| Evidence-Based Health Science ("Scienza Basata Sull'Evidenza" ENGLISH) |
|
Note on evidence-based health science: As a global term, EBHS (evidence-based health science) reflects clinical practice based on scientific research. The premise is that if healthcare professionals perform an action there should be scientific evidence that the action will produce the desired outcomes. This all sounds very nice, logic and seems beneficial for positive patient outcomes, till Archie Cochrane decided that the only valid research has to be based on randomized controlled trials (RTC). In 1993, the Cochrane Collaboration, serving as an international research review board, was founded to provide clinicians with a resource aimed at increasing clinician-patient interaction time by facilitating clinicians’ access to valid research. As one of the main requirements to belong to the Cochrane database is that research must be based on the RTC design, all other research, which constitutes 98% of the literature, is deemed by them as scientifically imperfect (like almost a 99% of all chiropractic research). In the last 10 years the Cochrane group has grown into a hierarchy that has been endorsed by many academic institutions and is creating for itself an enhancing image that conditions researchers and students up to the point of becoming the only “regime of scientific truth” , excluding many other forms of knowledge, by labelling them as recklessly non-scientific. Although for certain forms of scientific knowledge RTC is probably the best way of research, it is doubtful that it promotes the multiple ways of knowing deemed important within most health disciplines, especially chiropractic.
Criticisms from the scientific world upon EBM:
- Not all knowledge, especially medical can be proved or disproved by randomized clinical trial, e. g. : answering questions about diagnosis or prognosis. - There is big gap between theory and practice, which is creating a paucity of evidence that evidence-based medicine works. It is a mistake to think that medical or chiropractic practice can be reduced to an algorithmic application of evidence from RCTs. This evidence is not directly applicable to individual patients, as the knowledge gained from RCT’s does not directly answer the primary clinical question of what is best for the patient at hand. - Difficulties in applying evidence to the care of individual patients, also because it ignores the patient value’s and the interrelationship patient - doctor. - The capacity of reflecting on itself has been excluded by the way the whole EBHS has been set up. This is leading to the fact that medical researchers, using EBM principles, come to believe that they hold the monopoly on generating and interpreting evidence for evaluating treatment efficacy. - A lot of knowledge (98%) is doomed to not being further researched, because increased belief in the principles of evidence-based medicine among policy-makers, sponsors, researchers will lead to the preservation of funding only for the “so- called proven efficacious therapies”. Just read what Hoffer, a leading evidence-based medical researcher, already wrote in 2003 in the Canadian Medical Association Journal; “What bright young researcher would choose to devote a scientific career to confirming the inefficacy of implausible treatments of CAM ( Complementary or Alternative Medicine)?.” Up to the point that mainstream medicine promotes the notion that not only it alone should be considered “real” medicine and that all we need is their science-based procedures and a huge spectrum of drugs, but also that complementary medicine or other approaches are dangerous and inferior to their own training. This is done daily by brainwashing people through the mass media with the help of “scientific” researchers, medical promoters, MD’s, medical schools etc... many of them directly or indirectly paid by big pharmaceutical companies. All these starts already in medical journals where industry-supported trials (most often on drugs) are much more cited than other trials and other types of research ( Kulkarni and Conen.). The conclusions in negative trials are often presented in such a way that they appear to be more positive (Boutron et al.) and positive industry trials are more cited than negative ones. Furthermore, sponsoring companies employ various strategies to increase the awareness of their studies: a) including ghost authored reviews that cite them (Ross, Steinman, Healy and PLos Medicine Editors ) b) purchase and disseminate of reprints (a single trial may lead to an income of 1 million US dollars with a profit margin around 70%, like the VIGOR trial of rofecoxib of Merck; Smith ) c) creation of media attention (Kulkarni, Hopewell and Smith) d) or when a journal dares to publish a study that is critical of industry advertisements, it may loss up to a 1,5 million dollars in advertising revenue (Lexhin) e) most articles that rightfully criticize EBM or the corrupt situation around research never are published in major medical journals.
- Lack of evidence can easily be confused as evidence of lack of differences between different types of therapy.
- The output of the Cochrane collaborative reviews are not always better, less biased or less tainted by conflict of interest than others as some recent research has demonstrated. When investigating one or another therapy, some people in the Cochrane collaborative group apparently have, consciously or unconsciously, something “a priori” against a therapy because they use only preformed trials with negative findings in the review group and when assessed with a standard checklist for evaluating systematic reviews they were found to be deficient in terms of trials not being included ,and the omission of data, including subgroup analyses. These were consistently in the direction of supporting the negative conclusions of the review. - Meta-analyses that puts the Cochrane centre in a favourable light are co-authored by the director of the Cochrane centre !!!! - Clinical trials for neck or back problems generally select highly motivated patients with relatively narrow medical complaints. They filter out individuals with other physical and psychological issues, negative behaviour, and other complicating factors. And unfortunately those are the typical patients with low back pain that we see every day in practice. How then should we treat patients with serious comorbidity, who would not have been eligible for the reference trials? Even more important is the fact that between 1993 and 2008 the rate of hospital stays more than doubled for patients with back pain diagnosis with comorbidities, while inpatient stays with only back problems remained roughly the same. ( Owens et al.) So, if the main problem of the increasing cost of back problems are the comorbidities, than what is the use of expensive RCT’s, where those patients are excluded? - A recent study by Carman et al. demonstrates that consumers current knowledge, beliefs, attitudes, and experiences related to healthcare are often incompatible with evidence-based approaches. - All this notwithstanding, at their website the Cochrane collaborative modestly describes itself as “the gold standard in evidence-based healthcare” and they are achieving hegemony in an ever increasing number of faculties of health sciences where the paradigm (= an entire constellation of beliefs, values, techniques, and so on shared by the members of a given community) of EBHS has become mandated . Up to the point that any other health profession (CAM) in order to obtain recognition by the dominant political, economic, and judicial structures must demonstrate that their therapies or practice methods are evidence based according their rules. - It is important to know that there is no scientific proof that the results of these studies applied in practice are more effective on patients than diagnosis and treatment by an individual doctor on each single patient. Not even one RCT has been done to confront evidence-based practice with other methods or standard practices in any healing art, therefore we don’t know if their results are really superior or even better for the overall healthcare. So my question is where is the scientific proof that EBH is any better than other methods and on what basis apart from self designation do they pretend by to be the only “regime of scientific truth” ? (Similar to a liar who says he’s honest).
Another motive to worry about EBM is the fact that even if treatments are proven to have no benefit and are based on doubtful diagnosis they keep on being employed : F.s.; Articular facet syndrome is a frequent diagnosis done in patients with low back or neck pain, notwithstanding the fact that there are no validated methods of diagnosing painful facet joint or any evidence that they are the cause of the low back or neck pain (Nordin). Moreover all treatments (steroid injections, medial branch block or radiofrequency denervation) have been proven by RCT’s (Staal) to have no benefit or are no better than placebo treatments and a lot of this is known since 1991 (Carette et al.) . Yet there has been an explosive growth in facet joint procedures (543% increase) in the last 10 years with a total cost of 511 million dollars only in 2006. (Chou, Carragee, Manchikani). Also vertebroplasty has been proved to be no better than a sham procedure and still the cost of this procedure is over 1 billion dollars only in the U.S.A..( Elshaug et al.). My questions are: - Does the medical profession read and/or belief in their own research? - why doing all this type of expensive research, if they are ignored by the medical practitioners? These is also one of the reasons why every year more and more people use CAM therapies because conventional medical treatment would not help.
- Many times using “common sense” is more than enough without all those expensive RCT’s, like e. g. Smith demonstrated in his systematic review of (randomized) controlled trials that there is no evidence that parachute use prevents death and major trauma related to gravitational challenge. (So he invites the Cochrane collaborative people to do a double blind randomised controlled trial among themselves to show evidence that you better jump from an airplane with than without a parachute!!!)
Medicine is not a science but rather a rational science-using art based on a philosophy about life combined with sound clinical experience and should never be disassociated from comforting and caring. If “modern” medicine keeps on sliding into a positivistic reductionism based on RCT and leading to the embrace of scientism than this period will be remembered in history as empiricist quackery and its practitioners as empiricist quacks. (Scientism is a philosophical position that exalts the methods of the natural sciences above all other modes of human inquiry. It is totalitarian by its nature and with strident arrogance assumes and asserts that science and scientific inquiry based on empiricism and mechanical materialistic thoughts alone have the capacity to describe reality and to determine what is knowledge and what is not. It directly diminishes importance of all of the things which matter in human life namely “emotions” , love, art etc.. )
Criticisms from a chiropractic point of view:
-The RCT is specially designed to validate categories of medical interventions that are observable and measurable, therefore the very nature of chiropractic disqualifies RTC as a suitable research methodology. Just try to fake an adjustment(double-blind) or measure the force, experience, speed, dexterity of the chiropractor. Think about all the technics we have in our profession and how ever individual practice is based on “complex” and “personalized” episodes between the chiropractor and the patient and how our regimes of treatment are specifically tailored to suit the particular problems and needs of that patient at that moment. This is why our treatments can differ considerably from one patient to another (and possibly for the same person) even if they apparently have the same symptoms, like low back pain or neck pain. (Ireh) - If you think logical about all I said above you should start to suspect that the concept of evidence-based medicine also has been created to discredit CAM and to eliminate competition. - Most important of all is that it reduces the health sciences to what is essentially a Newtonian, mechanistic world view that has been proven to be inaccurate model for at least 50 years. They believe that reality is objective, which is to say that it exists, “out there”, absolutely independent of the human observer, and of the observer’s intentions and observations. (The observer creates the reality). So if you consider all the information I gave you before and understand a little about quantum physics, the importance of the mind, the interaction patient – doctor, etc., there shouldn’t be any doubt that evidence-based science is neither “progressive” nor a “natural” development in health sciences. - It leaves no place for the art of healing, the compassion, or a holistic approach. ( B.J. Palmer: “Art and science have no enemies but those who are ignorant”). - EBM is also based on an unproven basic scientific conception of chemistry and the body (Newtonian) which makes it impossible for alternative medicine to be evidence-based. In other words, statistical information from an RCT is virtually uninterpretable and meaningless if stripped away from the backdrop of our basic understanding and belief of physiology and biochemistry.: e. g. if current “accepted” basic science believes that homeopathic remedies are nothing more than water, how can they be effective and therefore why waste time with those therapies, even if meta-analysis showed that subjects receiving the homeopathic remedy did statistically significant better than those receiving a placebo. Same can be said about chiropractic, because if we have to be judged in the light of our theory about life and disease, it seems a silly and pointless exercise to be evaluated for evidence by those Cochrane guys in the light of the fact that they only belief in their Newtonian theory or vision of life and the human body and therefore a priory think that ours is wrong and false. If we let those people go ahead it will kill real chiropractic, and a lot of chiropractic knowledge based on observational studies and clinical experience, is doomed to disappearI. Up to the point that there will be no need for a “Doctor” title anymore as they will consider us just as any other physical therapist who manipulates. So remember: Plurality is the condition of human action because we are all the same, that is , human, in such a way that nobody is ever the same as anyone else who ever lived, lives, or will live. Therefore no therapy can ever have a constant or proven outcome because every patient is unique.
Considering all of the above, I don’t know if I should laugh or cry when I hear colleagues proudly claim on how evidence-based and therefore scientific their way of practicing is !!!
( If you look at all the long-lasting successful chiropractic practices, you will not find one that has a purely mechanical and evidenced-based approach, nor one that is purely philosophical and subluxation based.)
Do not forget we are in the healing arts and that in chiropractic, philosophy and art are just as important as science. Don’t get me wrong, science is certainly necessary and research is crucial, but take them for what they are by being a good clinician in the first place.
Bibliografia:
Bekelman JE et al., Scope and impact of financial conflicts of interest in biomedical research: A systematic review, JAMA, 2002; 289:454-65. Boutron I. et al., Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes; JAMA, 303: 2058-2064, 2010. Carman KL et al., Evidence that consumers are skeptical about evidence-based healthcare, Health affairs. Pubblicato online, 3/06/2010, healthaffairs.org Carragee EJ et al., treatment of neck pain: injections and surgical interventions: results of the bone and joint decade, 2000-2010 task force on neck pain and associated disorders, Spine, 2008.- 33 (4 Suppl): S 153-S169. Chou R et al., Interventional therapies, surgery and interdisciplinary rehabilitation for low back pain, Spine, 2009; 34: 1066- 1077. Conen D. et al., Differential citation rates of major cardiovascular clinical trials according to the source of funding: a survey from 2000 to 2005. Circulation 118: 1321-1327, 2008. Dabbs, V, Lauretti, W, A risk assessment of cervical manipulation vs. NSAIDS for the treatment of neck pain; JMPT, 18: 530-536, 1995. Deyo R.A., Gaps, tensions, and conflicts in the FDA approval process: Implications for clinical practice; Journal of the American Board of Family Practice, 17: 142-9, 2004. Deyo R.A. and Patrick D.L.; Hope or Hype: The obsession with medical advances and the high cost of false promises. New York: Amacom; 2005. Djulbegovic B., et al., The uncertainty principle and industry-sponsored research; Lancet, 356:635-638, 2000. Ezzet K, The prevalence of corporate funding in adult lower extremity research and its effect on reporting of results. Presented at the annual meeting of the American Academy of Orthopedic Surgeons, New Orleans 200310: 84. Elshaug et al., New Engl. J. of Med.; 2009; 361(6): 557-68;569-79. New Engl. J. of Med.; 2011; 364(15: 1390- 3). Phillips DP. et al., Importance of the lay press in the transmission of medical knowledge to the scientific community; N Engl J Med 325: 1180-1183, 1991. Friedman B.W., et al., Systemic steroids ineffective for back pain; Journal of emergency Medicine, 4: 365-370, 2006. Goodman N.W., Who will challenge evidence-based medicine? ; J R Coll. Physicians Lond., 33: 249-251, 1999. Hopewell S. et al., How important is the size of a reprint order?; Int J Technol Assess Health Care 19: 711-714, 2003. Kirkaldy-Willis W.H., Swartz A., Orthodox and complementary Medecine: An Alliance for a changing world; Berkely CA: North Atlantic Books, 2001. Kirsch I., Apples, oranges, and placebo: Heterogeneity in a meta-analysis of placebo effects; Advances in Mind-body Medicine, 17: 298-307; 2001. Kulkarni AV. et al., Characteristics associated with citation rate of the medical literature. PLoS ONE, 2: e403. Doi:10.1371/journal.pone.0000403, 2007. Lexchin, J., et al., Pharmaceutical industry sponsorship and research outcome and quality; Systematic review; BMJ, 326: 1167- 1179, 2003. Lexchin J., Light, D.W., Commercial influence on the content of medical journals; BMJ, 332: 1444-1447, 2006. Lundh A. et al., Conflicts of interest at medical journals: The influence of industry-supported randomised trials on journal impact factors and revenue – color study, PLoS Med 7: 10 e1000354 Oct. 2010. Manchikanti L. et al., Explosive growth in facet joint interventions in the Medicare population in the US: a comparative evaluation of 1997, 2002, and 2006 data, BMC Health Services Research, 2010. Martinson B.C., Scientists behaving badly; Nature, 435: 737-738, 2005. Melander H. et al., Evidence b(i)ased medicine – selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug application. BMJ , 326: 1171-1176, 2003. Miettinen O.S., The modern scientific physician: 1 Can practice be science ?; Can. Med. Ass. Journal ,165: 441-441, 2001. Moynihan R., Who pays for the pizza? Redefining the relationship between doctors and drug companies. 1,2: Entanglement; BMJ, 326: 1189-1196, 2003. Moynihan R., Cassels A., Selling sickness: How the worlds biggest pharmaceutical companies are turning us all into patients; Nation books, New York, 2005. Williams & Williams. Owens at al., AHRQ Statistical Brief # 105, February 2011. Palmer D.D., D.C., Textbook of the science, art and philosophy of Chiropractic; Portland Printing House Company, 1910. PLoS Medicine Editors. Ghostwriting: the dirty little secret of medical publishing that just got bigger. PLoS Med 6: e1000156. doi:10.1371/journal.pmed.1000156, 2009. Ross JS. et al., Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecobix litigation. JAMA 299: 1800-1802, 2008. Shah, R.V., et al., Industry support and correlation to study outcome for papers published in Spine; Spine, 30:1099- 104, 2005. Smith R., Medical journals are an extension of the marketing arm of pharmaceutical companies. PLos Med. 2: e138. Doi:10.1371/journal. Pmed.00201138. 2005. Smith R., Lapses at the New England journal of medicine. J R Soc Med 99; 380-382, 2006. Smith R., Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ 326: 1202-1205, 2003. Staal JB et al., Injection therapy for sub acute and chronic low back pain: an updated Cochrane review, Spine, 2009, 34:49-59. Turtle M.J. ,M.D.: Huge gap in medical knowledge about back pain; Backletter, Vol.21, No 9, Sept.: 108, 2006. and BMJ, 332: 1430-4, 2006. Vogt F et al, General practitioners' perceptions of the effectiveness of medical interventions: An exploration of underlying constructs. Implementary science, 2010; 5 (17): 1-8.
|
Gli orari di Como sono
Vi preghiamo di chiamarci allo 031.57.44.44 per fissare un appuntamento.
Gli orari di Reggio sono
Vi preghiamo di chiamarci allo 0522.511.211 per fissare un appuntamento.