Efficacy and Safety of Galantamine Hydrobromide in the Treatment of Mild to Moderate Dementia

2010 ◽  
Vol 2 ◽  
pp. CMT.S5884
Author(s):  
Mark Oremus ◽  
Pasqualina Santaguida ◽  
Parminder Raina
Keyword(s):  
Daily Living ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Disease Course ◽  
Efficacy And Safety ◽  
Screening Process ◽  
Global Function ◽  
Randomized Controlled ◽  
Moderate Dementia

We conducted a systematic review and meta analysis of randomized controlled trials of galantamine hydrobromide in the treatment of mild to moderate dementia. Following a literature search and screening process, we included 15 trials and five companion papers in the review. Moderate-quality evidence suggested galantamine-treated persons generally had better outcomes than placebo-treated persons after a maximum 6-month follow-up. Outcome domains included cognitive function, global function, behaviour and mood, and activities of daily living. The evidence requires careful interpretation because ‘better outcomes’ can mean less deterioration, rather than improvement, relative to placebo. Galantamine has not been shown to halt dementia progression nor reverse disease course. The most frequently reported harms were nausea, diarrhea, and dizziness. Reported rates of these harms were highly variable (range, 0%–40%); reporting was at high risk of bias because authors rarely specified the frequency or timing of harms assessment, nor did they report active methods of collecting harms.

scholarly journals Risk of malignancies in patients with spondyloarthritis treated with biologics compared with those treated with non-biologics: a systematic review and meta-analysis

2020 ◽  
Vol 12 ◽  
pp. 1759720X2092569
Author(s):  
Yu Heng Kwan ◽  
Ka Keat Lim ◽  
Warren Fong ◽  
Hendra Goh ◽  
Linkai Ng ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Interleukin 17 ◽  
Randomized Controlled ◽  
Risk Of Malignancy ◽  
Meta Analyses ◽  
Analytical Approaches

Background: The aim of our study was to synthesize evidence on the occurrence of malignancy in spondyloarthritis (SpA), from randomized controlled trials (RCTs) comparing biologics with non-biologics and biologics to each other. Methods: We systematically searched Medline, Cochrane Library, EMBASE, Scopus and ClinicalTrials.gov from inception until 31 October 2018. RCTs with ⩾24-week follow-up were included. We extracted data using standardized forms and assessed the risk of bias using the Cochrane Risk of Bias Tool. We performed pair-wise meta-analyses and network meta-analyses to compare the risk of malignancy for each biologics class and SpA type. We reported the Peto odds ratio (OR) of any malignancy along with 95% confidence intervals (95% CI). Bayesian posterior probabilities comparing risk of malignancy of each biologic class with non-biologics were computed as supplementary measures. Results: Fifty-four trials were included; most (44/54) had follow-up <1 year. Among 14,245 patients, 63 developed a malignancy. While most Peto ORs were >1, they had wide 95% CI and p >0.05. The overall Peto OR comparing biologics with non-biologics was 1.42 (95% CI 0.80–2.53). Only interleukin-17 inhibitors in peripheral SpA had p <0.05 (Peto OR 2.77, 95% CI 1.07–7.13); the posterior probability that the risk was higher than non-biologics was 98%. Stratified analyses revealed no consistent trend by prior exposure to biologics, duration of follow-up, study quality, study-arm crossover, analytical approaches and type of malignancy. Conclusions: Our findings indicate no overall elevated risk of malignancy with biologics in SpA. As our meta-analyses are unable to conclude on the long-term risk, long-term pharmacovigilance of biologics in SpA may still be warranted.

scholarly journals Efficacy and Safety of Shengmai Injection for Chronic Heart Failure: A Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Yanping Wang ◽  
Xu Zhou ◽  
Xiaofan Chen ◽  
Fei Wang ◽  
Weifeng Zhu ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Chronic Heart Failure ◽  
Western Medicine ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Shengmai Injection ◽  
Randomized Controlled

Background. Shengmai injection (SMI) is made from purified ginseng, Radix Ophiopogonis, and Schisandra chinensis. It has cardiotonic effects and is clinically used for the adjuvant treatment of chronic heart failure (CHF). However, its efficacy and safety are uncertain. The purpose of this study was to systematically evaluate the existing efficacy and safety evidence in randomized controlled trials (RCTs) that studied SMI for the treatment of CHF. Methods. PubMed, Embase, Cochrane Library, clinicaltrials.gov, CNKI, Wanfang, VIP, and CBM databases were searched up to September 10, 2019. RCTs that compared basic Western medicine treatment with SMI + basic Western medicine were included. The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias in the RCTs. The meta-analysis used the random effects model; the mean difference (MD) and 95% confidence intervals (CIs) were combined using the inverse variance method, and the Mantel–Haenszel method was used to combine the relative risk (RR) and 95% CIs. Heterogeneity was assessed using I2 and Q tests, and the source of heterogeneity was explored by analyzing three preset subgroup hypotheses. Results. A total of 20 RCTs were included (n = 1562), with a moderate-to-high risk of bias. The meta-analysis showed that, compared with Western medicine alone, SMI adjuvant therapy significantly improved cardiac function indicators, including left ventricular ejection fraction (MD 6.8%, 95% CI 4.68 to 8.91), stroke volume (MD 9.81 ml, 95% CI 5.67 to 13.96), cardiac output (MD 0.96 L/min, 95% CI 0.66 to 1.25), and cardiac index (MD 0.53 L/min, 95% CI 0.36 to 0.70); heterogeneity was generally high among these outcomes. Compared with the controls, patients receiving SMI adjuvant therapy also had a higher response to treatment (RR 2.89, 95% CI 2.10 to 3.99; I2 = 0%), a greater decrease in brain natriuretic peptide levels (MD −284.66 ng/l, 95% CI −353.73 to −215.59, I2 = 0%), and a greater increase in six‐minute walk test performance (MD 70.67 m, 95% CI 22.92 to 118.42; I2 = 84%). Nine studies reported mild adverse events, such as gastrointestinal reactions, and no serious adverse events were reported. Conclusion. Currently, available evidence indicates that SMI, as an adjuvant for basic Western medicine treatment, can improve the cardiac function of patients with CHF with good safety outcomes. Because of the high risk of bias among the included RCTs and the large heterogeneity of partial outcomes, the findings of this study must be verified by high-quality studies with large sample sizes.

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

scholarly journals Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

2021 ◽  
Vol 15 ◽  
Author(s):  
Xinglin Ruan ◽  
Fabin Lin ◽  
Dihang Wu ◽  
Lina Chen ◽  
Huidan Weng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Dopamine Agonists ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Motor Fluctuations ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Troublesome Dyskinesia

Background: Movement fluctuations are the main complication of Parkinson's disease (PD) patients receiving long-term levodopa (L-dopa) treatment. We compared and ranked the efficacy and safety of dopamine agonists (DAs) with regard to motor fluctuations by using a Bayesian network meta-analysis (NMA) to quantify information from randomized controlled trials (RCTs).Methods and Findings: We carried out a systematic review and meta-analysis, and only RCTs comparing DAs for advanced PD were included. Electronic databases (PubMed, Embase, and Cochrane Library) were systematically searched for relevant studies published until January 2021. Two reviewers independently extracted individual study data and evaluated studies for risk of bias using the Cochrane Risk of Bias tool. Network meta-analyses using a Bayesian framework were used to calculate the related parameters. The pre-specified primary and secondary outcomes were efficacy (“ON” time without troublesome dyskinesia, “OFF” time, “ON” time, “UPDRS-III,” and “UPDRS-II”) and safety [treatment-emergent adverse events (TEAE) and other adverse events] of DAs. The results are presented as the surface under the cumulative ranking (SUCRA) curve. A total of 20 RCTs assessing 6,560 patients were included. The general DA effects were ranked from high to low with respect to the amount of “ON” time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%).Conclusions: This network meta-analysis shows that apomorphine increased “ON” time without troublesome dyskinesia and decreased “OF” time for advanced PD patients. The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased “ON” time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD.

scholarly journals Therapeutic efficacy of alternative primaquine regimens to standard treatment in preventing relapses by Plasmodium vivax: A systematic review and meta-analysis

2015 ◽  
pp. 183-191 ◽  
Author(s):  
Lina Marcela Zuluaga Idarraga ◽  
Maria Eulalia Tamayo Perez ◽  
Daniel Camilo Aguirre Acevedo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Relative Risk ◽  
Fixed Effects ◽  
Standard Treatment ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Efficacy And Safety ◽  
Standard Regimen

Objective: To compare efficacy and safety of primaquine regimens currently used to prevent relapses by P. vivax. Methods: A systematic review was carried out to identify clinical trials evaluating efficacy and safety to prevent malaria recurrences by P. vivax of primaquine regimen 0.5 mg / kg / day for 7 or 14 days compared to standard regimen of 0.25 mg/kg/day for 14 days. Efficacy of primaquine according to cumulative incidence of recurrences after 28 days was determined. The overall relative risk with fixed-effects meta-analysis was estimated. Results: For the regimen 0.5 mg/kg/day/7 days were identified 7 studies, which showed an incidence of recurrence between 0% and 20% with follow-up 60-210 days; only 4 studies comparing with the standard regimen 0.25 mg/kg/day/14 days and no difference in recurrences between both regimens (RR= 0.977, 95% CI= 0.670 to 1.423) were found. 3 clinical trials using regimen 0.5 mg/kg/day/14 days with an incidence of recurrences between 1.8% and 18.0% during 330-365 days were identified; only one study comparing with the standard regimen (RR= 0.846, 95% CI= 0.484 to 1.477). High risk of bias and differences in handling of included studies were found. Conclusion: Available evidence is insufficient to determine whether currently PQ regimens used as alternative rather than standard treatment have better efficacy and safety in preventing relapse of P. vivax. Clinical trials are required to guide changes in treatment regimen of malaria vivax.

Efficacy of Pharmacotherapy for Smoking Cessation in Adolescent Smokers: A Meta-analysis of Randomized Controlled Trials

2018 ◽  
Vol 21 (11) ◽  
pp. 1473-1479 ◽  
Author(s):  
Seung-Kwon Myung ◽  
Joo-Young Park
Keyword(s):  
Smoking Cessation ◽  
Meta Analysis ◽  
Abstinence Rate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Adolescent Smokers ◽  
Meta Analyses

Abstract Introduction This study aimed to evaluate the efficacy of pharmacotherapy for smoking cessation among adolescent smokers by using a meta-analysis of randomized controlled trials (RCTs). Methods PubMed, EMBASE, and Cochrane Library were searched from the inception to January 20, 2018. We included RCTs of pharmacotherapy for smoking cessation among adolescent smokers aged less than 20 years. Data were pooled using a random-effects meta-analysis. The primary outcome measures were a smoking abstinence rate and its relative risk (RR) at the longest follow-up period in each study validated by biochemical markers. Results Among a total of 1035 articles searched, nine RCTs, which involved 1188 adolescent smokers aged 12–20 years with 627 in the intervention group and 561 in the control group, were included in the final analysis. In the random-effects meta-analysis of all the nine trials, pharmacotherapy showed a increased abstinence rate (RR = 1.62; 95% confidence interval [CI] = 1.08 to 2.44, I2 = 0.0%), compared with the control group. Subgroup meta-analyses by follow-up period showed an increased abstinence rate at 4 weeks (RR = 1.87; 95% CI = 1.22 to 2.87; n = 4) and a nonsignificantly increased abstinence rate during the longer term follow-up periods at 8, 12, 24, and 52 weeks. Conclusions The current meta-analysis suggests that pharmacotherapy can be considered as an aid for smoking cessation in the short-term period among adolescent smokers. However, further large RCTs are warranted to determine its long-term efficacy and safety. Implications In this meta-analysis of nine RCTs with 1188 adolescent smokers aged 12–20 years, pharmacotherapy showed an increased abstinence rate, compared with the control group. In the subgroup meta-analyses by follow-up period, it showed the increased abstinence rate at 4 weeks and no efficacy on abstinence during the longer term follow-up periods up to 52 weeks. Further large RCTs are warranted to determine the long-term efficacy and safety of pharmacotherapy in adolescent smokers.

scholarly journals Efficacy and Safety of Bevacizumab in the Treatment of Pterygium: An Updated Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Yi Sun ◽  
Bowen Zhang ◽  
Xiuhua Jia ◽  
Shiqi Ling ◽  
Juan Deng
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Complication Rates ◽  
Efficacy And Safety ◽  
Conjunctival Autograft ◽  
Randomized Controlled ◽  
Significant Difference

Purpose. Studies investigating efficacy and safety of bevacizumab in pterygium have increased and reported controversial results. Thus, we updated this meta-analysis to clarify the issue. Methods. Studies were selected through search of the databases Embase, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) from their inception up until June 2017. The pooled risk ratio (RR) and 95% confidence interval (CI) were calculated for recurrence and complication rates by using random effects model. Results. 1045 eyes in 18 randomized controlled trials (RCTs) enrolled. Overall, the pooled estimate showed a statistically significant effect of bevacizumab on the reduction of recurrence (RR 0.74, 95% CI 0.56–0.97, P=0.03). Subgroup analyses presented significant results beneficial to bevacizumab (primary pterygium group, RR 0.53, 95% CI 0.33–0.83, P=0.006; conjunctival autograft group, RR 0.48, 95% CI 0.25–0.91, P=0.02; and follow-up longer than 12 months group, RR 0.36, 95% CI 0.13–0.99, P=0.05). No statistically significant difference was observed in complication rates. Conclusions. Application of bevacizumab showed a statistically significant decrease in recurrence rate following removal of primary pterygia, or in cases with conjunctival autograft, or with follow-up longer than 12 months, while complications were not increased.

scholarly journals Efficacy and Safety of Safflower Yellow in Early Diabetic Nephropathy: A Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Xiuze Jin ◽  
Liuyan Shi ◽  
Feng Chang ◽  
Yun Lu
Keyword(s):  
Conventional Therapy ◽  
Urinary Albumin Excretion ◽  
Meta Analysis ◽  
Fasting Blood Glucose ◽  
Effective Rate ◽  
Urinary Albumin ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Excretion Rates

Background. Diabetic nephropathy (DN) is a major cause of end-stage renal disease. In order to palliate renal function impairment and reduce kidney related mortality, it is crucial to treating DN patients at the early stage. This study aims to assess the efficacy and safety of conventional therapy combined with safflower yellow versus conventional therapy alone in early DN patients. Methods. A meta-analysis of randomized controlled trials that compared safflower yellow plus conventional therapy with conventional therapy alone in early DN patients was conducted. Papers were searched using the electronic databases and reference lists. Two reviewers working independently extracted relevant data and carried out risk-of-bias assessments. Statistical analysis was undertaken in Review Manager 5.3. Results. Fourteen trials (1,072 patients) were included in the meta-analysis. Conventional therapy combined with safflower yellow was associated with a higher effective rate (RD, 0.24; 95% CI, 0.17 to 0.30) and a greater decline in urinary albumin excretion rates (SMD, -1.34; 95% CI, -1.77 to -0.92), fasting blood glucose (MD, -0.57; 95% CI, -0.98 to -0.16), serum creatinine (MD, -12.36; 95% CI, -14.66 to -10.06), and blood urea nitrogen (SMD, -0.93; 95% CI, -1.13 to -0.73) in the subgroup with a follow-up time > 15 days. The incidence of adverse events did not differ significantly between these two regimens (RD, -0.01; 95% CI, -0.03 to 0.01). Findings were similar in the subgroup with a follow-up time < 15 days. Conclusions. Conventional therapy combined with safflower yellow had a more beneficial effect than conventional therapy alone in early DN patients. There were significant differences in effective rate, urinary albumin excretion rates, fasting blood glucose, serum creatinine, and blood urea nitrogen between the two regimens and no significant difference in adverse events. More randomized controlled research using standardized protocols would be needed in the future to compare these two regimens.

scholarly journals The efficacy and safety of compound glycyrrhizin combined with desloratadine in the treatment of chronic urticaria: protocol for a systematic review of randomized controlled trials

2020 ◽  
Author(s):  
Qiuyue Wang ◽  
Xingxin Hu ◽  
Mao Li ◽  
Qian Luo ◽  
Pingsheng Hao
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Chronic Urticaria ◽  
Meta Analysis ◽  
Effective Rate ◽  
Risk Of Bias ◽  
Biomedical Literature ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Chronic urticaria (CU) is a common skin disease characterized by a short-term (<24 hours) spontaneous skin rash (urticaria) with or without angioedema that lasts longer than 6 weeks. CU is not life-threatening but has been shown to have a significant impact on the physical and mental health of patients. Because of chronic itching or physical discomfort in patients with CU, symptoms such as the repeated occurrence of red, swollen, itchy, anxiety, insomnia, and psychological stress are prone to occur. Whereas, there is no related systematic review and meta-analysis. Thus, this systematic review protocol aims to describe a systematic review and meta-analysis to testify the efficacy and safety of compound glycyrrhizin (CG) combined with desloratadine in the treatment of CU.Methods: Our systematic review will search all randomized controlled trials (RCTs) for CG combined with desloratadine in the treatment of CU, electronically and manually, regardless of publication status and language, until January 14, 2020. Databases include PubMed, EMBASE, Web of Science, Cochrane Controlled Trials Register (CENTRAL), China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), Chinese Science Journal Database (VIP Database) and Wanfang database. Other sources, including reference lists of identified publications and meeting minutes, will also be searched. Manually search for grey literature, including unpublished conference articles. The main outcomes contain the total effective rate, the urticaria activity score (UAS), Itching score, the chronic urticaria quality of life questionnaire (CU-Q2oL), or other validated symptom scores and the effective rate and adverse events from baseline to the end of studies. This study will provide a comprehensive review of the available evidence for the treatment of CU with this therapy. We will assess the risk of bias with the Cochrane Risk of Bias Tool, narratively synthesize the extracted data and conduct a meta-analysis of studies with similar characteristics. Two independent raters will screen articles and assess the risk of bias.Discussion: This study will provide a high-quality synthesis of the effects of compound glycyrrhizin (CG) combined with desloratadine in the treatment of CU. We hope that this review will give more convincing proof to assist clinicians during the decision-making process when dealing with CU.Systematic review registration: PROSPERO CRD42020165478

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