Updated Edition!
According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.
In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.
Nelson’s homeopathic pharmacy has a proud history:
Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”
The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”
A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).
The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.
The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.
We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.
Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).
The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.
I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Bach Flower Remedies have no effect whatsoever!
Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.
I reported previously on this blog that the Australian National Health and Medical Research Council (NH&MRC) has made the most thorough and independent assessment of homeopathy in the history of this form of alternative therapy. The report published at the time was preliminary, and further evidence from parties that were critical of it needed to be taken into account.
Today (11/3/2015), the NH&MRC has released its final report on homeopathy. In essence, it concluded that there is no scientific basis for homeopathy and no quality evidence of its efficacy.
The report is similar in its conclusions to the UK Government Science and Technology 2010 Report on Homeopathy.
The summary of the report sates the following:
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Professor Warwick Anderson, CEO of the Council, commented: “All medical treatments and interventions should be underpinned by reliable evidence. NH&MRC’s review shows that there is no good quality evidence to support the claim that homeopathy works better than a placebo.”
The report confirms what many scientific and public health experts have maintained since about 200 years, that not only does homeopathy not work, if it did, chemistry, physics and physiology could not.
“In short, the continued promotion of homeopathy would represent a commercial scam preying on the gullible,” said Professor John Dwyer AO, President of Friends of Science in Medicine (FSM), a non-industry aligned advocacy group for quality evidence in health. “Worse still, as a placebo therapy, harm may occur when it replaces effective therapies, as those given homeopathic treatments may wrongly think that they and their children are protected from serious infections,” he added.
The report emphasises that ‘People who choose homeopathy may put their health at risk, if they reject or delay treatments for which there is good evidence for safety and effectiveness’.
“With so many pressures on the Australian health dollar the Government must stop subsidising unproven alternative therapies such as homeopathy through student loans for homeopathy and similar courses,” said Professor Rob Morrison OAM, Co-Vice President of FSM, “The government should also not subsidise health funds offering cover for pseudoscientific electives of this kind,” said Professor Morrison. “The government should at least mandate that health funds offer a cheaper option that does not include ‘belief based’ therapies,” he said.
“It is completely unprofessional and unethical now for pharmacies to sell homeopathic products,” said Emeritus Professor Alastair MacLennan AO, Co-Vice President of FSM, “These products should now be removed from pharmacies and retail outlets”.
Chiropractors like to promote themselves as primary healthcare professionals. But are they? A recent survey might go some way towards addressing this question. It was based on a cross sectional online questionnaire distributed to 4 UK chiropractic associations. The responses were collected over a period of two months from March 26th 2012 to May 25th 2012.
Of the 2,448 members in the 4 participating associations, 509 chiropractors (~21%) completed the survey. The results of the survey show that the great majority of UK chiropractors surveyed reported evaluating and monitoring patients in regards to posture (97.1%), inactivity/overactivity (90.8%) and movement patterns (88.6%). Slightly fewer provided this type of care for psychosocial stress (82.3%), nutrition (74.1%) and disturbed sleep (72.9%). Still fewer did so for smoking (60.7%) and over-consumption of alcohol (56.4%). Verbal advice given by the chiropractor was reported as the most successful resource to encourage positive lifestyle changes as reported by 68.8% of respondents. Goal-setting was utilised by 70.7% to 80.4% of respondents concerning physical fitness issues. For all other lifestyle issues, goal-setting was used by approximately two-fifths (41.7%) or less. For smoking and over-consumption of alcohol, a mere one-fifth (20.0% and 20.6% respectively) of the responding chiropractors set goals.
The authors of this survey concluded that UK chiropractors are participating in promoting positive lifestyle changes in areas common to preventative healthcare and health promotion areas; however, more can be done, particularly in the areas of smoking and over-consumption of alcohol. In addition, goal-setting to support patient-provider relationships should be more widespread, potentially increasing the utility of such valuable advice and resources.
When I saw that a new UK-wide survey of chiropractic has become available, I had great expectations. Sadly, they were harshly disappointed. I had hoped that, after going to the considerable trouble of setting up a nationwide survey of this nature, we would have some answers to the most urgent questions that currently plague chiropractic and are amenable to study by survey. In my view, some of these questions include:
- How many chiropractors actually see themselves as primary care professionals?
- What conditions do chiropractors treat?
- Specifically how many of them believe they can treat non-spinal conditions effectively?
- How many chiropractors regularly treat children?
- For which conditions?
- How many patients get X-rayed by chiropractors?
- How many are in favour of vaccinations?
- How many are aware of adverse effects of spinal manipulation?
- How chiropractors obtain informed consent before starting treatment?
- What percentage of chiropractors use spinal manipulation?
- What other treatments are used how often?
- How often do chiropractors advise their patients about medications prescribed by real doctors?
- How often do they refer patients to other health care providers?
All of these questions are highly relevant and none of them has recently been studied. But, sadly, the new paper does not answer them. Why? As I see it, there are several possibilities:
- Chiropractors do not find these questions as relevant as I do.
- They do not want to know the answers.
- They do not like to research issues that might shine a bad light on them.
- They view research mostly as a promotional exercise.
- They did research (some of) these questions but do not dare to publish the results.
- They will publish the results in a separate paper.
It would be interesting to hear from the authors which possibility applies.
Reflexology is the treatment of reflex zones, usually on the sole of the feet, with manual massage and pressure. Reflexologists assume that certain zones correspond to certain organs, and that their treatment can influence the function of these organs. Thus reflexology is advocated for all sorts of conditions. Proponents are keen to point out that their approach has many advantages: it is pleasant (the patient feels well with the treatment and the therapist feels even better with the money), safe and cheap, particularly if the patient does the treatment herself.
Self-administered foot reflexology could be practical because it is easy to learn and not difficult to apply. But is it also effective? A recent systematic review evaluated the effectiveness of self-foot reflexology for symptom management.
Participants were healthy persons not diagnosed with a specific disease. The intervention was foot reflexology administered by participants, not by practitioners or healthcare providers. Studies with either between groups or within group comparison were included. The electronic literature searches utilized core databases (MEDLINE, EMBASE, Cochrane, and CINAHL Chinese (CNKI), Japanese (J-STAGE), and Korean databases (KoreaMed, KMbase, KISS, NDSL, KISTI, and OASIS)).
Three non-randomized trials and three before-and-after studies met the inclusion criteria. No RCTs were located. The results of these studies showed that self-administered foot reflexology resulted in significant improvement in subjective outcomes such as perceived stress, fatigue, and depression. However, there was no significant improvement in objective outcomes such as cortisol levels, blood pressure, and pulse rate. We did not find any randomized controlled trial.
The authors concluded that this study presents the effectiveness of self-administered foot reflexology for healthy persons’ psychological and physiological symptoms. While objective outcomes showed limited results, significant improvements were found in subjective outcomes. However, owing to the small number of studies and methodological flaws, there was insufficient evidence supporting the use of self-performed foot reflexology. Well-designed randomized controlled trials are needed to assess the effect of self-administered foot reflexology in healthy people.
I find this review quite interesting, but I would draw very different conclusions from its findings.
The studies that are available turned out to be of very poor methodological quality: they lack randomisation or rely on before/after comparisons. This means they are wide open to bias and false-positive results, particularly in regards to subjective outcome measures. Predictably, the findings of this review confirm that no effects are seen on objective endpoints. This is in perfect agreement with the hypothesis that reflexology is a pure placebo. Considering the biological implausibility of the underlying assumptions of reflexology, this makes sense.
My conclusions of this review would therefore be as follows: THE RESULTS ARE IN KEEPING WITH REFLEXOLOGY BEING A PURE PLACEBO.
Henry Louis Mencken (1880-1956) was an outspoken American journalist, essayist and literary critic famous for his vitriolic attacks on what he considered to be the hypocrisy of much of American life. In 1924, he published an essay on chiropractic which, I think, is still poignant today. I take the liberty of reproducing here in a slightly abbreviated form.
This preposterous quackery [chiropractic] flourishes lushly in the back reaches of the Republic, and begins to conquer the less civilized folk of the big cities. As the old-time family doctor dies out in the country towns, with no competent successor willing to take over his dismal business, he is followed by some hearty blacksmith or ice-wagon driver, turned into a chiropractor in six months, often by correspondence… [Chiropractic] pathology is grounded upon the doctrine that all human ills are caused by pressure of misplaced vertebrae upon the nerves which come out of the spinal cord — in other words, that every disease is the result of a pinch. This, plainly enough, is buncombe. The chiropractic therapeutics rest upon the doctrine that the way to get rid of such pinches is to climb upon a table and submit to a heroic pummeling by a retired piano-mover. This, obviously, is buncombe doubly damned.
…Any lout with strong hands and arms is perfectly equipped to become a chiropractor. No education beyond the elements is necessary. The takings are often high, and so the profession has attracted thousands of recruits — retired baseball players, work-weary plumbers, truck-drivers, longshoremen, bogus dentists, dubious preachers, cashiered school superintendents. Now and then a quack of some other school — say homeopathy — plunges into it. Hundreds of promising students come from the intellectual ranks of hospital orderlies.
…[The chiropractor’s] trade is mainly with ambulant patients; they must come to his studio for treatment. Most of them have lingering diseases; they tour all the neighborhood doctors before they reach him. His treatment, being nonsensical, is in accord with the divine plan. It is seldom, perhaps, that he actually kills a patient, but at all events he keeps any a worthy soul from getting well.
…But chiropractic, of course, is not perfect. It has superb potentialities, but only too often they are not converted into concrete cadavers. The hygienists rescue many of its foreordained customers, and, turning them over to agents of the Medical Trust, maintained at the public expense, get them cured. Moreover, chiropractic itself is not certainly fatal: even an Iowan with diabetes may survive its embraces. Yet worse, I have a suspicion that it sometimes actually cures. For all I know (or any orthodox pathologist seems to know) it may be true that certain malaises are caused by the pressure of vagrant vertebra upon the spinal nerves. And it may be true that a hearty ex-boilermaker, by a vigorous yanking and kneading, may be able to relieve that pressure. What is needed is a scientific inquiry into the matter, under rigid test conditions, by a committee of men learned in the architecture and plumbing of the body, and of a high and incorruptible sagacity. Let a thousand patients be selected, let a gang of selected chiropractors examine their backbones and determine what is the matter with them, and then let these diagnoses be checked up by the exact methods of scientific medicine. Then let the same chiropractors essay to cure the patients whose maladies have been determined. My guess is that the chiropractors’ errors in diagnosis will run to at least 95% and that their failures in treatment will push 99%. But I am willing to be convinced.
Where is there is such a committee to be found? I undertake to nominate it at ten minutes’ notice. The land swarms with men competent in anatomy and pathology, and yet not engaged as doctors. There are thousands of hospitals, with endless clinical material. I offer to supply the committee with cigars and music during the test. I offer, further, to supply both the committee and the chiropractors with sound wet goods. I offer, finally, to give a bawdy banquet to the whole Medical Trust at the conclusion of the proceedings.
I imagine that most chiropractors would find this comment rather disturbing. However, I do like it for several reasons:
- it is refreshingly politically incorrect; today journalists seem to be obsessed with the notion of ‘balance’ thus often creating the impression that there are two valid sides to an issue where, in fact, there is only one;
- it gets right at the heart of several problems which have plagued chiropractic from its beginning;
- it even suggests a way to establishing the truth about the value of chiropractic which could easily been followed some 90 years ago;
- finally it predicts a result of such a test – and I would not be surprised, if it turned out to be not far from the truth.
Please let me know what you think, regardless of whether you are a chiropractor or not.
Chapter 5 of my memoir is entitled ‘OFF WITH HIS HEAD’. It describes the role that Prince Charles played in promoting what he now likes to call ‘integrated medicine’. The weird thing is that he was instrumental in creating my Exeter chair…and eventually in getting it shut down. Here is a short sample to whet your appetite:
With the wisdom of hindsight, it is clear to me now that my hope of bringing the scientific method to bear on alternative medicine was doomed from the start. Reason cannot negotiate with unreason any more than fire and water can commingle peacefully. In either case, a great deal of spitting and hissing is bound to ensue—and precious little else.
Soon after arriving in Exeter, in 1993, I learnt of the long-standing interest Prince Charles had in alternative medicine: he had asked via my Vice Chancellor for a copy of my inaugural lecture, and I remember being delighted at this request. As I never give lectures or speeches from a script, I even composed a summary specifically for him. In return, I received a polite note of thanks from one of his secretaries. This is great, I thought.
I was thrilled that someone as influential as Prince Charles would be interested in my work. What could be better than having support in such high places? Surely, there would come the time when I could meet the Prince and have an open exchange of views. I had no doubt that he would be keenly aware of the obvious necessity for rigorous research—in fact, he often enough had publicly stressed it—and would thus support my research endeavours.
How wrong can one be? Prince Charles turned out to be no supporter of my work. To the contrary: he seemed to be a staunch advocate of unreason and a formidable opponent of any attempt to bring science or critical thinking to bear on alter-native medicine. What is more, subsequent events suggested to me that his intervention played a part in the closure of my unit.
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?
