The aim in scientific research is to isolate out two things (such as a particular condition and a particular drug), with everything else kept the same. This is a main reason why relatively healthy people are used in clinical trials. In the UK, drugs and some other forms of treatment have to go through clinical trials before being authoris
The aim in scientific research is to isolate out two things (such as a particular condition and a particular drug), with everything else kept the same. This is a main reason why relatively healthy people are used in clinical trials. In the UK, drugs and some other forms of treatment have to go through clinical trials before being authorised. The Western concept of placebo, is used to establish whether an effect is significant. A placebo is designed as something that cannot influence outcomes, so that any effect can be taken to be a result of the drug or intervention. In randomised controlled trials (RCTs) participants are randomly allocated to either a treatment or placebo group without them knowing which group they are in. If possible, the person administering the intervention also does not know if they are giving the intervention or the placebo (double-blind RCT)
If the thing being researched is more complex you will need much larger numbers of participants (both with the intervention and with the placebo).
Read more ....
Cause and effect (as understood in Western science) is not part of Chinese medical thinking. The aim of treatment in Chinese Medicine is to restore the physiological balance as they understand it. Diagnosis is about reading where and how the Qi and other physiological substances are disrupted. Treatment is about accessing and influencing
Cause and effect (as understood in Western science) is not part of Chinese medical thinking. The aim of treatment in Chinese Medicine is to restore the physiological balance as they understand it. Diagnosis is about reading where and how the Qi and other physiological substances are disrupted. Treatment is about accessing and influencing the Qi of the whole system in ways that will restore balance. Acupuncture points have been established over years and centuries of observation to be locations where Qi can be accessed and manipulated. Each point has specific actions and functions in relation to the flow of Qi and other substances, and are always used in combination as required for the condition in the particular individual. So needling one point for research is not the same as using it as part of a points prescription in a treatment.
The foundational concept in the Chinese world view is Qi. It is Qi that powers transformation in nature, through history, and in the body. Qi is often translated as 'life force', but can more usefully be thought of as what makes things flow. Disruption to this flow will show as symptoms such as heat and pain. Qi can only be observed indir
The foundational concept in the Chinese world view is Qi. It is Qi that powers transformation in nature, through history, and in the body. Qi is often translated as 'life force', but can more usefully be thought of as what makes things flow. Disruption to this flow will show as symptoms such as heat and pain. Qi can only be observed indirectly, though the full set of signs and symptoms as interpreted through CM's understanding of how the body works in health and illness (physiology and pathology). This form of analysis has built up through thousands of years of observation, experiment (treatments) and debate. In Chinese Medicine, 'health' is well regulated Qi, and 'illness' is when it is weak, or stuck, or flowing in the wrong direction.
Whilst some researchers insist that acupuncture be researched through controlled trials, others are starting to look at other methods that might substantiate aspects of Chinese Medicine theory.
Chinese Medicine (CM) has constantly evolved through clinical practice and observation, and with written case studies and debate as its main form of research and development. As it becomes global, however, Western scientific expectations for evidence-based medicine have led to expectations of randomised controlled trial (RCT) research.(more on RCTs and other forms of clinical trials) However, this method, when used with acupuncture, has led to some interesting anomalies that raise the question - is the RCT an appropriate method for researching Chinese Medicine?
The Society for Acupuncture Research (SAR) 2009 International Symposium, focussed on the phenomenon that .... a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture
'Sham acupuncture' is an attempt to give a placebo-form of acupuncture, and one of the issues of using RCTs to research the clinical effectiveness of acupuncture is that even placebo forms of acupuncture are more effective than the usual care offered by your GP. Placebos are supposed to be 'inert' or not capable of having a physiological effect, and so, many researchers have concluded that acupuncture is only a placebo. However, others question the appropriateness of the sham or placebo-form of acupuncture, and point out that both acupuncture and its sham version often significantly out-perform usual care methods. Western bio-medicine does not recognise Qi, and so it has no way of thinking through whether what seems an appropriate placebo might actually also simulate Qi to some extent.
More recent acupuncture research uses 'pragmatic controlled trials'. This method compares a group receiving the acupuncture treatment to a group receiving the usual Western care. With this approach the treatment group can receive an acupuncture treatment tailored to their CM diagnosis, so that CM acupuncture as a treatment for that condition becomes the focus of the research, rather than a specific point or set of points.
Biomedical science has developed the randomised controlled trial (RCT) as the 'gold standard' for proof of efficacy. It was specifically designed to test new drugs against a placebo, and in the UK new treatments (which includes Chinese Medicine Acupuncture) normally need to be verified through RCTs before they will be authorised for use within the NHS.
Some bio-medical researchers argue against further research into acupuncture. They base their argument on the outcomes from systematic reviews of the thousands of small RCTs involving acupuncture over the past forty years. Their argument is that, because these reviews do not show a significant effectness for acupuncture above the placebo effect, further research using different methods is a waste of time and money. They discount:
In other words, they do not accept that the RCT method has limitations for researching acupuncture. Instead, they take the inconclusive results from RCTs to conclude that acupuncture doesn't work and, that therefore there is no need for research using other methods. You may feel that, on the contrary, inconclusive results, and especially when you are investigating a process (such as the effects of needle-insertion) and not a product (such as a pill) strongly support the need for more research using different approaches.
Two links below go to papers from the Journal of Anesthesia and Analgesia (2013) present these two positions.
Bio-medical research is designed around measurement. It only recognises things through measurement - if it can't be measure, it doesn't exist.
Randomised Controlled Trials (RCTs) are designed to test if one thing (the drug or intervention) has a specific effect. Both the 'thing' (for example: an amount of a drug or a specific treatment) and the way the effect is measured (for example: changes in a particular anti-body, hormone etc) need to be standardised. Additionally, even if a positive effect is shown it needs to be established that the trial is measuring (a) what it set out to measure, and that (b) there are no detrimental side effects. Secondly, there needs to be a control group with participants randomly allocated to one or other group (random-isation) to show that any effects are caused by the 'thing' administered and not random factors or placebo. And finally RCTs are often done using relatively healthy participants because of the need to be testing one thing. Seriously ill people often have complex and overlapping problems that mean they are excluded from trials.
RCT trials are complex and expensive, and so results from a number of similar studies can be grouped together in what is called a systematic review or meta-analysis, so that evidence can be compounded. Studies will be screened to ensure that they share a common focus and that there are no obvious problems with study design. This process has highlighted some unusual results in acupuncture studies. In some studies, although acupuncture is shown to be significantly more effective than doing nothing, sham acupuncture (often used for the control group) also seems to be more effective than doing nothing. Some critics conclude from this that acupuncture doesn't work. However, other researchers conclude that the anomaly of both sham and real acupuncture showing a significant effect needs further investigation, including using different approaches. (more on this)
There is a different research design approach taken for clinical interventions, where individual differences in patients cannot be ignored. This form of clinical effectiveness trial has been used in some CM acupuncture research. A CM treatment plan arising from a CM diagnosis is given for each participant in the study, alongside a control group that is given 'usual' care for that condition. These sorts of studies have shown acupuncture to be significantly more effective than the usual care. More recently, there have been studies in basic research, where physiological effects are directly measured (ie. changes to cortisol levels, hormones, endorphins etc , or MRI scanning). This kind of test will normally use just one acupuncture point, but with the needling depth and manipulation according to Chinese Medicine protocols.
This BBC video looks into these two research approaches.
RCT design for CM acupuncture presents a number of issues:
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