Trial reportContemporary clinical trials2012
Adherence to placebo and mortality in the Beta Blocker Evaluation of Survival Trial (BEST).
Trial report in Contemporary clinical trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pharmacological interventions for heart failure in people with chronic kidney disease.The Cochrane database of systematic reviews · 2020Pooled it
- The effect of placebo adherence on reducing cardiovascular mortality: a meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2014Pooled it
- Placebo adherence and mortality in the Heart and Estrogen/Progestin Replacement Study.The American journal of medicine · 2012Trial
- Cardiorenal diseases in type 2 diabetes mellitus: clinical trials and real-world practice.Nature reviews. Endocrinology · 2023Review
- Healing in a Social Context: The Importance of Clinician and Patient Relationship.Frontiers in pain research (Lausanne, Switzerland) · 2021Review
- Implication Of Character Traits In Adherence To Treatment In People With Gout: A Reason For Considering Nonadherence As A Syndrome.Patient preference and adherence · 2019Article
- The neuroscience of placebo effects: connecting context, learning and health.Nature reviews. Neuroscience · 2015Review
- Adherence, expectations and the placebo response: why is good adherence to an inert treatment beneficial?Psychology & health · 2014Article
- The placebo response in medicine: minimize, maximize or personalize?Nature reviews. Drug discovery · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundRandomized controlled trials have reported lower mortality among patients who adhere to placebo compared with those who do not. We explored this phenomenon by reanalyzing data from the placebo arm of the Beta Blocker Evaluation of Survival Trial (BEST), a randomized, double-blind, placebo-controlled trial of bucindolol and mortality.
aimsOur primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the BEST trial. Secondary aims included assessment of the association between placebo adherence and cause-specific mortality.
methodsParticipants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication over the entire course of each individual's participation in the study, while those with "lower placebo adherence" took <75%. Primary outcome was in-study all-cause mortality. To account for confounding, we adjusted for all available modifiable, non-modifiable and psychosocial variables.
resultsAdherent participants had a significantly lower total mortality compared to less-adherent participants (HR=0.61, 95% Confidence Interval: 0.46-0.82). Adjusting for available confounders did not change the magnitude or significance of the estimates. When considering cause-specific mortality, CVD and pump failure showed similar associations.
conclusionsAnalyses of the BEST trial data support a strong association between adherence to placebo study medication and total mortality. While probably not due to publication bias or simple confounding by healthy lifestyle factors, the underlying explanation for the association remains a mystery. Prospective examination of this association is necessary to better understand the underlying mechanism of this observation.
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