The PGIH (currently chaired by the Tory MP David Tredinnick) was founded in 1992 (in the mid 1990, they once invited me to give a lecture which I did with pleasure). Its overriding aim is to bring about improvements in patient care. The PGIH have conducted a consultation that involved 113 SCAM-organisations and other stakeholders. The new PGIH-report is based on their feedback and makes 14 recommendations. They are all worth studying but, to keep this post concise, I have selected the three that fascinated me most:
Evidence Base and Research
NICE guidelines are too narrow and do not ﬁt well with models of care such as complementary, traditional and natural therapies, and should incorporate qualitative evidence and patient outcomes measures as well as RCT evidence. Complementary, traditional and natural healthcare associations should take steps to educate and advise their members on the use of Measure Yourself Medical Outcome Proﬁles (MYMOP), and patient outcome measures should be collated by an independent central resource to identify for what conditions patients are seeking treatment, and with what outcomes.
Every cancer patient and their families should be offered complementary therapies as part of their treatment package to support them in their cancer journey. Cancer centres and hospices providing access to complementary therapies should be encouraged to make wider use of Measure Yourself Concerns and Wellbeing (MYCaW) to evaluate the beneﬁts gained by patients using complementary therapies in cancer support care. Co-ordinated research needs to be carried out, both clinical trials and qualitative studies, on a range of complementary, traditional and natural therapies used in cancer care support.
The government should run NHS pilot projects which look at non-conventional ways of treating patients with long-term and chronic conditions affected by Effectiveness Gaps, such as stress, arthritis, asthma and musculoskeletal problems, and audit these results against conventional treatment options for these conditions to determine whether cost savings and better patient outcomes could be achieved.
END OF QUOTE
Here are a few brief comments on those three recommendations.
Evidence base and research
NICE guidelines are based on rigorous assessments of efficacy, safety and costs. Such evaluations are possible for all interventions, including SCAM. Qualitative data are useless for this purpose. Outcome measures like the MYMOP are measures that can and are used in clinical trials. To use them outside clinical trials would not provide any relevant information about the specific effects of SCAM because this cannot account for confounding factors like the natural history of the disease, regression towards the mean, etc. The entire paragraph disclosed a remarkable level of naivety and ignorance about research on behalf of the PGIH.
There is already a significant amount of research on SCAM for cancer (see for instance here). It shows that no SCAM is effective in curing any form of cancer, and that only very few SCAMs can effectively improve the quality of life of cancer patients. Considering these facts, the wholesale recommendation of offering SCAM to cancer patients can only be characterised as dangerous quackery.
Such a pilot project has already been conducted at the behest of Price Charles (see here). Its results show that flimsy research will generate flimsy findings. If anything, a rigorous trial would be needed to test whether more SCAM on the NHS saves or costs money. The data currently available suggests that the latter is the case (see also here, here, here, here, etc.).
Altogether, one gets the impression that the PGIH need to brush up on their science and knowledge (if they invite me, I’d be delighted to give them another lecture). As it stands, it seems unlikely that their approach will, in fact, bring about improvements in patient care.
In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.
As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.
Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.
The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.
Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.
To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.
In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.
Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.
It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).
To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.
Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.
In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.
An article alerted me to a new report on alternative medicine in the NHS. The report itself is so monumentally important that I cannot find it anywhere (if someone finds a link, please let us know). Behind it is our homeopathy-loving friend David Tredinnick MP, chair of the All-Party Parliamentary Group. I am sure you remember him; he is ‘perhaps the worst example of scientific illiteracy in government’. And what has David been up to now?
His new report by the All-Party Parliamentary Group for Integrated Healthcare is urging the NHS to embrace more medicine to ease the mounting burden on service provision. It claims that more patients suffer from two or more long-term health conditions than ever before, and that their number will amount to 18 million by 2025.
And the solution?
Isn’t it obvious?
David Tredinnick MP, chair of the All-Party Parliamentary Group, insists that the current approach being taken by the government is unsustainable for the long-term future of the country. “Despite positive signs that ministers are proving open to change, words must translate into reality. For some time our treasured NHS has faced threats to its financial sustainability and to common trust in the system. Multimorbidity is more apparent now in the UK than at any time in our recent history. As a trend it threatens to swamp a struggling NHS, but the good news is that many self-limiting conditions can be treated at home with the most minimal of expert intervention. Other European governments facing similar challenges have considered the benefits of exploring complementary, traditional and natural medicines. If we are to hand on our most invaluable institution to future generations, so should we.”
Hold on, this sounds familiar!
Wasn’t there something like it before?
Yes, of course, the ‘Smallwood Report‘, commissioned over a decade ago by Prince Charles. It also proclaimed that the NHS could save plenty of money, if it employed more bogus therapies. But it was so full of errors and wrong conclusions that its impact on the NHS was close to zero. At the time, I concluded that the ‘Smallwood report’ is one of the strangest examples of an attempt to review CAM that I have ever seen. One gets the impression that its conclusions were written before the authors had searched for evidence that might match them. Both Mr Smallwood and the ‘Freshminds’ team told me that they understand neither health care nor CAM. Mr Smallwood stressed that this is positive as it prevents him from being ‘accused of bias’. My response was that ‘severely flawed research methodology almost inevitably leads to bias’.
And which other European countries might the Tory Brexiter David refer to?
Sadly, I have not seen Tredinnick’s new oeuvre and do not know its precise content. What I do know, however, that the evidence, for alternative medicine’s cost effectiveness has not improved; if anything, it has become more negative. From that, one can safely conclude that Tredinnick’s notions of NHS-savings through more use of alternative medicine are erroneous. Therefore, I suspect the new report will swiftly and deservedly go the same way as its predecessor, the ‘Smallwood Report’: straight into the bins of Westminster.
The pro arguments essentially are the well-rehearsed points acupuncture-fans like to advance:
- Some guidelines do recommend acupuncture.
- Sham acupuncture is not a valid comparator.
- The largest meta-analysis shows a small effect.
- Acupuncture is not implausible.
- It improves quality of life.
Cummings concludes as follows: In summary, the pragmatic view sees acupuncture as a relatively safe and moderately effective intervention for a wide range of common chronic pain conditions. It has a plausible set of neurophysiological mechanisms supported by basic science.12 For those patients who choose it and who respond well, it considerably improves health related quality of life, and it has much lower long term risk for them than non-steroidal anti-inflammatory drugs. It may be especially useful for chronic musculoskeletal pain and osteoarthritis in elderly patients, who are at particularly high risk from adverse drug reactions.
Our arguments are also not new; essentially, we stress that:
- The effects of acupuncture are too small to be clinically relevant.
- They are probably not even caused by acupuncture, but the result of residual bias.
- Pragmatic trials are of little value in defining efficacy.
- Acupuncture is not free of risks.
- Regular acupuncture treatments are expensive.
- There is no generally accepted, plausible mechanism.
We concluded that after decades of research and hundreds of acupuncture pain trials, including thousands of patients, we still have no clear mechanism of action, insufficient evidence for clinically worthwhile benefit, and possible harms. Therefore, doctors should not recommend acupuncture for pain.
Neither Asbjorn nor I have any conflicts of interests to declare.
Dr Cummings, by contrast, states that he is the salaried medical director of the British Medical Acupuncture Society, which is a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. He is an associate editor for Acupuncture in Medicine, published by BMJ. He has a modest private income from lecturing outside the UK, royalties from textbooks, and a partnership teaching veterinary surgeons in Western veterinary acupuncture. He has participated in a NICE guideline development group as an expert adviser discussing acupuncture. He has used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989.
My question to you is this: WHICH OF THE TWO POSITION IS THE MORE REASONABLE ONE?
Please, do let us know by posting a comment here, or directly at the BMJ article (better), or both (best).
Chiropractors (and other alternative practitioners) tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure.
This sounds perfectly logical to me, but is there any evidence for it? Yes, there is!
The WSJ recently reported that over 80% of the money that Medicare paid to US chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens spent roughly $359 million on unnecessary chiropractic care that year, a review by the Department of Health and Human Services’ Office of Inspector General (OIG) found.
The OIG report was based on a random sample of Medicare spending for 105 chiropractic services in 2013. It included bills submitted to CMS through June 2014. Medicare audit contractors reviewed medical records for patients to determine whether treatment was medically necessary. The OIG called on the Centers for Medicare and Medicaid Services (CMS) to tighten oversight of the payments, noting its analysis was one of several in recent years to find questionable Medicare spending on chiropractic care. “Unless CMS implements strong controls, it is likely to continue to make improper payments to chiropractors,” the OIG said.
Medicare should determine whether there should be a cut-off in visits, the OIG said. Medicare does not pay for “supportive” care, or maintenance therapy. Patients who received more than a dozen treatments are more likely to get medically unnecessary care, the OIG found, and all chiropractic care after the first 30 treatment sessions was unnecessary, the review found. However, a spokesperson for US chiropractors disagreed: “Every patient is different,” he said. “Some patients may require two visits; some may require more.”
I have repeatedly written about the fact that chiropractic is not nearly as cost-effective as chiropractors want us to believe (see for instance here and here). It seems that this evidence is being systematically ignored by them; in fact, the evidence gets in the way of their aim – which often is not to help patients but to maximise their cash-flow.
MORE than £150,000 was spent by NHS Grampian on homeopathic treatments last year. Referrals to homeopathic practitioners cost £37,000 and referrals to the Glasgow Homoeopathic Hospital cost £7,315 in 2014-15. In view of the fact that highly diluted homeopathic remedies are pure placebos, any amount of tax payers’ money spent on homeopathy is hard to justify. Yet an NHS Grampian spokeswoman defended its use of by the health board with the following words:
“We have a responsibility to consider all treatments available to NHS patients to ensure they offer safe, effective and person-centred care. We also have a responsibility to use NHS resources carefully and balance our priorities across the population as well as individuals. We also recognise that patient reported outcome and experience measures are valued even when objective evidence of effectiveness is limited. Homeopathy can be considered in this arena and we remain connected with the wider debate on its role within the NHS while regularly reviewing our local support for such services within NHS Grampian.”
Mr Spence, a professional homeopath, was also invited to defend the expenditure on homeopathy: “When a friend started talking to me about homeopathy I thought he had lost his marbles. But it seemed homeopathy could fill a gap left by orthodox medicine. Homeopathy is about treating the whole person, not just the symptoms of disease, and it could save the NHS an absolute fortune. If someone is in a dangerous situation or they need surgery then they need to go to hospital. It’s often those with chronic, long-term problems where conventional treatment has not worked that can be helped by homeopathy.”
What do these arguments amount to, I ask myself.
The answer is NOTHING.
The key sentence in the spokeswomen’s comment is : “patient reported outcome and experience measures are valued even when objective evidence of effectiveness is limited.” This seems to admit that the evidence fails to support homeopathy. Therefore, so the argument, we have to abandon evidence and consider experience, opinion etc. This seemingly innocent little trick is nothing else than the introduction of double standards into health care decision making which could be used to justify the use of just about any bogus therapy in the NHS at the tax payers’ expense. It is obvious that such a move would be a decisive step in the wrong direction and to the detriment of progress in health care.
The comments by the homeopath are perhaps even more pitiful. They replace arguments with fallacies and evidence with speculation or falsehoods.
There is, of course, a bright side to this:
IF HOMEOPATHY IS DEFENDED IN SUCH A LAUGHABLE MANNER, ITS DAYS MUST BE COUNTED.
We could have expected it, couldn’t we? With so much homeopathy in the press lately, Dr Dixon (we have seen him on this blog before, for instance here, here and here) had to comment. His article in yesterday’s NURSING IN PRACTICE is far too perfect to abbreviate it; I just have to cite it in full (only the reference numbers are mine and refer to my comments below).
HERE WE GO
Should homeopathy be blacklisted in general practice?
I have not prescribed them myself but I know of many GPs and patients who find homeopathic preparations helpful, especially in clinical areas where there is no satisfactory conventional treatment . They are cheap and entirely safe , which cannot always be said of conventional treatment . Is the concern about cost? That is implausible as GP prescriptions cost a mere £100,000 per annum, approximately £10 per UK General Practice but effectively less as some patients will be paying for them and they may reduce other prescriptions or medical costs . Is it about evidence?  Possibly, and that is because the necessary pragmatic trials on comparative cost effectiveness have never been done . Homeopathy thus joins the frequently quoted 25% of general practice activity that has an insufficient evidence base… So, why not do the research rather than single out homeopathy for blacklisting ? Apparently, because it irritates a powerful fraternity of “scientists”  with a narrow biomedical perspective on health and healing, who feel the need to impose their atheism  on others. They seem opposed to “patient-centred medicine” which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them . Led by the World Health Organization, many countries are examining the appropriate role of complementary and traditional medicine (CAM). Indian Prime Minister Modi has created the first minister for medicine in this area (called AYUSH with the “H” standing for homeopathy). Australia, whose government and medical deans (unlike the UK ) are not intimidated by this breed of scientific fundamentalism, has invested money in research, regulated its herbal  practitioners and created important trade links with China in this area . Meanwhile the UK invests 0% of its research budget on CAM and appears to have a closed mind . General practice is at its best a subtle and complex blend of science and art combined in a heady mixture, which recognises personal belief and perspective and respects differences . Blacklisting homeopathy would be the thin edge of the wedge. It would be a mean-minded act of outside interference by many who do not treat patients themselves, denying patient choice and signifying a new age of intolerance and interference . It is a threat to the autonomy of general practice that should concern every GP and patient whatever their views on homeopathy .
About the Author
Chairman of the NHS Alliance and a GP
Mike Dixon, chairman of the NHS Alliance and a GP at College Surgery in Cullompton, Devon and a Royal College of General Practitioners presidential candidate.
END OF QUOTE AND BEGINNING OF MY DELIBERATELY BRIEF COMMENTS
- Whenever this argument comes up, people fail to cite an example. Are they afraid that we would point out what can be done for such a patient other than prescribing placebos?
- Actually, they are extremely expensive considering that they are just lactose or water. And the claim that homeopathy is safe merely displays an embarrassing lack of knowledge; see the many posts on this blog that deal with this issue.
- Classical ‘tu quoque’ fallacy; display of the ignorance of the risk/benefit concept for judging the value of medical interventions.
- Display of ignorance regarding the actual evidence, see here, for instance.
- Yes, it’s the evidence but also it’s the biological implausibility and the fact that disregarding it undermines rationality in general.
- Pure ignorance again, see my point 4.
- Are ~ 300 clinical trials and about 100 systematic reviews not enough? How much more money needs to be wasted?
- It seems that Dixon has a problem with science and those who pursue it to improve future health care for the benefit of patients.
- Does Dixon admit that homeopathy is a religion?
- Patient-centred medicine which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them – does Dixon not know that all good medicine fits this description, but homeopathy certainly does not?
- Every one with an IQ above 50 knows by now that herbal is not homeopathic; is Dixon the exception?
- What about the Australian report which concluded that “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.”
- This is simply not true, and Dixon should know it.
- No reason to include disproven nonsense like homeopathy.
- Intolerance is on Dixon’s side, I think. Improving health care by abandoning disproven therapies in favour of evidence-based treatments is no interference, it’s progress.
- This can only be true, if we misunderstand autonomy as arbitrariness without rules, checks, ethics and controls. Good general practice has, like all medicine, be in the best interest of patients. An obsolete, expensive, unsafe, ineffective and implausible treatment is clearly not.
Some people seem to believe that the field of alternative medicine resembles a quaint little cottage industry where money hardly matters. A new analysis shows how far from the truth this impression is.
In the 2007 US National Health Interview Survey, use of complementary health approaches, reasons for this use, and associated out of pocket (OOP) costs were captured in a nationally representative sample of 5,467 US adults. Ordinary least square regression models that controlled for co-morbid conditions were used to estimate aggregate and per person OOP costs associated with 14 painful health conditions.
The analyses suggest that individuals using complementary approaches spent a total of $14.9 billion OOP on these approaches to manage three painful conditions: arthritis, back pain and fibromyalgia. Around 7.5 billion of that total was spent on consulting practitioners such as chiropractors and acupuncturists. Total OOP expenditures seen in those using complementary approaches for their back pain ($8.7 billion) far outstripped that of any other condition, with the majority of these costs ($4.7 billion) resulting from visits to complementary providers. Annual condition-specific per-person OOP costs varied from a low of $568 for regular headaches, to a high of $895 for fibromyalgia. The total expenditure on complementary medicine was comparable to that on conventional care.
The authors concluded that adults in the United States spent $14.9 billion OOP on complementary health approaches (e.g., acupuncture, chiropractic, herbal medicines) to manage painful conditions including back pain ($8.7 billion). This back pain estimate is almost 1/3rd of total conventional healthcare expenditures for back pain ($30.4 billion) and 2/3rds higher than conventional OOP expenditures ($5.1 billion).
These are truly eye-watering sums. The obvious question is: IS THIS MONEY WELL-SPENT?
The short answer, I fear, is NO!
The alternative therapies in question are not based on compelling evidence in the management of these painful conditions. Some are clearly not better than placebo, and others are apparently supported by some research but its quality is hardly good enough to rely upon.
This level expenditure is both impressive and worrying. It highlights an enormous waste of resources, alerts us to an urgent need for truly rigorous research, and demonstrates how high the stakes really are.
The notion that the use homeopathy instead of real medicine might save money (heavily promoted by homeopaths and their followers, often to influence health politics) has always struck me as being utterly bizarre: without effectiveness, it is hard to imagine cost-effectiveness. Yet the Smallwood report (in)famously claimed that the NHS would save lots of money, if GPs were to use more homeopathy. At the time, I thought this was such a serious and dangerous error that I decided to do something about it. My objection to the flawed report might have prevented it being taken seriously by anyone with half a brain, but sadly it also cost me my job (the full story can be read here).
Later publications perpetuated the erroneous idea of homeopathy’s cost-effectiveness. For instance, an Italian analysis (published in the journal ‘Homeopathy’) concluded that homeopathic treatment for respiratory diseases (asthma, allergic complaints, Acute Recurrent Respiratory Infections) was associated with a significant reduction in the use and costs of conventional drugs. Costs for homeopathic therapy are significantly lower than those for conventional pharmacological therapy. Again, this paper was so badly flawed that, other than some homeopaths, nobody seemed to have taken the slightest notice of it.
Now a new article has been published on this very subject. The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group).
Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache).
Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14-7,414.29]) than in the control group (EUR 5,857.56 [5,650.98-6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48-3,809.53] vs. control EUR 3,092.84 [2,981.31-3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90-1,102.59] vs. control EUR 867.87 [853.52-882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant.
The authors of this paper (who have a long track record of being pro-homeopathy) concluded that, compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system.
The next time someone does a (no doubt costly) cost-effectiveness analysis of an ineffective treatment, it would be good (and cost-effective) to remember: WITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS.
“So what? We all know that homeopathy is nonsense,” I hear some people argue, “at the same time, it is surely trivial. Let those nutters do what they want; at least it is not harmful!”
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I THINK I CAN REST MY CASE.
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.