4. Discussion
RECRUITMENT
In the face of frequent reports of SAMS [Using a cut-off value (15%) which can be considered clinically relevant and a value greater than what is expected from test habituation, we showed a clearly greater proportion of patients showing improvement in objective measures of muscle performance when reporting SAMS (Our data must, of course, be nuanced in the context of a growing body of evidence for a large nocebo effect in patients self-reporting SAMS [It is of great importance to develop or validate tools that purport to identify likely sufferers of “true” SAMS [This study has several strengths. First, the lipid data indicate that we can be confident about compliance with statin withdrawal. Second, the inclusion of a No SAMS group and a Control group allows a more rigorous analysis and interpretation of results, even if these groups are somewhat smaller. Third, the use of validated and standardized sensitive objective measures allows us to discern little but real effects in muscle function. This study is also, to our knowledge, the first work to attempt to validate the SAMS-CI. Finally, the population recruited here represents a typical population of primary CV prevention patients treated with statins, which reinforces the clinical relevance of our data.A limitation of this study is that recruitment was based on self-reporting of SAMS. Even if we limited the sources of bias using various recruitment criteria, we cannot be certain of the potential influence of the nocebo effect on our results. On the other hand, considering the growing interest in patient-reported outcomes in clinical studies and especially their unique ability to be a true reflection of a “patient-centered approach” [