Evidence mapPaperPMID 33627334Full record

Trial reportBMJ (Clinical research ed.)2021

Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials.

Emily Herrett, Elizabeth Williamson, Kieran Brack, Danielle Beaumont, Alexander Perkins, Andrew Thayne, Haleema Shakur-Still, Ian Roberts, Danielle Prowse, Ben Goldacre and 11 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02781064. Cited by 65 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 5 pooled it
30.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02781064 phase4completed

A Series of Randomised Controlled N-of 1 Trials in Patients Who Have Discontinued or Are Considering Discontinuing Statin Use Due to Muscle-related Symptoms to Assess if Atorvastatin Treatment Causes More Muscle Symptoms Than Placebo

Ran2016Enrolled200Registered outcomes2Posted comparisons0ConditionsCardiovascular DiseaseArmsatorvastatin 20mg, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 5 syntheses or guidelines pooled it, 177 citations in OpenAlex.

  1. Pooled it
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  8. Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment.Journal of the American College of Cardiology · 2021
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5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 1 country.

Emily HerrettDepartment of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-9425-644X
Elizabeth WilliamsonDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0001-6905-876X
Kieran BrackClinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-8100-8949
Danielle BeaumontClinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-2530-9608
Alexander PerkinsDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-9817-2390
Andrew ThayneClinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-9702-1662
Haleema Shakur-StillClinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-6511-109X
Ian RobertsClinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0003-1596-6054
Danielle ProwseClinical Trials Unit, Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-7470-4823
Ben GoldacreNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-5127-4728
Tjeerd van StaaDivision of Informatics, Imaging and Data Sciences, University of Manchester, Manchester, UK.ORCID 0000-0001-9363-742X
Thomas M MacDonaldMEMO Research, University of Dundee, Dundee, UK.ORCID 0000-0001-5189-6669
Jane ArmitageMedical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0001-8691-9226
Jon WimborneBay Medical Practice, York Bridge Surgery, Morecambe, UK.ORCID 0000-0001-7679-8483
Paula MelroseBay Medical Practice, York Bridge Surgery, Morecambe, UK.ORCID 0000-0002-9007-4657
Jayshireen SinghNIHR Clinical Research Network, Guy's Hospital, London, UK.ORCID 0000-0001-9951-3700
Lucy BrooksKeats and Hampstead Group Practice, London, UK.ORCID 0000-0002-7951-0315
Michael MooreSchool of Primary Care and Population Sciences, University of Southampton, Southampton, UK.ORCID 0000-0002-5127-4509
Maurice HoffmanPatient member of the trial steering committee appointed by NIHR, London, UK.ORCID 0000-0002-8860-4786
Liam SmeethDepartment of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-9168-6022
StatinWISE Trial Group
London School of Hygiene & Tropical Medicine · GBUniversity of Oxford · GBGuy's Hospital · GBRoyal Free London NHS Foundation Trust · GBUniversity of Dundee · GBUniversity of Manchester · GBUniversity of Southampton · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.

designSeries of randomised, placebo controlled n-of-1 trials.

settingPrimary care across 50 sites in the United Kingdom, December 2016 to April 2018.

participants200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.

interventionsParticipants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.

main outcome measuresAt the end of each treatment period, participants rated their muscle symptoms on a visual analogue scale (0-10). The primary analysis compared symptom scores in the statin and placebo periods.

results151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis. Overall, no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. Two thirds of those completing the trial reported restarting long term treatment with statins.

conclusionsNo overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins. Most people completing the trial intended to restart treatment with statins. N-of-1 trials can assess drug effects at the group level and guide individual treatment.

trial registrationISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.

Indexed as

Primary Health CareAdultAgedAged, 80 and overAtorvastatinDouble-Blind MethodFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMuscular DiseasesSymptom AssessmentUnited KingdomAtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID33627334
PMCPMC7903384
OpenAlexW3118007133

What Socratic holds

Textmetadata
LicenceCC BY
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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.