Meta-analysis of the Placebo and Nocebo effects associated with Placebo treatment in randomized trials of lipid-lowering therapies

Abstract Background Randomized controlled trials (RCTs) of lipid-lowering therapy (LLT) in which the control groups received placebo without background LLT offer unique insights into the placebo and nocebo effects of lipid-lowering RCTs. Methods and results Embase and Medline were searched for hyper...

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Bibliographic Details
Published in:European heart journal. Quality of care & clinical outcomes 2023-08, Vol.9 (5), p.511-519
Main Authors: Chin, Yip H, Lim, Oliver, Lin, Chaoxing, Chan, Yu Y, Kong, Gwyneth, Ng, Cheng H, Chong, Bryan, Syn, Nicholas, Chan, Kai E, Muthiah, Mark D, Siddiqui, Mohammad S, Wang, Jiong-Wei, Figtree, Gemma, Chan, Mark Y, Chew, Nicholas W S
Format: Article
Language:English
Subjects:
High density lipoprotein
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Lipids
Meta-analysis
Nocebo Effect
Placebo effect
Randomized Controlled Trials as Topic
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Summary:Abstract Background Randomized controlled trials (RCTs) of lipid-lowering therapy (LLT) in which the control groups received placebo without background LLT offer unique insights into the placebo and nocebo effects of lipid-lowering RCTs. Methods and results Embase and Medline were searched for hyperlipidaemia RCTs with placebo-controlled arms. Placebo arms with background LLT were excluded. A single arm meta-analysis of proportions was used to estimate major adverse cardiovascular events (MACE) and adverse events (AE). A meta-analysis of means was used to estimate the pooled mean differences of total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoproteins (HDL) and triglycerides (TG). A total of 40 RCTs and 37 668 placebo-treated participants were included. The pooled mean changes for TC, LDL, HDL, and TG were −0.019 mmol/L, −0.028 mmol/L, 0.013 mmol/L, and 0.062 mmol/L respectively among placebo-treated participants, indicating a modest placebo effect. The pooled average nocebo effect among placebo-treated participants was 42.62% for all AEs and 3.38% for musculoskeletal-related AEs, 11.36% for gastrointestinal-related AEs, and 6.62% for headaches. Placebo-treated participants in secondary prevention RCTs had a far higher incidence of these nocebo effects than primary prevention RCTs: any AEs (OR 6.76, 95% CI: 5.56–8.24, P 
ISSN:2058-5225
2058-1742
DOI:10.1093/ehjqcco/qcac060