Trial reportJournal of the American College of Cardiology2021
Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment.
Trial report in Journal of the American College of Cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02668016. Cited by 74 papers, 5 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.
Self-Assessment Method for Statin Side-effects Or Nocebo
Open the trial in the graphWho cites it
74 citing papers in PubMed, 5 syntheses or guidelines pooled it, 169 citations in OpenAlex.
- Placebo rates in randomized clinical trials of ulcerative colitis: an individual patient data meta-analysis.Journal of Crohn's & colitis · 2025Pooled it
- Safety outcomes of statin vs non-statin lipid-lowering interventions in patients with prior statin-associated muscle symptoms: A systematic review and meta-analysis.PloS one · 2025 · on this mapPooled it
- The Clinical Efficacy and Safety of Bempedoic Acid in Patients at Elevated Risk of Cardiovascular Disease: A Meta-Analysis of Randomized Clinical Trials.Cardiovascular drugs and therapy · 2024Pooled it
- Intolerance upon statin rechallenge: A systematic review and meta-analysis of randomized controlled trials.PloS one · 2023Pooled it
- Association Between Vitamin D Supplementation and Statin-Associated Muscle Symptoms: A Systematic Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022Pooled it
- Sex Differences in Statin Intolerance: Insights From the CLEAR Outcomes Trial.Clinical cardiology · 2026Trial
- Intensive Lowering of LDL Cholesterol Levels With Evolocumab in Autoimmune or Inflammatory Diseases: An Analysis of the FOURIER Trial.Circulation · 2025Trial
- Safety and efficacy of atorvastatin for rebleeding in cerebral cavernous malformations (AT CASH EPOC): a phase 1/2a, randomised placebo-controlled trial.The Lancet. Neurology · 2025Trial
- Trial
- Statin Therapy and Cardiovascular Prevention: Contemporary Evidence, Challenges, and Future Directions-A Narrative Review.International journal of environmental research and public health · 2026Review
- Dyslipidaemia and cardiovascular risk - Key considerations in South Asians.Clinical medicine (London, England) · 2026Review
- Lipid lowering in coronary artery disease - not just statins.Clinical medicine (London, England) · 2026Review
- Article
- Statin-Associated Muscle Symptoms and Myotoxicity: A Clinically Oriented Narrative Review with a Practical Prevention, Evaluation, and Management Algorithm.Medicina (Kaunas, Lithuania) · 2026Review
- Statins, LDL-C and Beyond: A Contemporary Review of Atherosclerotic Cardiovascular Risk Assessment and Management.Journal of lipid and atherosclerosis · 2026Review
- Large Language Model-Based Analysis of Statin Therapy Discussions and Sentiment on Social Media: Cross-Sectional Observational Study.Journal of medical Internet research · 2026Observational
- Progress in risk assessment and management: Forecasting updates across international cholesterol guidelines.American journal of preventive cardiology · 2026Review
- Association between three lipid-lowering drugs and amnesia: a real-world pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Clinician-level variation in lipid management for secondary prevention of atherosclerotic cardiovascular disease: Opportunities for practice improvement.American journal of preventive cardiology · 2026Article
- Long-Term Adherence and Drug Utilisation Patterns Among New Users of Anti-Hyperlipidemic Monotherapy: Development of a Risk Prediction Model.Journal of evaluation in clinical practice · 2026Article
14 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
15 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundMost people who begin statins abandon them, most commonly because of side effects.
objectivesThe purpose of this study was to assess daily symptom scores on statin, placebo, and no treatment in participants who had abandoned statins.
methodsParticipants received 12 1-month medication bottles, 4 containing atorvastatin 20 mg, 4 placebo, and 4 empty. We measured daily symptom intensity for each using an app (scale 1-100). We also measured the "nocebo" ratio: the ratio of symptoms induced by taking statin that was also induced by taking placebo.
resultsA total of 60 participants were randomized and 49 completed the 12-month protocol. Mean symptom score was 8.0 (95% CI: 4.7-11.3) in no-tablet months. It was higher in statin months (16.3; 95% CI: 13.0-19.6; P < 0.001), but also in placebo months (15.4; 95% CI: 12.1-18.7; P < 0.001), with no difference between the 2 (P = 0.388). The corresponding nocebo ratio was 0.90. In the individual-patient daily data, neither symptom intensity on starting (OR: 1.02; 95% CI: 0.98-1.06; P = 0.28) nor extent of symptom relief on stopping (OR: 1.01; 95% CI: 0.98-1.05; P = 0.48) distinguished between statin and placebo. Stopping was no more frequent for statin than placebo (P = 0.173), and subsequent symptom relief was similar between statin and placebo. At 6 months after the trial, 30 of 60 (50%) participants were back taking statins.
conclusionsThe majority of symptoms caused by statin tablets were nocebo. Clinicians should not interpret symptom intensity or timing of symptom onset or offset (on starting or stopping statin tablets) as indicating pharmacological causation, because the pattern is identical for placebo. (Self-Assessment Method for Statin Side-effects Or Nocebo [SAMSON]; NCT02668016).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.