Methodological considerations for future controlled influenza treatment trials in complementary and alternative medicine.

BACKGROUND: The continuous threat of influenza pandemic, as well as the ongoing costs to human life and health care systems from yearly epidemics, create a continual need for progress in this area of public health. The diversity of available complementary and alternative medicine (CAM) treatment options are well known to the CAM profession, but poorly understood and accepted in mainstream medicine. This situation comes as no surprise given conventional medicine's reliance on repeated, large-scale randomized controlled trials of standardized design to support evidence-based clinical use of influenza antiviral drugs. The relatively low volume of well-conducted clinical trials on the treatment of influenza with CAM therapies compared to the high availability of conventional antiviral drug trials magnifies this problem.

OBJECTIVES: The aim of this article is to provide structured guidelines for future CAM influenza studies based on a thorough review of consistent and standard design elements present in the controlled-trial design of conventional antiviral influenza therapies.

RESULTS: A selection of high-quality, influenza antiviral controlled trials from the published literature is reviewed, and important design elements are extracted and summarized to show both the consistency and the flexibility within study design elements.

CONCLUSIONS: The standardized elements from influenza antiviral trials can be considered and mirrored in future CAM studies. In this way, CAM therapies might be looked at on similar grounds as conventional medicines in terms of potential usefulness and benefit in the treatment of influenza.