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Background: Recently, trials have supported changes in deep caries management. However, reporting might lack details, affecting interpretation and implementation. Thus, we aimed to evaluate the adherence to the CONSORT statement and the risk of bias of randomized controlled trials (RCTs) on deep caries management published in pediatric dental journals. Methods: We searched PubMed for RCTs in six pediatric dental journals between 2010 and 2022, focusing on deep caries lesion management. Adherence to the CONSORT guideline and the risk of bias were assessed using a modified tool with 19 items; each scored from 0 to 2 (maximum of 38 points), and the Cochrane risk-of-bias (RoB 2) tool. We performed descriptive and regression analyses (α = 5%). Results: We analyzed 127 RCTs. The mean (standard deviation) CONSORT adherence score was 21.1 (6.7). Notably, 96.1% of the studies received a score of 2 for the "intervention" item, whereas 83.5% scored 0 for the "estimated effect size". The risk of bias assessment revealed that 40.2% of the RCTs were at high risk, 59% were at low risk, and 0.8% were at low risk. RCTs with a high risk of bias had lower CONSORT scores (p<0.001) than those with low or some concerns. RCTs published in journals without the endorsement of the CONSORT statement had lower scores than those in journals with the endorsement of the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) showed significantly lower CONSORT statement compliance than trials published recently within 5 years. Conclusion: Adherence to the CONSORT was relatively low among the investigated RCTs. Moreover, lower adherence to the CONSORT was associated with a higher risk of bias. Trial Registration: This study protocol was prospectively registered on the Open Science Framework - DOI (10.17605/OSF.IO/V6SYZ). [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the efficacy of acupuncture in the treatment of pressure ulcers. Randomized controlled trials evaluating the effects of acupuncture on pressure ulcers were identified through a comprehensive literature search on public database. The quality assessment of the included trials was performed based on the guidance of the Cochrane Reviewers' Handbook, and pooled analyses were performed by using the RevMan 5.4 software. The pooled results demonstrated that acupuncture in combination with standard wound care was significantly superior to standard wound care alone with regard to effective rate (RR 1.17, 95% CI [1.10, 1.24]), reduction in Wound Size (MD −2.78, 95% CI [−2.43, −1.44]), healing time (MD −6.24, 95% CI [−12.32, −0.17]) and the amount of 24‐h exudate (MD −0.86, 95% CI [−1.54, −0.18]). In conclusion, this study suggests that acupuncture can be used as an adjunctive therapy to promote healing of pressure ulcers. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the effects of couple‐based dyadic interventions on breast cancer patients and their intimate partners and compare the effects between interventions with different durations (<3 months; =3 months; >3 months). Design: A systematic review and meta‐analysis. Data sources: Six English databases, PubMed, Embase, Web of Science Core Collection, the Cochrane Library, Medline, PsycINFO, and three Chinese databases, China National Knowledge Infrastructure (CNKI), WanFang, and Weipu (VIP), from database inception to 19 February 2022. Review Methods: The quality of the included RCTs was evaluated using the Cochrane risk‐of‐bias tool and the data analysis was performed by using RevMan 5.4 and Stata 15. The outcomes were categorized into five aspects: dyadic relationship, overall quality of life (QOL), physical health, psychological health and social adjustment. Results: Nineteen RCTs were included. For patients' overall effects, couple‐based dyadic interventions can improve sexual frequency, psychological health (anxiety; depression; well‐being; body image) and social adjustment (family function‐cohesion; social function‐total). In the subgroup analysis, it can adjust patients' relationship satisfaction (>3 months), sexual frequency (>3 months), depression (<3 months and >3 months), well‐being (>3 months), and body image (3 months). For intimate partners, no statistically significant overall effects were found, and all results in the subgroup analyses showed no statistical significance. Conclusions: The results revealed the different effects of couple‐based dyadic interventions on dyads. It also suggested that tailored intervention duration should be a focus in future studies to obtain the potential actor‐partner benefits. Impact: This study revealed that the overall effects of the couple‐based dyadic interventions include enhancing patients' sexual frequency, psychological health and social adjustment. Clinical practitioners should consider the intimate partners' outcomes and conduct couple‐based dyadic interventions that contain more tailored elements to achieve better effects. No Patient or Public Contribution: Registration: The systematic review and meta‐analysis of RCTs has been registered in PROSPERO (Number: CRD 42021286679). [ABSTRACT FROM AUTHOR]

Background: Garlic (Allium sativum), the underground bulb of the Allium genus, has been consumed on Earth for thousands of years. Many clinical trials of garlic supplementation on components of metabolic syndrome (MetS) have emerged in recent years, but there is no consensus on the effect. This meta-analysis aimed at systematically evaluating the effect of garlic supplementation on components of MetS. Methods: In this meta-analysis, we searched Pubmed, Embase, Cochrane, Medline, Web of Science databases, and clinical trials online sites from inception to November 1, 2022, with language restrictions to English. We engaged participants > 18 years and eligible for the clinical diagnosis of MetS or those with metabolic disorders and garlic was the only intervention. Outcomes included waist circumference, and body mass index, triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, blood pressure, and fasting blood glucose. Meta-regression and subgroup analyses were conducted based on six covariates (total sample size, the mean age, the mean dose, the duration of intervention, the oral form of garlic, and the dietary intervention). Results: Results from 19 RCTs were included engaging 999 participants. Compared to placebo, garlic significantly reduced TG [SMD (95%CI) = -0.66 (-1.23, -0.09)], TC [SMD (95%CI) = -0.43 (-0.86, -0.01)], LDL [SMD (95%CI) = -0.44(-0.88, -0.01)], DBP [SMD (95%CI) = -1.33 (-2.14, -0.53)], BMI [SMD (95%CI) = -1.10(-1.90, -0.20)], and WC [SMD (95%CI) = -0.78(-1.09, -0.47)]. Meta-regression showed age and sample size are potential effect modifiers. Conclusion: According to the results of meta-analysis, the modulatory effect of garlic on some MetS components is evident. More high-quality, large-scale RCTs are needed to confirm iat based on the high heterogeneity and potential publication bias of the current data. Trial registration: https://www.crd.york.ac.uk/prospero/display%5frecord.php?RecordID=373228, ID: CRD42022373228. [ABSTRACT FROM AUTHOR]

Aim: To answer the following PICO question: In systemically healthy humans with peri‐implant mucositis, what is the efficacy of patient‐performed or administered (by prescription) measures used adjunctively to submarginal instrumentation, as compared to submarginal instrumentation alone or combined with a negative control, in terms of reducing bleeding on probing (BOP), in randomized controlled clinical trials (RCTs) with at least 3 months of follow‐up? Materials and Methods: Three databases were searched until April 2022. Weighted mean differences (WMDs) with 95% confidence intervals (CIs) and predictive intervals were calculated. Results: Sixteen parallel RCTs corresponding to 14 studies with low/moderate risk of bias were included. Test groups showed greater reductions in BOP (%) than control groups (nstudies = 16; npatients = 650; WMD = 14.25%; 95% CI [9.06–19.45]; p <.001; I2 = 98.7%). The greatest WMD in BOP reductions (%) were obtained by antiseptics (ns = 5; np = 229; WMD = 22.72%; 95% CI [19.40–26.04]; p < 0.001; I2 = 94.8%), followed by probiotics (ns = 6; np = 260; WMD = 12.11%; 95% CI [3.20–21.03]; p =.008; I2 = 93.3%) and systemic antibiotics (ns = 3; np = 101; WMD = 5.97%; 95% CI [1.34–10.59]; p =.012; I2 = 58.1%). Disease resolution was scarcely reported (n = 6). Conclusions: Significant clinical improvements can be obtained when professional submarginal instrumentation is combined with patient‐performed or administered (by prescription) adjunctive measures, although a complete disease resolution may not be achieved. [ABSTRACT FROM AUTHOR]

Background: Depression during pregnancy and after the birth of a child is highly prevalent and an important public health problem. Psychological interventions are the first-line treatment and, although a considerable number of randomized trials have been conducted, no recent comprehensive meta-analysis has evaluated treatment effects. Methods: We used an existing database of randomized controlled trials of psychotherapies for adult depression and included studies aimed at perinatal depression. Random effects models were used in all analyses. We examined the effects of the interventions in the short and long term, and also examined secondary outcomes. Results: Forty-three studies with 49 comparisons and 6270 participants between an intervention and control group were included. The overall effect size was g = 0.67 [95% confidence interval (CI) 0.45~0.89; numbers needed-to-be-treated = 4.39] with high heterogeneity (I2 = 80%; 95% CI 75~85). This effect size remained largely unchanged and significant in a series of sensitivity analyses, although some publication bias was found. The effects remained significant at 6–12 months follow-up. Significant effects were also found for social support, anxiety, functional limitations, parental stress and marital stress, although the number of studies for each outcome was low. All results should be considered with caution because of the high levels of heterogeneity in most analyses. Conclusions: Psychological interventions are probably effective in the treatment of perinatal depression, with effects that last at least up to 6–12 months and probably also have effects on social support, anxiety, functional impairment, parental stress, and marital stress. [ABSTRACT FROM AUTHOR]

Objective: Non-pharmacological therapies (NPTs) have received increasing attention from researchers as a category of treatment to improve cognitive impairment in patients with dementia because of their fewer side effects. In this study, photobiomodulation (PBM), enriched environment (EE), exercise therapy (ET), computerized cognitive training (CCT), and cognitive stimulation therapy (CST) were selected to compare the effects of NPTs that improve dementia by quantifying information from randomized controlled trials (RCTs). Methods: We did a systematic review and network meta-analysis. We searched PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure Database, Wan Fang Database, Chinese Biomedical Literature Database, Web of Science, and VIP Database from the time of database creation to 1 August 2022. Two investigators independently screened the literature, extracted information, and assessed the RCTs' quality with the Cochrane Collaboration Network Risk of Bias 2.0. Network meta-analysis was performed using R language (X64 version 4.1.3) and STATA 17.0. Results: We identified 1,268 citations and of these included 38 trials comprising 3,412 participants. For improving dementia, the results of the network metaanalysis showed that compared with the control group (CON), PBM (SMD = 0.90, 95% CI: 0.43-1.37), EE (SMD = 0.71, 95% CI: 0.02-1.41), ET (SMD = 0.42, 95% CI: 0.16-0.68), and CST (SMD = 0.36, 95% CI: 0.11-0.62) were significantly different (P < 0.05); There was no significant difference in CCT (SMD = 0.41, 95% CI: 0.07-0.88) (P > 0.05). The ranked results showed that PBM has more potential to be the best intervention (P = 0.90). In addition, there was a significant difference between PBM and CST in improving cognitive function (SMD = 0.54, 95% CI: 0.00; 1.08, P < 0.05). Conclusion: In this study, NPTs have excellent potential to improve cognition in people with dementia, and PBM may have more significant benefits in improving cognition than the other four NPTs. [ABSTRACT FROM AUTHOR]

Summary: Dropout from placebo arms in randomized-controlled trials is a surrogate for nocebo responses, resulting from patients' negative expectations to treatment. Among 16,460 placebo-treated patients in oral anti-osteoporotic drug trials, nocebo dropouts were 8% on average, being higher in older patients. This implies that nocebo may contribute to the osteoporosis treatment gap in clinical practice. Purpose: Osteoporosis is a common disease requiring long-term treatment. Despite the availability of effective anti-osteoporotic drugs, adherence to treatment is low. Nocebo, a behavior mostly related to the negative expectations to a certain treatment, decreases adherence and negatively affects treatment outcomes and health-related care costs in chronic diseases. Since in double-blind placebo-controlled randomized trials any unfavorable outcome leading to discontinuation in placebo arms is considered as nocebo, we aimed to investigate the size of nocebo response in patients participating in osteoporosis trials. Methods: We searched MEDLINE, EMBASE, SCOPUS, and Cochrane databases for dropouts due to reported adverse events in the placebo arms (nocebo dropouts) in all double-blind trials investigating anti-osteoporotic drugs published between January 1993 and March 2022. Only data on bisphosphonates and selective estrogen receptor modulators (SERMs) were analyzed (Prospero registration number CRD42020212843). Results: Data from 44 trials were extracted. In 16,460 placebo-treated patients, the pooled nocebo-dropout was 8% both for bisphosphonates (average: 0.08; range 0.01–0.27; 95%CI 0.06–0.10) and SERMs (average: 0.08; range 0.03–0.15; 95%CI 0.05–0.13). Nocebo-dropouts were higher in bisphosphonate trials enrolling individuals ≥ 65 years (11%) (n = 18) compared to trials enrolling younger individuals (6%) (n = 18) (average: 0.11; 95%CI 0.08–0.13 vs. average: 0.06; 95%CI 0.05–0.08, respectively, p = 0.001). Participants' sex, dosing-intervals, publication year, or severity of osteoporosis had no impact on the nocebo-dropouts. Conclusion: Almost 1 in 10 osteoporosis patients receiving placebo in trials of bisphosphonates and SERMs experiences AEs leading to dropout, implying that nocebo contributes to treatment-discontinuation in clinical practice. Efforts to identify and minimize nocebo, especially in older patients, are warranted. [ABSTRACT FROM AUTHOR]

Diabetic kidney disease (DKD) is more prevalent with an increase in diabetes mellitus. Oxidative stress is a major factor in the occurrence and progression of DKD. Defending against oxidative stress and restoring antioxidant defense might be key to preventing and treating DKD. The purpose of this article is to provide an explanation of how oxidative stress affects DKD, conduct a systematic review and meta-analysis on DKD, and examine the effect of antioxidants on the disease. An analysis of 19 randomized controlled trials showed that the use of antioxidants could reduce UAE (albumin excretion rate) in patients with DKD (SMD: − 0.31; 95% CI [− 0.47, − 0.14], I2 = 0%), UACR (urine albumin/creatinine ratio) (SMD: − 0.60; 95% CI [− 1.15, − 0.06], I2 = 89%), glycosylated hemoglobin (hbA1c) (MD: − 0.61; 95% CI [− 1.00, − 0.21], I2 = 93%) and MDA (malonaldehyde) (SMD:-1.05; 95% CI [− 1.87, − 0.23], I2 = 94%), suggesting that antioxidants seemed to have therapeutic effects in patients with DKD, especially in reducing proteinuria and hbA1c. The purpose of this study is to provide new targets and ideas for drug research and clinical treatment of DKD. [ABSTRACT FROM AUTHOR]

Objective: Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture. Study design and setting: We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment. Results: Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = −0.15, 95% confidence interval: −0.91 to 0.62). Conclusion: Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control. [ABSTRACT FROM AUTHOR]

This study confirms the effectiveness of aerobic exercise on waist circumference, Vo2 max, blood glucose, insulin, serum lipid in middle-aged women. The Ovid-Medline, Embase, the Cochrane Library, and CINAHL were searched. The risk of bias 2 revised in 2019 was used to assess the risk of bias in randomized controlled trials (RCTs). Selected studies were meta-analyzed with Review Manager 5.3. Data were compiled from 15 RCTs comprising 1,110 participants. Overall, aerobic exercise reduced waist circumference and blood glucose, and increased VO2 max significantly. We recommend the application of aerobic exercise to prevent metabolic disease in middle-aged women. [ABSTRACT FROM AUTHOR]

Context Chronic inflammation is a major contributor to the development of noncommunicable diseases. Curcumin, a bioactive polyphenol from turmeric, is a well-known anti-inflammatory agent in preclinical research. Clinical evidence remains inconclusive because of discrepancies regarding optimal dosage, duration, and formulation of curcumin. Objective The aim of this systematic review, conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and checklist, was to evaluate the efficacy of curcumin supplementation on systemic inflammatory mediators, comparing dose, duration, and bioavailability status of interventions. Data Sources The Medline, CINAHL, EMBASE, Scopus, and Cochrane literature databases were searched from 1980 to May-end 2019. Randomized controlled trials investigating effects of dietary curcumin on inflammatory mediators in humans not receiving anti-inflammatory treatment were eligible for inclusion. Two authors independently assessed titles and abstracts of identified articles for potential eligibility and respective, retrieved, full-text articles; disagreements were resolved by a third author. Evidence quality was critically appraised using the Quality Criteria Checklist for Primary Research. Data Extraction Thirty-two trials (N = 2,038 participants) were included and 28 were meta-analyzed using a random-effects model; effect sizes were expressed as Hedges' g (95%CI). Data Analysis Pooled data (reported here as weighted mean difference [WMD]; 95%CI) showed a reduction in C-reactive protein (−1.55 mg/L; −1.81 to −1.30), interleukin-6 (−1.69 pg/mL, −2.56 to −0.82), tumor necrosis factor α (−3.13 pg/mL; −4.62 to −1.64), IL-8 (−0.54 pg/mL; −0.82 to −0.28), monocyte chemoattractant protein-1 (−2.48 pg/mL; −3.96 to −1.00), and an increase in IL-10 (0.49 pg/mL; 0.10 to 0.88), with no effect on intracellular adhesion molecule-1. Conclusion These findings provide evidence for the anti-inflammatory effects of curcumin and support further investigation to confirm dose, duration, and formulation to optimize anti-inflammatory effects in humans with chronic inflammation. Systematic Review Registration PROSPERO registration no. CRD42019148682. [ABSTRACT FROM AUTHOR]