Novel study designs to investigate the placebo response

BMC Medical Research Methodology

Stephan Zipfel²  Sibylle Klosterhalfen¹  Paul Enck² 

[1] University of Düsseldorf, Institute for Clinical Neurobiology and Medical Psychology, Düsseldorf, Germany;University Hospital Tübingen, Dept. of Psychosomatic Medicine, Tübingen, Germany

关键词: placebo;    experimental research;    study design;   

Others  :  1140155
DOI  :  10.1186/1471-2288-11-90

 received in 2010-09-14, accepted in 2011-06-10,  发布年份 2011

【 摘 要 】

Background

Investigating the size and mechanisms of the placebo response in clinical trials have relied on experimental procedures that simulate the double-blind randomized placebo-controlled design. However, as the conventional design is thought to elucidate drug rather than placebo actions, different methodological procedures are needed for the placebo response.

Methods

We reviewed the respective literature for trials designs that may be used to elucidate the size of the placebo response and the mechanisms associated with it.

Results

In general, this can be done by either manipulation the information provided to the subjects, or by manipulation the timing of the drug applied. Two examples of each strategy are discussed: the "balanced placebo design" (BDP) and the "balanced cross-over design" (BCD) and their variants are based on false information, while the "hidden treatment" (HT) and the ""delayed response test" (DRT) are based on manipulating the time of drug action. Since most such approaches include deception or incomplete information of the subjects they are suitable for patient only with authorized deception.

Conclusion

Both manipulating the information provided to subjects (BDP, DCD) or manipulating the timing of drug application (HT, DRT) allows overcoming some of the restrictions of conventional drug trials in the assessment of the placebo response, but they are feasible mostly in healthy subjects for ethical reasons.

【 授权许可】

   
2011 Enck et al; licensee BioMed Central Ltd.

【 图 表 】

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