The UK Professional Standards Authority for Health and Social Care (PSA) tries to promote the health, safety and wellbeing of patients, service users and the public by raising standards of regulation and voluntary registration of people working in health and care. They are an independent body, accountable to the UK Parliament.
In July 2014, the PSA audited all 75 of the cases that the General Chiropractic Council (GCC) had closed at the initial stages of its fitness to practise (FTP) process during the 12 month period from 1 June 2013 to 30 May 2014. The final verdict of the PSA’s audit seems devastating. Here is a short excerpt from the conclusions of its report:
The extent of the deficiencies we found in this audit (as set out in detail above) which related to failures across every aspect of the casework framework, as well as widespread failures to comply with the GCC’s own procedures, raises concern about the extent to which the public can have confidence in the GCC’s operation of its initial stages FTP process.
In summary, the particular areas of failures/weaknesses identified in our audit include:
- Ineffective screening on receipt of ‘complaints’ and inconsistent completion and updating of risk assessments
- Customer service issues, including failing to respond to/acknowledge correspondence promptly, failing to provide clear information about the FTP process and failing to provide updates about progress and outcomes within reasonable timeframes
- Inadequate investigation of cases through failures to gather or validate relevant evidence or to do so promptly – sometimes as a result of inconsistent and ineffective use of case plans and case reviews
- Deficiencies in the evaluation of information by decision-makers and weaknesses in the reasoning provided for decisions, including failures to address all the relevant allegations and/or reaching decisions on the basis of insufficient evidence
- Poor record keeping and various data protection breaches or potential breaches
- Ineffective systems for the sharing of relevant information between the Registration and FTP teams, leading to inappropriate action being taken in some cases
- Widespread non-compliance with internal guidance and procedures.
We have also concluded that the steps taken by the GCC, in particular the processes it introduced in its procedure manual in February had not at the time of the audit resulted in consistent improvement in the quality of its casework.
What does all of this mean?
The GCC’s website informs us that this organisation regulates all chiropractors in the UK to ensure the safety of patients undergoing chiropractic treatment. The GCC is an independent statutory body established by Parliament to regulate the chiropractic profession. We protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession. The title of ‘chiropractor’ is protected by law and it is a criminal offence for anyone to describe themselves as any sort of chiropractor without being registered with the GCC. We check that all chiropractors are properly qualified and are fit to practise.
The conclusions of the PSA audit seem to indicate nothing less than this: the GCC is not fit for purpose!
I have often said that the regulation of nonsense must inevitably result in nonsense – but I did not expect to get a confirmation from the GCC in this fashion.
The discussion whether acupuncture is more than a placebo is as long as it is heated. Crucially, it is also quite tedious, tiresome and unproductive, not least because no resolution seems to be in sight. Whenever researchers develop an apparently credible placebo and the results of clinical trials are not what acupuncturists had hoped for, the therapists claim that the placebo is, after all, not inert and the negative findings must be due to the fact that both placebo and real acupuncture are effective.
Laser acupuncture (acupoint stimulation not with needle-insertion but with laser light) offers a possible way out of this dilemma. It is relatively easy to make a placebo laser that looks convincing to all parties concerned but is a pure and inert placebo. Many trials have been conducted following this concept, and it is therefore highly relevant to ask what the totality of this evidence suggests.
A recent systematic review did just that; specifically, it aimed to evaluate the effects of laser acupuncture on pain and functional outcomes when it is used to treat musculoskeletal disorders.
Extensive literature searches were used to identify all RCTs employing laser acupuncture. A meta-analysis was performed by calculating the standardized mean differences and 95% confidence intervals, to evaluate the effect of laser acupuncture on pain and functional outcomes. Included studies were assessed in terms of their methodological quality and appropriateness of laser parameters.
Forty-nine RCTs met the inclusion criteria. Two-thirds (31/49) of these studies reported positive effects. All of them were rated as being of high methodological quality and all of them included sufficient details about the lasers used. Negative or inconclusive studies mostly failed to demonstrate these features. For all diagnostic subgroups, positive effects for both pain and functional outcomes were more consistently seen at long-term follow-up rather than immediately after treatment.
The authors concluded that moderate-quality evidence supports the effectiveness of laser acupuncture in managing musculoskeletal pain when applied in an appropriate treatment dosage; however, the positive effects are seen only at long-term follow-up and not immediately after the cessation of treatment.
Surprised? Well, I am!
This is a meta-analysis I always wanted to conduct and never came round to doing. Using the ‘trick’ of laser acupuncture, it is possible to fully blind patients, clinicians and data evaluators. This eliminates the most obvious sources of bias in such studies. Those who are convinced that acupuncture is a pure placebo would therefore expect a negative overall result.
But the result is quite clearly positive! How can this be? I can see three options:
- The meta-analysis could be biased and the result might therefore be false-positive. I looked hard but could not find any significant flaws.
- The primary studies might be wrong, fraudulent etc. I did not see any obvious signs for this to be so.
- Acupuncture might be more than a placebo after all. This notion might be unacceptable to sceptics.
I invite anyone who sufficiently understands clinical trial methodology to scrutinise the data closely and tell us which of the three possibilities is the correct one.
Chinese proprietary herbal medicines (CPHMs) are a well-established and a hugely profitable part of Traditional Chinese Medicine (TCM) with a long history in China and elsewhere; they are used for all sorts of conditions, not least for the treatment of common cold. Many CPHMs have been listed in the ‘China national essential drug list’ (CNEDL), the official reference published by the Chinese Ministry of Health. One would hope that such a document to be based on reliable evidence – but is it?
The aim of a recent review was to provide an assessment on the potential benefits and harms of CPHMs for common cold listed in the CNEDL.
The authors of this assessment were experts from the Chinese ‘Centre for Evidence-Based Medicine’ and one well-known researcher of alternative medicine from the UK. They searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the CNEDL for common cold.
Of the 33 CPHMs listed in the 2012 CNEDL for the treatment of common cold, only 7 had any type of clinical trial evidence at all. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) could be included in the assessments.
All these studies had been conducted in China and published in Chinese. All of them were burdened with poor study design and low methodological quality, and all had to be graded as being associated with a very high risk of bias.
The authors concluded that the use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.
I should state that it is, in my view, most laudable that the authors draw such a relatively clear, negative conclusion. This does certainly not happen often with papers originating from China, and George Lewith, the UK collaborator in this article, is also not known for his critical attitude towards alternative medicine. But there are other, less encouraging issues here to mention.
In the discussion section of their paper, the authors mention that the CNEDL has been approved by the Chinese Ministry of Public Health and is currently regarded as the accepted reference point for the medicines used in China. They also explain that the CNEDL was officially launched and implemented in August 2009. The CNEDL is now up-dated every 3 years, and its 2012 edition contains 520 medicines, including 203 CPHMs. The CPHMs listed in CNEDL cover 137 herbal remedies for internal medicine, 11 for surgery, 20 for gynaecology, 7 for ophthalmology, 13 for otorhinolaryngology and 15 for orthopaedics and traumatology.
Moreover, the authors inform us that about 3,100 medical and clinical experts had been recruited to evaluate the safety, effectiveness and costs of CPHMs. The selection process of medicines into CNEDL was strictly in accordance with the principle that they ‘must be preventive and curative, safe and effective, affordable, easy to use, think highly of both Chinese and Western medicine’. A detailed procedure for evaluation is, however, not available because the files are confidential.
The authors finally state that their paper demonstrates that the selection of CPHMs into the CNEDL is less likely to be ‘evidence-based’ and revealed the sharp contrast between the policy and priority given to by the Chinese government to Traditional Chinese Medicine(TCM).
This surely must be a benign judgement, if there ever was one! I would say that the facts disclosed in this review show that TCM seems to exist in a strange universe where commercial interests are officially allowed to reign supreme over patients’ interests and public health.
Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.
The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.
Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.
The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.
Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.
American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.
Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.
The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.
I know what my chiropractic friends will respond to this post:
- I am alarmist,
- I cherry-pick articles that are negative for their profession,
- these cases are extreme rarities,
- conventional medicine is much more dangerous.
To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.
Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?
Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?
Even though it has been published less than a month ago, my new book ‘A SCIENTIST IN WONDERLAND…‘ has already received many most flattering reviews. For me, the most impressive one was by the journal ‘Nature'; they called my memoire ‘ferociously frank’ and ‘a clarion call for medical ethics’.
I did promise to provide several little excerpts for the readers of this blog to enable them to make up their own minds as to whether they want to read it or not. Today I offer you the start of the chapter 6 entitled ‘WONDERLAND’. I do hope you enjoy it.
It has been claimed by some members of the lunatic fringe of alternative medicine that I took up the Laing Chair at Exeter with the specific agenda of debunking alternative medicine. This is certainly not true; if anything, I was predisposed to look kindly on it. After all, I had grown up and done my medical training in Germany where the use of alternative therapies in a supportive role alongside standard medical care was considered routine and unremarkable. As a clinician, I had seen positive results from alternative therapies. If I came to Exeter with any preconceived ideas at all, they were of a generally favourable kind. I was sure that, if we applied the rules of science to the study of alternative medicine, we would find plenty of encouraging evidence.
As if to prove this point, the managing director of a major UK homeopathic pharmacy wrote a comment on my blog in April 2014: “…I met you once in Exeter in the 90s when exploring a possible clinical study. I found you most encouraging and openly enthusiastic about homeopathy. I would go so far as to say I was inspired to go further in homeopathy thanks to you but now you want to close down something which in my experience does so much good in the world. What went wrong?”
The answer to this question is fairly simple: nothing went wrong, but the evidence demonstrated more and more indispu-tably that most alternative therapies are not nearly as effective as enthusiasts tried to make us believe…
A recent article from THE CHIROPRACTIC REPORT entitled ‘Media Criticism – Whether and How to Respond’ has caught my attention. It provides detailed and, in my view, quite remarkable advice to chiropractors as to how they should react to criticism. Here is an excerpt:
…the easiest media comment to challenge is one that makes an absolute claim – for example Salzberg’s claim that the practice of chiropractic is “highly dubious.” It also means that an effective response should usually not be absolute – claiming for example that chiropractic care can cure, or a specific chiropractic treatment is proven effective for, a specific condition.
Let’s explore this with an example. In 2008 a British journalist, Simon Singh, while promoting a new book he had co-authored that was heavily critical of chiropractic and complementary and alternative medicine in general, wrote an article in the Guardian newspaper in which he claimed that “there is not a jot of evidence” that chiropractic treatment can help children with “colic, sleeping and feeding problems . . . and prolonged crying.” In other words, a black and white claim.
There was and is evidence. Singh was wrong. How might you respond to this? Here are your options for reply, from the outspoken to the restrained:
a. Chiropractic is proven effective for the cure of infantile colic.
b. Spinal manipulation is proven effective for the cure of infantile colic
c. Manual treatments are proven effective for the cure of infantile colic
d. Chiropractic/spinal manipulation/ manual therapies may be effective in reducing the symptoms of infantile colic.
e. Where spinal joint dysfunction/subluxation is found, chiropractic/spinal manipulation/manual therapies may be effective in reducing abnormal and incessant crying in infants medically diagnosed as having infantile colic
f. Chiropractic care has a central focus of assessing and correcting spinal joint dysfunction/subluxation and its biomechanical and physiological effects, and where these are addressed many symptoms may be reduced including those associated with infantile colic.
The first three options are as black and white as Singh’s statement, and are not supported by the evidence. Some studies say yes, some no. All the other options, which have appropriate qualifiers and shades of gray, are supported by sound evidence.
Much of that evidence is referred to and referenced in the March 2010 issue of this Report, available online at www.chiropracticreport.com/pastissues. To answer Singh effectively one only has to produce some of the good quality research and question how he can be credible when he says “there is not a jot of evidence”.
With respect to evidence, in this context that means evidence published in peer-reviewed scientific journals. You may decide to comment on one or more anecdotal case reports from your practice to give your response greater human interest, but this will mean nothing unless supported by higher levels of published evidence.
Am I the only one to find this remarkable?
Am I wrong in interpreting this as detailed instructions to mislead the public?
Are these instructions not merely advice to defend chiropractic commercial interests at the expense of public health?
How can this be ethical?
Reiki healers believe they are able to channel ‘healing energy’ into patients’ body and thus enable them to get healthy. If Reiki were not such a popular treatment, one could brush such claims aside and think “let the lunatic fringe believe what they want”. But as Reiki so effectively undermines consumers’ sense of reality and rationality, I feel a responsibility to inform the public what Reiki truly amounts to.
This pilot study compared the effects of Reiki therapy with those of companionship on improvements in quality of life, mood, and symptom distress in cancer patients receiving chemotherapy. Thirty-six breast cancer patients received one of three treatments:
- usual care,
- Reiki + usual care,
- companionship + usual care.
First, data were collected from patients receiving usual care. Second, patients were randomized to either receive Reiki or a companionship during chemotherapy.
Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4.
The results show that Reiki was rated relaxing with no side effects. Reiki and companionship groups both reported improvements in quality of life and mood that were greater than those seen in the usual care group.
The authors concluded that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.
Yet another example of utterly bizarre conclusions from a fairly straight forward study and quite clear results. What they really demonstrate is the fact that Reiki is nothing more than a placebo; its perceived benefit relies entirely on non-specific effects. This view is also supported by our systematic review (its 1st author is a Reiki healer!): the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.
In other words, we do not need a trained Reiki master, nor the illusion of some mysterious ‘healing energy’. Simple companionship without woo or make-believe has exactly the same effect without undermining rationality. Or, to put it much more bluntly: REIKI IS NONSENSE ON STILTS.
Poor sleep quality during pregnancy is a frequent problem. Drug treatment can be problematic due to possible adverse effects for mother and embryo/foetus. Many pregnant women prefer natural treatments and assume that ‘natural’ equals harmless.
In the present study, the sedative effects of Bryophyllum pinnatum were investigated. This remedy is a phytotherapeutic medication predominantly used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a promising risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnosis.
In this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician’s consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse effects perceived by the patients during the treatment were recorded.
The results show that the number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a reduction in tiredness during the day. There was, however, no evidence for a prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.
From these data, the authors concluded that B. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.
Clinical trials of anthroposophic remedies, i.e. remedies which are based on the school of medicine founded by Rudolf Steiner, are very rare. Therefore this trial could be important.
B. pinnatum is a plant used in traditional Tai medicine against hypertension, and to some extend this makes sense: it contains cardiac glycosides which might help lowering elevated blood pressure. The reason for its use as a hypnotic, however, is not clear.
So, is B pinnatum really a ‘suitable treatment of sleep problems in pregnancy’? I doubt it for the following reasons:
- the effects documented in this study are far from convincing,
- we would need much more solid data to issue such a general recommendation,
- cardiac glycosides can cause very serious adverse effects,
- the sample size of the study is at least one dimension too small for assuming that it is safe,
- we know nothing about its potential to cause harm to the foetus.
Personally, I find it irresponsible to draw conclusions such as the ones above on the basis of data which are flimsy to the extreme. I ask myself, to what extend wishful thinking might be a regrettable characteristic for the entire field of anthroposophic medicine.
How often have we heard it on this blog and elsewhere?
- chiropractic is progressing,
- chiropractors are no longer adhering to their obsolete concepts and bizarre beliefs,
- chiropractic is fast becoming evidence-based,
- subluxation is a thing of the past.
American chiropractors wanted to find out to what extent these assumptions are true and collected data from chiropractic students enrolled in colleges throughout North America. The stated purpose of their study is to investigate North American chiropractic students’ opinions concerning professional identity, role and future.
A 23-item cross-sectional electronic questionnaire was developed. A total of 7,455 chiropractic students from 12 North American English-speaking chiropractic colleges were invited to complete the survey. Survey items encompassed demographics, evidence-based practice, chiropractic identity and setting, and scope of practice. Data were collected and descriptive statistical analyses were performed.
A total of 1,243 questionnaires were electronically submitted. This means the response rate was 16.7%. Most respondents agreed (34.8%) or strongly agreed (52.2%) that it is important for chiropractors to be educated in evidence-based practice. A majority agreed (35.6%) or strongly agreed (25.8%) the emphasis of chiropractic intervention is to eliminate vertebral subluxations/vertebral subluxation complexes. A large number of respondents (55.2%) were not in favor of expanding the scope of the chiropractic profession to include prescribing medications with appropriate advanced training. Most respondents estimated that chiropractors should be considered mainstream health care practitioners (69.1%). About half of all respondents (46.8%) felt that chiropractic research should focus on the physiological mechanisms of chiropractic adjustments.
The authors of this paper concluded that the chiropractic students in this study showed a preference for participating in mainstream health care, report an exposure to evidence-based practice, and desire to hold to traditional chiropractic theories and practices. The majority of students would like to see an emphasis on correction of vertebral subluxation, while a larger percent found it is important to learn about evidence-based practice. These two key points may seem contradictory, suggesting cognitive dissonance. Or perhaps some students want to hold on to traditional theory (e.g., subluxation-centered practice) while recognizing the need for further research to fully explore these theories. Further research on this topic is needed.
What should we make of these findings? The answer clearly must be NOT A LOT.
- the response rate was dismal,
- the questionnaire was not validated
- there seems to be little critical evaluation or discussion of the findings.
If anything, these findings seem to suggest that chiropractors want to join evidence based medicine, but on their own terms and without giving up their bogus beliefs, concept and practices. They seem to want the cake and eat it, in other words. The almost inevitable result of such a development would be that real medicine becomes diluted with quackery.
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.