Efficacy and safety of diosmectite in acute childhood diarrhoea: a meta-analysis

2015 ◽  
Vol 100 (7) ◽  
pp. 704-712 ◽  
Author(s):  
Rashmi Ranjan Das ◽  
Jhuma Sankar ◽  
Sushree Samiksha Naik
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Outcome Measures ◽  
Meta Analysis ◽  
Acute Diarrhoea ◽  
Randomised Clinical Trials ◽  
Secondary Outcome ◽  
Future Research ◽  
Open Label ◽  
Childhood Diarrhoea

ObjectiveWe evaluated the role of diosmectite as an add-on treatment to the ‘recommended treatment’ of acute diarrhoea in children.MethodsWe searched all published literature through the major databases: Medline via Ovid, PubMed, CENTRAL, Embase and Google Scholar till May 2014. Randomised clinical trials comparing diosmectite versus placebo were included (PROSPERO registration: CRD42014013783).Main outcome measuresThe primary outcome measures were duration of acute diarrhoea (h), and day-to-day cure rates (%). The secondary outcome measures were stool output (volume), stool output (frequency) and adverse events.ResultsOf 384 citations retrieved, a total of 13 randomised clinical trials (2164 children, 1–60 months old) were included in the meta-analysis. A dose of 3–6 grams per day of diosmectite was given for a duration from 3 days until recovery. Compared with placebo, diosmectite significantly decreased the duration of acute diarrhoea (mean difference, −23.39; 95% CI −28.77 to −18.01), and increased the cure rate (%) at day 5 (OR, 4.44; 95% CI 1.66 to 11.84), without any increases in the risk of adverse events. Diosmectite was effective in all types of acute childhood diarrhoea except dysentery. Because, most of the trials were open-label, and there was a high possibility of publication bias, the GRADE evidence generated was of ‘low quality’.ConclusionsDiosmectite may be a useful additive in the treatment of acute childhood diarrhoea. As the evidence generated was of ‘low quality’, future research is needed with higher quality designs before any firm recommendations can be made.Trial registration numberPROSPERO registration: CRD42014013783.

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

scholarly journals Favipiravir for treating patients with novel coronavirus (COVID-19): protocol for a systematic review and meta-analysis of randomised clinical trials

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e039730 ◽  
Author(s):  
Morteza Arab-Zozani ◽  
Soheil Hassanipour ◽  
Djavad Ghoddoosi-Nejad
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Code Of Ethics ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Secondary Outcome ◽  
Eligibility Criteria ◽  
Safety And Efficacy ◽  
Statistical Heterogeneity

IntroductionAn outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was reported in Wuhan, China, in mid-December 2019, and declared a pandemic by the WHO on 11 March 2020. Due to the unknown nature of the disease and the lack of specific drugs, several potential treatments were used for patients. This systematic review and meta-analysis will evaluate studies of the effects of favipiravir in COVID-19 pneumonia.Methods and analysisWe will search electronic databases including LitCovid hub, PubMed, Scopus, ISI Web of Sciences, Cochrane and Embase using keywords related to COVID-19 and favipiravir. We will search the reference lists of all included studies and reviews. We will also search for clinical trial registries, such as ClinicalTrials.gov, for the ongoing clinical trials. All randomised clinical trials investigating the safety and efficacy of favipiravir compared with other control groups for the treatment of patients with confirmed infection with SARS-CoV-2 will be included. Patients’ survival at the end of the treatment as well as the follow-up will be the primary outcome of the treatment, followed by the time and rate of the patient with a negative COVID-19 test. The desired secondary outcome will consist of a decreased rate of symptoms, proportion of intensive care unit (ICU) transfers, length of the hospital stay, ICU treatments, the quality of life and additional adverse events. Data synthesis will be conducted using CMA V.2. Two independent investigators will be screening titles, abstracts and full texts of included studies, based on eligibility criteria. These investigators will then independently extract the data and appraise the quality of said studies. All potential discrepancies will be resolved through consultation with the third reviewer. Statistical heterogeneity will be assessed using a standard I2 test. A funnel plot, Egger’s test and Begg’s test will be used for detecting asymmetry to explore possible publication bias.Ethics and disseminationAll findings of this systematic review and meta-analysis will help identify the safety and efficacy of favipiravir for patients with COVID-19. Given that the design of the study is a systematic review, there is no need to follow the code of ethics protocol. The results of this study will be published in a reputable journal.PROSPERO registration numberCRD42020180032.

Pembrolizumab with or without vismodegib in treating metastatic or unresectable basal cell skin cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS9593-TPS9593
Author(s):  
Anne Lynn S. Chang ◽  
Duy C Tran ◽  
Richard Brotherton ◽  
Sunil Reddy ◽  
A. Dimitrios Colevas
Keyword(s):  
Adverse Events ◽  
Outcome Measures ◽  
Basal Cell ◽  
Locally Advanced ◽  
Significant Proportion ◽  
Case Series ◽  
Progression Free Survival ◽  
Secondary Outcome ◽  
Open Label ◽  
Eligibility Criteria

TPS9593 Background: Basal cell carcinomas (BCCs) are the most common cancer in humans and have increased > 75% in the past two decades, with > 28,000 cases of advanced or metastatic diseases per year. Targeted therapy in the form of Smoothened inhibitors (SIs) are FDA approved for advanced BCC, however, over half of patients do not respond or become resistant to SI monotherapy after initial response. At this time, there are no other FDA approved drugs for advanced BCCs, however, emerging data indicates that a significant proportion of BCCs express programmed cell death ligand (PD-L)-1, suggesting potential response to PD-1 inhibition. In addition, BCCs are keratinocytic tumors, and our case series of PD-1 inhibitors against cutaneous squamous cell carcinomas, another keratinocytic tumor, have shown activity. Here, we present a proof-of-principle, phase 1b, open-label investigator initiated study of pembrolizumab for unresectable or metastatic BCC (NCT02690948). Methods: Following institutional review board approval, patients with locally advanced or metastatic BCCs who met all eligibility criteria were enrolled at a single academic center. Participants were allocated into either Arm 1 (pembrolizumab 200 mg IV every 3 weeks) or Arm 2 (pembrolizumab 200 mg IV every 3 weeks and concurrent vismodegib 150 mg by mouth daily) until disease progression or intolerable toxicity. Major inclusion criteria include individuals aged > or = 18 years with histologically verified unresectable and/or metastatic BCC, and with measurable disease by Response Evaluation Criteria for Solid Tumors version 1.1. Exclusion criteria include immunosuppresion, active infection, history of pneumonitis and autoimmune disease requiring systemic treatment. The primary outcome measures are the overall response rates in Arm 1 and 2. Secondary outcome measures include incidence and severity of adverse events (AEs) as defined by the Common Terminology Criteria for Adverse Events verson 4.0, and progression free survival. This study is currently enrolling, with 10 of 26 patients accrued to date (6 of 13 in Arm 1; 4 of 13 in Arm 2), and the study stopping rule (based on first 10 enrolled patients displaying progressive disease) did not need to be deployed. Clinical trial information: NCT02690948.

Vasoactive Agents for the Management of Variceal Bleeding: A Mixed Treatment Comparison Network Meta-analysis and Trial Sequential Analysis of Randomized Clinical Trials

Drug Research ◽  
2019 ◽  
Vol 69 (09) ◽  
pp. 487-495 ◽  
Author(s):  
Kannan Sridharan ◽  
Gowri Sivaramakrishnan
Keyword(s):  
Clinical Trials ◽  
Blood Transfusion ◽  
Adverse Events ◽  
Variceal Bleeding ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Vasoactive Agents ◽  
Bleeding Rate

Abstract Background Vasoactives such as terlipressin, somatostatin, vasopressin, octreotide and nitrates are commonly used to treat variceal bleeding. The present study is a network meta-analysis comparing the efficacy and safety of the above vasoactive agents for treating variceal bleeding. Methods Electronic databases were searched for appropriate randomized clinical trials evaluating vasoactives in cirrhotic patients with variceal bleeding. Random-effects model was used to generate the pooled estimates. Mortality was the primary outcome and bleeding control, re-bleeding rate, hospital stay, blood transfusion requirements and adverse events were the secondary outcome measures. Results Fifty randomized clinical trials were included of which 37 were included for the primary outcome. The overall analysis did not reveal any significant difference in the mortality risk between any of the vaso-active drugs except for terlipressin that had statistically significant benefits from direct pooled estimates. Somatostatin and terlipressin showed significant reduction in the mortality risks at 24 h. Terlipressin significantly reduced re-bleeding rate; somatostatin and vasopressin were associated with better hemostasis; and terlipressin and vasopressin significantly reduced the requirement for blood transfusion. Terlipressin, vasopressin and glyceryltrinitrate/vasopressin were also associated with increased risk of adverse events. Conclusion Terlipressin could be the best agent in the vasoconstrictor category for managing variceal bleeding. Somatostatin and vasopressin can serve as alternatives.

Drug Therapies for Patients with IgA Nephropathy: A Network Meta-analysis of Randomized Clinical Trials

2020 ◽  
Vol 15 (2) ◽  
pp. 132-144
Author(s):  
Kannan Sridharan ◽  
Gowri Sivaramakrishnan
Keyword(s):  
Clinical Trials ◽  
Iga Nephropathy ◽  
Outcome Measures ◽  
Randomized Clinical Trials ◽  
Angiotensin Receptor Blockers ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Mixed Treatment Comparison ◽  
Low Grade ◽  
Treatment Comparison

Background: Several drugs are used for treating IgA nephropathy (IgAN). We carried out a network meta-analysis evaluating these drugs. Methods: Electronic databases were searched for appropriate randomized clinical trials carried out in patients with IgAN. The primary outcome was proteinuria remission rates and there were several other secondary outcome measures. The risk of bias was assessed. Mixed treatment comparison estimates were modelled from direct and indirect comparison estimates. Grading of the evidence for key comparisons was carried out. Results: Fifty-seven clinical trials were included in the systematic review and 51 in the metaanalysis. Polyunsaturated fatty acids, corticosteroids/angiotensin receptor blockers (ARB), ARB, angiotensin converting enzyme inhibitors (ACEI), ARB/ACEI, corticosteroids/ACEI and hypolipidemics/ ARB were observed with significantly higher rates of proteinuria remission than the standard of care. Several benefits were observed with other drugs on the secondary outcome measures. A very low grade was observed for the interventions. Conclusion: We observed a few interventions to perform better in the management of IgAN. The results of this study will aid in further evaluation of such drugs that may assist in saving the resources and time. However, the readers should interpret the findings with great caution as the results might change with the advent of future head-to-head clinical trials.

scholarly journals Prevention and management of idiosyncratic drug-induced liver injury: Systematic review and meta-analysis of randomised clinical trials

2021 ◽  
Vol 164 ◽  
pp. 105404
Author(s):  
Hao Niu ◽  
Judith Sanabria-Cabrera ◽  
Ismael Alvarez-Alvarez ◽  
Mercedes Robles-Diaz ◽  
Simona Stankevičiūtė ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Liver Injury ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

scholarly journals Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Condition ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
Promising Treatment ◽  
Irritable Bowel

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.

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