Efficacy and Safety of Once-Weekly Semaglutide 2.0 mg vs 1.0 mg by Baseline HbA1c and BMI: SUSTAIN FORTE Subgroup Analyses

Aim. To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients (T2DM). Materials and Methods. This is a multi-center, open-label prospective observational study. 245 treatment-naive T2DM patients, who had not achieved glycemic goals on lifestyle therapy during first 12 weeks after the diagnosis, were enrolled in this study. Anti-diabetes treatment was initiated with glimepiride and continued during the 6-month follow-up period. Prescription of the initial dose (1 mg per day) and further dose adjustments were carried out by the attending physician in accordance with the glimepiride data sheet. Dynamics of HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), weight and waist circumference, as well as the incidence of hypoglycemia were the evaluated parameters. Results. The baseline HbA1c (mean: 7.9?0.5%; female: 7.8?0.4% ; male: 8.0?0.6%) was significantly reduced at week 12 (mean 7.2?0.6%, p

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Verification of the Efficacy and Safety of Qi-Replenishing Chinese Medicine in Treating Prediabetes: A Meta-Analysis and Literature Review

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7676281 ◽

2020 ◽

Vol 2020 ◽

pp. 1-15

Author(s):

Shujie Xia ◽

Bizhen Gao ◽

Shujiao Chen ◽

Xuejuan Lin ◽

Ping Zhang ◽

...

Keyword(s):

Clinical Practice ◽

Blood Glucose ◽

Chinese Medicine ◽

Adverse Events ◽

Clinical Outcomes ◽

Meta Analysis ◽

Postprandial Blood Glucose ◽

Syndrome Differentiation ◽

Efficacy And Safety ◽

Subgroup Analyses

Background. Qi-replenishing Chinese medicines (QCMs) are used for treating prediabetes in the traditional Chinese medicine (TCM) clinical practice. The aims of this meta-analysis were to (i) verify the efficacy and safety of QCMs in treating prediabetes and (ii) investigate the clinical outcomes between the trials complying with and not complying with the principle of “syndrome differentiation.” Methods. We included only randomized controlled clinical trials (RCTs) whose Jadad scores were not less than 4. The overall clinical outcomes, including the incidence rate of diabetes, normalization of blood glucose, changes in fasting blood glucose (FBG), 2 h postprandial blood glucose, HbA1c, and occurrence of adverse events, were evaluated. Subgroup analyses were performed. Results. A total of 11 RCTs that enrolled 2210 patients with prediabetes were included. We observed that overall treatment with QCMs significantly ameliorated the clinical outcomes of prediabetes without increasing incidence of adverse events. The results of subgroup analyses revealed that prescribing QCMs complying with syndrome differentiation ameliorated all the clinical indices, whereas prescribing not complying with syndrome differentiation could not achieve significant amelioration in FBG and HbA1c levels. Furthermore, the subgroup with syndrome differentiation reported more adverse events. Conclusions. The overall results suggested that QCMs are effective and safe in treating prediabetes. Results of subgroup analyses indicated that the groups with syndrome differentiation presented better efficacy but had a higher occurrence of adverse events. This study indicated the important role of the principle of syndrome differentiation in TCM and that the adverse events of QCMs cannot be ignored in TCM clinical practice.

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Intra-articular Injection of Autologous Adipose-Derived Stem Cells or Stromal Vascular Fractions: Are They Effective for Patients With Knee Osteoarthritis? A Systematic Review With Meta-analysis of Randomized Controlled Trials

The American Journal of Sports Medicine ◽

10.1177/03635465211053893 ◽

2022 ◽

pp. 036354652110538

Author(s):

Kang-Il Kim ◽

Myung-Seo Kim ◽

Jun-Ho Kim

Keyword(s):

Stem Cells ◽

Pain Relief ◽

Meta Analysis ◽

Functional Improvement ◽

Controlled Trials ◽

Adipose Derived Stem Cells ◽

Efficacy And Safety ◽

Knee Oa ◽

Randomized Controlled ◽

Subgroup Analyses

Background: Intra-articular injection of adipose-derived stem cells, which are divided into adipose-derived mesenchymal stem cells (ASCs) and adipose-derived stromal vascular fractions (ADSVFs), has been reported to be a viable treatment modality for knee osteoarthritis (OA); however, its efficacy remains limited. Purpose: This study aimed to provide comprehensive information about the efficacy and safety of intra-articular injections of autologous ASCs and ADSVFs without adjuvant treatment in patients with knee OA. Study Design: Meta-analysis; Level of evidence, 1. Methods: A systematic search of the MEDLINE, Embase, Web of Science, and Cochrane Library databases was performed to identify randomized controlled trials (RCTs) that evaluated the efficacy and safety of intra-articular injections of autologous ASCs or ADSVFs without adjuvant treatments compared with placebo or hyaluronic acid in patients with knee OA. Clinically, the 100-mm visual analog scale for pain relief and the Western Ontario and McMaster Universities Osteoarthritis Index for functional improvement were implemented. Radiologically, cartilage status was assessed using magnetic resonance imaging (MRI). Procedure-related knee pain, swelling, and adverse events (AEs) were evaluated for safety. Additionally, we performed subgroup analyses comparing ASCs versus ADSVFs. Methodological quality was assessed using the modified Coleman Methodology Score (mCMS). Results: A total of 5 RCTs were included in this study. Based on the meta-analysis, ASCs or ADSVFs showed significantly better pain relief at 6 months ( Z = 7.62; P < .0001) and 12 months ( Z = 7.21; P < .0001) and functional improvement at 6 months ( Z = 4.13; P < .0001) and 12 months ( Z = 3.79; P = .0002), without a difference in procedure-related knee pain or swelling compared with controls. Although a meta-analysis with regard to cartilage improvements was not performed owing to heterogeneous MRI assessment, 3 studies reported significantly improved cartilage status after the injection. No serious AEs associated with ASCs or ADSVFs were reported. Subgroup analyses showed similar efficacy between ASC and ADSVF treatments. The median mCMS was 70 (range, 55-75). Conclusion: For patients with knee OA, intra-articular injection of autologous ASCs or ADSVFs without adjuvant treatment showed remarkable clinical efficacy and safety at short-term follow-up. Some degree of efficacy has been shown for cartilage regeneration in knee OA, although the evidence remains limited. Further RCTs that directly compare ASCs and ADSVFs are needed.

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