Some chiropractors claim that their main intervention, spinal manipulation, works for nonspecific neck pain by improving inter-vertebral range of motion (IV-RoM). But IV-RoM is difficult to measure, and whether it is related to clinical outcomes seems uncertain. Researchers from the Institute of Musculoskeletal Research & Clinical Implementation and the Anglo-European College of Chiropractic have just published a study that might throw some light on this issue. According to its authors, it was aimed at answering the following research questions:
- Does cervical spine flexion and extension IV-RoM increase after a course of spinal manipulation?
- Is there a relationships between any IV-RoM increases and clinical outcomes?
- How does palpation compare with objective measurement in the detection of hypo-mobile segments?
Thirty patients with nonspecific neck pain and 30 healthy controls matched for age and gender received quantitative fluoroscopy (QF) screenings to measure flexion and extension IV-RoM (C1-C6) at baseline and 4-week follow-up. Patients received up to 12 neck manipulations and completed NRS, NDI and Euroqol 5D-5L at baseline, plus PGIC and satisfaction questionnaires at follow-up. IV-RoM accuracy, repeatability and hypo-mobility cut-offs were determined. Minimal detectable changes (MDC) over 4 weeks were calculated from controls. Patients and control IV-RoMs were compared at baseline as well as changes in patients over 4 weeks. Correlations between outcomes and the number of manipulations received and the agreement (Kappa) between palpated and QF-detected of hypo-mobile segments were calculated.
QF had high accuracy (worst RMS error 0.5σ) and repeatability (highest SEM 1.1σ, lowest ICC 0.9σ) for IV-RoM measurement. Hypo-mobility cut offs ranged from 0.8σ to 3.5σ. No outcome was significantly correlated with increased IV-RoM above MDC and there was no significant difference between the number of hypo-mobile segments in patients and controls at baseline or significant increases in IV-RoMs in patients. However, there was a modest and significant correlation between the number of manipulations received and the number of levels and directions whose IV-RoM increased beyond MDC (Rho=0.39, p=0.043). There was also no agreement between palpation and QF in identifying hypo-mobile segments (Kappa 0.04-0.06).
The authors concluded that this study found no differences in cervical sagittal IV-RoM between patients with non-specific neck pain and matched controls. There was a modest dose-response relationship between the number of manipulations given and number of levels increasing IV-RoM – providing evidence that neck manipulation has a mechanical effect at segmental levels. However, patient-reported outcomes were not related to this.
This conclusion seems a little odd to me. In my view the study suggests a clearly negative answer to all the three research questions formulated above. An interesting paragraph from the authors’ discussion section provides further insight: The lack of a relationship between symptomatic improvement and increased IV-RoM is also of interest. Clearly other mechanisms that improved the comfort and functional capacity of the patients in this study were in play, including spontaneous recovery. Other important biological factors may have included chemical factors in joint and muscle and activation patterns in the latter. However, this study seemed to rule out central pain hypersensitivity as a factor, as this was not detected at baseline in any of the patients. Psychological and social factors and their influence on functional behavior may also have had a role and may have been influenced by the interventions received.
So, spinal manipulation does not seem to work by improving IV-RoM. Could this be because spinal manipulation does not work at all?
In the US, the scope of practice of health care professionals is a matter for each state to decide. Only the one of doctors is regulated nationwide. Other health care professions’ scope of practice can vary considerably within the US. This means that a chiropractor in one state of the US might be allowed to do more (or less) than in the next state. But what exactly are US chiropractors legally allowed to do?
A recent paper was aimed at answering this very question. Its authors assessed the current status of chiropractic practice laws in the US.
A cross-sectional survey of licensure officials from the Federation of Chiropractic Licensing Boards e-mail list was conducted in 2011 requesting information about chiropractic practice laws and 97 diagnostic, evaluation, and management procedures. To evaluate content validity, the survey was distributed in draft form at the fall 2010 Federation of Chiropractic Licensing Boards regional meeting to regulatory board members and feedback was requested. Comments were reviewed and incorporated into the final survey.
Partial or complete responses were received from 96% (n = 51) of the jurisdictions. The states with the highest number of services that could be performed were Missouri (n = 92), New Mexico (n = 91), Kansas (n = 89), Utah (n = 89), Oklahoma (n = 88), Illinois (n = 87), and Alabama (n = 86). The states with the highest number of services that cannot be performed are New Hampshire (n = 49), Hawaii (n = 47), Michigan (n = 42), New Jersey (n = 39), Mississippi (n = 39), and Texas (n = 30).
The authors conclude that the scope of chiropractic practice in the United States has a high degree of variability. Scope of practice is dynamic, and gray areas are subject to interpretation by ever-changing board members. Although statutes may not address specific procedures, upon challenge, there may be a possibility of sanctions depending on interpretation.
For me, the most surprising aspect of this article was to realise how many ‘non-chiropractic’ activities chiropractors are legally permitted in some US states. Here are some of the items that amazed me most:
- birth certificates
- death certificates
- premarital certificates
- recto-vaginal exam
- i.v. injections
- prostatic exam
- genital exam
- ear irrigation
- colonic irrigation
- oral and i.v. chelation therapy
- hyperbaric chamber
I have to admit that I did not even know what a PREMARITAL CERTIFICATE’ is; so I looked it up. The first one I found on the internet was entitled “PURITY COVENANT” and committed the couple “to abstain from fornication and remain sincere to the Lord Jesus Christ and to each other”
I have to further admit that many other of the items on this list leave me equally speechless. For example, how can chiropractors with their training focussed on the musculoskeletal system responsibly complete a death certificate? Why are they allowed in some states to examine the genitalia of their patients?
I suspect the perceived need of chiropractors to do all these things must be closely related to their long-standing ambition to become primary care physicians. Just to be clear: a primary care physician is a physician who provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. I have always been more than just a bit perplexed how chiropractors, who state that they are musculoskeletal specialists, might even consider being competent primary care providers.
But regardless of common sense, they do! The US ‘Council of Chiropractic Education’ accreditation process, for instance, requires schools to educate and train students to become a “competent doctor of chiropractic who will provide quality patient care and serve as a primary care physician” and the chiro-literature is awash with statements such as this one: “The primary care chiropractic physician is a viable and important part of the primary health care delivery system, with many chiropractic physicians currently prepared to participate effectively and competently in primary care.” Moreover, the phenomenon is by no means limited to the US: “chiropractors in the UK view their role as one of a primary contact healthcare practitioner and that this view is held irrespective of the country in which they were educated or the length of time in practice.”
As far as I am concerned, chiropractors might view their role as whatever they want. The fact is that, even if they add many more items to the list of their ‘services’, they are very far from being competent primary care physicians. Being able to provide the first contact as well as continuous care of medical conditions, not limited by cause, organ system, or diagnosis is not a matter of wishful thinking.
My 2008 evaluation of chiropractic concluded that the concepts of chiropractic are not based on solid science and its therapeutic value has not been demonstrated beyond reasonable doubt. It also pointed out that the advice of chiropractors often is dangerous and not in the best interest of the patient: many chiropractors have a very disturbed attitude towards immunisation: anti-vaccination attitudes till abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit.
In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)
D. D. Palmer’s son, B. J. Palmer (after literally walking [actually it was driving] over his father’s body) provided a much more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)
Such sentiments and opinions are still prevalent in the chiropractic profession – but today they are expressed in a far less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.
Not all chiropractors share such opinions. The chiropractic profession is currently divided over the issue of immunisation. Some chiropractors now realise that immunisations have been one of the most successful interventions ever for public health. Many others, however, do still vehemently adhere to the gospel of the Palmers. Statements like the following abound:
Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….
Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?
Yes, I do agree: the position of far too many chiropractors is ‘crystal clear’ – unfortunately it is also dangerously wrong.
Times are hard, also in the strange world of chiropractic, I guess. What is therefore more understandable than the attempt of chiropractors to earn a bit of money from people who want to lose weight? If just some of the millions of obese individuals could be fooled into believing that chiropractic is the solution for their problem, chiropractors across the world could be laughing all the way to the bank.
But how does one get to this point? Easy: one only needs to produce some evidence suggesting that chiropractic care is effective in reducing body weight. An extreme option is the advice by one chiropractor to take 10 drops of a homeopathic human chorionic gonadotropin product under the tongue 5 times daily. But, for many chiropractors, this might be one step too far. It would be preferable to show that their hallmark therapy, spinal adjustment, leads to weight loss.
With this in mind, a team of chiropractors performed a retrospective file analysis of patient files attending their 13-week weight loss program. The program consisted of “chiropractic adjustments/spinal manipulative therapy augmented with diet/nutritional intervention, exercise and one-on-one counselling.”
Sixteen of 30 people enrolled completed the program. At its conclusion, statistically and clinically significant changes were noted in weight and BMI measures based on pre-treatment (average weight = 190.46 lbs. and BMI = 30.94 kg/m(2)) and comparative measurements (average weight = 174.94 lbs. and BMI = 28.50 kg/m(2)).
According to the authors of this paper, “this provides supporting evidence on the effectiveness of a multi-modal approach to weight loss implemented in a chiropractic clinic.”
They do not say so, but we all know it, of course: one could just as well combine knitting or crossword puzzles with diet/nutritional intervention, exercise and one-on-one counselling to create a multi-modal program for weight loss showing that knitting or crossword puzzles are effective.
With this paper, chiropractors are not far from their aim of being able to mislead the public by claiming that CHIROPRACTIC CARE IS A NATURAL, SAFE, DRUG-FREE AND EFFECTIVE OPTION IN THE MANAGEMENT OF OBESITY.
Am I exaggerating? No, of course not. There must be thousands of chiropractors who have already jumped on the ‘weight loss band-waggon’. If you don’t believe me, go on the Internet and have a look for yourself. One of the worst sites I have seen might be ‘DOCTORS GOLDMINE’ (yes, most chiropractors call themselves ‘doctor these days!) where a chiropractor promises his colleagues up to $100 000 per month extra income, if they subscribe to his wonderful weight-loss scheme.
It would be nice to be able to believe those who insist that these money-grabbing chiropractors are but a few rotten apples in a vast basket of honest practitioners. But I have problems with this argument – there seem to be far too many rotten apples and virtually no activity or even ambition to get rid of them.
A remarkable article about homeopathy and immunisation entitled THE IMMUNISATION DILEMMA came to my attention recently. Its abstract promised: “evidence quantifying the effectiveness of vaccination and HP (homeoprophylaxis) will be examined. New international research describing and analysing HP interventions will be reported. An evidence-based conclusion will be reached.”
Sounds interesting? Let’s see what the article really offers. Here is the relevant text:
…evidence does exist to support claims regarding the effectiveness of homeopathic immunisation is undeniable.
I was first invited to visit Cuba in December 2008 to present at an international conference hosted by the Finlay Institute, which is a W. H. O.-accredited vaccine manufacturer. The Cubans described their use of HP to control an outbreak of leptospirosis (Weilʼs syndrome – a potentially fatal, water-born bacterial disease) in 2007 among the residents of the three eastern provinces which were most severely damaged by a severe hurricane – over 2.2 million people . 2008 was an even worse year involving three hurricanes, and the countryʼs food production was only just recovering at the time of the conference. The HP program had been repeated in 2008, but data was not available at the conference regarding that intervention.
I revisited Cuba in 2010 and 2012, each time to work with the leader of the HP interventions, Dr. Bracho, to analyse the data available. Dr. Bracho is not a homeopath; he is a published and internationally recognised expert in the manufacture of vaccine adjuvants. He worked in Australia at Flinders University during 2004 with a team trying to develop an antimalarial vaccine.
In 2012 we accessed the raw leptospirosis surveillance data, comprising weekly reports from 15 provinces over 9 years (2000 to 2008) reporting 21 variables. This yielded a matrix with 147 420 possible entries. This included data concerning possible confounders, such as vaccination and chemoprophylaxis, which allowed a careful examination of possible distorting effects. With the permission of the Cubans, I brought this data back to Australia and it is being examined by mathematicians at an Australian university to see what other information can be extracted. Clearly, there is objective data supporting claims regarding the effectiveness of HP.
The 2008 result was remarkable, and could only be explained by the effectiveness of the HP intervention. Whilst the three hurricanes caused immense damage throughout the country it was again worse in the east, yet the three homeopathically immunised provinces experienced a negligible increase in cases whilst the rest of the country showed significant increases until the dry season in January 2009 .
This is but one example – there are many more. It is cited to show that there is significant data available, and that orthodox scientists and doctors have driven the HP interventions, in the Cuban case. Many people internationally now know this, so once again claims by orthodox authorities that there is no evidence merely serves to show that either the authorities are making uninformed/unscientific statements, or that they are aware but are intentionally withholding information. Either way, confidence is destroyed and leads to groups of people questioning what they are told…
The attacks against homeopathy in general and HP in particular will almost certainly continue. If we can achieve a significant level of agreement then we would be able to answer challenges to HP with a single, cohesive, evidence-based, and generally united response. This would be a significant improvement to the existing situation.
Reference 7 is the following article: Bracho G, Varela E, Fernández R et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99: 156-166. The crucial bit if this paper are as follows:
A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis. This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions.
After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions. No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall.
The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted.
The paper thus describes little more than an observational study. It shows that one region was less affected than another. I think it is quite clear that this could have many reasons which are unrelated to the homeopathic immunisation. Even the authors are cautious and speak in their conclusions not of a causal effect but of an “association”.
The 2012 data cited in the text remains unpublished; until it is available for public scrutiny, it is impossible to confirm that it is sound and meaningful.
Reference 8 refers to this article: Golden I, Bracho G. Adaptability of homœoprophylaxis in endemic, epidemic and stable background conditions. Homœopathic Links 2009; 22: 211-213. I have no access to this paper (if someone does, please fill us in) but, judging from both its title and the way it is described in the text, it does not seem to show reliable data about the efficacy of homeopathic immunisation.
So, is it true that “evidence does exist to support claims regarding the effectiveness of homeopathic immunisation”?
I do not think so!
Immunisation is by no means a trivial matter; wrong decisions in this area have the potential to cost the lives of millions. Therefore proofs of efficacy need to be published in peer-reviewed journals of high standing. These findings need then be criticised, replicated and re-criticised and re-replicated. Only when there is a wide consensus about the efficacy/safety or lack of efficacy/safety of a new form of immunisation, can it be generally accepted and implemented into clinical practice.
The current consensus about homeopathic immunisation is that it is nothing less than dangerous phantasy. Those who promote this quackery should be publicly exposed as charlatans of the worst kind.
Some practitioners of alternative medicine (doctors, naturopaths, chiropractors and others) earn a lot of money with the claim that chelation therapy (an effective mainstream treatment for acute heavy metal poisoning) is an effective means to treat cardiovascular disease. However, the notion is controversial and implausible. Several systematic reviews of the best evidence concluded less than optimistically:
More recently, important new evidence has emerged. The largest study of chelation therapy (TACT) ever conducted cost ~ $ 30 million and concluded that among stable patients with a history of MI, use of an intravenous chelation regimen with disodium EDTA, compared with placebo, modestly reduced the risk of adverse cardiovascular outcomes, many of which were revascularization procedures. These results provide evidence to guide further research but are not sufficient to support the routine use of chelation therapy for treatment of patients who have had an MI.
At the time, the TACT trial was heavily and rightly criticised for a whole host of reasons. For instance, because of the result of the FDA inspection of the highest accruing TACT site:
- The investigators didn’t conduct the investigation in accordance with the signed statement and investigational plan. Several examples were given of shoddy procedures, prefilled forms, and failure to train personnel.
- Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Examples are given, including failure to report the deaths of patients on the study in a timely fashion (in one case the death wasn’t reported to the IRB until four months later; in another case it was never reported at all). In other cases, adverse event reports were not submitted to the IRB.
- Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.
- Investigational drug disposition records are not adequate with respect to dates, quantity, and use by subjects.
Despite these problems, the study was published in JAMA, albeit with a very critical editorial:
Differential dropout in TACT suggests unmasking, but the problem of intentional unblinding is more concerning. The sponsors of the trial, the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), were unblinded throughout the trial. The National Institutes of Health policy unwisely allows the sponsor access to unblinded trial data, and both organizations sent observers to the closed sessions of the data monitoring committee. This gave them access to confidential data during each of the 11 interim analyses. The unblinding of the study sponsor represents a serious deviation from acceptable standards of conduct for supervision of clinical trials. If a pharmaceutical company sponsoring a trial were allowed access to actual outcome data during the study, there would be major objections. Like any sponsor, the NHLBI and NCCAM cannot be considered unbiased observers. These agencies made major financial commitments to the trial and may intentionally or inadvertently influence study conduct if inappropriately unblinded during the study…
Given the numerous concerns with this expensive, federally funded clinical trial, including missing data, potential investigator or patient unmasking, use of subjective end points, and intentional unblinding of the sponsor, the results cannot be accepted as reliable and do not demonstrate a benefit of chelation therapy. The findings of TACT should not be used as a justification for increased use of this controversial therapy.
Orac, makes several further critical points about the published trial:
First, the primary endpoint (i.e., the aggregated serious cardiovascular events) did indeed show a modest difference, namely 30% of placebo subjects versus 26.5% of the EDTA chelation subjects (hazard ratio 0.82 for chelation). However, one notes that the result is just barely statistically significant, p = 0.035, with the 99% confidence interval for the hazard ratio ranging from 0.69 to 0.99. (The predetermined level for statistical significance for purposes of this study was 0.036; so this is statistically significant by the barest margin.) More importantly, if you look at the individual endpoints that make up that aggregate, there was no statistically significant difference in death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. Subgroup analysis (always a questionable analysis that requires replication, even when preplanned, as in TACT) purported to show a much greater benefit for diabetics, with a hazard ratio of 0.61 (p=0.002), while patients without diabetes showed no statistically significant difference in any of the outcome measures, including the aggregated total bad outcomes.
Now a paper that has just emerged describes the intent-to-treat comparison of this trial in patients with diabetes.
This was a double-blind, placebo-controlled, 2 × 2 factorial multicenter randomized trial of 1,708 post-myocardial infarction (MI) patients ≥50 years of age and with creatinine ≤2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo. The primary end point was a composite of total mortality, MI, stroke, coronary revascularization, or hospitalization for angina.
Median age was 65 years, 18% were female, 94% were Caucasian, 37% were diabetic, 83% had prior coronary revascularization, and 73% were on statins. Five-year Kaplan-Meier estimates for the primary end point was 31.9% in the chelation + high-dose vitamin group, 33.7% in the chelation + placebo vitamin group, 36.6% in the placebo infusion + active vitamin group, and 40.2% in the placebo infusions + placebo vitamin group. The reduction in primary end point by double active treatment compared with double placebo was significant (hazard ratio 0.74, 95% CI 0.57-0.95, P = .016). In patients with diabetes, the primary end point reduction of double active compared with double placebo was more pronounced (hazard ratio 0.49, 95% CI 0.33-0.75, P < .001).
The authors conclude that in stable post-MI patients on evidence-based medical therapy, the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance.
I fear that these conclusions are erroneous and misleading: the marginally positive finding might have nothing to do with chelation per se; most likely they are due to the fact that the ‘vitamin’ mixture administered along with chelation contained ingredients like heparin and procaine which are potentially beneficial for cardiovascular conditions. Moreover, the placebo contained a considerable amount of glucose which could easily explain the better outcome of the diabetic subgroup receiving the verum – in other words, the verum generated better results not because it was effective but because the ‘placebo’ had detrimental effects.
Yesterday, BBC NEWS published the following interesting text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day:
Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in.
“He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it.”
Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.***
“I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved.
“And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.
*** obviously there is no homeopathic remedy for megalomania (but that’s a different story)
SPECTACULARLY GOOD RESULTS?
Let’s have a look at the ‘trial’ and its results. An easily accessible report provides the following details about it:
From February 2007 to February 2008, Get Well UK ran the UK’s first government-backed complementary therapy pilot. Sixteen practitioners provided treatments including acupuncture, osteopathy and aromatherapy, to more than 700 patients at two GP practices in Belfast and Derry.
The BBC made an hour long documentary following our trials and tribulations, which was broadcast on BBC1 NI on 5 May 2008.
Aims and Objectives
The aim of the project was to pilot services integrating complementary medicine into existing primary care services in Northern Ireland. Get Well UK provided this pilot project for the Department for Health, Social Services and Public Safety (DHSSPS) during 2007.
The objectives were:
- To measure the health outcomes of the service and monitor health improvements.
- To redress inequalities in access to complementary medicine by providing therapies through the NHS, allowing access regardless of income.
- To contribute to best practise in the field of delivering complementary therapies through primary care.
- To provide work for suitably skilled and qualified practitioners.
- To increase patient satisfaction with quick access to expert care.
- To help patients learn skills to improve and retain their health.
- To free up GP time to work with other patients.
- To deliver the programme for 700 patients.
The results of the pilot were analysed by Social and Market Research, who produced this report.
The findings can be summarised as follows:
Following the pilot, 80% of patients reported an improvement in their symptoms, 64% took less time off work and 55% reduced their use of painkillers.
In the pilot, 713 patients with a range of ages and demographic backgrounds and either physical or mental health conditions were referred to various complementary and alternative medicine (CAM) therapies via nine GP practices in Belfast and Londonderry. Patients assessed their own health and wellbeing pre and post therapy and GPs and CAM practitioners also rated patients’ responses to treatment and the overall effectiveness of the scheme.
• 81% of patients reported an improvement in their physical health
• 79% reported an improvement in their mental health
• 84% of patients linked an improvement in their health and wellbeing directly to their CAM treatment
• In 65% of patient cases, GPs documented a health improvement, correlating closely to patient-reported improvements
• 94% of patients said they would recommend CAM to another patient with their condition
• 87% of patient indicated a desire to continue with their CAM treatment
Painkillers and medication
• Half of GPs reported prescribing less medication and all reported that patients had indicated to them that they needed less
• 62% of patients reported suffering from less pain
• 55% reported using less painkillers following treatment
• Patients using medication reduced from 75% before treatment to 61% after treatment
• 44% of those taking medication before treatment had reduced their use afterwards
Health service and social benefits
• 24% of patients who used health services prior to treatment (i.e. primary and secondary care, accident and emergency) reported using the services less after treatment
• 65% of GPs reported seeing the patient less following the CAM referral
• Half of GPs said the scheme had reduced their workload and 17% reported a financial saving for their practice
• Half of GPs said their patients were using secondary care services less.
Impressed? Well, in case you are, please consider this:
- there was no control group
- therefore it is not possible to attribute any of the outcomes to the alternative therapies offered
- they could have been due to placebo-effects
- or to the natural history of the disease
- or to regression towards the mean
- or to social desirability
- or to many other factors which are unrelated to the alternative treatments provided
- most outcome measures were not objectively verified
- the patients were self-selected
- they would all have had conventional treatments in parallel
- this ‘trial’ was of such poor quality that its findings were never published in a peer-reviewed journal
- this was not a ‘trial’ but a ‘pilot study’
- pilot studies are not normally for measuring outcomes but for testing the feasibility of a proper trial
- the research expertise of the investigators was close to zero
- the scientific community merely had pitiful smiles for this ‘trial’ when it was published
- neither Northern Ireland nor any other region implemented the programme despite its “spectacularly good results”.
So, is the whole ‘trial’ story an utterly irrelevant old hat?
Certainly not! Its true significance does not lie in the fact that a few amateurs are trying to push bogus treatments into the NHS via the flimsiest pseudo-research of the century. The true significance, I think, is that it shows how Prince Charles, once again, oversteps the boundaries of his constitutional role.
Arnold Relman has died aged 91. He was a great personality, served for many years as editor-in-chief of ‘The New England Journal of Medicine’ and was professor of medicine and social medicine at Harvard Medical School. He also was an brilliantly outspoken critic of alternative medicine, and I therefore believe that he deserves to be remembered here. The following excerpts are from an article he wrote in 1998 about Andrew Weil, America’s foremost guru of alternative medicine; I have taken the liberty of extracting a few paragraphs which deal with alternative medicine in general terms.
Until now, alternative medicine has generally been rejected by medical scientists and educators, and by most practicing physicians. The reasons are many, but the most important reason is the difference in mentality between the alternative practitioners and the medical establishment. The leaders of the establishment believe in the scientific method, and in the rule of evidence, and in the laws of physics, chemistry, and biology upon which the modern view of nature is based. Alternative practitioners either do not seem to care about science or explicitly reject its premises. Their methods are often based on notions totally at odds with science, common sense, and modern conceptions of the structure and the function of the human body. In advancing their claims, they do not appear to recognize the need for objective evidence, asserting that the intuitions and the personal beliefs of patients and healers are all that is needed to validate their methods. One might have expected such thinking to alienate most people in a technologically advanced society such as ours; but the alternative medicine movement, and the popularity of gurus such as Weil, are growing rapidly…
That people usually “get better,” that most relatively minor diseases heal spontaneously or seem to improve with simple common remedies, is hardly news. Every physician, indeed every grandmother, knows that. Yet before we accept Weil’s contention that serious illnesses such as “bone cancer,” “Parkinson’s disease,” or “scleroderma” are similarly curable, or respond to alternative healing methods, we need at least to have some convincing medical evidence that the patients whom he reports in these testimonials did indeed suffer from these diseases, and that they were really improved or healed. The perplexity is not that Weil is using “anecdotes” as proof, but that we don’t know whether the anecdotes are true.
Anecdotal evidence is often used in the conventional medical literature to suggest the effectiveness of treatment that has not yet been tested by formal clinical trials. In fact, much of the mainstream professional literature in medicine consists of case reports — “anecdotes,” of a kind. The crucial difference between those case reports and the testimonials that abound in Weil’s books (and throughout the literature of alternative medicine) is that the case reports in the mainstream literature are almost always meticulously documented with objective data to establish the diagnosis and to verify what happened, whereas the testimonials cited by alternative medicine practitioners usually are not. Weil almost never gives any objective data to support his claims. Almost everything is simply hearsay and personal opinion.
To the best of my knowledge, Weil himself has published nothing in the peer-reviewed medical literature to document objectively his personal experiences with allegedly cured patients or to verify his claims for the effectiveness of any of the unorthodox remedies he uses. He is not alone in this respect. Few proponents of alternative medicine have so far published clinical reports that would stand the rigorous scientific scrutiny given to studies of traditional medical treatments published in the serious medical journals. Alternative medicine is still a field rich in undocumented claims and anecdotes and relatively lacking in credible scientific reports…
… Thus Weil can believe in miraculous cures even while claiming to be rational and scientific, because he thinks that quantum theory supports his views.
Yet the leading physicists of our time do not accept such an interpretation of quantum theory. They do not believe quantum theory says anything about the role of human consciousness in the physical world. They see quantum laws as simply a useful mathematical formulation for describing subatomic phenomena that are not adequately handled by classical physical theory, although the latter remains quite satisfactory for the analysis of physical events at the macro-level. Steven Weinberg has observed that “quantum mechanics has been overwhelmingly important to physics, but I cannot find any messages for human life in quantum mechanics that are different in any important way from those of Newtonian physics.” And overriding all discussions of the meaning of quantum physics is the fundamental fact that quantum theory, like all other scientific law, is only valid to the extent that it predicts and accords with the evidence provided by observation and objective measurement. Richard Feynman said it quite simply: “Observation is the ultimate and final judge of the truth of an idea.” Feynman also pointed out that scientific observations need to be objective, reproducible, and, in a sense, public — that is, available to all interested scientists who wish to check the observations for themselves.
Surely almost all scientists would agree with Feynman that, regardless of what theory of nature we wish to espouse, we cannot escape the obligation to support our claims with objective evidence. All theories must conform to the facts or be discarded. So, if Weil cannot produce credible evidence to validate the miraculous cures that he claims for the healing powers of the mind, and if he does not support with objective data the claims he and others make for the effectiveness of alternative healing methods, he cannot presume to wear the mantle of science, and his appeal to quantum theory cannot help him.
Some apologists for alternative medicine have argued that since their healing methods are based on a “paradigm” different from that of traditional medicine, traditional standards of evidence do not apply. Weil sometimes seems to agree with that view, as when he talks about “stoned thinking” and the “ambivalent” nature of reality, but more recently — as he seeks to integrate alternative with allopathic medicine — he seems to acknowledge the need for objective evidence. This, at least, is how I would interpret one of his most recent and ambitious publishing ventures, the editorship of the new quarterly journal Integrative Medicine***.
Integrative Medicine describes itself as a “peer-reviewed journal … committed to gathering evidence for the safety and efficacy of all approaches to health according to the highest standards of scientific research, while remaining open to new paradigms and honoring the healing power of nature.” The Associate Editors and Editorial Board include prominent names in both alternative medicine and allopathic medicine, who presumably support that mission. Yet the first two issues will disappoint those who were looking for original clinical research based on new, objective data. Perhaps subsequent issues will be different, but in any case it is hard to understand the need for Weil’s new journal if he truly intends to hold manuscripts to accepted scientific standards: there already exist many leading peer-reviewed medical journals that will review research studies of alternative healing methods on their merits. During the past decade or so, only a few such studies have passed rigorous review and have been published in first-rate journals. Recently, more studies have been published, but very few of them report significant clinical effects. And that is pretty much where matters now stand. Despite much avowed interest in research on alternative medicine and increased investment in support of such research, the evidentiary underpinnings of unconventional healing methods are still largely lacking…
The alternative medicine movement has been around for a long time, but it was eclipsed during most of this century by the success of medical science. Now there is growing public disenchantment with the cost and the impersonality of modern medical care, as well as concern about medical mistakes and the complications and side-effects of pharmaceuticals and other forms of medical treatment. For their part, physicians have allowed the public to perceive them as uninterested in personal problems, as inaccessible to their patients except when carrying out technical procedures and surgical operations. The “doctor knows best” attitude, which dominated patient-doctor relations during most of the century, has in recent decades given way to a more activist, consumer-oriented view of the patient’s role. Moreover, many other licensed health-care professionals, such as nurse-practitioners, psychotherapists, pharmacists, and chiropractors, are providing services once exclusively reserved to allopathic physicians.
The net result of all these developments has been a weakening of the hegemony that allopathic medicine once exercised over the health care system, and a growing interest by the public in exploring other healing approaches. The authority of allopathic medicine is also being challenged by a swelling current of mysticism and anti-scientism that runs deep through our culture. Even as the number and the complexity of urgent technological and scientific issues facing contemporary society increase, there seems to be a growing public distrust of the scientific outlook and a reawakening of interest in mysticism and spiritualism.
All this obscurantism has given powerful impetus to the alternative medicine movement, with its emphasis on the power of mind over matter. And so consumer demand for alternative remedies is rising, as is public and private financial support for their study and clinical use. It is no wonder that practicing physicians, the academic medical establishment, and the National Institutes of Health are all finding reasons to pay more attention to the alternative medicine movement. Indeed, it is becoming politically incorrect for the movement’s critics to express their skepticism too strongly in public…
There is no doubt that modern medicine as it is now practiced needs to improve its relations with patients, and that some of the criticisms leveled against it by people such as Weil — and by many more within the medical establishment itself — are valid. There also can be no doubt that a few of the “natural” medicines and healing methods now being used by practitioners of alternative medicine will prove, after testing, to be safe and effective. This, after all, has been the way in which many important therapeutic agents and treatments have found their way into standard medical practice in the past. Mainstream medicine should continue to be open to the testing of selected unconventional treatments. In keeping an open mind, however, the medical establishment in this country must not lose its scientific compass or weaken its commitment to rational thought and the rule of evidence.
There are not two kinds of medicine, one conventional and the other unconventional, that can be practiced jointly in a new kind of “integrative medicine.” Nor, as Andrew Weil and his friends also would have us believe, are there two kinds of thinking, or two ways to find out which treatments work and which do not. In the best kind of medical practice, all proposed treatments must be tested objectively. In the end, there will only be treatments that pass that test and those that do not, those that are proven worthwhile and those that are not. Can there be any reasonable “alternative”?
*** the journal only existed for a short period of time
Do you suffer from any of the following conditions/problems?
• Feeling of being forsaken and SEPARATION; huge despair.
• Oppression (political, family, abuse-sexual, religious, being bullied) and perceiving yourself as victim.
• States of possession.
• Children of ambitious parents who are pushed.
• Caring professions which give rise to burn out and/or brain deadness.
• Indescribable evil/darkness.
• Not showing anything: MASKS, unsmiling.
• Suspicious, uneasy, shifty eyes; cannot look you in the eye.
• Hangdog of head, beaten.
• Frequent weeping, tears just flow; sense of numbness or despair over them.
• Deep grief which cannot be accessed, unspoken, but it hangs in the air.
• Depression, sense of blackness, total isolation, aloneness, despair.
• Panic, need to escape but can’t. TERROR.
• Feel brainwashed, lack the courage to break free, unable to break from the past.
• Everything will fail; despair of recovery.
• Aggression against yourself.
• Impulsivity – anything can happen.
• Aggression to others or animals (fascinated by it). Child who hangs a cat with a rope around the neck to see what happens.
• Guilt, not resolvable.
• ASTHMA, crushing on chest, suffocation.
• Headache, deep crushing, congestion, bursting with depression and photophobia; gives the feeling of being cut off and isolated.
• After strokes, for parts not connected yet again.
• Temporary blindness and deafness in emotional situations.
• Stiffness of joints-swelling: ” a claw coming into it”.
• Emptiness, a hole in the gut (ulcers).
• Narcolepsia (20 hrs a day).
If so, you are, according to some homeopaths, in need of a very special homeopathic remedy: BERLIN WALL.
No, I am not joking! There are even case reports of successful treatments with this extraordinary remedy: A case of asthma, fear and depression, solved with the remedy ‘Berlin Wall’.
Homeopathy is based on the ‘like cures like’ principle. This means that anything which causes symptoms in a healthy person, can be used to treat these symptoms when they occur in a patient. ANYTHING! Even fragments from the BERLIN WALL.
Of course, the bits of the wall are not administered in their original form; this might be unhealthy and, eventually, it could even exhaust the supply of the raw material. It is ‘potentized‘ which means it is diluted and diluted and diluted and diluted and…
So, the homeopathic BERLIN WALL is as safe as a placebo – in fact, it is a placebo!
‘THE HINKLEY TIMES’ is not a paper that I read often, I have to admit – but maybe I should! It was there that I found the following remarkable article:
Bosworth MP David Tredinnick has asked questions in the House of Commons about the growing problem of antibiotic resistance within hospitals, suggesting herbal remedies could be answer.
The Tory MP, who has a keen interest in alternative medicine particularly herbal curatives, asked Jeremy Hunt, Secretary of State for Health, whether the problem was being discussed at the very top level.
He said: “Does my right honourable friend agree that a critical problem that A and E units will face in the future is antibiotic resistance? Is he aware that the science and technology committee, of which I am a member, has been looking at this issue and it also interests the health committee, of which I am also a member? Can he assure me that he is talking to the Prime Minister about how to stimulate new antibiotic research, and will he also remember that nature has its own remedies, such as tea tree oil?”
In reply Mr Hunt said: “My honourable friend is right about the seriousness of the issue of antimicrobial resistance. Some 25,000 people die in Europe every year as a result of the failure of antibiotics – more than die in road traffic accidents. I raised the issue at the World Health Assembly and I have discussed it closely with the Prime Minister.”
David Tredinnick is no stranger to strange ideas. Wikipedia (yes I know, many people do not like it as a source) sums it up quite succinctly:
He is a supporter of complementary and alternative medicine (CAM). He has made supportive comments in Parliament on homeopathy, despite continued lack of evidence of its effectiveness. He has supported chiropractic and mentioned the influence of the Moon on blood clotting. In this same debate he characterised scientists as “racially prejudiced”. He has tabled several early day motions in support of homeopathy’s continued funding on the National Health Service.Tredinnick’s views continue to cause amused disbelief in some quarters and a spokesman for the Royal College of Surgeons of England said they would “laugh their heads off” at the suggestion they could not operate at the full moon.
At the 2010 general election, in addition to candidates from the two main parties, Tredinnick was opposed by New Scientist journalist Dr. Michael Brooks who objected to “Tredinnick’s outspoken promotion of complementary and alternative medicine.”During a hustings debate called by Brooks to “highlight the scientific literacy of the UK’s elected representatives” Brooks claimed that Tredinnick regarded homeopathy as a suitable treatment for Malaria and HIV, which Tredinnick did not deny. Tredinnick in turn argued that “alternative treatments are incredibly good value for money” and stated his belief that randomised controlled trials are not effective at evaluating very dilute preparations.
In March 2013 Tredinnick was ridiculed as “nonsensical” by the government’s outgoing chief scientist, Sir John Beddington, who said the MP had fallen for the “Galileo fallacy” (Galileo was laughed at but was right, therefore since I am laughed at I must be right).
In July 2013 Tredinnick sponsored an EDM congratulating a farmer on his decision to use homeopathy with what were claimed to be positive results.The motion was supported by one other MP but the British veterinary association says there is no evidence of any benefit.
Tredinnick is a supporter of astrology especially the use of it in medical practice.In November 2009, he spoke at a meeting organised by the Astrological Association of Great Britain, where he related his personal experience of astrology and illness, advocating that astrology be integrated into the NHS.
Tredinnick’s appointment to the Health committee in June 2010 was criticised in two science reports in the Guardian. Martin Robbins said his appointment was “an extremely disturbing development” even though “Tredinnick is a figure unlikely to be taken seriously by policymakers” whilst Nature‘s Adam Rutherford described Tredinnick as “misinformed about a great many things” and said that “giving [him] influence on medical policy ..is a bad move.”The Telegraph writer Ian Douglas also described it as “a problem.”
His appointment to the Science and technology committee also drew criticism. Andy McSmith in the Independent, cited his views that homeopathy could cure HIV, TB, malaria, urinary infections, diarrhoea, skin eruptions, diabetes, epilepsy, eye infections, intestinal parasites, cancer, and gangrene amongst others and quoted Imran Khan, head of the Campaign for Science and Engineering, as saying that “someone with such incredibly odd views is not helpful”. Tom Whipple in the Times said his appointment caused despair,whilst Elizabeth Gibney in the Times Higher Education quoted the Skeptical Voter website as saying that Tredinnick is “perhaps the worst example of scientific illiteracy in government”…
In 2009 Tredinnick attempted to claim the £125 cost of attending a course on “intimate relationships” through his Parliamentary expenses. He was also found to have used expenses to purchase astrology software, claiming it was for a debate on alternative medicine.
Compared to some of theses bizarre activities, the notion that herbal remedies might provide the solution for antibiotic resistance seems almost reasonable and clever.
Tredinnick does not seem to know that:
- many antibiotics originate from plants or other natural substances,
- several large pharmaceutical companies are feverishly looking for more such substances from plants,
- most plants do actually contain substances which have antibiotic activity,
- however, most cannot be used as medicines, for instance, because they are far too toxic (tea tree oil is a good example for this),
- once a pure compound has been isolated from a plant and is used therapeutically, it ceases to be herbal medicine (which is defined as the use of full plant extracts),
- it is thus unlikely that full plant extracts, i. e. herbal medicine, will ever provide a solution to antibiotic resistance.
I have little doubt that Tredinnick will continue to mislead parliament and the public with his nonsensical views about alternative medicine. And even if it might have no effect whatsoever, I will continue to point out just how nonsensical they are.