National Institutes of Health List 1998

A claim was made for promising results in the following conditions:

This is an interesting, if eclectic, mix which reflects the random quality and quantity of research at the time.

Research concentrated on the physiological effects mediated by the nervous system, with some of the early work by Andersson and Lundeberg [2–6] providing some answers. Their work highlighted the similarities between the physiological effects of acupuncture and the more familiar effects of exercise, reassuring physiotherapists that the results of their acupuncture treatment could be understood within their own profession, although in a limited context.

Some new thinking was required and, since physiotherapists were well versed in neurophysiology, clinical reasoning began to centre on that. Lynley Bradnam was probably the first to offer a useful structure to support clinical decisions and point choices [7–9]. She suggested that if the known pathology was carefully considered then the choice of appropriate points for musculoskeletal pains would automatically become easy. This approach overcomes the credibility gap often found when a therapist chooses points from a Western perspective but finds a need to extend or amplify the effects by reverting to poorly understood TCM choices, because the simple formulae do not offer much by way of progression when patient improvement slows or stalls. Once the physiological mechanisms are better understood, there is no conflict. This approach also serves as a useful foundation for clinical reasoning when moving beyond treating just pain and considering the wider implications of treating neurological patients.

Although generally less concerned with the specific application of acupuncture in neurology, medical doctors in the UK and around the world have begun to concentrate on what is termed Western medical acupuncture, claiming that acupuncture is increasingly understood through scientifically plausible mechanisms. White, in the journal Acupuncture in Medicine, states that there is ‘evidence from systematic reviews that acupuncture is superior to placebo for treating nausea, chronic back and knee pain, tension headache and postoperative pain’ but continues that now phase II studies to determine the optimal acupuncture treatment should be encouraged [10]. He emphasizes that, although acupuncture involves only minimal technology, there are infinite complexities and uncertainties about the mechanisms involved.

It is useful to quote the definition of Western medical acupuncture in full as this is the thinking that underscores a great deal, although not all, of this textbook.

Evidence-based medicine

Evidence-based medicine is defined as ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients’ [12]. It has been argued that evidence-based approaches represent a narrow reductionism that ignores clinical judgement and experience and encourages a slavish reliance on statistical methodology, in particular a dogmatic support of the RCT [13]. It is nonetheless essential that we attempt to use what is still considered best evidence, even though not all of the current research work is of compelling quality.

There are two types of evidence that inform acupuncture practice. The standard RCT certainly has a place and information from these trials has slowly accumulated, making some choices of points or technique more valid than others. However, it must be remembered that the therapeutic encounter in all its richness is very poorly represented by most medical research protocols.

To counter this we also have access to the empirical evidence provided by historical sources, a form of consensus medicine. This has been reproduced since the first written records in a question/answer dialogue, offering a form of intellectual debate, although the terms and concepts are often unfamiliar to a Western health professional. Single case studies are widely published in the East and are also a valuable source of information, although ranked very low in the scale of ‘good’ evidence.

It is a truism that all medicine is now exhaustively researched before it is applied to a patient and the process for the discovery and subsequent release of new drugs tends to follow a well-worn pattern. The thrust of acupuncture research has been different to that for new drugs and treatments. This is generally because acupuncture is already in use. Indeed, it has been in use for at least 1000 years in parts of the world and shows no signs of dying out. This has been recognized by the World Health Organization, which has supported it in several ways, recommending minimum training standards, discussing terminology and assembling definitive point locations to make research methodologies more accurate [14]. Now, with definitive locations of acupuncture points agreed in the main by the major acupuncture nations, China, Korea and Japan, the possibility of having precisely repeatable treatment protocols incorporated into research projects is a real one [15]. This will naturally link in with the move to record and report all acupuncture intervention details in a scientific paper, as set out in the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines [16].

Good reporting is essential and, in addition to the STRICTA guidelines, adherence to the advice given by the Consolidated Standards for Reporting of Trials (CONSORT) organization, particularly that for non-pharmacologic interventions [17], will assist in gaining and maintaining scientific credibility for all acupuncture trials.

Nonetheless, the early work done when introducing a new drug on to the market usually begins with an investigation into the mechanism, followed by studies set up to look at the initial effectiveness and, provided the results are promising, efficacy and then safety. The progression of acupuncture research has often appeared to be reversed because the most immediately important factor has been seen as safety, since it is already widely used. Initially, studies were set up to see how it was being used and whether there were associated risks [18, 19].

This has had an effect on the acceptance of acupuncture by the medical community at large. The two major studies published in 2001 [18, 19] were very positive and provided excellent confirmation of the safety of this intervention. A total of 66 000 treatment episodes in the two studies provided very few adverse events, ‘the most common minor adverse events being bleeding, needling pain, and aggravation of symptoms; however, aggravation was followed by resolution of symptoms in 70% of cases. There were 43 significant minor adverse events reported, a rate of 14 per 10 000, of which 13 (30%) interfered with daily activities’ [18]. No serious adverse events were reported in the study by MacPherson et al. either [19]. The results gave rise to the editorial comment in the British Medical Journal that: ‘While the risks of acupuncture cannot be discounted, it certainly seems, in skilled hands, one of the safer forms of medical intervention’ [20].

The issue of safety having been dealt with, the way was opened for the RCTs and the results should have justified the inclusion of acupuncture in normal/orthodox medical practice a long time ago. Nothing is that easy however and the results have been equivocal. For every resounding success there have been several trials where the numbers were too few, the protocols too vague, the controls not adequate and the general impression given that acupuncture was not working.

Sometimes this impression was produced by the fact that the acupuncture selected for the condition was hopelessly inadequate, consisting of few treatments or limited points. This arose when the researchers were not acupuncturists and had little understanding of the clinical application of the intervention under scrutiny. A study which unfortunately became a source of much amusement in acupuncture circles [21] claimed that acupuncture had no place in the treatment of rheumatoid arthritis. On careful reading, the intervention proved to have been a single acupuncture point, Liv 3, Taichong, used on five occasions and retained only for 4 minutes each time. This conformed to neither TCM nor Western medical good acupuncture practice. The paper was subsequently heavily criticized but the damage was done [22]. Appearing, as it did, in an influential medical journal, it probably set the use of acupuncture by physiotherapists in this field back by a good 10 years.

Currently there is an increase in research into the mechanisms, including much functional magnetic resonance imaging work examining the effect of acupuncture on the brain, principally by Napadow and his group [23, 24]. Langevin et al., working in parallel, investigated the effect of needle manipulation on connective tissue, looking for a mechanical effect [25].

This change in focus is partly because, as the research community has worked through this process, it has become plain that the entire mechanism is not yet understood. We have parts of the picture but there are still many questions to be asked of what is now recognized as a complex intervention. Also the important German RCTs (Modellvorhaben Akupunktur), where both the true acupuncture and the sham control showed significant effects over normal care, have emphasized the problem of finding an inert placebo for the complex intervention that is acupuncture [26].

It is clear that the traditional construction of an RCT requires the use of a placebo control in order to be considered as first-class evidence but it is debatable whether this is the most appropriate way to investigate an intervention like acupuncture. If we do not fully understand all the neural pathways and mechanisms, how can we be sure that any placebo has no effect? Some researchers are exploring this issue and their early work seems to indicate that there is an additional response in the brain to real acupuncture, as compared to the sham procedures [27]. The different strands for acupuncture research are shown in Table 2.1.

Table 2.1 Useful summary of brain imaging correlates