Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis

Abstract Aims The difference in the benefit of invasive cardiovascular interventions compared with placebo controls has not been analysed systematically. Methods and results MEDLINE and Web of Science were searched through 29 March 2020. Randomized, placebo-controlled trials of invasive cardiovascular interventions (including catheter-based interventions and pacemaker-like devices) investigating predefined primary outcomes were included. Standardized mean differences (SMD) and odds ratios were calculated for continuous and dichotomous outcomes, respectively. Meta-regression analyses were performed to assess whether estimates of treatment effects were associated with methodological characteristics of trials. Thirty trials, including 4102 patients, were analysed. The overall risk of bias was judged to be low in only 43% of the trials. Ten trials (33%) demonstrated statistically significant superiority of invasive interventions over placebo controls for the respective predefined primary outcomes. In almost half of the 16 trials investigating continuous predefined primary outcomes, the SMD between the active and placebo procedure indicated a small (n = 4) to moderate (n = 3) treatment effect of active treatment over placebo. In contrast, one trial indicated a small treatment effect in favour of the placebo procedure. In the remaining trials, there was no relevant treatment effect of active treatment over placebo. In trials with a protocol-mandated stable and symmetrical use of co-interventions, the superiority of active procedures vs. invasive placebo procedures was significantly larger as compared with trials with frequent or unbalanced changes in co-interventions (P for interaction 0.027). Conclusions The additional treatment effect of invasive cardiovascular interventions compared with placebo controls was small in most trials.

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Abstract P082: Racial Disparities in Stroke Recovery: A Large Study Versus Meta-Analysis

Circulation ◽

10.1161/circ.135.suppl_1.p082 ◽

2017 ◽

Vol 135 (suppl_1) ◽

Author(s):

Pratik Y Chhatbar ◽

Hernan Bayona ◽

Yujing Zhao ◽

Bruce Ovbiagele ◽

Wuwei Feng ◽

...

Keyword(s):

Racial Disparities ◽

Wide Spectrum ◽

Meta Analysis ◽

Functional Independence ◽

Stroke Recovery ◽

Change Scores ◽

Data Heterogeneity ◽

The Difference ◽

Mean Differences ◽

Time Of Admission

Background: It is well known that Blacks have a higher stroke-related mortality compared to their White counterparts, but evidence on the influence of Black race on recovery after a stroke is not apparent. Objective: To verify our understanding on post-stroke rehabilitation trends between Blacks and Whites with the use of systematic review and meta-analysis. Methods: We performed literature search for cohort studies that investigated racial variation issues in stroke motor recovery between January 1970 and March 2016, in which outcome was measured by Functional Independence Measures (FIM) scale. We compared change scores (the difference score between discharge and admission) or endpoint scores (at the time of admission and discharge) as well as length of stay in days between Whites and Blacks by calculating standardized mean differences (Hedge’s g ) to derive a summary effect size. Random Effects model was used to account for data heterogeneity. Results: We identified 7 studies with a total 152,421 subjects, of which one influential study (Ottenbacher et al, 2008) offered a significant weight with 148,871 subjects. So, we performed meta-analysis on the remaining 6 studies (black diamond on the Figure ) and compared the results with this influential study (maroon square on the Figure ). We found that Blacks have higher FIM scores at admission and discharge, but poor change FIM scores, despite their shorter stay (about ¾ day) in rehab facility when compared to Whites. Our results contrasted findings of Ottenbacher et al. , which did not report change scores, that Whites have higher FIM scores at admission and discharge in spite of their comparable rehab facility stay. Conclusions: This meta-analysis identifies a significant evidence gap for current understanding of racial disparities in stroke recovery. At AHA SFRN WISSDOM (Wide spectrum Investigation of Stroke Outcome Disparities on Multiple Levels) center, we aim to address this gap by first-hand analyses of multiple datasets in the near future.

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Should syndesmotic screws be removed or retained? A meta-analysis

10.21203/rs.3.rs-17528/v1 ◽

2020 ◽

Author(s):

Wanjin Qin ◽

Peng Yang ◽

Nanning Lv ◽

Kaiwen Chen ◽

Huilin Yang ◽

...

Keyword(s):

Clinical Outcomes ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Search Terms ◽

Central Register ◽

Significant Difference ◽

The Difference ◽

Mean Differences ◽

American Orthopaedic

Abstract Background The aim of this study was to evaluate the different clinical outcomes after removing or retaining syndesmotic screws, and the difference in clinical outcomes after retaining broken or loose syndesmotic screws was also evaluated. Methods A systematic literature search was performed using PubMed, Web of Science, EMBASE and the Cochrane Central Register of Controlled Trials. In this meta-analysis, we conducted online searches using the search terms “syndesmotic diastasis”, “syndesmotic injury”, “syndesmotic screw”, “syndesmotic fixation”, and “tibiofibular syndesmosis”. The analysis was performed on individual patient data from all the studies that met the selection criteria. Clinical outcomes were expressed as standard mean differences for continuous outcomes with 95% confidence intervals. Heterogeneity was assessed using the Chi 2 test and the I 2 statistic. Results There were 2 randomized controlled trials (RCTs) and 6 observational articles included in this analysis. In the comparison between retained and removed screws and the comparison between broken or loose and removed screws, no significant difference was found in terms of visual analogue scale (VAS), Olerud-Molander Ankle Score (OMAS) and American Orthopaedic Foot and Ankle Society (AOFAS) ankle/hindfoot score. Broken or loose screws were associated with better AOFAS scores compared with removed or intact screws, and no significant difference was found in terms of VAS and OMAS scores. Conclusions According to our analysis, there was no significant difference in clinical outcomes between removed and retained screws. Broken or loose screws were not associated with bad functional outcomes and may even lead to better function compared with removed or retained screws.

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Differences of energy expenditure while sitting versus standing: A systematic review and meta-analysis

European Journal of Preventive Cardiology ◽

10.1177/2047487317752186 ◽

2018 ◽

Vol 25 (5) ◽

pp. 522-538 ◽

Cited By ~ 21

Author(s):

Farzane Saeidifard ◽

Jose R Medina-Inojosa ◽

Marta Supervia ◽

Thomas P Olson ◽

Virend K Somers ◽

...

Keyword(s):

Systematic Review ◽

Energy Expenditure ◽

Energy Content ◽

Meta Analysis ◽

Experimental Studies ◽

Final Analysis ◽

Ovid Medline ◽

The Difference ◽

Mean Differences

Background Replacing sitting with standing is one of several recommendations to decrease sedentary time and increase the daily energy expenditure, but the difference in energy expenditure between standing versus sitting has been controversial. This systematic review and meta-analysis aimed to determine this difference. Designs and methods We searched Ovid MEDLINE, Ovid Embase Scopus, Web of Science and Google Scholar for observational and experimental studies that compared the energy expenditure of standing versus sitting. We calculated mean differences and 95% confidence intervals using a random effects model. We conducted different predefined subgroup analyses based on characteristics of participants and study design. Results We identified 658 studies and included 46 studies with 1184 participants for the final analysis. The mean difference in energy expenditure between sitting and standing was 0.15 kcal/min (95% confidence interval (CI) 0.12–0.17). The difference among women was 0.1 kcal/min (95% CI 0.0–0.21), and was 0.19 kcal/min (95% CI 0.05–0.33) in men. Observational studies had a lower difference in energy expenditure (0.11 kcal/min, 95% CI 0.08–0.14) compared to randomised trials (0.2 kcal/min, 95% CI 0.12–0.28). By substituting sitting with standing for 6 hours/day, a 65 kg person will expend an additional 54 kcal/day. Assuming no increase in energy intake, this difference in energy expenditure would be translated into the energy content of about 2.5 kg of body fat mass in 1 year. Conclusions The substitution of sitting with standing could be a potential solution for a sedentary lifestyle to prevent weight gain in the long term. Future studies should aim to assess the effectiveness and feasibility of this strategy.

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Efficacy and safety of lavender essential oil (Silexan) capsules among patients suffering from anxiety disorders: A network meta-analysis

Scientific Reports ◽

10.1038/s41598-019-54529-9 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 2

Author(s):

Wuan Shuen Yap ◽

Anton V. Dolzhenko ◽

Zahraa Jalal ◽

Muhammad Abdul Hadi ◽

Tahir Mehmood Khan

Keyword(s):

Essential Oil ◽

Treatment Effect ◽

Meta Analysis ◽

Anxiolytic Effect ◽

Efficacy And Safety ◽

Weighted Mean ◽

Efficient Treatment ◽

League Tables ◽

Hamilton Anxiety Scale ◽

Mean Differences

AbstractA systematic review and network-meta analysis (NMA) were performed to estimate significance of the anxiolytic effect of lavender essential oil taken as silexan capsules versus other comparators (i.e., placebo/paroxetine/lorazepam). The outcome of interest was Hamilton Anxiety Scale (HAMA). Weighted mean differences (WMD) were calculated to estimate the treatment effect at the confidence interval of 95%. League tables were generated using treatment effect, for all pairwise comparisons, where WMD < 0 favors the column-defining treatment. Five studies were identified with a total of 524 participants receiving treatment with silexan 80 mg and 121 participants taking silexan 160 mg. The NMA results indicated that consumption of silexan 160 mg resulted in higher decline of HAMA score [WMD −1.14 (−1.10, 3.39)] in comparison to silexan 80 mg, placebo [−2.20 (−4.64, 0.24)] and paroxetine [−1.24 (−5.34, 2.85)]. The effect of silexan 80 mg was observed to be same as that of paroxetine. Overall, silexan 160 mg was noticed to be a more efficient treatment giving significant decline in HAMA score across other comparators. However, no improvements in HAMA score was observed for the group receiving lorazepam 0.5 mg when compared to silexan 160 mg, silexan 80 mg, paroxetine 20 mg, and placebo.

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Detecting heterogeneity of intervention effects using analysis and meta-analysis of differences in variance between arms of a trial

10.1101/2020.03.07.20032516 ◽

2020 ◽

Author(s):

Harriet L Mills ◽

Julian PT Higgins ◽

Richard W Morris ◽

David Kessler ◽

Jon Heron ◽

...

Keyword(s):

Meta Analysis ◽

Potential Effect ◽

Individual Characteristics ◽

Single Trial ◽

Heterogeneous Effects ◽

The Difference ◽

Mean Differences ◽

Randomised Controlled ◽

Meta Analyses ◽

Summary Data

AbstractRandomised controlled trials (RCTs) with continuous outcomes usually only examine mean differences in response between trial arms. If the intervention has heterogeneous effects (e.g. the effect of the intervention differs by individual characteristics), then outcome variances will also differ between arms. However, power of an individual trial to assess heterogeneity is lower than the power to detect the same size of main effect. The aim of this work was to describe and implement methods for examining heterogeneity of effects of interventions, in trials with individual patient data (IPD) and also in meta-analyses using summary data. Several methods for assessing differences in variance were applied using IPD from a single trial, and summary data from two meta-analyses.In the single trial there was agreement between methods, and the difference in variance was largely due to differences in depression at baseline. In two meta-analyses, most individual trials did not show strong evidence of a difference in variance between arms, with wide confidence intervals. However, both meta-analyses showed evidence of greater variance in the control arm, and in one example this was perhaps because mean outcome in the control arm was higher.Low power of individual trials to examine differences in variance can be overcome using meta-analysis. Evidence of differences in variance should be followed-up to identify potential effect modifiers and explore other possible causes such as varying compliance.

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Stump Invagination Versus Simple Ligation in Open Appendicectomy: A Systematic Review and Meta-Analysis

International Surgery ◽

10.9738/intsurg-d-15-00074.1 ◽

2015 ◽

Vol 100 (7-8) ◽

pp. 1199-1206 ◽

Cited By ~ 1

Author(s):

Daohai Qian ◽

Zhigang He ◽

Jie Hua ◽

Zhenshun Song

Keyword(s):

Meta Analysis ◽

Clinical Results ◽

Fixed Effect Model ◽

Postoperative Recovery ◽

Cochrane Library ◽

Open Appendicectomy ◽

Stump Closure ◽

The Difference ◽

Mean Differences ◽

The Cochrane Library

The aim of this meta-analysis was to compare the superiority of stump closure between stump invagination (SI) and simple ligation (SL) during open appendicectomy (OA). The literature searching was conducted in MEDLINE, EMBASE, the Cochrane Library, and http://scholar.google.com. Available data was extracted by 3 independent reviewers. The clinical outcomes were analyzed by meta-analytic software to compare the difference between 2 methods during OA. The pooled odds ratios (ORs) and weighted mean differences (WMDs) with 95% confidence intervals (95% CIs) were obtained by using fixed effect model. Eleven randomized controlled trials (RCTs) were finally included in this study involving 2634 patients. Postoperative pyrexia and infections were similar between SL and SI groups, respectively, but the former group had a shorter operative time (WMD: 8.72; 95% CI: 6.87–10.56; P < 0.00001); less incidence of postoperative ileus (WMD: 2.02; 95% CI: 1.36–3.01; P = 0.0005); and quicker postoperative recovery (WMD: 0.30; 95% CI: 0.11–0.48; P = 0.002). The above results were based on 5, 11, 4, 11, and 9 articles, respectively. The clinical results revealed that SL was significantly superior to SI. SL should be suggested during OA.

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Effect of chlorhexidine chip as an adjunct in non-surgical management of periodontal pockets: a meta-analysis

BMC Oral Health ◽

10.1186/s12903-020-01247-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lili Ma ◽

Xiuchun Diao

Keyword(s):

Clinical Outcomes ◽

Chronic Periodontitis ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Pocket Depth ◽

Probing Pocket Depth ◽

The Difference ◽

Mean Differences ◽

Microbiological Assays ◽

Attachment Level

Abstract Background The aim of this meta-analysis was to evaluate the difference in treatment outcomes between sub-gingival placement of chlorhexidine chip (CHX chip) in adjunct to scaling and root planing (SRP) and SRP alone for the management of periodontal pockets in patients suffering from chronic periodontitis. Methods We searched the MEDLINE (PubMed), SCOPUS and CENTRAL databases and identified 15 randomized clinical trials published within the last decade (2007–2019): 9 with split-mouth design and 6 with parallel study design. We extracted data and performed both qualitative and quantitative syntheses. The primary outcomes assessed were gain in clinical attachment level (CAL), reduction in probing pocket depth (PPD), improvement in gingival inflammation, and results of microbiological assays. Results We used meta-analysis plots to assess all the clinical outcomes. The mean differences in PPD reductions at 1 month (MD 0.63), 3 months (MD 0.69), and 6 months (MD 0.75); and the CAL gains at 1 month (MD 0.54), 3 months (MD 0.64), and 6 months (MD 0.68) showed more favorable responses in sites treated with the CHX chip as an adjuvant to SRP, than in sites treated with SRP alone. Conclusion SRP with adjunctive CHX chips showed better clinical outcomes than SRP alone for the management of periodontal pockets in patients with chronic periodontitis.

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A trial of sepia 200

British Homeopathic Journal ◽

10.1016/s0007-0785(05)80713-6 ◽

1995 ◽

Vol 84 (01) ◽

pp. 14-20 ◽

Cited By ~ 4

Author(s):

A.V. Williamson ◽

W.J. Crawford ◽

B. Rennie ◽

W.L. Mackie

Keyword(s):

Reproductive Performance ◽

Disease Risk ◽

Controlled Trial ◽

Mean Value ◽

Post Treatment ◽

Placebo Control ◽

Control Groups ◽

Placebo Controls ◽

Group Data ◽

The Difference

AbstractThe effect of Sepia 200c on the reproductive performance of Friesian cross dairy cows was assessed in a controlled trial from September 1989 until August 1990. Overall reproductive performance was monitored monthly and pregnancy diagnosis and cyclical status was determined. The cows were randomly allocated to 4 groups, untreated controls, placebo controls, Sepia-treated 24 to 48 hours postpartum and Sepia-teated day 14 postpartum.The trial was concluded in July 1990 when another treatment was employed to reduce declining herd reproductive status. Statistical analysis of the results was based on differences between the placebo control and the Sepia-treated, 24–48 hours postpartum, the pooled control groups and placebo control with Sepia day 14, and lastly the difference between the 2 Sepia-treated groups.The highest rates of periparturient disease occurred in the Sepia-treated groups, the highest single incidence rate of periparturient disease risk (cysts) found in the cows in the Sepia 24 to 48 hours postpartum group. Sepia day 14 produced the largest percentage of cows seen in first oestrus (45%), the largest number of observed heats (60%) in the cows without periparturient disease risk factors or recurrent traits and the lowest total mean value days to oestrus post-treatment.Sepia day 14 produced the largest percentage that held to first service, the lowest post-treatment period to first service, calving to conception interval, mean number of services and rectal examinations per conception, mean day calving interval and calving index. The results show that the effect of Sepia 200c administered to cows two weeks postpartum increased the numbers of cows observed in first oestrus, held to first service and lowered the calving to conception interval and calving index. The results of the Sepia day 14 postpartum group were also found to be compatible with the same group data reported in the previous study.

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Dental caries and preterm birth: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2017-018556 ◽

2018 ◽

Vol 8 (3) ◽

pp. e018556 ◽

Cited By ~ 9

Author(s):

Madhu Wagle ◽

Francesco D’Antonio ◽

Eirik Reierth ◽

Purusotam Basnet ◽

Tordis A Trovik ◽

...

Keyword(s):

Systematic Review ◽

Preterm Birth ◽

Dental Caries ◽

Meta Analysis ◽

Random Effect ◽

Primary Objective ◽

Case Control Studies ◽

The Difference ◽

Mean Differences ◽

Meta Analyses

ObjectivesThe primary objective of this systematic review was to evaluate the association between dental caries and preterm birth (PTB). The secondary objective was ascertaining the difference between women with dental caries who experienced PTB and those who did not with regard to decayed, missing and filled teeth (DMFT), and decayed, missing and filled surfaces (DMFS) indices.MethodsMEDLINE, Embase, CINAHL and Cochrane databases were searched initially in November 2015 and repeated in December 2016. We included observational cohort and case–control studies. Only studies reporting the risk of PTB in women affected compared with those not affected by dental caries in pregnancy were included. Random-effect meta-analyses were used to compute the summary OR of PTB among women with caries versus women without caries, and the mean difference in either DMFT or DMFS indices between women experiencing PTB and those without PTB.ResultsNine observational studies (4826 pregnancies) were included. Women affected by dental caries during pregnancy did not show a significantly higher risk of PTB (OR: 1.16, 95% CI 0.90 to 1.49, P=0.25, I2=35%). Also, the women with PTB did not show significantly higher DMFT or DMFS indices (summary mean differences: 1.56, P=0.10; I2=92% and −0.15, P=0.9, I2=89%, respectively).ConclusionDental caries does not appear to be a substantial risk factor for PTB.Trial registration numberNCT01675180; Pre-results.

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Should syndesmotic screws be removed or retained? A meta-analysis

10.21203/rs.3.rs-17528/v2 ◽

2020 ◽

Author(s):

Wanjin Qin ◽

Peng Yang ◽

Nanning Lv ◽

Kaiwen Chen ◽

Huilin Yang ◽

...

Keyword(s):

Clinical Outcomes ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Search Terms ◽

Central Register ◽

Significant Difference ◽

The Difference ◽

Mean Differences ◽

American Orthopaedic

Abstract Background The aim of this study was to evaluate the different clinical outcomes after removing or retaining syndesmotic screws, and the difference in clinical outcomes after retaining broken or loose syndesmotic screws was also evaluated.Methods A systematic literature search was performed using PubMed, Web of Science, EMBASE and the Cochrane Central Register of Controlled Trials. In this meta-analysis, we conducted online searches using the search terms “syndesmotic diastasis”, “syndesmotic injury”, “syndesmotic screw”, “syndesmotic fixation”, and “tibiofibular syndesmosis”. The analysis was performed on data from all the studies that met the selection criteria. Clinical outcomes were expressed as standard mean differences for continuous outcomes with 95 % confidence intervals. Heterogeneity was assessed using the Chi2 test and the I2 statistic.Results There were 2 randomized controlled trials (RCTs) and 6 observational articles included in this analysis. In the comparison between retained and removed screws and the comparison between broken or loose and removed screws, no significant difference was found in terms of visual analogue scale (VAS), Olerud-Molander Ankle Score (OMAS) and American Orthopaedic Foot and Ankle Society (AOFAS) ankle/hindfoot score. Broken or loose screws were associated with better AOFAS scores compared with removed or intact screws, and no significant difference was found in terms of VAS and OMAS scores.Conclusions According to our analysis, there was no significant difference in clinical outcomes between removed and retained screws. Broken or loose screws were not associated with bad functional outcomes and may even lead to better function compared with removed or retained screws.

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