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Evidence for the Efficacy of NXY-059 in Experimental Focal Cerebral Ischaemia Is Confounded by Study Quality
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Background and Purpose— The neutral results of the SAINT II trial have again highlighted difficulties translating neuroprotective efficacy from bench to bedside. Animal studies are susceptible to study quality biases, which may lead to overstatement of efficacy. We report the impact of study quality on published estimates of the efficacy of NXY-059 in animal models of stroke. Methods— We conducted a systematic review and stratified meta-analysis of published studies describing the efficacy of NXY-059 in experimental focal cerebral ischemia. Results— Overall, NXY-059 improved infarct volume by 43.3% (95% CI, 34.7 to 52.8). Only 2 of 9 publications reported randomization, concealment of treatment allocation, and blinded outcome assessment. Studies not reporting these quality items gave substantially higher estimates of efficacy than did higher-quality studies. Conclusions— The reported efficacy of NXY-059 in animal models of stroke is confounded by low study quality. The failure of SAINT II highlights the need for substantial improvements in the design, conduct, and reporting of animal studies; journals can play an important role in this by adopting standards for animal studies similar to those agreed over 10 years ago for clinical trials.
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“study quality is inversely related to effect size [79][80][81][82]”
From Power failure: why small sample size undermines the reliability of neuroscience (2013) · cites this paper as [81]
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“There are, however, compelling data from systematic reviews showing that nonblinded outcome assessment leads to the treatment effects being overestimated, and the lack of bias-reducing measures such as randomisation and blinding can contribute to as much as 30%–45% inflation of effect sizes [67,68,85].”
From Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0 (2020) · cites this paper as [85]
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“There are, however, compelling data from systematic reviews showing that nonblinded outcome assessment leads to the treatment effects being overestimated, and the lack of bias-reducing measures such as randomisation and blinding can contribute to as much as 30%–45% inflation of effect sizes [67,68,85].”
From Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0 (2020) · cites this paper as [85]
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Metadata
- Authors
- Macleod, M. R., van der Worp, H. B., Sena, E. S., Howells, D. W., Dirnagl, U., & Donnan, G. A.
- Affiliations
- University Medical Center Utrecht (NL)
- From Clinical Neurosciences (M.R.M., E.S.S.), University of Edinburgh, Scotland, UK; the Department of Neurology (H.B.v.d.W.), Rudolf Magnus Institute of Neuroscience, University Medical Centre, Utrecht, The Netherlands; the National Stroke Research Institute (E.S.S., D.W.H., G.A.D.), Melbourne, Australia; and the Department Neurology (U.D.), Charite Hospital, Berlin, Germany.
- Venue
- Stroke
- Published
- 2008-10
- Volume
- 39
- Issue
- 10
- Pages
- 2824-2829
- ISSN
- 0039-2499 (ISSN-L)
- 1524-4628
- OpenAlex
- W2168672683
- Cited by
- 319
- References
- 28
- Citations by year
- 2026: 4 · 2025: 12 · 2024: 11 · 2023: 12 · 2022: 16 · 2021: 15 · 2020: 17 · 2019: 33 · 2018: 11 · 2017: 18 · 2016: 26 · 2015: 19 · 2014: 28 · 2013: 26 · 2012: 19
- FWCI
- 12.87
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Stroke (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Neuroscience › Neurology › Neuroprotection in Cerebral Ischemia
- Keywords
- NXY-059, focal cerebral ischemia, animal models of stroke, study quality bias, infarct size, neuroprotection, translational research
- MeSH terms
- Animals, Benzenesulfonates, Cardiovascular Agents, Brain Ischemia, Clinical Trials as Topic, Research Design, Bias
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