Meta-analysis of the Placebo and Nocebo effects associated with Placebo treatment in randomized trials of lipid-lowering therapies
Authors' conclusion
Our meta-analysis of placebo-treated participants in RCTs with no background LLT indicate a modest placebo effect but prominent nocebo effect of musculoskeletal, headache, and gastrointestinal symptoms that was greatest among secondary prevention RCTs.
Study context
- Population
- Placebo-treated participants in hyperlipidaemia randomized controlled trials (RCTs) of lipid-lowering therapy without background lipid-lowering therapy (LLT)
- Participants
- 37,668 participants40 RCTs
- Outcome
- Placebo and nocebo effects in placebo-treated participants
Methodological detailssingle-arm meta-analysis of proportions, meta-analysis of means
- Single-arm meta-analysis of proportions
- Meta-analysis of means
Pooled result
As reported in the abstract
| Group | Pooled mean change total cholesterol (TC) | Pooled mean change low-density lipoprotein (LDL) | Pooled mean change high-density lipoproteins (HDL) | Pooled mean change triglycerides (TG) | All adverse events (AEs) (nocebo) | Musculoskeletal-related AEs | Gastrointestinal-related AEs | Headaches |
|---|---|---|---|---|---|---|---|---|
| Placebo | −0.019 mmol/L | −0.028 mmol/L | 0.013 mmol/L | 0.062 mmol/L | 42.62% | 3.38% | 11.36% | 6.62% |
Placebo
Pooled mean change total cholesterol (TC)−0.019 mmol/L
Pooled mean change low-density lipoprotein (LDL)−0.028 mmol/L
Pooled mean change high-density lipoproteins (HDL)0.013 mmol/L
Pooled mean change triglycerides (TG)0.062 mmol/L
All adverse events (AEs) (nocebo)42.62%
Musculoskeletal-related AEs3.38%
Gastrointestinal-related AEs11.36%
Headaches6.62%
Further pooled results
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| Nocebo effects, secondary vs primary prevention RCTs (placebo arms)Secondary prevention RCTsvs Primary prevention RCTsAny AEs | 6.76 (5.56–8.24) | P < 0.001 | |
| Nocebo effects, secondary vs primary prevention RCTs (placebo arms)Secondary prevention RCTsvs Primary prevention RCTsGastrointestinal-related AE | 1.23 (1.00–1.51) | P = 0.049 | |
| 0.10.31310Odds ratio (log scale) |
Nocebo effects, statin vs non-statin trials (placebo arms)
- No differences in nocebo effects between placebo arms of statin and non-statin trials
Original publication
Meta-analysis of the Placebo and Nocebo effects associated with Placebo treatment in randomized trials of lipid-lowering therapies. Eur Heart J Qual Care Clin Outcomes. Published 15 September 2022. doi:10.
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