RCT Trials Research Articles

Meta-analysis of the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion versus endoscopic lumbar interbody fusion for the treatment of lumbar degenerative diseases.

To compare the efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (UBE-LIF) and endoscopic lumbar interbody fusion (Endo-LIF) in the treatment of lumbar degenerative diseases in lumbar degenerative diseases. A thorough literature search was conducted according to the PRISMA guidelines and the PICO framework(PROSPERO 2024CRD42024592073). The databases searched included PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure(CNKI), and Wanfang Database, with a time frame of January 2020 to June 2024. Outcome metrics included operative time, rate of progress of surgical time for beginners, intraoperative bleeding, hidden blood loss(HBL), total blood loss(TBL), postoperative drainage, hospitalization time, visual analog score (VAS) for pain, Oswestry Disability Index (ODI), complications, fusion rates, and modified MacNab score excellence rates. A total of 10 papers were included, including two that were RCT trials. This study involved 710 patients, 348 in the UBE-LIF group and 362 in the Endo-LIF group. The results showed that the UBE-LIF group was superior to the Endo-LIF group in terms of operative time and rate of progress of surgical time for beginners. In contrast, the Endo-LIF group was superior to the UBE-LIF group in terms of hospitalization time, hidden blood loss, and total blood loss. There were no statistical differences between the two procedures regarding intraoperative bleeding, postoperative drainage, visual analog score for low back pain, Oswestry Disability Index, complications, fusion rates, and modified MacNab score excellence rates. Postoperative pain and safety were comparable between the two endoscopic procedures.The UBE-LIF procedure was shorter, whereas the Endo-LIF had less total blood loss and a shorter recovery time.

Honey As A Treatment For Diabetic Foot Ulcer: A Systematic Review

Background : Increased number of antibiotic-resistance bacteria has made honey widely reused as a modern wound treatment, including for Diabetic Foot Ulcer (DFU) treatment. Researchers have studied mean duration of wound healing and effectivity of honey dressing compared to other substances, such as povidone iodine, normal saline or alginate. This systematic review was conducted to objectively evaluate mean duration of wound healing using topical honey dressing compared to other substances in the treatment of DFU. Method : All RCT and CCT trials were collected from 4 electronic databases using keywords “Honey”, “Honey dressing”, “Diabetic foot ulcer”, and “Diabetic ulcer”. We included all English literatures with year of publication from January 2006 to November 2016; studies comparing honey with other substances; and patients with DFUs. Qualitative assessment of these studies were scored using Jadad Scale. Result : A total of 5 studies involving 517 participants were included. None of 5 studies obtained full Jadad score in quality assessment due to lack of description on randomization method, blinding and dropouts. Three studies reported significantly shorter mean duration of wound healing in honey dressing compared to normal saline and alginate dressing. Other 2 studies reported insignificant difference compared to povidone iodine, although honey still has shorter mean duration of wound healing. Two studies reported less pain during dressing changes in honey dressing group. Conclusion : Honey dressing was superior than control group (normal saline, alginate, and povidone iodine) in reducing mean duration of wound healing in DFU patients. It was also proven to cause less pain during dressing changes. Due to high heterogeneity we are unable to carry out a meta-analysis.

A Meta-analysis of Intensive and Standard Antihypertensive Safety in Elderly Hypertensive Patients

Objective: To evaluate the effect of intensive and standard antihypertensive pressure on cardiovascular and cerebrovascular events, serious adverse events and all-cause deaths in elderly hypertensive patients. Methods: Pubmed, Embase, Cochrane, CNKI, Wanfang and CBM databases were searched. All of the included studies were the RCT trials. Relative risk (RR) and 95% confidence interval (95%CI) were used to evaluate differences in enhanced and standard antihypertensive outcomes. Statistical analysis was applied using the Stata 17.0 software. Results: Seven tests were retrieved to meet the conditions, Different antihypertensive effects showed overall statistical differences in the incidence of cardiovascular and cerebrovascular events, Significant decrease in the intensive antihypertensive group [P=0.000, RR95%CI:0.79(0.69-0.90)], Among them, the incidence of acute myocardial infarction (AMI) and acute coronary syndrome (ACS) was significantly reduced in the intensive antihypertensive group [P=0.000, RR95%CI:0.62(0.48-0.81)], The incidence of stroke events was significantly fewer in the intensive group [P=0.000, RR95%CI:0.62(0.48-0.81)]; There was no significant difference in the incidence of acute HF (AHF) between the two groups [P=0.242, RR95%CI:0.55(0.20-1.50)]. There was no significant statistical difference in the incidence of serious adverse events overall by different antihypertensive criteria [P=0.251,RR95%CI:1.12(0.92-1.36)], of which two groups were eGFR<30ml/min/1.73m2There was no significant statistical difference in the incidence [P=0.280,RR95%CI:1.46(0.74-2.89)], no significant statistical difference in the incidence of orthostatic hypotension [P=0.473,RR95%CI:1.47(0.51-4.23)], no significant statistical difference in the incidence of falls [P=0.607,RR95%CI:1.24(0.54-42.86)], and the incidence of syncope in the intensive antihypertensive group was higher than that in the standard antihypertensive group [P=0.009,RR95%CI:2.43(1.24-4.77)]. There was no significant statistical difference in the effect of different antihypertensive criteria on all-cause death [P=0.156,RR95%CI:0.92(0.81-1.03)]. Conclusion: Compared with the standard antihypertensive in elderly patients with hypertension, there is no significant statistical difference in the incidence of serious adverse events and all-cause mortality in the elderly, and the incidence of cardiovascular and cerebrovascular events in the elderly.

The efficacy and safety of EGFR-TKI in recurrent/metastatic nasopharyngeal carcinoma patients: A systematic review and meta-analysis.

EGFR-tyrosine kinase inhibitor (TKI) is used to treat recurrent and metastatic nasopharyngeal carcinoma (rmNPC). This meta-analysis aims to study the efficacy and safety of EGFR-TKI in treating patients with rmNPC. We conducted a systematic search of PubMed, Embase, and Web of Science up to November 2023, and included literature that met the criteria. We extracted objective response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), median overall survival (mOS), and adverse reaction-related events and performed meta-analysis using Stata 14.0. A total of nine articles were included. The summary results showed that the ORR for patients treated with EGFR-TKI for rmNPC was 38% (95% CI = 27%-49%), the DCR was 71% (95% CI = 61%-80%), the mPFS was 6.29 months (95% CI = 5.22-7.35), and the mOS was 15.94 months (95% CI = 14.68-17.20). The most common grade 3-4 adverse reaction events in these patients were mucositis, nasopharyngeal necrosis, and oral ulceration. We found an incidence rate of 49% (95% CI = 38%-61%) for grade 3-4 adverse events (AEs). The anti-PD1 combined with TKI treatment method is more effective than the EGFR-TKI alone for treating rmNPC. The study shows that EGFR-TKI has good efficacy in treating rmNPC but does not translate into survival benefits and owns a high incidence of grade 3-4 AEs. More RCT trials are needed in the future to verify the efficacy of anti-PD1 combined with TKI treatment method.

Acupuncture modification treatment for female sexual dysfunction: A meta-analysis

BackgroundAcupuncture has potential in the treatment of female sexual dysfunction (FSD), but its effectiveness needs to be verified. AimA meta-analysis to provide a summary of studies that had investigated the efficacy of acupuncture as a treatment for FSD. MethodsA systematic screening was conducted on electronic databases such as Pubmed, Embase, Cochrane Library, CNKI, and CBM to select studies that met the criteria before April 2023. We only included those studies assessing women’s sexual functioning by the Female Sexual Function Index (FSFI). OutcomesBy calculating the relative risk (RR) using the standardized mean difference (SMD) and 95% confidence interval (CI), these data were combined to generate a summary of the findings. The pooled results were calculated using a random-effects model. ResultsA total of 4 studies involving 178 participants were included, and the comprehensive results indicated a significant difference in FSFI scores between the acupuncture group and the control group. In the desire and arousal scale, there was a statistically significant difference between the acupuncture group and the control group. But in the scale of lubrication, orgasm, satisfaction, and pain, there was no statistically significant difference between the two groups. ConclusionA comparison of overall FSFI scores, sexual desire, and sexual arousal revealed that acupuncture treatment can improve female sexual dysfunction to some extent. However, in terms of vaginal lubrication, orgasm, sexual satisfaction, and sexual pain, acupuncture treatment did not significantly improve female sexual dysfunction. In the future, it is necessary to include more RCT trials and expand the number of patients analyzed to make the conclusions more reliable.

Long-term prognostic value of stress echocardiography in patients with suspected coronary artery disease - Systematic review and meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Objective To evaluate the association between results of stress echocardiography and outcomes for patients with suspected coronary artery disease. Design Systematic review and meta-analysis. Data Sources Medline, Embase, Cochrane Library for clinical trials, PubMed, Web of Science, and Clinicaltrials. Eligibility criteria for selecting studies Randomised controlled trials (RCT) evaluating long term outcome of SE in patients suspected of coronary artery disease. Data Synthesis A meta-analysis utilising the fixed effects model to evaluate evidence from recent RCT trials on SE or comparing SE to other non-invasive diagnostic modalities. The primary outcome was the composite of all-cause mortality, or cardiovascular death and non-fatal myocardial infarction. Positive SE result was defined as inducible ischaemia in at least 1 of the 16 left ventricular segments. Results Six trials fulfilled the search criteria. A total of 19477 subjects who underwent either pharmacological (Dobutamine or Dipyridamole) or treadmill SE were recruited in the meta-analysis with a median follow-up of 31 months (range 21–101). The mean age was 59 years, and 55% were male. Fifty six percent had hypertension, 48% dyslipidaemia, 33% history of smoking, 21% diabetes mellitus and 26% history of myocardial infarction. The overall annual event rate was 1.79% for the composite of all-cause mortality or cardiovascular death and non-fatal myocardial infarction and for death 1.82%. Positive SE result was associated with an increased risk of the composite outcome and death with an annual event rate of 1.98% vs 1.26%, Odds Ratio 1.99 (CI 1.75–2.26) and 3.59% vs. 0.93, Odds Ratio 2.06 (CI 1.80–2.35) for the composite outcome and death, respectively Figure A,B. Heterogeneity and inconsistency (Chi2 1.7 P= 0.89) were low. Imprecision was low in the composite outcomes, and the optimal information size was achieved across the studies. Conclusions In this meta -analysis positive SE results were associated with poorer long-term composite outcome of all-cause or cardiovascular mortality and non-fatal myocardial infarction as well as for death only. Figure. Composite of all-cause mortality or cardiovascular death and non-fatal myocardial infarction. (Abstract picture 1) All-cause or cardiovascular death. (Abstract picture 2)

An Updated Review On Stationary Cycle Effects In Children With Cerebral Palsy

The spastic muscle in children with CP usually consumes more energy and oxygen during exercise than the usual muscle. Stationary cycling and its effect on children with cerebral palsy is a novel topic in rehabilitation. The stationary cycle is a promising rehabilitation method to address various issues in children with cerebral palsy. To date, only a few studies have been conducted in this area. This will be the first review of the effects of stationary cycling on children with cerebral palsy. Medical databases were searched for retrieving higher levels of evidence such as RCT, systematic review and clinical trials till 2022 from inception. Only 11 articles could retrieve based on inclusion-exclusion criteria. Most studies showed promising results that cycling training could improve muscle strength and endurance. Improvements in functional activities could not be concluded due to heterogenicity in results in a different study.

Characteristics of Depression Clinical Trials Registered on ClinicalTrials.gov.

Mental disorders are among the leading causes of the global health-related burden, and depression is one of the most disabling mental disorders. The emergence of the COVID-19 pandemic has created an environment where many determinants of mental health are exacerbated. Many studies have been registered and conducted over the past 16 years, but how to choose the proper design for depression clinical trials remains the main concern. This study aimed to characterize the current status of global depression clinical trials registered on ClinicalTrials.gov. We examined all the trials registered on ClinicalTrials.gov from 2007 to 2021. Overall, 7623 depression clinical trials were identified for analysis. Of those trials, 6402 (83.98%) were intervention trials and 1212 (15.90%) were observational trials. The majority of intervention types were behavioral (35.2%) and drug (28.55%), with very few procedures, dietary supplements, and diagnostic test studies. In addition, 55.53% of trials enrolled <100 participants. The proportions of trials registered in North America were higher than on other continents. Furthermore, the trials that involved only females (12.6%) were more than only males (0.87%) from 2019 to 2021. Depression clinical trials registered on ClinicalTrials.gov were dominated by small sample size trials, and there is a lack of trials related to COVID-19. The choice of study design is crucial, and properly designed trials can help improve study efficiency and reduce the likelihood of study failure. Given the increased number of RCT trials, the trial quality is gradually improving over the years. In addition, depression trials concentrating on children and older adults need more scientific attention. Further studies related to COVID-19 are needed, given the great damage that causes to people's physical and mental health.

86 An Emerging Role of Cannabis as an Anti-Nociceptive Agent in the Treatment of Chronic Back Pain

Abstract Aim This review aims to provide insight into current research regarding a role for the endocannabinoid signalling pathway as a target in the treatment of chronic pain with particular emphasis on potential use as part of the treatment of lower back pain. Method A literature review was conducted using PubMed, Google scholar, and web of science database. The terminologies used were endocannabinoids, cannabis-based medicines, chronic pain, and lower back pain. Results The analgesic effect of cannabinoids is produced by stimulating cannabinoid receptors within the endocannabinoid system. Animal studies show cannabinoid type 2 receptors stimulate the release of endogenous opioids, further enhancing anti-nociceptive properties. Pre-clinical studies demonstrated the amount of morphine required to achieve median effective dose was around 3.6 times lower when morphine was administered with cannabinoids compared to morphine alone. A systematic review of 24 RCT trials and 1334 participants revealed that inhaled cannabis results in improved neuropathic pain symptoms compared to placebo; however, only two studies showed clinical significance. The medicinal use of cannabis comes with adverse effects. Up to a tenth of users are at risk of developing Cannabis use disorder, characterized by psychosocial problems, increased drug-seeking behaviours including craving, withdrawal, and tolerance. Conclusions The use of cannabis is gaining traction as an alternative to opiates despite the ethical and legal considerations. There is scope for cannabinoids to be successful anti-nociceptive agents in the management of chronic back pain. The long-term effects and side effect profile of cannabis- based medicines need more research.

Efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic fatty liver: a systematic review and meta-analysis.

This study aims to systematically assess the effectiveness and safety of Huazhi Rougan granule in the treatment of non-alcoholic fatty liver. The PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), WanFang databases, VIP databases, Chinese Biomedical Literature Database (SinoMed) were searched to identify the relevant randomized controlled trials, from the establishment of the database to June 7, 2020. The Cochrane risk of bias tool for assessing risk of bias was employed to evaluate the quality of the literatures included. Meta-analyses were performed using RevMan 5.3 software. A total of 23 related literature were retrieved, 9 studies with 1,142 participants were included in the meta-analysis. The overall quality of evidence for this study is low. Meta-analysis results suggest that, Huazhi Rougan granule combined with conventional treatment was significantly superior to the silybin control group in the improvement of liver B-ultrasound, reduction of serological indexes, increase of high-density lipoprotein and total clinical effective rate, which was statistically significant. The improvement of serum lipid parameters included alanine aminotransferase (ALT): [mean deviation (MD) =-10.49, 95% confidence interval (CI): -17.09, -3.90, P<0.05], aspartate transaminase (AST): (MD =-9.44, 95% CI: -14.62, -4.26, P<0.05), total cholesterol (TC): (MD =-0.77, 95% CI: -0.94, -0.60, P<0.05), triglyceride (TG): (MD =-0.40, 95% CI: -0.56, -0.24, P<0.05). Reduce low-density lipoprotein cholesterol: (MD =-0.40, 95% CI: -0.56, -0.24, P<0.05). Clinical effective rate: [risk ratio (RR) =1.25, 95% CI: 1.16, 1.36, P<0.05]. Occurrence of adverse reactions: Of the 9 studies included, 5 reported adverse reactions, of which 3 reported no drug-related adverse reactions. Adverse reactions were reported in 2 cases, all of which were mild adverse reactions. The clinical efficacy of Huazhi Rougan granule combined with conventional basic therapy in the treatment of non-alcoholic fatty liver may be better than that of conventional basic therapy combined with silybin, which may improve the B-ultrasonic grading effect of the liver and reduce the serum lipid parameters of the patients. it may improve the clinical symptoms of non-alcoholic fatty liver, and the incidence of adverse reactions is low, but the number of existing clinical studies is small and the quality is low, in order to further verify the above conclusions. More high-quality clinical RCT trials need to be carried out, and internationally recognized outcome indicators should be selected and uniformly included in the scoring criteria.

Effects of Wine Components in Inflammatory Bowel Diseases.

With the rising prevalence of Inflammatory bowel disease (IBD) worldwide, and the rising cost of treatment with novel biological drugs, there is an increasing interest in various diets and natural foods as a potential way to control/modulate IBD. As recent data indicates that diet can modify the metabolic responses essential for the resolution of inflammation, and as wine compounds have been shown to provide substantial anti-inflammatory effect, in this review we aimed to discuss the current evidence concerning the impact of biological compounds present in wine on IBD. A number of preclinical studies brought forth strong evidence on the mechanisms by which molecules in wine, such as resveratrol or piceatannol, provide their anti-inflammatory, anti-oxidative, anti-tumor, and microbiota-modulation effects. However, concerning the effects of alcohol, it is still unclear how the amount of ethanol ingested within the framework of moderate wine consumption (1–2 glasses a day) affects patients with IBD, as human studies regarding the effects of wine on patients with IBD are scarce. Nevertheless, available evidence justifies the conductance of large-scale RCT trials on human subjects that will finally elucidate whether wine can offer real benefits to the IBD population.

Is Fun For Wellness Engaging? Evaluation of User Experience of an Online Intervention to Promote Well-Being and Physical Activity

Online well-being interventions demonstrate great promise in terms of both engagement and outcomes. Fun For Wellness (FFW) is a novel online intervention grounded in self-efficacy theory and intended to improve multidimensional well-being and physical activity through multi-modal methods. These strategies include capability-enhancing opportunities, learning experiences such as games, video vignettes, and self-assessments. RCT studies have suggested that FFW is efficacious in improving subjective and domain-specific well-being, and effective in improving mental health, physical health, physical activity, and self-efficacy in United States. adults who are overweight and in the general population. The present study uses qualitative and quantitative user experience data collected during two RCT trials to understand and evaluate engagement with FFW, its drivers, and its outcomes. Results suggest that FFW is enjoyable, moderately engaging, and easy to use; and contributes to positive outcomes including skill development and enhanced confidence, for both overweight individuals and the general adult population. Drivers of engagement appear to include rewards, gamification, scenario-based learning, visual tracking for self-monitoring, ease of use and simple communications, and the entertaining, interactive nature of program activities. Findings indicate that there are opportunities to streamline and simplify the experience. These results can help improve FFW and contribute to the science of engagement with online interventions designed to improve well-being.

Comprehensive Analysis of Clinical Trials Registration for Lupus Nephritis Therapy on ClinicalTrials.gov.

Objective: Clinical trials are the most effective method for evaluating therapeutic strategies. The purpose of this study was to comprehensively assess the characteristics of trials on lupus nephritis (LN) and provide a reference for LN treatment and research.Methods: Registered therapeutic trials on drug interventions for LN were obtained from ClinicalTrials.gov up to December 3, 2020. The general characteristics, methodological characteristics, detailed characteristics, investigated drugs, eligibility criteria, and outcome measures of these trials were analyzed.Results: A total of 126 eligible trials were evaluated, and these trials mainly investigated the initial treatment of adult proliferative LN. Half of the trials enrolled <50 participants, and 70.7% of the trials lasted for 6–24 months. In total, 95.2% of trials adopted an interventional study design. Of intervention trials, 56.6% were in phase 2 or phase 3, 76.7% were randomized, 77.5% employed a parallel assignment, and 41.7% were masked. The eligibility criteria and outcome measures of the included trials varied and involved a variety of indicators. Chemical agents and biologics are the most widely studied immunotherapies, of which mycophenolate mofetil, tacrolimus, and rituximab are the most studied. In addition, some trials studied cell transplantation treatment.Conclusions: The majority of clinical trials for LN therapy registered on ClinicalTrials.gov investigated the initial treatment of adult proliferative LN, and most of these trials were randomized, parallel assigned, and insufficiently masked interventional trials with small scale, short duration, various eligibility criteria, and outcome measures. We hope that more large-scale, long-term multicenter, and high-quality RCT trials with standardized inclusion criteria/exclusion criteria and treatment effect evaluation systems will be conducted and that more energy and funding will be put into exploring biological products and stem cell therapies. In addition, trials for membranous LN, childhood-onset LN, and maintenance phase LN are needed to establish optimal treatment strategies.

The catastrophization effects of an MRI report on the patient and surgeon and the benefits of 'clinical reporting': results from an RCT and blinded trials.

Inappropriate use of MRI leads to increasing interventions and surgeries for low back pain (LBP). We probed the potential effects of a routine MRI report on the patient's perception of his spine and functional outcome of treatment. An alternate 'clinical reporting' was developed and tested for benefits on LBP perception. In Phase-I, 44 LBP patients were randomized to Group A who had a factual explanation of their MRI report or Group B, who were reassured that the MRI findings showed normal changes. The outcome was compared at 6 weeks by VAS, PSEQ-2, and SF-12. In Phase-II, clinical reporting was developed, avoiding potential catastrophizing terminologies. In Phase-III, 20 MRIs were reported by both routine and clinical methods. The effects of the two methods were tested on four categories of health care professionals (HCP) who read them blinded on their assessment of severity of disease, possible treatment required, and the probability of surgery. Both groups were comparable initial by demographics and pain. After 6 weeks of treatment, Group A had a more negative perception of their spinal condition, increased catastrophization, decreased pain improvement, and poorer functional status(p = significant for all). The alternate method of clinical reporting had significant benefits in assessment of lesser severity of the disease, shift to lesser severity of intervention and surgery in three groups of HCPs. Routine MRI reports produce a negative perception and poor functional outcomes in LBP. Focussed clinical reporting had significant benefits, which calls for the need for 'clinical reporting' rather than 'Image reporting'.

The catastrophization effects of an MRI report on the patient and surgeon and the benefits of 'clinical reporting' - Results from an RCT and blinded trials

The catastrophization effects of an MRI report on the patient and surgeon and the benefits of 'clinical reporting' - Results from an RCT and blinded trials

Efficacy and safety of immunological checkpoint inhibitors combined with anti-angiogenic drugs in first-line treatment of metastatic renal cell carcinoma: a systematic review and meta-analysis.

BackgroundImmune checkpoint inhibitors (ICIs) have shown promising results for the second-line treatment of metastatic renal cell carcinoma (mRCC). Several randomized controlled trials have so far also evaluated the efficacy of ICIs for first-line treatment of mRCC. In this study, we conducted a meta-analysis of relevant studies to further clarify the efficacy and safety of ICIs combined with anti-angiogenic drugs for the treatment of mRCC.MethodsWe searched the PubMed, Embase, and Cochrane libraries for RCT trials of ICIs combined with anti-angiogenic drugs for first-line treatment of mRCC published before November 20, 2019. A meta-analysis was conducted based on methodological recommendations by the Cochrane Collaboration.ResultsFour articles with a total of 2,967 patients met the inclusion criteria. Our meta-analysis revealed that progression-free survival (PFS) and objective response rate (ORR) were significantly improved in the experimental group while there was no significant difference in overall survival (OS) (HR 0.75, 95% CI: 0.67–0.84; HR 1.43, 95% CI: 1.07–1.91; HR 0.74, 95% CI: 0.53–1.03). After stratification for PD-L1 expression, OS, PFS, and ORR of PD-L1 positive patients were significantly increased in the experimental group (HR 0.74, 95% CI: 0.56–0.96; HR 1.66, 95% CI: 1.11–2.49; HR 0.65, 95% CI: 0.57–0.75).ConclusionsImmunological checkpoint inhibitors combined with anti-angiogenic drugs as a first-line treatment for mRCC improve PFS and ORR. This effect is more pronounced in PD-L1 positive patients, where ICIs also improve OS. ICIs do not increase the incidence of adverse events.

Comparative efficacy and safety of traditional Chinese patent medicine for anxiety disorders in children or adolescence: A protocol for systematic review and network meta-analysis.

Background:Anxiety is the most common mental illness among adolescents and children, and its incidence is increasing year by year, which has a serious adverse effect on the academic and growth of adolescents and children. Conventional treatment methods such as oral administration of western medicine and psycho-behavioral therapy have obvious limitations. Chinese patent medicines play an irreplaceable role in the treatment of this disease. At present, there is no comparison of the safety and effectiveness of various Chinese patent medicines curing anxiety in adolescents. So we take advantage of the method of network meta-analysis to systematically compare the efficacy of various Chinese patent medicines curing this disease.Methods:We will systematically and comprehensively search the following databases, including PubMed, Web of Science, EMBASE, The Cochrane Library, China BioMedical Literature (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang database. We will include all RCT trials that meet the inclusion criteria, starting from the establishment of the database until August 2020. Two researchers will independently screen the literature based on inclusion criteria. While extracting data, we also assess the risk of bias in the included studies. All the data and evidence obtained will be evaluated by the method of Bayesian network meta-analysis. STATA and WinBUGS software will be used.Results:This study will evaluate the effectiveness and safety of various TCPMs for anxiety disorders in children or adolescence.Conclusion:The results of this study will provide valuable references for the clinical application of Traditional Chinese patent medicines, and assist clinicians in formulating more reasonable diagnosis and treatment strategies.Ethics and dissemination:This study does not require ethical approval.INPLASY registration number:INPLASY202080048.

Impact of physical activity and exercise on bone health in patients with chronic kidney disease: a systematic review of observational and experimental studies

BackgroundChronic Kidney Disease (CKD) patients frequently develop life-impairing bone mineral disorders. Despite the reported impact of exercise on bone health, systematic reviews of the evidence are lacking. This review examines the association of both physical activity (PA) and the effects of different exercise interventions with bone outcomes in CKD.MethodsEnglish-language publications in EBSCO, Web of Science and Scopus were searched up to May 2019, from which observational and experimental studies examining the relation between PA and the effect of regular exercise on bone-imaging or -outcomes in CKD stage 3–5 adults were included. All data were extracted and recorded using a spreadsheet by two review authors. The evidence quality was rated using the Cochrane risk of bias tool and a modified Newcastle-Ottawa scale.ResultsSix observational (4 cross-sectional, 2 longitudinal) and seven experimental (2 aerobic-, 5 resistance-exercise trials) studies were included, with an overall sample size of 367 and 215 patients, respectively. Judged risk of bias was low and unclear in most observational and experimental studies, respectively. PA was positively associated with bone mineral density at lumbar spine, femoral neck and total body, but not with bone biomarkers. Resistance exercise seems to improve bone mass at femoral neck and proximal femur, with improved bone formation and inhibited bone resorption observed, despite the inconsistency of results amongst different studies.ConclusionsThere is partial evidence supporting (i) a positive relation of PA and bone outcomes, and (ii) positive effects of resistance exercise on bone health in CKD. Prospective population studies and long-term RCT trials exploring different exercise modalities measuring bone-related parameters as endpoint are currently lacking.

Association between complementary feeding method and BMI at 19–36 months of life: an Internet-based cross-sectional study from two European countries

AbstractOver the last years, there has been increasing interest in Baby-Led Weaning (BLW), an approach in which infants feed themselves with finger foods. Previous studies have shown that BLW may be associated with lower food fussiness and risk of obesity, but in the other hand with growth flattering. However, the results are limited and still inconclusive. The aim of this study was to investigate the associations between complementary feeding method and body mass index (BMI) z-score in children aged 19–36 months from Poland and Austria. This anonymously, the cross-sectional internet-based study was conducted in 2018 and 2019 among 6645 mothers of children aged 12–36 months, recruited through social media. The analysis included data from 5856 mothers (35.5% from Austria) with complete data. Complementary feeding method was categorized as traditional spoon feeding (TSF), partial BLW (children was both spoon-fed and fed themselves), as well as BLW. BMI z-score was calculated based on declared body mass and height using the WHO cut-off points. BLW method was used in 16.4% of children, whereas the TSF in 30.5% of the total study group. Normal BMI z-score was observed in 73.8% of the total study group, thinness in 9.6% and overweight and obesity in 4.3%. The BLW increased the risk of thinness only in children aged 31–36 months (aOR: 1.48; 95%CI: 1.04–2.11) but did not influence the risk of overweight and obesity. In this present large cross-sectional study conducted in two European countries, we did not find an association between BLW and overweight and obesity risk. However, in the older group, BLW increased the risk of thinness. Previous studies observing a risk of thinness were also cross-sectional, although conducted among smaller study groups. In contrary to this, In contrary to this, the RCT trials using modified BLW version Baby-Led Introduction to SolidS (BLISS) did not observe any case of growth flattering. In another cross-sectional study investigating dietary intake of infants aged 6–8 months, who were complementary fed using BLW or TSF method, authors did not observe a difference in energy intake between the two groups. Further studies investigating the role of complementary feeding method and subsequent BMI, especially in long-term are necessary.

What are the most effective interventions to improve physical performance in pre-frail and frail adults? A systematic review of randomised control trials

BackgroundWith life expectancy continuing to rise in the United Kingdom there is an increasing public health focus on the maintenance of physical independence among all older adults. Identifying interventions that improve physical outcomes in pre-frail and frail older adults is imperative.MethodsA systematic review of the literature 2000 to 2017 following PRISMA guidelines and registered with PROSPERO (no. CRD42016045325).ResultsTen RCT trials fulfilled selection criteria and quality appraisal. The study quality was moderate to good. Interventions included physical activity; nutrition, physical activity combined with nutrition. Interventions that incorporated one or more physical activity components significantly improved physical outcomes in pre-frail and/or frail older adults.ConclusionsPhysical activity interventions are key to maintaining independence in pre-frail and frail older adults. A lack of consensus regarding the definition of frailty, and an absence of core measures to assess this means any attempt to create an optimal intervention will be impeded. This absence may ultimately impact on the ability of older and frail adults to live well and for longer in the community.