Randomized clinical trials in oncology stopped early for benefit (RCTSEB)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6039-6039 ◽  
Author(s):  
E. Segota ◽  
H. P. Soares ◽  
B. Djulbegovic ◽  
A. Kumar ◽  
D. Bassler ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Guidelines ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Hematologic Malignancies ◽  
True Positive ◽  
Inclusion Criteria ◽  
Early Results ◽  
Cancer Guidelines ◽  
The Impact

6039 Background: Randomized clinical trials (RCT) that stop earlier than planned because of apparent benefit often receive great attention. However, how often these early results get confirmed by other subsequent meta-analysis/randomized studies, and how often results get included in clinical guidelines is not known. We conducted systematic review of oncologic RCTSEB to further determine if the results from RCTSEB are confirmed by the subsequent studies and/or included in guidelines. Methods: RCT of any intervention reported as having stopped early because of the results favoring the intervention were previously identified (JAMA.2005;294:2203).Trials with interventions in prevention and treatment of solid and hematologic malignancies were included for this review. Citation search was conducted by two reviewers to identify meta-analysis (MA), systematic reviews (SR) and RCTs that used similar trial design as the RCTSEB. National Comprehensive Cancer Guidelines were reviewed to identify the impact of the results on recommendations on clinical practice. Results: 33 trials were identified, and 5 were excluded because they did not fit the inclusion criteria. MA/SR were available for the assessment of interventions reported in 15/28 RCTSEB. Results of subsequent MA confirmed 12/15 findings, while 3 trials were contradicted. Of the remaining 13 trials, for 7 there was at least one subsequent RCT identified. 6/7 were confirmed as beneficial in the subsequent RCTs and 1 was contradicted. For 6/28 RCTSEB we did not find any subsequent MA/SR/RCTS. We also looked at the inclusion of interventions from RCTSEB in the clinical guidelines. 18/28 interventions from RCTSEB were mentioned in the formulation of clinical guidelines.16/18 were recommended as true positive recommendations. The other 2 interventions which were addressed in the guidelines were either not confirmed (n = 1) or incorrectly recommended (n = 1). Conclusions: In this set of oncology of RCTSEBs the findings were subsequently confirmed in 64% (18/28) cases. Guidelines developers used 2/28 (7%) of RCTSEB for which reliable confirmatory data were available. However, caution should be applied in the interpretation of our results because the same RCTSEB was also included in confirmatory MAs which possibly could have introduced bias. No significant financial relationships to disclose.

Abstract 2391: Impact of Therapies for Anemia on Outcomes in Patients with Heart Failure in Randomized Clinical Trials

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Howard M Julien ◽  
Preetika Muthukrishnan ◽  
Eldrin F Lewis
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Ejection Fraction ◽  
Serum Creatinine ◽  
Exercise Capacity ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
The Impact

Anemia is common in heart failure (HF) patients and has been well-established as a risk factor for increased risk of HF hospitalization and mortality. Treatment with erythropoietin stimulating agents (ESA) has increased hemoglobin, but outcomes trials are limited and use of ESA has been controversial given disparate results in other populations. This meta-analysis aimed to evaluate the impact of ESA and iron on outcomes in HF patients. A systematic review of four databases was conducted in April 2008 (n = 95 unique trials). Analysis inclusion criteria included randomized controlled trial to ESA/iron with clinically defined HF, yielding 10 eligible trials published between 6/01–3/08. Data was independently extracted and cross-checked for accuracy and reliability (2 investigators). A total of 768 subjects (421 treated and 338 controls) are included (Characteristics in Table 1 ). Randomization to ESA produced a significant improvement in exercise capacity 0.39 standard units [95% CI 0.1– 0.6, p = 0.001], a 5.72% [95% CI 1.2–10.3, p = 0.014] increase in left ventricle ejection fraction and a 0.23 mg/dL [95% CI 0.4 – 0.1 p = 0.001] reduction in serum creatinine. There was no difference in all-cause mortality - RR 0.79 [95% CI 0.49, 1.26, p = 0.320]. Trends were noted in reduced hospitalization rates, decreased brain natriuretic peptide, and improved quality of life. Meta-analysis of randomized studies of treatment of anemia in HF patients suggests significant benefit in exercise capacity, left ventricular ejection fraction, and serum creatinine. There does not appear to be excess mortality with ESA/iron treatment. Despite favorable findings, definitive randomized clinical trials are needed to assess the role of this treatment modality in HF management. Table 1. Baseline Patient and Study Characteristics

scholarly journals Acupuncture Treatments for Post-stroke Depression: A Systematic Review and Network Meta-analysis

2021 ◽  
Author(s):  
Lam Wai Ching ◽  
Hui Juan Li ◽  
Jianwen Guo ◽  
Liang Yao ◽  
Janita Chau ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Depression Symptoms ◽  
Post Stroke ◽  
Significant Difference ◽  
Post Stroke Depression ◽  
The Impact

Abstract Background: Depression is one of the most common complications after stroke, with a prevalence of 30-33%. Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. In this review, we aimed to explore the impact of acupuncture in alleviating symptoms of PSD and to evaluate the difference in effectiveness between acupuncture combined with pharmacotherapies and various non-pharmacotherapies in order to provide guides and advice for clinical personnel. Methods: Six databases (Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang Database, Chongqing VIP Database) and two clinical trials registration platforms were searched from inception to May 2021. Randomized clinical trials (RCTs) comparing needle-based acupuncture with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies. Two reviewers independently abstracted and recorded data into a pre-made form. A Bayesian network meta-analysis (NMA) was conducted to assess and compare different techniques using RStudio 3.6.0. The primary outcome was the change in scores of scales measuring depressive symptoms. The secondary outcomes were changes in serotonin levels and in quality of life. Results: Fifty-nine RCTs were included. The results of this NMA showed that compared with western medicine (WM), acupuncture alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, acupuncture alone or plus other therapies could significantly decrease scores of the Hamilton Depression Rating scale. However, there was no significant difference found among acupuncture, WM, TCM with AC plus any of other treatment.Conclusions: The results of this study indicate that acupuncture alone or combined with other therapies appear to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison with WM, acupuncture alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms. Also, acupuncture with RTMS seems to be the most effective with the highest probability.

Efficacy of acupuncture in the management of fatigue related to breast cancer antineoplastic treatment: a systematic review

2019 ◽  
Vol 9 (2) ◽  
pp. 264-272
Author(s):  
Ana Carolina Moraes Costa ◽  
Alena Peixoto Medrado
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
Total Sample ◽  
Inclusion Criteria ◽  
Antineoplastic Treatment

INTRODUCTION: Breast cancer is the most prevalent cancer among women worldwide. Similar to chemotherapy, antineoplastic treatment is associated with many side effects, with fatigue being one of the most common. It is important to investigate potential treatments, especially non-pharmacological alternatives, to control symptoms that directly affect women’s quality of life. OBJECTIVE: The objective of this study was to provide scientific evidence to verify the efficacy of acupuncture in the management of fatigue in patients with breast cancer. METHODS: This study involved a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) methodology. Randomized clinical trials published in indexed scientific journals were compiled. The literature search was performed using the electronic databases, PubMed, PEDro, and BIREME, using the descriptors ‘breast cancer’, ‘fatigue’, ‘acupuncture’, and ‘randomized trial’. Inclusion criteria included fully available online articles that were classified as randomised clinical trials published from 2012 to 2017 in either English or Portuguese. Study eligibility was based on the Population, Intervention, Control, Outcome, and Study (PICO) design criteria, in which the (1) population included women 18–65 years of age with breast cancer, (2) intervention was acupuncture, (3) comparison referred to standard care or sham acupuncture, and (4) outcome was the evaluation of fatigue. The PEDro scale was applied to evaluate the quality of the studies. WebQualis was also used to evaluate the quality of the journals of the selected articles. RESULTS: In total, 66 articles were selected, but only four fulfilled all inclusion criteria, giving a total sample size of 620 women. All trials evaluated the effect of acupuncture on fatigue and other symptoms related to the treatment of breast cancer with different treatment durations. Three articles reported statistically significant results, and all articles described clinical improvement in fatigue after the application of acupuncture. The average PEDro score of the manuscripts was 6.25. All articles were published in non-Brazilian journals with WebQualis scores that ranged from B2 to A1. CONCLUSION: Scientific evidence confirms the efficacy of acupuncture in the management of fatigue reported by women with breast cancer. Acupuncture was effective in reducing fatigue in the studies selected for this review.

Systematic review and meta-analysis of randomized clinical trials appraising the impact of cilostazol after percutaneous coronary intervention

2008 ◽  
Vol 155 (6) ◽  
pp. 1081-1089 ◽  
Author(s):  
Giuseppe G.L. Biondi-Zoccai ◽  
Marzia Lotrionte ◽  
Matteo Anselmino ◽  
Claudio Moretti ◽  
Pierfrancesco Agostoni ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Percutaneous Coronary Intervention ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Percutaneous Coronary ◽  
The Impact

Terlipressin for Hepatorenal Syndrome: A Meta-Analysis of Randomized Trials

2009 ◽  
Vol 32 (3) ◽  
pp. 133-140 ◽  
Author(s):  
Fabrizio Fabrizi ◽  
Vivek Dixit ◽  
Piergiorgio Messa ◽  
Paul Martin
Keyword(s):  
Clinical Trials ◽  
Renal Function ◽  
Hepatorenal Syndrome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Significant Heterogeneity ◽  
End Point ◽  
Study Results ◽  
The Impact

Background Hepatorenal syndrome (HRS) is a severe complication of end-stage renal disease whose management still constitutes a big challenge. Various approaches have been used for hepatorenal syndrome treatment, including vasoconstrictor therapy. Terlipressin, a vasopressin analogue, has frequently been used. Aim To evaluate the efficacy and safety of terlipressin in patients with HRS by performing a systematic review with a meta-analysis of controlled, clinical trials. Methods Only prospective, placebo-controlled, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird, with heterogeneity and subgroups analyses. The primary end-point of interest was the HRS reversal after terlipressin (or placebo) therapy in study patients vs. control patients (as a measure of efficacy). The secondary outcome was the rate of ischemic side-effects in study patients vs. placebo patients (as a measure of tolerability). The additional end-point was the impact of terlipressin on survival in the HRS population. Results We identified five studies involving 243 unique patients with HRS. Pooling of study results showed a significant increase in HRS reversal among study (terlipressin) versus control (placebo) patients; the pooled odd ratio (OR) of HRS reversal was 8.09; 95% CI, 3.521; 18.59; p=0.0001. The p-value was 0.5 for our test of study heterogeneity. In a subgroup analysis excluding case-control trials these results did not change. The rate of severe ischemic events was higher in study than control patients, pooled OR=2.907; 95% CI, 1.094; 7.723 (p=0.032). The test for heterogeneity was not significant. Terlipressin use had no significant impact upon survival (pooled OR for survival rate, 2.064; 95% CI, 0.939; 4.538; p=0.07). No significant heterogeneity (NS) was found. Conclusions Our meta-analysis shows that terlipressin has higher efficacy than placebo in reversing renal function in the HRS population. There was no apparent impact of terlipressin therapy on survival in HRS patients but further large-size trials are needed. Terlipressin use in the HRS population requires careful selection of patients and close clinical surveillance. These results support the use of terlipressin for reversal of renal function in the HRS population.

Effect of Pycnogenol on Blood Pressure: Findings From a PRISMA Compliant Systematic Review and Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled, Clinical Studies

Angiology ◽  
2019 ◽  
Vol 71 (3) ◽  
pp. 217-225 ◽  
Author(s):  
Federica Fogacci ◽  
Giuliano Tocci ◽  
Amirhossein Sahebkar ◽  
Vivianne Presta ◽  
Maciej Banach ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Randomized Clinical Trials ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Impact

Results of previous clinical trials evaluating the effect of pycnogenol supplementation on blood pressure (BP) are controversial. Therefore, we aimed to assess the impact of pycnogenol on BP through a systematic review of literature and meta-analysis of available randomized, double-blind, placebo-controlled clinical studies (randomized clinical trials [RCTs]). Literature search included SCOPUS, PubMed-Medline, ISI Web of Science, and Google Scholar databases up to January 10, 2019 to identify RCTs investigating the impact of pycnogenol on BP. Two investigators independently extracted data on study characteristics, methods, and outcomes. This systematic review and meta-analysis is registered in International Prospective Register of Systematic Reviews (PROSPERO) under number CRD42018112172. Overall, the impact of pycnogenol on BP was reported in 7 trials involving 626 participants. Meta-analysis did not suggest any significant improvement in systolic BP (weighted mean difference [WMD]: −0.028 mm Hg; 95% confidence interval [CI]: −0.182 to 0.127; P = .726; I2 = 46%), diastolic BP (WMD: −0.144 mm Hg; 95% CI: −0.299 to 0.010; P = .067; I2 = 0%), mean arterial pressure (WMD: −0.091 mm Hg; 95% CI: −0.246 to 0.063; P = .246; I2 = 0%), and pulse pressure (WMD: −0.003 mm Hg; 95% CI: −0.151 to 0.158; P = .966; I2 = 0%) following pycnogenol treatment. Results persisted in the leave-one-out sensitivity analysis. Therefore, the present meta-analysis does not suggest any significant effect of pycnogenol on BP.

scholarly journals Religious and spiritual interventions in mental health care: a systematic review and meta-analysis of randomized controlled clinical trials

2015 ◽  
Vol 45 (14) ◽  
pp. 2937-2949 ◽  
Author(s):  
J. P. B. Gonçalves ◽  
G. Lucchetti ◽  
P. R. Menezes ◽  
H. Vallada
Keyword(s):  
Mental Health ◽  
Systematic Review ◽  
Health Care ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Extensive Literature ◽  
Spiritual Interventions ◽  
Comparison Groups ◽  
The Impact

Background.Despite the extensive literature assessing associations between religiosity/spirituality and health, few studies have investigated the clinical applicability of this evidence. The purpose of this paper was to assess the impact of religious/spiritual interventions (RSI) through randomized clinical trials (RCTs).Method.A systematic review was performed in the following databases: PubMed, Scopus, Web of Science, PsycINFO, Cochrane Collaboration, Embase and SciELO. Through the use of a Boolean expression, articles were included if they: (i) investigated mental health outcomes; (ii) had a design consistent with RCTs. We excluded protocols involving intercessory prayer or distance healing. The study was conducted in two phases by reading: (1) title and abstracts; (2) full papers and assessing their methodological quality. Then, a meta-analysis was carried out.Results.Through this method, 4751 papers were obtained, of which 23 remained included. The meta-analysis showed significant effects of RSI on anxiety general symptoms (p < 0.001) and in subgroups: meditation (p < 0.001); psychotherapy (p = 0.02); 1 month of follow-up (p < 0.001); and comparison groups with interventions (p < 0.001). Two significant differences were found in depressive symptoms: between 1 and 6 months and comparison groups with interventions (p = 0.05). In general, studies have shown that RSI decreased stress, alcoholism and depression.Conclusions.RCTs on RSI showed additional benefits including reduction of clinical symptoms (mainly anxiety). The diversity of protocols and outcomes associated with a lack of standardization of interventions point to the need for further studies evaluating the use of religiosity/spirituality as a complementary treatment in health care.

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