Methodological Quality Of Trials Research Articles

Effects of Exercise on DNA Methylation: A Systematic Review of Randomized Controlled Trials.

Regular exercise reduces chronic disease risk and extends a healthy lifespan, but the underlying molecular mechanisms remain unclear. DNA methylation is implicated in this process, potentially altering gene expression without changing DNA sequence. However, previous findings appear partly contradictory. This review aimed to elucidate exercise effects on DNA methylation patterns. PubMed, Scopus and Web of Science databases were searched following PRISMA 2020 guidelines. All articles published up to November 2023 were considered for inclusion and assessed for eligibility using the PICOS (Population, Intervention, Comparison, Outcomes and Study) framework. Randomized controlled trials that assessed the impact of exercise interventions on DNA methylation in previously inactive adults were included. We evaluated the methodological quality of trials using the PEDro scale. A total of 852 results were identified, of which 12 articles met the inclusion criteria. A total of 827 subjects were included in the studies. Intervention lengths varied from 6weeks to 12months. Most trials indicated that exercise interventions can significantly alter the DNA methylation of specific genes and global DNA methylation patterns. The heterogeneity of results may arise from differences in participant demographics, intervention factors, measurement techniques, and the genomic contexts examined. Future research should analyze the influences of activity type, intensity, and duration, as well as the physical fitness outcomes on DNA methylation. Characterizing such dose-response relationships and identifying genes responsive to exercise are crucial for understanding the molecular mechanisms of exercise, unlocking its full potential for disease prevention and treatment.

SARS-CoV-2 infection rebound among patients receiving antiviral agents, convalescent plasma, or no treatment: a systematic review with meta-analysis.

There is some evidence showing rebound of COVID-19 infections in patients treated with nirmatrelvir-ritonavir between 2 and 8 days following cessation of the antiviral treatment. COVID-19 rebound is not unique to patients treated with nirmatrelvir-ritonavir, but is also observed in molnupiravir recipients, in patients who did not receive any antiviral treatment and in patients who received convalescent plasma (CP). This was a systematic review with meta-analysis of clinical trials evaluating rates of virologic and clinical rebound in COVID-19 patients receiving antiviral agents, CP or no treatment. Both randomized clinical trials and controlled cohort studies were considered. The methodological quality of trials was assessed using ROB-2 and ROBIN-1 checklists, and the GRADE approach. Data were available from 16 trials. The occurrence of virologic rebound was more commonly observed among nirmatrelvir recipients than among untreated patients (relative risk [RR]=2.12; 95% confidence interval [CI]: 1.38-3.28; p=0.0007). No differences were observed in the occurrence of virologic rebound between nirmatrelvir-ritonavir and molnupiravir recipients (RR=1.01; 95% CI: 0.71-1.43). Similar rates of virologic rebounds were observed in molnupiravir recipients and untreated patients (RR=1.14; 95% CI: 0.81-1.6). One study in the pre-omicron period compared rates of virologic rebound between patients receiving standard of care with or without CP: no differences were observed between groups (RR=1.04; 95% CI: 0.55-1.99). Rates of clinical rebound were reported in seven trials, five evaluating nirmatrelvir-ritonavir and untreated patients, and two evaluating nirmatrelvir-ritonavir and molnupiravir recipients. No statistically significant differences between groups were observed. For all these comparisons, the certainty of the available evidence was graded as low or moderate. Virologic rebound of COVID-19 infections appears to be mild and self-limited, and was observed more commonly in nirmatrelvir-ritonavir recipients than in untreated patients, but was also observed in patients treated with molnupiravir or CP.

Non-pharmacological interventions on quality of life in stroke survivors: A systematic review and meta-analysis.

Non-pharmacological interventions have been used in the rehabilitation of stroke survivors, but their effects on stroke survivors' quality of life (QoL) are unknown. This review aimed to summarize the existing evidence regarding non-pharmacological interventions for QoL in stroke survivors and to evaluate the effectiveness of different types of interventions. We systematically searched databases including PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Chinese BioMedical Literature Database, China Science and Technology Journal Database, and Wanfang data from the earliest available records to March 2023. Randomized controlled trials which explored the effects of non-pharmacological interventions on QoL in stroke patients were included. The meta-analysis was conducted to evaluate the effectiveness of different interventions on QoL. The Review Manager 5.3 was used to conduct the meta-analysis and the revised Cochrane risk-of-bias tool was used to assess the methodological quality of trials. A total of 93,245 records were identified, and 34 articles were reviewed and summarized, of which 20 articles were included in the meta-analysis. The summary of the findings of the included studies revealed fitness training, constraint-induced movement therapy (CIMT), physical exercise, music therapy (MT), and art-based interventions may have positive effects on QoL. The fitness training improved total QoL, especially in physical domains including physical functioning (mean difference [MD] = 10.90; 95% CI [7.20, 14.59]), role physical (MD = 10.63; 95% CI [6.71, 14.55]), and global health (MD = 8.76; 95% CI [5.14, 12.38]). The CIMT had a slight effect on general QoL (standardized mean difference [SMD] = 0.48, 95% CI [0.16, 0.80]), whereas significantly improved strength (MD = 8.84; 95% CI [1.31, 16.38]), activities of daily living/instrumental activities of daily living (ADL/IADL; MD = 10.42; 95% CI [2.98, 17.87]), and mobility (MD = 8.02; 95% CI [1.21, 14.83]). MT had a positive effect on the mental health domain (SMD = 0.54; 95% CI [0.14, 0.94]). Our findings suggest that fitness training and CIMThave a significant effect on improving physical QoL, while MThas a positive effect on improving psychological QoL. Future studies may use comprehensive and multicomponent interventions to simultaneously improve the patients' physical, psychological, and social QoL.

Effects and Mechanisms of Exercise on Brain-Derived Neurotrophic Factor (BDNF) Levels and Clinical Outcomes in People with Parkinson's Disease: A Systematic Review and Meta-Analysis.

Exercise therapy may increase brain-derived neurotrophic factor (BDNF) levels and improve clinical outcomes in people living with Parkinson's disease (PD). This systematic review was performed to investigate the effect of exercise therapy on BDNF levels and clinical outcomes in human PD and to discuss mechanisms proposed by authors. A search on the literature was performed on PubMed up to December 2023 using the following key words: Parkinson's disease AND exercise, exercise therapy, neurological rehabilitation AND brain-derived neurotrophic factor, brain-derived neurotrophic factor/blood, brain-derived neurotrophic factor/cerebrospinal fluid AND randomized clinical trial, intervention study. Only randomized clinical trials comparing an exercise intervention to treatment as usual, usual care (UC), sham intervention, or no intervention were included. A meta-analysis of BDNF outcomes with pooled data from five trials (N = 216 participants) resulted in a significant standardized mean difference (SMD) of 1.20 [95% CI 0.53 to 1.87; Z = 3.52, p = 0.0004, I2 = 77%], favoring exercise using motorized treadmill, Speedflex machine, rowing machine, and non-specified exercise. Significant improvements were found in Unified Parkinson's Disease Rating Scale (UPDRS), UPDRS-III, 6 Minute Walk Test (6MWT), and Berg Balance Scale (BBS). Methodological quality of trials was categorized as "good" in three trials, "fair" in one trial, and "poor" in one trial. Key results of this systematic review are that exercise therapy is effective in raising serum BDNF levels and seems effective in alleviating PD motor symptoms. Exercise therapy confers neuroplastic effects on Parkinson brain, mediated, in part, by BDNF.

The Efficacy of Acceptance and Commitment Therapy for Chronic Pain: A Systematic Review and Meta-analysis.

Previous meta-analyses of a small number of trials showed that acceptance and commitment therapy (ACT) might improve chronic pain. Many new trials have been published afterward, and the factors that may impact the efficacy of ACT are less understood. We, therefore, conducted an updated systematic review with meta-analysis to investigate the efficacy of ACT for people with chronic pain. Randomized controlled trials that investigated the efficacy of ACT in clinical or community setting for adult populations with chronic pain were included. The methodological quality of trials was assessed with the Cochrane Risk of Bias tool. Standardized mean differences between ACT and comparison groups in their effects on 6 outcomes (ie, pain acceptance, quality of life, pain-related functioning, pain intensity, anxiety, and depression) were pooled across studies. Of the 3171 records identified, 21 trials with 1962 participants were included for analysis. The comparison groups included active treatment and waitlist control/usual care. The standardized mean difference was 0.67 (95% CI: 0.48, 0.87) for pain acceptance, 0.43 (95% CI: 0.29, 0.57) for quality of life, -0.88 (95% CI: -1.14, -0.63) for pain-related functioning, -0.45 (95% CI: -0.62, -0.27) for pain intensity, -0.35 (95% CI: -0.54, -0.15) for anxiety, and -0.74 (95% CI, -0.98, -0.50) for depression, all favoring ACT. Subgroup analyses showed that the effects were statistically significant across almost all subgroups and for some outcomes were greater in the trials conducted in people with a specific diagnosis (as compared with those conducted in people with general chronic pain), the trials with waitlist or usual care control, the trials with a greater number of sessions of ACT, and the trials with a longer ACT intervention. ACT is effective and comparable to, if not better than, some other available active treatments for chronic pain.

Comparative short-term effectiveness of non-surgical treatments for insertional Achilles tendinopathy: a systematic review and network meta-analysis

BackgroundThe incidence of Achilles tendinopathy has risen over the past decades. Insertional Achilles tendinopathy is characterised by tissue degeneration of the Achilles tendon from its insertion in the calcaneus to up to 2 cm proximally. This clinical condition is accompanied by pain, loss of function and diminished exercise tolerance. Numerous conservative treatment modalities are available to participants with insertional Achilles tendinopathy, including eccentric exercises, extracorporeal shockwave therapy, laser therapy, cryotherapy, therapeutic ultrasound, and orthotics. Eccentric exercise and extracorporeal shockwave therapy may reduce pain in participants with non-calcified insertional Achilles tendinopathy. However, no specific treatment is recommended over another due to the low methodological quality of trials. Given the lack of standard or preferred non-surgical treatment and the potential risks of surgical treatment, there is an imminent need to reassess different non-surgical treatments based on the newest evidence. Thus, this systematic review aims to evaluate the clinical effectiveness of the various non-surgical treatments for insertional Achilles tendinopathy.MethodsAMED EBSCOhost, CINAHL, EBSCOhost, EMBASE, PEDro, PubMed, Web of Science, and Clinicaltrials.gov were searched from 1992 to 14th October 2022, randomised controlled trials of adults with insertional Achilles tendinopathy investigating non-surgical treatments compared with each other or no treatment, placebo/sham control. Two reviewers independently screened and extracted the data. Random effects of network meta-analysis immediately after treatments were used to report comparative treatment effects. The surface under the cumulative ranking probabilities was calculated to assess the relative ranking of treatments.ResultsNine trials (total n = 464 participants) were included. This review recommended the combination of eccentric exercise and soft tissue therapy to manage insertional Achilles tendinopathy. With the highest SUCRA values of 84.8, and the best mean rank of 1.9, Eccentric exercise plus soft tissue treatment ranked as the most effective treatment for short-term pain.ConclusionsThis is the first NMA of non-surgical treatment focusing on short-term pain control for IAT which eccentric exercise plus soft-tissue therapy was found to be the most effective treatment combination. However, the overall confidence in non-surgical treatments from all included trials was very low. No recommendation of the best treatment option can be made from this review.

Efficacy of Early Enteral Nutrition on Gastrointestinal Surgery Outcomes: A Systematic Review and Meta-Analysis.

Congenital anomalies, congenital malformations, or birth defects can be defined as any structural or functional anomalies that develop prenatally and could be identified before, at birth, or later in life. Approximately 6% of babies are born with a congenital anomaly, which results in 2.4 million newborn deaths worldwide. This systematic review and meta-analysis ascertained the quantitative studies published in PubMed, ClinicalKey, Embase, CINAHL, Cochrane Library, and Google Scholar. Two authors independently screened and extracted the data from the primary studies that analyzed the efficacy of early enteral nutrition (EEN) on the postoperative outcome. This systematic review and meta-analysis adopted Cochrane Collaboration guidelines and reported using the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) statement. The methodological quality of trials was assessed by Cochrane Collaboration's risk of bias tool. Six trials, representing 488 children, with age ranging from 10 days to 6.5 years, fulfilled the inclusion criteria. EEN has significantly shortened hospital stay, induced early fecal movement, and reduced postoperative wound infections in children with congenital gastrointestinal abnormalities undergoing gastrointestinal anastomosis compared with children who received late enteral nutrition. The review also found that the experimental group who received EEN had no significant impact on the anastomosis leakage, vomiting, and abdominal distension. EEN has some positive effects on postsurgery outcomes among children with congenital gastrointestinal anomalies undergoing gastrointestinal anastomosis.

The Role and Clinical Observation of Traditional Chinese Medicine in Relieving Senile Insomnia: A Systematic Review and Meta-Analysis.

Objective To assess the role and clinical observation of traditional Chinese medicine (TCM) in relieving senile insomnia and conduct a systematic evaluation and meta-analysis. Methods We searched Chinese literatures from some database, including the China Knowledge Network database, Chongqing CQVIP Chinese database, Wanfang database, and Chinese Biomedical Literature database. In addition, English literature retrieval database PubMed and the Cochrane Library were included in this meta-analysis. The randomized controlled trial (RCT) of cognitive behavioral therapy was found in the treatment of chronic insomnia. All articles were current up to December 1, 2021, and references in the literature were hand searched. Results About 16 studies were included, involving 1260 elderly patients with insomnia. Meta-analysis results showed that compared with the control group, the sleep latency of the experimental group MD = −8.02, 95% CI (10.95, 5.01), the number of awakenings of the experimental group MD = −0.41, 95% CI (0.68, 0.14), the total sleep time of the experimental group MD = 39.41, 95% CI (27.05, 51.71), the sleep efficiency of the experimental group MD = 7.82, 95% CI (1.87, 13.75) the Pittsburgh sleep quality index of the experimental group MD = 2.41, 95% CI (3.12, 1.46), the effective rate of the experimental group: OR = 3.12, 95% CI (1.76, 5.48), and the insomnia severity index of the experimental group MD = 1.05, 95% CI (2.04, 0.52). Conclusion Our current study has indicated that TCM may play a central role in relieving senile insomnia and may be effective when treating insomnia. However, due to the low quality of trial methodology and publication bias, it cannot be fully confirmed. Further high-quality trials are needed to be investigated in the future.

Add-On Effect of Honeysuckle in the Treatment of Coronavirus Disease 2019: A Systematic Review and Meta-Analysis.

Background: The outbreak of coronavirus disease 2019 (COVID-19) has rapidly spread to become a global emergency since December 2019. Chinese herbal medicine plays an important role in the treatment of COVID-19. Chinese herbal medicine honeysuckle is an extremely used traditional edible and medicinal herb. Many trials suggest that honeysuckle has obtained a good curative effect for COVID-19; however, no systematic evaluation on the clinical efficacy of honeysuckle in the treatment of COVID-19 is reported. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine honeysuckle in the treatment of COVID-19.Methods: Seven electronic databases (PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Database, and China Biology Medicine) were searched to identify randomized controlled trials (RCTs) of honeysuckle for adult patients (aged ≥ 18 years) with COVID-19. The Cochrane Risk of Bias Tool was applied to assess the methodological quality of trials. Review Manager 5.3 software was used for data analysis.Results: Overall, nine RCTs involving 1,286 patients were enrolled. Our meta-analyses found that combination therapy of honeysuckle and conventional therapy was more effective than conventional therapy alone in lung computed tomography (CT) [relative risk (RR) = 1.24, 95% confidence interval (95%CI) (1.12, 1.37), P < 0.0001], clinical cure rate [RR = 1.21, 95%CI (1.12, 1.31), P < 0.00001], and rate of conversion to severe cases [RR = 0.50, 95%CI (0.33, 0.76), P = 0.001]. Besides, combination therapy can improve the symptom score of fever, cough reduction rate, symptom score of cough, and inflammatory biomarkers (white blood cell (WBC) count; C-reactive protein (CRP)) (P < 0.05).Conclusion: Honeysuckle combined with conventional therapy may be beneficial for the treatment of COVID-19 in improving lung CT, clinical cure rate, clinical symptoms, and laboratory indicators and reducing the rate of conversion to severe cases. Besides, combination therapy did not increase adverse drug events. More high-quality RCTs are needed in the future.

Hypnosis and the Alleviation of Clinical Pain: A Comprehensive Meta-Analysis

ABSTRACT This is the first comprehensive meta-analysis in approximately 20 years of all controlled studies of the use of hypnosis for relieving clinical pain. To be included, studies were required to utilize a between-subjects or mixed model design in which a hypnosis intervention was compared with a control condition in alleviating any form of clinical pain. Of 523 records screened, 42 studies incorporating 45 trials of hypnosis met the inclusion criteria. Our most conservative estimates of the impact of hypnosis on pain yielded mean weighted effect sizes of 0.60 (p ≤ .001) for 40 post trials and 0.61 (p ≤ .001) for 9 follow-up trials. These effect sizes fall in the medium range according to Cohen’s guideline and suggest the average participant receiving hypnosis reduced pain more than about 73% of control participants. Hypnosis was moderated by the overall methodological quality of trials—the mean weighted effect size of the 19 post trials without high risk ratings on any of the Cochrane Risk of Bias dimensions was 0.77 (p ≤ .001). Hypnosis was also moderated by hypnotic suggestibility, with 6 post trials producing a mean weighted effect size of r = 0.53 (p ≤ .001). Our findings strengthen the assertion that hypnosis is a very efficacious intervention for alleviating clinical pain.

Effectiveness, Core Elements, and Moderators of Response of Cognitive Remediation for Schizophrenia

Cognitive impairment is a core feature of schizophrenia, with negative consequences on functional outcomes. Although cognitive remediation (CR) is effective and mentioned in treatment guidance for schizophrenia, its active ingredients and ideal candidates are still debated. To provide a comprehensive update on CR effectiveness for cognition and functioning in schizophrenia and analyze the core ingredients of efficacy and role of patient characteristics. The reference list of the last comprehensive meta-analysis in 2011 was screened against eligibility criteria. Then, electronic databases (PubMed, Scopus, and PsycInfo) were systematically searched for articles published from January 2011 to February 2020. Reference lists of included articles and relevant reviews were hand searched, and Google Scholar was manually inspected. Eligible studies were randomized clinical trials comparing CR with any other control condition in patients diagnosed with schizophrenia spectrum disorders (with an unrestricted clinical status). Screening was performed by at least 2 independent reviewers. The PRISMA guidelines were followed. Study data were independently extracted and pooled using random-effect models. Cohen d was used to measure outcomes. Trial methodological quality was evaluated with the Clinical Trials Assessment Measure. Primary outcomes were changes in global cognition and overall functioning from baseline to after treatment, subsequently investigated through metaregressions, subgroup, and sensitivity analyses based on prespecified hypotheses, to identify potential moderators of response associated with treatment modality and patient characteristics. Of 1815 identified reports, 358 full texts were assessed and 194 reports on 130 studies were included. Based on 130 studies with 8851 participants, CR was effective on cognition (d, 0.29 [95% CI, 0.24-0.34]) and functioning (d, 0.22 [95% CI, 0.16-0.29]). An active and trained therapist (cognition: χ21, 4.14; P = .04; functioning: χ21, 4.26; P = .04), structured development of cognitive strategies (cognition: χ21, 9.34; P = .002; functioning: χ21, 8.12; P = .004), and integration with psychosocial rehabilitation (cognition: χ21, 5.66; functioning: χ21, 12.08) were crucial ingredients of efficacy. Patients with fewer years of education (global cognition: coefficient, -0.055 [95% CI, -0.103 to -0.006]; P = .03; global functioning: coefficient, -0.061 [95% CI, -0.112 to -0.011]; P = .02), lower premorbid IQ (global functioning: coefficient, -0.013 [-0.025 to -0.001]; P = .04), and higher baseline symptom severity (global cognition: coefficient, 0.006 [95% CI, 0.002 to 0.010]; P = .005) emerged as optimal candidates. These findings show that CR is an evidence-based intervention that should be included consistently into clinical guidelines for the treatment of individuals with schizophrenia and implemented more widely in clinical practice.

Education-based, lifestyle intervention programs with unsupervised exercise improve outcomes in adults with metabolic syndrome. A systematic review and meta-analysis.

To determine whether lifestyle intervention programs comprising dietary intervention and prescribed, unsupervised exercise improve outcomes for people with metabolic syndrome. A systematic review and meta-analysis of randomised controlled trials. Online databases CINAHL, MEDLINE, PubMed and Embase were searched from the earliest date available to October 2020. Post-intervention data were pooled to calculate mean differences (MD) or standardised mean differences (SMD) and 95% confidence intervals (CI) using inverse variance methods and random effects models. Trial methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) scale and overall quality of each meta-analysis was assessed using the Grading of Recommendation Assessment, Development and Evaluation approach. Eleven studies from 9 randomised controlled trials with 1,835 participants were included. There was high quality evidence that lifestyle intervention programs with unsupervised exercise reduced waist circumference (MD -2.82 cm, 95%CI -5.64 to 0.00, I2 91%) and blood pressure (systolic: MD -3.89 mmHg, 95%CI -5.19 to -2.58, I2 4%; diastolic: MD -3.16 mmHg, 95%CI -4.83 to -1.49, I2 50%) and increased physical activity levels (SMD 0.47, 95%CI 0.24 to 0.70, I2 45%) when compared to usual care. There was low quality evidence that they improved quality of life (SMD 0.59, 95%CI 0.05 to 1.13, I2 84%). Unsupervised programs had no significant effect on fasting blood glucose (unless > 3 months duration), metabolic syndrome prevalence or cholesterol. Lifestyle intervention programs with prescribed, unsupervised exercise are a practical alternative to supervised programs for people with metabolic syndrome when time, access or resources are limited or when social distancing is required.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11154-021-09644-2.

The efficacy and safety of health qigong for anti-aging: Protocol for a systematic review and meta-analysis.

Background:Aging is a phenomenon that human's physiology and psychology is progressive decline for natural environment. Health Qigong, as a convenient and effective exercise therapy,is widely used for anti-aging. However, there are no systematic reviews or meta-analysises to evaluate the efficacy and safety of Health Qigong on anti-aging.Methods:We will systematically search for 7 English databases(PubMed, Excerpta Medica Database, MEDLINE, Web of Science, Cochrane Library, SpringerLink, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases(namely the China National Knowledge Infrastructure Database, the Wanfang Database, the Chinese Scientific Journal Database, and the Chinese BioMedical Literature Database) from their inceptions to August 2020. Randomized controlled trials (RCTs) using Health Qigong to anti-aging will be included. After the selection and extraction of eligible studies, a meta-analysis will be undertaken to assess the efficacy and safety of Health Qigong on anti-aging. Moreover, study selection, data extraction, and the evaluation of the methodological quality of trials will each be independently completed by at least 2 researchers. The Review Manager Software V.5.3 will be employed for meta-analysis to assess the risk of bias, data synthesis, and subgroup analysis.Results:This review will provide the latest knowledge and evidence on the efficacy and safety of Health Qigong for anti-aging through the analysis of various evaluation scales.Conclusion:The conclusion of this review will help clinicians provide effective exercise therapy for anti-aging.Registration number:INPLASY202090017

The impact of a run-in period on treatment effects in cardiovascular prevention randomised control trials: A protocol for a comprehensive review and meta-analysis

Background: A run-in period is often employed in randomised controlled trials to increase adherence to the intervention and reduce participant loss to follow-up in the trial population. However, it is uncertain whether use of a run-in period affects the magnitude of treatment effect. Methods: We will conduct a sensitive search for systematic reviews of cardiovascular preventative trials and a complete meta-analysis of treatment effects comparing cardiovascular prevention trials using a run-in period (“run-in trials”) with matched cardiovascular prevention trials that did not use a run-in period (“non-run-in trials”). We describe a comprehensive matching process which will match run-in trials with non-run-in trials by patient populations, interventions, and outcomes. For each pair of run-in trial and matched non-run-in trial(s), we will estimate the ratio of relative risks and 95% confidence interval. We will evaluate differences in treatment effect between run-in and non-run-in trials and our and our priamry outcome will be the ratio of relative risks for matched run-in and non-run-in trials for their reported cardiovascular composite outcome. Our secondary outcomes are comparisons of mortality, loss to follow up, frequency of adverse events and methodological quality of trials. Conclusions: This study will answer a key question about what influence a run-in period has on the magnitude of treatment effects in randomised controlled trials for cardiovascular prevention therapies.

Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults.

Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults.

Corticosteroids for treating sepsis in children and adults.

Sepsis occurs when an infection is complicated by organ failure. Sepsis may be complicated by impaired corticosteroid metabolism. Thus, providing corticosteroids may benefit patients. The original review was published in 2004 and was updated in 2010 and 2015 prior to this update. To examine the effects of corticosteroids on deathin children and adults with sepsis. We searched CENTRAL, MEDLINE, Embase, LILACS, ClinicalTrials.gov, ISRCTN, and the WHO Clinical Trials Search Portal, on 25 July 2019. In addition, we conducted reference checking and citation searching, and contacted study authors, to identify additional studies as needed. We included randomized controlled trials (RCTs) of corticosteroids versus placebo or usual care (antimicrobials, fluid replacement, and vasopressor therapy as needed) in children and adults with sepsis. We also included RCTs of continuous infusion versus intermittent bolus of corticosteroids. All review authors screened and selected studies for inclusion. One review author extracted data, which was checked by the others, and by the lead author of the primary study when possible. We obtained unpublished data from the authors of some trials. We assessed the methodological quality of trials and applied GRADE to assess the certainty of evidence. Review authors did not contribute to assessment of eligibility and risk of bias, nor to data extraction, for trials they hadparticipated in. We included 61 trials (12,192 participants), of which six included only children, two included children and adults, and the remaining trials included only adults. Nine studies are ongoing and will be considered in future versions of this review. We judged 19 trials as being at low risk of bias. Corticosteroids versus placebo or usual care Compared to placebo or usual care, corticosteroids probablyslightly reduce 28-day mortality (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.84 to 0.99; 11,233 participants; 50 studies; moderate-certainty evidence). Corticosteroids may result in little to no difference in long-term mortality (RR 0.97, 95% CI 0.91 to 1.03; 6236 participants; 7 studies; low-certainty evidence) and probablyslightly reduce hospital mortality (RR 0.90, 95% CI 0.82 to 0.99; 8183 participants; 26 trials; moderate-certainty evidence). Corticosteroids reduced length of intensive care unit (ICU) stay for all participants(mean difference (MD) -1.07 days, 95% CI -1.95 to -0.19; 7612 participants; 21 studies; high-certainty evidence) and resulted in a large reduction in length of hospital stay for all participants(MD -1.63 days, 95% CI -2.93 to -0.33; 8795 participants; 22 studies; high-certainty evidence). Corticosteroids increase the risk ofmuscle weakness(RR 1.21, 95% CI 1.01 to 1.44; 6145 participants; 6 studies; high-certainty evidence). Corticosteroids probably donot increase the risk of superinfection (RR 1.06, 95% CI 0.95 to 1.19; 5356 participants; 25 studies; moderate-certainty evidence). Corticosteroids increase the risk of hypernatraemia (high-certainty evidence) and probably increase the risk of hyperglycaemia (moderate-certainty evidence).Moderate-certainty evidence shows that there is probably little or no difference in gastroduodenal bleeding, stroke, or cardiac events, and low-certainty evidence suggests that corticosteroids may result in little to no difference in neuropsychiatric events. Continuous infusion of corticosteroids versus intermittent bolus We are uncertain about the effects of continuous infusion of corticosteroids compared with intermittent bolus administration. Three studies reported data for this comparison, and the certainty of evidence for all outcomes was very low. Moderate-certainty evidence indicates that corticosteroids probably reduce 28-day and hospital mortality among patients with sepsis. Corticosteroids result in large reductions in ICU and hospital length of stay (high-certainty evidence). There may be little or no difference in the risk of major complications;however, corticosteroids increase the risk of muscle weakness and hypernatraemia, and probably increase the risk of hyperglycaemia. The effects of continuous versus intermittent bolus administration of corticosteroids are uncertain.

Reporting and methodological quality of clinical trials on exercise therapy for Parkinson's disease

BackgroundExercise therapy is becoming extremely relevant as a new efficacious intervention in multiple medical fields. Although several clinical trials have reported benefits of exercise therapy for Parkinson's disease (PD), recommendations and prescriptions for its use in clinical practice remain limited. ObjectivesTo evaluate the methodological quality and publication rate of clinical trials on exercise therapy for PD. MethodsWe analyzed all clinical trials assessing exercise therapy for PD registered in the WHO International Clinical Trials Registry Platform and the ClinicalTrials.gov registries, from 2000 to 2017. We evaluated the methodological quality of trials using the Cochrane Risk of Bias criteria. ResultsA total of 236 clinical trials were identified. Only 70 (29.7%) trials reported their findings, and 61 (25.8%) had results published in scientific journals. Most trials had an unclear risk of bias concerning incomplete and selective outcome reporting and lacked data on the randomization process, allocation concealment, blinding of participants and personnel, and outcomes assessors. Aerobic capacity was the most frequent type of exercise intervention. ConclusionsAlthough a large number of trials on exercise are registered in international portals, the quality of reporting remains suboptimal and only a quarter of trials have their results published in scientific journals. These two factors, in addition to the heterogeneity of the interventions tested and the unsatisfactory reported methodological quality of most trials, compromise the interpretation of study results. Therefore, higher quality clinical trials reports are needed to establish exercise as part of the PD armamentarium.

Tai Chi exercise for sleep problems in older adults: A protocol of systematic review and meta-analysis.

Sleep plays a crucial role in the general health of the human body. However, sleep problems become increasingly severe with age, and its incidence is on the rise. Notably, Tai Chi exercise may be an efficacious means to ameliorate sleep problems among older adults. This is especially since Tai Chi has been widely used to manage sleep problems in China for many years, but there is limited evidence regarding its effectiveness. We will conduct this study aiming to investigate the efficacy of Tai Chi as a complementary and alternative therapy for sleep problems in older adults. We will systematically search Scopus, Embase, PubMed, Cochrane Library, China National Knowledge Infrastructure, and Wanfang database from their inceptions to August 2019. Only randomized controlled trials of Tai Chi for sleep problems among older adults will be considered for inclusion and the Pittsburgh sleep quality index will be the primary outcome measurement. Moreover, study selection, data extraction, and the evaluation of the methodological quality of trials will each be independently completed by at least 2 researchers. We will employ the software Stata version 12.0 to implement the statistical analysis. The current systematic review and meta-analysis will provide synthesized results of the effectiveness and safety of Tai Chi exercise for sleep problems among older adults. This systematic review and meta-analysis will provide high-quality evidence on the effectiveness and safety of Tai Chi exercise for sleep problems in older adults. PEROSPERO CRD42019129782.

Auricular acupressure for overweight and obese individuals: A systematic review and meta-analysis.

Auricular acupressure has been used for treating obesity, but inconsistent outcomes have been reported. Moreover, systematic reviews and meta-analyses have seldom addressed the effects of auricular acupressure and duration of treatment in overweight/obese individuals. This study reviewed research articles on auricular acupressure for weight reduction, analyzed the related effects on obesity, and explored the relationships between weight reduction and treatment duration, as well as outcome variables. We searched PubMed, Cochrane Library, CINAHL, MEDLINE with Full Text, National Digital Library of Theses and Dissertation in Taiwan, and Airiti Library for articles up to July 4, 2018. Eight eligible trials were identified for qualitative synthesis, and one of them was excluded from quantitative synthesis. Inclusion criteria were as follows: intervention contained auricular acupressure, study subjects were overweight and/or obese, as defined by published authors, and the study design had 2 or more arms for comparison. Pooled analysis of the 7 remaining studies revealed that auricular acupressure alone, or with diet and/or exercise, was effective for weight reduction, particularly for decreasing body weight (BW), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), body fat mass (BFM), and body fat percentage (BFP), compared with no treatment, sham treatment, or use of surgical tape with diet and/or exercise. However, there was no effect on hip circumference. A 12-week acupressure intervention was associated with a larger effect on lowering BW and BMI compared with 4-, 6-, and 8-week interventions. The methodologic quality of trials included in the quantitative synthesis ranged from scores 2 to 6 based on the modified Jadad scale. Additionally, this meta-analysis combined studies that used different acupoints and outcomes evaluated at different timepoints, which may have been potential sources of bias. The study results indicate that auricular acupressure is effective for weight reduction. However, further vigorous studies that use double-blind randomized controlled design are needed to verify these findings. WC, WHR, BFP, or BFM should be used as obesity-related parameters in weight reduction studies to detect changes in fat, muscle, and skeletal weight.

Pharmacological Prevention of Postoperative Delirium: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background The high prevalence of delirium among postoperative patients has increased morbidity and mortality. The kind of drug that can effectively reduce the incidence of delirium has become the focus of discussion in recent years. However, a consensus in this respect has yet to be reached. Methods Randomized controlled trials (RCTs) were retrieved from the PubMed, Cochrane Library, ClinicalTrials.gov, and Embase databases from their inception through October 12, 2018. We included RCTs of pharmacological prevention for postoperative delirium in adults (at least 18 years), and the Cochrane risk of bias tool was used to evaluate the methodological quality of trials. The primary outcomes were the risk ratios (RRs) of incidence of postoperative delirium, and the secondary outcomes were the RRs of mortality and adverse events in the intervention and control groups. Results Thirty-eight trials, which comprised 20302 patients and 18 different drugs, were included in the analysis. Of the 38 studies, 17 were rated as low risk with respect to methodological quality. Dexmedetomidine administration (RR 0.58, 95%CI 0.44-0.76, P<0.01) was associated with a significantly lower incidence of postoperative delirium than the control conditions. However, the findings from the studies with a low risk of bias did not show a significant difference in this beneficial effect (RR 0.64, 95%CI 0.39-1.04, P=0.07). The antipsychotic drugs olanzapine (RR 0.44, 95%CI 0.30- 0.65, P<0.01) and risperidone (RR 0.42, 95%CI 0.19-0.92, P=0.03) had promising effects, but there was a lack of sufficient evidence to obtain a definitive conclusion. The beneficial effect of other drugs, including haloperidol, methylprednisolone, dexamethasone, gabapentin, ketamine, cyproheptadine, donepezil, hypertonic saline, melatonin, nimodipine, ondansetron, pregabalin, rivastigmine, TJ-54, and tryptophan, was not proven on the basis of present evidence. Conclusion Among the pharmacological prophylactic measures for postoperative delirium, dexmedetomidine, olanzapine, and risperidone showed higher efficacy than other drugs. However, more high-quality evidence is needed to confirm these results.