Nocebo/Drucebo Effect of Statin-Associated Muscle Symptoms:A Systematic Review
Objective To evaluate the nocebo/drucebo effect of statin-associated muscle symptoms(SAMS),and to provide evidence-based reference for clinical medication decision-making.Methods Literature related to SAMS in PubMed,Embase,CNKI,and WanFang databases was searched from the inception to August 1,2023,and the randomized controlled trials(RCTs)or N-of-1 trials of comparing the incidence or intensity differences of muscle-related adverse events(AEs)during the blinded and open-lable period of a statin intervention,comparing the difference of muscle symptoms during the baseline and the blinded phase of rechallenge trials in patients with previous statin intolerance,or comparing the incidence or intensity differences of muscle-related AEs between statin intervention and placebo during the blinded phase were included.The Cochrane Risk of Bias 2(RoB 2)tool was used to evaluate the quality of RCTs.The methods of data processing(quantitative analysis or qualitative description)were selected according to the heterogeneity among studies,and the nocebo/drucebo effect value was estimated.Results A total of 1 229 relevant studies were searched and ultimately eight studies were included.Due to heterogeneity in the methodology design,outcome indicators,and outcome reports of the eight studies,only qualitative descriptions of the results were provided.Approximately 38.00％to 77.78％of reported SAMS or drug intolerance during statin therapy were affected by nocebo/drucebo effect,and the nocebo/drucebo ratio in the SAMSON trial was 90％.Conclusion Proper identification and management of SAMS and drug intolerance during statin therapy,as well as vigilance against nocebo/drucebo effect on making clinical decisions,will help to improve patients'long-term compliance with lipid-lowering therapy and reduce the incidence of major adverse cardiovascular events and mortality.
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