scholarly journals Frovatriptan for the Acute Treatment of Migraine

2011 ◽  
Vol 6 (4) ◽  
pp. 262 ◽  
Author(s):  
Peer Tfelt Hansen ◽  
Keyword(s):  
Acute Treatment ◽  
Randomised Controlled Trials ◽  
Primary Efficacy ◽  
Primary Efficacy Measure ◽  
First Choice ◽  
Headache Relief ◽  
Efficacy Measure ◽  
The Mean ◽  
Randomised Controlled ◽  
Severe Migraine

Frovatriptan 2.5 mg has been investigated for the treatment of moderate or severe migraine attacks in six placebo-controlled, randomised controlled trials (RCTs). The mean headache relief (a decrease from moderate or severe to none or mild) was 43 % after frovatriptan and 24 % after placebo. The mean therapeutic gain (active minus placebo) was 19 % (95 % confidence interval 16–22 %). In one large comparative RCT, sumatriptan 100 mg was superior to frovatriptan 2.5 mg for headache relief at two hours (47 versus 37 %). In three cross-over RCTs in which the patients treated migraine attacks as early as possible, frovatriptan 2.5 mg was quite similar to zolmitriptan 2.5 mg, rizatriptan 10 mg and almotriptan 12.5 mg for preference – the primary efficacy measure. It is concluded that frovatriptan is not the triptan of first choice in established moderate to severe migraine attacks (based on systematic reviews and one comparative RCT). However, if the patients can treat their migraine attacks at the start of an attack (and are not triptan-resistant), then frovatriptan is a reasonable treatment choice among the triptans.

Interferon-beta injection in multiple sclerosis patients is related to the induction of headache and flu-like pain symptoms: a systematic review and meta-analysis of randomised controlled trials

2021 ◽  
Vol 19 ◽  
Author(s):  
Leonardo Gomes Pereira ◽  
Gabriela Trevisan ◽  
Patrícia Rodrigues ◽  
Fernanda Tibolla Viero ◽  
Julia Maria Frare ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Adverse Effects ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
First Choice ◽  
Pain Symptoms ◽  
Randomised Controlled ◽  
Multiple Sclerosis Patients

: Multiple sclerosis (MS) is a chronic neurodegenerative, inflammatory and autoimmune disease characterised by the demyelination of the central nervous system. One of the main approaches to treating MS is the use of disease-modifying therapies (DMTs). Among the DMTs are interferons (IFNs), which are cytokines responsible for controlling the activity of the immune system, exerting immunomodulatory, antiviral, and antiproliferative activities. IFN-beta (IFN-β) is the first-choice drug used to treat relapsing-remitting MS. However, the administration of IFN-β causes numerous painful adverse effects, resulting in lower adherence to the treatment. Therefore, this study aimed to investigate the headache and flu-like pain symptoms observed after IFNβ injection in MS patients using a systematic review and meta-analysis of randomised controlled trials. The search of research databases identified 2370 articles. Nine articles were included (three involving IFNβ-1b and six involving IFNβ-1a). All studies included in the meta-analysis had a low risk of bias. Headache and flu-like pain symptoms frequency increased in MS patients treated with IFN-β. Thus, the adverse effects of headache and flu-like pain symptoms appear to be linked to IFN-β treatment in MS. The protocol of the study was registered in the Prospective International Registry of Systematic Reviews.

P332Comparative efficacy of intracoronary agents for acute treatment of coronary no-reflow: a network meta-analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Stibleichinger ◽  
J Wendt ◽  
F Hofbauer ◽  
G Klappacher
Keyword(s):  
Coronary Flow ◽  
Acute Treatment ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Secondary Outcome ◽  
No Reflow ◽  
Randomised Controlled

Abstract Background Coronary no-reflow is a potentially lethal complication of percutaneous coronary intervention (PCI). There is a growing body of evidence on how to best prevent this condition by the proper stenting technique and other mechanical measures or adjunctive drug treatments. However, it is still controversial how to tackle coronary no-reflow when it occurs. Purpose We aimed to compare and rank intracoronary agents for acute treatment of coronary no-reflow by considering both indirect and direct evidence from the literature in a network meta-analysis. Methods We searched the databases PubMed, Embase and Central for randomised controlled trials of the acute treatment of coronary no-reflow following primary PCI in patients with ST-elevation myocardial infarction (STEMI) and non-STEMI. Trials with patients suffering from stable angina and/or receiving elective PCI, observational study design and no measure of coronary flow were excluded. Two blinded reviewers independently collected studies, assessed risk of bias with the Cochrane risk of bias tool and extracted data. The primary outcome was a measure of coronary flow immediately following the intervention (TIMI flow grade, TIMI frame count or myocardial bush grade), secondary outcome were major adverse cardiovascular events during follow-up. Pairwise and network meta-analysis were performed using the random-effects model within a frequentist framework. Results 8 studies with a total of 540 participants were identified, including 4 multi-arm studies. This enabled 19 pairwise comparisons of 12 different treatments, all administered via intracoronary route (ADE=adenosine, DIL=diltiazem, DIP=dipyridamole, NIT= nitroglycerin, NPR=nitroprusside, PLA=placebo, TIR=tirofiban, U+V=urokinase combined with verapamil, URA=urapidil, URO=urokinase, VER=verapamil X+T= Xuesaitong combined with tirofiban). Overall, risk of bias in these studies was rated moderate. For graphical representation of the network for the primary outcome, see left panel of the figure. It exhibited a low level of inconsistency and heterogeneity with a global I2 value of 20.9%. Among the different treatments, URA, X+T, and TIR were more effective in re-establishing coronary flow with the caveat that the results of URA depended on one singular trail with a large variance, see right panel of the figure. NIT was even slightly worse than placebo in the primary outcome, the other agents were equivalent with placebo. In terms of major cardiovascular events during follow-up, TIR exhibited a protective effect compared with placebo at borderline statistical significance (OR 0.3843 [95% CI 0.1488; 0.9923]. For URA, data on secondary outcome were not available. Conclusions Urapidil and Tirofiban are potentially effective candidate drugs for larger randomised controlled trials, which are needed to validate the sparse evidence that is available to date on the acute treatment of coronary no-reflow.

scholarly journals Combination therapy of anabolic agents and bisphosphonates on bone mineral density in patients with osteoporosis: a meta-analysis of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e015187 ◽  
Author(s):  
Shenghan Lou ◽  
Houchen Lv ◽  
Zhirui Li ◽  
Licheng Zhang ◽  
Peifu Tang
Keyword(s):  
Combination Therapy ◽  
Femoral Neck ◽  
Randomised Controlled Trials ◽  
Mineral Density ◽  
Anabolic Agents ◽  
Total Hip ◽  
Optimal Period ◽  
Full Period ◽  
The Mean ◽  
Randomised Controlled

ObjectiveWe aimed to determine whether the concomitant combination therapy of anabolic agents and bisphosphonates produces more effects on bone mineral density (BMD) than anabolic agents alone in patients with osteoporosis.MethodsWe searched MEDLINE, EMBASE and the Cochrane Library for publications from 1 January 1980 to 1 August 2016 to identify all the randomised controlled trials (RCTs) and quasi-RCTs. The primary outcome was the mean per cent changes in BMD at the lumbar spine, the total hip and the femoral neck with an optimal period of treatment (6 to 12 months). The secondary outcome was the mean per cent changes in BMD at the same sites with the full period of recommendation (18 to 24 months). A random-effects model was used to estimate the standardised mean differences (SMDs) and the 95% CIs.ResultsSeven studies, with 747 patients, were included. With the optimal period, the concomitant combination therapy demonstrated a significant advantage over a monotherapy in BMD improvement at the total hip (SMD 0.42; 95% CI 0.26 to 0.58) and the femoral neck (SMD 0.30; 95% CI 0.14 to 0.46), but not for the spine BMD (SMD 0.13; 95% CI −0.17 to 0.43). With the full period, the concomitant combination therapy did not improve the BMD at the lumbar spine (SMD −0.06; 95% CI −0.71 to 0.59), the total hip (SMD 0.05; 95% CI −0.71 to 0.82) and the femoral neck (SMD −0.32; 95% CI −1.15 to 0.50).ConclusionsCompared with anabolic monotherapy, the concomitant combination therapy of anabolic agents and bisphosphonates significantly improved the BMD at the total hip and femoral neck with a shorter term (6 to 12 months) and produced similar benefits on BMD for the longer term (18 to 24 months). Also, the effect of concomitant combination therapy might be affected by the dose of anabolic agents.PROSPERO registration numberCRD42016041335.

FC03-04 - Lamotrigine treatment of acute alcohol hallucinosis comorbid depersonalizations disorders: A randomimized double-blind, placebo-controlled study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1825-1825 ◽  
Author(s):  
N. Aliyev ◽  
A.A. Aliyev ◽  
Z.N. Aliyev ◽  
A. Aliyev
Keyword(s):  
Controlled Study ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Parallel Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Primary Efficacy Measure ◽  
Efficacy Measure ◽  
Alcohol Hallucinosis ◽  
Icd 10

AimsWe compared the efficacy and safety of lamotrigine versus placebo for the treatment of acute alcohol hallucinosis comorbid depersonalization disorders.Methods10 days, randomized, double-blind, parallel study. A total of 40 patients with an ICD-10 diagnosis of acute alcohol hallucinosis comorbid depersonalization disorders were randomized to lamotrigine 300 mg/d (n = 40), or placebo (n = 40). The primary efficacy measure was the PANSS subscale for hallucinosis and Cambridge Depersonalization Scale (CDS).ResultsIamotrigine treated patients demonstrated a statistically significant greater improvement in PANSS subscale for hallucinosis and CDS than placebo-treated patients.ConclusionLamotrigine demonstrated greater efficacy than placebo in treatment of acute hallucinosis comorbid depersonalization disorders and was generally well tolerated.

scholarly journals Parenteral dexamethasone for acute severe migraine headache: meta-analysis of randomised controlled trials for preventing recurrence

BMJ ◽  
2008 ◽  
Vol 336 (7657) ◽  
pp. 1359-1361 ◽  
Author(s):  
Ian Colman ◽  
Benjamin W Friedman ◽  
Michael D Brown ◽  
Grant D Innes ◽  
Eric Grafstein ◽  
...  
Keyword(s):  
Migraine Headache ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Severe Migraine

scholarly journals A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017462 ◽  
Author(s):  
Anthony Chauvin ◽  
David Moher ◽  
Doug Altman ◽  
David L Schriger ◽  
Sabina Alam ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Cross Sectional Study ◽  
Early Career ◽  
Sectional Study ◽  
Cross Sectional ◽  
Online Tool ◽  
Peer Reviewers ◽  
The Mean ◽  
Randomised Controlled ◽  
Completeness Of Reporting

IntroductionSystematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports.Methods and analysisThis is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals,BMJ,BMJ OpenandAnnals of Emergency Medicineand indexed with the publication type ‘Randomised Controlled Trial’. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers.Ethics and disseminationThe research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent.Trial registration numberNCT03119376.

scholarly journals A RANDOMIZED CONTROLLED TRIAL OF CURCUMIN AND DICLOFENAC COMBINATION IN KNEE OSTEOARTHRITIS

2019 ◽  
pp. 111-114 ◽  
Author(s):  
DHANESHWAR SHEP ◽  
CHITRA KHANWELKAR ◽  
PRAKASHCHANDRA GADE ◽  
SATYANAND KARAD
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Primary Efficacy ◽  
Inclusion Criteria ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Primary Efficacy Measure ◽  
Efficacy Measure ◽  
Laboratory Investigations ◽  
To Receive

Objective: The objective of the study was to evaluate pain relief and safety of the combination of curcumin and diclofenac versus diclofenac alone in the treatment of knee osteoarthritis (OA). Methods: 140 patients of knee OA meeting inclusion criteria were randomized to receive either curcumin 500 mg with diclofenac 50 mg twice daily or diclofenac 50 mg tablet al. one twice daily for 28 d. Patients were assessed at baseline, Day 14 and Day 28. Primary efficacy measure was severity of pain (VisualAnalogue Scale) at day 14 and day 28. Safety after treatment was evaluated by recording side effects and laboratory investigations. Results: Patients receiving curcumin plus diclofenac showed significantly superior improvement in severity of pain at each study visit (p<0.001) when compared to diclofenac. Adverse effects were significantly less in the curcumin plus diclofenac group (p<0.001). Conclusion: Combination of curcumin and diclofenac showed a significant improvement in pain on the basis of VAS when compared to diclofenac which may be due to the synergistic effect between curcumin and diclofenac

scholarly journals Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

2021 ◽  
pp. svn-2021-001070
Author(s):  
Nawaf Yassi ◽  
Henry Zhao ◽  
Leonid Churilov ◽  
Bruce C V Campbell ◽  
Teddy Wu ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Sample Size ◽  
Phase Ii ◽  
Intracerebral Haemorrhage ◽  
Absolute Difference ◽  
Primary Efficacy ◽  
Double Blind ◽  
Stroke Units ◽  
Primary Efficacy Measure ◽  
Efficacy Measure

RationaleHaematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth.Methods and designStopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework.HypothesisIn patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimatesA sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.InterventionParticipants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo.Primary efficacy measureThe primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.DiscussionWe describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.

scholarly journals Impact of low-carbohydrate diet on renal function: a meta-analysis of over 1000 individuals from nine randomised controlled trials

2016 ◽  
Vol 116 (4) ◽  
pp. 632-638 ◽  
Author(s):  
Chikako Oyabu ◽  
Yoshitaka Hashimoto ◽  
Takuya Fukuda ◽  
Muhei Tanaka ◽  
Mai Asano ◽  
...  
Keyword(s):  
Renal Function ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Control Diet ◽  
Controlled Trials ◽  
Carbohydrate Diet ◽  
Low Carbohydrate Diet ◽  
Low Carbohydrate ◽  
The Mean ◽  
Randomised Controlled

AbstractWe aimed to clarify the effect of low-carbohydrate diet (LCD) on renal function in overweight and obese individuals without chronic kidney disease (CKD). Literature searches were performed using EMBASE, MEDLINE and Cochrane Library until December 2015. We selected articles that reported human studies from their inception until December 2015 in English using the following searching terms: ‘Low carbohydrate diet’ AND (‘Clinical trial’ OR ‘Clinical study’ OR ‘Clinical investigation’ OR ‘Observational study’ OR ‘Cohort study’). We compared the effects of LCD on renal function, defined as change in estimated glomerular filtration rate (eGFR), assessed in randomised-controlled trials. We calculated the mean change in eGFR and the mean change in standard deviations by eGFR or creatinine clearance, and compared the mean change in eGFR and standard deviations in LCD with those in the control diet using fixed-effects models. We selected nine randomised controlled trials including 1687 participants (861 were fed LCD and 826 were fed the control diet). The mean change in eGFR in the LCD group was −4·7 to 24·0 ml/min per 1·73 m2 and that in the control diet group was −4·1 to 10·8 ml/min per 1·73 m2. The mean change in eGFR in the LCD group was greater than that in the control diet (0·13 ml/min per 1·73 m2; 95 % CI 0·00, 0·26). In the present meta-analysis, we identified that the increase in eGFR was greater in LCD compared with the control diet in overweight and obese individuals without CKD.

scholarly journals Immobilisation in external rotation after first-time traumatic anterior shoulder instability reduces recurrent instability: a meta-analysis

2020 ◽  
pp. jisakos-2020-000511
Author(s):  
Eoghan T Hurley ◽  
Jordan W Fried ◽  
Michael J Alaia ◽  
Eric J Strauss ◽  
Laith M Jazrawi ◽  
...  
Keyword(s):  
Internal Rotation ◽  
Shoulder Dislocation ◽  
Randomised Controlled Trials ◽  
External Rotation ◽  
Rate Of Return ◽  
Controlled Trials ◽  
Anterior Shoulder Dislocation ◽  
The Mean ◽  
Randomised Controlled ◽  
First Time

ImportanceCadaveric and MRI findings have demonstrated significantly less labral separation and displacement when the shoulder is placed in external rotation as compared with internal rotation.ObjectiveThe purpose of the current study is to meta-analyse the randomised controlled trials in the literature to compare immobilisation in external versus internal rotation after first-time anterior shoulder dislocation.Evidence reviewA literature search of MEDLINE, EMBASE and the Cochrane Library was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomised controlled trials comparing immobilisation in external rotation versus internal rotation for first-time anterior shoulder dislocation were included.FindingsNine randomised controlled trials with 795 patients were included. The mean age of included patients was 29 years, 82.4% were male and the mean follow-up was 25.5 months. As compared with immobilisation in internal rotation, compliance was significantly higher (74.5% vs 67.4%, p=0.01), and the rate of recurrent dislocations was significantly lower (22.2% vs 33.4%, p=0.02) with immobilisation in external rotation. Additionally, in patients 20–40 years old the rate of recurrent dislocations was significantly lower in those treated with immobilisation in external rotation than internal rotation (12.1% vs 31.4%, p=0.006). Immobilisation in external rotation also resulted in a higher rate of return to preinjury level of play (60.1% vs 42.6%, p=0.0001).Conclusions and relevanceImmobilisation of the shoulder in external rotation after a traumatic first-time anterior shoulder dislocation results in a higher compliance rate, a lower recurrent dislocation rate and a higher rate of return to play as compared with immobilisation in internal rotation.Level of evidenceLevel I.

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