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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Fu, Yu Persson, Monica S. M. Bhattacharya, Archan Goh, Siew-Li Stocks, Joanne van Middelkoop, Marienke Bierma-Zeinstra, Sita M. A. Walsh, David Doherty, Michael Zhang, Weiya |
| Abstract | Background The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA. Methods This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses. Discussion This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects. Systematic review registration PROSPERO CRD42016033212 |
| Related Links | https://systematicreviewsjournal.biomedcentral.com/counter/pdf/10.1186/s13643-016-0362-x.pdf |
| Ending Page | 6 |
| Page Count | 6 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 20464053 |
| DOI | 10.1186/s13643-016-0362-x |
| Journal | Systematic Reviews |
| Issue Number | 1 |
| Volume Number | 5 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2016-10-28 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Osteoarthritis Placebo response Individual patient data meta-analysis Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
| Journal Impact Factor | 6.3/2023 |
| 5-Year Journal Impact Factor | 4.5/2023 |
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