Balneotherapy: from Basic Research to Clinical Challenges
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© Aluna Balneotherapy: from Basic Research to Clinical Challenges Pedro Cantista Centro Hospitalar Universitário do Porto, Portugal Acta Balneol, TOM LXI, Nr 2(156);2019:75-77 SOME THOUGHTS ABOUT THE SCIENTIFIC Is medicine a science that simply aims and is exhausted “PROOF” IN MEDICINE in the diagnosis, prevention, treatment and rehabilitation When we want to discuss what the “proof” in science consists of diseases, through the application of a set of techniques, of, we are automatically transposed into the philosophical or still remains an art, as it was considered by many old field. I’m convinced that when we speak of knowledge we masters? In Medicine what is more important: the experimental cannot escape from the ancestral dialectic philosophy / science data converted into “knowledge” or the true “wisdom” that and pass through the successive thoughts and arguments of includes the very attitude of calling into question the “facts” of philosophers and scientists. “evidence”? Against facts there are no arguments or precisely There is obviously a historical evolution of epistemology. against “facts” there are arguments? From Metaphysics to Logic, from Rationalism to Empiricism, Carrying these reflections into the daily life of our scientific from Positivism to Structuralism, human knowledge evolves “production”, I would say that in our time the knowledge in in a flow of successive acquisitions brought to our minds by Medicine comes from the so-called “basic sciences”, essentially diverse methodologies, with which humanity continually data from the “laboratory”, which aim at understanding seeks the Truth. biological, physiological or pathological phenomena. This Nowadays, thought is closely linked to technological knowledge allows us to formulate therapeutic hypotheses whose evolution, influencing the scientific method for an ever adoption, implementation and regulatory institutionalization closer approximation to mathematical rigor and to the follows from a translational scientific process, concluded by utopia of certainty. Far away seems to be the “methodical pragmatic clinical trials, validated by probabilistic methods doubt”. Automatic information (informatics) dominates and (mathematical demonstrations). So we fall into reality and constraints thought. instead of “causality” we stand by “probability”. Sometimes we forget that the Scientific Method is not in itself In this subject we cite Sir Austin Bradford Hill who in 1965 a unique way of proceeding, but rather that a model of thought published a set of criteria to evaluate if an association could aims, to guide the investigation, formulated in the hypothesis, be considered as causal. These include strength, consistency by obtaining and discussing experimental data that may lead to (observation at different times), specificity, temporality (cause possible conclusions. We want exact science. However, in 1927 precedes consequence), biological gradient (dose-response Werner Heisenberg, introducing the concept of the “uncertainty relationship), plausibility (consistent with biological evidence), principle,” sets a limit on the accuracy with which certain pairs of consistency, experimental evidence, and analogy). The evaluation properties of a given physical particle, known as complementary of the existence or not of association and of causal relation, variables (such as position and linear momentum), can be known. must comprise two fundamental aspects: the identification Although the principle of uncertainty may have its validity restricted of the effect and its quantification. to the subatomic level, by inserting values as indetermination and Several models of study are developed. Studies without probability into the field of empirical experiment, this principle control group (individual cases or individual case sets) constitutes a fundamental epistemological transformation for and studies with control group; case series studies without modern science. randomization (case control, cohort) or randomization Will there be exact sciences? Is this question wrong because (clinical trial, community trial). The studies with control of its apparent contradiction? Or is there really no exact group allow a direct and objective comparison between the science or absolute certainty? group under study and another group that will not have the With regard to the so-called “medical sciences” it seems same characteristics in appreciation. unquestionable that the infallible determinism of an immutable The random distribution of study participants, which we cause-effect relationship is far from reality. That is why it is call “randomization”, forms the basis of the trials considered to so often said: “death is the only certainty of our life ...” be of the highest degree of evidence, the so-called randomized 75 Pedro Cantista controlled trials. We generally adopt the acronym of the English Obviously this is not possible. And it is not possible because designation when we intend to refer (RCTs - randomized this model is not applicable. Do not order an RCT for a surgical, controlled trials). psychotherapeutic, or for many Physical and Rehabilitation In this process, in order to homogenise the groups, each Medicine techniques. There are medical procedures for which participant should have the same probability of integrating the same methodology applied to drugs is not possible. How each of the groups formed, trying to isolate the variable to proceed to establish the therapeutic indications of natural that we want to evaluate (in most cases the intervention in mineral waters? We lack scientifically-developed medical- question). hydrological studies, of course. Prior to any test, the classification In the observational studies we included the cohort of new natural mineral waters is required. We start from this methodology studies, which may be prospective or retrospective, premise and can investigate in laboratory the influence of where the cause precedes the effect and that starts from the physical, chemical and biological factors on the physiological identification of the presence or the absence of exposure to and pathological mechanisms, constructing hypotheses to the factor in question. Observational studies are those of be demonstrated by the clinical trials. This raises the need to case-control methodology. These are retrospective and in establish appropriate methodologies for the agent or process them the effect precedes the cause. in question. Given this step, in order to respond to the claim Based on the pragmatic studies, there is the challenge of of the dealers to add new therapeutic indications in waters many usual clinical attitudes and interventions, considered to be already qualified as natural minerals, I would say that a better true and beneficial. The so-called “Evidence-Based Medicine” definition of these therapeutic indications is necessary. But (EBM) was born, much influenced by Archibald Leman let’s not fall for fundamentalisms. The present non-existence Cochrane (1909-1988), who introduced these “randomized of a test does not mean that a particular practice is invalid or studies”, that is, therapeutic trials in which a comparison does not act. We should be critical, but use common sense. is made between groups of participants (random), whose The proof has not yet been produced, perhaps because we results are applied statistical methods. The conclusion will have not yet obtained a method for its demonstration. not be 100% accurate, but it tends toward that percentage Can EBM be applied to crenotherapy? Clinical evidence the stricter the study design and the larger the sample size, can only be proven for an agent, an application form or a health which means the number of participants in a given trial. condition. However, most therapeutic agents cannot be subjected Depending on the design of the clinical trials (retrospective, to double-blind trials. On the other hand, it is necessary to take prospective, longitudinal, cross sectional, controlled, into account that thermal therapy is usually complex, that is, uncontrolled, single or double blind, randomization, etc.) it adds to the effects of mineral water or other crenotherapy and their conclusions or, where possible meta-analysis of agent, climate, diet, physical and psychological relaxation, data from various studies), a “level of evidence” can be physical activity and social interaction. That is: contextual established, hierarchically positioned in a graded classification, factors (environmental and personal). In the investigation of whose representative image is the well-known “pyramid of the medical field in crenotherapy are essential elements: evidence”. 1) Natural mineral waters (Na, Ca, Mg, Cl, SO4, H2S, The level of evidence reached in a given hypothesis CO2), gases (CO2, H2S, Rn), peloids, climatic factors and other determines according to this classification a “degree of therapies (massage, diet, physiotherapy, psychotherapy). recommendation” that guides clinical behaviour, aiming to 2) Modes of application: oral ingestion (hidropinia), baths, condition medical performance in an established model of showers, ablutions, steam techniques, irrigations, sprays, “good practices”. sprays, inhalations, injections, enemas, etc. 3) Dosage: simple use, series, combinations. SOME THOUGHTS ABOUT THE SCIENTIFIC Regarding the type of clinical trial and validation criteria “PROOF” IN CRENOTHERAPY of the studies, much has been discussed. The subject has If we want to ask how we can establish a Scientific Evidence been the subject