Valleron A J, Grimfeld A
Unité de Recherches Biomathématiques et Biostatiques de l'INSERM, Faculté de Médecine Saint-Antoine, Université Pierre et Marie Curie, Paris, France.
Dev Biol Stand. 1992;77:149-58.
Despite numerous clinical studies showing "significant differences" in favour of immunomodulators versus placebo in the treatment and/or prevention of recurrent respiratory tract infections, the efficiency of such treatments is still not readily acknowledged by a large part of the medical profession nor by governmental authorities in several countries. In an effort to analyze the causes of this scepticism we performed a retrospective study of 15 clinical trials, using a series of quality assessment criteria. From the results of our analysis we propose a series of recommendations for improving the quality of clinical trials with immunomodulators. Furthermore, in order to avoid suspicion of a publication bias, we recommend setting up a registry of all ongoing clinical studies with immunomodulators.
尽管众多临床研究表明，在治疗和/或预防复发性呼吸道感染方面，免疫调节剂相对于安慰剂有“显著差异”，但这类治疗方法的有效性仍未得到很大一部分医学专业人士以及一些国家政府当局的认可。为了分析这种怀疑态度的原因，我们使用一系列质量评估标准，对15项临床试验进行了回顾性研究。根据我们的分析结果，我们提出了一系列提高免疫调节剂临床试验质量的建议。此外，为避免被怀疑存在发表偏倚，我们建议建立所有正在进行的免疫调节剂临床研究的登记册。
