OBJECTIVE: This review aimed to answer the following research question: 'Does pulpotomy (partial or full) (I) result in better patient and clinical reported outcomes (O), compared with RCT (C) in permanent teeth with pulpitis characterized by spontaneous pain (P) evaluated at various time intervals?' (T).
METHODS: Two authors independently performed study selection, data extraction and risk of bias assessment. The literature search was conducted in the following electronic databases: Clarivate Analytics' Web of Science, Scopus, PubMed and Cochrane Central Register of Controlled Trials. English language clinical trials comparing the patient and clinical reported outcomes between RCT and pulpotomy were included. The meta-analysis was performed on a fixed-effect model and the quality of evidence assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.
RESULTS: Two randomized clinical trials were included. Amongst two trials, one has published four reports at different time points involving the same cohorts. The meta-analysis revealed no difference in postoperative pain (Day 7) between RCT and pulpotomy (OR = 0.99, 95% CI 0.63-1.55, I2 = 0%) and quality of evidence was graded as 'High'. Clinical success was high at year 1, 98% for both interventions, however, decreased over time to 78.1% (pulpotomy) and 75.3% (RCT) at 5 years.
DISCUSSION: Pulpotomy is a definitive treatment modality that is as effective as RCT. This could have a significant impact on treatment of such patients affording the advantages of retaining a vital pulp and preventing the need for RCT.
CONCLUSION: This review could only include two trials, hence there is insufficient evidence to draw robust conclusions. The clinical data accumulated so far suggests no difference in pain between RCT and pulpotomy at Day 7 postoperatively and a single randomized control trial suggests that the clinical success rate for both treatment modalities is similar long term. There is a need for more well-designed trials by different research groups to develop a stronger evidence base in this area.
REGISTRATION: PROSPERO database (CRD42021259744).
METHODS: PubMed, EMBASE, Medline, Cochrane Library, CINAHL, PEDro, and Airiti Library were searched from inception until May 5, 2023. Randomized controlled trials that examined exercise, vitamin D and protein supplementation effects on muscle mass, strength, and physical function. Quality assessment used the Cochrane risk of bias tool, and analysis employed Comprehensive Meta-Analysis version 2.0.
RESULTS: A total of 27 randomized controlled trials, involving 1,989 participants were identified. Meta-analysis results showed exercise improved lean body mass (SMD = 0.232, 95% CI: 0.097, 0.366), handgrip strength (SMD = 0.901, 95% CI: 0.362, 1.441), knee extension strength (SMD = 0.698, 95% CI: 0.384, 1.013). Resistance training had a small effect on lean body mass, longer exercise duration (> 12 weeks) and higher frequency (60-90 min, 3 sessions/week) showed small to moderate effects on lean body mass. Vitamin D supplementation improved handgrip strength (SMD = 0.303, 95% CI: 0.130, 0.476), but not knee extension strength. There was insufficient data to assess the impact of protein supplementation on muscle strength.
CONCLUSIONS: Exercise effectively improves muscle mass, and strength in menopausal women. Resistance training with 3 sessions per week, lasting 20-90 min for at least 6 weeks, is most effective. Vitamin D supplementation enhances small muscle group strength. Further trials are needed to assess the effects of vitamin D and protein supplementation on sarcopenia prevention.
REGISTRATION NUMBER: This review was registered on PROSPERO CRD42022329273.
METHODS: We performed a wide-ranging systematic search in several databases, including PubMed, Web of Science, Scopus, EMBASE, and Google Scholar up to April 2023. The overall effect sizes were calculated using effect size (ES) values and their corresponding confidence intervals (CI).
RESULTS: Out of a total of 580 related articles, 39 studies were qualified for inclusion in the analysis. The results of the analysis revealed a significant reduction of C-reactive protein (CRP) (ES = -1.02; 95% CI: -1.23, -0.80, p
METHODS AND ANTICIPATED RESULTS: A cluster randomized controlled study will be conducted, involving 250 Middle Eastern adolescents, in Arabic schools in Malaysia. The participants will be randomly assigned to the intervention and control groups. While the intervention group participates in six weeks of fortnightly six sessions (45 minutes per session), the control group will carry on with their regular curriculums, and normal physical activity routines. The variables which will be evaluated include anthropometric measurements, knowledge, attitude, daily routines, physical activity, sedentary behaviour, food assessment, eating attitudes test-26, and a structured questionnaire based on the HBM. Data will be collected from the intervention and control groups at baseline, post-intervention, and two months following the intervention. Data analysis will be performed by way of the SPSS Statistics software version 26. The generalized estimating equation (GEE) will be used, to test the effect of the intervention program, with regards to the selected variables (outcomes), between and within-group at baseline, as well as six weeks and two months following intervention, after adjusting for clustering. Outcomes will be assessed at each time point, along with a derived average over all three-time points; thus, ensuring that both the cumulative and overall effects are determined.
CONCLUSIONS: This trial will provide useful information for improving the knowledge, attitude, and practices of Middle Eastern adolescents, with regards to body weight status, physical activity level, nutrition status (BMI and dietary intake), and disordered eating. This will go a long way, towards ensuring their adherence to appropriate physical activities, and a healthy diet, to keep non-communicable diseases at bay.
TRIAL REGISTRATION: This study is registered at NCT: NCT05694143.
METHOD: A comprehensive search of Medline, Embase, Web of Science, and the Cochrane Library was conducted from database inception to October, 2023. Included studies were randomized controlled trials (RCTs) reporting the effects of exercise on JIA patients. Two independent reviewers assessed the literature quality using the Cochrane Collaboration's risk of bias tool. Standardized mean differences (SMD) were combined using random or fixed effects models. The level of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
RESULT: Five RCTs met the inclusion criteria, containing 216 female participants and 90 males. The meta-analysis results showed that exercise had no significant effect on JIA patients based on the Child Health Assessment Questionnaire (CHAQ) (SMD=-0.32, 95%CI: -0.83, 0.19; I2 = 73.2%, P = 0.011) and Quality of Life (QoL) (SMD = 0.27, 95%CI: -0.04, 0.58; I2 = 29.4%, P = 0.243) and no significant effect on peak oxygen uptake (VO2peak). However, exercise significantly reduced visual analog scale (VAS) pain scores in JIA patients (SMD = 0.50, 95%CI: -0.90, -0.10; I2 = 50.2%, P = 0.134). The quality of evidence assessed by GRADE was moderate to very low.
CONCLUSION: Exercise does not significantly affect the quality of life and exercise capacity in JIA patients but may relieve pain. More RCTs are needed in the future to explore the effects of exercise on JIA.
METHODS AND ANALYSIS: A systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient's demographic, clinical and prestroke neuroradiological characteristics.
ETHICS AND DISSEMINATION: No new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.
PROSPERO REGISTRATION NUMBER: CRD42019141136.
METHODS: A total of five international databases including PubMed, SCOPUS, Web of Science, CINAHL Plus, and EBSCOhost were searched with keywords related to "active video games," "physical activity," and "obese college students" from July 2022. A systematic review was conducted using the PRISMA guidelines and randomised controlled trial (RCT) studies that met the inclusion criteria were included. Furthermore, the quality assessment of the studies was measured using the PEDro scale.
RESULTS: One thousand and twenty-three articles were retrieved, of which eight randomised controlled trial studies met the inclusion criteria. AVGs can reduce sedentary behaviour and positively affect physical activity, time spent on moderate-to-vigorous physical activity (MVPA), positive psychological factors, and game attendance rate. Combining AVGs with other assistive devices (such as mini-trampolines and stationary bikes) can enhance the effects of AVGs and provide greater physiological stimulation. Different types of AVGs and game modes can achieve different emotional responses, physiological stimulation, and physical activity levels.
CONCLUSION: The research findings prove that AVGs can be a viable intervention to increase physical activity in overweight or obese college students, ultimately reaching the recommended physical activity level(PAL). Physical activity can be further increased by incorporating assistive devices or using features supported by self-determination theory (SDT). As a new modality, AVGs could be a potential alternative to traditional physical activity.Systematic Review Registration:https://www.crd.york.ac.uk/prospero, identifier: CRD42022363993.
METHOD AND ANALYSIS: We will conduct a systematic review of randomised controlled trials that investigate the effect and safety of GO for the treatment of patients with AML. We will search for any eligible articles from selected electronic databases. We will follow the Preferred Reporting Items for Systematic reviews and Meta-Analysis for study selection and reporting. We will use The Cochrane Handbook for Systematic Reviews of Interventions and Meta-Analysis as guidance to select eligible studies. All data will be extracted using a standardised data extraction form.
ETHICS AND DISSEMINATION: There was no patient involved in this study, therefore no ethical consideration is needed. The findings of this study will be disseminated in a peer-reviewed journal and any relevant conference presentation.
PROSPERO REGISTRATION NUMBER: CRD42019123286.
METHODS: From personal files, citation searching, and three databases searched up to 29-5-2023, we included randomized controlled trials (RCTs) of adult critically ill patients that compared higher vs lower protein delivery with similar energy delivery between groups and reported clinical and/or patient-centred outcomes. We conducted random-effect meta-analyses and subsequently trial sequential analyses (TSA) to control for type-1 and type-2 errors. The main subgroup analysis investigated studies with and without combined early physical rehabilitation intervention. A subgroup analysis of AKI vs no/not known AKI was also conducted.
RESULTS: Twenty-three RCTs (n = 3303) with protein delivery of 1.49 ± 0.48 vs 0.92 ± 0.30 g/kg/d were included. Higher protein delivery was not associated with overall mortality (risk ratio [RR]: 0.99, 95% confidence interval [CI] 0.88-1.11; I2 = 0%; 21 studies; low certainty) and other clinical outcomes. In 2 small studies, higher protein combined with early physical rehabilitation showed a trend towards improved self-reported quality-of-life physical function measurements at day-90 (standardized mean difference 0.40, 95% CI - 0.04 to 0.84; I2 = 30%). In the AKI subgroup, higher protein delivery significantly increased mortality (RR 1.42, 95% CI 1.11-1.82; I2 = 0%; 3 studies; confirmed by TSA with high certainty, and the number needed to harm is 7). Higher protein delivery also significantly increased serum urea (mean difference 2.31 mmol/L, 95% CI 1.64-2.97; I2 = 0%; 7 studies).
CONCLUSION: Higher, compared with lower protein delivery, does not appear to affect clinical outcomes in general critically ill patients but may increase mortality rates in patients with AKI. Further investigation of the combined early physical rehabilitation intervention in non-AKI patients is warranted.
PROSPERO ID: CRD42023441059.
MATERIALS AND METHOD: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197).
RESULTS: Multiple barriers were identified, and were regrouped as patient- related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.
OBJECTIVES: This study sought to conduct a systematic published data review and meta-analysis of RCTs comparing RM with IO follow-up.
METHODS: Electronic databases and reference lists were searched for RCTs reporting clinical outcomes in ICD patients who did or did not undergo RM. Data were extracted from 9 RCTs, including 6,469 patients, 3,496 of whom were randomized to RM and 2,973 to IO follow-up.
RESULTS: In the RCT setting, RM demonstrated clinical outcomes comparable with office follow-up in terms of all-cause mortality (odds ratio [OR]: 0.83; p = 0.285), cardiovascular mortality (OR: 0.66; p = 0.103), and hospitalization (OR: 0.83; p = 0.196). However, a reduction in all-cause mortality was noted in the 3 trials using home monitoring (OR: 0.65; p = 0.021) with daily verification of transmission. Although the odds of receiving any ICD shock were similar in RM and IO patients (OR: 1.05; p = 0.86), the odds of inappropriate shock were reduced in RM patients (OR: 0.55; p = 0.002).
CONCLUSIONS: Meta-analysis of RCTs demonstrates that RM and IO follow-up showed comparable overall outcomes related to patient safety and survival, with a potential survival benefit in RCTs using daily transmission verification. RM benefits include more rapid clinical event detection and a reduction in inappropriate shocks.
METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are HBT (experimental group) and usual practice (UP) (control group). Based on sample size calculation using GPower, a total number of 42 participants will be recruited and allocated into either the HBT or the UP group. Participants in HBT group will receive a set of structured exercise therapy consisting of progressive strengthening, balance and task-related exercises. While participants in UP group will receive a usual "intervention" practised by rehabilitation professional prior to discharging stroke patients from their care. Both groups are advised to perform the given interventions for 3 times per week for 12 weeks under the supervision of their caregiver. Outcomes of interventions will be measured using timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level). All data will be analyzed using descriptive and inferential statistics.
DISCUSSION: This study will provide the information on the effectiveness of HBT in comparison to UP among stroke population who are discharged from rehabilitation. Findings from the study will enable rehabilitation professionals to design effective discharge care plan for stroke survivors in combating functional decline when no longer receiving hospital-based therapy.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001182189 (last updated 22/11/2019).
OBJECTIVE: Our study aimed to determine the clinical effects and safety of D. scandens for musculoskeletal pain treatment compared with standard regimen, nonsteroidal anti-inflammatory drugs (NSAIDs).
METHODS: International and Thai databases were searched from inception through August 2015. Comparative randomized controlled trials investigating oral D. scandens for musculoskeletal pain were included. Outcomes of interest included level of pain and adverse event. Mean changes of the outcomes from baseline were compared between D. scandens and NSAIDs by calculating mean difference.
RESULTS: From 42 articles identified, 4 studies involving a total of 414 patients were included for efficacy analysis. The effects of oral D. scandens on reducing pain score were no different from those of non-steroidal anti-inflammatory drugs at any time points (3, 7, 14 days and overall). The overall pain reduction in the D. scandens group was not inferior to treatment with NSAIDs (weighted mean difference 0.06; 95% CI: -0.20, 0.31) without evident of heterogeneity (I(2)=0.00%, p=0.768). When compared, the adverse events (AEs) of D. scandens showed no different relative risk with NSAIDs. The major adverse events were gastrointestinal symptoms.
CONCLUSION: D. scandens may be considered as an alternative for musculoskeletal pain reduction.