any literature searches in this area a nightmare) but also the fact that, in different countries, osteopaths are entirely different professionals. In the US, osteopathy has long been fully absorbed by mainstream medicine and there is hardly any difference between MDs and ODs. In the UK, osteopaths are alternative practitioners regulated by statute but are, compared to chiropractors, of minor importance. In Germany, osteopaths are not regulated and fairly ‘low key’, while in France, they are numerous and like to see themselves as primary care physicians.
And what about the evidence base of osteopathy? Well, that’s even more confusing, in my view. Evidence for which treatment? As US osteopaths might use any therapy from drugs to surgery, it could get rather complicated. So let’s just focus on the manual treatment as used by osteopaths outside the US.
Anyone who attempts to critically evaluate the published trial evidence in this area will be struck by at least two phenomena:
- the wide range of conditions treated with osteopathic manual therapy (OMT)
- the fact that there are several groups of researchers that produce one positive result after the next.
The best example is probably the exceedingly productive research team of J. C. Licciardone from the Osteopathic Research Center, University of North Texas. Here are a few conclusions from their clinical studies:
- The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.
- The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.
- Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy.
- Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.
- The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.
- Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.
- The only consistent finding in this study was an association between type 2 diabetes mellitus and tissue changes at T11-L2 on the right side. Potential explanations for this finding include reflex viscerosomatic changes directly related to the progression of type 2 diabetes mellitus, a spurious association attributable to confounding visceral diseases, or a chance observation unrelated to type 2 diabetes mellitus. Larger prospective studies are needed to better study osteopathic palpatory findings in type 2 diabetes mellitus.
- OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.
Based on this brief review of the evidence origination from one of the most active research team, one could be forgiven to think that osteopathy is a panacea. But such an assumption is, of course, nonsensical; a more reasonable conclusion might be the following: osteopathy is one of the most confusing and confused subject under the already confused umbrella of alternative medicine.
If we go on the internet, we find no end of positive claims for TM. The official TM website, for instance, claims that more than 350 peer-reviewed research studies on the TM technique have been published in over 160 scientific journals. These studies were conducted at many US and international universities and research centers, including Harvard Medical School, Stanford Medical School, Yale Medical School, and UCLA Medical School.
This may well be true – but do those studies amount to more than a heap of beans? Let’s find out.
The objective of our Cochrane review was to determine the effectiveness of TM for the primary prevention of cardiovascular disease (CVD). We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 10); MEDLINE (Ovid) (1946 to week three November 2013); EMBASE Classic and EMBASE (Ovid) (1947 to week 48 2013); ISI Web of Science (1970 to 28 November 2013); and Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment Database and Health Economics Evaluations Database (November 2013). We also searched the Allied and complementary Medicine Database (AMED) (inception to January 2014) and IndMed (inception to January 2014). We hand searched trial registers and reference lists of reviews and articles and contacted experts in the field. We applied no language restrictions.
We included randomised controlled trials (RCTs) of at least three months’ duration involving healthy adults or adults at high risk of CVD. Trials examined TM only and the comparison group was no intervention or minimal intervention. We excluded trials that involved multi-factorial interventions. Outcomes of interest were clinical CVD events (cardiovascular mortality, all-cause mortality and non-fatal events) and major CVD risk factors (e.g. blood pressure and blood lipids, occurrence of type 2 diabetes, quality of life, adverse events and costs). Two authors independently selected trials for inclusion, extracted data and assessed the risk of bias.
We identified 4 RCTs with a total of 430 participants for inclusion in this review. The included trials were small, short term (three months) and at risk of bias. In all studies, TM was practised for 15 to 20 minutes twice a day. None of the included studies reported all-cause mortality, cardiovascular mortality or non-fatal endpoints as trials were short term, but one study reported survival rate three years after the trial was completed. In view of the considerable statistical heterogeneity between the results of the studies for the only outcomes reported, systolic blood pressure (I2 = 72%) and diastolic blood pressure (I2 = 66%), we decided not to undertake a meta-analysis. None of the four trials reported blood lipids, occurrence of type 2 diabetes, adverse events, costs or quality of life.
We concluded that there are few trials with limited outcomes examining the effectiveness of TM for the primary prevention of CVD. Due to the limited evidence to date, we could draw no conclusions as to the effectiveness of TM for the primary prevention of CVD. There was considerable heterogeneity between trials and the included studies were small, short term and at overall serious risk of bias. More and larger long-term, high-quality trials are needed.
Even though I am a co-author of this review, I am not entirely sure that the last sentence of our conclusion is totally correct. The TM movement has, in my view, all the characteristics of a cult with all its the dangers that cults entail. This means, I think, we ought to be cautious about TM and sceptical about their research and results. At the risk of provoking harsh criticism, I would even say we should be distrustful of their aims and methods.
The very first article on a subject related to alternative medicine with a 2015 date that I came across is a case-report. I am afraid it will not delight our chiropractic friends who tend to deny that their main therapy can cause serious problems.
In this paper, US doctors tell the story of a young woman who developed headache, vomiting, diplopia, dizziness, and ataxia following a neck manipulation by her chiropractor. A computed tomography scan of the head was ordered and it revealed an infarct in the inferior half of the left cerebellar hemisphere and compression of the fourth ventricle causing moderately severe, acute obstructive hydrocephalus. Magnetic resonance angiography showed severe narrowing and low flow in the intracranial segment of the left distal vertebral artery. The patient was treated with mannitol and a ventriculostomy. Following these interventions, she made an excellent functional recovery.
The authors of the case-report draw the following conclusions: This report illustrates the potential hazards associated with neck trauma, including chiropractic manipulation. The vertebral arteries are at risk for aneurysm formation and/or dissection, which can cause acute stroke.
I can already hear the counter-arguments: this is not evidence, it’s an anecdote; the evidence from the Cassidy study shows there is no such risk!
Indeed the Cassidy study concluded that vertebral artery accident (VBA) stroke is a very rare event in the population. The increased risks of VBA stroke associated with chiropractic and primary care physician visits is likely due to patients with headache and neck pain from VBA dissection seeking care before their stroke. We found no evidence of excess risk of VBA stroke associated chiropractic care compared to primary care. That, of course, was what chiropractors longed to hear (and it is the main basis for their denial of risk) – so much so that Cassidy et al published the same results a second time (most experts feel that this is a violation of publication ethics).
But repeating arguments does not make them more true. What we should not forget is that the Cassidy study was but one of several case-control studies investigating this subject. And the totality of all such studies does not deny an association between neck manipulation and stroke.
Much more important is the fact that a re-analysis of the Cassidy data found that prior studies grossly misclassified cases of cervical dissection and mistakenly dismissed a causal association with manipulation. The authors of this new paper found a classification error of cases by Cassidy et al and they re-analysed the Cassidy data, which reported no association between spinal manipulation and cervical artery dissection (odds ratio [OR] 5 1.12, 95% CI .77-1.63). These re-calculated results reveal an odds ratio of 2.15 (95% CI.98-4.69). For patients less than 45 years of age, the OR was 6.91 (95% CI 2.59-13.74). The authors of the re-analysis conclude as follows: If our estimates of case misclassification are applicable outside the VA population, ORs for the association between SMT exposure and CAD are likely to be higher than those reported using the Rothwell/Cassidy strategy, particularly among younger populations. Future epidemiologic studies of this association should prioritize the accurate classification of cases and SMT exposure.
I think they are correct; but my conclusion of all this would be more pragmatic and much simpler: UNTIL WE HAVE CONVINCING EVIDENCE TO THE CONTRARY, WE HAVE TO ASSUME THAT CHIROPRACTIC NECK MANIPULATION CAN CAUSE A STROKE.
As promised, I will try with this post to explain my reservations regarding the new meta-analysis suggesting that individualised homeopathic remedies are superior to placebos. Before I start, however, I want to thank all those who have commented on various issues; it is well worth reading the numerous and diverse comments.
To remind us of the actual meta-analysis, it might be useful to re-publish its abstract (the full article is also available online):
A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.
The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.
Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).
Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.
Since my team had published an RCTs of individualised homeopathy, it seems only natural that my interest focussed on why the study (even though identified by Mathie et al) had not been included in the meta-analysis. Our study had provided no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.
I was convinced that this trial had been rigorous and thus puzzled why, despite receiving ‘full marks’ from the reviewers, they had not included it in their meta-analysis. I thus wrote to Mathie, the lead author of the meta-analysis, and he explained: For your trial (White et al. 2003), under domain V of assessment, we were unable to extract data for meta-analysis, and so it was attributed high risk of bias, as specified by the Cochrane judgmental criteria. Our designated main outcome was the CAQ, for which we needed to know (or could at least estimate) a mean and SD for both the baseline and the end-point of the study. Since your paper reported only the change from baseline in Table 3 or in the main text, it is not possible to derive the necessary end-point for analysis.
It took a while and several further emails until I understood: our study did report both the primary (Table 2 quality of life) and secondary outcome measure (Table 3 severity of symptoms). The primary outcome measure was reported in full detail such that a meta-analysis would have been possible. The secondary outcome measure was also reported but not in full detail, and the data provided by us would not lend themselves to meta-analyses. By electing not our primary but our secondary outcome measure for their meta-analysis, Mathie et al were able to claim that they were unable to use our study and reject it for their meta-analysis.
Why did they do that?
The answer is simple: in their methods section, they specify that they used outcome measures “based on a pre-specified hierarchical list in order of greatest to least importance, recommended by the WHO“. This, I would argue is deeply flawed: the most important outcome measure of a study is usually the one for which the study was designed, not the one that some guys at the WHO feel might be important (incidentally, the WHO list was never meant to be applied to meta-analyses in that way).
By following rigidly their published protocol, the authors of the meta-analysis managed to exclude our negative trial. Thus they did everything right – or did they?
Well, I think they committed several serious mistakes.
- Firstly, they wrote the protocol, which forced them to exclude our study. Following a protocol is not a virtue in itself; if the protocol is nonsensical it even is the opposite. Had they proceeded as is normal in such cases and used our primary outcome measure in their meta-analyses, it is most likely that their overall results would not have been in favour of homeopathy.
- Secondly, they awarded our study a malus point for the criterium ‘selective outcome reporting’. This is clearly a wrong decision: we did report the severity-outcome, albeit not in sufficient detail for their meta-analysis. Had they not committed this misjudgment, our RCT would have been the only one with an ‘A’ rating. This would have very clearly highlighted the nonsense of excluding the best-rated trial from meta-analysis.
There are several other oddities as well. For instance, Mathie et al judge our study to be NOT free of vested interest. I asked Mathie why they had done this and was told it is because we accepted free trial medication from a homeopathic pharmacy. I would argue that my team was far less plagued by vested interest than the authors of their three best (and of course positive) trials who, as I happen to know, are consultants for homeopathic manufacturers.
And all of this is just in relation to our own study. Norbert Aust has uncovered similar irregularities with other trials and I take the liberty of quoting his comments posted previously again here:
I have reason to believe that this review and metaanalysis in biased in favor of homeopathy. To check this, I compared two studies (1) Jacobs 1994 about the treatment of childhood diarrhea in Nicaragua, (2) Walach 1997 about homeopathic threatment of headaches. The Jacobs study is one of the three that provided ‘reliable evidence’, Walach’s study earned a poor C2.2 rating and was not included in the meta-analyses. Jacobs’ results were in favour of homeopathy, Walach’s not.
For the domains where the rating of Walach’s study was less than that of the Jacobs study, please find citations from the original studies or my short summaries for the point in question.
Domain I: Sequence generation:
“The remedy selected was then mailed to a notary public who held a stock of placebos. The notary threw a dice and mailed either the homeopathic remedy or an appropriate placebo. The notary was provided with a blank randomisation list.”
Rating: UNCLEAR (Medium risk of bias)
“For each of these medications, there was a box of tubes in sequentially numbered order which had been previously randomized into treatment or control medication using a random numbers table in blocks of four”
Rating: YES (Low risk of bias)
Domain IIIb: Blinding of outcome assessor
“The notary was provided with a blank randomization list which was an absolutely unique document. It was only handed out after the biometrician (WG) had deposited all coded original data as a printout at the notary’s office. (…) Data entry was performed blindly by personnel not involved in the study. ”
Rating: UNCLEAR (Medium risk of bias)
“All statistical analyses were done before breaking the randomisation code, using the program …”
Rating: YES (Low risk of bias)
Domain V: Selective outcome reporting
Study protocol was published in 1991 prior to enrollment of participants, all primary outcome variables were reported with respect to all participants and the endpoints.
Rating: NO (high risk of bias)
No prior publication of protocol, but a pilot study exists. However this was published in 1993 only after the trial was performed in 1991. Primary outcome defined (duration of diarrhea), reported but table and graph do not match, secondary outcome (number of unformed stools on day 3) seems defined post hoc, for this is the only one point in time, this outcome yielded a significant result.
Rating: YES (low risk of bias)
Domain VI: Other sources of bias:
Rating: NO (high risk of bias), no details given
Imbalance of group properties (size, weight and age of children), that might have some impact on course of disease, high impact of parallel therapy (rehydration) by far exceeding effect size of homeopathic treatment
Rating: YES (low risk of bias), no details given
In a nutshell: I fail to see the basis for the different ratings in the studies themselves. I assume bias of the authors of the review.
So, what about the question posed in the title of this article? The meta-analysis is clearly not a ‘proof of concept’. But is it proof for misconduct? I asked Mathie and he answered as follows: No, your statement does not reflect the situation at all. As for each and every paper, we selected the main outcome measure for your trial using the objective WHO classification approach (in which quality of life is clearly of lower rank than severity). This is all clearly described in our prospective protocol. Under no circumstances did we approach this matter retrospectively, in the way you are implying.
Some nasty sceptics might have assumed that the handful of rigorous studies with negative results were well-known to most researchers of homeopathy. In this situation, it would have been hugely tempting to write the protocol such that these studies must be excluded. I am thrilled to be told that the authors of the current new meta-analysis (who declared all sorts of vested interests at the end of the article) resisted this temptation.
Each year, during the Christmas period, we are bombarded with religious ideology, soapy sentimentality and delusive festive cheer. In case you are beginning to feel slightly nauseous about all this, it might be time to counter-balance this abundance with my (not entirely serious) version of the ’10 commandments of quackery’?
- You must not use therapies other than those recommended by your healer – certainly nothing that is evidence-based!
- You must never doubt what your healer tells you; (s)he embraces the wisdom of millennia combined with the deep insights of post-modernism – and is therefore beyond doubt.
- You must happily purchase all the books, gadgets, supplements etc. your healer offers for sale. For more merchandise, you must frequent your local health food shops. Money is no object!
- You must never read scientific literature; it is the writing of evil. The truth can only be found by studying the texts recommended by your healer.
- You must never enter into discussions with sceptics or other critical thinkers; they are wicked and want to destroy your well-being.
- You must do everything in your power to fight the establishment, Big Pharma, their dangerous drugs and vicious vaccines.
- You must support Steiner Schools, Prince Charles and other enlightened visionaries so that the next generation is guided towards the eternal light.
- You must detox regularly to eliminate the ubiquitous, malignant poisons of Satan.
- You must blindly, unreservedly and religiously believe in vitalism, quantum medicine, vibrational energy and all other concepts your healer relies upon.
- You must denounce, vilify, aggress and attack anyone who disagrees with the gospel of your healer.
Few subjects make chiropractors more uneasy than a discussion of the safety of their spinal manipulations. Many chiropractors flatly deny that there are any risks at all. However, the evidence seems to tell a different story.
The purpose of a new review was to summarise the literature for cases of adverse events in infants and children treated by chiropractors or other manual therapists, identifying treatment type and if a preexisting pathology was present. English language, peer-reviewed journals and non-peer-reviewed case reports discussing adverse events (ranging from minor to serious) were systematically searched from inception of the relevant searchable bibliographic databases through March 2014. Articles not referring to infants or children were excluded.
Thirty-one articles met the selection criteria. A total of 12 articles reporting 15 serious adverse events were found. Three deaths occurred under the care of various providers (1 physical therapist, 1 unknown practitioner, and 1 craniosacral therapist) and 12 serious injuries were reported (7 chiropractors/doctors of chiropractic, 1 medical practitioner, 1 osteopath, 2 physical therapists, and 1 unknown practitioner). High-velocity, extension, and rotational spinal manipulation was reported in most cases, with 1 case involving forcibly applied craniosacral dural tension and another involving use of an adjusting instrument. Underlying preexisting pathology was identified in a majority of the cases.
The authors concluded that published cases of serious adverse events in infants and children receiving chiropractic, osteopathic, physiotherapy, or manual medical therapy are rare. The 3 deaths that have been reported were associated with various manual therapists; however, no deaths associated with chiropractic care were found in the literature to date. Because underlying preexisting pathology was associated in a majority of reported cases, performing a thorough history and examination to exclude anatomical or neurologic anomalies before applying any manual therapy may further reduce adverse events across all manual therapy professions.
This review is a valuable addition to our knowledge about the risks of spinal manipulations. My own review summarised 26 deaths after chiropractic manipulations. In several of these instances, the age of the patient had not been reported. Therefore the above conclusion (no deaths associated with chiropractic) seems a little odd.
The following text is a shortened version of the discussion of my review which, I think, addresses most of the pertinent issues.
… numerous deaths have been associated with chiropractic. Usually high-velocity, short-lever thrusts of the upper spine with rotation are implicated. They are believed to cause vertebral arterial dissection in predisposed individuals which, in turn, can lead to a chain of events including stroke and death. Many chiropractors claim that, because arterial dissection can also occur spontaneously, causality between the chiropractic intervention and arterial dissection is not proven. However, when carefully evaluating the known facts, one does arrive at the conclusion that causality is at least likely. Even if it were merely a remote possibility, the precautionary principle in healthcare would mean that neck manipulations should be considered unsafe until proven otherwise. Moreover, there is no good evidence for assuming that neck manipulation is an effective therapy for any medical condition. Thus, the risk-benefit balance for chiropractic neck manipulation fails to be positive.
Reliable estimates of the frequency of vascular accidents are prevented by the fact that underreporting is known to be substantial. In a survey of UK neurologists, for instance, under-reporting of serious complications was 100%. Those cases which are published often turn out to be incomplete. Of 40 case reports of serious adverse effects associated with spinal manipulation, nine failed to provide any information about the clinical outcome. Incomplete reporting of outcomes might therefore further increase the true number of fatalities.
This review is focussed on deaths after chiropractic, yet neck manipulations are, of course, used by other healthcare professionals as well. The reason for this focus is simple: chiropractors are more frequently associated with serious manipulation-related adverse effects than osteopaths, physiotherapists, doctors or other professionals. Of the 40 cases of serious adverse effects mentioned above, 28 can be traced back to a chiropractor and none to a osteopath. A review of complications after spinal manipulations by any type of healthcare professional included three deaths related to osteopaths, nine to medical practitioners, none to a physiotherapist, one to a naturopath and 17 to chiropractors. This article also summarised a total of 265 vascular accidents of which 142 were linked to chiropractors. Another review of complications after neck manipulations published by 1997 included 177 vascular accidents, 32 of which were fatal. The vast majority of these cases were associated with chiropractic and none with physiotherapy. The most obvious explanation for the dominance of chiropractic is that chiropractors routinely employ high-velocity, short-lever thrusts on the upper spine with a rotational element, while the other healthcare professionals use them much more sparingly.[REFERENCES FOR THE ABOVE STATEMENTS CAN BE FOUND IN MY REVIEW]