Novel study designs to investigate the placebo response
<p>Abstract</p> <p>Background</p> <p>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 thoug...
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| Format: | Article |
| Language: | English |
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BMC
2011-06-01
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| Series: | BMC Medical Research Methodology |
| Subjects: | |
| Online Access: | http://www.biomedcentral.com/1471-2288/11/90 |
| _version_ | 1811318031851192320 |
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| author | Klosterhalfen Sibylle Enck Paul Zipfel Stephan |
| author_facet | Klosterhalfen Sibylle Enck Paul Zipfel Stephan |
| author_sort | Klosterhalfen Sibylle |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> |
| first_indexed | 2024-04-13T12:18:48Z |
| format | Article |
| id | doaj.art-cf2d681f5d5a410f879644dd3b443b11 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-04-13T12:18:48Z |
| publishDate | 2011-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-cf2d681f5d5a410f879644dd3b443b112022-12-22T02:47:17ZengBMCBMC Medical Research Methodology1471-22882011-06-011119010.1186/1471-2288-11-90Novel study designs to investigate the placebo responseKlosterhalfen SibylleEnck PaulZipfel Stephan<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p>http://www.biomedcentral.com/1471-2288/11/90study designexperimental researchplacebo |
| spellingShingle | Klosterhalfen Sibylle Enck Paul Zipfel Stephan Novel study designs to investigate the placebo response BMC Medical Research Methodology study design experimental research placebo |
| title | Novel study designs to investigate the placebo response |
| title_full | Novel study designs to investigate the placebo response |
| title_fullStr | Novel study designs to investigate the placebo response |
| title_full_unstemmed | Novel study designs to investigate the placebo response |
| title_short | Novel study designs to investigate the placebo response |
| title_sort | novel study designs to investigate the placebo response |
| topic | study design experimental research placebo |
| url | http://www.biomedcentral.com/1471-2288/11/90 |
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