Literature Review on Efficacy in Acupuncture

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Findings (5500)

The reputation of acupuncture in the West has been damaged through previous exaggerated claims, misrepresentation and demonstrations supplemented illegitimately bylocal anaesthetics, sedatives or other means of pain control (Singh and Ernst (2008).

But anxious about application to the patient who has not been properly evaluated psychologically and possible misuse by Charlatans in attempting to treat a variety of serious illnesses, diverting the patient from accessing established medical therapy.

In Acupuncture: the WHO view, 1979 Bannerman stated that although it is ‘clearly not a panacea for all ills,…..the sheer weight of evidence demands that acupuncture must be taken seriously as a clinical procedure of considerable value’. By 1990 in Europe alone there were 88,000 acupuncturists and over 20 million patients had received treatment. British Medical Association survey in 2002, which revealed that roughly half of all practising doctors had arranged acupuncture sessions for their patients despite the mechanism which made acupuncture effective.

Research to establish efficacy

The development of narrative to explain health and illness between eastern and western medicine is one area which highlights the process of the social construction of these concepts.  The notions of meridians or the flow of Ch’i have limited meaning in terms of biology, chemistry or physics, grounded in ancient tradition. Chinese medicine emerged from a society that rejected human dissection, and, being unable to explore the internal workings of the human body, developed a principally imaginary model of human anatomy based on the external world. Alternatively, European scientists gradually developed an acceptance that dissecting the human body was a necessary part of medical research, resulting in establishing an apparently physically accurate picture of our anatomy. As Western medicine is based on tangible physical structures and measurable physiological changes, it is highly sceptical of the Eastern explanations. The Western model is however very reductionist,    …there being strengths in both approaches….

Theories that have been used to explain the method of effect for acupuncture include Gate Control Theory of Pain, (Melzack and Wall, 1960’s) where nerve fibres that conduct pain impulses also have the ability to close pathways so other impulses, perhaps also associated with pain, are restricted from reaching the brain. Therefore relatively minor stimuli might have the ability to suppress major pain from other sources.

Alternatively, studies have shown that acupuncture stimulates the release of opioids or endorphins in the brain, which act as powerful, natural painkillers(reference ….). Finally, the placebo effect has been identified as being responsible for the benefits reported, a dynamic which warrants more careful disentangling.

Acupuncture research

Research that wrestled with the challenge of whether acupuncture was offering real or merely placebo benefitwas demonstrated by that of Dr Richard Coan (1982). (The use of the descriptor ‘merely’ again throws light on the negative judgements surrounding this dynamic) Although 80 per cent of patients in the acupuncture group reported an improvement, compared to only 13 per cent of the control group, and the extent of pain relief in the acupuncture group resulted in participants halvingpainkiller requirement, whereas the control group reduced requirement by only one tenth.

These results indicate that improvement due to acupuncture is much greater than can be explained by natural recovery. Whether the benefit from acupuncture was due to psychological or physiological factors, or a combination of the two was questioned. Further clarification was needed as to whether acupuncture triggered a genuine and effective healing mechanism, or stimulate a placebo response, resulting in further higher quality research in 1990’s. Viable placebosare given to the control group, seeming identical but inert, such as superficial needling, misplaced needling (needling at points that are not acupuncture points) and more recently telescopic needle.

The WHO report (2003) endorsed acupuncture for a listed range of conditions andconcluded that the benefits of acupuncture were either ‘proven’ or ‘had been shown’ for 91 conditions, was mildly positive or equivocal about a further 16, and did not exclude the use of acupuncture for any conditions (see appendix). This endorsement by such an international authority on medical issues gave the impression that the evidence base had been established and the practice had legitimacy. Further analysis of the report, however,found this to be biased, misleading and potentially dangerousbecause the WHO had been remiss in how it had judged the effectiveness of acupuncture. It had taken into consideration the results from too many, poor quality trials, creating misleading and distorted conclusions. Reliability would have improved if it had implemented a level of quality control on the studies which we included. A large number of the acupuncture trials used originated from China. Rejecting them may have created tensions and been seen as critical and discriminatory, but Chinese research has been associated with publication bias (publishing only positive results) and delivering results influenced by the unconscious pressure to get a particular outcome. The WHO expert review panel was also not diverse or balanced in that it did not include any critical voices.

According to Cochrane review (date….), the list of conditions is significant for which there is no significant evidence to show that acupuncture is an effective treatment, and any perceived benefit from acupuncture for these conditions is merely a placebo effect. For other conditions, including back pain, headaches, post operative nausea, the review was cautiously optimistic. What is still significant, however, is that Cochrane confirmed that ‘The quality of the included trials was inadequate to allow any conclusion.’And Ernst (2009) in his study found Thirty-two reviews, Twenty-five of them failed to demonstrate the effectiveness of acupuncture, Five reviews arrived at positive or tentatively positive conclusions and two were inconclusive. These findings fundamentally question the relevance of recent studies, and meaning that at the very least, further more rigorous, or possibly qualitative research,would be needed to establish any conclusions.

More recent high quality studies (references…..) where researchers have further eliminated bias from their trials and increased the size of study populations,provide no convincing evidence that acupuncture is significantly more effective than placebo acupuncture in the treatment of chronic tension headache, nausea after chemotherapy, post-operative nausea and migraine prevention. These latest results, therefore, contradict even some of the more positive conclusions from Cochrane reviews. If these results are repeated in other trials, then it is probable that the Cochrane Collaboration will revise its conclusions and make them less positive.

Although there are some high-quality trials that support the use of acupuncture for chemotherapy-induced nausea/vomiting, postoperative nausea/vomiting, and idiopathic headache, there are also high-quality trials that contradict this conclusion. In short, the evidence is neither consistent nor convincing – it is borderline. There are conventional painkilling drugs that can achieve levels of pain relief with reasonable reliability, which are vastly cheaper than acupuncture sessions. Despite the lack of evidence for effectiveness to treat particular conditions, except as a placebo, thousands of clinics in Europe and Americacontinue to promote acupuncture for a wide-ranging list of ailments.

A perfect acupuncture trial,based on scientific principles, would be impossible, the ideal trial being double-blind, meaning that neither the patient nor the practitioner knows if real or placebo treatment is being given. In an acupuncture trial, the practitioner will always know if the treatment is real or a placebo, creating the risk that the practitioner will unconsciously,through body language or tone of voice, communicate to the patient whether or not a placebo is being administered. Singh and Ernst (  ) propose that the marginally positive results for acupuncture for pain relief and nausea apparent in some trials are merely due to the slight remaining biases that occur with single blinding.

Practitioners have argued that like many alternative therapies, acupunctureis an individualised, complex treatment and therefore is not suitable for the sort of large-scale testing that is involved in a trial. This argument is based on the misunderstanding that clinical trials necessarily disregard individualisation or complexity. However, such features can be incorporated into the design of clinical trials and most conventional medicine claims to beequally complex and individualised, and yet it has progressed under the clinical trial model.

Many acupuncturists claim that the underlying philosophy of their therapy is so at odds with conventional science, of which the clinical trial is part, that it would be inappropriate to use this model for testing efficacy. Singh and Ernst (   ) feelthis accusation is irrelevant, because clinical trials have nothing to do with philosophy….. (counter argument….) Instead, clinical trials are solely concerned with establishing whether or not a treatment works !!!!!! (too simplistic….)

Acupuncturists also highlight that the clinical trial is inappropriate for alternative therapies because the impact of the treatment is very subtle and may occur over time. If the effect of acupuncture is so subtle that it cannot be detected, then it could be questioned as to whether it is really a worthwhile therapy. Also, the modern clinical trial is a highly sophisticated, flexible and sensitive approach to assessing the efficacy of any treatment, and very subtle effect.

As scientific rigour has increased, then the balance of evidence has moved increasingly against acupuncture. The counter arguments of Acupuncturist are not definitive, and to some extent, irrespective of placebo controls, randomised allocation and large scale testing, if studies are not measuring the right thing in the right way, are pointless.

The controlled clinical trial is an attempt to avoid being taken in by this conspiracy of good will.

We have already seen that the placebo effect can be a very powerful and positive influence in healthcare, and acupuncture seems to be very good at eliciting a placebo response. Hence, can acupuncturists justify their existence by practising placebo medicine and helping patients with an essentially fake treatment?

The fact that real and sham acupuncture are roughly as effective as each other implies that real acupuncture merely exploits the placebo effect – but does this matter as long as patients are deriving benefit? In other words, does it matter that the treatment is fake, as long as the benefit is real?

Acupuncture works only because the patients have faith in the treatment, but if the latest research were to be more strongly promoted, then some patients would lose their confidence in acupuncture and the placebo benefits would largely melt away. Some people might therefore argue that there should be a conspiracy of silence so that the mystique and power of acupuncture is maintained, which in turn would mean that patients could continue to benefit from needling. Others might feel that misleading patients is fundamentally wrong and that administering placebo treatments is unethical.

The concept and achievement of safety in this context is of considerable importance, being a cornerstone of Evidence based practice, and yet it is not entirely the preserve of either science or CAMs. Science would point to the considerable, technical lengths which researchers and clinicians go to to ensure conventional approaches and techniques are harmless, or the benefits to recovery and cure outweigh the damage causedby, for example, side-effects of pharmaceutical drugs or complications associated with surgery.

Despite alternative approaches have the perception of being gentle, benign or harmless, Acupuncture treatments can result in transient minor pain, bruisingor bleeding, in approximately 10 per cent of patients. More serious, but rare,side-effects, usually associated with anxious patients and those who fear needles, include dizziness, fainting, nausea and vomiting. Infections such as Hepatitis can occur through not sterilising and reusing needles. More significant injuries involve the needles damaging nerves or organs, or needling at the base of the skull causing brain damage.

One way of balancing the extent of risk is an inverse proportion, where the extent of the evidence for the efficacy of an approach offsets the degree of harm possible. For conventional medicine, high gains can compensate for harmful side effects, but the benefits of acupuncture range from none for many conditions, to borderline for some specific kinds of pain and nausea. Therefore rationally, it would only be worth undertaking acupuncture for treating pain and nausea, and only then if you believethe apparentbenefits are enough to outweigh the risks.

Other less direct risks include where CAM’s practitioners inappropriately take the place of key clinician and act outside their expertise, promoting particular advice which could be harmful, such as not supporting immunisation or adjusting conventional drug-treatment programme. Their behaviourmay be biased to promote alternative therapies, due to ideological convictions or remuneration purposes,when patients need conventional medicine.Some alternative therapists who sell useless remedies for dangerous conditions may do this consciously, happy to profit. Others may be acting with the best of intentions, and are simply misguided therapists, deluding themselves and their patients.

The phenomenon known as the healing crisis can be described aspart of the alternative healing process, where therapy may be expected to cause symptoms to deteriorate before they improve. Thisis explained as the body reacting to therapy or expelling toxins. As they expect to feel worse, some may fail to escalate potentially dangerous physical deterioration,missing out on essential urgent medical attention as they have been inappropriately advised that this is nothing to worry about.

Truth and Evidence

2,000 years ago, the statement by Hippocrates of Cos’There are, in fact, two things, science and opinion; the former begets knowledge, the latter ignoranceemphasised the divide between the approaches, and apparent dominance of science. Theuse of experiments, observations, trials, argument and discussion to arrive at truth and objective consensus on efficacy was advocated, rather than relying on opinion which may be subjective, conflicting and open to biased persuasion. Singh and Ernst (2009) assert that ‘the scientific method is without doubt the best mechanism for getting to the truth’, while accepting that scientists are not omniscient.

This fails to take into consideration alternative viewpoints from other schools of philosophy.

Also the complexity of healthcare given that ‘No one paradigm of medicine or system of health care holds a monopoly….cultures have invariably developed pluralistic ways of understanding health, ill health, approaches to wellbeing and forms of treatment’. (Trad, Comp and Integ Med, Adams, 2012, p.1)

Adams also points out that over time, culture and location, what is defined and understood to be ‘’official’, ‘legitimate’, ‘authentic’ and ‘effective’’ (Adams, 2012, p.1) are also fluid.

History of Scientific Research

Prior to the development of evidence-based medicine, doctors were ineffective, if not injurious (Singh and Ernst, 2009). Patients who recovered may have done so despite rather than because of the treatment. Doctors could attribute any success to treatment and dismiss failure as the fault of the patient, destined to die anyway.Demonstrating that a treatment is effective is now accepted as a pre requisite in medicine; understanding the underlying mechanism is secondary, as long as it is safe. From 1746 when James Lind implemented the first controlled clinical trial, to 1809when Alexander Hamilton randomised his research on bloodletting, and Hill and Dolls (1950) prospective cohort study on lung cancer, the framework of modern medicine has emerged as scientific methods have been used to gather evidence in order to get to the truth. Evidence-based medicine provides a mechanism by which to explore which treatments are best, effective, useless and dangerous.

Clinical trials have enabled doctors to decide treatments for individual patients using evidence, data and information, from broader experience and on a wider scale, and not simply relying on personal preferences or memory of a few previous similar cases, initial training and limitedpeer group advice.Although it is not certain that a treatment which was successfulin trials would cure a particular patient, adoption of this approach (according to Singh and Ernst, 2009) gives the patient the best chance of recovery by increasing the likelihood that the most appropriate treatment will be provided.

Evidence-based medicine, defined by Sackett, 1992 as ‘the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.’ requires practitioners to remain open to new evidence and revising conclusions. Involvement in research can provide a reflexivity that is beneficial to patient care, helping practitioners meet the obligation to ensure that patients receives the best available treatment. (Zick and Benn, 2004, Steinsbekk, 2007) in Adams 2012 p. 269).

As well as this being a principle for contemporary medicine, there is also an argument for Alternative Therapists to be more receptive to innovation and revision. Evidence-based medicine has been looked on with mistrust, perceived as being a strategy to enable the medical establishment to defend and perpetuate its position, membership and preferred practices, while excluding those offering alternative treatment. However, evidence-based medicine should endorses any effective treatment, regardless of modality or proponent, and could enable outsiders to have influence. However, this process may not be impartial and how possible it is in practice is affected by the medical establishment hurdles created to achieve the standards set.

Evidence Base practice, defined as,…………………….

In order to comply with the requirements of EBP, establishing that an approach or technique is safe and effective is a pre requisite (reference) . In the past, it appears to have been convenient to confirm that CAMs work through mechanisms that are outside the current understanding of conventional medicine, or that are biologically implausible, depending on your standpoint. Despite this stand off, much energy continues to be devoted to attempting to identify the mechanisms underlying alternative medicine.

Push factors from conventional medicine include dissatisfaction, lack of confidence in treatment of chronic conditions, negative side effects of drugs, failure to meet emotional needs (p. 13 for references….)Pull factors to TCM are focussed more on the attractions of holistic and personalised care, time, spirituality, consistency with personal values, part of wider identification with alternative ideology or subculture, and with an over riding perception of what is effective when conventional medicine fails. Many proponents refer to a desire to control treatment and have a closer practitioner relationship, where seeking natural solutions as opposed toaccepting the invasive and iatrogenic toll of contemporary pharmacology.

Deconstructing Evidence Based Practice

(Freshwater and Rolfe (2004))

All aspects of  the picture that makes up the context of acupuncture need to be challenged and deconstructed. In terms of research methods,  issues of validity and reliability can be explored without accepting as self evident that research is concerned with the pursuit of knowledge and truth. Despite the assertions of (reference….), alternatives to challenge the concept that EBP is the gold standard should be considered.

Before EBP, the Former paradigm consisted of assertions that the unsystematic observations from clinical experience are a valid way of building and maintaining knowledge about patient prognosis, the value of diagnostic tests and the efficacy of treatment. The study and understanding of basic mechanisms of disease and pathophysiologic principles are a sufficient guide for clinical practice. A combination of thorough traditional medical training and common sense is sufficient to allow one to evaluate new tests and treatment and Content expertise and clinical experience are a sufficient base from which to generate valid guidelines for clinical practice.

The New paradigm confirms that clinical experience and the development of clinical instincts are a critical and necessary part of becoming a competent physician, but, crucially, many aspects of clinical practice cannot, or will not ever be adequately tested. Clinical experience and its lessons are particularly important in these situations.

Despite confirmation that an understanding of certain rules of evidence is necessary to correctly interpret literature on causation, prognosis, diagnostic tests and treatment strategy. Freshwater and Rolfe (2004) state that it follows practitioners must be ready to accept and live with uncertainty and to acknowledge that management decisions are often made in the face of relative ignorance.

(Aveyard, H. and Sharp, P. Beginners Guide to Evidence Base Practice in health and Social Care)

Values based practice refers to the balanced decision making within a framework of shared values. In the pluralistic health community, it is decision making in a framework of diverse values which is required.A natural path of development may occur – Trial and error, tradition and ritual , then interest in science and research, then able to communicate and share.

EBP is required because of the fast – paced changes in technological healthcare and the need to keep up with changes in approach, technique and research. CAMs may have a qualitatively different focus or type of engagement with EBP because, although its practice is traditional and in the most part established, unchanging and consistent, there are still innovative developments and the need to understand methods of efficacy. Exploration may be more around these issues and the depth of personal growth and understanding.

Stakeholder Positions and Perspectives

The current landscape is a network of competing groups and power interests. In order to appreciate and explain how acupuncture is developing, it is important to understand their shifting positions and perceptions.

The Medical establishment has a well established position in the UK Health system and has a responsibility and duty to ensure the safety and well being of their patients. In this context, it is understandable that they would see the need to control or eliminate approaches that they perceive lack definitive evidence as to efficacy. (reference)

There is the view that Medics may also be influenced by the other key stakeholder into a more adversarial position. Large pharmaceutical corporations are no longer a homogenous group with profits threatened by CAM therapy. They have shifted their position and interest and are extending their activities to monopolise the herbal medicine supply chain. Medics have developed a realisation that CAMs can be more complementary to conventional medicine and pharma than competitive, and many large companies are now involved in sourcing, researching, commercialising CAMs preparations. Other therapies are more difficult to commercialise, integrate and control.

Holism, reflective practice and EBP is part of the dominant discourse, attracting power, resources and promotion. Nursing struggles with this tension – what it wishes to become, and what is pragmatic to survive.

Given the EBP is an open system, the dominant discourse has to be seen to encourage diversity, despite the risk that this could lead to a dilution of power, authority and dominance. Therefore, what is apparent is an overt rhetoric of tolerance or sharing, and an almost insidious ‘ assimilation’ of CAMs into the mainstreamto neutralise the threat in terms of challenge to the existing model of healthcare.

This process for acupuncturevia integration has stalled somewhat as the strength and legitimacy for this modality has been damaged by the most recent studies and NICE guidance changes. Prior to this,and for other modalities, support of the dominant isgrudgingly admitted, confirming that the competing discourse has something useful to offer, whilst at the same time relegating and marginalising the contribution to a subservient position. An alternative narrative justified mainstream control more in terms of managing risks, and maximising the benefits of integration for patients.

EBP requires the imposition of standards resulting in consistency and ensuring the quality of nursing intervention. This also serves to exert control over practitioners by ensuring they respond in the same way to the same clinical situations, regulating practice, minimising choice, and development.

(Aveyard, H. and Sharp, P. Beginners Guide to Evidence Base Practice in health and Social Care)

Within this context, according to Aveyard and Sharp (….), nurses need to find a way of reconciling these tensions,

What is required now is transparency, with ongoing more creative research design, quantitative and qualitative to continue to develop understanding of the effective dynamics at play ******, alongside clear guidelines and guidance on useage of CAMs to mediate risk within the existing legacy of perception and practice (see Tovey on advice labels).

Further work is required to integrate CAMs values and practice approach (practitioner depth and term of relationship, and/ focus on mindset expectation) back into contemporary health practice.

‘Complementary’ therapy is a useful definition as there are many ways in which CAMS complements conventional medicine. Possibly, however, the primacy should be contrary to this original definition, given that traditional therapy came first, should this not be that contemporary medicine complement CAMS.

Research Approach for CAMs

Lewith (2011)

An exploration of the position of research in the area of CAMs, draws on Ontological (beliefs about nature of reality and what exists) and Epistemological (the nature of knowledge – what is true, justification and the rationality of belief – what can be studied)debates. This CAMs research provides a fascinating case study exploring the epistemological challenge of whether belief or knowledge provides an adequate basis for study, as well as the nature of the dynamic being studied.

Qualitative research is constructionistontological assumption of relativism – no intrinsic reality that can be found/known…truth is socially constructed and historically situated. How groups perceive and create reality. Epistemological – interpretivist or transactional approach – researcher and researchee mutually create knowledge

Traditionally, research from a scientific standpoint is quantitative in nature, drawing from positivist traditions looking at natural phenomena, properties and relations, but through a realist lens where there is an objective reality independent of social construction. Therefore there is a continued emphasis on study design to factor out all influences and interferences to collect the data to achieve an understanding of the cause and effect relationships under scrutiny. As the difficulties of achieving this in practice have become apparent, a reductionist approach has been adopted, where studies have continued to be simplified and concentrated down. Although this has yielded some results in challenging the efficacy of some CAMs approaches, it has also resulted in much criticism. Some of these scientific results are not defensible as the research design is subsequently found to be compromised. Challenges also continue to be made in the area of CAMs on the fundamental grounds that the ontological assumption that the real world can be observed and understood is flawed, and that there are connections and interactions occurring in CAMs that it is not possible to capture scientifically. Some examples are grounded inenergy and dynamic interactions that could be expected to be scrutinised with appropriate research methodology and equipment, for example Chi in acupuncture, but also……… . Alternatively, if the effective dynamic is self healing / placebo in nature, qualitative studies may be better suited. Epistemological – dualist or objective standpoint – find an objective truth.

Process of keep researching, justified because part of best practice to continue to challenge and review any area of practice, rather than the unhealthymotivation to keep repeating studies until the analysis and conclusions expected or desiredare achieved. Calls for an end to the debate on the basis that CAMs has been disproven, demonstrates at worse a dismissive arrogance but misunderstanding of the possibility of finality and conclusively,but at best a desire to avoid further waste of research and health service resources on ineffectual approaches.

Research methodology in the area of acupuncture has demonstrated an enthusiasm and creativity for designing new approaches to increase the validity of studies. The use of sham needling and development of ……as well asattempts to factor out the placebo effect, show an eagerness to conform and achieve scientific standards of research, to progressanalytical methodologies and sophisticated technologies, to confirm evidence base. Further refinement is always possible, although a more productive direction now may be to explore how to design studies to factor in and focus on the placebo effect.

CAMs do not conform to reductionist paradigm that dominates conventional research (Kurakin2005, 2007 in Lewith  p. 79) and there is growing understanding that the placebo RCT offers us a very limited evidence base and that expansion of research methodology and its interpretation is required in order to understand the dynamics in these complex therapeutic interactions. It is felt that mixed qualitative and quantitative research methods are beginning to unpick and make sense in these areas. The distinction is made that research may allow us to understand how CAMs may offer benefit, but also provide insights into the management, and self management, of a variety of chronic conditions. The view that it is considered safe and cost effective for some common conditions has resulted in thoughtful evidence based integration, for example Acupuncture in cancer centres, with scientific progress based on sound and rigorous evidence.

The critical question still to be answered appears how we can more effectively and ethically utilise the benefits of the placebo effect and trigger self healing. A focus on self healing provide a better concept of the dynamics which need to be explored, which should support and inform better designed research methods to determine conclusions.

CAMs can be conceptualised as methods of making use of this self healing response, and there is an argument for Practitioners in this field to discontinue the use of tenuous pseudo science explanations, and focus on the legitimate power of these approaches in terms of self healing. As scepticism regarding unorthodox practice continues to be significant, and the degree to which self healing is effective is as yet unproven, rigorous evidence would be required prior to approval. There is the sense of a watershed period at present, making it difficult to shift from one set of albeit unconvincing assertions, which are at least connected to the relatively well respected medical model, to a different as yet unproven narrative for efficacy. The other key conflict and risk in this context is that this transparency may destroy the effective dynamic.

Existing research confirms the benefits for Medics to embrace CAMS and adjust their own professional approach in line with various CAMs elements, however, in the light of the status quo, there are also significant benefitsand attractions to patient for CAMs being outside the Medical model. Lewith 2011 reminds that Medicine is served by science, and yet thepractice of medicine is still perceived as an art, that should use scientific evidence when and where it is needed and helpful. Ideally all situations should draw upon scientific evidence, but with an appreciation that even with the best evidence, practitionersmay have to be content with partial knowledge, and continue to use clinical judgement as to whether approaches have been effective. Expecting CAMs to deliver a higher level of confirmation of efficacy is therefore unfair and points to other factors affecting.

Amri in Lewith (p. 79) argues that CAM research has not had a similar level of attention as other health approaches and innovations as a result of various factors includingpolitical expediency, economic exploitation, and the additional complexity and heterogeneity of constructs around mode of action. Study tends to occur motivated by step change, innovation or untoward incidents, and as CAMs have been established, consistent and generally harmless from ancient times, and CAM practitioners have been secure in their belief of efficacy, and therefore having limited engagement with an expectation of continuous improvement, the reason toresearch has come mainly from those wishing to condemn, and therefore alienating engagement from CAMs practitioners, or around a desire for purely academic understanding. Where funding has been secured for other areas of CAMs such as herbal preparations, as commercial benefit can be anticipated, there has not been the interest in areas which are practitioner resource led. Also, the effects so far have been shown to be moderate, or less than conventional medicine, for only a selection of symptoms, therefore the cost benefit analysis does not stack up to devote resources.

If CAMs is further explored using the conventional scientific approach, the technological tools to assess whole body response to treatment are now available using Microarray and mass spectrometry, which may balance the reductionist paradigm usually associated. Advances to capture cellular and molecular mechanisms through genome analysis and proteomic, metabolic and other bioinformatics analysis may find the pathophysiological processes or physiological markers. CAMs also naturally forces up from this reductionist perspective to a naturalistic, holistic and integrative paradigms. As more CAMs practitioners become engaged in research and as current reductionist scientific approaches have failed to adequately progress understanding in these approaches, still within the conventional scientific paradigm, focus has shifted to systems biology and systems medicine, where large databases and technological advances can draw maps of multitude pathways and interactions. The new phase in allopathic medicine of Personalised treatment, facilitated by genome developments,may prove to provide a resonance in the form of a shared patient perspective between CAM and conventional medicine, and other emerging system integration of biology and biomedical research may still achieve an evidence based approach to CAM research (p.94).

Placebo effects

Whilst research is ongoing to find pathophysiological processes or physiological explanations for the effectiveness of CAMs, alternative explanations continue to focus on this dynamic being the result of the placebo effect. Definitions of placebo range from ‘an insincere or ineffective treatment that can nevertheless be consoling’(reference) to ‘…………….‘Placebo’ hides our ignorance and perpetuates partial truths about clinical work and outcomes whilst at the same time obscuring and preventing better understanding (Peters, 2011)

Singh and Ernst (2008) articulate the generally held view that any form of treatment that relies heavily on the placebo effect is fraudulent. Improvement in some studies was based on subjective feelings rather than objective change in physiology. Modern clinical trials aim to exclude human variables and bias by randomisation and blinding in order to be able to attribute improvement to treatment alone. Yet the fact that around 60% of control groups tend to improve forces to ask what the personal and interpersonal factors are that so profoundly affect the outcomes p.xiThe associations of insincere, deceptive and unethical practice, and as something to be factored out in research or used to trick patients in a control group, have dominated the narrative for placebo, and made it problematic to explore the positive dynamics impacting on motivation to engage and commit to treatment, and the power of suggestion on recovery, and have tainted CAMs because of the strong association.

In practice, the placebo effect has been shown to reduce the experience of pain, insomnia, nausea and depression. Practitioners and Researchers have observed physiological changes, suggesting that the placebo effect not only impacts on the mind  but also on physiology (examples…….). It is widely acknowledge that psycho-social pressures are met by physiological and potentially patho-physiological changes. Beneficial psychosomatic effects (Antoni, 2006) have been observed, so to dismiss the placebo effect is not satisfactory. Placebos are said to draw on conditioning, suggestion, persuasion, role demands, hope, faith, labelling, misattribution, cognitive dissonance, control theory, anxiety reduction, expectancy effects , endorphin release…

Building on Pavlovs work (1890’s) to condition dogs to salivate to a bell, further animal studies have shown how immune responses can be conditioned, causing guinea pigs to develop a rash when injected with a certain mildly toxic substance, building to the same response occurring when merely scratching the skin (Russia ….). This conditioning dynamic could account for where patients improve with the placebo influences of association of recovery with contact with a practitioner or taking medication.

Expectation theory also provides a possible explanation, purporting that if benefit from a treatment is expected, it is more likely to occur. Conditioning exploits the unconscious mind to provoke a placebo response, expectation theory suggests that the conscious mind may also be affected. Expectations somehow interact with the body’s acute phase response, activated on injury. As the placebo effect is particularly effective in addressing issues such as pain, swelling, fever, lethargy and loss of appetite, the placebo effect may be a consequence of an innate ability to block the acute phase response at a fundamental level, possibly by the power of expectation.

As the placebo effect for a particular patient is dependent upon their personal belief system and experiences, which therefore creates variability and unpredictability of placebo effect among patients. It’s potentially powerful influence on recovery means that it can be a distorting factor when attempting to assess the actual efficacy of a treatment. Treatment may appear to be effective in a trial where a group of patients being actively treated might expect to recover, thus stimulating a beneficial placebo response. The simple trial design can produce misleading results, as even a useless treatment can give positive results.

In none clinical trial situations, the placebo effect may become problematic when symptoms have been relieved alongside an otherwise ineffective treatment, and a false sense of reassurance is achieved which results in the patient not seeking treatment for the continuing underlying condition.

Peters 2011 CAM practitioners recognises the positive power of belief and sees the patient’s belief system as a powerful ally in treatment. Practitioners use symbols to represent and confirm information about basic cultural premises to create a context to restate basic premises of everyday life to reassure the sick, unhappy, confused that despite their suffering, the world still makes sense. This helps create belief and expectations, and makes the patient intrinsic to and having control in process. This approach has many tensions with Western medicine where patients are still perceived as passive, their beliefs are ignored or ridiculed, and they are excluded from control in the process.

Despite the ethical restraints on deceiving patients with deliberate placebo administration, empathic reassurance has been found to produce better results than truth and uncertainty (Peters, 2011). There is a growing realisation and appreciation of the placebo effect, and the need to optimise rather than ignore or control it, but more understanding is needed to support an ethical practice approach.

‘ come to the conclusion that the widespread data in the literature on the magnitude and frequency of the placebo effect are largely exaggerated, if not altogether false’( p.46 Peters 2011) Analysis proves placebo effect does not exist achieved by mere

Building on from a placebo effect created through conditioning or expectation, CAMs Practitioners promote the idea that CAMs somehow switches on self organising processes (Peters (2001). This effect may also be influencing improvement in patients condition, as the patient’s own response is triggered through the practitioner relationship, and their resilience facilitates natural remission and recovery. The assertion that personal and inter personal elements are lesser parts of medical practice than technical procedures has simplified and enabled a focus on science, played to the natural clinician preferences and perpetuatingpossibly useful professional group skill differentiation. Despite this, there is much written on the benefits ofDoctors re integrating this dynamic into their interactions with patients, confronting established pathology and learning how to catalyse the process of healing. This change in practice would require a significant shift in health belief system and an admission that previous practice was could be improved upon. The extent to which our therapeutic effectiveness is determined by humanity and presence or technical skill is brought into sharp relief through exploration of this dynamic.

‘CAM therapies might be elegant, efficient and comparatively harmless ways to harness these processes (Walach 2001 in Lewith 2011, p. 325)

The research dilemma, according to Aickin (in Lewith 2011, p. 333)is how to operate within the current paradigm to ensure results are accepted as valid, whilst capturing the effects of healing methods that are too complex and multi causal for the unitary model to handle. One solution is to return to fundamental principles of designand analysis which resonate with aspects of CAM, while keeping within the bounds of the general philosophy of science. These include

  • Clinical trials should be about people first, treatments second
  • More measurements on each individual to ensure participant level outcomes are captured in results
  • CAM research to employ early phase research methods, in line with stage of development, and to reconsider and challenge mature phase methods and expectations where inappropriate

CAM research provides an opportunity to refocus on the patient as the unit of concern, and enrich both medical science and clinical practicewith multiple outcome and whole system studies. This will be problematic in the current commercially and medically dominant research context which significantly determines career progression is dependent upon the need to attract funding.

Evidence Based Practice is set to persist, but thechallenges inherent in conforming to this approach where CAM is concerned are as follows

achieving meeting the requirements of the breadth of evidence that underpins practice,

compromising on delivering individualised care  in order to meet the need to provide standardised care (clinical guidelines)

providing standardised care at the loss of innovation

devising the organisational cultures that can support individualisation and corporate Evidence Base Practice,

develop channels for the dissemination of evidence and encourage communities of practice and knowledge networks to share and evaluate approaches

develop alternative methods of researching CAMs and self healing

Verhoef et al (2005) confirm that as CAM approaches often consist of complex whole systems of care, including a wide range of modalities in the provision of individualised treatment, researching the unique healing theory, therapeutic context, and synergistic factor, requires innovative evaluation approaches. Whole systems research (WSR) is proposed with a mixed methods approach, inclusive of a range of holistic outcome measures, and not only a focus on active elements. The non-hierarchical and adaptive nature of WSR framework recognises that no one method can adequately capture the meaning, process and outcomes of these interventions.

Heron in…… (p.189) therefore suggests the need to deploy Cooperative Inquiry approach around researching self healing.This provides a more adequate, creative paradigm, being systemic, holistic, relational and experiential, for contemporary studies – ‘competes with the positivism and the extreme relativism of the deconstructive post-modern alternative’ (p. 190 – 191)

The principle that has been driving the demand for CAMs is the desire to find ‘good healing encounters, good safe therapy in a good safe therapeutic environment, from a good safe and wise carer or healer’. P.97.

Integration and Implications for Nursing Practice

(Complementary and Alternative Medicine in Nursing and Midwifery, Adams and Tovey (8888)

Tovey (1997 p. 13 in Adams 2008) ‘there is a schism within orthodoxy…and that schism is occupationally based: at the extremes, consultants (ie. Medical specialists) remain characteristically dismissive of alternative practitioners, nurses overwhelmingly enthusiastic (p.1129)

Professional practice had been influenced recently by WHO and NICE support following tentatively positive scientific research findings providing the context for increased discussion, an air of consensus and rhetoric around integration,

According to the Centre for Integrative Medicine at University of Arizona,  Integrative Medicine (IM) is ‘healing-oriented medicine that takes account of the whole person, including all aspects of lifestyle. It emphasizes the therapeutic relationship between practitioner and patient, is informed by evidence, and makes use of all appropriate therapies’.

Despite barriers to successful integration (Barret 2003, Hughes 2004, Coulter 2004), CAMS was positioned as a credible accompaniment or supplement to conventional treatment, as well as shifting through social to a position of prominence(Tovey and Adams (2002)). More recently formal professional support for integration has waned following criticism of WHO report and of supportive research. However, no overt statements have been made confirming a change in policy. Indicators have been covert in the form of revised NICE guidance and closing of forums.This lack of central guidance may create an additional pressure for practitioners to have to update themselves.

The position on CAMs of significant professional groups is affected not only by external evidence on CAMs but byrelative structural and cultural positions, philosophical perspectives, and speciality.

Nursing has apparently seen an opportunity to extend role and influenceover optimistically assumed the appropriateness and benefits of CAM, but subsequently perceived to have failed to apply critical perspective in the inquiry of efficacy or reflection, and medical respect.It is a fundamental professional requirement to keep abreast of research and although acceptable to continue practice if the position is unclear, when more robust research demonstrates no benefit or placebo, a shift in practice would be expected. The consideration that CAMs is not a mainstream practice, may explain the lack of official policy, or that nursing is rejecting the medical model and looking to a credibility and validity of CAM in relation to wider evidence, experience, embracing a more ……approach to CAMS.

The threat of CAM on the practice of established professional groups is possibly overstated, the medical model being so dominant in this society. Moves to integrate have been engineered more from a, possibly over protective, motivation to reduce risk and harm, rather than a move to neutralise a real competitor. The threat of CAM is more likely to be significant on the occupational status of nursing, where association with alternative approaches can affect credibility by association, risking continuing to be relatively marginalised, and discredited. Rather than embracing CAMsto advance themselves as independent practitioners, or distance themselves from specific negatively interpreted features of modern medicine, Morrall in Adams (2008 p.4) feel that a better strategy to enhance professional status would be to reinforce the unglamorous but essential aspects of basic patient care and basic natural care. Instead Nurses are simultaneously attempting and being required to extend beliefs and practice at each end of the spectrum, more transcendental and more technical.

A narrative of historical connection, based aroundfeminism and female roles in health,has been developed to authenticate the relationship between nursing and CAMs, and facilitate future integration. Nurses training in CAMs has been an easy fusion of practices, especially midwifery where CAMs proficiency has provided the opportunity for midwives to reinforce their position as primary care givers, promote individualisation in health care, and facilitate patient decision making, choice and control. (reference….) Integration of CAM therapies to contemporary healthcare has also been supported by relating broader notions of care and holism, with which CAM and contemporary nursing are closely linked and where there has been increased recent prominence. Rhetorical strategies used to advocate for integration include nostalgic and nostophobic referencing

‘Survey of English Language literature’ revealed that physicians in ‘developed’ nations demonstrate both tolerance for and a moderate interest in CAM but no apparent increase in the perception of its usefulness’ ( Adams 2008, page 11)taken from writers up to 2002. This may have changed following positive WHO support and subsequent publicityof negative research findings. Most medics confirm the need for more reliable studies, but have a selective belief in at least one CAM modality.Bourgeault 1996, found ‘Specifically, that physicians were much more open to patients using CAM when their prognosis with conventional medicine was poor’ (Adam 2008, p. 27)

Tovey (1997, p. 1132 in Adams 2008, p. 15) status related schism – greater flexibility to the non orthodox being expressed amongst those least effectively rewarded by existing arrangements. Nurses are a less powerful group within the existing arrangements and are therefore less oppositionary. Physicians paradigms of practice are viewed inherently as more contradictory, the power relation between them and CAM practitioners being most diverse.

‘a lot of therapies could be disempowered by having them removed from the paradigms and philosophies in which they were developed.’ (Adams, 2008, p. 19)

What may occur is a focus on patient experience and wellbeing that is already a part of conventional medicine at its best, but CAMs presence encourages and focuses this, or acts as a secondary distinct treatment option / phase where this is delivered.Holistic Wellness nursing has developed with a nursing philosophy stressing the importance of maintaining health, whole person and self responsibility for health and wellbeing (Chambers-Clarke 1986 in Adams, 2008, p.156). Nurses embrace as fosters self care, emotional support, spiritual , healing energy of love (compassion ?//)

Look at paradox and explode meanings of interventions, roles, health care….enable CAMs to operate in conventional settings (or redefine these settings…) – while still embracing beliefs in holism, inter relationships and subjectivity.

Integration is an attempt at intertwining two distinctive and incomparable epistemologies – ‘reasoning from ancient civilisations, European renaissance and industrial epochs, and convictions from a matrix of folklore, hocuspocus, mysticism and snake oil’ (Adams 2008, p. 56)

CAM does not avail itself of systematic critique in the same way that scientific medicine does and isperceived as complacent and stagnant. Scientific medicine is in a constant state of dissatisfaction and transformation – seek to find better understanding for disease, and more pleasant treatments.

Popper (1959) science cannot establish permanent truths. Rather than science proclaiming to prove the existence of facts, the mission is reinterpreted as aiming to falsify correlations between variables. Each test either weakens a suggested link between variables, or implies that this link can be taken as valid, but only for so long as a subsequent test is not invented that then refutes the link.

Blackburn 2006 concluded that we should respect the authority and goal of scientific truth while remaining sceptical about future developments. Finding that what was once considered the truth can no longer be sustained, does not negate the search for real truth.

Although the website now states that it is widely regarded that using complementary therapies in conjunction with conventional medical care can improve a patient’s health and well being’ RCN advice mainly consists of Indemnity Documentation confirming support for acupuncture, hypnotherapy, using essential oils within recognised health or social care settings, and massage.

CAM expansionism driven by commercial opportunism (Collyer 2004, in Adams 2008, p.150)

Not scientific philosophies but holism, vitalism and naturalism – partnership with patient, holistic and autonomy from medical positivism and reductionism.

While most conventional medical practices focus on treating disease with science and state-of-the-art medical technology, a common-sense approach to health care mandates using humanistic, simpler, less invasive and less costly therapies as adjuncts to conventional medicine (Norred, 2000).

Conclusion

Integration and engagement with CAMs comes at an interesting time in the development of nursing, in terms of shifting and enhanced roles, and how the relationship with the patient and the mutual responsibility for health and wellbeing should be informing this debate. Expansion in interest in acupuncture should not be conflated with consensus, although more professionals have been trained recently (reference )providing a cohort who can better advocate or critique from a perspective of authority and knowledge. Nursing seems to feel a self imposed pressure to advocate, legitimise and defend CAM integration in the face of increasing research evidencing reduced efficacy, or possibly as a reaction to medicalised treatment regimes dominating at the expense of human contact.Discussion of formal integration and utilisation appears to be waning, but professional and interest and societal usage continues to persist.

Acupuncture provides a valuable opportunity for further investigation, providing the opportunity to develop and extend what is meant by evidence based practice and research methods, and in what to measure in terms of health and illness experience.

The use of acupuncture should be based on efficacy, but determining a satisfactory method and standard of proof has been problematic. Evidence of physiological impact appears to be explainable through the placebo effect, or the impact of relaxation, distraction and gentle muscle movement or improved blood flow on our ability to cope with pain and other minor symptoms. In terms of a curative effect, there is no convincing evidence using current research method approaches.  In this enduring area of practice, there will continue to be enhanced study looking to challenge and advance current understanding. Nursing needs to consider how to engage with acupuncture and other CAMs in this shifting terrain.

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