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.
- Chronic low back pain (CLBP) is a condition which affects so many people that it represents a huge burden to individual patients’ suffering as well as to society in terms of loss of work time and increased economic cost. The number of therapies that have been claimed to be effective for CLBP can hardly be counted. Two of the most common treatments are spinal manipulation and exercise.
The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with CLBP. Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review.
A search of the current literature was conducted using a keyword process in CINAHL, Cochrane Register of Controlled Trials Database, Medline, and Embase. The searches included studies available up to August 2014. Studies were included based on PICOS criteria 1) individuals with CLBP defined as lasting 12 weeks or longer; 2) spinal manipulation performed by a health care practitioner; 3) prescribed exercise for the treatment of CLBP and monitored by a health care practitioner; 4) measurable clinical outcomes for reducing pain, disability or improving function; 5) randomized controlled trials. The methodological quality of all included articles was determined using the criteria developed and used by the Physiotherapy Evidence Database (PEDro).
Only three RCTs met the inclusion criteria of this systematic review. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term.
The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.
Whenever there are uncounted treatments for a given condition, one has to ask oneself whether they are all similarly effective or equally ineffective. The present review does unfortunately not answer this question, but I fear the latter might be more true than the former.
Considering how much money we spend on treating CLBP, it is truly surprising to see that just three RCTs are available comparing two of the most commonly used treatments for this condition. Equally surprising is the fact that we simply cannot tell, on the basis of these data, which of the two therapies is more effective.
What consequences should we draw from this information. Obviously we need more high quality trials. But what should we do in the meantime?
Whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently) is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of CLBP – and consequently consulting a chiropractor should not be the first choice for CLBP patients.
Many experts are critical about the current craze for dietary supplements. Now a publication suggests that it is something that can save millions.
This article examines evidence suggesting that the use of selected dietary supplements can reduce overall disease treatment-related hospital utilization costs associated with coronary heart disease (CHD) in the United States among those at a high risk of experiencing a costly, disease-related event.
Results show that:
- the potential avoided hospital utilization costs related to the use of omega-3 supplements at preventive intake levels among the target population can be as much as $2.06 billion on average per year from 2013 to 2020. The potential net savings in avoided CHD-related hospital utilization costs after accounting for the cost of omega-3 dietary supplements at preventive daily intake levels would be more than $3.88 billion in cumulative health care cost savings from 2013 to 2020.
- the use of folic acid, B6, and B12 among the target population at preventive intake levels could yield avoided CHD-related hospital utilization costs savings of an average savings of $1.52 billion per year from 2013 to 2020. The potential net savings in avoided CHD-related health care costs after accounting for the cost of folic acid, B6, and B12 utilization at preventive daily intake levels would be more than $5.23 billion in cumulative health care cost net savings during the same period.
The authors conclude that targeted dietary supplement regimens are recommended as a means to help control rising societal health care costs, and as a means for high-risk individuals to minimize the chance of having to deal with potentially costly events and to invest in increased quality of life.
These conclusions read like a ‘carte blanche’ for marketing all sorts of useless supplements to gullible consumers. I think we should take them with more than a pinch of salt.
To generate results of this nature, it is necessary to make a number of assumptions. If the assumptions are wrong, so will be the results. Furthermore, we should consider that the choice of supplements included was extremely limited and highly selected. Finally, we need to stress that the analysis related to a very specific patient group and not to the population at large. In view of these facts, caution might be advised in taking this analysis as being generalizable.
Because of these caveats, my conclusion would have been quite different: provided that the assumptions underlying these analyses are correct, the use of a small selection of dietary supplements by patients at risk of CHD might reduce health care cost.
Many proponents of chiropractic claim that chiropractic spinal manipulation therapy (SMT) for chronic low back pain (LBP) might save health care cost. As LBP is a hugely expensive condition, this is a mighty important question. The evidence on this issue is, however, flimsy to say the least. Most experts seem to conclude that more reliable data are needed. On this background, it seems relevant to note that a new relevant study has just become available.
The purpose of this analysis was to report the incremental costs and benefits of different doses of SMT in patients with LBP.
The researchers randomized 400 patients with chronic LBP to receive doses of 0, 6, 12, or 18 sessions of SMT. Patients were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a chiropractor. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days.
The results show that costs for treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age, greater disability, lower quality-adjusted life year scores, and higher costs in the period preceding enrolment. Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days and 19.8 disability-free days. No statistically significant group differences in quality-adjusted life years were noted.
The authors drew the following conclusions from these data: a dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.
So, is chiropractic SMT for LBP cost-effective? I leave it to my readers to answer this question.
As mentioned several times on this blog, homeopathy lacks a solid evidence base (to put it mildly). There are powerful organisations which attempt to mislead the public about this fact, but most homeopathy-fans know this only too well, in my opinion. Some try to bypass this vexing fact by trying to convince us that homeopathy is value for money, never mind the hard science of experimental proof of its principles or the complexity of the clinical data. They might feel that politicans would take notice, if homeopathy would be appreciated as a cheap form of health care. In this context, it is worth mentioning that researchers from Sheffield have just published a systematic review of economic evaluations of homeopathy
They included 14 published assessments in their review. Eight studies found cost savings associated with the use of homeopathy. Four investigations suggested that improvements in homeopathy patients were at least as good as in control group patients, at comparable costs. Two studies found improvements similar to conventional treatment, but at higher costs. The researchers also noted that studies were highly heterogeneous and had numerous methodological weaknesses.
The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Thre are, of course, several types of economic evaluations of medical interventions; the most basic of these simply compares the cost of one medication with those of another. In such an analysis, homeopathy would normally win against conventional tratment, as homeopathic remedies are generally inexpensive. If one adds the treatment time into the equation, things become a little more complex; homeopathic consultations tend to be considerably longer that conventional ones, and if the homeopaths’ time is costed at the same rate as the time of conventional doctors, it is uncertain whether homeopathy would still be cheaper.
Much more relevant, in my view, are cost-effective analyses which compare the relative costs and outcomes of two or more treatments. The results of such evaluations are often expressed in terms of a ratio where the denominator is a gain in health from a treatment and the numerator is the cost associated with the health gain. The most common measure used to express this is the QUALY.
Any cost-effective analysis can only produce meaningfully positive results, if the treatment in question supported by sound evidence for effectivenes. A treatment that is not demonstrably effective cannot be cost-effective! And this is where the principal problem with any cost-effectiveness analysis of homeopathy lies. Homeopathic remedies are placebos and thus can be neither effective nor cost-effective. Arguments to the contrary are in my view fallacious.
The authors of the new article say they have identified evidence of the potential benefits of homeopathy. How can this be? They based this conclusion only on the 14 studies included in their review. But this is only about 5% of the total available data. Reliable estimates of effectiveness should be based on the totality of the available evidence and not on a selection thereof.
I therefore think it is wise to focus on the part of the authors’ conclusion that does make sense: ” It is… not possible to draw firm conclusions based on existing economic evaluations of homeopathy“. In plain English: economic evaluations of homeopathy fail to show that it is value for money.