Friday, October 23, 2009

From Indigenous Medicine to Integrative Medicine

In the span of three centuries, the indigenous medical practices of the world have gone through a complete cycle of fall and rise to reemerge in the new millennium as an indispensable component of a budding concept of integrative medicine.

Before 1750 CE, indigenous medical practices flourished in various parts of the globe. Ayurveda is one of the oldest codified medical traditions in the world with an impressive evolutionary history and an unbroken tradition spanning a time frame of more than 2000 years.

In the18th and 19th Centuries CE, scientific medicine emerged on the scene and began to advance in leaps and bounds, even as the scientific method gained universal acceptance. In the process, indigenous medicine became relegated as ‘proto-scientific’, ‘pre-scientific’ or ‘primitive medicine’. Consequently, state patronage was subsidized and the circumstances became unfavorable for the practice of indigenous medicine.

In the first part of the 20th Century CE, scientific medicine attained the status of cosmopolitan medicine. Albeit steps were taken to promote indigenous medicine in India after independence, step motherly treatment prevailed. However, indigenous medicine survived the scientific challenge and unfavorable circumstances to function silently in the background.

In the second half of the 20th Century CE, scientific medicine continued to progress, but remained out of reach of a large section of humanity esp. in developing countries. In 1970s WHO recognized the need to promote indigenous medicine in the name of Traditional Medicine (TM) to achieve the goal of self sufficiency in the field of Primary Health Care (PHC) in the developing countries.

In the second half of the 20th Century, despite making path breaking progress, scientific medicine failed to meet the health care requirements in developed countries too. People of the prosperous nations, paying out of pockets, turned to alternative modes of healing, which came to be collectively known as CAM (Complementary and Alternative Medicine)

In this scenario, National Institutes of Health, USA constituted then CAM (National Center for Complementary and Alternative Medicine) to monitor the safety, efficacy and quality of TM/CAM practices. Under these circumstances, Ayurveda emerged into prominence in the global scenario under the umbrella term TM/CAM. In the 21st Century, WHO and NCCAM have evolved 5 year plans to regulate the practice of TM/CAM. The strategy is to assimilate the useful and effective TM/CAM practices into mainstream medicine to create a new system of integrative medicine.

Changing perceptions on indigenous medical practices

In this process, the perceptions on indigenous medical practices have oscillated between the extremes of uninformed skepticism and uncritical enthusiasm. In the1970s, the survival of indigenous medicine was attributed to the inability of scientific medicine to trickle down to all sections of the society in developing countries due to political and economic reasons. Traditional Medicine (TM) was welcomed as an ad hoc arrangement to deliver primary health care till scientific medicine could reach out to the grassroots level.

However, the emergence of TM in the1990s in developed countries demanded a better explanation. It was pointed out that public disappointment that cosmopolitan medicine cannot guarantee happiness nor wholly eliminate disabilities of degenerative diseases as well as the potential danger of modern drugs led to revival of TM and adoption of medical cults in developed countries. TM came to be known as Complementary and Alternative Medicine (CAM) in the developed countries. The initial response to resurgence of TM/CAM was very conservative and cautious. The judgment was that TM/CAM served as a belief system for people with solution less problems to fall back upon to get psychological support.

It was pointed out that TM/CAM does not compete with scientific medicine as it is resorted to only for problems which scientific medicine cannot handle. Moreover, such patients typically had a bad prognosis or severe organic functional disability or a major psychological component and were deeply unhappy. The scientific establishment dismissed TM/CAM as cults because they were characterized by absence of scientific thinking, naive acceptance of hypotheses, uncritical acceptance of causation and reliance on anecdotes, assumption that if recovery follows treatment, it is due to the treatment (post hoc ergo proper hoc fallacy) and over emphasis on patient’s personal feelings to judge the outcome of treatments.

The persistence of TM/CAM in the eve of the 21st century and its encroachment into certain strongholds of scientific medicine forced a re-evaluation of TM/CAM. For example, in US, visits to CAM practitioners increased by47 percent, exceeding visits to MDs by 243 million. Conservative estimates put expenditures for alternative medicine professional services at $ 21.2billion in 1997, with at least 12.2 billion paid out of pocket. Americans spent more out of pocket for CAM than they paid for all hospitalizations.

TM/CAM is looked at with better understanding today. It has been realized that longer life expectancy has increased the incidence of chronic debilitating diseases and that CAM offers gentler means to manage such diseases. TM/CAM provides safer alternatives to adverse effects of chemical drugs. It has been also realized that many of the approaches and assumptions of scientific medicine are questionable. On top of it all, randomized clinical trials for use of acupuncture, herbal medicines and manual therapies have evinced a new interest and open mindedness in the scientific community.

Prospects of TM/CAM in the 21st century

As we step into the new millennium, the Government is under pressure to formulate policies to regulate the practice of TM/CAM. At the same time, people are looking forward to gain access to reliable information on TM/CAM to take informed decisions. There is an urgent need to prevent commercial exploitation in the name of TM/CAM by spreading awareness. The onus is on motivated researchers to generate reliable information to promote better understanding of TM/CAM.

Tested CAM practices will become adopted into mainstream medicine if they are proven safe and effective. On the other hand, untested CAM therapies which may have unintended negative consequences and may interfere with or displace effective treatments will be discouraged. The cause for concern is that increased use of TM/CAM has not been accompanied by a proportionate increase in clinical evidence to support TM/CAM claims. Therefore the watch word in the new millennium is clinical research to generate evidence in TM/CAM practices.

Trends in evaluation of TM/CAM

The scientific method of experiment with randomized clinical trials as the gold standard continues to be the most desirable and acceptable means of evaluating TM/CAM to generate evidence on its efficacy. However, it is being increasingly realized that research models that have been designed within the reductionism framework of scientific medicine may be inadequate to test TM/CAM practices that have evolved in a holistic framework. Indeed, there is at present a shift in focus from the study of components of TM/CAM to its study as a whole. This is reflected for example, in the NCCAM strategy which looks at CAM under the five major domains of (a) Alternative medical systems, (b) Mind-body interventions, (c) Biologically based treatments,(d) Manipulative and body-based methods and (e) Energy therapies

The reductionism methods of science applied to evaluate traditional systems of medicine like Ayurveda has yielded limited success. While these efforts did demystify certain aspects of TM/CAM, they failed to unravel aspects of TM/CAM that was beyond the scope of scientific evaluation. On the other hand, recent advances in science comes with the promise of better understanding certain aspects of TM/CAM that was hitherto not amenable to scientific enquiry.

Progress in neuroscience can probably throw better light on the effects of acupuncture and meditation. Better knowledge about the interactions between nervous system and endocrine and immune systems have already helped in better understanding the practice of meditation, hypnosis, prayer etc. While such advances in science are encouraging, the continued application of conventional research protocols to evaluate TM/CAM often transforms it back into scientific medicine perpetuating a vicious circle. For example, TM/CAM is often looked at as a safer alternative. An herbal recipe is tested, active molecules are isolated and a new chemical drug is discovered that is far from being safe by any standards.

We are faced with a serious question here. Are we to look forward to the emergence of a more advanced science to better understand TM/CAM or are we to transcend the scientific paradigm itself to achieve this end? The opinions will be divided on this key issue. We will look at the situation from the standpoint of Ayurveda.

Discovering alternative ways of knowing in a bid to understand alternative medicine

Ayurveda, by its own standards is not just a medical system. The very word Ayurveda means knowledge of life. It wouldn’t be wrong to say that Ayurveda stands for a healthy vision on life. Ayurveda is a knowledge systemover and above its being approaches to health care. The etymological analysis of the word Veda defines a knowledge system that can be used to characterize Ayurveda. The word Veda can be derived from four roots in Sanskrit. (a)sattA – meaning existence, (b) jJAna – meaning concept, (c) vicAra – meaning analysis and (d) prApti – meaning attainment or experience. Thus Veda is an approach to knowledge building that begins with an enquiry into objects that have real existence, which can be conceptualized, reflected upon and experienced. Veda is thus an experiential approach to knowledge building and is not speculative in nature. In this regard, it is in tune with the method of science as we know it today. However, it differs from science in that it does not emphasize the experimental approach. The Vedic approach also relies on extra sensory modalities of cognition that can occur in altered states of consciousness like meditation, which science looks at with great suspicion.

It was perhaps Karl Popper, the renowned scientific philosopher, who first defined science as a distinct, unique and powerful tool of knowing in an exclusive manner. He proposed the criterion of falsifiability as the ultimate test of science. However, he accepts other approaches to knowledge. In his book, "In search of a better world" he writes 'I wish to begin by saying that I regard scientific knowledge as the most important kind of knowledge we have, though I am far from regarding it as the only one'. This then is the challenging question that we have to answer. Given the fact that science is truly a most powerful and manipulative method of knowledge building that human kind has ever produced, do we have to suppose that it is the only valid way of knowing? Are all pre-scientific methods of knowing to be dismissed as proto-scientific because they have already been absorbed into the scientific paradigm?

Karl Popper’s statement has in it the seed of a new perspective – the pluralism of knowledge systems. Perhaps pre-scientific ways of knowing represent a primary and natural system of knowledge acquisition that need not be discarded in the wake of the emergence of science. Science and other methods of knowing can co-exist to enrich the human experience. Veda, for example, is an inclusive concept and can accommodate the scientific enterprise in its gambit. On the other hand, science is an exclusive concept and cannot embrace Veda.

Going by this argument, we have to understand alternative ways of knowing in order to fully appreciate alternative systems of healing. The challenge is to subject alternative systems of medicine like Ayurveda to scientific evaluation without at the same time reducing it to a science.

The interaction between Ayurveda and scientific medicine has created three expressions in the field of Ayurveda. There is the classical Ayurveda, the scientific Ayurveda and then the semi-scientific Ayurveda. These expressions of Ayurveda can be distinguished from each other on the basis of diagnostic, therapeutic and pharmaceutical decisions taken by the physicians in the course of their practice or research.

In the context of classical Ayurveda, diagnostic, therapeutic and pharmaceutical decisions are taken purely from within the epistemological framework of Ayurveda. A disease would be diagnosed on the basis of Ayurvedic nosology (classification of diseases) or Ayurvedic concept of pathogenesis. Likewise, a therapeutic strategy would be evolved on the basis of Ayurvedic principles of disease management and a variety of dosage forms and pharmaceutical methods utilized to administer the medicines. Normally, the typical Ayurvedic treatment schedule includes changes in mental attitude, behavior, diet and a combination of internal medications and external therapies.

Semi-scientific Ayurveda relies on parameters of scientific medicine to diagnose diseases and then attempts to apply Ayurvedic treatment with a bio-chemical understanding of the disease process. This approach often shifts the emphasis from the person to the disease process and the holistic perspective of Ayurveda is lost. Semi-scientific Ayurveda represents an attempt to mimic scientific medicine in form, if not always in substance. Treatment strategy is visualized with a scientific understanding of the disease. A major drawback of semi-scientific Ayurveda is that tablets become the predominant dosage form in name of convenience and the non-medical components of treatment like diet, life style, mental attitude etc becomes sidelined.

Scientific Ayurveda is visible much more in the context of research than in practice. In this approach, Ayurveda becomes transmuted to scientific medicine at the levels of diagnostic, therapeutic and pharmaceutical decision making. This form of Ayurveda emerges at the pre-doctoral, doctoral and post-doctoral levels of Ayurvedic education as well as in research centers of scientific medicine that attempt to evaluate Ayurveda. Energy concepts of Ayurveda get translated into bio-molecular mechanisms, formulations get reduced to single drugs and specific molecules and treatment aims to interfere with specific molecular mechanisms in the disease process. The holistic perspective of Ayurveda is completely lost in the bargain.

The transformation of classical Ayurveda into scientific Ayurveda reminds us of the story of the goose that laid golden eggs. This process will culminate in the death of Ayurveda as an independent approach to health care as well as a knowledge system and we will be left with only those aspects of Ayurveda that have been successfully assimilated into the conceptual framework of scientific medicine.

Preservation of Ayurveda in the classical form will give to the world a different perspective on health care that can be integrated into a holistic healthcare delivery system. Indigenous medical knowledge represents a fertile field of serendipitous discoveries and intuitive insights on which scientific advancements can grow and flourish. We should not forget that plastic surgery owes it origin to the practice of rhinoplasty that was first performed in the Indian subcontinent by suCruta, the father of surgery belonging to the Ayurvedic tradition. Modern drugs like reserpine and cocaine were discovered on the basis of leads and first clues obtained from indigenous medical practices.

Ayurveda as a knowledge system

The statement that Ayurveda is not a science does not mean that it is unscientific. Indeed, we do not have to tolerate unscientific attitudes in the name of tradition. The point is that knowledge systems like Ayurveda are trans-scientific. It is important to make this distinction between what is unscientific and what is trans-scientific. Ayurveda is open to the scientific approach but does not restrict itself to this enterprise. The scientific elements of Ayurveda can be amplified by a healthy interaction with modern science. But epistemologically, Ayurveda transcends the operational realms of science in knowledge building.

The salient features of Ayurveda as a knowledge system can be summarized as follows. It was earlier pointed out that the very word veda indicates experiential knowledge about objects that have an actual existence. The knowledge of Ayurveda is also organized in a three tier system of principle(tattva), theory (Castra) and practice (vyavahAra). There is a three pronged strategy for validation which includes investigation (parIkSA), evaluation(tarka) and evidence (siddhi).

An investigation is carried out only after consideration of ten important factors like the investigator, the drug, the disease process, primary endpoint, secondary endpoints, follow up outcome, location, duration, procedure and coordination.

A clinical success which has not been properly evaluated is to be dismissed as accidental success (yadRcchA siddhi). A proper evaluation should demonstrate an unambiguous correlation (liGgaliGgI sambandha) between the variables under study and should be free from fallacies of observation (hetvAbhAsa).

Ayurveda recognizes that there are three types of diseases viz., (1)which gets cured even without any medical assistance (abheSaja sAdhya)(2) which get cured only with medical assistance (bheSaja sAdhya) and (3)which do not get cured even with medical assistance (bheSajAsAdhya). Ayurvedic text books emphasize that the physician must be sharp enough to differentiate between the cases that get cured spontaneously and those that really depend on medication to get cured. The Ayurvedic tradition perhaps proclaimed for the first time in the history of medicine about the placebo effect, self limiting diseases and the phenomenon of spontaneous remission. Siddhi is tested success, which is backed up by proper evidence. siddhAnta usually translated as theory actually means a conclusion that has been arrived at as a result of investigations carried out by multiple investigators. Such conclusions may be multicentric and universal (sarvatantra), unicentric(pratitantra), hypothetical (abhyupagama) or contextual (adhikaraNa).

The meeting point of science and Ayurveda

It can be easily discovered that evidence building is a common meeting point of both Ayurveda and scientific medicine. While the application of science seems to distort the original approach of Ayurveda in making diagnostic, therapeutic and pharmaceutical decisions because of epistemological incompatibility, it can nevertheless be applied to generate reliable evidence regarding the clinical applications of Ayurveda.

Scientific medicine can offer powerful tools for objectively evaluating the progress of a disease. By designing appropriate protocols, it will be possible to test and see whether classical Ayurvedic treatment is really working as it is claimed to. The bottleneck here is the inappropriateness of available research models that can be applied effectively to evaluate classical Ayurvedic treatments which are multi-interventional. The typical randomized controlled clinical trial protocols are designed to test single modalities of treatment and the very adoption of such a protocol becomes detrimental to the holistic approach of Ayurveda. Even uncontrolled clinical trials are problematic not to speak of controlled and randomized clinical trials.

The TM/CAM realm and the field of Ayurveda represent a proliferation of anecdotal accounts on clinical successes. The first challenge is to upgrade such anecdotal reporting to more acceptable standards of case studies or observational studies. Meaningful RCT designs can be envisaged only on the basis of long term observational studies. And observational studies can be carried out only at accredited centers of evidence based practice in the field of Ayurveda.

The ideal program for evaluation of Ayurveda has to be phased out in two stages. In the first stage, the focus should be on the setting up of accredited centres of Ayurvedic practice where observational studies will be compiled on a long term basis. In the second stage, appropriate clinical trial protocols can be designed on the basis of inputs derived from the observational studies.

A three pronged strategy is to be adopted to establish an evidence based practice center of Ayurveda dedicated to observational studies. First of all, it should be a center where classical Ayurveda is practiced, which should be recognizable on the basis of diagnostic, therapeutic and pharmaceutical decision making. Secondly, there should be scientific evaluation of all cases with rigorous parameters to monitor the progress of the disease. An independent comparison of the data obtained from Ayurvedic and scientific components will generate insights on the fundamental differences in approach of Ayurveda and scientific medicine towards diagnosis and treatment. Observational studies can be analyzed to project claims and clues on the scope and limitations of Ayurvedic treatment with reasonable objectivity.

Diagnosis is an area where Ayurvedic physicians are also using modern laboratory techniques to confirm their assessment of the disease. For example, tests for blood sugar levels, presence of bilirubin in the serum, X rays etc are commonly used by Ayurvedic physicians. Results of many such investigations can also be interpreted within the conceptual framework of Ayurveda. However, such assessments may not always satisfy rigorous criteria for scientific research and hence there is a need for independent scientific documentation.

There may be some instances where the Ayurvedic physician must be made aware of the scientific assessment of the patient’s condition, if that will influence the outcome of the therapeutic intervention favorably. There may be some instances where the Ayurvedic physician is unable to diagnose and where scientific medicine is unable to diagnose, some instances where the Ayurvedic diagnosis and scientific diagnosis are not epistemologically comparable and some instances where they are comparable. These issues will become clear only in the course of the documentation program.

A very important outcome of this exercise would be the identification of conditions that can be managed independently by Ayurveda, managed with support of scientific medicine, managed by scientific medicine with support of Ayurveda and which cannot be managed by Ayurveda at all.

The overall strategy can be summarized as follows – Establish practice of classical Ayurveda; perform independent scientific evaluation and project objective clues and claims. First plan for rigorous observational studies and then design randomized clinical trials. If science can accept Ayurveda as trans-scientific and Ayurveda can welcome science to amplify its own scientific inclinations, then the outcome would be a golden era that synthesizes the holistic and reductionist paradigms of knowing. The former can help humankind to harmonize with nature and may not give us sophisticated technology and the latter can help humankind to control nature and interfere with natural processes to create a technoscape that eulogizes human creativity. The meeting of Ayurveda and scientific medicine will not merely be the coming together of two medical traditions. It will indeed be the vast expanse of the vedic ocean embracing the detailed landscape of scientific knowledge.

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