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The n-of-1 trial could be adopted by clinicians who are looking to establish the best course of treatment for patients, in general practice or outpatient settings, who present with muscle symptoms associated with statins. Of the 200 randomised participants, 86 did not complete the whole trial, of whom 49 did not provide sufficient data to contribute to the primary analysis. Adherence was similar for the statin and placebo periods, and the trial was adequately powered y http account for this level of attrition.

We did not measure levels of creatine kinase in participants who withdrew from the study so y http do not know what proportion of participants had biochemical evidence of muscle effects.

For simplicity, we assessed the effect of one statin, atorvastatin 20 mg, on muscle symptoms. Our results, therefore, might not apply to higher doses of atorvastatin or to other statins. Although we intended to collect outcomes with web based methodology, over half of the participants preferred y http report their symptoms on paper or by telephone. Our two month treatment periods were designed to be long enough y http allow the previous treatment y http washout, and to allow the current treatment to have an y http. It is possible, however, that this time period y http not long enough for some of our patients, y http that the scores on the visual analogue scale were affected by treatment from the previous period.

The analysis of our series of n-of-1 trials found no overall effect of y http on muscle symptoms in participants selected on the basis of having experienced severe muscle symptoms but no important increases in levels of enzymes during previous treatment with statins.

The lack of effect in patients y http the trial, combined with y http low number of withdrawals owing y http muscle symptoms, suggests a nocebo effect among users of statins, or of high tolerance to blinded rechallenge. Treatment with statins for those at high risk has potential health benefits that are lost by those who stop treatment.

The availability of n-of-1 trial packs in y http care would allow patients and clinician to replicate this study in individuals, for any statin and at any Lidocaine and Prilocaine Periodontal Gel (Oraqix)- FDA to suit clinical needs, in primary care or in lipid clinics. Our results suggest that most patients would restart treatment after such a trial.

Future work could focus on conducting n-of-1 trials for other types of statins and higher doses, and for other drugs which are associated with transient adverse effects. A causal link between y http and rare but severe muscle adverse effects is well characterised but the causal effect of statins on less severe muscle symptoms, such as stiffness, pain, and weakness, is uncertainWidely publicised results of unblinded observational studies has led to many patients stopping treatment, believing their muscle symptoms are caused by statins, thus increasing morbidity and mortality from cardiovascular diseaseBlinded, randomised n-of-1 trials y http provide evidence of the role of statins in muscle symptomsIn a series of randomised, placebo controlled n-of-1 trials, no overall effect of statins on the frequency or severity of muscle symptoms was found in participants y http had previously reported severe muscle symptoms intp taking statinsThe n-of-1 trial could be a powerful clinical tool for clinicians and patients to determine how best to investigate muscle symptoms associated with statinsWe thank the participants, collaborating general practitioners, members of the steering committee and data monitoring committee, and all the administrative and clinical staff who helped to conduct the trial.

Members of the StatinWISE Trial Group are listed here and in appendix 2. Contributors: EH designed the study, oversaw the study conduct, and wrote the first draft of the manuscript with Y http. EW designed the study, analysed the results, and reviewed the manuscript.

KB and DB designed and managed the study and reviewed the manuscript. AP managed the study and reviewed the manuscript. AT coordinated the data collection and Tobradex ST (Tobramycin / Dexamethasone Ophthalmic Suspension 0.3%/0.05%)- FDA the manuscript.

HS-S and IR designed the study, oversaw its conduct as co-directors of the Clinical Trials Unit, and reviewed the manuscript. DP designed the study, managed the study data, and reviewed the manuscript. BG, TvS, TMM, and JA designed the study and reviewed the manuscript.

JW was PI at the y http recruiting site and reviewed the manuscript. PM was lead research nurse at the top recruiting site y http reviewed the manuscript.

JS was lead research nurse at the top recruiting network of sites and reviewed the manuscript. LB was research co-ordinator at the first site to recruit and reviewed the manuscript. MM provided oversight of the whole study and reviewed the manuscript. MH contributed to study design Plendil (Felodipine)- Multum conduct as a patient representative and reviewed the manuscript. LS designed and led the study and wrote the first draft of the manuscript with EH.

LS is the guarantor for the study. The study was sponsored by the London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT.

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