Tag: statistics

Psychiatry Clin Neurosci. 2021 Dec 21. doi: 10.1111/pcn.13323. Online ahead of print.

ABSTRACT

AIM: To evaluate the efficacy and safety of berberine as an adjuvant in treating antipsychotic-associated weight gain and metabolic syndrome (MetS).

METHODS: One hundred and thirteen participants with schizophrenia spectrum disorders who had developed MetS were recruited. They were randomly assigned to berberine (600 mg/day, n=58) or placebo (n=55) groups for 12 weeks. The primary outcome was the change from baseline to week 12 in net weight. Secondary outcomes included body mass index (BMI), waist circumference, serum glucose and lipid profiles, and the severity of psychotic symptoms.

RESULTS: Compared with the placebo group, the berberine group showed a significantly greater reduction in weight gain at 9 weeks (mean difference [MD]=-0.75, 95% confidence interval [CI]: -1.42 to -0.07, P=0.031, d=0.41) and 12 weeks (MD=-1.08, 95% CI: -1.76 to -0.40, P=0.002, d=0.59). Patients who received berberine also showed statistically significant improvements in endpoint in BMI (MD=-0.41, 95% CI: -0.65 to -0.17, P=0.001, d=0.64), total cholesterol (MD=-0.58, 95% CI: -0.74 to -0.41, P<.001, d=1.31), low-density lipoprotein (MD=-0.52, 95% CI: -0.68 to -0.35, P<.001, d=1.19), and glycated hemoglobin (MD=-0.09, 95% CI: -0.18 to 0, P=0.05, d=0.37). Berberine was well tolerated without serious adverse events and aggravation of psychotic symptoms compared with placebo.

CONCLUSIONS: Findings suggest that berberine is effective in attenuating antipsychotic-associated weight gain and MetS. This article is protected by copyright. All rights reserved.

PMID:34931749 | DOI:10.1111/pcn.13323

Eur J Public Health. 2021 Dec 21:ckab106. doi: 10.1093/eurpub/ckab106. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence based health policy, such as that put forward in the European Food and Nutrition Action Plan 2015-2020 and the WHO Global Action Plan on the Prevention and Control of Noncommunicable Diseases, has a role in curbing the consumption of unhealthful foods and drink. We ask how countries are performing in the adoption of these policies and how the comprehensiveness of their food environment policies explains variations in consumption of unhealthful products across Europe.

METHODS: In order to assess the state of policy adoption, we developed a composite indicator-the Food Regulatory Environment Index (FREI) for which we calculated unweighted and weighted formulations according to the strength of the evidence base. We used linear regression models to explain variations in the consumption of unhealthful products as well as variations in a composite indicator of obesogenic diets.

RESULTS: Overall, wealthier countries in the Region perform better. The weighting of the constituent policies does not affect the rankings. We find negative associations between unweighted and weighted formulations of the Index and household consumption of sugary and carbonate drinks as well as with the composite indicator for obesogenic diets.

CONCLUSIONS: The main strength of this study is the comprehensiveness and comparability of the policy data across the relatively large number of countries covered. There is a negative association that is statistically significant, between all formulations of the FREI and the household consumption of sugary and carbonated drinks. There is also a negative association between some FREI formulations and obesogenic diets.

PMID:34931673 | DOI:10.1093/eurpub/ckab106

Clin Transplant. 2021 Dec 21:e14565. doi: 10.1111/ctr.14565. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the clinical efficacy and safety of iguratimod (IGU) for reducing panel reactive antibody (PRA) in high-mismatched renal transplant recipients.

METHODS: Eligible recipients positive for PRAs who received or did not receive IGU treatment were enrolled. We retrospectively reviewed, collected, and analyzed statistically the clinical data of the recipients.

RESULTS: A total of 80 recipients were included for further analysis. After IGU was administered for nine months, no significant difference was found in the change rates of donor specific antibodies between two groups. Meanwhile, the reduction in the PRAs in the IGU group was greater than that in the non-IGU group in anti-human leukocyte antigen (HLA) class I and class II, anti-HLA class I, anti-HLA class II, anti-HLA A, and anti-HLA DR antibodies. However, no differences were found in the anti-HLA B, anti-HLA Cw, anti-HLA DP, and anti-HLA DQ antibodies between the two groups. No serious adverse events were reported, and the incidence of adverse events was comparable between the two groups.

CONCLUSION: PRA levels in high-mismatched renal transplant recipients were significantly reduced after the administration of IGU. The high safety of IGU was also determined. This article is protected by copyright. All rights reserved.

PMID:34931720 | DOI:10.1111/ctr.14565

Iran J Immunol. 2021 Dec;18(4):8. doi: 10.22034/IJI.2021.92669.2167.

ABSTRACT

BACKGROUND: Interleukin-37 (IL-37) is a recently described cytokine that emerges as a natural inhibitor of inflammatory and immune responses. However, IL-37 has not yet been investigated in bladder cancer, and its biological role is unknown.

OBJECTIVE: The purpose of this study was to investigate IL-37 serum levels in patients with bladder cancer and determine whether they were linked to the patients’ pathological characteristics.

METHODS: IL-37 serum levels were measured using a commercial ELISA kit in 60 patients with transitional cell carcinoma (TCC) of the bladder (mean age: 64.55±12.93) and 50 healthy controls (mean age: 62.94±12.69). Non-parametric tests were used for statistical comparisons, and the Cohen’s d effect size was calculated to evaluate the practical and clinical significance of the results.

RESULTS: Our findings indicated an increasing trend in IL-37 serum levels in patients with TCC (42.77±3.36 pg/ml) in comparison with controls (40.51±3.88 pg/ml, p=0.09). However, IL-37 serum levels were found to be significantly higher in male patients (44.72±3.81 pg/ml) and patients aged ≥70 (46.92±6.77 pg/ml) in comparison with male controls (29.96±3.30 pg/ml, p=0.026) and controls aged ≥70 (23.62±4.34 pg/ml, p=0.009). In comparison to similar controls, Cohen’s d effect size for patients aged ≥70 years was found to be 0.90.

CONCLUSION: The findings reveal a higher serum level of IL-37 in patients with TCC, which might be clinically associated with immunosuppression and tumor growth. However, this is a preliminary study, and more research on the biological role of IL-37 and its potential therapeutic effects in bladder cancer is required.

PMID:34931620 | DOI:10.22034/IJI.2021.92669.2167

Am J Chin Med. 2021 Dec 20:1-27. doi: 10.1142/S0192415X22500057. Online ahead of print.

ABSTRACT

The efficacy and safety of Shengmai preparation combined with Western medicine (SMP-WM) to treat coronary heart disease (CHD) were reviewed. Twenty-five randomized controlled trials of SMP-WM treatment for CHD were retrieved from seven databases and other trial sources between their inception and April 10, 2021. The risk of bias domains was accessed by Cochrane Collaboration’s tool, and the data were statistically analyzed using RevMan 5.3 and Stata 12.0 software. The majority of included studies had a low or unclear risk of overall bias. Total mortality was not reduced (RR = 0.39, 95% CI: 0.13-1.19, [Formula: see text] = 0.10), but the cardiovascular events (RR = 0.35, 95% CI: 0.22-0.54, [Formula: see text] < 0.01), weekly frequency (SMD = -2.38, 95% CI: -2.89 – -1.88, [Formula: see text] < 0.01), and duration (SMD = -3.24, 95% CI: -3.76 – -2.71, [Formula: see text] < 0.01) of angina pectoris attacks were significantly decreased by SMP-WM. The SMP-WM combination exerted antiplatelet activity by reducing platelet adhesion (SMD = -0.97, 95% CI: -1.49 – -0.45, [Formula: see text] = 0.0003) and the platelet reactivity index (SMD = -1.75, 95% CI: -2.04 – -1.46, [Formula: see text] < 0.01). SMP-WM could protect endothelial function by increasing nitric oxide (SMD = 1.28, 95% CI: 0.54-2.02, [Formula: see text] < 0.01) and decreasing endothelin (SMD = -1.26, 95% CI: -1.85 – -0.66, [Formula: see text] < 0.01). The combination also improved hemorheology by reducing whole blood viscosity (SMD = -1.59, 95% CI: -2.32 – -0.85, [Formula: see text] < 0.01), plasma viscosity (SMD = -0.65, 95% CI: -0.86 – -0.45, [Formula: see text] < 0.01), and fibrinogen (SMD = -4.21, 95% CI: -4.58 – -3.83, [Formula: see text] < 0.01). The SMP-WM combination favorably impacts cardiovascular events, angina symptoms, endothelial function, platelet aggregation, and blood viscosity, with comparable safety to that of routine Western medicine. Further investigation is required to enhance the strength of the evidence.

PMID:34931586 | DOI:10.1142/S0192415X22500057

Clin Nephrol. 2021 Dec 21. doi: 10.5414/CN110516. Online ahead of print.

ABSTRACT

Ravulizumab and eculizumab are approved terminal complement inhibitor treatments for atypical hemolytic uremic syndrome (aHUS). Ravulizumab was engineered from eculizumab to have an increased half-life allowing for reduced dosing frequency (8-weekly vs. 2-weekly). To account for differences in respective clinical trials, a validated balancing technique was used to enable an indirect comparison of ravulizumab and eculizumab treatment efficacy in aHUS. Patient-level data from four eculizumab clinical trials were available for pooling and comparison with data from two ravulizumab trials. In the primary analysis, adult native kidney data were compared. Propensity scores were calculated from baseline characteristics (dialysis status, estimated glomerular filtration rate, platelet count, serum lactate dehydrogenase). Stabilized inverse probability weighting was used to balance groups. Changes in outcomes from baseline to 26 weeks were compared between treatment groups. Sensitivity and subgroup analyses were conducted to assess the robustness of findings. Overall, 85 patients (46 ravulizumab, 39 eculizumab) were included in the primary analysis. Demographic and clinical characteristics were well balanced after weighting at baseline. At 26 weeks, clinical outcomes (including renal function, hematological markers, and dialysis prevalence), and fatigue and quality of life measures were improved with eculizumab and ravulizumab treatment. No differences between treatment groups reached statistical significance, although confidence intervals were wide. Sensitivity and subgroup analysis results were consistent with those of the primary analysis. Using appropriate methodology for indirect comparison of studies, no differences in outcomes were seen between ravulizumab and eculizumab, although, owing to small sample sizes, confidence intervals were wide. .

PMID:34931610 | DOI:10.5414/CN110516

Percept Mot Skills. 2021 Dec 21:315125211060187. doi: 10.1177/00315125211060187. Online ahead of print.

ABSTRACT

In the current study, we investigated the effects of gender and regular physical activity (PA) on PA decision-making and speed of information processing. We enrolled 110 university students (Mage = 20.91, SD =2.28 years) in an experiment involving two tasks and a questionnaire. One of the two tasks assessed how much participants agreed with presented PA words and phrases and the other task predicted behavior and responses to future situations. We collected and measured the participants’ choices and the time they took to make them. The questionnaire, the International Physical Activity Questionnaire (IPAQ), consisted of exercise self-schema and PA questions. We conducted a 2 (gender: male or female) ×2 (regular PA or not) multivariate analysis of variance (MANOVA) and found statistically significant differences between variables as a function of participants’ gender (λ = .66, p < .001) and regular PA engagement (λ = .51, p < .001). In a regression analysis, we also found gender differences [males showed relationships between agreement with PA information and information processing speed for decisions on future behavior (R² = .31, F = 12.50); females showed relationships between their exercise self-schema (R² = .26, F = 18.18) and regular PA such that, in the non-regular PA group, exercise self-schema was related to reaction time in making decisions on future behavior (R² = .29, F = 11.23), and in the regular PA group, agreement with PA information was related to reaction time for PA-related words, and agreement with non-PA information (R² = .29, F = 8.91)]. These results highlight the need to consider participant characteristics when designing exercise interventions, and we present supplementary data regarding exercise self-schemas, decision-making, and the speed of processing PA information.

PMID:34931560 | DOI:10.1177/00315125211060187

Hisp Health Care Int. 2021 Dec 21:15404153211063639. doi: 10.1177/15404153211063639. Online ahead of print.

ABSTRACT

Introduction: Latinx children are the fastest-growing ethnic minority of children under the age of 5 years in a tri-county area in the Southeastern United States (US Census, 2018). There are limited culturally and linguistically appropriate school preparedness initiatives in this geographic region. Methods: A cultural and linguistic appropriate program was developed in coordination with the state’s largest Latinx advocacy organization and two patient-centered pediatric medical homes (PCPMHs) after securing extramural grant funding for an evidenced-based home visitation program using skilled community health workers (CHWs) aimed at Latinx children at the age of 0-5 years and their caregivers. The program includes developmental screenings using the Ages & Stages Questionnaires®, Third Edition (ASQ®-3), CHW role modeling of developmentally appropriate play, early literacy, connection to resources, oral health, nutrition, and physical activity. Results: Of the 103 unique children represented in this programmatic evaluation that received an initial and follow-up ASQ®-3 developmental screening, paired t-tests indicate statistically significant improvement in mean scores from the first to second ASQ®-3 in all five major developmental domains with the largest gains represented in the communication and fine motor skill domains. Conclusion: This evaluation suggests that low-frequency home visits from skilled CHWs can have a beneficial effect on development in early childhood. PPCMHs can serve as a hub for these community-based programs.

PMID:34931566 | DOI:10.1177/15404153211063639

Bone Jt Open. 2021 Dec;2(12):1082-1088. doi: 10.1302/2633-1462.212.BJO-2021-0119.R1.

ABSTRACT

AIMS: Single-shot adductor canal block (ACB) after total knee arthroplasty (TKA) for postoperative analgesia is a common modality. Patients can experience breakthrough pain when the effect of ACB wears off. Local anaesthetic infusion through an intra-articular catheter (IAC) can help manage breakthrough pain after TKA. We hypothesized that combined ACB with ropivacaine infusion through IAC is associated with better pain relief compared to ACB used alone.

METHODS: This study was a prospective double-blinded placebo-controlled randomized controlled trial to compare the efficacy of combined ACB+ IAC-ropivacaine infusion (study group, n = 68) versus single-shot ACB+ intra-articular normal saline placebo (control group, n = 66) after primary TKA. The primary outcome was assessment of pain, using the visual analogue scale (VAS) recorded at 6, 12, 24, and 48 hours after surgery. Secondary outcomes included active knee ROM 48 hours after surgery and additional requirement of analgesia for breakthrough pain.

RESULTS: The study group (mean visual analogue scale (VAS) pain score of 5.5 (SD 0.889)) experienced significant reduction in pain 12 hours after surgery compared to the control group (mean VAS 6.62 (SD 1.356); mean difference = 1.12, 95% confidence interval (CI) -1.46 to 0.67; p < 0.001), and pain scores on postoperative day (POD) 1 and POD-2 were lower in the study group compared to the control group (mean difference in VAS pain = 1.04 (-1.39 to -0.68, 95% CI, p < 0.001). Fewer patients in the study group (0 vs 3 in the control group) required additional analgesia for breakthrough pain, but this was not statistically significant. The study group had significantly increased active knee flexion (mean flexion 86.4° (SD 7.22°)), compared to the control group (mean 73.86° (SD 7.88°), mean difference = 12.54, 95% CI 9.97 to 15.1; p < 0.014).

CONCLUSION: Combined ACB+ ropivacaine infusion via IAC is a safe, reproducible analgesic modality after primary TKA, with superior analgesia compared to ACB alone. Further large volume trials are warranted to generate evidence on clinical significance on analgesia after TKA. Cite this article: Bone Jt Open 2021;2(12):1082-1088.

PMID:34931538 | DOI:10.1302/2633-1462.212.BJO-2021-0119.R1

Regen Med. 2021 Dec 21. doi: 10.2217/rme-2021-0056. Online ahead of print.

ABSTRACT

Aim: The present study aimed to investigate photobiomodulation’s (PBM) effect on inflamed dental pulp stem cells (IDPSCs) under different nutritional conditions. Methods: Cell proliferation and odontogenic differentiation were evaluated using the MTT assay and real-time quantitative reverse transcription PCR, respectively after laser PBM of cells in 5 or 10% fetal bovine serum (FBS) culture conditions. Results: A significant positive effect of laser irradiation on cell proliferation under both nutritional conditions after 24 and 48 h was observed. DMP-1 gene expression increased in the groups with laser irradiation and 5% FBS. Comparison of gene expression levels in the four groups revealed no statistically significant stimulatory effect. The highest gene expression was observed in the non-laser group with 5% FBS. Conclusion: Further studies are required to obtain an irradiation setup to ideally improve inflamed dental pulp stem cells’ proliferation and differentiation.

PMID:34931540 | DOI:10.2217/rme-2021-0056