scholarly journals Herbal Formula Modified Buzhong-Yiqi-Tang for Functional Constipation in Adults: A Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Hanlin Gong ◽  
Feng Qin ◽  
Hongbo He
Keyword(s):  
Clinical Trials ◽  
Therapeutic Effect ◽  
Randomized Clinical Trials ◽  
Functional Constipation ◽  
Adult Patients ◽  
Controlled Trials ◽  
Herbal Formula ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Prokinetic Agents

Background. Herbal formula Modified Buzhong-Yiqi-Tang (MBYT) has been widely used for the treatment of functional constipation in East Asia, but its efficacy and safety are unclear. Methods. The study was to evaluate the efficacy and safety of MBYT for adult patients with functional constipation. Randomized clinical trials were selected according to predefined inclusion and exclusion criteria. Results. In total, twenty-five randomized controlled clinical trials were included with 2089 patients. There was evidence that MBYT treatment significantly improved the symptoms of functional constipation compared with stimulant laxatives, osmotic laxatives, and prokinetic agents. Our results also demonstrated that, when used as an adjuvant therapy, MBYT significantly improved the symptoms of functional constipation, when compared with osmotic laxatives alone, prokinetic agents alone, and biofeedback alone. Moreover, patients taking MBYT experienced fewer adverse events compared to the control groups. Conclusion. This review suggests that MBYT appears to have excellent therapeutic effect on adult patients with functional constipation and no serious side effects were identified. However, due to overall limited quality, the therapeutic benefit of MBYT may be substantiated to a limited degree. Better methodological quality and large controlled trials are expected to further quantify the therapeutic effect of MBYT.

scholarly journals Hydroxychloroquine plus standard care compared with the standard care alone in COVID-19: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Bahman Amani ◽  
Ahmad Khanijahani ◽  
Behnam Amani
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

AbstractBackground & ObjectiveThe efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease COVID-19 pandemic is disputed. This study aimed to examine the efficacy and safety of HCQ plus the standard of care in COVID-19 patients.MethodsPubMed, The Cochrane Library, Embase, and web of sciences were searched up to June 1, 2020. The references list of the key studies was reviewed for additional relevant resources. Clinical studies registry databases were searched for identifying potential clinical trials. The quality of the included studies was evaluated using the Cochrane Collaboration’s tool. Meta-analysis was performed using RevMan software (version 5.3).ResultsThree randomized controlled trials with total number of 242 patients were identified eligible for meta-analysis. No significant differences were observed between HCQ and standard care in terms of viral clearance (Risk ratio [RR] = 1.03; 95% confidence interval [CI] = 0.91, 1.16; P = 0.68), disease progression (RR = 0.92; 95% CI = 0.10, 0.81; P = 0.94), Chest CT (RR = 1.40; 95% CI = 1.03, 1.91; P = 0.03). There is a significant difference between HCQ and standard care for adverse events (RR = 2.88; 95% CI = 1.50, 5.54; P = 0.002).ConclusionAlthough the current meta-analysis failed to confirm the efficacy and safety of HCQ in the treatment of COVID-19 patients, further rigorous randomized clinical trials are necessary to evaluate conclusively the efficacy and safety of HCQ against COVID-19.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

The Efficacy and Safety Of Therapeutic Aheresis In Sepsis and Septic Shock: A Systematic Review and Meta-Analysis

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1119-1119
Author(s):  
Emily K. Rimmer ◽  
Brett L. Houston ◽  
Anand Kumar ◽  
Ahmed Abou-Setta ◽  
Carol Friesen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Septic Shock ◽  
Clinical Trials ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
The Mean ◽  
Sepsis And Septic Shock

Abstract Introduction Sepsis and septic shock are leading causes of ICU mortality. They are characterized by excessive host inflammation, upregulation of procoagulant proteins and depletion of natural anticoagulants. Therapeutic apheresis has the potential to improve survival in sepsis by removing injurious elements and inflammatory cytokines and restoring deficient plasma proteins. The objective of our systematic review was to evaluate the efficacy and safety of apheresis in patients with sepsis or septic shock. Methods We searched PubMed, EMBASE, and CENTRAL (from inception to February 2013), the International Clinical Trials Registry Platform, relevant conference proceedings and bibliographies of pertinent reviews and included clinical trials. Two reviewers independently identified randomized controlled trials of patients diagnosed with sepsis, severe sepsis, septic shock or disseminated intravascular coagulation due to infection who received plasmapheresis, plasma exchange, or plasma filtration compared to placebo or usual care. Two reviewers independently extracted trial-level data including population characteristics, interventions, outcomes, and funding sources. We assessed risk of bias using the Cochrane risk of bias tool. Our primary outcome was all-cause mortality reported at the longest follow-up. Secondary outcomes were hospital and ICU lengths of stay, and reported adverse events. We expressed summary effect measures as odds ratios (OR) with 95% confidence intervals (CI). Random effect models using the Mantel-Haenszel method were used for pooled analyses. Results We identified 1771 potential citations of which 3 trials (144 patients) met inclusion criteria. The mean age of patients ranged from 38 to 53 years in the two adult trials and 1 to 18 years in the single pediatric trial. The mean APACHE score was 25.2 (APACHE II) in one study and 54.9 (APACHE III) in the other study reporting illness severity scores. All 3 studies were adjudicated to be unclear or high risk of bias. We observed that the use of apheresis was not associated with a significant reduction in all cause mortality (OR 0.42, 95% CI 0.16 - 1.12, I2=30%) (see Figure). In a subgroup analysis of studies including children exclusively, we observed that apheresis was associated with a significant reduction in mortality (OR 0.03, 95% CI 0.00 – 0.94). None of the included studies reported ICU or hospital length of stay. Only one study reported adverse events associated with apheresis including 6 episodes of hypotension and one allergic reaction to fresh frozen plasma. Central-venous catheter related complications were not reported. Conclusions In patients with sepsis or septic shock, apheresis is not associated a significant reduction in all cause mortality. There is currently insufficient evidence to recommend apheresis as an adjunctive therapy in patients with sepsis or septic shock. Rigorous randomized controlled trials powered to detect differences in patient-centered, clinically relevant outcomes are required to evaluate the impact of apheresis in this patient population. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Hui-ru Jiang ◽  
Shuang Ni ◽  
Jin-long Li ◽  
Miao-miao Liu ◽  
Ji Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled ◽  
Central Register

The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21]), SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]), and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]). All trials did not report adverse events. These results were limited by the methodological flaws of trials.

Randomized Controlled Trials in the Evaluation of Antenatal Care

1992 ◽  
Vol 8 (S1) ◽  
pp. 40-45 ◽  
Author(s):  
Murray W. Enkin
Keyword(s):  
Clinical Trials ◽  
Antenatal Care ◽  
Randomized Controlled Trials ◽  
Perinatal Outcome ◽  
Randomized Clinical Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Adverse Perinatal Outcome ◽  
Randomized Controlled

AbstractMany of the practices carried out during antenatal care improve the well-being of mother or baby and reduce the burden of adverse perinatal outcome. Other practices have either not been evaluated or have been shown to be ineffective. Evidence from randomized clinical trials provides the best evidence about the effectiveness of these practices.

scholarly journals Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

2020 ◽  
Author(s):  
Joseph A. Ladapo ◽  
John E. McKinnon ◽  
Peter A. McCullough ◽  
Harvey Risch
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Side Effects ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Exposure Prophylaxis

Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

scholarly journals Ceftaroline Efficacy and Safety in Treatment of Complicated Skin and Soft Tissue Infection: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 8 (6) ◽  
pp. 776 ◽  
Author(s):  
Shao-Huan Lan ◽  
Shen-Peng Chang ◽  
Chih-Cheng Lai ◽  
Li-Chin Lu ◽  
Chien-Ming Chao
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Meta Analysis ◽  
Adult Patients ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Randomized Controlled ◽  
Complicated Skin

This study aims to assess the clinical efficacy and safety of ceftaroline for the treatment of complicated skin and skin structure infections (cSSSIs) in adult patients through meta-analysis. PubMed, Embase, ClinicalTrials.gov, and Cochrane databases were searched up to April 2019. Only randomized controlled trials (RCTs) that evaluated ceftaroline and other comparators for treating cSSSIs in adult patients were included. The primary outcome was the clinical cure rate, whereas the secondary outcomes were clinical failure rate, microbiological eradication rate, relapse rate, and risk of an adverse event (AE). Five RCTs were included. Overall, ceftaroline had a clinical cure rate similar to comparators in the treatment of cSSSIs in the modified intent-to-treat population (risk ratio (RR), 1.00; 95% confidence interval (CI), 0.97–1.04; I2 = 0%) and in the clinically evaluable population (RR, 1.00; 95% CI, 0.97–1.03; I2 = 0%). In addition, no significant difference was observed between ceftaroline and comparators for the treatment of infection with Staphylococcus aureus (RR, 1.01; 95% CI, 0.98–1.05; I2 = 0%), methicillin-resistant S. aureus (RR, 0.99; 95% CI, 0.94–1.05; I2 = 0%), methicillin-susceptible S. aureus (RR, 1.01; 95% CI, 0.96–1.06; I2 = 26%), Streptococcus spp. (RR, 1.07; 95% CI, 0.92–1.24; I2 = 73%), and Gram-negative bacteria (RR, 0.94; 95% CI, 0.83–1.08; I2 = 0%). Furthermore, ceftaroline had a similar rate of microbiological eradication (92.2% vs. 92.6%, RR, 1.00; 95% CI, 0.97–1.03; I2 = 9%) and relapse (6.9% vs. 9.1%, RR, 0.48; 95% CI, 0.14–1.74; I2 = 0%) as comparators. Finally, the risks of treatment-emergent AEs (RR, 0.96; 95% CI, 0.88–1.05; I2 = 0%), serious AEs (RR, 1.03; 95% CI, 0.63–1.68; I2 = 0%), and discontinuation of study drug due to an AE (RR, 0.86; 95% CI, 0.50–1.49; I2 = 34%) did not differ significantly between ceftaroline and comparators. In conclusion, the clinical efficacy of ceftaroline is as high as that of comparators in the treatment of cSSSIs in adult patients, and this antibiotic is well tolerated like the comparators.

scholarly journals Efficacy and Safety of Acupuncture at Tianshu (ST25) for Functional Constipation: Evidence from 10 Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Pengfan Li ◽  
Yue Luo ◽  
Qi Wang ◽  
Shi Shu ◽  
Kanjun Chen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
High Frequency ◽  
Meta Analysis ◽  
Low Frequency ◽  
Functional Constipation ◽  
Colonic Transit ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Dilatational Wave

Objective. To evaluate the evidence for the efficacy and safety of acupuncture at Tianshu (ST25) for functional constipation (FC). Methods. We systematically searched seven databases to identify randomized controlled trials of acupuncture at ST25 alone or in combination with conventional therapy in the treatment of FC. Risk ratios (RRs) and mean differences (MDs) were calculated using RevMan 5.3 with 95% confidence interval (CI). Results. The study included ten trials with 1568 participants. Meta-analysis showed that the Cleveland Constipation Score (CCS) for deep needling was significantly lower than that for lactulose (deep needling with low-frequency dilatational wave: MD −0.58, 95% CI −0.94 to −0.22; deep needling with sparse wave: MD −3.67, 95% CI −6.40 to −0.94; deep needling with high-frequency dilatational wave: MD −3.42, 95% CI −5.03 to −1.81). Furthermore, CCS for shallow needling with high-frequency dilatational wave was lower than that for lactulose (MD −1.77, 95% CI −3.40 to −0.14). In addition, when deep needling was combined with high-frequency dilatational wave, the weekly frequency of spontaneous defecation (FSD) was significantly higher than that for lactulose (MD 1.57, 95% CI 0.93 to 2.21). Colonic Transit Time (CTT) scores were significantly higher when deep needling was combined with sparse wave (MD −14.36, 95% CI −18.31 to −10.41) or high-frequency dilatational wave (MD −11.53, 95% CI −19.25 to −3.81). The time of first defecation after treatment (TFD) of the shallow needling therapy was significantly longer than that of the lactulose (MD 13.67, 95% CI 5.66 to 21.67). The CCS 6 months after treatment (CCS6m) for deep needling was significantly lower than that for lactulose (MD −4.90, 95% CI −5.97 to −3.84). Moreover, the FSD 6 months after treatment (FSD6m) for shallow needling was significantly higher than that for lactulose (MD 0.49, 95% CI 0.02 to 0.97). The adverse event (AE) rate for lactulose was significantly higher than that achieved with the needling treatments, and this held true for both deep needling therapy (RR 0.41, 95% CI 0.23 to 0.72) and shallow needling therapy (RR 0.33, 95% CI 0.15 to 0.77). Conclusions. The meta-analysis demonstrates that acupuncture at ST25 appears to be more effective than lactulose in the treatment of functional constipation. This was found to be especially true for deep needling with high-frequency dilatational wave, which had a greater impact on improving CCS, FSD, CTT, and CCS6m. Additionally, acupuncture at ST25 was shown to be safer than conventional treatment, with the rate of AE being significantly lower for both deep needling and shallow needling. The trial is registered with https://www.crd.york.ac.uk/prospero/(CRD42019141017)).

scholarly journals Effectiveness of Educational Intervention on Influenza Vaccine Uptake: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
Xiaoju ZHOU ◽  
Xuequn ZHAO ◽  
Jun LIU ◽  
Wenjie YANG
Keyword(s):  
Clinical Trials ◽  
Influenza Vaccine ◽  
Publication Bias ◽  
Uptake Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Intervention Group ◽  
Vaccine Uptake ◽  
Controlled Trials ◽  
Randomized Controlled

Background: This study aimed to explore effective education method to improve influenza vaccine uptake rate. Methods: Meta-analysis of Randomized Clinical Trials was conducted in this study including subgroup analysis and publication bias test. Electronic databases comprised PubMed, EBSCO, Elsevier, Springer, Wiley, and Cochrane were searched for studies published up to Oct 8, 2019. Results: Influenza vaccination was significantly different in massages or letters intervention group (OR=1.30, 95%CI: 1.05-1.61). No heterogeneity and publication bias existed in this meta-analysis (I 2=43.60%, P=0.131, Pbegg =0.754, Pegger=0.051). Conclusion: Education by messages and letters was effective according to this study. Education messages could be more efficacy combined with easer vaccine access.

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