Sialyllactoses (SL) are an abundant component of human milk. There have been many studies on the biological effects of SL in humans. SL can be produced using an economical method of enzyme synthesis. Although the European Food Safety Authority has published the human safety and appropriate intake dose of 6'-SL sodium salt as a novel food, it has suggested that the appropriate dose for particular medical purposes be judged on a case-by-case basis. Also, as revealed in the same report, there are no data on toxicity when 6'-SL is used in human intervention. However, clinical studies have only confirmed the safety of 3'-SL for therapeutic intervention in humans, and the safety for therapeutic use of 6'-SL, which is more abundant than 3'-SL in human milk, has not been confirmed. In this study, to determine the safety of 6'-SL use in humans, participants were randomly assigned to the placebo (maltodextrin) and 6'-SL groups, and then 3 g of powder was orally administered twice a day for 12 weeks. There were no serious adverse reactions, such as life-threatening complications requiring hospitalization, causing disability, or causing deformity during the use of 6'-SL. There were no clinically significant differences among the baseline, sixth, and twelfth week clinical chemistry tests, such as aspartate aminotransferase, alanine aminotransferase, and creatinine. Most of the adverse reactions were gastrointestinal problems such as diarrhea, abdominal discomfort, and bloating, with no significant difference in the proportions between the placebo and 6'-SL groups. These results support the safety of the 6'-SL for human use.
Digital therapeutics (DTx), novel treatment methods that have the potential to surpass traditional approaches such as pills, have received considerable research attention. Various efforts have been made to explore effective treatment methods that actively integrate DTx. This review investigates DTx treatment outcomes comprehensively through a meta-analysis. The analysis—a manual search of studies on “digital therapeutics”—includes DTx studies from January 2017 to October 2022. Hedges’ g is used to quantify effect size for fifteen studies analyzed, encompassing eight control groups. Further, a quality assessment is performed using the Bias Risk Assessment Tool. The Hedges’ g analysis results provide weighted average effect sizes across the eight control groups, revealing a substantial value of 0.91 (95% CI: 0.62 to 1.20); this signifies a moderate to large effect size. Further refinement, which excludes one study, yields an increased weighted average effect size of 1.13 (95% CI: 0.91 to 1.36). The quality assessment results consistently indicate a low risk of bias across studies. The meta-analysis results indicate that DTx can provide significant pivotal therapeutic impacts and offer a means to personalize treatment approaches and streamline the management of patients’ treatment processes.
28 February 2019 in Annals of Rehabilitation Medicine
To elucidate the effect of task-specific lower extremity training (TSLET) on cognitive and gait function in stroke patients. Thirty-eight patients were assigned to either the TSLET group or the control group. The individuals of TSLET group went through a TSLET plus conventional physical therapy. The control group received two sessions of conventional physical therapy. The primary outcome involved the assessment with visual and auditory digit span test. The secondary outcome was evaluated by the Korean version of Mini-Mental State Examination (K-MMSE) and Global Deterioration Scale (GDS) for cognitive function, Berg Balance Scale (BBS), Time Up and Go Test (TUG), 10 meters Walking Test (10mWT), 6 minutes Walking Test (6MWT), and Korean version of Modified Barthel Index (K-MBI) for gait, balance, and functional ability. After intervention (3 weeks) and 2 weeks of follow-up, the TSLET group showed statistically significant improvement in the visual digit span test backwards compared with the control group. In secondary outcome, a significant improvement was observed in GDS, BBS, TUG, and 10mWT in the TSLET group. There was no significant difference between the two groups concerning visual digit span test forward, auditory forward and backward digit span tests, K-MMSE, 6MWT, and K-MBI. TSLET could be a useful alternative strategy for improving cognitive and gait function in stroke patients.
Knee osteoarthritis (OA) is one of the most common degenerative diseases in old age. Recent studies have suggested new treatment approaches dealing with subchondral remodeling, which is a typical feature of OA progression. However, diagnostic tools or therapeutic approaches related to such a process are still being researched. The automated artificial intelligence (AI) algorithm-based texture analysis is a new method used for OA-progression detection. We designed a prospective case series study to examine the efficacy of the AI algorithm-based texture analysis in detecting the restoration of the subchondral remodeling process, which is expected to follow therapeutic intervention. In this study, we used polynucleotide (PN) filler injections as the therapeutic modality and the treatment outcome was verified by symptom improvement, as well as by the induction of subchondral microstructural changes. We used AI algorithm-based texture analysis to observe these changes in the subchondral bone with the bone structure value (BSV). A total of 51 participants diagnosed with knee OA were enrolled in this study. Intra-articular PN filler (HP cell Vitaran J) injections were administered once a week and five times in total. Knee X-rays and texture analyses with BSVs were performed during the screening visit and the last visit three months after screening. The Visual Analogue Scale (VAS) and Korean-Western Ontario MacMaster (K-WOMAC) measurements were used at the screening visit, the fifth intra-articular injection visit, and the last visit. The VAS and K-WOMAC scores decreased after PN treatment and lasted for three months after the final injection. The BSV changed in the middle and deep layers of tibial bone after PN injection. This result could imply that there were microstructural changes in the subchondral bone after PN treatment, and that this change could be detected using the AI algorithm-based texture analysis. In conclusion, the AI- algorithm-based texture analysis could be a promising tool for detecting and assessing the therapeutic outcome in knee OA.
31 August 2020 in Annals of Rehabilitation Medicine
Objective To determine the immediate and short-term impact of the application of wearable balance compensation system (BCS) on balance impairment in patients with spinocerebellar ataxia (SCA).Methods The study enrolled 6 participants with SCA with varying degrees of balance impairment. After adjustment for individual fitting, wearable BCS with up to 3% body weight was placed in a garment on the trunk. Sway direction and magnitude were measured with sensors placed posteriorly at the lumbosacral junction, immediately before and after, and at day 1, day 2, and day 7 after wearing the BCS. Timed Up & Go test (TUG) and 25-foot timed walk test were performed, and static foot pressure was measured.Results A significant improvement in static and dynamic balance was found during the 25-foot timed walk and in static foot pressure measurement results after wearing the BCS, when compared with that at baseline (p=0.044 vs. p=0.011). Anterior and posterior sway showed improvements from baseline after wearing the BCS. Improvement in the lateral swaying movement control was also seen.Conclusion Application of the BCS might be beneficial in the improvement ofthe static and dynamic balance in patients with SCA. Further research on long-term effects and with a larger sample size is indicated.
(1) Background: The intravoxel incoherent motion (IVIM) model can provide information about both molecular diffusion and blood flow for the evaluation of skeletal muscle inflammation. MRI-based fat quantification is advantageous for assessing fat infiltration in skeletal muscle. (2) Purpose: We aimed to quantitatively measure various parameters associated with IVIM diffusion-weighted imaging (DWI) and fat quantification in the muscles of patients with polymyositis and dermatomyositis using magnetic resonance imaging and to investigate the relationship between these parameters and electromyography (EMG) findings. (3) Material and methods: Data were retrospectively evaluated for 12 patients with polymyositis and dermatomyositis who underwent thigh MRI, including IVIM-DWI and fat quantification. The IVIM-derived parameters included the pure diffusion coefficient (D), pseudodiffusion coefficient (D*), and perfusion fraction (f). Fat fraction values were assessed using the six-point Dixon technique. Needle EMG was performed within 9 days of the MRI. (4) Results: The f values (19.02 ± 4.87%) in muscles with pathological spontaneous activity on EMG were significantly higher than those (14.60 ± 5.31) in muscles without pathological spontaneous activity (p < 0.027). There were no significant differences in D, D*, ADC, or fat fraction between muscles with and without pathologic spontaneous activity. Significant negative correlations were observed between fat fraction and amplitude (r = −0.402, p < 0.015) and between fat fraction and duration (r = −0.360, p < 0.031). (5) Conclusion: The current study demonstrates that IVIM-DWI and fat quantification using 3.0 T MRI may aid in predicting EMG findings in patients with polymyositis and dermatomyositis and promote the pathophysiological study of idiopathic inflammatory myopathies.