Randomized Controlled Trials Studies Research Articles

A Meta-Analysis on the Effect and Safety of LCZ696 in the Treatment of Hypertension.

Objectives To systematically evaluate the differences in effect and safety of LCZ696 and angiotensin receptor blockers (ARBs) in the treatment of hypertension. Methods We searched PubMed, Cochrane, Web of Science, and Ovid, collected randomized controlled trials (RCTs) about the effect and safety of LCZ696 and ARBs in hypertensive patients, extracted relevant data and evaluated the quality of the included literature according to the RCT quality evaluation standard recommended by Cochrane Reviewer's Handbook, using RevMan 5.3, and performed meta-analysis. Results Eight RCTs studies were included, with a total of 4313 patients. Compared with ARBs, LCZ696 can better reduce systolic blood pressure (msSBP) (WMD −4.29 mmHg; 95% CI: −5.37 to −3.21; P < 0.001), diastolic blood pressure (msDBP) (WMD −1.87 mmHg; 95% CI:−2.38 to −1.36; P < 0.01), ambulatory systolic blood pressure (maSBP) (WMD −3.37 mmHg; 95% CI:−4.26 to −2.47; P < 0.01), and ambulatory diastolic blood pressure (maDBP) (WMD −1.47 mmHg; 95% CI: −1.97 to −0.97; P < 0.01). In terms of safety, LCZ696 is basically the same as ARBs, but LCZ696 is more likely to cause cough than ARBs (OR = 2.38; 95% CI: 1.27 to 4.47; P < 0.01). Conclusion LCZ696 can significantly reduce the blood pressure level of patients with hypertension, but it is necessary to pay attention to whether the patient will experience coughing after taking the drug.

The effect of cumin (Cuminum cyminum L.) supplementation on glycemic indices: A systematic review and meta-analysis of randomized controlled trials.

We aimed to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to examine the effect of cumin supplementation on markers of glycemic control in adults. A comprehensive literature search was conducted up from inception to November 2020 on PubMed, Scopus, Web of Sciences, and Cochrane electronic databases. Studies that compared the effect of cumin with placebo on fasting blood sugar (FBS), serum insulin, and homeostasis model assessment-estimated insulin resistance (HOMA-IR) index in adults were considered eligible. Weighted mean difference (WMD) (with 95% confidence intervals) for endpoints were calculated using the random-effects model. Finally, a total of eight RCT studies involving 552 participants were included in the review. The results of the meta-analysis suggest that cumin supplementation did not significantly alter serum FBS (WMD: -17.77 mg/dl; 95% CI: -36.42 to 0.87, p= .06), insulin (WMD: -0.49 Hedges' g; 95% CI: -1.19 to 0.21, p=.16) levels and HOMA-IR (WMD: -0.06; 95% CI: -0.21 to 0.10, p= 0.48) index. These results do not support the use of cumin supplementation for improving glycemic markers in adults. However, further high-quality trials are still needed to confirm these results.

Association between convalescent plasma and the risk of mortality among patients with COVID-19: a meta-analysis

Background: Convalescent plasma (CCP) has been used for treating some infectious diseases; however, the efficacy of CCP in coronavirus disease 2019 (COVID-19) remains controversial. The aim of this research was to assess the efficacy of CCP as an adjunctive treatment in COVID-19 patients. Methods: Embase, PubMed, Web of Science, Cochrane and MedRix were searched for potentially relevant articles. All included papers were assessed for the quality using modified jadad scale and Newcaste-ottawa scale for randomized controlled trial (RCT) and non – RCT, respectively. We used a Q test and Egger test to assess the heterogeneity and publication bias among studies, respectively. Mortality rates between patients treated with standard treatment and standard treatment with CCP were compared using a Z test. Results: A total of 12 papers consisting of three cross-sectional studies, one prospective study, five retrospective studies, and two RCT studies were included in our analysis. Of them, a total of 1,937 patients treated with CCP and 3,405 patients without CCP were involved.. The risk of mortality was 1.92-fold higher in patients without CCP compared to patients treated with CCP (OR: 1.92; 95%CI: 1.33, 2.77; p=0.0005). In severe COVID-19 sub-group analysis, we found that patients without the CCP had a 1.32 times higher risk of mortality than those treated with the CCP (OR: 1.32; 95%CI: 1.09, 1.60; p=0.0040). Conclusions: CCP, as adjunctive therapy, reduces the mortality rate among COVID-19 patients.

Association of pharmacist counseling with adherence, 30-day readmission, and mortality: A systematic review and meta-analysis of randomized trials

Objective(s)To determine the association of pharmacist medication counseling with medication adherence, 30-day hospital readmission, and mortality. MethodsThe initial search identified 21,590 citations. After applying the inclusion and exclusion criteria, 62 randomized controlled trials (RCTs) (49 for the meta-analysis) were included in the final analysis. Data were pooled using a random-effects model. ResultsThe participants in most of the studies were older patients with chronic diseases who, therefore, were taking many drugs. The overall methodologic quality of evidence ranged from low to very low. Pharmacist medication counseling versus no such counseling was associated with a statistically significant 30% increase in relative risk (RR) for medication adherence, a 24% RR reduction in 30-day hospital readmission (number needed to treat = 4.2), and a 30% RR reduction in emergency department visits. RR reductions for primary care visits and mortality were not statistically significant. ConclusionThe evidence supports pharmacist medication counseling to increase medication adherence and to reduce 30-day hospital readmissions and emergency department visits. However, higher-quality RCT studies are needed to confirm or refute these findings.

Research Trends on Mobile Mental Health Application for General Population: A Scoping Review

Background: Scoping reviews of the literature on the development and application of mental health apps based on theoretical suggestions are lacking. This study systematically examines studies on the effects and results of mental health mobile apps for the general adult population. Methods: Following PICOs (population, intervention, comparison, outcome, study design), a general form of scoping review was adopted. From January 2010 to December 2019, we selected the effects of mental health-related apps and intervention programs provided by mobile to the general adult population over the age of 18. Additionally, evaluation of methodological quality was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) checklist. Results: Fourteen studies were analyzed of 1205 that were identified; duplicate and matching studies were excluded. One was a descriptive study and 13 were experimental, of which randomized control trials (RCTs) accounted for 71.4%. Four of the mobile apps were developed based on cognitive behavior theory, one based on stress theory, and one on ecological instant intervention theory. These apps included breathing training, meditation, and music therapy. Stress, depression, and anxiety decreased using these apps, and some were effective for well-being. Conclusion: With the rapid development of technology related to mental health, many mobile apps are developed, but apps based on theoretical knowledge and well-designed research are lacking. Further research and practices should be conducted to develop, test, and disseminate evidence-based mHealth for mental health promotion. RCT studies are needed to expand the application to mental health services to various populations.

Melatonin serum level, sleep functions, and depression level after bilateral anodal transcranial direct current stimulation in patients with Parkinson's disease: a feasibility study.

ObjectiveParkinson’s disease (PD) is associated with non-motor complications such as sleep disturbance and depression. Transcranial direct current stimulation (tDCS) showed therapeutic effects on the motor dysfunctions. However, the potential effects of tDCS therapy on melatonin hormone, sleep dysfunctions, and depression in patients with PD still unclear. This feasibility study aimed to identify any potential changes in melatonin serum level, sleep functions and depression after the bilateral anodal tDCS in patients with PD.Material and MethodsTensessions of bilateral anodal tDCS stimulation applied over left and right prefrontal and motor areas were given to twenty-five patients with PD. Melatonin serum level, Pittsburgh sleep quality index, and geriatric depression scale examined before and after tDCS stimulation.ResultsAfter bilateral anodal tDCS, there was a significant reduction in melatonin serum level, improvement in depression, improvements in overall sleep quality, and sleep latency. Correlations test showed significant associations between melatonin serum level reduction and changes in subjective sleep quality, and sleep duration, as well as between improvements in depression and overall sleep quality, sleep latency, and sleep disturbance.ConclusionBilateral anodal tDCS therapy was a feasible and safe tool that showed potential therapeutic effects on melatonin serum level, sleep quality, and depression level in patients with PD. Although the further large scale and randomized-control trial studies are crucially needed, there is still a need for such a feasibility study to be established before such trials can be implemented as is recommended in the new medical research council guidelines.

Association between convalescent plasma and the risk of mortality among patients with COVID-19: a meta-analysis

Background: Convalescent plasma (CCP) has been used for treating some infectious diseases; however, the efficacy of CCP in coronavirus disease 2019 (COVID-19) remains controversial. The aim of this research was to assess the efficacy of CCP as an adjunctive treatment in COVID-19 patients. Methods: Embase, PubMed, Web of Science, Cochrane and MedRix were searched for potentially relevant articles. All included papers were assessed for the quality using modified Jadad scale and Newcastle-Ottawa scale for randomized controlled trial (RCT) and non – RCT, respectively. We used a Q test and Egger test to assess the heterogeneity and publication bias among studies, respectively. Mortality rates between patients treated with standard treatment and standard treatment with CCP were compared using a Z test. Results: A total of 12 papers consisting of three cross-sectional studies, one prospective study, five retrospective studies, and three RCT studies were included in our analysis. Of them, a total of 1,937 patients treated with CCP and 3,405 patients without CCP were included. The risk of mortality was 1.92-fold higher in patients without CCP compared to patients treated with CCP (OR: 1.92; 95%CI: 1.33, 2.77; p=0.0005). In severe COVID-19 sub-group analysis, we found that patients without CCP had a 1.32 times higher risk of mortality than those treated with CCP (OR: 1.32; 95%CI: 1.09, 1.60; p=0.0040). Conclusions: CCP, as adjunctive therapy, could reduce the mortality rate among COVID-19 patients.

Clinical Efficacy of Traditional Chinese Medicine for COVID-19: A Systematic Review and Meta-Analysis

Background: Traditional Chinese Medicine (TCM) has played crucial roles in treating COVID-19 in China. But its effectiveness has not been widely realized over the world. It is imperative to timely report the efficacy of TCM medicine in the treatment for COVID-19 based on the data from randomized controlled trials (RCTs) clinical studies. Methods: We performed a systematic review and meta-analysis to investigate the clinical efficacy of TCM medicine in the treatment for COVID-19. We obtained the data for COVID-19 and Traditional Chinese Medicine from PubMed, Medline, Web of Science, medRxiv, bioRxiv, the Cochrane Central Register of Controlled Trials (CENTRAL), and China National Knowledge Infrastructure (CNKI). We searched these data sources from their inception to January 06, 2021, with no restriction by language, for the comparative clinical trial studies of treatment of COVID-19 with TCM medicinal formulae. We screened records, extracted data, and assessed risk of bias. We rated the certainty of evidences according to Cochrane methods in the meta-analyses. This study is registered with PROSPERO, CRD42020205856. Findings: Our search identified 20 RCT studies in different cities across China (n= 1949 patients). The treatment of COVID-19 by TCM combined with conventional treatment is more effective than by the conventional treatment alone shown from many aspects, including increasing of the effective rate [OR=2.48, 95%CI (1.85, 3.32), PInterpretation: The findings of this meta-analysis suggest that TCM can effectively relieve symptoms, boosted patients' recovery, cut the rate of patients developing into severe conditions, and reduced the mortality rate. The advantages of the TCM medicine are effective, cheap, and personalized; particularly it can be promptly refined according to the change of pandemic pattern. Although more robust randomized trials are still needed to better inform the efficacy of TCM medicine, this systematic appraisal of currently best available evidence might inform interim guidance for understanding the effectiveness of TCM in treating COVID-19. Funding: National Science Foundation of China (NSFC).Declaration of Interests: All the authors declare no competing interests.

From hydroxychloroquine to ivermectin: what are the anti-viral properties of anti-parasitic drugs to combat SARS-CoV-2?

BackgroundNearly a year into the COVID-19 pandemic, we still lack effective anti-SARS-CoV-2 drugs with substantial impact on mortality rates except for dexamethasone. As the search for effective antiviral agents continues, we aimed to review data on the potential of repurposing antiparasitic drugs against viruses in general, with an emphasis on coronaviruses.MethodsWe performed a review by screening in vitro and in vivo studies that assessed the antiviral activity of several antiparasitic agents: chloroquine, hydroxychloroquine (HCQ), mefloquine, artemisinins, ivermectin, nitazoxanide (NTZ), niclosamide, atovaquone and albendazole.ResultsFor HCQ and chloroquine we found ample in vitro evidence of antiviral activity. Cohort studies that assessed the use of HCQ for COVID-19 reported conflicting results, but randomized controlled trials (RCTs) demonstrated no effect on mortality rates and no substantial clinical benefits of HCQ used either for prevention or treatment of COVID-19. We found two clinical studies of artemisinins and two studies of NTZ for treatment of viruses other than COVID-19, all of which showed mixed results. Ivermectin was evaluated in one RCT and few observational studies, demonstrating conflicting results. As the level of evidence of these data is low, the efficacy of ivermectin against COVID-19 remains to be proven. For chloroquine, HCQ, mefloquine, artemisinins, ivermectin, NTZ and niclosamide, we found in vitro studies showing some effects against a wide array of viruses. We found no relevant studies for atovaquone and albendazole.ConclusionsAs the search for an effective drug active against SARS-CoV-2 continues, we argue that pre-clinical research of possible antiviral effects of compounds that could have antiviral activity should be conducted. Clinical studies should be conducted when sufficient in vitro evidence exists, and drugs should be introduced into widespread clinical use only after being rigorously tested in RCTs. Such a search may prove beneficial in this pandemic or in outbreaks yet to come.

Was femoral nerve block effective for pain control of medial opening-wedge high tibial osteotomy?: A single blinded randomized controlled study.

Background and Purpose:Medial compartment femoro–tibial osteoarthritis (OA) is a common disease and opening-wedge high tibial osteotomy (OWHTO) is the common surgical procedure carried out for these patients. While most researchers are focusing on the surgical techniques during operation, the aim of this study is to evaluate the pain control effect of femoral nerve block (FNB) for OWHTO patients.Methods:In this prospective, single-center, randomized controlled trial (RCT) study, 41 patients were operated on by OWHTO for OA during 2017 to 2018. Twenty of them (group A) accepted epidural anesthesia with FNB and 21 patients (group B) only had their single epidural anesthesia. All blocks were successful and all the 41 patients recruited were included in the analysis and there was no loss to follow-up or withdrawal. Systematic records of visual analog scores (VAS), quadriceps strength, mean number of times of patient-controlled intravenous analgesia (PCIA), using of additional opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), and complications were done after hospitalization. The Student t test and Chi-Squared test was used and all P values ≤.05 were considered statistically significant.Results:VAS scores at rest (3.48 ± 1.0 vs 4.68 ± 1.1) and on movemment (4.51 ± 0.6 vs 4.97 ± 0.8) decreased more in group A than group B with significance at follow-up of 12 hours. The quadriceps strength, consumption of additional opioids or NSAID injections and mean number of times that the patients pushed the PCIA button didnot differ significantly within each group.Conclusion:This RCT study shows that FNB in patients undergoing OWHTO for unicompartmental osteoarthritis of the knee could result in significant reduction in VAS scores at 12 hours postoperatively.Research registry, Researchregistry4792. Registered April 7, 2019 - Retrospectively registered, http://www.researchregistry.com.

Risk of Skin Cancer Associated with Metformin Use: A Meta-Analysis of Randomized Controlled Trials and Observational Studies.

Previous studies demonstrate mixed evidence regarding the association between metformin and skin cancer risk. To synthesize prior evidence and evaluate the association between metformin and skin cancer risk in patients with diabetes/prediabetes, we conducted a meta-analysis. A systematic literature search was performed up to March 23, 2020 to identify randomized controlled trials (RCT) and observational studies of metformin that reported any event of squamous cell carcinoma (SCC), basal cell carcinoma (BCC), and melanoma. In a meta-analysis of 6 trials involving 8,541 patients (Peto method), compared with controls, metformin was not significantly associated with decreased risk of melanoma [OR, 0.82; 95% confidence interval (CI), 0.27-2.43], BCC (OR, 0.75; 95% CI, 0.36-1.57), SCC (OR, 0.98; 95% CI, 0.06-15.60), total nonmelanoma skin cancer (NMSC; OR, 0.69; 95% CI, 0.38-1.24), or total skin cancer (OR, 0.71; 95% CI, 0.42-1.20). This nonsignificant association pattern was consistent with the random-effects meta-analysis of 4 cohort studies with 354,746 patients (melanoma: RR, 0.91; 95% CI, 0.62-1.33; NMSC: RR, 0.65; 95% CI, 0.35-1.18; total skin cancer: RR, 0.83; 95% CI, 0.59-1.16). In conclusion, meta-analyses of both RCT and cohort studies showed no statistically significant association between metformin and skin cancer risks, although suggestive evidence of modestly reduced risks of skin cancer among metformin users was observed. Further studies are needed. PREVENTION RELEVANCE: Meta-analyses of RCT and cohort studies showed no significant association between metformin and skin cancer, although suggestive evidence of modestly reduced skin cancer risks among metformin users was observed. These findings suggest metformin use should not influence current medical decision making for diabetes patients at risk of developing skin cancer.

Early mobilization on mortality of patients with mechanical ventilation in intensive care unit after discharge: a Meta-analysis

To evaluate the effect of early mobilization on mortality in intensive care unit (ICU) patients with mechanical ventilation after discharge by Meta-analysis. Databases including SinoMed, China National Knowledge Infrastructure (CNKI), Wanfang data, PubMed, the Cochrane Library, Web of Science, and Embase were searched from inception to September 17th, 2020, to collect randomized controlled trials (RCT) about early mobilization on mortality of patients with mechanical ventilation in ICU after discharge, the references included in the literature were traced. The control group was given routine care, the experimental group was given early mobilization on the basis of the control group, including passive or active mobilization on the bed, sitting on the bed, standing by the bed, transferring to the bedside chair and assisting walking. The literature screening, data extracting, and the bias risk assessment of included studies were conducted independently by two reviewers. Stata 12.0 software was then used to perform Meta-analysis. Funnel plot was used to test publication bias. A total of 10 RCT studies involving 1 323 patients were included, with 660 patients in the control group and 663 patients in the experimental group. The results of literature quality evaluation showed that 7 studies were grade A and 3 studies were grade B, indicating that the overall quality of included literatures was high. The Meta-analysis results showed that early mobilization did not increase the mortality of patients with mechanical ventilation in ICU after discharge [odds ratio (OR) = 0.92, 95% confidence interval (95%CI) was 0.75-1.13, P = 0.449]. Subgroup analysis results showed that early mobilization had a tendency to reduce the mortality of ICU patients with mechanical ventilation at 3, 6 and 12 months after discharge, but the difference was not statistically significant (3-month mortality: OR = 1.02, 95%CI was 0.74-1.40, P = 0.927; 6-month mortality: OR = 0.95, 95%CI was 0.70-1.27, P = 0.712; 12-month mortality: OR = 0.60, 95%CI was 0.33-1.10, P = 0.101). Funnel plot showed that the distribution of included literatures was not completely symmetrical, suggesting that publication bias might exist. Early mobilization does not increase the mortality of ICU patients with mechanical ventilation after discharge. Although it tends to have a favorable outcome in reducing mortality, and has a trend to reduce the mortality. However, due to the small number of included literatures, small sample size and differences in the specific implementation of early mobilization among various studies, a large number of high-quality RCT studies are still needed for further verification.

Systematic review and meta-analysis: dipeptidyl peptidase-4 inhibitors and rheumatoid arthritis risk.

This review evaluated the risk of rheumatoid arthritis in patients with type 2 diabetes treated with dipeptidyl peptidase-4 inhibitors (Dpp-4i). The MEDLINE (via PubMed), Embase, the Cochrane Library databases and web of science were used to search the effects of Dpp-4i on rheumatoid arthritis in patients with type 2 diabetes from inception to 7 September, 2020. We included studies that met the following criteria:(i) A randomized controlled trial (RCT), prospective or retrospective cohort study examining the relationship between Dpp-4i and rheumatoid arthritis. Exclusion criteria included the following: Reviews and researches related to other diseases or subjects; and studies without data on the prevalence of rheumatoid arthritis were excluded. Risk of Bias table contained in Review Manager 5.3 and Newcastle-Ottawa scale (NOS) were used for quality assessment of included RCT and observational studies separately. Meta-analysis was used to estimate the risk of disease. We conducted a subgroup analysis of duration of follow-up, adjusted (adjusted RR or unadjusted RR), sample size and study design. A total of 10 independent studies assessing 1,420,414 patients were included in this analysis. In this meta-analysis, we found that there was nonsignificant increase of rheumatoid arthritis with Dpp-4 inhibitor exposure (RR 0.96, 95%CI (0.69-1.32)). Our results revealed that Dpp-4 inhibitors do not seem to increase the risk of rheumatoid arthritis. Long-term follow-up monitoring is necessary.

Randomized Controlled Trials versus Single Cohort Studies in Relapse Refractory Multiple Myeloma

Background: The Randomized Controlled Trial (RCT) is considered the gold-standard for the evaluation of treatment efficacy. For rare or end stage cancers for which there are no effective treatments, or the number of patients is sparse, the use of RCTs for the assessment of efficacy and safety may be difficult. In these circumstances the single cohort study (SC) can be considered as an alternative to the RCT. Purpose: The purpose of this study was to compare the measures of efficacy as assessed with estimates of the Overall Response Rate (ORR) or Overall Survival (OS) obtained in RCT and SC studies that evaluate the same treatments for Relapse Refractory Multiple Myeloma (RRMM). The study also compared the estimates of ORR and OS ratios between treatments estimated in RCTs and extrapolated in SCs for the same treatments of RRMM. Methods: The study utilized data from 42 RCTs and 47 SCs assessing 18 different treatment protocols for RRMM that were identified through a MEDLINE search. Results: The results showed that there were no material differences in the demographics of patients enrolled in RCTs and SCs. The estimates of ORR and OS obtained in RCTs and SCs were comparable. Statistically significant Intra-Class Correlation Coefficient (ICC = 0.618, P = 0.027) was observed for ORR and for OS (ICC = 0.734; P = 0.014) indicating good agreement between RCTs and SCs. Treatment effect size as measured by the ORR and OS ratios (new treatment / control) was ascertained directly from RCTs and extrapolated for SCs based on the control ORR and OS observed in RCTs. There was agreement between RCTs and SCs with respect to the magnitude and direction of the ORR ratios (91% of the studies) and the OS ratios (75% of the studies). With respect to the conclusion regarding the relative efficacy of the new treatment versus the control, there was agreement between RCTs and SCs for 8/11 treatments based on ORR ratios and for 6 / 8 based on OS ratios. Conclusions: The results of this study have shown that for RRMM single cohort studies can be used to assess the efficacy of new treatments, given that sufficient data are available on controls treatments used as standard of care. The results may have implications for the evaluation of treatments of rare and advanced cancers as well as other conditions.

Reporting of sample size parameters for randomized controlled trials published in high impact factor endodontic journals in the last decade: A bibliometric analysis

Introduction: Analysis of journals helps in identifying areas of improvement in the respective field as an author/reviewer. The aim of the present study was to report the parameters used in sample size calculations for randomized controlled trials (RCTs) published in Journal of Endodontics (JOE) and International Endodontic Journal (IEJ) in the last decade. Materials and Methods: A Medline search retrieved all published RCTs in JOE and IEJ from the last decade. The searche was limited to RCTs studies published in english language from January 01, 2010 to April 31, 2020 having enrolled human participants. Articles were reviewed for description of method used to calculate sample size and reporting of parameters i.e. (level of significance, power, effect size, and variance) used for sample size calculation. The data were statistically analyzed. Results: Sample size was mentioned in 94.5% of all articles. Alpha was reported in 81.6% followed by power, effect size, and variance as 67.3%, 57.1%, and 11.5%, respectively. Only 8.7% articles explicitly reported all four parameters of sample size. Conclusion: The reporting of sample size calculation parameters for RCTs was inconsistent. Authors, editors, and reviewers need to increase the reporting of adequate sample size parameters to make the results of RCTs more robust for clinical applications.

Implementing implementation science in a randomized controlled trial in Norwegian early childhood education and care

The emerging interest in implementation processes in the social, health, and educational sciences has increased the recognition of implementation science. Still, the literature provides limited practical insights on how to successfully develop and conduct interventions within educational settings in randomized controlled trials (RCTs) in line with implementation science. This paper uses the Agder RCT study to provide such insights. We describe how the theory of change and implementation framework supported systematic tailoring and implementation of a new Early Childhood Education and Care (ECEC) intervention. The paper contributes to the emerging use of implementation science in education in general, and more specifically in ECEC. Finally, we discuss how implementation science also needs to be utilized during the upscaling of the project.

Effect of Anethum graveolens L. (Dill)Consumption on Serum Lipids: A Systematic Review and Meta-analysis

Background: Anethum graveolens L. (dill) has been used as traditional medicinal plant for abdominal discomfort, colic, sleep disprders and for promoting digestion since ancient times. Recently, lipid-lowering effect of dill has been noticed. Aim of the study: We conducted a meta-analysis to evaluate the effect of dill supplementation on human serum lipid profile. Methods: A systematic search for English published randomized controlled trials (RCTs) was performed up to December 2019 covering PubMed, EMBASE, Scopus and Coherence library. Inclusion criteria were RCT study design, at least one of lipid profile components (triglyceride, total cholesterol, LDL-C and HDL-C) levels measured before dill use and also reported as result. The pooled weighted mean difference (MD) and its 95% confidence interval (CI) were calculated and pooled using a random-effects model. Results: Pooled data of six RCTs involving 171 intervention cases indicated that dill supplementation was associated with a significant reduction in mean serum total cholesterol (MD 95% CI=-3.71 (-5.71,-1.70); p < 0.001), low-density lipoprotein cholesterol (LDL-C) (MD 95% CI=-1.51 (-2.65,-0.47); p=0.005), triglycerides (MD 95% CI=-2.48 (-3.98,-0.98); p=0.001) and interestingly high-density lipoprotein cholesterol level (HDL-C) (MD 95% CI=-2.19 (-3.58,-0.81); p=0.002). Subgroup analysis showed that dill use was more effective in lowering triglyceride in both hyperlipidemic patients, MD 95% CI=-3.54 (-6.49,-0.60); p=0.02) and type 2 diabetes (MD 95% CI=-3.64 (-5.69,-1.58); p=0.001). Dill use reduced the LDL levels more effectively in patients with type 2 diabetes (MD 95% CI=-3.54 (-6.49,-0.60); p=0.03). Conclusion: Dill supplementation significantly improved LDL-C, TG and TC levels but not HDL-C. Further high quality controlled clinical trials on human is needed for more accurate and confirm conclusion.

Consumer behaviour and climate action: insights from a Randomised Control Trial experiment in India's residential cooling sector

Air-conditioning is expected to be the largest consumer of residential energy in India in the future. Good consumer practices related to servicing air-conditioners (ACs) are critical for maintaining high operational efficiency of ACs and reducing leakages of high global warming potential (GWP) refrigerant gases. Little information, however, is available about the knowledge and practices of Indian AC consumers in terms of their operational practices. The Government of India's ‘India Cooling Action Plan (ICAP)’ recommends a massive consumer awareness program to inform and change AC user behaviour. Within this context of the ICAP that aims to provide access to sustainable cooling to its masses while minimising its environmental impacts, we undertake a survey and a Randomised Control Trial (RCT) experiment including Indian consumers. The survey and experiment together aim to understand the AC servicing behaviour of Indian consumers and experiment with alternative interventions to influence their behaviour and glean insights for India's energy and climate policies. The behavioural experiment is a unique and novel methodological contribution to India's cooling and climate debate. This research is a first-of-its-kind RCT study of Indian consumers' AC servicing practices. We find that the AC users' knowledge of the importance of preventive servicing is much lower than required. The interventions were successful in enhancing general awareness related to the importance of servicing practices, but not in enhancing technical knowledge related to specific good servicing practices. Our analysis shows that consumers who know about the economic benefit of servicing are more likely to undertake preventive servicing. Our findings highlight the presence of information asymmetry in the Indian residential cooling market and argue that this needs to be addressed for achieving the desired behavioural change and actions to mitigate climate change.

Effect of Zinc supplementation on child development: a systematic review and metaanalysis Protocol.

Child development is one of the principal aspects of pediatrics. It is a multidimensional process, on which many factors may have different effects. Zinc is a nutritional trace element that has an essential role in neuronal activity and, consequently, in brain development. Since Zinc deficiency is prevalent in developing countries, some clinical trials were conducted to evaluate the impact of zinc supplementation on child development. Thus, we decided to run a systematic review in this area to identify the effectiveness of zinc supplements on child development. This systematic review protocol will include randomized controlled trials studies (RCTs) in which zinc supplementation was used versus placebo or no intervention, zinc supplementation with other micronutrients versus the same micronutrients without zinc. We will evaluate the effect of zinc alone and zinc co-supplementation with iron on child development. We will search the Medline, Pubmed, EMBASE, ERIC, Psychinfo, the Cochrane Central Register of Controlled Trials (CENTRAL), clinicaltrials.gov, WHO International Clinical Trials Registry Platform (ICTRP), ISRCTN Registry CINAHL, Web of Science and Scopus databases. The clinicaltrials.gov and the Cochrane Library website will also be searched for randomized trials which were registered and completed but not published yet. Two researchers will independently screen titles and abstracts of citations and read the full texts of potentially relevant studies. The data extraction and quality assessment of the papers will be done independently. Any disagreements that arise between the reviewers in the above-mentioned steps will be resolved through discussion. We will report our findings based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and use the Cochrane Collaboration’s tool for assessing the risk of bias. We will aim to synthesize the results in a meta-analysis if the interventions are similar in methods. Based on the similarities and differences of primary studies, we will use the best statistical methods. This is a protocol of systematic Review and meta-analysis of the effect of zinc supplementation on child development.The strengths of this protocol after meta-analysis are as follows:We will identify the strengths and weaknesses of each study.We will also study if zinc alone and zinc co-supplementation with iron are useful for improving child development in terms of their age, their nutritional status, dose of the zinc supplementation, type of the zinc supplementation (salt), duration of the intervention and iron or other nutrient co supplementations.We will assume that the measures used for the outcome will be heterogeneous between studies. We know that each study has its own quantity. We will use the random effect models for these heterogeneous data.

Effects of metformin on body weight in polycystic ovary syndrome patients: model-based meta-analysis

ABSTRACT Objectives The present study aimed to investigate the effects of metformin on body weight in polycystic ovary syndrome (PCOS) patients by model-based meta-analysis (MBMA). Methods Randomized controlled trial (RCT) studies of metformin in treatment of PCOS patients were collected and efficacy indicators were the body mass index (BMI) change rates from baseline. Results 28 RCT studies, 1631 PCOS patients were included for analysis. Model of metformin monotherapy, and model of metformin combination therapy were established, respectively. After deducting control group effects, the Emax of metformin on BMI were −5.88% and −11.8% in metformin monotherapy and metformin combination therapy, respectively. In order to play better curative effects, for metformin monotherapy, 1000 mg/day metformin needs for at least 25.5 weeks; For metformin combination therapy, 1000 mg/day metformin needs for at least 58.6 weeks. Conclusion It was the first time to quantify the effects of metformin on body weight and recommend dose and duration for metformin monotherapy and metformin combination therapy in PCOS patients.