Science, evidence-based medicine and CAM…..it´s controversial!

Introduction

Patients are increasingly making their own healthcare their own responsibility, and are becoming more selective in what treatment and therapies they use in their recovery from illness. Dissatisfaction with conventional treatment that is indifferent of a holistic view of health, may produce more or less severe side-effects, or even concomitant diseases, makes patients seek new approaches for relief of their suffering. Frequently, the choice is an alternative and complementary medical discipline [1] [2] [3].

This happens much to the dismay of practitioners and representatives of orthodox medicine. They view the practices of alternative and complementary medicine critically. They describe CAM as being unscientific and treatments as lacking proof of effectiveness [2] [3] [4] [5] [6]. Yet, this critique itself needs to be viewed critically. The impression is that it follows a distinct purpose, may be far from justified and not necessarily reflects the best interest for patients.

Who says what science is?

Traditional Chinese Medicine and Ayurveda, beside others, are folk medicines that have withstood the test of time, and are in use since 2000 to 3000 years, treating their patients successfully with a holistic view of healthcare and disease [4] [7]. Only very recently, compared to the time-span of existence of the old folk medicines, came a novel, modern therapeutic approach, termed western medicine. This medical branch darted to the top, and became acknowledged as the principal approach to health care, having overtaken the older, traditional medical systems and having become, by implementation of frameworks and paradigms, largely the only form of patient health care acknowledged as scientific. The older, traditional treatment forms have increasingly, more or less successfully, been pushed into the periphery of medical practice, and are being discredited as being non-scientific according to the scientific standards that have evolved with the rising of this newer, allopathic treatment approach [4]. As such the newer western approach has become the conventional, allopathic medical system, and all other practices of medicine, the unconventional or alternative therapies [8].

The conventional approach demands all other treatment approaches provide evidence of scientificity of their practices, to be measured against those newly implemented conventional standards, in order to be acknowledgeable as safe treatment practice [4]. As such an evidence-based practice is sought to be created, whereby “individual clinical experience” is teamed “with the best available external clinical evidence from systematic research” [9](p.52). By insistence on this, practitioners of the allopathic medical route have over the years manifest their practice as the “superior” form of treatment, as scientific, evidence-based, against the methods of old that have been in practice much longer than the creation of the “young” allopathic medical concept, but do not meet up to the new scientific paradigm.

Viewed from a historical perspective, according to Riley [4], “the emphasis on science was intended to eliminate the unorthodox kinds of medicine” (p.552), to further modernization and improve the quality of medical practices. In his article Riley [4] demonstrates with the example of Thailand how, in particular from the USA, educational boards and foundations funded the establishment of orthodox medical schools and systems, seeking to promote digression toward the newer system of health care. In the consequence of such progression that took place in many countries during the colonization, as Riley mentions, an eradication of folk medical practices took place. This development was most successful in underdeveloped countries. In China and India, for example, this was less effectual, as the indigenous treatments there, TCM and Ayurveda respectively, had been successful since thousands of years without any dependence on scientific proof of efficacy [4].

CAM and science

The call for evidence of scientificity of the unconventional practices has in its persistence suggested that science is immediately a true fact and that consequently a therapy that is measurable by the scientific framework of conventional medicine, is equally as immediately a treatment that is efficacious [4]. This is not so. While it must be acknowledged that with the development and progression of science have come life-saving treatments that were yet unknown to folk medical practices, such as the identification and development of penicillin, it has to be noted that medical science has limits, and does not provide a cure-all for all diseases [4] [6]. In fact, the extent of “curing” disease under the label of medical science has been relatively small, the greatest praise having to be accredited to the improvement of hygienic conditions [4].

The demand for scientific evidence is flawed at the fundamental base-line of the claim, because, “although discrimination in the name of science is practiced, it is difficult to find an explicit basis for characterizing one specific medical system as more scientific than another” [4](p.549). Furthermore, there is lack of consensus as to what is to be considered as proof of evidence [5].

The notion therefore, that all therapeutic treatment approaches to health care, should be applicable to methods of allopathic testing and be thus supported by an evidence-base is unrealizable; too different are the underlying philosophies of the different disciplines [3]. Yet, to assume that the disciplines of CAM entirely lack evidence of efficacy is incorrect and to adopt the presupposition that the allopathic practices do is equally deceptive.

Investigations into the efficacy of CAM therapies have been and are problematic. Science follows the concept of a “materialistic causality” [3](p.669), and the CAM therapies fall short of fitting into the framework this concept of materialistic causality has generated. It appears that changes in the inherent world-view of the predominant scientific paradigm are necessary in order for the concept of CAM to be evaluable [10] [3]. The core of Sciences´ primary conflicts with the CAM practices, demonstrates dissonance of the conventional concept of standardization with that of individualization that is fundamental to the alternative, non-conventional practices [11]. As such therefore, the gold standard of the randomized controlled trial (RCT) as the principle tool for evaluation of efficacy of a treatment approach is rendered inapplicable, to investigations into holistic medical concepts of health [11].

Alternative therapies such as homeopathy, for example, have proceeded to adopt the testing methodologies inherent of conventional trials and studies, and are following the standard procedures as outlined by the Consort statement [13] (plus extensions [16]), but have extended investigations to include data specific of homeopathic treatment practice, by reporting on aspects that are outlined in the REDHOT guidelines [14].

While most trials and studies into CAM are undertaken with the focus of investigation being on the efficacy of the alternative treatment compared to placebo, Walach [5] insists that testing CAM therapies with the RCT should follow a different structure. He stresses that the holistic treatment is better tested against the efficacy of a treatment of another discipline as opposed to that of placebo. Riley [4] considers the placebo a bias to the claim of scientificity itself. “Placebos depend upon a patient`s (and perhaps a physician`s) belief that a therapy is likely to work” [4](p.556); a subjective experience, and therefore, science itself has an `unscientific´ aspect.

Is allopathy EBM?

Beside all the heated discussions and the persistent demand for evidence-based medical practices of CAM, one issue frequently receives little attention, namely, the extent to which the orthodox medical practices are in fact practicing what they preach and provide scientific evidence of efficacy. LaRiccia [8] and Patel [3] point out that few good quality trials exist that have investigated CAM therapies, but fail not to stress that this is likewise an issue in the evaluation of those practices described as evidence-based or scientific.

“Clinical Evidence comprises a database of high-quality, rigorously developed systematic overviews assessing the benefits and harms of treatments” [15](n.p.), and has proceeded to categorise the effectiveness of 3000 treatments with an astonishing and in fact shocking outcome. The data exhibited reflects to what extent treatments are evidence-based. The outcome of this categorisation has shown that a mere 11% of trials and studies show beneficial outcome, 23% are considered likely to be beneficial with the remaining 66% ranging from questionable, of unknown effectiveness, to ineffective or harmful [15].

Chart: http://clinicalevidence.bmj.com/x/mce/file/newchart20111028-1.jpg
Chart from: http://clinicalevidence.bmj.com/x/set/static/cms/efficacy-categorisations.html

 

This elevation draws into question the justification for the persistent and resolute demand for evidence of efficacy of CAM treatments. With so little profound evidence available from so called scientific medicine, the legitimacy of critique from the medical orthodoxy, concerning an insufficiently existent evidence base of the non-conventional practices, is questionable and appears shameful.

Why therefore, is the insistence on proof of efficacy of the CAM practices so persistently demanded, in particular from the conventional medical spheres? The reason becomes quite obvious if one takes into consideration the increase of interest in, acceptance of and use of CAM disciplines by ever increasing patient numbers. CAM has advanced to become somewhat of a threat to conventional medical practice [3].

The therapies of CAM are in existence because patients demand treatments outside of the conventional realm of medical practice [10]. Patients notice and experience that orthodox medicine has flaws [6]. They are not blind to the impact a course of treatment makes on them, to adverse effects or to the concomitant developments that frequently originate from the mainstream treatment of diseases.  Patients have become sensitized for their own well-being and health, and have therefore become critical of the handling of their discomforts and ailments [5] [6]. Consequently patients demand to be treated holistically, gently, alternatively.

Conclusion

Patel [2] stresses that an integrative approach to treatment may be most valuable to the patient.  He emphasizes that the factor `time of existence´ of a discipline is inappropriate as measure of efficacy, and that testing with standard scientific means is necessary for the acknowledgement of a non-conventional practice. Yet, he maintains that there are many challenges to such evaluation, and that CAM therapies should not aim at providing evidence of being a superior approach to healthcare. Rather should emphasis be on discovering “ the strengths and weaknesses of each system in order to be able to show that specific types of cases should be treated by specific holistic therapies, while other specific types of cases should be treated by scientific medical physicians” [2](pp.173-174).

If CAM practices were found to fully comply and be testable with the standard scientific methodologies, the alternative and non-conventional therapies would lose what makes them `different´. If CAM became scientifically standardised according to the orthodox scientific paradigm it would have to be incorporated into mainstream medicine and would consequently become conventional. The CAM practices would have to be reclassified, as specialities of conventional practice [10]. Is this at all favoured?

LaRiccia [8] points out that “the lack of RCT´s does not disprove a therapy”, and albeit Patel´s [2] call for CAMs compliance with the scientific methodologies of investigation, the traditional medical practices offer valuable concepts of health care. Practitioners cannot ignore the evidence of efficacy of a treatment that has been practiced successfully, and is documented by experience in practice, only on account of philosophical unacceptability within a fixed superimposed framework. It is the currently inexplicable that promotes investigation and has “in the past, been linked with significant scientific advances” [3](p.669).

References:

[1] Michlig, M, Ausfeld-Hafter, B. & Busato, A. (2008) Patient satisfaction with primary care: A comparison between conventional care and traditional Chinese medicine [online] article from Complementary therapies in medicine last accessed September 2012 at URL http://www.sciencedirect.com

[2] Patel, M. (1987a) Evaluation of holistic medicine [online] article from Soc. Sci. & Med. Last accessed September 2012 at URL http://www.sciencedirect.com

[3] Patel, M. (1987b) Problems in the evaluation of alternative medicine [online] article from Soc. Sci. & Med. Last accessed September 2012 at URL http://www.sciencedirect.com

[4] Riley, J. (1977) Western medicine´s attempt to become more scientific: Examples from the United States and Thailand [online] article from Soc. Sci. & Med. Last accessed September 2012 at URL http://www.sciencedirect.com

[5] Walach, H. (2009a) The campaign against CAM and the notion of “evidence-based” [online] article from The Journal of alternative and complementary medicine last accessed September 2012 at URL http://ehis.ebscohost.com

[6] Walach, H. (2009b) The campaign against CAM – a reason to be proud [online] article from The Journal of holistic healthcare last accessed September 2012 at URL http://www.ecpm-europe.ch

[7] Patwardhan, B. Warude, D, Pushpangadan, P. & Bhat, N. (2005) Ayurveda and traditional Chinese medicine: A comparative overview [online] article from Advance Access Publication last accessed September 2012 at URL http://www.ncbi.nlm.nih.gov

[8] LaRiccia, P. (2003) Point of view: A Physician´s experience with integrating complementary and alternative medicine: Opportunities, problems & directions [online] article from Seminars in integrative medicine last accessed September 2012 at URL http://www.sciencedirect.com

[9] White, B. (2004) Making evidence-based medicine doable in everyday practice [online] article from Family practice management last accessed September 2012 at URL http://www.aafp.org/fpm

[10] Chez A. & Jonas, W. (1997) The challenge of CAM [online] article from Am J Obstet Gynecol last accessed September 2012 at URL http://www.sciencedirect.com

[11] Yamey, G. (2000) Can complementary medicine be evidence-based? [online] article from West J Med last accessed September 2012 at URL http://www.ncbi.nlm.nih.gov

[12] Huffard, D. (2003) Evaluating complementary & alternative medicine: The limits of Science and Scientists [online] article from Journal of Law, Medicine & Ethics last accessed September 2012 at URL http://onlinelibrary.wiley.com

[13] Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. (http://www.consort-statement.org)

[14] Dean, M., Coulter, M., Fisher, P., Jobst, K. & Walach, H. (2007) Reporting data on homeopathic treatments (RedHot): A supplement to CONSORT [online] from The Journal of alternative and complementary medicine last accessed September 2012 at URL http://www.audesapere.in

[15] BMJ (2012) What conclusions has Clinical Evidence drawn about what works, what doesn´t based on randomised controlled trial evidence? [online] article from Clinical Evidence last accessed September 2012 at URL http://clinicalevidence.bmj.com

[16] Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, for the CONSORT Group. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial. BMJ 2010;340:c869. (http://www.consort-statement.org)

The controversial integration of Homeopathy into Conventional medical systems

The increasing demand for alternative and complementary medical treatment requests further discussions on the integration of CAM into conventional primary health care. The existent controversy concerning safety, lack of proof of effectiveness of the alternative therapy and in certain cases the absence of a regulatory body [1] [2] [3], have in the past raised heated discussions against the integration of CAM. But the increased interest of the public is impacting on the `conventional´ consultations, resulting in alterations of many a general practitioners stance toward CAM [3]. Patients´ quest for more autonomy in their health management, a fear of adverse reactions and the awareness of limitations to the allopathic treatment, has led patients to self-medication with alternative remedies and to dispense on private visits to CAM practitioners, outside the health system [3] [4]. Beyond that it is the congruence of the alternative approach to patients´ most personal beliefs and values, and the knowledge of a safe and effective treatment that is at the same time cautious of the patients´ orientation toward leading a healthy life [5] that has increased the awareness and acceptance of CAM therapies. General practitioners have recognized this trend, since they are often the first contact patients turn to for information regarding alternative therapies, and have attempted to adapt to this new tendency. Many that would in the past have had inadequate knowledge of the alternative and complementary methods have done training, permitting them to provide sufficient information about the alternative treatments available and the possible effects to the patients´ specific ailment [1] [2] [3].

One major step toward the integration of CAM is communication. This applies both to the practitioner-patient relationship and the cooperation between general practitioner and CAM-provider [3] [5] [6]. The need for collaboration between the two strands of health care practice is evident and could permit understanding and acceptance, resulting in an efficient service meeting patient requests [6].  Referral to CAM-practitioners usually occurs where a wider range of treatment options is sought to be available to patients, and where allopathic treatment has been ineffective or has brought forth adverse reactions and side-effects [1]. For the general practitioner to be able to respond significantly to patients´ interrogations, about alternative and complementary methods of treatment, requires handing the power of individual and personal decision making, back to the patient. As such it is assured that the ethical principle of autonomy is met and one essential point for successful integration of CAM into health care is fulfilled [2] [6]. Non-maleficience is another ethical factor that is thoroughly questioned when discussing integration as there is a lack of agreement over the scientific evidence of available CAM therapies [1] [7]. Available evidence of the effectiveness of CAM practice has already suggested a legitimate incorporation into primary health care but is still questioned due to the differences to conventional practice such as conception and interpretation, context of health and ailment, as well as the deviation in the relationship to science [2].To the general practitioner the CAM therapies are often still a challenge, because here practice is taking place in a zone that lies outside of the boundaries of conventional health care, in an area where the general practitioners training may not fully permit him to accept and understand the restricted but growing scientific body of evidence available [3] [7].

It has also been questioned if integration of CAM into conventional health care is, beyond questioning the feasibility of it, at all to be aspired [2]. Profound alterations could occur if evidence-based CAM treatments were fully integrated. By repressing CAM into the boundaries of conventional practice, CAM may be altered in its foundations, becoming standardized, resulting in the loss of it as an alternative option, and a merging of the two health strands beyond the identifiable features of CAM-practice [2]. Pro integration stands another factor, that of the financial aspect. CAM practice has been identified as being potentially cost saving in the long term, since expensive conventional treatments could be avoided and repeat consultations may be reduced. Arguments opposing this are of increased NHS spending on CAM, fearing the possibility of reduction of monetary funding and expenditure on other sectors of medical care [3]. Constituting a major factor opposing integration is the scientific evidence and the lack of research into CAM therapies [1] [2] [3] [5] [6] [7]. Ernest et al [6] go as far as to claim no reliable risk-benefit assessment can be undertaken in CAM to confidently confirm beneficence is greater than the risks possibly associated to CAM treatment. Controversy here exists, as funding for further research that could provide evidence for the safety and efficacy of CAM, usually goes into other sectors of medical research where existent evidence already promises efficient results for the justification of the research to be conducted [6].

In summary there needs to be said that for a successful integration of CAM into conventional health care practice, general practitioners are required to have a basic knowledge, from reliable source, of the CAM therapies that are available [1] [2] [3] [5]. There is the requirement for clear guidelines concerning referral and administrative issues [5]. Referral and cooperation with CAM practitioners has to be reliable, safe and efficient [1] [6]. From the point of view of the CAM practitioner, he needs to continually expand his knowledge in his field and should be prepared to seek assistance and advice on medical issues outside of his field from a general practitioner [1] [5].  For the cooperation of both the CAM provider and the general practitioner there is the need of intensive communication [3]. Conventional diagnosis prior to CAM treatment is an advisable feature of integration [1] and the interaction should result in CAM complementing general practice and vice versa conventional treatment supporting CAM for a successful integration to take place [5].

[Many thanks to Ian Townsend, University of Central Lancashire, U.K., for his assistance with this assignment]

References:

[1] Grace, S., Velmupad, S., Reid, A.,Beirman, R. 2007 CAM practitioners in integrative practice in New South Wales, Australia: A descriptive study [Online] last accessed 27.01.09 at URL http://www.sciencedirect.com

[2] Kerridge, I., McPhee, J. 2004 Ethical and legal issues at the interface of complementary and conventional medicine [Online] last accessed 26.01.09 at URL http://www.mja.com.au

[3] Maha, N., Shaw, A. 2007 Academic doctors’ views of complementary and alternative medicine (CAM) and its role within the NHS: an exploratory qualitative study [Online] last accessed 06.02.09 at URL http://www.biomedcentral.com

[4] Dumoff, A. 2004 Legal issues presented by integrative health care practice [Online] last accessed 27.01.09 at URL http://www.sciencedirect.com

[5] Frenkel, M., Borkan, J. 2003 An approach for integrating complementary-alternative medicine into primary care [Online] last accessed 07.02.09 at URL  http://fampra.oxfordjournals.org

[6] Ernst, E., Cohen, M., Stone, J. 2003 Ethical problems arising in evidence based complementary and alternative medicine [Online] last accessed 21.12.08 at URL http://jme.bmj.com

[7] Adams, K., Cohen, M., Eisenberg, D., Jonsen, A. 2002 Ethical Considerations of Complementary and Alternative Medical Therapies in Conventional Medical Settings [Online] last accessed 26.01.09 at URL http://www.annals.org

In a nutshell…..Intercurrents

According to a dictionary definition an intercurrent is something that occurs” during or in between” two events. In medical terms it applies to a “pathology occurring during the course of another disease” [1]. This appears to be a very simple definition but in application of homoeopathic treatment the issue is slightly more complex.

Koehler [2] in “The Handbook of Homoeopathy” describes an intercurrent as an intermediary drug used for a patient where the best selected drug does not achieve a permanent cure. Yasgur [3] points to its ability of providing motion in a halted case, while Farrington [4] pronounces its efficacy in bringing the indications for a follow-up prescription to the foreground, and restricts its usage to times when the patient has only shown little reaction to the initial prescription.

So, one could say an intercurrent is a tool to apply if one seeks to identify the underlying aspects of a disease, that have not been touched by the previous, well-chosen homoeopathic prescription.

Hahnemann [5] mentions in Aphorism 234 of the Organon that in non-febrile morbid conditions and recurrent fevers homoeopathic China has been a useful intercurrent. Opium also served well for this purpose.

In the `Encyclopedia of remedy relationships in homoeopathy’, Rehman [6] describes intercurrents as “reaction-remedies”, coming into effect if there was no, or little action of the initially administered remedy. He also states their use as interim remedies between two adversary or incompatible remedies. Such remedies should not follow up on one another, and therefore require an intermediary prescription. This may be the case for example, where Hepar sulf. is to follow onto Mercurius sol. or Silicea, or where Nux vom. is needed to complement Causticum or Phosphorus. Rehman [6] also praises the application of the intestinal-nosodes as Intercurrents for the purpose of unravelling a case. He states that these nosodes make the previously administered remedy spur into action. The intestinal-nosode itself has no effect other than the unravelling of the symptom-jumble.

The use of intercurrents has to be differentiated further, as there are acute and chronic applications. Schepper [7] points to Aphorisms 36 to 40 for the use of intercurrents in an acute case. Here the intercurrent remedy is used to to treat the acute crisis of a case. If a chronic prescription were made in such a case, the symptom picture of the patient could be altered and undesirable aggravations could be the consequence. Therefore an acute intercurrent in a chronic case is selected by only taking into account the prominent acute symptoms and not the deeper chronic case history. As such, the acute intercurrent is a superficial agent that is used to remove the influence of the acute disease, without having an impact on the constitutional treatment of the chronic case. Hahnemann [5] describes this in Aphorism 221 of the Organon: The constitutional/chronic treatment has to stop when there is an acute crisis. Once this acute intermediate state is over, the chronic one will continue.

According to Little [8] in the chronic case an intercurrent is frequently necessary where miasmatic interference is present in the case. Here the symptom picture may be unclear, or symptoms may be scarce. Once an intercurrent has removed the miasmatic layer, symptoms may show more clearly and an appropriate constitutional remedy selection may be possible. Koehler [2] describes this with relation to the remedy Tuberculinum. As an intermediate remedy, Tuberculinum is indicated where symptoms remain after the first prescription, and the symptom-totality expresses a specific miasmatic taint.

References:

[1] The free dictionary(2012) Intercurrent last accessed 15 May 2012 at URL http://www.thefreedictionary.com

[2] Koehler (1989) The Handbook of Homeopathy Vermont, Healing arts press.

[3] Yasgur, J. (2003) Homeopathic Dictionary New Delhi, B. Jain Publishers (P) Ltd

[4] Farrington, H. (n.d.) Homeopathy and homeopathic prescribing New Delhi, B.Jain Publishers (P) Ltd

[5] Hahnemann, S. (1974) Organon der Heilkunst (2.Auflage) 6B Heidelberg:Karl F. Haug Verlag.

[6] Rehmann, A. (2000) Handbuch der homöopathischen Arzneibeziehungen Heidelberg, Karl F. Haug Verlag

[7] Schepper, Luc de (n.d.) Using Acute Intercurrent or Intermediate Remedies in Chronic Diseases last accessed 15 May 2012 at URL http://www.drluc.com

[8] Little, D. (2007) Part 2: The chronic Intercurrents last accessed 15 May 2012 at URL http://www.simillimum.com

The Dilemma with Ethics

Within the health care profession, as practitioners, we find ourselves in a sector that is subject to the most intensive and sensitive regulation. We are entrusted with the highest good of all, the life of human beings. This confidence in our credentials requires sincere monitoring, directing, and legislative and ethical boundaries. We are dealing with a patients´ most vulnerable existence, illness, a state when his vitality is weakened by imbalance.  Whether practicing in general medicine or complementary and alternative fields, we are all dealing with this highest good and have to prove our worthiness and are required to abide to the rules that assure the patients security.

Samuel Hahnemann laid out the initial rules of professional practice in the field of homeopathy, in his first aphorisms of his Organon [1]. Aphorism 1 states that it is a practitioners´ highest good and only profession to retrieve the sick man from illness and render healthy again. Aphorism 2 then tells us that the highest ideal of curing is to do it quickly, gentle and such that the healing is of permanence. We are to remove and abolish in entirety the disease and are to do this most rapidly, reliably and following precise, comprehensive motives. These words can well be translated into our times and are contingent to many professional codes of the health practices, ever since first pledged in the oath of Hippocrates [2]; and today manifest in the declaration of Geneva [3]. These phrases constitute the ethical principle of beneficence.

Beneficence, whether to the allopath or the homeopath, in practice, means the same thing; that it is our duty to our patients, to act in their best interest and to do good [4]. But at the same time of laying out an ethical boundary for the practitioner, it is here perceivable that these boundaries are liable to flexibility. Because, with Beneficence, what is good for the patient is left to be declared by whom? Is the practitioner competent enough to explain to the patient all aspects of a therapy such that he, the patient can make the decision for or against a therapy himself? Is the autonomy, the ability of the patient to actively make his own decisions [5], at all times sustained with the patient? What about non-maleficience, that requires us to do no harm to our patients [4]? With vaccinations, for example, patients are receiving injections of a harmful nature. Is the general practitioner committing non-maleficience?

For a general practitioner abiding to the code of ethics seems slightly more complicated than it is for the homeopath. What if the general practitioner has to treat a patient that is brought into his care unconsciously [6]; who decides on beneficence and where does that leave autonomy? An overall rule that needs to be followed is that whatever a practitioner decides on, the benefits of a treatment have to outweigh the risks.

In homeopathic practice, to fully explain to the patient all aspects of homeopathy and all effects that a remedy reaction may bring forth would exceed the time available for a consultation. So are we practicing unethically? We cannot possibly provide all information that there is. But we are required to provide enough information for our patient to understand and be able to make an autonomous decision [7].This decision the patient then makes has to be respected, even if it should, to our beliefs, be inappropriate to the patients´ positive health development. We are complying with the principle of autonomy. But it is here that beneficence and autonomy may clash. Especially in general medicine, this clash is apparent, so for example where patients need, yet refuse to have a blood transfusion because their religious believes prohibit them to [8]. In order to protect the practitioner it is therefore, important to have the patient sign a consent form where he declares his abstinence from treatment or therapy. Likewise if the patient wishes to proceed with a treatment, in order to protect the practitioner, the former should have to sign a form of contract where he declares his approval and understanding of the procedure and the possible consequences [5].

Where such “contracts”, or consent forms, have not been signed, from a legislative aspect, a practitioner may be exposed to claims of civil liability. This may also occur where tort of negligence of the practitioner towards the patient is claimed. But to be proven guilty of negligence the principles of negligence must have been violated. 1. To owe a duty of care, 2. To breach that duty,3. This breach of duty must have caused the damage complained of [9].

What about ethical justice? Are we able to provide our services to everybody on equal terms [5]? The diverse health systems of many countries have shown us that this is impossible. We already have medical systems today that at the most provide essential medicinal services rather than fulfil the necessary requirements [10]. The discrepancy in the health care system lies in deep confrontation to the ethical principle of justice which states that all patients have to be treated equally and have to be given access to the same resources [5]. Therapies of complementary and alternative practice though are not integrated into the health care systems and have to be disbursed privately by the patient and are therefore not obtainable for every patient. From this point of view justice is not met.

The issue of ethics is not a simple one and it is evident that stretchable boundaries are necessary. To assure that these boundaries are maintained, a health care professional is a member of a board or society monitoring professional practice within the practitioners´ field of competence. Ethics is the code of behavior that guides our actions in our professional environment [11]. To abide by these rules is essential for any practitioner in the health care sector. What is important to remember is that at all times the benefit has to outweigh the risk.

So can we as homeopaths, meet the ethical demands that our professional body codified for us, fully and at all times? We have to attempt to fully comply, but have to accept and be aware of the fact that the ethical principles overlap and their restrictive boundaries are slightly flexible.

[Thanks to Jean Duckworth, University of Central Lancashire, for assistance with this assignment]

References:

[1] Hahnemann, S., 1974. Organon der Heilkunst. 2te Auflage. Heidelberg: Karl F. Haug Verlag.

[2] Bauer, A., Anon. Der Hippocratische Eid [online] last accessed 24 January 2009 at URL http://www.rzuser.uni-heidelberg.de

[3] Jones, D., 2006. The Hippocratic Oath II [online] last accessed 09 February 2009 at URL http://www.catholicdoctors.org.uk

[4] Pantilat, S., 2008. Beneficence vs. Nonmaleficence [online] last accessed 05 February 2009 at URL http://missinglink.ucsf.edu

[5] Swagerty, D. Anon. Ethics: Terms [online] last accessed 10 February 2009 at URL http://classes.kumc.edu

[6] Davenport, J. 1997. Ethical principles in clinical practice [online] last accessed 05 February 2009 at URL http://xnet.kp.org

[7] Ernst, E., Cohen, M., and Stone, J., 2003. Ethical problems arising in evidence based complementary and alternative medicine [online] last accessed 19 January 2009 at URL http://jme.bmj.com

[8] Gardiner, P., 2003. A virtue ethics approach to moral dilemmas in medicine [online] last accessed 07 February 2009 at URL http://jme.bmj.com

[9] Duhaime, L., 2006. Negligence an Introduction [online] last accessed 07 February 2009 at URL http://www.duhaime.org

[10] Schulz-Ehring, F., Weber, C., 2008. Zwei-Klassen-Medizin [online] last accessed 24 January 2009 at URL http://www.pkv.de

[11] Fieser, J., 2006. The Internet Encyclopedia of Philosophy [online] last accessed 10 February 2009 at URL http://www.iep.utm.edu

To swallow or not to swallow…that is the question!

Abstract

A high degree of satisfaction is reported by patients of the homeopathic approach to health care [11]. Hahnemanns [10] postulations in Aphorism 2 of the Organon insist on a treatment that acts “in the shortest, most reliable and least detrimental of ways” (p.35). The routes by which remedies are administered can influence patient satisfaction with a regimen.

Central to this essay lies the question of the efficacy of the oral transmucosal remedy delivery over the oral swallow method. It is a common belief that, in homeopathic practice, an administered remedy needs to be dissolved on or under the tongue, such that absorption of the active properties via the oral mucosa is established. A survey has been conducted amongst practicing homeopaths evaluating their beliefs and experiences. The alternative routes of remedy delivery and the prevalence of the oral route have been identified via a second survey undertaken amongst suppliers of homeopathic remedies in 4 European countries.

The survey results have emphasized that the oral route of remedy administration has predominance over other routes of remedy delivery. Furthermore the outcome has clearly shown that the efficacy of a homeopathic remedy is believed not to be impaired if it is administered via the oral swallow route, without prior contact to the oral mucosa. The research of relevant literature has identified the homeopathic routes of administration as rated high in patient convenience and satisfaction.

In conclusion to the results of the surveys undertaken, it can be said that in future homeopathic practice the custom of supplying instructions of remedy administration to the patient can be facilitated immensely. Consequently, this may lead to increased patient compliance with the regimen. Further research is suggested.

Keywords: oral, swallow, transmucosal, routes of administration, convenience, compliance, satisfaction, homeopathy

Introduction

In the existing market economy that we have in the western world today, health care is increasingly being viewed as any other commodity that is demanded and supplied. With this development consumer satisfaction is augmented in value [18]. A patients´ satisfaction is influenced by aspects surrounding care and treatment, and may be decisive of acceptance and compliance with approaches that consequently may impact on the outcome of a therapeutic intervention [1].

The “empathic interaction with the health provider” [18] (p.377) is equally as important to the patient as are aspects such as the satisfaction with medication. The latter may influence the correct and continued intake of medicines and may ensure compliance with the prescribed regimen [1], [8], [25].

Besides the expected efficacy of medications, patients decisions are influenced by side-effects in relation to their medicine intake, the dosing regimen prescribed, the dietary restrictions associated and the routes of administration by which the medicinal substance is delivered into the patients system [8], [25]. The more convenient a drug delivery is, the better the patient feels in terms of compliance [5].

This paper aims to critically evaluate the routes of administration used in homeopathic prescribing. The deconstruction of the beliefs surrounding the oral-transmucosal route of remedy administration is sought to be refuted via the evaluation of available literature. The results of two surveys that have been undertaken are meant to deliver a re-constructive conclusion of the oral-swallow administration as a viable route for homeopathic remedy delivery.

 De-constructing the oral – mucosal route of administration

In conventional medicine the oral route of administration is the predominant method of drug delivery [24]. It is “the most convenient, inexpensive and safest route” [5] (p.197). The majority of drugs administered, whether in solid or liquid form, are being delivered into the body via the digestive system. What is taken in orally and swallowed is “absorbed into the blood system from the gastro-intestinal tract” [3](p.1398). For this purpose tablets, pills and capsules have to be produced in forms that withstand the exposure to the acidic environment of the stomach [2], the passage through the hepatic metabolism and rapid decomposition in the intestines [2], [3], [7], [24]. If this cannot be overcome, the exposure of the drug to the patients system in the digestive tract is diminished [3] and not enough active ingredient can be retained for the expected medicinal purposes of the drug to take action [5].

In my homeopathic practice, I have primarily made use of the `other´ oral route of drug delivery. I recommend to my patients, to allow dissolving on or under the tongue of the homeopathic tablet, pill, or granule such that the remedy may be absorbed through the mucosal lining of the mouth. The sub-lingual, gingival, buccal and soft-palatal mucosa are, according to research in allopathic medicine, the sites of the mouth where medicinal substances may best be absorbed into a patients’ system [24]. Hereby the above mentioned difficulties of degradation in the digestive tract are avoided, but exposure to drug substance is short and the drug action may be interfered by drink, food and other irritants that are absorbed through the mouth [24], [25]. Carlston [4] and Schütt [23] point this out for homeopathy and recommend that certain foods should be avoided directly before and after a remedy is allowed to dissolve in the mouth.

Although Hahnemann [10] suggests in the Organon (Aph.259 & 260) that obstacles to the cure, dietary and of regimen that could have a medicinal effect, are to be removed from the patient, no evidence could be found of Hahnemann being as precise as Carlston [4] and Schütt [23] above are. Hahnemann also does not suggest the inefficacy of a remedy if it is exposed to the acidic environment of the digestive tract. In fact, Hahnemann in Aphorism 284 describes the stomach as site of absorption, suggesting that he did not expect remedial action to be diminished if a remedy had been swallowed without prior contact to the oral mucosa.

From the Organon [10] it could not be extrapolated that Hahnemann explicitly insisted on the oral-transmucosal remedy delivery. Hahnemann [10] speaks in the Organon of “Gabe”, what is best translated as `administration´ [14]. In the Footnote to Aphorism 247 Hahnemann [10] employs the term “einnehmen” which refers to `ingestion of´ [15]. In Aphorism 272 he describes to the homeopath that a “granule placed dry on the tongue, is one of the smallest administrations for the less severe, only recently developed cases of disease” [10] (p.158). He goes on to point out that as such, only few nerves are touched by the medication. Further he describes that if the granule is dissolved in water and is prior to repeated ingestion succussed; a much stronger medication is created of which even the tiniest dose comes into instant contact with many nerves [10]. Yet, this also does not deliver indications for a definite necessity of transmucosal absorption.

This raises the question if the practice, of keeping the remedy in the oral cavity for transmucosal absorption is at all necessary. Many authors [4], [6], [13], [21], [23] suggest this as an explicit necessity for the remedy to be able to unfold its healing action.

Consequently, more questions have arisen. In what form are remedies most prevalently prescribed? What are the beliefs of practising homeopaths? Is it necessary to allow the remedy to dissolve in the mouth or is it also effective if swallowed? What other routes of administration are being used in practice?

Questions and answers – Survey 1

In a quest to answer those questions, two colleagues and I forwarded a questionnaire to fellow homeopaths on two homeopathic social networking sites, asking them to share their experiences and beliefs of the efficacy of oral-swallow versus oral-transmucosal remedy absorption and other routes of administration they used in their practice. The outcome was interesting.

Table 1

Table 2

As can be extrapolated from table 1 all homeopaths that replied to the questionnaire use the oral route of administration of remedies. 70% also used topical, 20% olfaction and 10% other forms of remedy delivery, namely playing with/holding of the closed vial. In table 2 is shown that 89% of homeopaths believe that if a remedy is swallowed, without prior dissolving in the mouth, it is still effective. 11% oppose this belief and state that swallowing is not effective.

Survey 2

A second questionnaire was formulated that was sent to suppliers of homeopathic remedies in the U.K., Germany, Austria and Switzerland. Here it was of interest to us to identify the greatest demand for and supply of different remedy types. Of 11 companies that were contacted, 10 replies were received in time for inclusion in this paper. The following table shows the companies contacted:

U.K.AustriaGermanySwitzerland
HeliosRemediaWeledaOmida
FreemansSpagyraAlceaSimilisan
Ainsworth Staufen 
  DHU (*) 

(*) the reply from the DHU, came too late for inclusion in this paper.

Chart A: Suppliers contacted

In the U.K. the main remedy forms supplied are tablets and pillules, in Austria and Switzerland it is granules, whilst in Germany granules, liquid, and tablet are greatest in demand. Austria and Switzerland have producers that supply Collyria of homeopathic remedies. Only in Germany are remedies available as injections. Crèmes and Suppositories / Pessaries are in supply in all four countries. The greatest variety of homeopathic remedies forms is available via suppliers in the U.K.. It is interesting that in the U.K., Tablets and Pills are the predominantly purchased forms of remedy, while in continental Europe granules are highest in demand.

What becomes evident is that the oral administration has predominance in homeopathy. The highest demand is for remedy forms that are delivered via the oral route of administration.

There is a demand for homeopathic remedies in the form of injections in Germany, an invasive route, belonging to allopathic medicine that is low in patient compliance [1] and much in opposition to the gentle homeopathic approach postulated by Hahnemann [10]. In survey 1, of homeopaths in practice, this route could not be identified as one common to the field of homeopathy. It requires therefore to be pointed out that Staufen is a producer of homeopathic products and of spagyria, and Weleda a supplier of homeopathic and anthroposophic remedies. It could not be identified whether injections were of a greater quantity in use for spagyric and anthroposophic treatment or classic homeopathic use.

In their response `Staufen´ point out that the increasing demand of granules may be down to self-medication of the public with homeopathic remedies, while the demand for injections reflects a pure practitioner demand [20].

The replies also showed that there are other sites of transmucosal drug passage used in practice. These may be the nose, eyes, rectum, and vagina [3], [24]. The demand for remedies in the form of Collyria, pessaries and suppositories, shows that homeopaths also use these routes of administration.

Below is a table that illustrates the quantitative differences in the demand for certain remedy forms. As not all suppliers have shared numeric data, the graph contains only the data of those that have. I have only included 3 product items for each supplier.

Chart B: Approximate quantities supplied

What becomes visual in this chart is the great prevalence of oral solid remedy forms over oral liquid forms. Chart b also provides an idea of the quantities demanded of other remedy forms that are not visually shown in this graph. They are very low.

Reconstruction – The other routes of administration

The results extrapolated from the surveys, and the lack of evidence insisting on the oral-transmucosal remedy administration, have shown clearly that the efficacy of homeopathic remedies is believed not to be reduced if administered by swallowing.  At the same time the evidence for the requirement of precautions and restrictions ultimately before and after the intake of remedies is absent in the principal homeopathic literature. Hahnemanns [10] exclamations made in the Organon relate to the intake of substances with medicinal effect only (Aph.259 & 260), and he does not make any restrictions as to time, such as before and after remedy intake. This may remove, in future practice, the directions of remedy administration supplied by practitioners to their patients and narrows the general restrictions frequently given by the practitioner; a development Hahnemann [10] much criticized in followers of homeopathy (Aph.260). Thus convenience for the patient is augmented.

Alternative methods of administration are being used by practicing homeopaths, as can be seen in table 1. Taking into consideration the results visualized in chart B, the use of these is relatively small. Within the Aphorisms of the 6th Organon there is little mentioning of other routes by which remedies could be delivered. Only in Aphorism 284 does Hahnemann [10] describe sites of absorption other than tongue, mouth and stomach, mentions olfaction and inhalation and points out that the skin is also appropriate for remedy administration especially if concomitant to the oral intake of the remedy.

Of the alternative routes, topical administration finds greatest mentioning in the 6th Organon and is further described in Aphorism 285, and the footnote of Aphorism 282 in the case of Warts. There is supply of topical applications by 7 of the 10 suppliers of homeopathic remedies interrogated for our survey and table 1 shows that this route is one chosen in practice by 70% of homeopaths. According to Atkinson et al. [1] oral and topical administrations in conventional medicine are rated by patients as of highest satisfaction and convenience.

In Aphorism 272, as mentioned above, Hahnemann [10] describes the single granule dry on the tongue as the smallest dose, and in `The Chronic Diseases´ he also says this of “moderate smelling of an open vial” [16].

According to Little [17] alternative routes of administration may become necessary, where a remedy cannot be given orally, so for example if a patient is unconscious, or as McKay [19] describes, if patients are “in their final stages of life” (n.p.), when the open vial can simply be held under the sleeping patients nose to allow administration via inspiration. Also with children and infants this is an effective alternative form of remedy delivery [19]. Little [17] points out that in the 5th Organon (Aph.288) Hahnemann describes in detail how inspiration via mouth or nose can be used to deliver the remedy and further explains that it may even suffice for the sensitive patient to hold or touch the closed remedy vial. This is being practiced by 10% of homeopaths who replied to our questionnaire (Table 1).

An indirect delivery method Hahnemann [10] goes on to describes in Aph. 284. Here the remedy for the ill baby is to be given to the breast feeding mother. The child will consequently receive the remedy via the breast-milk [10].

Homeopathy is a person-centred approach that values the totality of the patient and respects the patients´ individuality [11]. As such the methods of remedy delivery offer a wide range of routes to be used to the patients convenience and best compliance. Kayne [13] points out that in conventional medicine the therapeutic efficiency is the prime determinant of the form in which a drug is delivered. In homeopathy the choice of form of remedy is one dependant on patient convenience solely [6], [13]. The same applies to the routes by which drugs are delivered [9].

Conclusion

In conclusion it can be said that improvement of methods of administration is not relevant to the practice of homeopathy. Hahnemann propagated different routes of remedy delivery ever since the creation of homeopathy [23]. The results of the above surveys have indicated that the oral route of delivery is by far the most extensively employed route of administration and that homeopaths in practice have a marked preference of using remedies in solid forms. The common belief that remedies need to be kept in the mouth and be allowed to dissolve has not been affirmed in practice as our survey has shown. Efficacy is maintained even if a remedy is swallowed.

The outcomes of the surveys and the preceding literature search have helped to identify the homeopathic method of remedy delivery as one of increased convenience and compliance to the patient. These routes, as postulated by Hahnemann [10], are non-invasive and adaptable to patient request and preference. By Hahnemanns own words in Aphorism 2, a homeopathic treatment should lead to “fast, gentle and durable recovery to health or elimination and annihilation of disease in all its complexity, in the shortest, most reliable and least detrimental of ways” [10] (p.35).

As much as convenience of the homeopathic methods of remedy delivery may receive high ratings of satisfaction and compliance by the patient, one problem may remain. There may be scepticism towards the efficacy of some of the alternative routes of administration of homeopathic remedies. Patients may doubt efficacy when the homeopathic practitioner insists that smelling a remedy may suffice for the expected healing action to take place [12]. Likewise it may be viewed rather sceptically if it is suggested to simply hold the closed vial [17]. Belief in the efficacy of these routes may be frail, despite the trust in homeopathy as an effective therapeutic approach.

It needs to be pointed out that further research to verify the efficacy of the oral swallow administration in homeopathy is relevant. The representativeness of survey 1above, reflecting the experience of practicing homeopaths, is very low as participation was only approximately 4.2 % of all homeopaths to whom the questionnaire was made available. For further research it can therefore be said that a social networking platform appears inadequate for the appraisal of a survey, even if, as in our case, the focus of the sites our questions were posted on was strictly homeopathic.

Acknowledgements

Many thanks to Rehana B. Issat for the assistance with the surveys used for this assignment and the presentation associated.

[Thanks to Hazel Partington and Jean Duckworth, University of Central Lancashire, for assistance with this assignment]

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