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Rapid Responses: Rapid Responses published:
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EBM: the new religion - a further thought
- Luis Vitetta, Fernando Cortizo (Senior Lecturer); Avni Sali (Professor and Head) (30 May 2003)
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At least, there is a bias in a lot of results...
- Sergio Stagnaro (1 June 2003)
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Debate about whether antidepressants are better than placebos
- D B Double (2 June 2003)
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Luis Vitetta, Director of Research Graduate School of Integrative Medicine, Swinburne University, Melbourne, Australia, 3122., Fernando Cortizo (Senior Lecturer); Avni Sali (Professor and Head)
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Sir. That the best evidence could be biased was always an issue by both those in medical practice and scientific research. However, what seems to have been forgotten is: what about the average patient? - an important participant in the equation towards better management of disease and promotion of health. The best evidence based medicine approach is not only selectively biased in its reporting, it has also major biased constraints for the care of the individual patient. It is widely accepted that the integration of clinical expertise with the best available evidence from systematic research is the foundation of evidence based medicine. Properly designed Randomised Placebo Controlled Trials evaluated by a meta - analysis is regarded as the best evidence on which to base treatment. Yet, a timely reminder from Feinstein and Horwitz's (1) article shows that the best evidence data that is derived almost exclusively from randomised trials and meta - analyses that do not include many types of treatments or patients seen in clinical practice. Also that 'the best evidence results show comparative efficacy of treatment for an average randomized patient and not for pertinent subgroups formed by such cogent clinical features as severity of symptoms, illness, co-morbidity, and other clinical nuances.' Moreover they report that randomised trial information is seldom available for issues in aetiology, diagnosis, and prognosis, and for clinical decisions that depend on pathophysiologic changes, psychosocial factors and support, personal preferences of patients, and strategies for giving comfort and reassurance. Evidence b(i)ased medicine (2) certainly is biased, even more so for the average patient who does not adhere to the inclusion criteria that make up the best practice guidelines of best evidence practice. Therefore, general practitioners need to assess all of the scientific evidence rather than just be provided with biased evidence that is limited to that which is deemed best evidence only. General Practitioners are then in a position to properly assess treatment options and to monitor the progress of their patients accordingly. Otherwise the community will continue to perceive general practitioners to be about biased treatment only and alternative health practitioners to be about health promotion and disease prevention.(3) References 1.Feinstein AR, Horwitz RI. Problems in the "evidence" of "evidence-based medicine". Am J Med. 1997; 103(6):529-35. 2.Hans Melander, Jane Ahlqvist-Rastad, Gertie Meijer, and Björn Beermann Evidence b(i)ased medicine-selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications BMJ 2003; 326: 1171-1173. 3.Reilly D. Comments on complementary and alternative medicine in Europe. J Altern Complement Med. 2001; 7 Suppl 1:S23-31. Competing interests: None declared |
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Sergio Stagnaro, Specialist in Blood, Gastrointestinal, and Metabolic Diseases. Researcher in Biophysical Semeiotics. Via Erasmo Piaggio 23/8 16037 Riva Trigoso 8genoa) Italy.
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Editors, A 46 year-long clinical experience allows me to state that the authors are right stating “any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence” (1). As a matter of fact, in the course of efficacious therapy with selective serotonin reuptake inhibitors, both neuronal and cerebral evoked potentials, now-a-days assessed at the bed- side with the aid of Biophysical Semeiotics in reliable way (2, 3; and HONCode site 233736, http://digilander.libero.it/semeioticabiofisica) , ameliorate clearly. In addition, under identical condition, cerebral microcirculatory functional reserve improves statistically (3, 4). Unfortunately, pharmaceutical descriptions of drug significant effects often do not parallels the reality. Finally, no pharmaceutical companies have published an only critical paper of mine. God thanks, doctor can utilize EBM as well as SPBM, i.e. "Single Patient Based Medicine". 1) Melander H., Ahlqvist-Rastad J. et al. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171 -1173 (31 May) 2) Stagnaro S., Percussione Ascoltata degli Attacchi Ischemici Transitori. Ruolo dei Potenziali Cerebrali Evocati. Min. Med. 76, 1211 (Pub-Med indexed for Medline) 1985. 3) Stagnaro S., Valutazione percusso-ascoltatoria della microcircolazione cerebrale globale e regionale. Atti, XII Congr. Naz. Soc. It. di Microangiologia e Microcircolazione. 13-15 Ottobre, Salerno, e Acta Medit. 145, 163, 1986). 4) Stagnaro-Neri M., Stagnaro S., Diagnosi precoce dell’invecchiamento cerebrale con la percussione ascoltata. Monitoraggio terapeutico con la Nicergolina. Ricerca Med. 6, 348,1989 Competing interests: None declared |
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D B Double, Consultant Psychiatrist Norfolk mental Health Care NHS Trust, Norwich NR6 5BE
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Melander et al seem to think that their review of data from new drug applications for the serotonin specific reuptake inhibitor (SSRI) class of antidepressants submitted to the Swedish drug regulatory authority is unique.1 In fact, the New Drug Application (NDA) data sets sent to the US Food and Drug Administration (FDA) by the manufacturers of the six most widely prescribed antidepressants have been well analysed.2, 3 This issue of bias in clinical trials of antidepressants is to be debated in a motion that antidepressants are no better than placebos at the Critical Psychiatry Network Annual Conference on 13 June 2003 (details at www.criticalpsychiatry.co.uk/AnnualConference2003.htm). The debate is open to the public, as is the whole day conference.
Competing interests: Founding member of Critical Psychiatry Network |
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