The Placebo Effect on Symptoms, Quality of Life, and Functional Outcomes in Patients With Angina Pectoris: A Meta-analysis of Randomized Placebo-Controlled Trials

Gallone, Guglielmo; Baldetti, Luca; Angelini, Filippo; Saglietto, Andrea; Bellettini, Matteo; Beneduce, Alessandro; Ranotti, Viola; Chiarito, Mauro; Pagnesi, Matteo; Filippo, Ovidio De; Landra, Federico; Bruno, Francesco; Marengo, Giorgio; Collino, Massimo; Ferrante, Giuseppe; Colombo, Antonio; Al‐Lamee, Rasha; Francis, Dárrel P.; Jolicoeur, Marc; Henry, Timothy D.; Giannini, Francesco; D’Ascenzo, Fabrizio; Ferrari, Gaetano Maria De

doi:10.1016/j.cjca.2021.04.022

Cited by 7 publications

(3 citation statements)

References 25 publications

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“…In terms of β-blockers use, data are consistent with currently available data, but on the other hand, the lack of improvement with calcium channel blockers can be partially attributed to a small number of patients using the drug. Interestingly, a significant placebo effect was suggested by Gallone et al in their meta-analysis of randomized control trials in patients with coronary artery disease treated either pharmacologically or by any sort of procedure [30]. In our observational study, there was no sham procedure.…”

Section: Antianginal Treatment and Cmdmentioning

confidence: 53%

The change of angina levels in patients with chronic coronary syndromes and coronary microcirculatory dysfunction – a prospective study with 24 months follow-up

Niewiara,

Kleczyński,

Szolc

et al. 2023

pwki

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Introduction: A substantial proportion of patients with chronic coronary syndromes suffer from angina even after medical treatment and revascularization. Coronary microvascular dysfunction (CMD) is discussed as a potential mechanism.Aim: To assess angina status in patients with chronic coronary syndromes undergoing functional assessment of coronary circulation regarding the presence of coronary microcirculatory dysfunction.Material and methods: The study included 101 consecutive patients referred for coronary angiography requiring functional stenosis assessment, with median age of 66 years, 74% male, diagnosed or treated for dyslipidemia (91%) and diabetes type 2 (42%), 20% with a history of prior non-ST myocardial infarction. Fractional flow reserve (FFR), coronary flow reserve (CFR), resistive reserve ratio (RRR), and index of microcirculatory resistance (IMR) were measured. The diagnosis of CMD was defined by either IMR ≥ 25 units or CFR ≤ 2.0 in case of no significant stenosis. A change of one CCS class over 24 months follow-up was considered clinically significant.Results: In patients without CMD diagnosis, there was a significant decrease in angina intensity (p < 0.001). Lack of angina improvement was associated with lower median RRR (2.30 (1.70, 3.30) vs. 3.05 (2.08, 4.10), p = 0.004) and lower median CFR (1.90 (1.40, 2.50) vs. 2.30 (IQR: 1.60, 3.00), p = 0.021), as compared to patients with angina improvement.Conclusions: The presence of CMD is a risk factor for no angina improvement. Impaired coronary resistive reserve ratio and lower microvascular reactivity may be one of the pathomechanisms leading to the lack of angina improvement in patients with chronic coronary syndromes.

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Section: Antianginal Treatment and Cmdmentioning

confidence: 53%

The change of angina levels in patients with chronic coronary syndromes and coronary microcirculatory dysfunction – a prospective study with 24 months follow-up

Niewiara,

Kleczyński,

Szolc

et al. 2023

pwki

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“…Compared with that of the non-CR group, the quality-of-life improvement of the CR group was significant at 6 months but not in 1 year. The placebo effect should be considered ( 12 ). The dose-response association was noted in the survival rate.…”

Section: Discussionmentioning

confidence: 99%

Outcomes With Multidisciplinary Cardiac Rehabilitation in Post-acute Systolic Heart Failure Patients—A Retrospective Propensity Score-Matched Study

Chen

Wang

Liaw

et al. 2022

Front. Cardiovasc. Med.

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BackgroundCardiac rehabilitation (CR) is recommended for patients with acute heart failure (HF). However, the results of outcome studies and meta-analyses on CR in post-acute care are varied. We aimed to assess the medium- to long-term impact of CR and ascertain the predictors of successful CR.MethodsIn this propensity score-matched retrospective cohort study, records of consecutive patients who survived acute HF (left ventricular ejection fraction <40) and participated in a multidisciplinary HF rehabilitation program post-discharge between May 2014 and July 2019 were reviewed. Patients in the CR group had at least one exercise session within 3 months of discharge; the others were in the non-CR group. After propensity score matching, the primary (all-cause mortality) and secondary (HF readmission and life quality assessment) outcomes were analyzed.ResultsAmong 792 patients, 142 attended at least one session of phase II CR. After propensity score matching for covariates related to HF prognosis, 518 patients were included in the study (CR group, 137 patients). The all-cause mortality rate was 24.9% and the HF rehospitalization rate was 34.6% in the median 3.04-year follow-up. Cox proportional hazard analysis revealed that the CR group had a significant reduction in all-cause mortality compared to the non-CR group (hazard ratio [HR]: 0.490, 95% confidence interval [CI]: 0.308–0.778). A lower risk of the primary outcome with CR was observed in patients on renin-angiotensin-aldosterone system (RAAS) inhibitors, but was not seen in patients who were not prescribed this class of medications (interaction p = 0.014).ConclusionsCardiac rehabilitation participation was associated with reduced all-cause mortality after acute systolic heart failure hospital discharge. Our finding that the benefit of CR was decreased in patients not prescribed RAAS inhibitors warrants further evaluation.

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“…No placebo bias was considered in the present study. In the meta-analysis conducted by Gallone et al ( 24 ) to quantify the impact of placebo on endpoints of symptoms, quality of life, and functional outcomes in randomized placebo-controlled trials (RCTs) of symptomatic stable CAD, a significant placebo effect was observed for all secondary outcomes with overall high heterogeneity. In addition, a substantial effect in placebo-controlled patients emerged in several functional activities and quality-of-life metrics.…”

Section: Limitationsmentioning

confidence: 99%

A budget impact model and a cost–utility analysis of reducer device (Neovasc) in patients with refractory angina

Fortunato,

Valentini,

Rumi

et al. 2024

Front. Cardiovasc. Med.

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BackgroundRefractory angina (RA) is a chronic condition characterized by the presence of debilitating angina symptoms due to established reversible ischemia in the presence of obstructive coronary artery disease (CAD). Treatments for this condition have undergone major developments in recent decades; however, the treatment for RA remains a challenge for medicine. In this sense, the Coronary Sinus Reducer System (CSRS) stands as the last line of therapy for ineligible patients for revascularization with reversible ischemia. The purpose of this report is to evaluate the potential burden on the National Health Service (NHS) and measure the health effects in terms of both quantity (life years) and quality-of-life aspects related to the reducer.MethodsTwo different economic evaluation models were developed as part of the analysis. The budget impact was developed to estimate the potential burden on the NHS from incremental uptake of the use of the reducer in the target population. The utility cost analysis compares and evaluates the quality of life and health resource use and costs between the two alternatives, based on the research of Gallone et al. A deterministic and probabilistic sensitivity analysis was carried out to characterize the uncertainty around the parameters of the model.ResultsIn the budget impact analysis (BIA), the reducer is shown to be more expensive in the first 2 years of the model, due to the gradual uptake in the market and the cost of the device. Starting from the third year, assuming maintenance of effectiveness, there are savings in terms of resource absorption in direct healthcare costs arising from hospitalizations, emergency department accesses, coronarography, and visits avoided.ConclusionThe BIA and cost-effectiveness model show that the reducer device, despite an increase in resources absorbed in the first years of implementation and use, has the potential to result in increased quality of life in patients with RA. These costs are largely offset in the short term by the improved clinical outcomes achievable leading to savings from the third year onward in the BIA and a dominance ratio in the cost–utility analysis.

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The Placebo Effect on Symptoms, Quality of Life, and Functional Outcomes in Patients With Angina Pectoris: A Meta-analysis of Randomized Placebo-Controlled Trials

Cited by 7 publications

References 25 publications

The change of angina levels in patients with chronic coronary syndromes and coronary microcirculatory dysfunction – a prospective study with 24 months follow-up

The change of angina levels in patients with chronic coronary syndromes and coronary microcirculatory dysfunction – a prospective study with 24 months follow-up

Outcomes With Multidisciplinary Cardiac Rehabilitation in Post-acute Systolic Heart Failure Patients—A Retrospective Propensity Score-Matched Study

A budget impact model and a cost–utility analysis of reducer device (Neovasc) in patients with refractory angina

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