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Acupuncture is intent on not being classified as an alternative medicine and in fact it seems to have had a favourable reception both by the public and the medical profession. Its scientific status remains unclear and will be hard to establish as long as the criteria of evidence-based medicine are required to prove therapeutic effectiveness. The most consistent therapeutic effects have been shown by patients suffering from pain or nausea. Diseases based on structural disorders have disclosed unconvincing results.
Bioethics should be expectant in case acupuncture does confirm its place in medical therapeutics, for developing world countries would develop a keen interest in an effective procedure that may be less expensive than pharmacological agents. A five-point programme is suggested in order to eventually substantiate the incorporation of acupuncture in national health policies: (a) select disorders with high probability of successful response; (b) concentrate on diseases that do not have adequate therapies; (c) research using appropriate strategies, preferring crossover, historical or active control group methods instead of placebo controls; (d) standardise the therapeutic technique; (e) professionalise practitioners. Should acupuncture solidly confirm its usefulness, it would be ethically improper to withhold it especially from those patients who have not been helped by current therapies or do not have access to them.
Alternative medicines have been gaining momentum in Western cultures for a variety of reasons, including: high medical costs with insufficient insurance coverage; increasing presence of managed medical services; and loss of confidence in practitioners and pharmaceutical companies. Acupuncture is the one alternative therapeutic procedure that has profited most from this shift in patients’ orientation, to the point where there is no agreement as to whether it belongs to the bulk of alternative medicines or is to be classified as a “therapy within a modern health service”.1 It has been plausibly suggested that current scientific medicine is alternative to classical Hippocratic medical practice, so that we are really juggling names and paradigms, an exercise that carries a substantial dose of ideological thinking.2 Some scholars simply do not accept the distinction between conventional and alternative medicines, claiming that any kind of medical practice is only valid if informed by evidence-based clinical science.3 It still remains undecided whether acupuncture can perform consistently enough to gain widespread acceptance. The question is especially relevant for countries with healthcare resources that are limited and insufficient to adequately endorse state organised medical services.
An ethically uncomfortable situation is created whenever the affluent can afford procedures with extravagant and unsubstantiated, but perhaps true, claims, while public medical services lack sufficient information to allocate resources accordingly. Inasmuch as the public good is involved, bioethics takes a special interest in evaluating and eventually recommending medical methods that are efficient, cost-effective and devoid of risks. Unfortunately, healthcare services are chronically underfinanced, especially in less developed countries with heavy disease burdens, so that strict gate-keeping is mandatory to incorporate only what can be demonstrated as useful. To this purpose, this paper will address five queries: does acupuncture have a special status among alternative therapies? What is the scientific status of acupuncture? What is its therapeutic standing? How does acupuncture fare ethically? Should acupuncture be incorporated in public health policies with limited resources?
Acupuncture between alternative and conventional medicine
Sociologist Thomas’ dictum applies: “if enough people believe something to be real, it is real”, and since many more people believe in acupuncture than in any other single alternative procedure, acupuncture has reached an undisputed presence in many societies. One reason is because the millenarian tradition of Chinese medicine has been around long enough to acquire the respectability of endurance. Paradoxically, though the procedure is acknowledged by Western medicine, its theoretical background is rejected. Practitioners who have adopted this therapeutic method insist that the underlying Yin/Yang and qi explanations are unacceptable ideology. A second reason for the acceptance of acupuncture is that anecdotal evidence and informal accounts have been consistently positive, stimulating physicians to take up a procedure initially practiced outside of medicine. Acceptance of a therapeutic modality helps enhance and fulfil expectations, stimulating a sort of virtuous circle. Therapies that are expected to help will probably increase their efficacy by way of a self-fulfilling prophecy, as has been shown by a number of studies on placebo responses. Both conditioning and expectancy influence the analgesic response to placebos, perhaps also to needling, a fact that should be looked upon approvingly instead of being dismissed because of lacking supportive evidence.4
The scientific status of acupuncture
Even though ditching Chinese ideology came naturally to Western medical acupuncture (WMA), it has not been easy to replace it with plausible explanations or hard data concerning the effectiveness of acupuncture. Considerable efforts have been invested in trying to elucidate in scientific terms the mode of action of needling, a difficulty resulting from the quest for a physiological language that would appear more convincing to contemporary medicine. Although supported by a number of objective methods, some of them highly sophisticated, most of these effects are also seen when non specific sites are needled, sham punctures are performed or when placebos are studied, giving little support to cause-effect interpretations. The question seems pertinent whether acupuncture is a procedure amenable to neurophysiological explanations which deliver hard, but for the most part, non specific data. Apparently, there exist “largely overlapping pain-modulating circuits in the brain”, which can be activated by a number of agents, possibly including acupuncture.4
These ambiguities should not be taken too seriously, for medicine is known to suffer from chronic and severe underdetermination, leading to an uneasy fit between theory and fact.5 Many traditional explanations are being superseded by genetics or confounded by the multi-causality of environmental factors, so it should come as no surprise that acupuncture is also plagued by similar uncertainties. Ultimately, it is advantageous to know how a therapeutic agent works in order to reduce risks and negative side-effects, and to enhance its beneficial action, but one ought to bear in mind that basic research may consume time and resources without too much yield. Medical agents often prove useful before explanatory research is engaged in. In the 18th century, William Withering introduced the cardiac drug digitalis into medical therapy believing it to be a purely diuretic agent, long before physiological studies showed its specific action on the heart muscle.
Underdetermination in medical knowledge and practice were probably major factors in the development of evidence based medicine (EBM). Nevertheless, EBM has been subjected to heavy methodological and ethical criticism, one being that the quest for internal validity through rigorous randomised clinical trials does not go hand in hand with external validity, a major reason why the majority of practitioners do not follow the recommendations of EBM research.6 A second look is mandatory because meta-analysis has shown that the conditions of many clinical trials are not comparable and cannot be lumped to produce a meaningful body of reliable knowledge. In spite of EBM’s shortcomings, WMA pretends to abide by its tenets and has in fact been challenged to do so: “Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments.”7
Even if randomised clinical trials (RCTs) are at the heart of EBM, and constitute the gold standard of objective medical research, acupuncture may fail to be an adequate subject for this method of research. Needling is not always performed in a standardised way and the influence of such variables as duration, site, or sham techniques are poorly understood. A double blind study using placebos to clarify these issues is not conceivable. Beyond the fact that it is not easy to devise an inactive procedure that will simulate the acupuncture treatment under scrutiny, it must also be considered that placebos, usually recommended in RCT, are weaker comparators than using current treatment in the control group, so that a standard RCT with placebos does not seem to be an adequate research strategy to validate acupuncture. If acupuncture is to validate itself by means of a modified RCT, best existing therapies should be used as comparators, thus complying with a more rigorous and ethically preferable research design as compared to the use of inactive control procedures.
A therapeutic method must have a well-designed and proven application scheme before it can be subjected to comparative trials with other procedures in a phase III clinical trial. A step in the right direction has been the publication of the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) criteria that require standardisation when reporting research results using acupuncture, but these criteria in fact confirm that procedural methods in the application of acupuncture are far from uniform.8 Therefore, even if reports are standardised, it will not be easy to create meta-analytical data using treatment protocols that are not comparable. It does not seem fair to deny therapeutic value to acupuncture because it cannot stand up to the standards of mostly drugs related EBM protocols, for the simple reason that its effects are only partially quantifiable. And yet, appropriate research strategies must be devised to substantiate its therapeutic value.
The therapeutic status of acupuncture
Acupuncture has been shown to be better than placebo in treating nausea and a variety of conditions where pain is a salient symptom. It has not done too well beyond four or five treatment indications and even here the final conclusions are often guarded: “acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches”.9 Acupuncture has been tried in a striking number of medical situations, many of which, like glaucoma or acute stroke, are difficult to imagine as being amenable to a needling procedure.
Beyond scientific methodology, clinical applications of acupuncture have been irregular in method and content, reflecting the variability of needling techniques used. When targeting specific points seems to work just as well as choosing random sites, and if no agreement is reached about the length of time the needles should remain inserted, or fake acupuncture works almost as well as the correct treatment, the whole procedure becomes dubious. Length of time and frequency of needling in chronic or recurrent conditions also appear to lack standardisation. Is there a difference in beneficial effect between experienced professionals and poorly trained performers? What is the standard procedure regarding informed consent given by patients or by research subjects? The placebo effect is said to rely to some extent on misleading or incomplete information: does this in any way apply to acupuncture?
The effects of acupuncture can be reasonably expected to go beyond measurable neurophysiological processes, probably having psychological components. This is in agreement with most medical procedures, which should consider that people “come into clinics and research settings with a variety of prior experiences, predispositions and expectations, and with innate, learned or not-yet-determined, healing response patterns.”10 Many authors have stressed the influence of patient attitude, expectations and the quality of the healer-patient relationship in the therapeutic effect beyond strict pharmacological action or lack of it. Acupuncture supporters will do well in stressing that confidence is an important element in the procedure and this is another reason why needling should be performed by regularly trained, ethics-code-conscious, accountable professionals. At present, roughly half of acupuncturists are physicians or formally trained professionals, the rest, according to WHO statistics, are “licensed to practice”.11
The ethical status of acupuncture
The ethical validation of any medical procedure depends on the demonstration of favourable benefits versus risks and costs ratios.12 13 Benefits are accepted when scientific research has confirmed therapeutic efficacy, which has to be pitted against the risks of the procedure and its accessibility. This is far from a quantitative assessment, because the evaluation of therapeutic benefit varies according to the symptoms or the disease being studied. A very beneficial agent for a trivial malaise may be considered less important than a drug that leads to minor improvements in a very severe or lethal disease. More risks will be acceptable when a drug substantially influences a very annoying symptom or unruly disease, and a very expensive procedure may be subsidised and made more accessible if it is of vital import. In some countries, analysts may be concerned about the cost-effectiveness ratio in expensive treatments for rare diseases, whereas others concentrate on the more traditional routine benefit-costs evaluations to rationalise scarce resources allocation, but they all must rely on hard evidence in their decision-making process.14
In spite of these vagaries, acupuncture, like any medical procedure, must find a way of testing and demonstrating its therapeutic worth, and it is here suggested that a five-tiered programme might be considered:
Therapeutic indications should be sought for diseases that can be reasonably expected to respond because they have strong subjective components like pain or nausea. It is hardly likely that degenerative processes will be influenced by needling, except as a palliative for accompanying discomfort or pain, and the value of acupuncture will be ill served if indications are overextended beyond plausibility.
For conditions that already have adequate treatment it may be redundant to test acupuncture unless a substantial improvement in benefit/cost ratio can be expected.
Research addressing the efficacy of acupuncture will have to go its own way in order to provide reliable results, shunning standard placebo RCT strategies in favour of protocols comparing with best available treatments, relying on active control groups or crossover techniques and observation over time.
Credibility of acupuncture will be increased if standardised therapeutic procedures are studied and promoted.
Unless acupuncture becomes a licensed therapeutic method, it will remain an uncontrolled one, thereby increasing the risk factor of incompetent practitioners. If not practiced by healthcare professionals, it ought to develop its own professional code, including training, adherence to a moral code and legal accountability.
Should acupuncture enter public healthcare schemes?
Alternative medicines are rarely if ever subsidised or included in insurance or national healthcare schemes. The World Health Organization has repeatedly campaigned in favour of studying and supporting the use of alternative medications, especial herbal medicine, which are part of the culture of many less developed societies, enjoying widespread acceptance in well over 100 developing world nations.15 In contrast to acupuncture, traditional healthcare practices are intent on gaining local recognition and tolerance, but show no interest in being integrated with academic medicine. Acupuncture concentrates its influence in a few developed countries, notably UK and Germany, weakly reaching out to about 40 countries, but progressively gaining more widespread acceptance. Should acupuncture definitely prove to be therapeutically effective, perhaps even to the point of filling a therapeutic void, it would fly in the face of justice to neglect making it more widely accessible.
Should the therapeutic spectrum of acupuncture be confirmed and specified, it will become a matter of healthcare equity to make the procedure routinely accessible at least to all those who have failed to find relief in standard medical procedures and suffer ailments that have been proven to respond to acupuncture.
The quest for effective but less expensive medical methods is of prime importance for nations that have limited healthcare resources and cannot keep up with the soaring costs of highly sophisticated developments. It therefore becomes a matter of public healthcare justice and economics that less onerous procedures be privileged provided quality and efficacy are not compromised. Furthermore, if equipoise between accepted therapies and acupuncture is obtained, economic common sense will give preference to the less expensive method, making it affordable to patients and healthcare institutions in the quest for equity in healthcare matters. Rather than being political in nature, these considerations are inspired by justice and sound economics in healthcare delivery. From the point of view of bioethics in public health, such an inclusion would then be mandatory, lest the beneficiaries of state-funded medical care be deprived of a useful, cost-effective therapeutic alternative. Persistent cultural barriers held by patients and healthcare providers who solely rely on classical medicine, must accept that alternative procedures, if proven to be effective, are usefully incorporated in public healthcare schemes, especially if current treatments are not accessible, unavailable or non existent. Such a change of attitude is not merely a matter of private choice and privileged access. If convincingly shown to be effective, it ought to be widely accepted in developing world countries, leading public health policy to incorporate the procedure in state-financed medical care, where it should take the proper place of its eventually proven value merits.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
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