Naudet Florian, Falissard Bruno, Boussageon Rémy, Healy David
Centre d'Investigation Clinique, CIC-P INSERM 1414, Centre Hospitalier Universitaire de Rennes et Université de Rennes 1, Rennes, France,
Intern Emerg Med. 2015 Aug;10(5):631-4. doi: 10.1007/s11739-015-1227-3. Epub 2015 Apr 1.
Evidence-based medicine (EBM) is generally considered as the most complete paradigm in the practice of clinical medicine. Its application should preclude all kinds of quackery. Therapeutic reformers of the second half of the twentieth century have convinced the medical community that the double-blind randomized controlled trial (RCT) versus placebo is the gold standard in clinical research to establish evidence of treatment usefulness. Nevertheless, this paradigm ignores the importance of non-specific effects in the healing process and can generate misrepresentations. Additionally, because of methodological limitations, RCTs as they are used in practice can give rise to new forms of quackery by promoting drugs that are not useful for the patients who actually receive them, or are so expensive that their value is open to criticism. This is precisely the case when surrogate outcomes, with questionable clinical significance, are used. These can divert attention from clinically relevant outcomes, such as safety issues that are probably the core of treatment evaluation. The boundaries between quackery and EBM that clinicians are faced with are not so clear-cut. There is a need for doctors to acknowledge their share in quackery and to be continually conscious of the possible pitfalls of their therapeutic practice.
循证医学(EBM)通常被认为是临床医学实践中最完整的范式。其应用应杜绝一切庸医行为。20世纪后半叶的治疗方法改革者已使医学界确信,与安慰剂对照的双盲随机对照试验(RCT)是临床研究中确立治疗有效性证据的金标准。然而,这种范式忽视了非特异性效应在愈合过程中的重要性,并且可能产生误解。此外,由于方法学上的局限性,实际应用中的RCT可能会催生新的庸医行为形式,即推广那些对实际使用药物的患者并无益处或价格昂贵以至于其价值受到质疑的药物。当使用临床意义存疑的替代结局时,情况正是如此。这些替代结局可能会转移对临床相关结局的注意力,比如安全问题,而安全问题可能是治疗评估的核心。临床医生面临的庸医行为与循证医学之间的界限并非如此清晰。医生有必要承认自己在庸医行为中所扮演的角色,并始终意识到其治疗实践中可能存在的陷阱。