4. Discussion
sarcopenia
ADVERSE EVENTS, MINOR, SARCOPENIA, SECONDARY, CORONAVIRUS, COMPLICATIONS
This study assessed the efficacy and dose dependence of ALA in sarcopenia. No significant intergroup difference in the change in SMI compared to the placebo group was observed at the 12-week follow-up; this may have been due to the small sample size (20 cases per group), short intervention period (12 weeks), and large individual differences in the change in SMI, resulting in a large SD. In addition, the target sample size in this study was determined based on a previous cross-sectional study that investigated the prevalence of sarcopenia among the elderly Japanese population [Among the secondary endpoints, hand grip significantly increased or tended to increase from baseline to week 12 with all doses of ALA or SFC compared with the placebo group. Although it was reported that hand grip was associated with physical and mental health-related QOL in elderly [No safety concerns were observed for any doses of ALA or SFC. A previous study reported that a dose increase of ALA from 100 mg to 200 mg did not cause serious adverse events or increase the frequency of non-serious adverse events compared with the placebo [This study has several limitations. First, as described above, owing to the small sample size and a minor change in the primary endpoint than assumed in the sample size calculation, the power to detect intergroup differences might be insufficient. Further investigation is required in the future with a more appropriate sample size and extended intervention period based on the calculation of the change and SD in this study. Second, SMI was measured using the BIA method in this study. Although measurement with a more accurate method (dual-energy X-ray absorptiometry) might be more appropriate to assess the effect of ALA on sarcopenia under conditions close to actual medical care, this study employed the BIA method. This study used InBody270, whose accuracy is relatively high compared to that of the BIA method; however, the employment of the BIA method might be a reason for the large SD. Third, no consistent change in the endpoints, except for hand grip, was observed. Although hand grip strength significantly increased or tended to increase from baseline to week 12 with all doses of ALA or SFC compared to the placebo group, no obvious dose dependency was observed. However, the effects of certain external factors cannot be ignored. Since this study was conducted during the coronavirus pandemic of 2019, physical activity or dietary habits might have been affected by the pandemic, and these changes might have affected the results. Fourth, the effects of other medications and complications were not assessed in this study. Since polypharmacy is an Important problem in elderly [